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Rogue virus in the vaccine: Early polio vaccine harbored virus now feared to cause cancer in humans
San Francisco Chronicle - Sunday, July 15, 2001
William Carlsen, Chronicle Staff Writer
A growing number of medical researchers fear that a monkey virus that contaminated polio vaccine given to tens of millions of Americans in the 1950s and '60s may be causing rare human cancers. For four decades, government officials have insisted that there is no evidence the simian virus called SV40 is harmful to humans. But in recent years, dozens of scientific studies have found the virus in a steadily increasing number of rare brain, bone and lung-related tumors - the same malignant cancer SV40 causes in lab animals.
Even more troubling, the virus has been detected in tumors removed from people never inoculated with the contaminated vaccine, leading some to worry that those infected by the vaccine might be spreading SV40. The discovery of SV40 in human tumors has generated intense debate within the scientific community, pitting a handful of government health officials, who believe that the virus is harmless, against researchers from Boston to China who now suspect SV40 may be a human carcinogen. At stake are millions of research dollars and potential medical treatments for those afflicted with the cancers SV40 may be causing.
In April, more than 60 scientists met in Chicago to discuss the controversial virus and how it works to defeat certain cells' natural defenses against cancer.
"I believe that SV40 is carcinogenic (in humans)," said Dr. Michele Carbone of Loyola University Medical Center in Maywood, Ill. "We need to be creating therapies for people who have these cancers, and now we may be able to because we have a target - SV40." But scientists at the National Cancer Institute say their studies show almost no SV40 in human tumors and no cancer increase in people who received the contaminated vaccine. "No one would dispute there's been a widespread, very scary exposure to the population of potentially cancer-causing virus," said Dr. Howard Strickler, NCI's chief investigator. "But none of our studies and other major analyses have shown an inkling of an effect on the population."
Critics charge, however, that the few studies done by the government are scientifically flawed and that health officials have downplayed the potential risks posed by SV40 ever since they learned in 1961 that the virus contaminated the polio vaccine and caused tumors in rodents. "How long can the government ignore this?" asked Dr. Adi Gazdar, a University of Texas Southwestern Medical Center cancer researcher. "The government has not sponsored any real research. Here's something possibly affecting millions of Americans, and they're indifferent.
"Maybe they don't want to find out."
The recent SV40 discoveries come at a time of growing concern over the dangers posed by a range of animal viruses that have crossed the species barrier to humans, including HIV, which scientists now believe came from chimpanzees and ultimately caused the AIDS epidemic. Based on dozens of interviews and a review of the medical research, this is the story of how the campaign to eradicate polio may have inadvertently permitted another potentially deadly monkey virus to infect millions of people - and why the government for years discounted the accumulating evidence suggesting that SV40 may be a health risk for humans.
Polio epidemic, 1955
During the first half of the 20th century, polio struck down hundreds of thousands of people, leaving many paralyzed - some in iron lung machines - and killing others. The worst year was 1952, when more than 57,000 polio cases were reported in the United States. Three thousand died. Then on April 12, 1955, Dr. Jonas Salk, a slightly built, soft-spoken researcher from Pittsburgh, mounted the podium at the University of Michigan and announced that he had developed a vaccine. That afternoon, the government licensed the vaccine for distribution.
Salk's vaccine was made by growing live polio virus on kidney tissue from Asian rhesus monkeys. The virus was then killed with formaldehyde. When the vaccine was injected in humans, the dead virus generated antibodies capable of fending off live polio. Dr. Dwight Murray, then chairman of the American Medical Association, called Salk's announcement "one of the greatest events in the history of medicine." Within weeks, the stockpiled vaccine was being injected into the arms of millions of people worldwide.
Virus and the tumors, 1959
Four years later, Bernice Eddy, a researcher at the National Institutes of Health, noticed something strange while looking through her microscope. Monkey kidney cells - the same kind used to make the vaccine - were dying without apparent cause. So she tried an experiment. She prepared kidney extracts from eight to 10 rhesus monkeys and injected tiny amounts under the skin of 23 newborn hamsters. Within nine months, "large, malignant, subcutaneous tumors" appeared on 20 of the animals.
On July 6, 1960, concerned that a monkey virus might be contaminating the polio vaccine, Eddy took her findings to Dr. Joseph Smadel, chief of the NIH's biologics division. Smadel dismissed the tumors as harmless "lumps." The same year, however, at a Merck laboratory in Pennsylvania, Dr. Maurice Hilleman and Dr. Ben Sweet isolated the virus. They called it simian virus 40, or SV40, because it was the 40th virus found in rhesus kidney tissue.
Immunization campaign, 1961
By then, the nation was winning the war against polio. Nearly 98 million Americans - more than 60 percent of the population - had received at least one injection of the Salk vaccine, and the number of cases was plummeting.
At the same time, an oral polio vaccine developed by virologist Albert Sabin was in final trials in Russia and Eastern Europe, where tens of millions had been inoculated, and it was about to be licensed in the United States. Unlike the Salk vaccine, the oral version contained a live but weakened form of polio virus and promised lifelong immunity.
But U.S. Public Health Service officials were worried. Tests had found SV40 in both the Sabin and Salk vaccines - it was later estimated that as much as a third of the Salk vaccine was tainted - and that SV40 was causing cancer in lab animals. In early 1961, they quietly met with the agency's top vaccine advisers. The agency found no evidence that the virus had been harmful to humans, but in March, the officials ordered manufacturers to eliminate SV40 from all future vaccine.
New procedures were adopted to neutralize the tainted polio virus seed stock and SV40-free African green monkeys were used to produce the bulk vaccine instead of rhesus monkeys. But officials did not recall contaminated Salk vaccine - more than a year's supply - still in the hands of the nation's doctors. And they did not notify the public of the contamination and SV40's carcinogenic effect on newborn hamsters.
Hilleman would later explain that government officials were worried that any potentially negative information could ignite a panic and jeopardize the vaccination campaign. The first public disclosure that the Salk vaccine was contaminated came in the New York Times on July 26, 1961. A story on Page 33 reported that Merck and other manufacturers had halted production until they could get a "monkey virus" out of the vaccine. When asked to comment, the U.S. Public Health Service stressed there was no evidence the virus was dangerous.
No cause for alarm, 1962
The next year, a young Harvard-trained epidemiologist named Dr. Joseph Fraumeni joined the National Cancer Institute and was assigned one of the agency's most important projects: to determine if there was any cancer increase among those injected with the Salk vaccine. His research would form the basis of the government's position for decades. Working with two colleagues, Fraumeni tested stored vaccine samples from May and June of 1955, the first months of the national immunization campaign, then ranked the samples according to how much SV40 they contained - no, low or high amounts.
It would be the only time U.S. health officials measured the level of SV40 in the 1955-1962 vaccine. Stored samples from that period were later discarded. Fraumeni identified the states where the SV40-contaminated vaccines had been distributed during those two months. California, for example, received vaccine with a low level of the virus.
The study looked at cancer mortality rates for 6- to 8-year-old children vaccinated during that narrow time frame, tracking the group for four years. The findings, which were published in the Journal of the American Medical Association, showed no significant difference in cancer deaths in states with high or low levels of SV40 in the vaccine when compared with cancer deaths in states with no SV40 in the vaccine.
Cleveland children, 1976
Fourteen years later, after isolated reports linking the virus and human cancers, Fraumeni decided to look at another group that had received contaminated vaccine. The group had been the subject of experiments conducted in the early 1960s at Cleveland Metropolitan General Hospital. To determine the effect of different amounts of the vaccines, researchers at the hospital inoculated newborns from mostly lower-income black families with doses ranging up to more than 100 times the dose recommended for adults.
The experiments took place over three years and involved 1,073 infants. Most were given Sabin oral vaccine later determined to contain SV40. From 1976 to 1979, Fraumeni and his associates sent letters to the children - now age 17 to 19 - but fewer than half responded. The researchers found no SV40-related health problems from exposure to contaminated vaccine.
However, their 1982 report published in the New England Journal of Medicine acknowledged the study's limitations: A majority of the children had not responded; SV40-related cancers might take longer than 17 to 19 years to develop, and SV40 appears less likely to infect humans through the oral vaccine.
Nevertheless, they called their findings "reassuring and consistent with the prevailing view that SV40 is not carcinogenic in human beings." Then they decided to end the study, citing "the mounting complexities and obstacles in tracing this particular group and the negative results to date." The study's closure appeared to end the government's research into the virus. But a few years later there would be a tectonic shift in SV40 research.
First discovery, 1988
In Boston, two researchers stumbled onto something disturbing. Dr. Robert Garcea and his assistant, Dr. John Bergsagel, were using a powerful new tool called polymerase chain reaction, or PCR, to look for a pair of common human viruses in children's brain tumors. But a different DNA footprint kept popping up in more than half the tumors. They finally realized they were seeing SV40.
For more than a decade, scientists had reported sporadic findings of SV40- like proteins in human tumors. But the earlier tests were primitive and the results suspect. PCR, however, is capable of amplifying infinitesimal fragments of DNA, which makes detections far more credible. The findings were troubling. The researchers noted in their published report that the children were too young to have received the contaminated vaccine. But somehow the virus had infected them and embedded itself in their tumors.
Mesothelioma, 1988
That same year, Dr. Michele Carbone was surprised to find a milky, rind like tumor in a laboratory hamster at the National Institutes of Health in Bethesda, Md. The animal was one of a group given an SV40 injection directly into their hearts. Sixty percent of those hamsters developed the fatal cancer called mesothelioma.
Carbone, a postdoctoral fellow at the institute, knew that SV40 caused tumors in hamsters but only in specific locations where large doses of virus were injected. Here the mesothelial membrane lining the lungs apparently became cancerous from minuscule amounts of SV40 shed by the tip of the needle on the way to the hamsters' hearts. So he tried another experiment, this time injecting SV40 directly into the thin mesothelial walls of another group of hamsters. Within six months, every animal developed mesothelioma.
Carbone was puzzled. Mesothelioma is a rare cancer. Few human cases were reported before the 1950s, but its incidence had been increasing steadily, reaching several thousand cases a year in the United States by 1988. Studies had linked mesothelioma to asbestos exposure - with tumors usually appearing many decades later. Yet 20 percent of victims had no asbestos exposure. Carbone decided to use PCR to test 48 human mesotheliomas stored at the NIH. He was stunned: 28 of them contained SV40.
More cancers, 1996
PCR unleashed a wave of SV40 discoveries.
By the end of 1996, dozens of scientists reported finding SV40 in a variety of bone cancers and a wide range of brain cancers, which had risen 30 percent over the previous 20 years. Then, Italian researchers reported finding SV40 in 45 percent of the seminal fluid samples and 23 percent of the blood samples they had taken from healthy donors. That meant SV40 could have been spreading through sexual activity, from mother to child, or by other means, which could explain how those never inoculated with the contaminated vaccine, such as the Boston children, were being infected.
Government assurances, 1996
At the National Cancer Institute in Bethesda, officials were growing increasingly concerned about the SV40 discoveries. The findings were of particular interest to Fraumeni, who had been promoted to director of NCI's Division on Cancer Epidemiology and Genetics. His earlier studies concluding that SV40 posed little or no health risk were now under challenge.
But the scientific community was skeptical of the recent SV40 discoveries. As a potent carcinogen in lab animals, SV40 had been used for years as a tool to study cancer. Therefore, the powerful PCR test was suspected of finding stray SV40 fragments that might have contaminated laboratories.
So Dr. Howard Strickler, one of Fraumeni's epidemiologists, led a study using PCR on 50 mesotheliomas from Armed Forces hospitals across the country. And he found no SV40. Although the findings bolstered the government's long-standing position that SV40 did not appear to be a health risk, federal officials decided to convene a conference on the virus. In January 1997, 30 scientists gathered at the National Institutes of Health in Maryland. Garcea, Carbone and others presented their evidence showing SV40 in tumors and pleaded for research funding.
Strickler presented his mesothelioma study, as well as new research he had just completed, this time working with Fraumeni. Their new study compared 20 years of cancer rates of people born between 1947 and 1963, and therefore likely to have been exposed to the contaminated polio vaccine, with people born after 1963, who they believed weren't exposed.
Their study found no significant difference between the two groups.
Letter of protest, 1998
But when Susan Fisher read Strickler and Fraumeni's study in the Journal of the American Medical Association, she fired off a letter of protest to the publication. An epidemiologist at Loyola University Medical Center in Maywood, Ill., Fisher challenged the study's methodology, calling it "an error in judgment" and misleading. Using the same 20-year national cancer database for the two groups, Fisher compared people of the same age - "because these cancers are highly correlated with age" - and she came up with very different results.
Studying 18- to 26-year-olds who probably had been exposed to the contaminated vaccine, Fisher found a 19.6 percent greater incidence of the two major brain cancers linked to SV40 when compared with the incidence in people the same age who were not exposed. She also found 16.6 percent more bone cancers and 178 percent more mesotheliomas among those exposed to the vaccine.
But Fisher cautioned against comparing the two groups. She argued that if SV40 is being transmitted and circulating in the population, then many people in the "unexposed" group would also be carrying the virus and that would undermine the comparison.
Two types of SV40, 1999
For years, researchers had believed that all SV40-contaminated Salk vaccine made between 1955 and 1963 had been used or discarded. Then in 1999, Carbone was contacted by a former public health director in Oak Park, Ill., who said he had seven sealed vials of vaccine dated October 1955 in a refrigerator in his basement. Carbone, who had left the NIH and joined the faculty at Loyola University Medical Center, ran tests on the vaccine and made a startling discovery: Not only was the vaccine contaminated, it contained a second form of the virus - an "archetypal" SV40 strain.
Although manufacturers switched from rhesus monkeys to SV40-free green African monkeys to grow the bulk vaccine in 1961, they have continued to use potentially contaminated polio seed strains originally grown on the rhesus monkey tissue to start the bulk vaccine process. Manufacturers check the purity of their vaccine with a series of 14-day tests to detect whether any SV40 slipped through. But when Carbone replicated the tests, he found that the second, slower- growing "archetypal" strain took 19 days to emerge. It was possible, Carbone noted in a published report, that this second strain of SV40 had been evading manufacturers' screening procedures for years - and infecting vaccine recipients after 1962.
Controversial study, 2000
Meanwhile, a new study led by Strickler had bogged down in bitter internal conflict.
After the NIH's 1997 conference, nine laboratories were recruited to participate in a government-sponsored study to determine if tests were really finding SV40 in tumors or whether earlier detections were the result of laboratory contamination. Carbone and other researchers considered the study unnecessary. A similar multilab study led by Dr. Joseph Testa of Philadelphia had just been completed, and it virtually eliminated the contamination theory. The prestigious journal Cancer Research published Testa's findings in 1998.
But Strickler pressed on.
An independent laboratory in Maryland prepared mesothelioma samples for the nine labs.
When tests revealed almost no SV40 in the tumor samples, some participants questioned the preparation methods used by the Maryland lab. They also challenged Strickler's written conclusion implying that contamination had caused the earlier findings of SV40 in tumors. If Strickler was right, the earlier SV40 detections were probably the result of stray SV40 in the labs. But critics argued that the study was scientifically flawed and should be scrapped.
The dispute became so contentious that FDA officials were forced to intervene and a neutral arbitrator assigned to mediate. Finally, in early 2000, more than two years after the study was initiated, a carefully rewritten report emerged for publication. It concluded that contamination was an unlikely explanation for earlier SV40 findings. Then it struggled to explain the discrepancy between earlier detections of SV40 in about half of all mesotheliomas tested and the fact that the nine labs found the virus in only slightly more than 1 percent of the study's tumor specimens.
The report noted that discrepancy might be because of the inefficiency of the method used by the Maryland lab to recover DNA - like the genetic sequences of SV40 - from the mesothelial tissue to create the test samples. The Maryland lab also had inadvertently contaminated some of the laboratory controls and "theoretically" could have contaminated others. The report concluded by calling for further research. Despite the study's ambivalent conclusions and technical problems, the NCI submitted it to Cancer Research, the journal that had published Testa's study.
It was rejected.
Further discoveries, 2000
In laboratories around the world, researchers continued to find SV40 in a widening range of tumors that now included pituitary and thyroid cancers and some lymphomas. Meanwhile, an NCI investigator named Dr. David Schrump was able to gut a common respiratory virus and use it to deliver genetic material called "antisense" into SV40-infected mesothelial cells and stop the cells' malignant growth.
His discovery, which was patented by the government, strongly suggested that SV40 contributed to mesothelioma and that a treatment might be possible. Then in August, Carbone and several colleagues published a major study providing a "mechanistic" explanation of how SV40 contributes to the uncontrolled growth of mesothelial cells. The key, they found, was the large number of "tumor suppressor" proteins found in the mesothelial cells that makes them unusually susceptible to SV40.
In most human cells, they said, the virus reproduces itself and kills the infected cell in the process. But in mesothelial cells, SV40 is especially attracted to the "tumor suppressor" proteins and binds to them, knocking them out of action. The virus then lives on in the cell. The result, they said, is a rate of malignant cell transformation in tissue cultures 1,000 times higher than has ever been observed. In a paper published in the Proceedings of the National Academy of Science, Carbone further explained that asbestos fibers appear to act as a co- carcinogen in mesothelioma by somehow suppressing the immune system's response, which is designed to kill the infected cells.
Chicago conference, 2001
Carbone and others believed that the time had come for another conference on the virus he calls "a perfect little war machine." In April, more than 60 scientists gathered on a warm weekend at the University of Chicago's downtown conference center. Despite numerous faxes and certified letters inviting him, Strickler declined to attend.
Carbone opened the conference by confronting the question of whether SV40 is present in humans.
"Sixty-two papers from 30 laboratories from around the world have reported SV40 in human tissues and tumors," he said. "It is very difficult to believe that all of these papers, all of the techniques used and all of the people around the world are wrong." For two days, scientists from as far away as China and New Zealand presented the results of their studies, with almost every speaker concluding that SV40 was present in the tissues they examined.
One of the newest discoveries came from Dr. Jeffrey Kopp, an NIH scientist who reported finding SV40 in a high percentage of patients with kidney disease. The virus was also present, he said, in 60 percent of a new "collapsing" type of renal disease that was unknown before 1980 but has since increased rapidly in incidence. There were also reports on efforts to develop a vaccine, recently funded by the NCI, that would allow the immune system to target and eliminate SV40. At times, the meeting took on almost revivalist overtones as scientist after scientist said he or she was initially very skeptical of SV40's presence in human tumors but was now a believer. "I was a hard sell," said Testa, the Philadelphia geneticist who conducted the first multilaboratory tests, noting that the study had convinced him.
Gazdar, the cancer researcher from Texas, showed a slide describing his transformation: "Nonbeliever -- Believer - Zealot." The conference concluded with a consensus among the leading scientists that SV40's presence in human tumors was no longer in question. They were more circumspect about the virus' possible role in causing cancer. If SV40 is a human carcinogen, they said, the virus probably requires interaction with other cancer-causing substances like asbestos.
Dr. Janet Butel from Baylor Medical College in Houston said that it simply might be too soon to make a determination, citing the many years it has taken to establish that other viruses cause cancer. But even renowned tumor biologist George Klein from Sweden said he was impressed by Carbone and Schrump's work.
"This strongly suggests that the virus plays a role (in causing tumors)," said Klein, a former chairman of the Nobel Assembly.
Low priority, 2001
In May, shortly after the conference, Strickler's multilab study was published in a small journal called Cancer Epidemiology, Biomarkers & Prevention. Carbone and other SV40 experts dismissed the study. "A garbage paper in a garbage journal," said Garcea, now on the faculty at the University of Colorado School of Medicine.
But Strickler strongly defends the study. He said it was the first to use strict controls not used in other studies. He acknowledged, however, that the study "doesn't prove that SV40 is not out there." Strickler, who now teaches at Albert Einstein School of Medicine in New York, said he remains skeptical about whether SV40 has infected humans, a suspicion he says is shared by the broader scientific community.
But the NCI recently acknowledged that there is evidence to suggest that SV40 "may be associated with human cancer." The NCI statement, released last month, also said that SV40's interaction with "tumor suppressor proteins" indicates "possible mechanisms that could contribute to the development of cancer." Top NCI officials declined to be interviewed on the record for this report. Fraumeni also declined several requests for an interview.
Dr. James Goedert, the chief of the NCI's Viral Epidemiology Branch who supervised Strickler's work, said that if SV40 is in human tumors, it must be at extremely low levels. To critics who claim the government has downplayed SV40's potential health risks, Goedert responded: "Absolutely not." He acknowledged that research is needed to resolve the question of whether SV40 is prevalent in the human population and, if so, how it might be spreading. But Goedert said he has no plans for such studies.
"It's not our highest priority," he said. Key figures in developing vaccines and tracing SV40 Dr. Jonas Salk Developed the first polio vaccine using killed virus in 1955. Virologist Albert Sabin Developed an oral vaccine using weakened live virus. Dr. Robert Garcea Used new technology to trace SV40 in children's brain tumors.
Q&A on polio vaccine contaminated with SV40 Q: How widespread is the SV40 infection?
A: Scientists and government health officials don't know because no comprehensive studies have addressed the question.
What is known: During the 1950s and '60s, more than 100 million people worldwide were given SV40-contaminated polio vaccine. The virus also has been found in people who did not receive contaminated vaccine, as well as laboratory workers and monkey handlers. No studies, however, have examined how SV40 might be transmitted between people, or if somehow humans might have become infected with SV40 before the introduction of the tainted vaccines.
Q: Can I be tested for SV40?
A: An accurate blood test does not exist. Current antibody blood tests can be inaccurate, scientists say, because they may also detect the presence of other closely related viruses, and SV40 may be present at such a low level that no antibodies are produced. Researchers are working to create an effective test.
Q: Is the current polio vaccine safe?
A: Vaccine producers, health officials and most scientists believe that it is safe. Manufacturers say they take elaborate steps to test their vaccine for SV40, and the government says it recently tested vaccine samples back to 1972 and found no trace of SV40.
Some scientists, including Dr. Michele Carbone, have raised questions about whether manufacturers' testing techniques have been adequate. Carbone, however, tested vaccine from 1996 and found no SV40. He has had his children inoculated.
Q: In which kinds of cancers has SV40 been found?
A: The virus has been detected in rare cancers:
-- Mesothelioma, a fatal tumor of the membrane surrounding the lungs. Few cases were reported prior to 1950, but the incidence has grown in the United States to 2,000 to 4,000 cases a year, with greater incidence in Europe.
-- Brain cancers: Primarily ependymoma and choroid plexus tumors, but also astrocytoma, glioblastoma, medulloblastoma and meningioma. These make up a total of less than 1,000 U.S. cases each year.
-- Bone cancers: Primarily osteosarcoma but also chondrosarcoma and giant cell tumors. These also make up less than 1,000 cases annually.
-- Other cancers: A few detections in pituitary and thyroid tumors and lymphomas.
Report sources
The sources for this report include the books "The Saga of Jonas Salk" by Richard Carter and "The Health Century" by Edward Shorter; articles in Atlantic Monthly and New York magazine; newspaper archives at The Chronicle and the New York Times; transcript of the 1997 National Institutes of Health Conference in Bethesda; a review of dozens of scientific journal articles and scores of interviews.
Related series: Quest for the Origin of AIDS.
How SV40 contaminated polio vaccine
When Dr. Jonas Salk introduced the first polio vaccine in 1955, it was hailed as "one of the greatest events in medicine." Within 10 years, U.S. polio cases plummeted from 30,000 to less than 1,000. But in 1960, a monkey virus called SV40 was found in the Salk vaccine. As much as one-third of the vaccine was contaminated. SV40 was also found in earlier versions of an oral vaccine developed by Dr. Albert Sabin that replaced the Salk vaccine in the 1960s.
When it was discovered that SV40 caused cancer in lab animals, U.S. health officials ordered vaccine manufacturers in 1961 to eliminate the virus from all future vaccine, although questions remain about whether they succeeded with the Sabin vaccine. .
Making the Sabin vaccine: 1955-1961 Starting in the mid-1950s, both Sabin and Salk vaccines are made by growing polio virus on kidney tissue from Asian rhesus monkeys, which are natural hosts for the simian virus known as SV40.
Special weakened seed strain of polio virus developed by Sabin is grown on rhesus kidney tissue to make large bulk amounts of vaccine. SV40 from the kidney tissue contaminates the vaccine. Making the vaccine safe: 1961 In 1961, after SV40 is discovered in the vaccines, U.S. health officials order manufacturers to eliminate SV40. Antiserum is used to neutralize SV40 in seed stock, and SV40-free African green monkeys are used to grow bulk vaccine. But some researchers believe small amounts of SV40 may have survived. .
Testing Manufacturers check the safety of the vaccine pools by using a series of 14- day growth tests to see if SV40 is present. Making the Salk vaccine: 1955-1961 Full strength polio virus is grown on rhesus kidney to make bulk Salk vaccine. SV40 from the kidney tissue contaminates the vaccine. The polio virus is then killed with formaldehyde, but some SV40 survives. .
Making the vaccine safe: 1961 In the original vaccine, the SV40 survives, contaminating up to 30 million Americans. But after 1961, African green monkeys are used to grow bulk vaccine and SV40 is eliminated.
Sources: Children's Hospital of Philadelphia; SEER; virus images by Jean Yves Sgro, University of Wisconsin; Chronicle research
BIBLIOGRAPHIC NOTE
For more information about the simian virus SV40, the following studies or scientific reviews were published during that past year:
A multicenter evaluation of assays of detection of SV40 DNA and results in masked mesothelioma specimens. Strickler H, Goedert J., Cancer Epidemiology, Biomarkers & Prevention. Vol. 10, 523-532, May 2001.
Simian virus 40 and human cancers, Strickler H., Einstein Quarterly J. Biol. and Med. (2001) 18:14-21. This includes a detailed bibliography that will lead readers to earlier scientific articles.
Oral polio vaccine and human cancer: a reassessment of SV40 as a contaminant based upon legal documents. Kops S., Anticancer Research (2000) 20: 4745-4750.
Human mesothelial cells are unusually susceptible to SV40-mediated transformation and asbestos cocarcinogenicity. Bocchetta M, Di Resta I, Powers A, Fresco R, Tosolini A, Testa J, Pass H, Rizzo P, Carbone M., Proc. Natl. Acad. Sci. USA, Vol. 97, Issue 18, 10214-10219, Aug. 29, 2000.
In addition, a bibliography of journal articles by leading SV40 researcher Dr. Michele Carbone can be viewed by clicking on the following link: www.chestsurg.org/carbone7.htm
E-mail William Carlsen at wcarlsen@sfchronicle.com.
Today's News Stories News Archive:
SV40, polio vaccine, and cancer: Now beyond coincidence?
http://news.bmn.com/news/story?day=020410&story=2
9 April 2002 10:40 EST by Apoorva Mandavilli, BioMedNet News San
Francisco -
At the American Association of Cancer Research meeting here today, controversy continued to swirl around accusations that contaminated polio vaccine stocks are to blame for certain cancers, based on the publication a month ago of two high-profile papers linking the simian virus SV40 to human lymphomas.
Less than a week after the papers were published in March, the US National Cancer Institute contacted the researchers to establish plans to send blinded results to three independent labs, lead researcher Adi Gazdar told BioMedNet News today.
But Gazdar seems unconvinced of the NCI's intentions. "They just want to prove us wrong," he said. Gazdar and his colleagues scanned 99 lymphomas, 235 epithelial tumors and 40 control tissues for the virus. They found the virus in 43% of non-Hodgkin's lymphomas, 9% of Hodgkin's lymphomas, and in none of the control tissues. A second team independently found the virus in 42% of non-Hodgkin's lymphomas, "almost unbelievable agreement," said Gazdar, who is professor of pathology at the University of Texas Southwestern medical center.
"These are very respectable labs with basically identical results," said Michele Carbone, associate professor of pathology at Loyola University in Chicago. The "clear clustering of positives" is "no accident," he told BioMedNet News.
This is not the first time scientists have linked SV40 to human cancers. Researchers suggested for years that millions of vials of polio vaccine, contaminated with SV40, infected individuals between 1953 and 1963 and caused human tumors. Until recently, they were inevitably met with skepticism, even contempt - and some NCI researchers published directly contradictory results.
In 1997, the US National Institutes of Health, with other organizations, organized an international conference to review the SV40 literature and address the possibility that the virus causes human tumors. At the meeting, Carbone, presented his then-controversial data linking the virus to mesotheliomas. (Since then, more than 30 independent reports have confirmed his results).
After the meeting, Carbone says, a conscientious Chicago public health official contacted Carbone and gave him the last remaining stocks of polio vaccine from the 1950s. In her paper, Butel isolated a strain of SV40 from three patients that closely matches the strain Carbone sequenced from the polio vaccine vials.
The evidence proves Butel's results are no artifact, Carbone says. "You cannot contaminate with something that doesn't exist," he said. "This thing only exists in my freezer."
Since publication of their research in the Lancet last month, Gazdar and his colleagues have been investigating rarer subtypes like leukemia and multiple myelomas. The experiments have not been proceeding as fast as they would like, Gazdar says, partly because "there's no government funding" for the research. "The lymphoma story might force them to [fund it]."
An important next step, Gazdar says, is to prove that the SV40 virus causes lymphomas and isn't just a "passenger" in the cells. That is no easy task, since researchers have only been able to isolate the virus in rare instances. For the most part, they believe, the virus launches a "hit-and-run" attack, initiating a cascade of tumorigenic events before it is destroyed by the body.
Still, it is critical that this research continue, Gazdar says, because molecular and immunologic data suggest those born after 1963 have also been exposed to the virus, via horizontal or vertical transmission, or through sexual contact.
The rates of mesotheliomas, lymphomas and brain tumors have also all gone up "dramatically" in the last 30 years. "Coincidence or not, we have to find out," he said. "It's something to think about."
"Now Carbone was asking Pass for his help in proving a controversial theory he had developed about the origins of mesolthelioma, a deadly cancer that afflicts the mesothelial cells in the lining of the chest and the lung. Mesolthelioma was virtually unheard of prior to 1950, but the incidence of the disease has risen steadily since then. Though it is considered rare-accounting for the deaths of about 3,000 Americans a year, or about one half of one percent of all domestic cancer deaths-the disease is particularly pernicious. Most patients die within eighteen months of diagnosis.
Pass, one of the world's leading mesothelioma surgeons, knew, like other scientists, that the disease was caused by asbestos exposure. But Carbone had a hunch he wanted to explore. He told Pass that he wondered if the cancer might also be caused by a virus-a monkey virus, known as simian virus 40 or SV40, that had widely contaminated early doses of the polio vaccine, but that had long been presumed to be harmless to people.
Pass listened as Carbone described for him the history of the early polio vaccine. A breakthrough in the war against polio had come in the early 1950's, when Jonas Salk took advantage of a new discovery: monkey kidneys could be used to culture the abundant quantities of polio virus necessary to mass-produce a vaccine. But there were problems with the monkey kidneys. In 1960 Bernice Eddy, a government researcher, discovered that when she injected hamsters with the kidney mixture on which the vaccine was cultured, they developed tumors. Eddy's superiors tried to keep the discovery quiet, but Eddy presented her data at a cancer conference in New York. She was eventually demoted and lost her laboratory. (Gosh, that sounds so much like Wakefield doesn't it. Interesting how history repeats itself. Suzan's comments.) The cancer-causing virus was soon isolated by other scientists and dubbed SV40, because it was the fortieth simian virus discovered. Alarm spread through the scientific community as researchers realized that nearly every dose of the vaccine had been contaminated. In 1961 federal health officials ordered vaccine manufacturers to screen for the virus and eliminate it from the vaccine. Worried about creating a panic, they kept the discovery of SV40 under wraps and never recalled existing stocks. For two more years millions of additional people were needlessly exposed-bringing the total to 98 million Americans from 1955 to 1963. But after a flurry of quick studies, health officials decided that the virus, thankfully, did not cause cancer in human beings."End quote
But, alas, the research has shown, as demonstrated and revealed in this well-written article, that it does indeed cause cancer. In fact it is THE most oncogenic virus known to man.
Another excerpt:
"The virus has also been located in other kinds of tumors. More than a dozen laboratories have found SV40 in various kinds of rare brain and bone tumors. In 1996 Carbone reported that he had found SV40 in a third of the osteosarcomas (bone cancers of a type that afflicts about 900 Americans a year and nearly half of the other bone tumors he tested-research that has since been confirmed by numerous laboratories. The virus has also been detected in pituitary and thyroid tumors.
The possibility of a link between SV40 and brain tumors is particularly intriguing. Like mesothelioma, brain tumors have become dramatically more common in recent years. Brain tumors will be diagnosed in about 3,000 children in the United Stated alone this year. In 1995 Janet Butel, the chairman of the department of molecular virology and microbiology at the Baylor College of Medicine, in Texas, and her chief collaborator, John Lednicky, also a Baylor virologist, reported that they had found SV40 in a number of children's brain tumors. Butel and Lednicky reported that DNA sequencing revealed that the virus was not a hybrid but rather authentic SV40-the same as the SV40 found in monkeys. In the fall of 1996 an Italian research team, led by Mauro Tognon, of the University of Ferrara, announced that it had found SV40 DNA in a large percentage of brain and neurological tumors, including glioblastoma, astrocytomas, ependymomas, and papillomas of the choroid plexus. The researchers suggested that SV40 may be a "viral co-factor" involved in the sharp rise in human brain tumors. Late last year an extensive study undertaken in China reinforced those results. The study examined sixty-five brain tumors, finding SV40 in each of the eight ependymomas and two choroid-plexus papillomas, common brain tumors among CHILDREN.(my emphasis). It also found the virus in 33 to 90% of five other kinds of brain tumor examined. The authors, writing in the November, 1999, issue of Cancer, noted that the virus was actively expressing proteins.
Recent research also indicated that SV40 has gained a secure foothold in the human species. In 1996 Tognon and his collaborators reported that they had also found the virus in 45 percent of sperm samples and 23 percent of the blood samples they tested from healthy people, suggesting that the monkey virus could spread through sexual contact or unscreened blood products. In 1998 the presence of SV40 antibodies in human blood samples was reported by Butel, who tested several hundred American blood samples and found antibodies to SV40 in about 10 percent of them. Butel's laboratory also tested samples from children born from 1980-1995-decades after the contaminated vaccine was removed from the market. A surprising six percent tested positive-offering evidence that the virus may now be spreading from person to person, including from mother to child."
[Here is a remarkable piece of investigative journalism on the SV40 virus and the contaminated polio vaccines being linked to all kinds of cancers - part of this article was picked up in the Houston Chronicle too. Please see bottom of note for the email address to send letters of thanks to the journalist. Dawn]
http://www.sfgate.com/cgi-bin/article.cgi?file=/chronicle/archive/2001/07/15
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by Geraldo Fuentes
Editor's Note:
When we first ran Geraldo's first story, SV-40, A Deadly Cure? we thought it was a bit on the conspiratory side, but it seemed well researched. We were pleased that many other journalists also investigated the material, proving the sad truth that Geraldo reported in ViewZone.
Research has now firmly linked many of today's cancers with tainted virus vaccinations given in the early 1950s. Could there be any more shocking and horrific revelations like this? We didn't think so - but we were wrong.
The latest horror story is posted HERE: SV40 Part Two for you to ponder. As you read it, also do not forget the Black Americans that were knowingly infected with Syphilis or the soldiers made to march through the fallout of our nuclear bomb tests...
But first, read Geraldo Fuentes original story.
If you received a polio vaccination in the 50's,
you may have gotten more than you know...
It was 1956. I was only six years old and attended grade school in Springfield, Massachusetts. I was too young to recollect the first round of polio vaccinations, but I have a few memories. I remember that my first grade class was escorted to the school gymnasium. There was a peculiar smell in the air. I think it was probably rubbing alcohol. And some of the other kids were crying. The shot itself wasn't so bad. I didn't cry, but my best friend did. At the end of the ordeal we all got a lollipop.
A few years later, when we marched again to the gymnasium it was different. There was no crying and no alcohol odor. Instead, there were long tables bearing neat rows of small paper cups, filled about half way with a liquid that tasted like bitter orange juice. White clad Nurses watched as each child drank the vaccine. There was no lollipop and, after we handed back the cup, we simply returned to class.
The government had initiated the mandatory polio vaccination programs in 1955. Prior to this, polio had killed or crippled thousands of children and adults all over the world. Attacking the central nervous system, this viral infection was transmitted by human contact, sewage and even by contaminated milk. Victims who contracted polio would incubate the virus in their intestines, where it would multiply and enter the lymphatic system. Eventually the virus would penetrate the nerves and travel along nerve paths, destroying neurons and rendering the muscles connected to them paralyzed.
The polio epidemic reached its height in 1952. It turned thousands of victims into cripples and confined countless children to large pressure chambers called "iron lungs," which helped them to breath when their diaphragm muscles were stilled. There was and still is no treatment for polio. Aside from attempts to maintain life functions, the disease must run its course.
And so, in 1955, just one year before I received it, Jonas Salk had performed no small miracle when he successfully mass-produced an effective polio vaccine by growing a form of the virus on the kidneys of rhesus monkeys. This virus would be harvested, killed, and given to healthy children like me, who would then develop antibodies which would kill any future invasion of the body by the polio virus.
This happy story of medical marvel has a deadly glitch. And it is especially deadly if, like me, you received your vaccinations in the 1950s, in certain states like Massachusetts.
In 1960, researchers discovered that the polio vaccine distributed to certain states was infected with another virus called "Simian Virus 40." SV-40 is a monkey virus that is not normally found in humans. Unknown at the time, it was present in hundreds of rhesus monkeys that were used to grow and harvest the polio vaccine. Injected into research animals, the SV-40 virus causes brain and lung cancers. Now, some forty years later, its effect on humans is just being investigated.
SV-40 has appeared in 61% of all new cancer patients -- patients too young to have received the contaminated vaccine being administered forty years ago!
Michele Carbone, Assistant Professor of Pathology at Loyola University in Chicago, has recently isolated fragments of the SV-40 virus in human bone cancers and in a lethal form of lung cancer called mesotheliomas. He found SV-40 in 33% of the osteosarcoma bone cancers studied, in 40% of other bone cancers, and in 60% of the mesotheliomas lung cancers. Dr. Carbone believes this study explains why 50% of the current mesotheliomas being treated were no longer occurring in association with asbestos exposure, their traditional cause.
Researchers from the Institute of Histology and General Embryology of the University of Ferrara, lead by Dr. Fernanda Martini, discovered SV-40's presence in a variety other tumors. They found the rhesus monkey virus in 83% of choriod plexus papillomas, in 73% of ependymomas, in 47% of astrocytomas, in 50% of glioblastomas, and in 14% of meningiomas.
SV-40 also has been found in 23% of blood samples and 45% of sperm fluids taken from normal individuals! Researchers have determined the SV-40 virus can be transmitted sexually and through blood transfusions.
Even more shocking, SV-40 has appeared in 61% of all new cancer patients -- patients even too young to have received the contaminated vaccine being administered forty years ago! How could this happen?
My second vaccination was from a cup. This was the brainstorm of the FDA. Instead of getting the "dead" virus in an injection, the Federal vaccination policy mandated that children should be given the new live "oral polio vaccine" (OPV). This decision was based upon the belief that the OPV recipient would "shed" the virus through body contact with other non-vaccinated children and adults, thereby spreading the "live" virus throughout the population. Since the infection was extremely small, it would produce the desired antibodies while posing no threat of contracting polio. This, it was thought, would assure the total immunization of America and the eradication of the disease. The public was never informed that this national health strategy was being implemented, despite several cases of polio which were directly attributed to the vaccine.
By 1963, the estimated number of tainted polio vaccinations was estimated to be upwards of 98-million!
The SV-40 virus that contaminated the oral polio vaccine quickly spread from child to child and from child to adult, crossing state lines and national boundaries. By 1960, when the virus was first detected, it was already too late to prevent its dissemination throughout the population. The FDA quietly and gradually instituted a program to eliminate rhesus monkeys, who harbor the SV-40, and replace them with African Green monkeys that are free of the virus. By 1963 the monkeys had been replaced but the estimated number of tainted polio vaccinations was estimated to be 98-million!
According to the National Institutes of Health, high levels of SV-40 were identified in polio vaccines in Washington, Oregon, Wyoming, Utah, Minnesota, Iowa, Wisconsin, Illinois, Michigan, Pennsylvania, Washington DC, Maryland, Delaware, New York, Connecticut, Rhode Island, Massachusetts, Vermont and New Hampshire. Low levels of SV-40 were found in California, Arizona, New Mexico, Colorado, Texas, Kansas, Nebraska, North Dakota, Missouri, Louisiana, Georgia, Tennessee, Kentucky, Ohio, and West Virginia. Polio vaccines in the other states show no SV-40 present.
This revelation has only recently come to public attention. Many people, like myself, were unaware that a potential for cancer had been implanted in their body. Researchers say that, by age fifteen, the virus stops shedding to others. I cannot but wonder how many people I contacted between the age of eight and fifteen... Did I shed the SV-40 virus to my mother, who eventually died of brain cancer? Will I contract brain, lung or bone cancer? Many other people in my age group are asking similar questions.
A number of public statements have been made by the National Cancer Institute in the past few months, attempting to put their spin on these disturbing revelations. In an statement published in the January (1999) New England Journal of Medicine, the institute states that there is no evidence of an increase in humans of the types of cancers found in laboratory animals that have been injected with SV-40. But other researchers remind us that SV-40 has already been found in a wide variety of other tumors. It has been shown that individuals who received the tainted oral vaccine demonstrate a higher occurrence of these cancers.
For example: people who lived in Massachusetts and Illinois in the 1950s, and received identified lot numbers of the contaminated oral vaccine, are now contracting osteosarcoma bone tumors at a rate of ten times more than those who received the vaccine free of the SV-40.
But the National Cancer Institute has been silent about these facts.
There needs to be more demographic studies to explore the relationship of SV-40 to adult onset cancers. Not surprisingly, the US government and its agencies are reluctant to pursue this matter. In fact, requests to the National Institute for Health for grants to study the SIV and simian cyto-megalovirus (SCMV) were recently denied. Microbiologist Howard Urnovitz, Ph.D., may have an explanation as he stated in the Boston Globe:
"that almost 100 million Americans were exposed (to SV-40) through a government sponsored program, but for over 30 years, there has been virtually no government effort to see if anyone's been harmed by the exposure." He added, "The government will not fund science that makes it look culpable."
Another method used by the National Cancer Institute to divert public concern is to issue statements that "many of the cancers under suspicion were contracted by people who are too young to have received the tainted vaccine in the 1950s." This argument, although true, ignores the potential of spreading the live SV-40 by "shedding" through personal contact. The oral polio vaccine was designed to be transmitted to non-vaccinated individuals by this very method. In fact, this was the reason that OPV was preferred over injection. If SV-40 is still being spread by contact today it is not surprising that these cancers are now affecting younger people.
Regardless of blame, severe damage to world health has already been done by the unsavory practice of growing vaccination products in animals. An example of these horrors was presented by Dr. Urnovitz at the Eighth Annual Houston Conference on AIDS.
Dr. Urnovitz revealed significant evidence that human immunodeficiency virus type 1 (HIV-1) is a monkey hybrid virus which was produced when 320,000 Africans were injected with polio virus contaminated with live simian immunodeficiency virus (SIV) in the late 1950's.
Apparently, viral fragments combine easily with other viruses to produce these hybrids called "chimeras." Prior to this revelation, health officials were blaming AIDS on the habit of certain Africans to consume monkey flesh.
What can be done now? "Make it in anything but animals," said Barbara Loe Fisher of the National Vaccine Information Center, which criticizes vaccine safety. "We have the technology to make vaccines in human cell lines that are clean," said Dr. Michele Carbone of Loyola University Medical Center, one of the first to discover SV-40 inside human tumors.
Until then we can only hope that researchers continue their work, regardless of the repercussions. Millions of people are already infected with SV-40 and are in danger. Many cancers do not develop until mid-life. Future generations must be protected. We must prohibit any future contamination of the world population, whether for our own good or not, by well-meaning governmental agencies.
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
www.researchprotection.org
Tue, 06 Aug 2002 20:24:12 +1200
Contact: Vera Hassner Sharav
212-595-8974 FAX 212-595-9086
veracare@rcn.com
The anthrax vaccine is not the only vaccine that has been linked to severe, debilitating illness. And this is not the first time that government public health agencies lied to the public about the health hazards associated with a vaccine. In her July 19 column in The Wall Street Journal (below), Sharon Begley reported that in 1961 the U.S. Public Health Service learned about SV40 contaminated polio vaccines given to (possibly) 98 million babies and kept that information from the public.
SV40 (known as the "monkey virus") is a known carcinogen that may change DNA to make humans more vulnerable to cancer. One year earlier, on July 15, 2001, The San Francisco Chronicle brought the issue to light: "Based on dozens of interviews and a review of the medical research, this is the story of how the campaign to eradicate polio may have inadvertently permitted another potentially deadly monkey virus to infect millions of people - and why the government for years discounted the accumulating evidence suggesting that SV40 may be a health risk for humans."
"How long can the government ignore this?" asked Dr. Adi Gazdar, a University of Texas Southwestern Medical Center cancer researcher. "The government has not sponsored any real research. Here's something possibly affecting millions of Americans, and they're indifferent. "Maybe they don't want to find out."
"The recent SV40 discoveries come at a time of growing concern over the dangers posed by a range of animal viruses that have crossed the species barrier to humans, including HIV, which scientists now believe came from chimpanzees and ultimately caused the AIDS epidemic. Based on dozens of interviews and a review of the medical research, this is the story of how the campaign to eradicate polio may have inadvertently permitted another potentially deadly monkey virus to infect millions of people - and why the government for years discounted the accumulating evidence suggesting that SV40 may be a health risk for humans."
[See, William Carsen, Rogue Virus in the Vaccine:Early Polio Vaccine Harbored Virus Now Feared to Cause Cancer in Humans, the San Francisco Chronicle,
http://www.sfgate.com/cgi-bin/article.cgi?file=/chronicle/archive/2001/07/15 / MN193825.DTL; William Carlsen, New Documents Show the Monkey Virus is Present in More Recent Polio Vaccine, San Francisco Chronicle, July 22, 2001,
http://www.sfgate.com/cgi-bin/article.cgi?file=/c/a/2001/07/22/MN173141.DTL
See also, Nicholas Regush, The Monkey Connection, ABC News,
http://abcnews.go.com/sections/living/SecondOpinion/secondopinion_47.html ]
Begley interviewed a former public health official, H.M. Ratner, who had refused to inoculate babies with the contaminated vaccine and kept a batch as evidence.
THE WALL STREET JOURNAL SCIENCE JOURNAL
Are Tainted Vaccines Given to Baby Boomers Now Causing Cancer?
By Sharon Begley 07/19/2002, B1 SNAPSHOTS OF YOUR government at work:
-- 1961. The U.S. Public Health Service, having learned in 1960 that millions of batches of polio vaccine were accidentally laced with a simian virus (vaccine was grown on minced monkey kidneys), quietly orders manufacturers to rid the vaccine of the contaminant, called SV40. PHS issues neither recall nor public announcement. Contaminated stocks already distributed are used until 1963.
-- 1999. H.M. Ratner, a former public-health official in Oak Park, Ill., invites Michele Carbone of nearby Loyola University School of Medicine over for coffee. In 1955, Dr. Ratner says, he had refused to administer the Salk polio vaccine. He felt it might not be safe. But he kept seven vials in his basement refrigerator for 44 years, hoping that, one day, someone would be interested in them. Someone is. Dr. Carbone is investigating the possibility that SV40-contaminated polio vaccine made by several manufacturers was, decades after being given to about 98 million baby boomers, increasing the risk of three rare cancers.
-- 2002. Last week, the Immunization Safety Review Committee of the Institute of Medicine (IOM) meets to consider evidence for and against that unthinkable hypothesis. Amid dueling data, some facts are uncontested. An estimated two-thirds of the polio vaccines -- the oral Sabin and the injected Salk -- administered from 1955 to 1963 contained SV40, including the vials Dr. Ratner saved. Contaminated vaccine was also given to children and some adults in Australia, Canada, Denmark and Germany, and possibly Russia, Mexico and other countries.
SV40 IS A KNOWN carcinogen. It targets the lung's mesothelial cells, brain cells, bone cells and blood cells, producing a protein that knocks out two human tumor-suppressor genes, p53 and Rb. There is no reliable blood test for SV40 exposure. Government data show the incidence of SV40-linked cancers has risen. A brain cancer called ependymoma is up 25%. Bone malignancies are up 23%.
Mesothelioma (infamous for being triggered by asbestos) is up 90%. All are extremely rare: Ependymoma, for example, strikes one in a million. Are the rising cancer rates coincidence? In 1994, Loyola's Dr. Carbone and colleagues examined human mesotheliomas. He found SV40 genetic sequences in 29 of 48 studied. SV40 has now been found in up to 80% of mesotheliomas in the U.S. and Europe. Dozens of labs have found SV40 in bone and brain cancers. Those, as I said, are rare. Epidemiologist Howard Strickler of Albert Einstein College of Medicine in New York, a leading skeptic of the vaccine-cancer link, notes that many studies fail to find SV40 in human tumors.
In March, however, researchers led by Janet Butel of Baylor College of Medicine, Houston, reported that 42% of the non-Hodgkin lymphomas they analyzed contained genetic sequences from SV40. And not just any SV40: In several tumors, it was precisely the genome of the SV40 in the vials of the 1955 polio vaccine that Dr. Ratner had held onto, waiting for someone to care. Lab-grown SV40 harbors a variant genome. There might be other sources, in addition to vaccine, of this strain of SV40, but to more and more scientists Dr. Butel's findings were the smoking gun.
WITH NON-HODGKIN lymphoma, we're no longer talking about rare malignancies. This cancer has spiked 82% in the U.S. since 1973, epidemiologist Susan Fisher of the University of Rochester, New York, told the IOM panel, with 56,200 new cases in 2001 and 24,000 deaths.
An analysis by Dr. Strickler shows no extra cancers among people thought to have been exposed to SV40-laced polio vaccine -- or, no extra increase that can't be explained by chance. Trouble is, with no test for SV40 exposure, it's impossible to be sure you're comparing an exposed to an unexposed group. You might be comparing populations exposed to SV40 with populations also exposed. Of course there'd be no difference.
What are the ramifications of this? Today's children are at no risk from polio vaccine; it's now grown in SV40-free cells. The public-health risk from SV40-laced polio vaccine is . . . well, one scientist told me it's "minimal." Another says "unknown." Tumors linked to SV40 are, except for lymphomas, so rare that even a doubling of risk due to SV40 still leaves you with good odds of never developing these cancers.
A wild card, though, is the World Trade Center collapse, which released asbestos into the air. Although SV40 alone rarely causes mesothelioma, when you add asbestos to the mix, all bets are off. The IOM committee's conclusions on SV40, polio vaccine and cancer are due out by the end of summer.
(Copyright (c) 2002, Dow Jones & Company, Inc.)
FAIR USE NOTICE: This may contain copyrighted () ) material the use of which has not always been specifically authorized by the copyright owner. Such material is made available to advance understanding of ecological, political, human rights, economic, democracy, scientific, moral, ethical, and social justice issues, etc. It is believed that this constitutes a 'fair use' of any such copyrighted material as provided for in section 107 of the US Copyright Law. In accordance with Title 17 U.S.C. Section 107, this material is distributed without profit to those who have expressed a prior general interest in receiving similar information for research and educational purposes. For more information go to:
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Sewage Yields Clues to SV40 Transmission
http://jama.ama-assn.org/issues/v288n11/ffull/jmn0918-1.html
(entire paper available at URL)
Washington
It was a dirty job and nobody had to do it. But an international team of scientists did it anyway, testing dozens of sewage samples for simian virus 40 (SV40), which in the 1950s and 1960s contaminated millions of doses of polio vaccine. The unsavory task yielded compelling evidence of person-to-person transmission of SV40, evidence that complicates the contentious search for links between the monkey virus and human cancers.
The sewage study is a wild card. In their figuring, epidemiologists assume that only certain recipients of the vaccines were exposed to SV40. This assumption allows them to isolate SV40 as a variable and gauge whether cancer rates increased after 1961, when the last known contaminated vaccines were given. But what if SV40 circulates in people like it does in monkeys?
"If SV40 is transmitted from person to person and I'm not saying that it is that would throw the epidemiology off," said Susan Fisher, PhD, chief of the epidemiology department at the University of Rochester School of Medicine, during a July presentation to the vaccine safety review committee assembled by the Institute of Medicine (IOM). "Any cohort called 'unexposed' after 1961 may not truly be unexposed." If no group is truly unexposed, the effect of SV40 on cancer rates would be difficult to discern.
Speaking of sewage.
Isolation of vaccine-derived type 1 polioviruses displaying similar properties to virulent wild strain Mahoney from sewage in Japan. Horie H, Yoshida H, Matsuura K, Miyazawa M, Wakabayashi K, Nomoto A, Hashizume S. Japan Poliomyelitis Research Institute, Higashimurayama-shi, Tokyo, Japan.
Type 1, 2, and 3 vaccine-derived polioviruses were isolated from a sewage disposal plant located downstream of the Oyabe River in Toyama Prefecture, Japan, between October 1993 and September 1995. Neurovirulence was analyzed in 13 type 1 vaccine-derived strains, using mutant analysis by polymerase chain reaction and restriction enzyme cleavage (MAPREC). Nine strains (69%) were estimated to have marked neurovirulence. Some of the neutralizing antigenic sites, temperature sensitivity, and plaque-forming ability of two virulent vaccine-derived poliovirus strains were similar to Mahoney strain. The neutralizing activity of human sera obtained after oral poliomyelitis vaccine (OPV) administration against one of the virulent vaccine-derived polioviruses was examined. Although all human sera showed sufficient neutralizing activity for the prevention of poliomyelitis by vaccine-derived poliovirus strains, a lower titer than that against Sabin type 1 strain was observed. Vaccination against virulent vaccine-derived poliovirus will be effective. However, the environmental presence of viruses that have properties similar to those Mahoney strain is a threat. The introduction of inactivated poliovirus vaccine (IPV), and well-maintained herd immunity, together with reinforced environmental surveillance is important for the final phase of the polio eradication program by the World Health Organization (WHO). J. Med. Virol. 68:445-451, 2002. Copyright 2002 Wiley-Liss, Inc.
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Rogue virus in the vaccine: Early polio vaccine harbored virus now feared to cause cancer in humans
San Francisco Chronicle - Sunday, July 15, 2001
William Carlsen, Chronicle Staff Writer
A growing number of medical researchers fear that a monkey virus that contaminated polio vaccine given to tens of millions of Americans in the 1950s and '60s may be causing rare human cancers. For four decades, government officials have insisted that there is no evidence the simian virus called SV40 is harmful to humans. But in recent years, dozens of scientific studies have found the virus in a steadily increasing number of rare brain, bone and lung-related tumors - the same malignant cancer SV40 causes in lab animals.
Even more troubling, the virus has been detected in tumors removed from people never inoculated with the contaminated vaccine, leading some to worry that those infected by the vaccine might be spreading SV40. The discovery of SV40 in human tumors has generated intense debate within the scientific community, pitting a handful of government health officials, who believe that the virus is harmless, against researchers from Boston to China who now suspect SV40 may be a human carcinogen. At stake are millions of research dollars and potential medical treatments for those afflicted with the cancers SV40 may be causing.
In April, more than 60 scientists met in Chicago to discuss the controversial virus and how it works to defeat certain cells' natural defenses against cancer.
"I believe that SV40 is carcinogenic (in humans)," said Dr. Michele Carbone of Loyola University Medical Center in Maywood, Ill. "We need to be creating therapies for people who have these cancers, and now we may be able to because we have a target - SV40." But scientists at the National Cancer Institute say their studies show almost no SV40 in human tumors and no cancer increase in people who received the contaminated vaccine. "No one would dispute there's been a widespread, very scary exposure to the population of potentially cancer-causing virus," said Dr. Howard Strickler, NCI's chief investigator. "But none of our studies and other major analyses have shown an inkling of an effect on the population."
Critics charge, however, that the few studies done by the government are scientifically flawed and that health officials have downplayed the potential risks posed by SV40 ever since they learned in 1961 that the virus contaminated the polio vaccine and caused tumors in rodents. "How long can the government ignore this?" asked Dr. Adi Gazdar, a University of Texas Southwestern Medical Center cancer researcher. "The government has not sponsored any real research. Here's something possibly affecting millions of Americans, and they're indifferent.
"Maybe they don't want to find out."
The recent SV40 discoveries come at a time of growing concern over the dangers posed by a range of animal viruses that have crossed the species barrier to humans, including HIV, which scientists now believe came from chimpanzees and ultimately caused the AIDS epidemic. Based on dozens of interviews and a review of the medical research, this is the story of how the campaign to eradicate polio may have inadvertently permitted another potentially deadly monkey virus to infect millions of people - and why the government for years discounted the accumulating evidence suggesting that SV40 may be a health risk for humans.
Polio epidemic, 1955
During the first half of the 20th century, polio struck down hundreds of thousands of people, leaving many paralyzed - some in iron lung machines - and killing others. The worst year was 1952, when more than 57,000 polio cases were reported in the United States. Three thousand died. Then on April 12, 1955, Dr. Jonas Salk, a slightly built, soft-spoken researcher from Pittsburgh, mounted the podium at the University of Michigan and announced that he had developed a vaccine. That afternoon, the government licensed the vaccine for distribution.
Salk's vaccine was made by growing live polio virus on kidney tissue from Asian rhesus monkeys. The virus was then killed with formaldehyde. When the vaccine was injected in humans, the dead virus generated antibodies capable of fending off live polio. Dr. Dwight Murray, then chairman of the American Medical Association, called Salk's announcement "one of the greatest events in the history of medicine." Within weeks, the stockpiled vaccine was being injected into the arms of millions of people worldwide.
Virus and the tumors, 1959
Four years later, Bernice Eddy, a researcher at the National Institutes of Health, noticed something strange while looking through her microscope. Monkey kidney cells - the same kind used to make the vaccine - were dying without apparent cause. So she tried an experiment. She prepared kidney extracts from eight to 10 rhesus monkeys and injected tiny amounts under the skin of 23 newborn hamsters. Within nine months, "large, malignant, subcutaneous tumors" appeared on 20 of the animals.
On July 6, 1960, concerned that a monkey virus might be contaminating the polio vaccine, Eddy took her findings to Dr. Joseph Smadel, chief of the NIH's biologics division. Smadel dismissed the tumors as harmless "lumps." The same year, however, at a Merck laboratory in Pennsylvania, Dr. Maurice Hilleman and Dr. Ben Sweet isolated the virus. They called it simian virus 40, or SV40, because it was the 40th virus found in rhesus kidney tissue.
Immunization campaign, 1961
By then, the nation was winning the war against polio. Nearly 98 million Americans - more than 60 percent of the population - had received at least one injection of the Salk vaccine, and the number of cases was plummeting.
At the same time, an oral polio vaccine developed by virologist Albert Sabin was in final trials in Russia and Eastern Europe, where tens of millions had been inoculated, and it was about to be licensed in the United States. Unlike the Salk vaccine, the oral version contained a live but weakened form of polio virus and promised lifelong immunity.
But U.S. Public Health Service officials were worried. Tests had found SV40 in both the Sabin and Salk vaccines - it was later estimated that as much as a third of the Salk vaccine was tainted - and that SV40 was causing cancer in lab animals. In early 1961, they quietly met with the agency's top vaccine advisers. The agency found no evidence that the virus had been harmful to humans, but in March, the officials ordered manufacturers to eliminate SV40 from all future vaccine.
New procedures were adopted to neutralize the tainted polio virus seed stock and SV40-free African green monkeys were used to produce the bulk vaccine instead of rhesus monkeys. But officials did not recall contaminated Salk vaccine - more than a year's supply - still in the hands of the nation's doctors. And they did not notify the public of the contamination and SV40's carcinogenic effect on newborn hamsters.
Hilleman would later explain that government officials were worried that any potentially negative information could ignite a panic and jeopardize the vaccination campaign. The first public disclosure that the Salk vaccine was contaminated came in the New York Times on July 26, 1961. A story on Page 33 reported that Merck and other manufacturers had halted production until they could get a "monkey virus" out of the vaccine. When asked to comment, the U.S. Public Health Service stressed there was no evidence the virus was dangerous.
No cause for alarm, 1962
The next year, a young Harvard-trained epidemiologist named Dr. Joseph Fraumeni joined the National Cancer Institute and was assigned one of the agency's most important projects: to determine if there was any cancer increase among those injected with the Salk vaccine. His research would form the basis of the government's position for decades. Working with two colleagues, Fraumeni tested stored vaccine samples from May and June of 1955, the first months of the national immunization campaign, then ranked the samples according to how much SV40 they contained - no, low or high amounts.
It would be the only time U.S. health officials measured the level of SV40 in the 1955-1962 vaccine. Stored samples from that period were later discarded. Fraumeni identified the states where the SV40-contaminated vaccines had been distributed during those two months. California, for example, received vaccine with a low level of the virus.
The study looked at cancer mortality rates for 6- to 8-year-old children vaccinated during that narrow time frame, tracking the group for four years. The findings, which were published in the Journal of the American Medical Association, showed no significant difference in cancer deaths in states with high or low levels of SV40 in the vaccine when compared with cancer deaths in states with no SV40 in the vaccine.
Cleveland children, 1976
Fourteen years later, after isolated reports linking the virus and human cancers, Fraumeni decided to look at another group that had received contaminated vaccine. The group had been the subject of experiments conducted in the early 1960s at Cleveland Metropolitan General Hospital. To determine the effect of different amounts of the vaccines, researchers at the hospital inoculated newborns from mostly lower-income black families with doses ranging up to more than 100 times the dose recommended for adults.
The experiments took place over three years and involved 1,073 infants. Most were given Sabin oral vaccine later determined to contain SV40. From 1976 to 1979, Fraumeni and his associates sent letters to the children - now age 17 to 19 - but fewer than half responded. The researchers found no SV40-related health problems from exposure to contaminated vaccine.
However, their 1982 report published in the New England Journal of Medicine acknowledged the study's limitations: A majority of the children had not responded; SV40-related cancers might take longer than 17 to 19 years to develop, and SV40 appears less likely to infect humans through the oral vaccine.
Nevertheless, they called their findings "reassuring and consistent with the prevailing view that SV40 is not carcinogenic in human beings." Then they decided to end the study, citing "the mounting complexities and obstacles in tracing this particular group and the negative results to date." The study's closure appeared to end the government's research into the virus. But a few years later there would be a tectonic shift in SV40 research.
First discovery, 1988
In Boston, two researchers stumbled onto something disturbing. Dr. Robert Garcea and his assistant, Dr. John Bergsagel, were using a powerful new tool called polymerase chain reaction, or PCR, to look for a pair of common human viruses in children's brain tumors. But a different DNA footprint kept popping up in more than half the tumors. They finally realized they were seeing SV40.
For more than a decade, scientists had reported sporadic findings of SV40- like proteins in human tumors. But the earlier tests were primitive and the results suspect. PCR, however, is capable of amplifying infinitesimal fragments of DNA, which makes detections far more credible. The findings were troubling. The researchers noted in their published report that the children were too young to have received the contaminated vaccine. But somehow the virus had infected them and embedded itself in their tumors.
Mesothelioma, 1988
That same year, Dr. Michele Carbone was surprised to find a milky, rind like tumor in a laboratory hamster at the National Institutes of Health in Bethesda, Md. The animal was one of a group given an SV40 injection directly into their hearts. Sixty percent of those hamsters developed the fatal cancer called mesothelioma.
Carbone, a postdoctoral fellow at the institute, knew that SV40 caused tumors in hamsters but only in specific locations where large doses of virus were injected. Here the mesothelial membrane lining the lungs apparently became cancerous from minuscule amounts of SV40 shed by the tip of the needle on the way to the hamsters' hearts. So he tried another experiment, this time injecting SV40 directly into the thin mesothelial walls of another group of hamsters. Within six months, every animal developed mesothelioma.
Carbone was puzzled. Mesothelioma is a rare cancer. Few human cases were reported before the 1950s, but its incidence had been increasing steadily, reaching several thousand cases a year in the United States by 1988. Studies had linked mesothelioma to asbestos exposure - with tumors usually appearing many decades later. Yet 20 percent of victims had no asbestos exposure. Carbone decided to use PCR to test 48 human mesotheliomas stored at the NIH. He was stunned: 28 of them contained SV40.
More cancers, 1996
PCR unleashed a wave of SV40 discoveries.
By the end of 1996, dozens of scientists reported finding SV40 in a variety of bone cancers and a wide range of brain cancers, which had risen 30 percent over the previous 20 years. Then, Italian researchers reported finding SV40 in 45 percent of the seminal fluid samples and 23 percent of the blood samples they had taken from healthy donors. That meant SV40 could have been spreading through sexual activity, from mother to child, or by other means, which could explain how those never inoculated with the contaminated vaccine, such as the Boston children, were being infected.
Government assurances, 1996
At the National Cancer Institute in Bethesda, officials were growing increasingly concerned about the SV40 discoveries. The findings were of particular interest to Fraumeni, who had been promoted to director of NCI's Division on Cancer Epidemiology and Genetics. His earlier studies concluding that SV40 posed little or no health risk were now under challenge.
But the scientific community was skeptical of the recent SV40 discoveries. As a potent carcinogen in lab animals, SV40 had been used for years as a tool to study cancer. Therefore, the powerful PCR test was suspected of finding stray SV40 fragments that might have contaminated laboratories.
So Dr. Howard Strickler, one of Fraumeni's epidemiologists, led a study using PCR on 50 mesotheliomas from Armed Forces hospitals across the country. And he found no SV40. Although the findings bolstered the government's long-standing position that SV40 did not appear to be a health risk, federal officials decided to convene a conference on the virus. In January 1997, 30 scientists gathered at the National Institutes of Health in Maryland. Garcea, Carbone and others presented their evidence showing SV40 in tumors and pleaded for research funding.
Strickler presented his mesothelioma study, as well as new research he had just completed, this time working with Fraumeni. Their new study compared 20 years of cancer rates of people born between 1947 and 1963, and therefore likely to have been exposed to the contaminated polio vaccine, with people born after 1963, who they believed weren't exposed.
Their study found no significant difference between the two groups.
Letter of protest, 1998
But when Susan Fisher read Strickler and Fraumeni's study in the Journal of the American Medical Association, she fired off a letter of protest to the publication. An epidemiologist at Loyola University Medical Center in Maywood, Ill., Fisher challenged the study's methodology, calling it "an error in judgment" and misleading. Using the same 20-year national cancer database for the two groups, Fisher compared people of the same age - "because these cancers are highly correlated with age" - and she came up with very different results.
Studying 18- to 26-year-olds who probably had been exposed to the contaminated vaccine, Fisher found a 19.6 percent greater incidence of the two major brain cancers linked to SV40 when compared with the incidence in people the same age who were not exposed. She also found 16.6 percent more bone cancers and 178 percent more mesotheliomas among those exposed to the vaccine.
But Fisher cautioned against comparing the two groups. She argued that if SV40 is being transmitted and circulating in the population, then many people in the "unexposed" group would also be carrying the virus and that would undermine the comparison.
Two types of SV40, 1999
For years, researchers had believed that all SV40-contaminated Salk vaccine made between 1955 and 1963 had been used or discarded. Then in 1999, Carbone was contacted by a former public health director in Oak Park, Ill., who said he had seven sealed vials of vaccine dated October 1955 in a refrigerator in his basement. Carbone, who had left the NIH and joined the faculty at Loyola University Medical Center, ran tests on the vaccine and made a startling discovery: Not only was the vaccine contaminated, it contained a second form of the virus - an "archetypal" SV40 strain.
Although manufacturers switched from rhesus monkeys to SV40-free green African monkeys to grow the bulk vaccine in 1961, they have continued to use potentially contaminated polio seed strains originally grown on the rhesus monkey tissue to start the bulk vaccine process. Manufacturers check the purity of their vaccine with a series of 14-day tests to detect whether any SV40 slipped through. But when Carbone replicated the tests, he found that the second, slower- growing "archetypal" strain took 19 days to emerge. It was possible, Carbone noted in a published report, that this second strain of SV40 had been evading manufacturers' screening procedures for years - and infecting vaccine recipients after 1962.
Controversial study, 2000
Meanwhile, a new study led by Strickler had bogged down in bitter internal conflict.
After the NIH's 1997 conference, nine laboratories were recruited to participate in a government-sponsored study to determine if tests were really finding SV40 in tumors or whether earlier detections were the result of laboratory contamination. Carbone and other researchers considered the study unnecessary. A similar multilab study led by Dr. Joseph Testa of Philadelphia had just been completed, and it virtually eliminated the contamination theory. The prestigious journal Cancer Research published Testa's findings in 1998.
But Strickler pressed on.
An independent laboratory in Maryland prepared mesothelioma samples for the nine labs.
When tests revealed almost no SV40 in the tumor samples, some participants questioned the preparation methods used by the Maryland lab. They also challenged Strickler's written conclusion implying that contamination had caused the earlier findings of SV40 in tumors. If Strickler was right, the earlier SV40 detections were probably the result of stray SV40 in the labs. But critics argued that the study was scientifically flawed and should be scrapped.
The dispute became so contentious that FDA officials were forced to intervene and a neutral arbitrator assigned to mediate. Finally, in early 2000, more than two years after the study was initiated, a carefully rewritten report emerged for publication. It concluded that contamination was an unlikely explanation for earlier SV40 findings. Then it struggled to explain the discrepancy between earlier detections of SV40 in about half of all mesotheliomas tested and the fact that the nine labs found the virus in only slightly more than 1 percent of the study's tumor specimens.
The report noted that discrepancy might be because of the inefficiency of the method used by the Maryland lab to recover DNA - like the genetic sequences of SV40 - from the mesothelial tissue to create the test samples. The Maryland lab also had inadvertently contaminated some of the laboratory controls and "theoretically" could have contaminated others. The report concluded by calling for further research. Despite the study's ambivalent conclusions and technical problems, the NCI submitted it to Cancer Research, the journal that had published Testa's study.
It was rejected.
Further discoveries, 2000
In laboratories around the world, researchers continued to find SV40 in a widening range of tumors that now included pituitary and thyroid cancers and some lymphomas. Meanwhile, an NCI investigator named Dr. David Schrump was able to gut a common respiratory virus and use it to deliver genetic material called "antisense" into SV40-infected mesothelial cells and stop the cells' malignant growth.
His discovery, which was patented by the government, strongly suggested that SV40 contributed to mesothelioma and that a treatment might be possible. Then in August, Carbone and several colleagues published a major study providing a "mechanistic" explanation of how SV40 contributes to the uncontrolled growth of mesothelial cells. The key, they found, was the large number of "tumor suppressor" proteins found in the mesothelial cells that makes them unusually susceptible to SV40.
In most human cells, they said, the virus reproduces itself and kills the infected cell in the process. But in mesothelial cells, SV40 is especially attracted to the "tumor suppressor" proteins and binds to them, knocking them out of action. The virus then lives on in the cell. The result, they said, is a rate of malignant cell transformation in tissue cultures 1,000 times higher than has ever been observed. In a paper published in the Proceedings of the National Academy of Science, Carbone further explained that asbestos fibers appear to act as a co- carcinogen in mesothelioma by somehow suppressing the immune system's response, which is designed to kill the infected cells.
Chicago conference, 2001
Carbone and others believed that the time had come for another conference on the virus he calls "a perfect little war machine." In April, more than 60 scientists gathered on a warm weekend at the University of Chicago's downtown conference center. Despite numerous faxes and certified letters inviting him, Strickler declined to attend.
Carbone opened the conference by confronting the question of whether SV40 is present in humans.
"Sixty-two papers from 30 laboratories from around the world have reported SV40 in human tissues and tumors," he said. "It is very difficult to believe that all of these papers, all of the techniques used and all of the people around the world are wrong." For two days, scientists from as far away as China and New Zealand presented the results of their studies, with almost every speaker concluding that SV40 was present in the tissues they examined.
One of the newest discoveries came from Dr. Jeffrey Kopp, an NIH scientist who reported finding SV40 in a high percentage of patients with kidney disease. The virus was also present, he said, in 60 percent of a new "collapsing" type of renal disease that was unknown before 1980 but has since increased rapidly in incidence. There were also reports on efforts to develop a vaccine, recently funded by the NCI, that would allow the immune system to target and eliminate SV40. At times, the meeting took on almost revivalist overtones as scientist after scientist said he or she was initially very skeptical of SV40's presence in human tumors but was now a believer. "I was a hard sell," said Testa, the Philadelphia geneticist who conducted the first multilaboratory tests, noting that the study had convinced him.
Gazdar, the cancer researcher from Texas, showed a slide describing his transformation: "Nonbeliever -- Believer - Zealot." The conference concluded with a consensus among the leading scientists that SV40's presence in human tumors was no longer in question. They were more circumspect about the virus' possible role in causing cancer. If SV40 is a human carcinogen, they said, the virus probably requires interaction with other cancer-causing substances like asbestos.
Dr. Janet Butel from Baylor Medical College in Houston said that it simply might be too soon to make a determination, citing the many years it has taken to establish that other viruses cause cancer. But even renowned tumor biologist George Klein from Sweden said he was impressed by Carbone and Schrump's work.
"This strongly suggests that the virus plays a role (in causing tumors)," said Klein, a former chairman of the Nobel Assembly.
Low priority, 2001
In May, shortly after the conference, Strickler's multilab study was published in a small journal called Cancer Epidemiology, Biomarkers & Prevention. Carbone and other SV40 experts dismissed the study. "A garbage paper in a garbage journal," said Garcea, now on the faculty at the University of Colorado School of Medicine.
But Strickler strongly defends the study. He said it was the first to use strict controls not used in other studies. He acknowledged, however, that the study "doesn't prove that SV40 is not out there." Strickler, who now teaches at Albert Einstein School of Medicine in New York, said he remains skeptical about whether SV40 has infected humans, a suspicion he says is shared by the broader scientific community.
But the NCI recently acknowledged that there is evidence to suggest that SV40 "may be associated with human cancer." The NCI statement, released last month, also said that SV40's interaction with "tumor suppressor proteins" indicates "possible mechanisms that could contribute to the development of cancer." Top NCI officials declined to be interviewed on the record for this report. Fraumeni also declined several requests for an interview.
Dr. James Goedert, the chief of the NCI's Viral Epidemiology Branch who supervised Strickler's work, said that if SV40 is in human tumors, it must be at extremely low levels. To critics who claim the government has downplayed SV40's potential health risks, Goedert responded: "Absolutely not." He acknowledged that research is needed to resolve the question of whether SV40 is prevalent in the human population and, if so, how it might be spreading. But Goedert said he has no plans for such studies.
"It's not our highest priority," he said. Key figures in developing vaccines and tracing SV40 Dr. Jonas Salk Developed the first polio vaccine using killed virus in 1955. Virologist Albert Sabin Developed an oral vaccine using weakened live virus. Dr. Robert Garcea Used new technology to trace SV40 in children's brain tumors.
Q&A on polio vaccine contaminated with SV40 Q: How widespread is the SV40 infection?
A: Scientists and government health officials don't know because no comprehensive studies have addressed the question.
What is known: During the 1950s and '60s, more than 100 million people worldwide were given SV40-contaminated polio vaccine. The virus also has been found in people who did not receive contaminated vaccine, as well as laboratory workers and monkey handlers. No studies, however, have examined how SV40 might be transmitted between people, or if somehow humans might have become infected with SV40 before the introduction of the tainted vaccines.
Q: Can I be tested for SV40?
A: An accurate blood test does not exist. Current antibody blood tests can be inaccurate, scientists say, because they may also detect the presence of other closely related viruses, and SV40 may be present at such a low level that no antibodies are produced. Researchers are working to create an effective test.
Q: Is the current polio vaccine safe?
A: Vaccine producers, health officials and most scientists believe that it is safe. Manufacturers say they take elaborate steps to test their vaccine for SV40, and the government says it recently tested vaccine samples back to 1972 and found no trace of SV40.
Some scientists, including Dr. Michele Carbone, have raised questions about whether manufacturers' testing techniques have been adequate. Carbone, however, tested vaccine from 1996 and found no SV40. He has had his children inoculated.
Q: In which kinds of cancers has SV40 been found?
A: The virus has been detected in rare cancers:
-- Mesothelioma, a fatal tumor of the membrane surrounding the lungs. Few cases were reported prior to 1950, but the incidence has grown in the United States to 2,000 to 4,000 cases a year, with greater incidence in Europe.
-- Brain cancers: Primarily ependymoma and choroid plexus tumors, but also astrocytoma, glioblastoma, medulloblastoma and meningioma. These make up a total of less than 1,000 U.S. cases each year.
-- Bone cancers: Primarily osteosarcoma but also chondrosarcoma and giant cell tumors. These also make up less than 1,000 cases annually.
-- Other cancers: A few detections in pituitary and thyroid tumors and lymphomas.
Report sources
The sources for this report include the books "The Saga of Jonas Salk" by Richard Carter and "The Health Century" by Edward Shorter; articles in Atlantic Monthly and New York magazine; newspaper archives at The Chronicle and the New York Times; transcript of the 1997 National Institutes of Health Conference in Bethesda; a review of dozens of scientific journal articles and scores of interviews.
Related series: Quest for the Origin of AIDS.
How SV40 contaminated polio vaccine
When Dr. Jonas Salk introduced the first polio vaccine in 1955, it was hailed as "one of the greatest events in medicine." Within 10 years, U.S. polio cases plummeted from 30,000 to less than 1,000. But in 1960, a monkey virus called SV40 was found in the Salk vaccine. As much as one-third of the vaccine was contaminated. SV40 was also found in earlier versions of an oral vaccine developed by Dr. Albert Sabin that replaced the Salk vaccine in the 1960s.
When it was discovered that SV40 caused cancer in lab animals, U.S. health officials ordered vaccine manufacturers in 1961 to eliminate the virus from all future vaccine, although questions remain about whether they succeeded with the Sabin vaccine. .
Making the Sabin vaccine: 1955-1961 Starting in the mid-1950s, both Sabin and Salk vaccines are made by growing polio virus on kidney tissue from Asian rhesus monkeys, which are natural hosts for the simian virus known as SV40.
Special weakened seed strain of polio virus developed by Sabin is grown on rhesus kidney tissue to make large bulk amounts of vaccine. SV40 from the kidney tissue contaminates the vaccine. Making the vaccine safe: 1961 In 1961, after SV40 is discovered in the vaccines, U.S. health officials order manufacturers to eliminate SV40. Antiserum is used to neutralize SV40 in seed stock, and SV40-free African green monkeys are used to grow bulk vaccine. But some researchers believe small amounts of SV40 may have survived. .
Testing Manufacturers check the safety of the vaccine pools by using a series of 14- day growth tests to see if SV40 is present. Making the Salk vaccine: 1955-1961 Full strength polio virus is grown on rhesus kidney to make bulk Salk vaccine. SV40 from the kidney tissue contaminates the vaccine. The polio virus is then killed with formaldehyde, but some SV40 survives. .
Making the vaccine safe: 1961 In the original vaccine, the SV40 survives, contaminating up to 30 million Americans. But after 1961, African green monkeys are used to grow bulk vaccine and SV40 is eliminated.
Sources: Children's Hospital of Philadelphia; SEER; virus images by Jean Yves Sgro, University of Wisconsin; Chronicle research
BIBLIOGRAPHIC NOTE
For more information about the simian virus SV40, the following studies or scientific reviews were published during that past year:
A multicenter evaluation of assays of detection of SV40 DNA and results in masked mesothelioma specimens. Strickler H, Goedert J., Cancer Epidemiology, Biomarkers & Prevention. Vol. 10, 523-532, May 2001.
Simian virus 40 and human cancers, Strickler H., Einstein Quarterly J. Biol. and Med. (2001) 18:14-21. This includes a detailed bibliography that will lead readers to earlier scientific articles.
Oral polio vaccine and human cancer: a reassessment of SV40 as a contaminant based upon legal documents. Kops S., Anticancer Research (2000) 20: 4745-4750.
Human mesothelial cells are unusually susceptible to SV40-mediated transformation and asbestos cocarcinogenicity. Bocchetta M, Di Resta I, Powers A, Fresco R, Tosolini A, Testa J, Pass H, Rizzo P, Carbone M., Proc. Natl. Acad. Sci. USA, Vol. 97, Issue 18, 10214-10219, Aug. 29, 2000.
In addition, a bibliography of journal articles by leading SV40 researcher Dr. Michele Carbone can be viewed by clicking on the following link: www.chestsurg.org/carbone7.htm
E-mail William Carlsen at wcarlsen@sfchronicle.com.
Today's News Stories News Archive:
SV40, polio vaccine, and cancer: Now beyond coincidence?
http://news.bmn.com/news/story?day=020410&story=2
9 April 2002 10:40 EST by Apoorva Mandavilli, BioMedNet News San
Francisco -
At the American Association of Cancer Research meeting here today, controversy continued to swirl around accusations that contaminated polio vaccine stocks are to blame for certain cancers, based on the publication a month ago of two high-profile papers linking the simian virus SV40 to human lymphomas.
Less than a week after the papers were published in March, the US National Cancer Institute contacted the researchers to establish plans to send blinded results to three independent labs, lead researcher Adi Gazdar told BioMedNet News today.
But Gazdar seems unconvinced of the NCI's intentions. "They just want to prove us wrong," he said. Gazdar and his colleagues scanned 99 lymphomas, 235 epithelial tumors and 40 control tissues for the virus. They found the virus in 43% of non-Hodgkin's lymphomas, 9% of Hodgkin's lymphomas, and in none of the control tissues. A second team independently found the virus in 42% of non-Hodgkin's lymphomas, "almost unbelievable agreement," said Gazdar, who is professor of pathology at the University of Texas Southwestern medical center.
"These are very respectable labs with basically identical results," said Michele Carbone, associate professor of pathology at Loyola University in Chicago. The "clear clustering of positives" is "no accident," he told BioMedNet News.
This is not the first time scientists have linked SV40 to human cancers. Researchers suggested for years that millions of vials of polio vaccine, contaminated with SV40, infected individuals between 1953 and 1963 and caused human tumors. Until recently, they were inevitably met with skepticism, even contempt - and some NCI researchers published directly contradictory results.
In 1997, the US National Institutes of Health, with other organizations, organized an international conference to review the SV40 literature and address the possibility that the virus causes human tumors. At the meeting, Carbone, presented his then-controversial data linking the virus to mesotheliomas. (Since then, more than 30 independent reports have confirmed his results).
After the meeting, Carbone says, a conscientious Chicago public health official contacted Carbone and gave him the last remaining stocks of polio vaccine from the 1950s. In her paper, Butel isolated a strain of SV40 from three patients that closely matches the strain Carbone sequenced from the polio vaccine vials.
The evidence proves Butel's results are no artifact, Carbone says. "You cannot contaminate with something that doesn't exist," he said. "This thing only exists in my freezer."
Since publication of their research in the Lancet last month, Gazdar and his colleagues have been investigating rarer subtypes like leukemia and multiple myelomas. The experiments have not been proceeding as fast as they would like, Gazdar says, partly because "there's no government funding" for the research. "The lymphoma story might force them to [fund it]."
An important next step, Gazdar says, is to prove that the SV40 virus causes lymphomas and isn't just a "passenger" in the cells. That is no easy task, since researchers have only been able to isolate the virus in rare instances. For the most part, they believe, the virus launches a "hit-and-run" attack, initiating a cascade of tumorigenic events before it is destroyed by the body.
Still, it is critical that this research continue, Gazdar says, because molecular and immunologic data suggest those born after 1963 have also been exposed to the virus, via horizontal or vertical transmission, or through sexual contact.
The rates of mesotheliomas, lymphomas and brain tumors have also all gone up "dramatically" in the last 30 years. "Coincidence or not, we have to find out," he said. "It's something to think about."
"Now Carbone was asking Pass for his help in proving a controversial theory he had developed about the origins of mesolthelioma, a deadly cancer that afflicts the mesothelial cells in the lining of the chest and the lung. Mesolthelioma was virtually unheard of prior to 1950, but the incidence of the disease has risen steadily since then. Though it is considered rare-accounting for the deaths of about 3,000 Americans a year, or about one half of one percent of all domestic cancer deaths-the disease is particularly pernicious. Most patients die within eighteen months of diagnosis.
Pass, one of the world's leading mesothelioma surgeons, knew, like other scientists, that the disease was caused by asbestos exposure. But Carbone had a hunch he wanted to explore. He told Pass that he wondered if the cancer might also be caused by a virus-a monkey virus, known as simian virus 40 or SV40, that had widely contaminated early doses of the polio vaccine, but that had long been presumed to be harmless to people.
Pass listened as Carbone described for him the history of the early polio vaccine. A breakthrough in the war against polio had come in the early 1950's, when Jonas Salk took advantage of a new discovery: monkey kidneys could be used to culture the abundant quantities of polio virus necessary to mass-produce a vaccine. But there were problems with the monkey kidneys. In 1960 Bernice Eddy, a government researcher, discovered that when she injected hamsters with the kidney mixture on which the vaccine was cultured, they developed tumors. Eddy's superiors tried to keep the discovery quiet, but Eddy presented her data at a cancer conference in New York. She was eventually demoted and lost her laboratory. (Gosh, that sounds so much like Wakefield doesn't it. Interesting how history repeats itself. Suzan's comments.) The cancer-causing virus was soon isolated by other scientists and dubbed SV40, because it was the fortieth simian virus discovered. Alarm spread through the scientific community as researchers realized that nearly every dose of the vaccine had been contaminated. In 1961 federal health officials ordered vaccine manufacturers to screen for the virus and eliminate it from the vaccine. Worried about creating a panic, they kept the discovery of SV40 under wraps and never recalled existing stocks. For two more years millions of additional people were needlessly exposed-bringing the total to 98 million Americans from 1955 to 1963. But after a flurry of quick studies, health officials decided that the virus, thankfully, did not cause cancer in human beings."End quote
But, alas, the research has shown, as demonstrated and revealed in this well-written article, that it does indeed cause cancer. In fact it is THE most oncogenic virus known to man.
Another excerpt:
"The virus has also been located in other kinds of tumors. More than a dozen laboratories have found SV40 in various kinds of rare brain and bone tumors. In 1996 Carbone reported that he had found SV40 in a third of the osteosarcomas (bone cancers of a type that afflicts about 900 Americans a year and nearly half of the other bone tumors he tested-research that has since been confirmed by numerous laboratories. The virus has also been detected in pituitary and thyroid tumors.
The possibility of a link between SV40 and brain tumors is particularly intriguing. Like mesothelioma, brain tumors have become dramatically more common in recent years. Brain tumors will be diagnosed in about 3,000 children in the United Stated alone this year. In 1995 Janet Butel, the chairman of the department of molecular virology and microbiology at the Baylor College of Medicine, in Texas, and her chief collaborator, John Lednicky, also a Baylor virologist, reported that they had found SV40 in a number of children's brain tumors. Butel and Lednicky reported that DNA sequencing revealed that the virus was not a hybrid but rather authentic SV40-the same as the SV40 found in monkeys. In the fall of 1996 an Italian research team, led by Mauro Tognon, of the University of Ferrara, announced that it had found SV40 DNA in a large percentage of brain and neurological tumors, including glioblastoma, astrocytomas, ependymomas, and papillomas of the choroid plexus. The researchers suggested that SV40 may be a "viral co-factor" involved in the sharp rise in human brain tumors. Late last year an extensive study undertaken in China reinforced those results. The study examined sixty-five brain tumors, finding SV40 in each of the eight ependymomas and two choroid-plexus papillomas, common brain tumors among CHILDREN.(my emphasis). It also found the virus in 33 to 90% of five other kinds of brain tumor examined. The authors, writing in the November, 1999, issue of Cancer, noted that the virus was actively expressing proteins.
Recent research also indicated that SV40 has gained a secure foothold in the human species. In 1996 Tognon and his collaborators reported that they had also found the virus in 45 percent of sperm samples and 23 percent of the blood samples they tested from healthy people, suggesting that the monkey virus could spread through sexual contact or unscreened blood products. In 1998 the presence of SV40 antibodies in human blood samples was reported by Butel, who tested several hundred American blood samples and found antibodies to SV40 in about 10 percent of them. Butel's laboratory also tested samples from children born from 1980-1995-decades after the contaminated vaccine was removed from the market. A surprising six percent tested positive-offering evidence that the virus may now be spreading from person to person, including from mother to child."
[Here is a remarkable piece of investigative journalism on the SV40 virus and the contaminated polio vaccines being linked to all kinds of cancers - part of this article was picked up in the Houston Chronicle too. Please see bottom of note for the email address to send letters of thanks to the journalist. Dawn]
http://www.sfgate.com/cgi-bin/article.cgi?file=/chronicle/archive/2001/07/15
/MN193825.DTL
by Geraldo Fuentes
Editor's Note:
When we first ran Geraldo's first story, SV-40, A Deadly Cure? we thought it was a bit on the conspiratory side, but it seemed well researched. We were pleased that many other journalists also investigated the material, proving the sad truth that Geraldo reported in ViewZone.
Research has now firmly linked many of today's cancers with tainted virus vaccinations given in the early 1950s. Could there be any more shocking and horrific revelations like this? We didn't think so - but we were wrong.
The latest horror story is posted HERE: SV40 Part Two for you to ponder. As you read it, also do not forget the Black Americans that were knowingly infected with Syphilis or the soldiers made to march through the fallout of our nuclear bomb tests...
But first, read Geraldo Fuentes original story.
If you received a polio vaccination in the 50's,
you may have gotten more than you know...
It was 1956. I was only six years old and attended grade school in Springfield, Massachusetts. I was too young to recollect the first round of polio vaccinations, but I have a few memories. I remember that my first grade class was escorted to the school gymnasium. There was a peculiar smell in the air. I think it was probably rubbing alcohol. And some of the other kids were crying. The shot itself wasn't so bad. I didn't cry, but my best friend did. At the end of the ordeal we all got a lollipop.
A few years later, when we marched again to the gymnasium it was different. There was no crying and no alcohol odor. Instead, there were long tables bearing neat rows of small paper cups, filled about half way with a liquid that tasted like bitter orange juice. White clad Nurses watched as each child drank the vaccine. There was no lollipop and, after we handed back the cup, we simply returned to class.
The government had initiated the mandatory polio vaccination programs in 1955. Prior to this, polio had killed or crippled thousands of children and adults all over the world. Attacking the central nervous system, this viral infection was transmitted by human contact, sewage and even by contaminated milk. Victims who contracted polio would incubate the virus in their intestines, where it would multiply and enter the lymphatic system. Eventually the virus would penetrate the nerves and travel along nerve paths, destroying neurons and rendering the muscles connected to them paralyzed.
The polio epidemic reached its height in 1952. It turned thousands of victims into cripples and confined countless children to large pressure chambers called "iron lungs," which helped them to breath when their diaphragm muscles were stilled. There was and still is no treatment for polio. Aside from attempts to maintain life functions, the disease must run its course.
And so, in 1955, just one year before I received it, Jonas Salk had performed no small miracle when he successfully mass-produced an effective polio vaccine by growing a form of the virus on the kidneys of rhesus monkeys. This virus would be harvested, killed, and given to healthy children like me, who would then develop antibodies which would kill any future invasion of the body by the polio virus.
This happy story of medical marvel has a deadly glitch. And it is especially deadly if, like me, you received your vaccinations in the 1950s, in certain states like Massachusetts.
In 1960, researchers discovered that the polio vaccine distributed to certain states was infected with another virus called "Simian Virus 40." SV-40 is a monkey virus that is not normally found in humans. Unknown at the time, it was present in hundreds of rhesus monkeys that were used to grow and harvest the polio vaccine. Injected into research animals, the SV-40 virus causes brain and lung cancers. Now, some forty years later, its effect on humans is just being investigated.
SV-40 has appeared in 61% of all new cancer patients -- patients too young to have received the contaminated vaccine being administered forty years ago!
Michele Carbone, Assistant Professor of Pathology at Loyola University in Chicago, has recently isolated fragments of the SV-40 virus in human bone cancers and in a lethal form of lung cancer called mesotheliomas. He found SV-40 in 33% of the osteosarcoma bone cancers studied, in 40% of other bone cancers, and in 60% of the mesotheliomas lung cancers. Dr. Carbone believes this study explains why 50% of the current mesotheliomas being treated were no longer occurring in association with asbestos exposure, their traditional cause.
Researchers from the Institute of Histology and General Embryology of the University of Ferrara, lead by Dr. Fernanda Martini, discovered SV-40's presence in a variety other tumors. They found the rhesus monkey virus in 83% of choriod plexus papillomas, in 73% of ependymomas, in 47% of astrocytomas, in 50% of glioblastomas, and in 14% of meningiomas.
SV-40 also has been found in 23% of blood samples and 45% of sperm fluids taken from normal individuals! Researchers have determined the SV-40 virus can be transmitted sexually and through blood transfusions.
Even more shocking, SV-40 has appeared in 61% of all new cancer patients -- patients even too young to have received the contaminated vaccine being administered forty years ago! How could this happen?
My second vaccination was from a cup. This was the brainstorm of the FDA. Instead of getting the "dead" virus in an injection, the Federal vaccination policy mandated that children should be given the new live "oral polio vaccine" (OPV). This decision was based upon the belief that the OPV recipient would "shed" the virus through body contact with other non-vaccinated children and adults, thereby spreading the "live" virus throughout the population. Since the infection was extremely small, it would produce the desired antibodies while posing no threat of contracting polio. This, it was thought, would assure the total immunization of America and the eradication of the disease. The public was never informed that this national health strategy was being implemented, despite several cases of polio which were directly attributed to the vaccine.
By 1963, the estimated number of tainted polio vaccinations was estimated to be upwards of 98-million!
The SV-40 virus that contaminated the oral polio vaccine quickly spread from child to child and from child to adult, crossing state lines and national boundaries. By 1960, when the virus was first detected, it was already too late to prevent its dissemination throughout the population. The FDA quietly and gradually instituted a program to eliminate rhesus monkeys, who harbor the SV-40, and replace them with African Green monkeys that are free of the virus. By 1963 the monkeys had been replaced but the estimated number of tainted polio vaccinations was estimated to be 98-million!
According to the National Institutes of Health, high levels of SV-40 were identified in polio vaccines in Washington, Oregon, Wyoming, Utah, Minnesota, Iowa, Wisconsin, Illinois, Michigan, Pennsylvania, Washington DC, Maryland, Delaware, New York, Connecticut, Rhode Island, Massachusetts, Vermont and New Hampshire. Low levels of SV-40 were found in California, Arizona, New Mexico, Colorado, Texas, Kansas, Nebraska, North Dakota, Missouri, Louisiana, Georgia, Tennessee, Kentucky, Ohio, and West Virginia. Polio vaccines in the other states show no SV-40 present.
This revelation has only recently come to public attention. Many people, like myself, were unaware that a potential for cancer had been implanted in their body. Researchers say that, by age fifteen, the virus stops shedding to others. I cannot but wonder how many people I contacted between the age of eight and fifteen... Did I shed the SV-40 virus to my mother, who eventually died of brain cancer? Will I contract brain, lung or bone cancer? Many other people in my age group are asking similar questions.
A number of public statements have been made by the National Cancer Institute in the past few months, attempting to put their spin on these disturbing revelations. In an statement published in the January (1999) New England Journal of Medicine, the institute states that there is no evidence of an increase in humans of the types of cancers found in laboratory animals that have been injected with SV-40. But other researchers remind us that SV-40 has already been found in a wide variety of other tumors. It has been shown that individuals who received the tainted oral vaccine demonstrate a higher occurrence of these cancers.
For example: people who lived in Massachusetts and Illinois in the 1950s, and received identified lot numbers of the contaminated oral vaccine, are now contracting osteosarcoma bone tumors at a rate of ten times more than those who received the vaccine free of the SV-40.
But the National Cancer Institute has been silent about these facts.
There needs to be more demographic studies to explore the relationship of SV-40 to adult onset cancers. Not surprisingly, the US government and its agencies are reluctant to pursue this matter. In fact, requests to the National Institute for Health for grants to study the SIV and simian cyto-megalovirus (SCMV) were recently denied. Microbiologist Howard Urnovitz, Ph.D., may have an explanation as he stated in the Boston Globe:
"that almost 100 million Americans were exposed (to SV-40) through a government sponsored program, but for over 30 years, there has been virtually no government effort to see if anyone's been harmed by the exposure." He added, "The government will not fund science that makes it look culpable."
Another method used by the National Cancer Institute to divert public concern is to issue statements that "many of the cancers under suspicion were contracted by people who are too young to have received the tainted vaccine in the 1950s." This argument, although true, ignores the potential of spreading the live SV-40 by "shedding" through personal contact. The oral polio vaccine was designed to be transmitted to non-vaccinated individuals by this very method. In fact, this was the reason that OPV was preferred over injection. If SV-40 is still being spread by contact today it is not surprising that these cancers are now affecting younger people.
Regardless of blame, severe damage to world health has already been done by the unsavory practice of growing vaccination products in animals. An example of these horrors was presented by Dr. Urnovitz at the Eighth Annual Houston Conference on AIDS.
Dr. Urnovitz revealed significant evidence that human immunodeficiency virus type 1 (HIV-1) is a monkey hybrid virus which was produced when 320,000 Africans were injected with polio virus contaminated with live simian immunodeficiency virus (SIV) in the late 1950's.
Apparently, viral fragments combine easily with other viruses to produce these hybrids called "chimeras." Prior to this revelation, health officials were blaming AIDS on the habit of certain Africans to consume monkey flesh.
What can be done now? "Make it in anything but animals," said Barbara Loe Fisher of the National Vaccine Information Center, which criticizes vaccine safety. "We have the technology to make vaccines in human cell lines that are clean," said Dr. Michele Carbone of Loyola University Medical Center, one of the first to discover SV-40 inside human tumors.
Until then we can only hope that researchers continue their work, regardless of the repercussions. Millions of people are already infected with SV-40 and are in danger. Many cancers do not develop until mid-life. Future generations must be protected. We must prohibit any future contamination of the world population, whether for our own good or not, by well-meaning governmental agencies.
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
www.researchprotection.org
Tue, 06 Aug 2002 20:24:12 +1200
Contact: Vera Hassner Sharav
212-595-8974 FAX 212-595-9086
veracare@rcn.com
The anthrax vaccine is not the only vaccine that has been linked to severe, debilitating illness. And this is not the first time that government public health agencies lied to the public about the health hazards associated with a vaccine. In her July 19 column in The Wall Street Journal (below), Sharon Begley reported that in 1961 the U.S. Public Health Service learned about SV40 contaminated polio vaccines given to (possibly) 98 million babies and kept that information from the public.
SV40 (known as the "monkey virus") is a known carcinogen that may change DNA to make humans more vulnerable to cancer. One year earlier, on July 15, 2001, The San Francisco Chronicle brought the issue to light: "Based on dozens of interviews and a review of the medical research, this is the story of how the campaign to eradicate polio may have inadvertently permitted another potentially deadly monkey virus to infect millions of people - and why the government for years discounted the accumulating evidence suggesting that SV40 may be a health risk for humans."
"How long can the government ignore this?" asked Dr. Adi Gazdar, a University of Texas Southwestern Medical Center cancer researcher. "The government has not sponsored any real research. Here's something possibly affecting millions of Americans, and they're indifferent. "Maybe they don't want to find out."
"The recent SV40 discoveries come at a time of growing concern over the dangers posed by a range of animal viruses that have crossed the species barrier to humans, including HIV, which scientists now believe came from chimpanzees and ultimately caused the AIDS epidemic. Based on dozens of interviews and a review of the medical research, this is the story of how the campaign to eradicate polio may have inadvertently permitted another potentially deadly monkey virus to infect millions of people - and why the government for years discounted the accumulating evidence suggesting that SV40 may be a health risk for humans."
[See, William Carsen, Rogue Virus in the Vaccine:Early Polio Vaccine Harbored Virus Now Feared to Cause Cancer in Humans, the San Francisco Chronicle,
http://www.sfgate.com/cgi-bin/article.cgi?file=/chronicle/archive/2001/07/15 / MN193825.DTL; William Carlsen, New Documents Show the Monkey Virus is Present in More Recent Polio Vaccine, San Francisco Chronicle, July 22, 2001,
http://www.sfgate.com/cgi-bin/article.cgi?file=/c/a/2001/07/22/MN173141.DTL
See also, Nicholas Regush, The Monkey Connection, ABC News,
http://abcnews.go.com/sections/living/SecondOpinion/secondopinion_47.html ]
Begley interviewed a former public health official, H.M. Ratner, who had refused to inoculate babies with the contaminated vaccine and kept a batch as evidence.
THE WALL STREET JOURNAL SCIENCE JOURNAL
Are Tainted Vaccines Given to Baby Boomers Now Causing Cancer?
By Sharon Begley 07/19/2002, B1 SNAPSHOTS OF YOUR government at work:
-- 1961. The U.S. Public Health Service, having learned in 1960 that millions of batches of polio vaccine were accidentally laced with a simian virus (vaccine was grown on minced monkey kidneys), quietly orders manufacturers to rid the vaccine of the contaminant, called SV40. PHS issues neither recall nor public announcement. Contaminated stocks already distributed are used until 1963.
-- 1999. H.M. Ratner, a former public-health official in Oak Park, Ill., invites Michele Carbone of nearby Loyola University School of Medicine over for coffee. In 1955, Dr. Ratner says, he had refused to administer the Salk polio vaccine. He felt it might not be safe. But he kept seven vials in his basement refrigerator for 44 years, hoping that, one day, someone would be interested in them. Someone is. Dr. Carbone is investigating the possibility that SV40-contaminated polio vaccine made by several manufacturers was, decades after being given to about 98 million baby boomers, increasing the risk of three rare cancers.
-- 2002. Last week, the Immunization Safety Review Committee of the Institute of Medicine (IOM) meets to consider evidence for and against that unthinkable hypothesis. Amid dueling data, some facts are uncontested. An estimated two-thirds of the polio vaccines -- the oral Sabin and the injected Salk -- administered from 1955 to 1963 contained SV40, including the vials Dr. Ratner saved. Contaminated vaccine was also given to children and some adults in Australia, Canada, Denmark and Germany, and possibly Russia, Mexico and other countries.
SV40 IS A KNOWN carcinogen. It targets the lung's mesothelial cells, brain cells, bone cells and blood cells, producing a protein that knocks out two human tumor-suppressor genes, p53 and Rb. There is no reliable blood test for SV40 exposure. Government data show the incidence of SV40-linked cancers has risen. A brain cancer called ependymoma is up 25%. Bone malignancies are up 23%.
Mesothelioma (infamous for being triggered by asbestos) is up 90%. All are extremely rare: Ependymoma, for example, strikes one in a million. Are the rising cancer rates coincidence? In 1994, Loyola's Dr. Carbone and colleagues examined human mesotheliomas. He found SV40 genetic sequences in 29 of 48 studied. SV40 has now been found in up to 80% of mesotheliomas in the U.S. and Europe. Dozens of labs have found SV40 in bone and brain cancers. Those, as I said, are rare. Epidemiologist Howard Strickler of Albert Einstein College of Medicine in New York, a leading skeptic of the vaccine-cancer link, notes that many studies fail to find SV40 in human tumors.
In March, however, researchers led by Janet Butel of Baylor College of Medicine, Houston, reported that 42% of the non-Hodgkin lymphomas they analyzed contained genetic sequences from SV40. And not just any SV40: In several tumors, it was precisely the genome of the SV40 in the vials of the 1955 polio vaccine that Dr. Ratner had held onto, waiting for someone to care. Lab-grown SV40 harbors a variant genome. There might be other sources, in addition to vaccine, of this strain of SV40, but to more and more scientists Dr. Butel's findings were the smoking gun.
WITH NON-HODGKIN lymphoma, we're no longer talking about rare malignancies. This cancer has spiked 82% in the U.S. since 1973, epidemiologist Susan Fisher of the University of Rochester, New York, told the IOM panel, with 56,200 new cases in 2001 and 24,000 deaths.
An analysis by Dr. Strickler shows no extra cancers among people thought to have been exposed to SV40-laced polio vaccine -- or, no extra increase that can't be explained by chance. Trouble is, with no test for SV40 exposure, it's impossible to be sure you're comparing an exposed to an unexposed group. You might be comparing populations exposed to SV40 with populations also exposed. Of course there'd be no difference.
What are the ramifications of this? Today's children are at no risk from polio vaccine; it's now grown in SV40-free cells. The public-health risk from SV40-laced polio vaccine is . . . well, one scientist told me it's "minimal." Another says "unknown." Tumors linked to SV40 are, except for lymphomas, so rare that even a doubling of risk due to SV40 still leaves you with good odds of never developing these cancers.
A wild card, though, is the World Trade Center collapse, which released asbestos into the air. Although SV40 alone rarely causes mesothelioma, when you add asbestos to the mix, all bets are off. The IOM committee's conclusions on SV40, polio vaccine and cancer are due out by the end of summer.
(Copyright (c) 2002, Dow Jones & Company, Inc.)
FAIR USE NOTICE: This may contain copyrighted () ) material the use of which has not always been specifically authorized by the copyright owner. Such material is made available to advance understanding of ecological, political, human rights, economic, democracy, scientific, moral, ethical, and social justice issues, etc. It is believed that this constitutes a 'fair use' of any such copyrighted material as provided for in section 107 of the US Copyright Law. In accordance with Title 17 U.S.C. Section 107, this material is distributed without profit to those who have expressed a prior general interest in receiving similar information for research and educational purposes. For more information go to:
http://www.law.cornell.edu/uscode/17/107.shtml
Sewage Yields Clues to SV40 Transmission
http://jama.ama-assn.org/issues/v288n11/ffull/jmn0918-1.html
(entire paper available at URL)
Washington
It was a dirty job and nobody had to do it. But an international team of scientists did it anyway, testing dozens of sewage samples for simian virus 40 (SV40), which in the 1950s and 1960s contaminated millions of doses of polio vaccine. The unsavory task yielded compelling evidence of person-to-person transmission of SV40, evidence that complicates the contentious search for links between the monkey virus and human cancers.
The sewage study is a wild card. In their figuring, epidemiologists assume that only certain recipients of the vaccines were exposed to SV40. This assumption allows them to isolate SV40 as a variable and gauge whether cancer rates increased after 1961, when the last known contaminated vaccines were given. But what if SV40 circulates in people like it does in monkeys?
"If SV40 is transmitted from person to person and I'm not saying that it is that would throw the epidemiology off," said Susan Fisher, PhD, chief of the epidemiology department at the University of Rochester School of Medicine, during a July presentation to the vaccine safety review committee assembled by the Institute of Medicine (IOM). "Any cohort called 'unexposed' after 1961 may not truly be unexposed." If no group is truly unexposed, the effect of SV40 on cancer rates would be difficult to discern.
Speaking of sewage.
Isolation of vaccine-derived type 1 polioviruses displaying similar properties to virulent wild strain Mahoney from sewage in Japan. Horie H, Yoshida H, Matsuura K, Miyazawa M, Wakabayashi K, Nomoto A, Hashizume S. Japan Poliomyelitis Research Institute, Higashimurayama-shi, Tokyo, Japan.
Type 1, 2, and 3 vaccine-derived polioviruses were isolated from a sewage disposal plant located downstream of the Oyabe River in Toyama Prefecture, Japan, between October 1993 and September 1995. Neurovirulence was analyzed in 13 type 1 vaccine-derived strains, using mutant analysis by polymerase chain reaction and restriction enzyme cleavage (MAPREC). Nine strains (69%) were estimated to have marked neurovirulence. Some of the neutralizing antigenic sites, temperature sensitivity, and plaque-forming ability of two virulent vaccine-derived poliovirus strains were similar to Mahoney strain. The neutralizing activity of human sera obtained after oral poliomyelitis vaccine (OPV) administration against one of the virulent vaccine-derived polioviruses was examined. Although all human sera showed sufficient neutralizing activity for the prevention of poliomyelitis by vaccine-derived poliovirus strains, a lower titer than that against Sabin type 1 strain was observed. Vaccination against virulent vaccine-derived poliovirus will be effective. However, the environmental presence of viruses that have properties similar to those Mahoney strain is a threat. The introduction of inactivated poliovirus vaccine (IPV), and well-maintained herd immunity, together with reinforced environmental surveillance is important for the final phase of the polio eradication program by the World Health Organization (WHO). J. Med. Virol. 68:445-451, 2002. Copyright 2002 Wiley-Liss, Inc.
Received this from Raphaele Horwin - letter to the IOM committee
Their lawsuit is continuing. More info on that in November, hopefully.
Raphaele says......
"We wish that we could say more at this time, but the information in the 4 page letter is still important for parents. (check out the footnotes) "
******
July 29, 2002
Immunization Safety Review Committee:
Marie McCormick, M.D., Sc.D. (Chair), Ronald Bayer, Ph.D., Alferd Berg, M.D., M.P.H., Rosemary Casey, M.D., Joshua Cohen, Ph.D., Betsy Foxman, Ph.D., Constantine Gatsonis, Ph.D., Steven Goodman, M.D., M.H.S., Ph.D., Ellen (Abby) Horak, M.S.N., Michael Kaback, M.D., Gerald Medoff, M.D., Rebecca Parkin, Ph.D., Bennett Shaywitz, M.D., Christopher Wilson, M.D., Richard B. Johnston, Jr., M.D.
Dear Members of the Immunization Safety Review Committee:
This letter is written regarding the public meeting on SV40 Contamination of Polio Vaccine and Cancer that took place on July 11, 2002 and we ask that it be added to the record.
Our lives were full of joy when on June 7, 1996 our first and only child was born. We named him Alexander Roy Horwin and he grew tall and strong. He could speak French and English by the age of two. He loved the ocean and wanted nothing more than to grow up, go to school, and see the world with his mommy and daddy.
We were a hard working happy family building our future. But everything came apart on August 10th, 1998. On that day, we were told that Alexander had a pediatric brain tumor called medulloblastoma. The next six months became a race against time to try to understand the disease, find the appropriate treatment, and save Alexander. However, despite two operations and three rounds of “state-of-the-art” chemotherapy Alexander died on January 31, 1999, six months after being diagnosed. He was not yet three years old.
After he died, we were told that there was monkey virus in Alexander’s brain called SV40. We visited medical libraries and discovered a vast body of literature on this virus. There were numerous studies performed at reputable universities that demonstrated that the existence of this virus has been known for forty years. Other studies from leading virologists, microbiologists, and pathologists reported how the virus had been found in human cancers, including pediatric brain tumors, using a variety of technologies. In addition, there were literally thousands of articles that described how SV40 was the “gold standard” to transform (i.e. turn malignant) normal human cells in vitro.
Despite this body of knowledge, we discovered that the federal government had decided that SV40 was not a virus that deserved serious concern. Now, your committee has a rare opportunity to change this long-standing position. This opportunity may never present itself again. An objective report from your committee will be a significant step towards defeating this deadly virus.
The Evidence
We ask you to consider the evidence - objectively. Compare SV40 with other known human carcinogens. Consider which human carcinogen can:
A) transform a variety of human somatic cells on contact in vitro;
B) create tumors/cancers in animal models with regularity;
C) be found in the same human cancers that it creates in animals in vivo?
We challenge you to find another known human carcinogen that is as carcinogenic as SV40.
If you are perplexed about the uncertainty of the epidemiology, consider that there is no unexposed cohort. Documents now conclusively prove that SV40 was never removed from the vaccine stocks after 1963. The contaminated oral polio vaccine seeds from Dr. Sabin were so full of SV40 that they were used as the source of SV40 by the early virologists. These SV40 contaminated seeds were never thrown away, but instead have been used to make Oral Polio Vaccine (OPV) for millions of children over the last four decades. Moreover, despite their assertion to the contrary, the manufacturer of OPV continued to use Rhesus Monkeys after 1963 as a substrate for the manufacture of the vaccine.
Err on the Side of Caution
Being a member of this IOM committee comes with a serious responsibility - not to gamble with the public health. That means that you must focus on the ramifications of your decisions and must err on the side of caution. Why is this important? Consider what happens when an authority labels an agent as a carcinogen or pathogen. Serious efforts are made to understand the agent’s etiology and epidemiology. Funding is made available to discover ways to treat individuals who carry the agent. And newer, more rational therapies are employed to attend those who have a disease process related to the agent. If you think the data regarding SV40 and human cancers is not 100% perfect be cautious with what you decide. How many more people will have to die with SV40 positive cancers before the data is flawless?
More rational therapies are needed for SV40 positive cancers right now. For example, there is no orthodox treatment for medulloblastoma in young children. The following quotations come from reputable medical journals:
“[In] medulloblastoma, the most common primary tumor of the CNS [central nervous system] in childhood. . .[t]he role of adjuvant chemotherapy is unclear. . .virtually no cures are reported.” “Aggressive treatment of medulloblastoma, the most common pediatric brain tumor, has not improved survival.” “[T]he absolute benefit of chemotherapy for the treatment of medulloblastoma in childhood is, as yet, not proven.” “The median time to progression [return of the tumor] was 6 months.” “For many years, chemotherapy has been utilized for the treatment of malignant brain tumors with minimal success.” “The outcome for the majority of children with malignant brain tumors remains poor, despite surgery, irradiation and conventional chemotherapy.”
Various studies have found that medulloblastoma can contain SV40. Moreover, the biological mechanisms of SV40’s oncogenic potential is well understood - the virus binds to p53 and RB. As you know p53 is a tumor suppressor gene. It drives a damaged cell towards apoptosis. As you may also know, cytotoxic cancer therapies (i.e. radiation and chemo) rely on an intact tumor suppressor system because these agents cause point mutations, strand breaks, and other disturbances to a cell’s DNA. Without a working p53 gene, chemo and radiation do nothing more than to take a transformed cell and create more mutations. However, children are only permitted to be treated with surgery, chemo and radiation. Greater focus on the role of SV40 in these cancers will lead to more rationale therapies. This is another example of the type of progress your committee can facilitate right now.
The Role of the Federal Government
Given all that we already know about SV40, why does the federal government report the virus is not yet a serious concern? Why has the federal government refused to spend $.01 to investigate why a monkey virus that is considered the “gold standard” in creating human cancers in vitro (including brain cancers) is often found in pediatric brain tumors? The rhetoric from government scientists at the 1997 SV40 Conference in Bethesda is the same rhetoric from these same scientists at the IOM Committee meeting on July 11, 2002. In the intervening five years how many children have died of SV40 positive cancers? How much farther has SV40 spread throughout the U.S. and the world?
The federal government has ostensibly mandated a product (OPV) for consumption by millions of American children for forty years. During these four decades, the federal government was in charge of ensuring the safety of this vaccine. But, it was misled by at least one vaccine manufacturer. A product the government thought was pure and safe was contaminated and potentially deadly. Now, the government is faced with potential embarrassment and liability resulting from this deception.
Each one of you has been chosen to participate in this committee because of your outstanding scientific achievements. But, most of you owe your careers to some extent to the funding you have received from the federal government. As recipients of tax money, you can demonstrate that scientists who receive NIH funding act responsibly and independently despite the less than stellar record of the government’s earlier decisions. In addition, most of the universities that each of you are affiliated with receive substantial contributions and grants from vaccine manufacturers including the corporation responsible for the contaminated OPV. An objective and unbiased investigation from your committee will proclaim to the American people that decisions that affect millions of lives especially children’s lives are not for sale.
Conclusion
Our son, Alexander was not the first child to die from a SV40 positive brain cancer and, unfortunately, he was not the last. SV40 concerns all children, yours included. Do your children or grandchildren harbor SV40 in their blood? Is there a deadly tumor that will be born out of the joining of a SV40 virion and a cell somewhere in their body? What happens if they were diagnosed with a SV40 positive cancer? Statistically, there is no cure. And, unfortunately, the probability of such an occurrence is increasing. Cancer is now the leading cause of death by disease in children and pediatric brain tumors have been increasing steadily at a rate of about 3% a year. As you reflect on your roles as vanguards of the public health, consider also your own children and your children’s children.
History will judge the wisdom of your decisions.
Sincerely,
Michael Horwin M.A., J.D. Raphaele Horwin M.A., MFS
Alexander
More from his father:
http://www.mindspring.com/~chiroken/health_news.htm Editorial Reply Re: Congressional Hearings on Vaccines and Autism
Mandating Vaccines: Government Practicing Medicine Without a License?
Editorial Reply Re: Congressional Hearings on Vaccines and Autism
- GCN - NEWS @ 8:31 am PST
From: Dawn Richardson PROVE
This is a phenomenal letter written by a parent of a vaccine injured child in response to an editorial comment published on WebMD. It clearly illustrates the incestuous ties some of those who make vaccine decisions for our children have with drug companies. These are the very people who are critical of the parents and elected representatives who are doing such a great job shedding light on some of the dangers of vaccines because of the threat the truth poses to their pocketbooks. The internet (source of all this information) is a wonderful thing.
In Reply to Editorial Comment from: Wayne L. Pines Re: Congressional Hearings on Vaccines and Autism
Wayne L. Pines, you belittle Congressman Burton as an "angry grandfather" when his goal is to make vaccines safer for children. Your feeble attempt to undermine Congressman Burton's efforts made sense only after your ties to the vaccine manufacturers and drug companies were revealed. This is a day in your life Wayne L. Pines. Let's see who you really are and then people will understand that your words are meaningless because they are motivated by avarice.
You started your career in Washington as the associate editor for The Pink Sheet a pharmaceutical trade magazine. Then you went to work at the FDA for 10 years from 1972 to 1982. Your next job was with the PR firm Burson-Marsteller. After that, you got a job with APCO Associates. Then you joined a company called Therametrix (1). In between you became involved with various pharmaceutical trade groups such as the Food and Drug Law Institute (2), the Drug Information Association (3), and the Internet Healthcare Coalition (4).
Now let's start connecting the dots to see why you would not want a public discussion about how to improve the safety of our children's vaccines. We'll pick-up your career after you leave the FDA. You immediately landed a job with the PR firm Burson-Marsteller (a subsidiary of the advertising agency Young & Rubicam). Your title there was executive vice president. Marsteller clients include Monsanto and their bio-engineere foods and Dow-Corning and their silicon breast implants. In addition, Marsteller has several large drug companies as clients including Eli Lilly. Lilly produces the drug Prozac which has accumulated more adverse reaction reports than any substance (besides vaccines) in the history of the FDA's adverse drug reporting system. Documents released under the Freedom of Information Act challenged the veracity of Prozac's clinical trials that led to FDA approval. Lilly's PR firm Burson-Marsteller was called in to do damage control. There, according to the Campaign Against Fraudulent Medical Research, it was reported that you helped Lilly get past its troubles by exploiting your contacts with current FDA officials (5).
You then became president of the Health Care Practice of APCO Associates a "communications consulting firm." According to PR Watch, APCO Associates specializes in setting up front groups and coalitions for the tobacco and insurance companies (6). In fact, APCO's website boasts that "excellence in public affairs and public relations, like excellence in art, is about the power of communication" (7). No it's not. Excellence in public affairs is about honest communication and adding substance to the public discourse. It's what Congressman Burton is doing. It's not about ridiculous, crude and poorly veiled attempts to protect and further your client base. You may think excellence in public affairs and public relations is about power, but power won't help you when it comes to our children. As much as it may disturb your plans, parents will not sacrifice the health and lives of their children in order to drive up the stock prices of your drug company clients.
Next you joined Therametrix whose website gloats that "Wayne L.Pines is a world-renowned health care consultant (who) has consulted for virtually all of the major pharmaceutical companies..."(1). It also states that Therametrix is a "medical marketing research agency that serves the pharmaceutical, biotechnology, medical device and consumer health products industries" (8). Your clients are listed as including: Abbot Laboratories, Bayer, Bristol-Myers Squibb, Du Pont
Pharmaceuticals, Eli Lilly, Glaxo Wellcome, Novartis
Pharmaceuticals, Pharacia & Upjohn, Procter & Gamble
Pharmaceuticals, Roche Laboratories, Schering-Plough, Triangle
Pharmaceuticals and Warner Lambert - all of them drug and vaccine
manufacturers (9). Your company's mission statement declares, "We see nothing more important than meeting our client's needs" (9). I don't doubt it.
You are also on the marketing and advertising committee of the Drug Information Association which describes itself as a "member-driven scientific association with a membership of over 22,000 primarily from the regulatory agencies, academia, contract service organizations, pharmaceutical, biological and device industry, and from other health care organizations" (10). Who are some of the
other committee members in the Drug Information Association? They include Dr. R. Venkataraghaven of Lederle Laboratories (3)manufacturer of Orimune, Tetramune and other vaccines, Dr. Elizabeth B. D'Angelo of AstraZeneca (3), and Dr. John F. Bedard of Bristol-Myers Squibb (3). The board of directors include Stuart W. Cummings of Merck, Sharp & Dohme manufacturer of the vaccines associated with autism - MMR, MR Vax, Meruvax II, Mumpsvax, Varivax and others, Francoise de Cremiers of Wyeth-Ayerst another major vaccine manufacturer, Charles C. Depew of SmithKline Beecham, Brenton James of Glaxo Wellcome, Murray Lumpkin of the FDA, and Irwin G. Martin of Parke-Davis (11).
In addition, you are a member of the Food and Drug Law Institute which describes itself "as a private organization, not affiliated with the FDA.(but our) mission, however, does relate to the activities, policies and procedures of the FDA..."(12). As a participant in this institute you work with the other members, and in fact, you are scheduled to moderate one of the institute's conferences on medical technology, drugs and biologics (i.e. vaccines) in June of this year (2). Nearly every drug company including the major vaccine manufacturers is a member of this organization. The list includes: American Home Products (i.e.Lederle), Bayer, Medeva Pharmaceuticals, Merck & Co., Organon Teknika, and SmithKline Beecham.
I could go on and on about your affiliations with vaccine manufacturers and drug companies but I believe the point has been made ad nauseam.
One of Congressman Burton's assertions is that an inherent conflict of interest may exist amongst the people who decide what gets injected into our children's veins. The Congressman understands that many of the individuals in our halls of government who make health decisions affecting our children get money from the very drug companies they are supposed to be regulating. During the hearings, when Coleen Boyle of the CDC was asked if she thought there was anything wrong with such a conflict she was literally speechless. Wayne L. Pines your behavior is a text book example of what Congressman Burton and tens of thousands of parents disdain.
As a former employee of the FDA you use your clout to influence what should be a scientifically sound, reasonable and objective decision making process. But even with all of your industry's money and consultants and PR firms and communication experts and doctors on payrolls you are still missing one key ingredient - the truth. The truth can't be bought, spun, manipulated, or turned into a sound bite. Parents know the truth when they watch their children become ill, disabled and die. So despite your supreme efforts to sell more vaccines, we will not allow some greedy industry to decide what is safe and to dictate to us what should be put into our children's bodies.
Wayne L. Pines go back to your "medical marketing research agency" and your "communications consulting firm," shut up, and leave our children alone.
Sincerely,
Michael Horwin Father of Alexander - a vaccine injured child who passed away at the age of 2 ½ years old
Footnotes:
1) http://www.therametrix.com/staff.html
http://www.therametrix.com/wayne.html
2) http://www.fdli.org/conf/medsymagd.htm
3) http://www.diahome.org/dhp2d12.htm
4) http://www.ihealthcoalition.org/content/fda_1.html
5) http://www.pnc.com.au/~cafmr/newsl/prozac.html
6) http://www.prwatch.org/prw_issues/1996-Q3/index.html
7) http://www.apcoassoc.com/gallery/gallery.html
8) http://www.therametrix.com/company.html
9) http://www.therametrix.com/clients.html
10) http://www.diahome.org/
11) http://www.diahome.org/dhp2c.htm
12) http://www.fdli.org/about/index.html
VITAL info here as MUCH cannot be revealed as court required gag June 7, 2003 - ALL TO BE SECRET
Child who was born in 1996 - did not have SV40 in cord blood but did later after vaccine and parents do not have
But you can figure out much from below...........still contaminated vaccine
They lost their case due to the judge and he defendant asked for and was granted a Protective Order. As a result, all of its production documents cannot be quoted directly or shared with Congress, the media, or health authorities. However, our motions and pleadings are in the Court Record and have not been put under a Protective Order. Therefore, we are able to cite our own arguments set-out in these papers. We believe this Protective Order should be lifted because public health interests should take precedence over the interests of pharmaceutical companies
*******
Letter sent to The Honorable Dan Burton, Chairman of the House Government Reform Subcommittee on Human Right and Wellness, to Demand a Congressional Investigation and Hearing on the Introduction of Simian Virus 40 (SV40), a Cancer-Causing Monkey Virus, into the American Population From Contaminated Polio Vaccines
1. 2 issues here - SV40 in polio vaccine found in Alexander's tumor (it was not in his cord blood & parents did not have so did not inherit from them). He got polio vaccine (see point by point below)
2. An SV40 positive cancer means that chemo and radiation will be ineffective and they did not know this & accepted this type of treatment for Alexander.......and not allowed the treatment they wanted. - the FDA would not allow our son to have access to a non-toxic cancer therapy that offered him the best chance of saving his life.
SV40 is not only responsible for causing the cancer, but also for making these particular cancers incurable. Orthodox cancer therapies such as chemotherapy and radiation can not cure an SV40 positive cancer. Pediatric brain cancers and other solid cancers have been found to contain SV40. SV40 binds with the tumor suppressor genes p53 and RB and stops tumor cells from undergoing apoptosis (programmed cell death). Apoptosis is what radiation and chemo depend on to work in order to trigger the cancer cell to die. Exposing SV40 positive cancer cells to chemo and radiation does not kill the cells but simply creates more genetic mutations - making the cancer more aggressive. The bottom-line is that SV40 causes human cancer, stops orthodox cancer therapies (i.e. chemo and radiation) from providing any benefit, and can make the cancer even more aggressive.
http://www.ouralexander.org/BurtonSV40%20Letter%20(2003).doc
June 7, 2003
The Honorable Dan Burton
Chairman of the House Government Reform
Subcommittee on Human Rights and Wellness
U.S. House of Representatives
2157 Rayburn House Office Building
Washington, DC 20515
By Facsimile
Letter to Demand a Congressional Investigation and Hearing on the Introduction of Simian Virus 40 (SV40), a Cancer-Causing Monkey Virus, into the American Population From Contaminated Polio Vaccines
Dear Representative Burton:
I am writing this letter on June 7, 2003. Exactly seven years ago, on June 7, 1996, my son Alexander was born. He would die in my arms 30 months later in a little motel room in Houston, Texas as we, his parents, tried desperately to safe his life. This letter is written in commemoration of Alexander's short life and the injustice that befell him and the cause of the brain tumor (medulloblastoma) that killed him.
This letter is also the result of four long years of struggle by myself and my husband to find out why our beautiful healthy young son would be stricken by cancer. Now, our lawsuit against the manufacturer of the oral polio vaccine, American Home Products, (i.e. Lederle), has come to a close.
As a result, much of the information that has been under a protective order for over three years has been entered into the public record through our legal documents filed with the Federal Court for the Central District of California in Los Angeles. What happened to Alexander is not an isolated event. We contend that his death was caused by a Public Health Disaster that has befallen others and will continue to kill children until it is addressed.
On August 12, 1999, we wrote you when you where Chairman of the Committee on House Government Reform in support of your investigations into pediatric vaccines - Vaccines; Finding the Balance Between Public Safety and Personal Choice. In this letter we described how various childhood vaccines contain known carcinogens and yet not a single vaccine is tested for carcinogenicity. While shampoos and cosmetics are tested to see if they cause cancer, incredibly, biological substances that are squirted or injected into healthy infants and children have never been tested.
On June 7, 2000, My husband and I also appeared before your Committee to discuss the FDA's control of effective non-toxic pediatric cancer therapies in Cancer Care for The New Millenium - Integrative Oncology. During our sworn testimony we described how Alexander suffered enormously and unnecessarily as a result of the administration of four toxic but ineffective chemotherapy drugs (vincristine, cytoxan, etoposide, and cisplatin - Protocol CCG 9921). We described how the FDA would not allow our son to have access to a non-toxic cancer therapy that offered him the best chance of saving his life. We presented photographs to your Committee that demonstrated how Alexander struggled to stay alive and then suffered a horrific death.
From your own considerable effort in investigating vaccine production, testing, and safety you know that childhood vaccines contain formaldehyde (i.e. formalin), mercury (i.e. thimerosal), aluminum, and other toxic substances. In addition, vaccines can also contain animal viruses - contaminants from the animal substrates upon which the vaccines are manufactured. One of these viruses, a monkey virus called Simian Virus 40 is carcinogenic and found its way into the oral polio vaccine (OPV) and the inactivated polio vaccine (IPV) in the late 1950's and early 1960's. Such an event was not surprising because monkey kidneys contain a multitude of simian viruses and the polio vaccine is grown on monkey kidney cells.
The oral polio vaccine is a "live" trivalent vaccine which means that it contains three strains of poliovirus - Types I, II, and III, and each strain is attenuated (i.e. weakened). Dr. Albert Sabin, who was responsible for the creation of the licensed OPV, had to passage his poliovirus strains through a myriad of animals and animal host cells in order to attain the right virulence-strong enough to illicit an immune response, but sufficiently attenuated so as to not cause polio in the recipient. For example, Type I has the following lineage:
In 1941, Drs. Francis and Mack isolated the Mahoney poliovirus "from the pooled feces of three healthy children in Cleveland." Dr. Salk then passed this strain through fourteen living monkeys and two cultures of monkey testicular cultures. In 1954, the strain (now called Monk14 T2) was given to Drs. Li and Schaeffer who subjected the virus to nine more passages through monkey testicular cultures. Next, the strain (now called Monk14 T11) underwent fifteen more passages in monkey testicular cultures, eighteen passages in monkey kidney cells, two passages through living rhesus monkeys skin, and additional passages through African Green monkey skin and monkey kidney cell cultures. This strain was now called MS10 T43 and LS-c. In 1956, Dr. Sabin took this virus and passaged it through seven cultures of African Green Monkey kidney cells. That same year, the pharmaceutical company, Merck, Sharp & Dohme, passed the strain (now called LS-c, 2ab/KP2) through a rhesus monkey kidney cell culture. The resulting material was called Sabin Original Merck (SOM) and was provided to Lederle in 1960 as the seed material to manufacture its polio vaccine.
Types II and III were created in a similar fashion.
Once the strains were isolated, the pharmaceutical companies needed a method to propagate the viruses in order to produce the vast quantities of vaccine needed for nation-wide immunization campaigns. This required a substrate upon which the poliovirus could be efficiently grown and harvested. Kidney cells from rhesus monkeys were chosen because they were found to be an effective growth medium. A small quantity of poliovirus could be added to the minced kidneys removed from these monkeys and within a few days, large quantities of poliovirus could then be harvested from these same monkey cells.
Between 1959 and 1960, Bernice Eddy, Ph.D., of the National Institute of Health (NIH) examined minced rhesus monkey kidney cells under a microscope. These were the cells of the same species of monkeys used to create and produce the oral polio vaccine. Dr. Eddy discovered that the cells would die without any apparent cause. She then took suspensions of the cellular material from these kidney cell cultures and injected them into hamsters. Cancers grew in the hamsters. Within a few months, the virus responsible for creating these cancers would be isolated and identified by Dr. Eddy and other scientists. Because it was the 40th simian virus found it was named simian virus 40 (SV40).
According to the FDA:
The discovery in 1960 that a DNA tumor virus, designated simian virus 40 (SV40), was an inadvertent contaminant of rhesus monkey cells, and consequently the poliovirus and adenovirus vaccines that were made in these cells, was a watershed event in vaccine development…"
By 1960, the Salk injectable polio vaccine (IPV) had been administered to about 98 million American children and adults, and Sabin's oral polio vaccine (OPV) had been administered to about 10,000 Americans and millions in the USSR where the clinical trials had been conducted. It was estimated that 10% to 30% of the vaccines contained live SV40. The federal agency in charge of vaccine licensing and safety at the time was the Division of Biologics Standards (DBS) of the National Institute of Health (NIH). Incredibly, this agency did not order a recall of any of the SV40-contaminated vaccines. The tainted vaccines continued to be administered until 1963 when they were all used and replaced by allegedly SV40-free vaccines as required by the new federal regulations promulgated in 1961.
In 1961, federal regulations were implemented to ensure that SV40 would no longer contaminate the polio vaccine. Despite these regulations, we contend that the OPV has been sporadically contaminated with SV40 for the last four decades. As a result, we allege that some of the children who have been administered the contaminated vaccines have been stricken with cancer and others are at risk. The main points are summarized below:
1) SV40 (Simian Virus Number 40) is a cancer causing monkey virus found in the kidney cells of Rhesus and African Green Monkeys. The kidney cells of these two species of monkeys comprise the substrate that has been used to create poliovirus strains and manufacture the oral polio vaccine for four decades.
2) SV40 is a human carcinogen for brain cancer and mesothelioma and it is a suspected carcinogen in osteosarcomas (bone cancers) and Non-Hodgkin's Lymphomas.
3) Alexander was administered the OPV in November 1997. He was diagnosed with a brain tumor in August 1998. Alexander died on January 31, 1999. 4) Four independent laboratories using DNA testing and laser micro-dissection found SV40 in Alexander's brain tumor.
5) SV40 has been found in the cancers of many other children. Pediatric brain tumors and other childhood cancers including osteosarcomas (bone cancer) and Non-Hodgkins Lymphomas have been found to contain SV40.
6) When Alexander was born on June 7th, 1996, I had his cord blood saved and stored by a private laboratory. The cord blood was the blood shared by Alexander and myself at the time of Alexander's birth. We had this blood tested for SV40. This marked the very first time the cord blood of a child
with an SV40 positive brain tumor would be tested for SV40. To the astonishment of the scientists it was negative for SV40. This suggested that at the time Alexander was born he had not been exposed to SV40.
7) It is known that SV40 can be spread through contaminated blood so my husband and myself underwent a battery of tests from 2000 to 2001. Using a variety of sophisticated DNA tests to isolate the genetic fingerprint of the SV40 virus including Polymerase Chain Reaction (PCR), the scientists checked blood, urine and semen multiple times looking for any trace of SV40 (even antibodies). The scientists were once again surprised. Despite the repeated tests by leading SV40 laboratories both in the United States and Europe, we had absolutely no trace of SV40.
8) The scientists concluded that Alexander did not get SV40 from his parents, nor did he give SV40 to us.
9) The original oral polio vaccine (OPV) seed stocks created by Dr. Albert Sabin and used to make OPV since 1961 were known to be contaminated with SV40. In fact, SV40 was isolated from Sabin's OPV seeds - the original material used to make OPV for four decades.
10) Dr. Sabin had admitted that OPV seeds were contaminated with SV40 in a peer-reviewed scientific publication. Dr. Sabin wrote, "The three types of the large lots produced by Merck, Sharp and Dohme in rhesus monkey kidney cell cultures contained SV40."
11) Lederle, the sole American manufacturer of OPV for many years, received their OPV seeds from Merck, Sharp and Dohme. There is no evidence that Lederle ever tested their seeds for SV40 nor discarded their presumably contaminated seed stocks.
12) There are Lederle documents (not under a protective order) that demonstrate that their early OPV vaccines were contaminated with SV40.
13) Lederle did not use the SV40-neutralization procedures recommended by Dr. Sabin.
14) Monkeys used to produce OPV were not tested for SV40 by Lederle because of economic considerations.
15) After reviewing all of the Lederle records and the Lederle systems in place, our expert concluded that the contamination detected in the OPV material ultimately administered to Alexander was SV40.
16) The medical literature is unequivocal - the pediatric brain cancer rate in the U.S. has been climbing at a rate of approximately 3% for the last four decades.
17) A recent study has demonstrated that 11% of Americans are currently infected or have been infected with SV40.
SV40 is not only responsible for causing the cancer, but also for making these particular cancers incurable. Orthodox cancer therapies such as chemotherapy and radiation can not cure an SV40 positive cancer. Pediatric brain cancers and other solid cancers have been found to contain SV40.
SV40 binds with the tumor suppressor genes p53 and RB and stops tumor cells from undergoing apoptosis (programmed cell death). Apoptosis is what radiation and chemo depend on to work in order to trigger the cancer cell to die. Exposing SV40 positive cancer cells to chemo and radiation does not kill the cells but simply creates more genetic mutations - making the cancer more aggressive. The bottom-line is that SV40 causes human cancer, stops orthodox cancer therapies (i.e. chemo and radiation) from providing any benefit, and can make the cancer even more aggressive.
Despite these facts, children diagnosed with cancer are not given a choice of whether they should undergo debilitating and toxic chemo and radiation. Alexander should have been tested for SV40 upon his diagnosis, not after he died. He should not have been administered ineffective and unnecessary chemotherapy which provided no benefit and only made him suffer. Children with SV40 positive cancers (or p53 mutations) should not be used as guinea pigs and profit centers for pediatric oncologists, hospitals, and pharmaceutical companies.
A Congressional Hearing should be immediately convened to examine how a federally policed vaccine program has introduced a deadly monkey virus into countless American men, women and children for the past 45 years and what the public health consequences have been of this tragedy.
This government investigation should demand to know:
· Why a vaccine manufacturer was allowed to use vaccine seed stocks for four decades that came from a source contaminated with SV40? · Why did this manufacturer violate federal regulations and allowed contaminated vaccines to be released? · Why weren't sophisticated tests to detect SV40 during OPV production and to eliminate the virus ever required by the federal government? · Why aren't children with cancer tested for SV40 when they are diagnosed, not when they are dead, because an SV40 positive cancer means that chemo and radiation will be ineffective? · Why is there a significant percentage of Americans (children and adults) walking around with evidence of having had an SV40 infection and what does that mean for their risk of cancer and chances for a successful treatment?
Like our son, many children are already dead, victims of this virus, and many adults will be stricken later. Time is of the essence, not for our beloved Alexander anymore, but for other children who are infected with this cancer causing virus.
Sincerely,
Raphaele Moreau-Horwin M.A., M.F.S. Michael
Horwin, M.A., J.D.
www.ouralexander.org
Footnotes
1 The case was Horwin v. American Home Products, American Cyanamid Company, Lederle Laboratories, Case No. CV00-04523 WJR (EX), United States District Court for the Central District of California originally filed on January 31, 2000. The District Court Judge decided that the testimony of the plaintiffs' experts on the issue of whether SV40 caused Alexander's tumor was admissible under the Daubert standard. (United States District Court Central District of California Tentative Ruling Case No. CV00-04523 WJR (EX), Daubert Motion, Thursday May 8, 2003.) Nonetheless, the judge excluded critical evidence related to the source of SV40 because it believed that it could require that all exhibits used to qualify a witness under Daubert be identified in a FRCP Rule 26(a)(2) disclosure. After excluding critical evidence, the court decided that since there was no
direct evidence that the dose of Orimune administered to Alexander was contaminated that the expert's opinion was inadmissible under Daubert. As a result, the judge granted the defendant's (Lederle's) motion for summary judgement.
2 The defendant asked for and was granted a Protective Order. As a result, all of its production documents cannot be quoted directly or shared with Congress, the media, or health authorities. However, our motions and pleadings are in the Court Record and have not been put under a Protective Order. Therefore, we are able to cite our own arguments set-out in these papers. We believe this Protective Order should be lifted because public health interests should take precedence over the interests of pharmaceutical companies
3 Passage is defined as the introduction of infectious material into an experimental animal or culture medium followed by recovery of the infectious agent. Dorland's Medical Dictionary, 25th edition, page 1146. 4 A.B. Sabin, A.B. & L. Boulger, History of Sabin Attenuated Poliovirus Oral Live Vaccine Strains. 1 J. BIOL. STAND. 115, 115-18 (1973). The Mahoney virus was isolated in 1941 by Drs. Fancis and Mack.
5 Id.
6 Id.
7 Id
8 Id
9 Id
10 Id.
11 M.R. Hilleman, Discovery of Simian Virus (SV40) and its Relationship to Poliomyelitis Virus Vaccines, in SIMIAN VIRUS 40 (SV40): A POSSIBLE HUMAN POLYOMAVIRUS, 94 DEV. BIOL. STAND. 183-90 (F. Brown & A.M. Lewis eds., 1998).
12 Bernice E. Eddy, Tumors Produced in Hamsters by SV40, 21 FED'N PROC 930, 930-35 (1962) [hereinafter Eddy I]; Bernice E. Eddy et al., Identification of the Oncogenic Substance in Rhesus Monkey Kidney Cell Cultures as Simian Virus 40, 17 VIROLOGY 65-75 (1962) [hereinafter Eddy et
al. II]; EDWARD SHORTER, THE HEALTH CENTURY 195-99 (1987).
13 Eddy I, supra note 34, at 930; Eddy et al. II, supra note 34, at 65.
14 Simian Virus 40 (SV40): A Possible Human Polyomavirus, Developments in Biological Standardization Vol. 94, 1998.
15 INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES, IMMUNIZATION SAFETY REVIEW: SV40 CONTAMINATION OF POLIO VACCINE AND CANCER 4, 21 (Kathleen Stratton et al. eds., 2002), http://www.nap.edu/books/0309086108/html (last visited May 26, 2003) [hereinafter IMMUNIZATION SAFETY REVIEW].
16 Id.
17 National Institutes of Health (NIH) Division of Biologics Standards (DBS) was a forerunner of today's Center for Biologics Evaluation and Research (CBER). Paul Parkman, Harry Meyer, Jr., MD Lecture, CBER Centennial-Slide Presentation (Sept. 23-24, 2002), at http://www.fda.gov/cber/summaries/cent092302pp.htm (last visited May 26,
2003). "The transfer of DBS to the Food and Drug Administration took place in 1972." Id. The DBS became the FDA's Bureau of Biologics (BoB). Id. "Later incarnations of this organization included the Center for Drugs and Biologics (CDB) and finally, the present day Center for Biologics
Evaluation and Research (CBER)." Id.
18 Immunization Safety Review, supra note 45, at 21.
19 Id.
20 A.B. Sabin, A.B. & L. Boulger, History of Sabin Attenuated Poliovirus Oral Live Vaccine Strains. 1 J. Biol. Stand. 115, 115-18 (1973).
21Adi F. Gazdar et al., SV40 and Human Tumours: Myth, Association or Causality?, 2 Nat. Rev. Cancer 957, 957-64 (2002). In addition, in July 2002, the National Academy of Science Institute of
Medicine (IOM) Immunization Safety Committee convened a study into SV40 and cancer which culminated in a report published in October 2002. According to the IOM report "SV40 Contamination of Polio Vaccine and Cancer": The committee concludes that the biological evidence is strong that SV40 is a transforming [i.e., cancer-causing] virus, . . . that the biological evidence is of moderate strength that SV40 exposure could lead to cancer in humans under natural conditions, [and] that the biological evidence is of moderate strength that SV40 exposure from the polio vaccine is related to SV40 infection in humans. See Immunization Safety Review: SV40 Contamination of Polio Vaccine and Cancer.
22John A. Lednicky and Janet S. Butel, Simian virus 40 regulatory region structural diversity and the association of viral archetypal regulatory regions with human brain tumors, Semin Cancer Biol. 2001 Feb;11(1):39-47. Bharat Jasani, et al., Association of SV40 with human tumours, Semin Cancer Biol. 2001 Feb;11(1):49-61.
23 See Sara Stinebaugh and Joseph Melnick, Plaque Formation by Vacuolating Virus SV40, Virology Vol. 16, March 1962 ("The strain of virus (SV40) used was isolated from Sabin's lot of type 2 oral poliomyelitis vaccine . . . ."); Asaria Ashkenazi and Joseph L. Melnick, Induced Latent Infection of Monkeys with Vacuolating SV40 Papova Virus: Virus in Kidneys and Urine, Proceedings of the Society for Experimental Biology and Medicine, Vol. 111, October-December 1962 ("The [SV40] virus used was isolated from Sabin's seed stock of type 3 oral polio-vaccine. . . .")
24A.B. Sabin, A.B. & L. Boulger, History of Sabin Attenuated Poliovirus Oral Live Vaccine Strains. 1 J. BIOL. STAND. 115, 115-18 (1973).
25 Id.
26 These documents are attached as exhibits to the Declaration of Stanley P. Kops in Support of Plaintiff's Motion For Reconsideration (Case No. CV-00-04523 WJR (Ex) Pending in the U.S. District Court for the Central District of California.)
27 Declaration of Stanley P. Kops in Support of Plaintiff's Motion For Reconsideration (Case No. CV-00-04523 WJR (Ex) Pending in the U.S. District Court for the Central District of California.)
28 From Brown v. Lederle; Civil Action 73-1920. Deposition of Dr. Ronald Vallancourt of July 24, 1975. Dr. Vallancourt, the responsible head of American Cyanamid, testified that the reason for the lack of testing of the monkey sera for SV40 was based on economic considerations. 29 Declaration of Stanley P. Kops in Support of Plaintiff's Motion For Reconsideration (Case No. CV-00-04523 WJR (Ex) Pending in the U.S. District Court for the Central District of California.)
30 D.E. Rollison, et al., Serum Antibodies to JC Virus, BK Virus, Simian Virus 40, and the Risk of Incident Adult Astrocytic Brain Tumors, Cancer Epidemiol Biomarkers Prev. 2003 May;12(5):460-3.
31 S.D. Conzen, et al, Identification of a novel antiapoptotic functional domain in simian virus 40 large T antigen, J Virol. 1997 Jun;71(6):4536-43; J.W. Ludlow, Interactions between SV40 large-tumor antigen and the growth suppressor proteins pRB and p53,FASEB J. 1993 Jul;7(10):866-71; Michele Carbone, et al., The pathogenesis of mesothelioma, Semin Oncol. 2002 Feb;29(1):2-17.
32 THE CHEMOTHERAPY SOURCE BOOK 4 (Michael C. Perry ed., 3d ed. 2001). One tumor gene in particular, p53 is designed to kill cells through apoptosis or "cell suicide" so that mutated cells to not lead to cancer through uncontrolled multiplication and metastasis. Chemotherapy and
radiation depend, to a large degree, on p53. Id.
Following is the transcript of Savini's report, "Vaccine Virus."
Dave Savini: At age two and a half, Stacey Girardi and Tim Brennan battled the same brain cancer -- an ependymoma. Both had tumors removed. Years later, Tim is doing well.
(Addressing Tim) You feel good now?
Tim: Yeah.
Savini: But part of Stacey's tumor remains, and she suffers from side effects.
Stacey: Made me lose the back of my hair and my hearing.
Savini: Mark Moreno had the same kind of tumor removed when he was two and a half years old, too. His surgery left him permanently disabled, and he now wears a helmet to protect his head. What connects these three people is a fear over what was found in Moreno's case, inside his tumor: a virus typically not found in humans but in monkeys -- Simian Virus 40 or SV-40.
It's a virus that's also been found in a contaminated vaccine: the polio vaccine. Scientists used monkeys to grow the polio vaccine in the late 1950s and early 1960s. They later learned the monkeys were infected with SV40, and an unknown number of people were given the vaccine that contained the virus.
(Addressing a physician) You believe SV40 causes cancer?
Dr. Michele Carbone (Loyola Medical Center): SV40 is a virus that is capable of causing cancer.
Savini: Mark Moreno's SV40 was found when his tumor was tested for it. That type of testing is uncommon, and neither Stacey nor Tim's tumors were tested. But their parents want to know if that's what caused their rare cancers, and they want the government to fund more studies.
Melony Girardi (Stacey's Mother): If they are indeed doing research on ependymomas and finding that there is SV40 in them, everyone diagnosed with ependymoma -- their tumor, their specimen of that tumor should be tested.
Eileen Brennan (son had cancer): I don't understand why they won't unless somewhere out there somebody is trying to cover something up.
Savini: There is now growing concern that the polio vaccine that was given to millions may also have exposed people to cancer. Dozens of medical research studies are now confirming the link between the monkey virus and some tumors. There's new concern that the virus can spread, but researchers are not sure how. Meanwhile, lawsuits are being filed claiming that more recent polio vaccines have been infected with the same virus.
Stacey and Tim were too young to have received the original batch of contaminated vaccine.
The same is true for Moreno, who lives in New Jersey. So how did he get infected? Moreno's mother filed a lawsuit claiming that later versions of the polio vaccine also were contaminated. Their lawsuit claims that drug manufacturers did not get rid of the SV40 when the government ordered it (to be done) in 1961.
Loyola doctors Michele Carbone and John Lednicky, both of Loyola Medical Center, have been researching SV40 for years. They fear young people are testing positive for SV40 because, somehow, the virus is spreading. One discovery that leads them to believe this is that, in 1997, Carbone tested an unused vial of the 40-year-old tainted polio vaccine. It was the only one known to exist, and it tested positive for SV40.
An identical strain of SV40 was found in tumors of non-Hodgkins Lymphoma patients, in Texas. All the patients were too young to have received the originally contaminated vaccines from teh 1950s and early 1960s.
Carbone: At least some of the virus came from the vaccine, yes, no question.
Lednicky: Some people would say that it was a smoking gun.
Savini: It's a smoking gun to researchers who are trying to find out if the virus is spreading, and how. Is it spread from a parents who were vaccinated to their children? Or is it spread from person to person?
Researchers are hoping for more funding to study this, along with SV40's link to cancer.
Melony Girardi: It needs to be stopped. It needs to be checked.
Savini: It's important to know that even if you have SV40 in your system, that does not mean you will get cancer -- just like so many of us spend time in the sun but never get skin cancer.
SV40 experts, including Dr. Carbone, say that the benefits of the polio vaccine far outweight any potential risks, and even he made sure he was vaccinated.
With regards to the lawsuits, at least four have been filed.
Drug manufacturers and some medical researchers say the polio vaccine has been free of the monkey virus for decades, and that includes the vaccine on the market today. Today the polio vaccine is tested to ensure it is free of the virus. But the link between the virus and tumors remains a medical mystery, and many researchers are urging that more funding be provided to study SV40.
http://www.eurekalert.org/pub_releases/2002-12/jotn-etc122002.php
Public release date: 31-Dec-2002
Contact: Linda Wang
jncimedia@oupjournals.org
301-841-1287
Journal of the National Cancer Institute
Exposure to contaminated poliovirus vaccine not likely linked to rare cancer
The poliovirus vaccine used in mass immunization programs in the late 1950s and early 1960s was contaminated with the monkey virus SV40, which has been detected in some human tumors, particularly pleural mesothelioma. However, the rise in incidence of pleural mesothelioma between 1975 and 1997 is not likely the result of immunization with the SV40-contaminated vaccine, according to an analysis in the January 1 issue of the Journal of the National Cancer Institute.
SV40, or simian virus 40, can cause tumors in rodents when injected at high levels. However, most epidemiologic studies of people who were immunized as children with poliovirus vaccine that was potentially contaminated with SV40 have not found an association between SV40-contaminated poliovirus vaccine and the risk of cancer--even more than 30 years after exposure. Still, the presence of SV40 in some tumors raises the possibility that there may be an association.
To determine whether immunization with the contaminated poliovirus vaccine had any affect on the incidence of pleural mesothelioma, a rare cancer of the membrane that covers the lungs, Howard D. Strickler, M.D., of the Albert Einstein College of Medicine in New York, and his colleagues used cancer incidence data from the National Cancer Institute's Surveillance, Epidemiology, and End Results Program to estimate age- and sex-specific incidence rates of pleural mesothelioma from 1975 through 1997. They then compared trends in mesothelioma incidence with prevalence of exposure to SV40-contaminated poliovirus vaccine.
The authors found that incidence rates increased the most among males who were age 75 or older, the age group least likely to have been exposed to the contaminated poliovirus vaccine. Incidence rates among males in the age groups most heavily exposed to SV40-contaminated poliovirus vaccine (between ages 25 and 54) remained stable or decreased from 1975 through 1997.
Similar trends were seen among females. The authors point out that even though women had similar exposure to SV40 contaminated vaccine, female pleural mesothelioma remained very rare, and the few female cases that did occur were mainly among the elderly who were unlikely to have ever received any poliovirus vaccine. In addition, statistical assessment of trends in pleural mesothelioma incidence did not reveal any increases in rates of the disease that could be attributed to SV40-contaminated poliovirus vaccine in males or females.
"Thus, after almost 40 years of follow-up, U.S. cancer incidence data have not shown an increased incidence of pleural mesothelioma among the birth cohorts that were exposed to SV40-contaminated poliovaccine," the authors conclude. However, they note that "continued surveillance of all vaccine-exposed cohorts is needed, in view of conflicting reports on the detection of SV40 genomic DNA sequences in mesothelioma tumor samples."
Contact: Abe Habenstreit, Albert Einstein College of Medicine, 718-430-3101; fax: 718-430-3703, habenstr@aecom.yu.edu
Strickler H, Goedert J, Devesa S, Lahey J, Fraumeni J, Rosenberg P. Trends in U.S. pleural mesothelioma incidence rates following simian virus 40 contamination of early poliovirus vaccines. J Natl Cancer Inst
2003;95:38–45.
Note: The Journal of the National Cancer Institute is published by Oxford University Press and is not affiliated with the National Cancer Institute. Attribution to the Journal of the National Cancer Institute is requested in all news coverage.
http://www.viewzone.com/sv40.html
SV-40 - A deadly Cure
by Geraldo Fuentes
Editor's Note:
When we first ran Geraldo's first story, SV-40, A Deadly Cure? we thought it was a bit on the conspiratory side, but it seemed well researched. We were pleased that many other journalists also investigated the material, proving the sad truth that Geraldo reported in ViewZone. Research has now firmly linked many of today's cancers with tainted virus vaccinations given in the early 1950s. Could there be any more shocking and horrific revelations like this? We didn't think so - but we were wrong.
The latest horror story is posted HERE: SV40 Part Two for you to ponder. As you read it, also do not forget the Black Americans that were knowingly infected with Syphilis or the soldiers made to march through the fallout of our nuclear bomb tests... But first, read Geraldo Fuentes original story. Also, important new information is at the end of this story.
PART I
If you received a polio vaccination in the 50's, you may have gotten more than you know...
It was 1956. I was only six years old and attended grade school in Springfield, Massachusetts. I was too young to recollect the first round of polio vaccinations, but I have a few memories. I remember that my first grade class was escorted to the school gymnasium. There was a peculiar smell in the air. I think it was probably rubbing alcohol. And some of the other kids were crying. The shot itself wasn't so bad. I didn't cry, but my best friend did. At the end of the ordeal we all got a lollipop.
A few years later, when we marched again to the gymnasium it was different. There was no crying and no alcohol odor. Instead, there were long tables bearing neat rows of small paper cups, filled about half way with a liquid that tasted like bitter orange juice. White clad Nurses watched as each child drank the vaccine. There was no lollipop and, after we handed back the cup, we simply returned to class.
The government had initiated the mandatory polio vaccination programs in 1955. Prior to this, polio had killed or crippled thousands of children and adults all over the world. Attacking the central nervous system, this viral infection was transmitted by human contact, sewage and even by contaminated milk. Victims who contracted polio would incubate the virus in their intestines, where it would multiply and enter the lymphatic system. Eventually the virus would penetrate the nerves and travel along nerve paths, destroying neurons and rendering the muscles connected to them paralyzed.
The polio epidemic reached its height in 1952. It turned thousands of victims into cripples and confined countless children to large pressure chambers called "iron lungs," which helped them to breath when their diaphragm muscles were stilled. There was and still is no treatment for polio. Aside from attempts to maintain life functions, the disease must run its course.
And so, in 1955, just one year before I received it, Jonas Salk had performed no small miracle when he successfully mass-produced an effective polio vaccine by growing a form of the virus on the kidneys of rhesus monkeys. This virus would be harvested, killed, and given to healthy children like me, who would then develop antibodies which would kill any future invasion of the body by the polio virus.
This happy story of medical marvel has a deadly glitch. And it is especially deadly if, like me, you received your vaccinations in the 1950s, in certain states like Massachusetts. In 1960, researchers discovered that the polio vaccine distributed to certain states was infected with another virus called "Simian Virus 40." SV-40 is a monkey virus that is not normally found in humans. Unknown at the time, it was present in hundreds of rhesus monkeys that were used to grow and harvest the polio vaccine. Injected into research animals, the SV-40 virus causes brain and lung cancers. Now, some forty years later, its effect on humans is just being investigated.
SV-40 has appeared in 61% of all new cancer patients -- patients too young to have received the contaminated vaccine being administered forty years ago! Michele Carbone, Assistant Professor of Pathology at Loyola University in Chicago, has recently isolated fragments of the SV-40 virus in human bone cancers and in a lethal form of lung cancer called mesotheliomas. He found SV-40 in 33% of the osteosarcoma bone cancers studied, in 40% of other bone cancers, and in 60% of the mesotheliomas lung cancers. Dr. Carbone believes this study explains why 50% of the current mesotheliomas being treated were no longer occurring in association with asbestos exposure, their traditional cause.
Researchers from the Institute of Histology and General Embryology of the University of Ferrara, lead by Dr. Fernanda Martini, discovered SV-40's presence in a variety other tumors. They found the rhesus monkey virus in 83% of choriod plexus papillomas, in 73% of ependymomas, in 47% of astrocytomas, in 50% of glioblastomas, and in 14% of meningiomas.
SV-40 also has been found in 23% of blood samples and 45% of sperm fluids taken from normal individuals! Researchers have determined the SV-40 virus can be transmitted sexually and through blood transfusions. Even more shocking, SV-40 has appeared in 61% of all new cancer patients -- patients even too young to have received the contaminated vaccine being administered forty years ago! How could this happen?
My second vaccination was from a cup. This was the brainstorm of the FDA. Instead of getting the "dead" virus in an injection, the Federal vaccination policy mandated that children should be given the new live "oral polio vaccine" (OPV). This decision was based upon the belief that the OPV recipient would "shed" the virus through body contact with other non-vaccinated children and adults, thereby spreading the "live" virus throughout the population. Since the infection was extremely small, it would produce the desired antibodies while posing no threat of contracting polio. This, it was thought, would assure the total immunization of America and the eradication of the disease. The public was never informed that this national health strategy was being implemented, despite several cases of polio which were directly attributed to the vaccine.
By 1963, the estimated number of tainted polio vaccinations was estimated to be upwards of 98-million!
The SV-40 virus that contaminated the oral polio vaccine quickly spread from child to child and from child to adult, crossing state lines and national boundaries. By 1960, when the virus was first detected, it was already too late to prevent its dissemination throughout the population. The FDA quietly and gradually instituted a program to eliminate rhesus monkeys, who harbor the SV-40, and replace them with African Green monkeys that are free of the virus. By 1963 the monkeys had been replaced but the estimated number of tainted polio vaccinations was estimated to be 98-million!
According to the National Institutes of Health, high levels of SV-40 were identified in polio vaccines in Washington, Oregon, Wyoming, Utah, Minnesota, Iowa, Wisconsin, Illinois, Michigan, Pennsylvania, Washington DC, Maryland, Delaware, New York, Connecticut, Rhode Island, Massachusetts, Vermont and New Hampshire. Low levels of SV-40 were found in California, Arizona, New Mexico, Colorado, Texas, Kansas, Nebraska, North Dakota, Missouri, Louisiana, Georgia, Tennessee, Kentucky, Ohio, and West Virginia. Polio vaccines in the other states show no SV-40 present. This revelation has only recently come to public attention. Many people, like myself, were unaware that a potential for cancer had been implanted in their body. Researchers say that, by age fifteen, the virus stops shedding to others. I cannot but wonder how many people I contacted between the age of eight and fifteen... Did I shed the SV-40 virus to my mother, who eventually died of brain cancer? Will I contract brain, lung or bone cancer? Many other people in my age group are asking similar questions.
A number of public statements have been made by the National Cancer Institute in the past few months, attempting to put their spin on these disturbing revelations. In a statement published in the January (1999) New England Journal of Medicine, the institute states that there is no evidence of an increase in humans of the types of cancers found in laboratory animals that have been injected with SV-40. But other researchers remind us that SV-40 has already been found in a wide variety of other tumors. It has been shown that individuals who received the tainted oral vaccine demonstrate a higher occurrence of these cancers. For example: people who lived in Massachusetts and Illinois in the 1950s, and received identified lot numbers of the contaminated oral vaccine, are now contracting osteosarcoma bone tumors at a rate of ten times more than those who received the vaccine free of the SV-40. But the National Cancer Institute has been silent about these facts.
There needs to be more demographic studies to explore the relationship of SV-40 to adult onset cancers. Not surprisingly, the US government and its agencies are reluctant to pursue this matter. In fact, requests to the National Institute for Health for grants to study the SIV and simian cyto-megalovirus (SCMV) were recently denied. Microbiologist Howard Urnovitz, Ph.D., may have an explanation as he stated in the Boston Globe:
"that almost 100 million Americans were exposed (to SV-40) through a government sponsored program, but for over 30 years, there has been virtually no government effort to see if anyone's been harmed by the exposure." He added, "The government will not fund science that makes it look culpable."
Another method used by the National Cancer Institute to divert public concern is to issue statements that "many of the cancers under suspicion were contracted by people who are too young to have received the tainted vaccine in the 1950s." This argument, although true, ignores the potential of spreading the live SV-40 by "shedding" through personal contact. The oral polio vaccine was designed to be transmitted to non-vaccinated individuals by this very method. In fact, this was the reason that OPV was preferred over injection. If SV-40 is still being spread by contact today it is not surprising that these cancers are now affecting younger people.
Regardless of blame, severe damage to world health has already been done by the unsavory practice of growing vaccination products in animals. An example of these horrors was presented by Dr. Urnovitz at the Eighth Annual Houston Conference on AIDS. Dr. Urnovitz revealed significant evidence that human immunodeficiency virus type 1 (HIV-1) is a monkey hybrid virus which was produced when 320,000 Africans were injected with polio virus contaminated with live simian immunodeficiency virus (SIV) in the late 1950's. Apparently, viral fragments combine easily with other viruses to produce these hybrids called "chimeras." Prior to this revelation, health officials were blaming AIDS on the habit of certain Africans to consume monkey flesh.
What can be done now? "Make it in anything but animals," said Barbara Loe Fisher of the National Vaccine Information Center, which criticizes vaccine safety. "We have the technology to make vaccines in human cell lines that are clean," said Dr. Michele Carbone of Loyola University Medical Center, one of the first to discover SV-40 inside human tumors.
Until then we can only hope that researchers continue their work, regardless of the repercussions. Millions of people are already infected with SV-40 and are in danger. Many cancers do not develop until mid-life. Future generations must be protected. We must prohibit any future contamination of the world population, whether for our own good or not, by well-meaning governmental agencies.
UPDATE: October-November 2002 -- The following article appeared in the NY Times on October 22, 2002, partially quoted as follows:
Monkey Virus - Cancer Link Debated (THE ASSOCIATED PRESS)
WASHINGTON (AP) -- Despite years of study, there remains too little evidence to conclude a monkey virus that once tainted some polio vaccine can cause cancer in humans. Still, the Institute of Medicine said Tuesday, although studies of people who received the vaccine have not shown increased cancer rates, a connection cannot be completely ruled out. The institute, an arm of the National Academy of Sciences, recommended development of a federal response plan for dealing with contaminated vaccines and better tests for the monkey virus to determine how widespread it is.
The test in this article was to compare the group of people who got the original "live" virus in the 1950's, in school immunization programs, with the cancer rates of the general population. But, remember, the whole purpose of the mandatory "live" virus immunization program was to make sure that EVERYONE was exposed to the new batches of vaccine. This was done by having innoculated children "shed" the virus to others -- their parents, other children and virtually anyone that had contact with them after they were vaccinated. In other words, the entire American population was subjected to the SV-40 in either the original innoculation or from the shedding. So it is natural that the rates of cancer would be no different between the school children and anyone else that they infected.
On the whole, cancer rates have sky-rocketed, especially those rare forms related to the SV40, yet this type of misleading (i.e. lies) is typical of what the current administration and Federal offices are attempting to do with everything from the threat of Iraq to the infecting of its own population in the past.
If you want to get involved in a potential class action suit, you might want to contact a woman whose daughter contracted one of these rare forms of cancer (medulloblastoma), attributed to the SV40 contamination. Not only does she suffer from having her child impacted by this horrible governmental error, but she also has the uncertain guilt of possibly infecting her daughter from her own exposure to the live virus back in the 1950s.
Maybe you have had a similar experience. Are you angry? Then contact Sandy at bambitsg@winco.net. Remember the words of Mahatma Gandhi: "Even if you are a minority of one, the truth is still the truth."
Monkey virus in humans may trigger cancer: experts
Last Updated: 2002-07-12 10:01:08 -0400 (Reuters Health)
By Alicia Ault
WASHINGTON (Reuters Health) - Though there is still no clear consensus, a majority of researchers told a quasi-governmental health panel Thursday that simian virus 40 (SV40) has become established in humans, and that it plays a role in causing cancer, including in people who had virus-contaminated polio vaccines in the 1950s and 1960s.
The experts addressed the Institute of Medicine's (IOM) Immunization Safety Committee, which met to hear the latest epidemiologic and lab data on SV40. In 2 to 3 months, the committee will issue a report, along with recommendations based on their assessment of the data. SV40's role in cancer has been debated since the early 1960s, when it was discovered that inactivated polio vaccine contained the naturally occurring monkey virus. Monkey kidney cells were fingered as the source; they were used to grow polio for the shot. In 1961, scientists discovered SV40 caused cancer in rodents. The government required all future polio vaccine to be SV40-free.
Even so, some contaminated vaccine still on shelves may have been used, and as many as 98 million children had already been exposed during the government's Mass Immunization Program from 1955 until early 1963. Several attorneys alleged that the three polio vaccine makers--Wyeth, Lederle and Pfizer--knowingly distributed contaminated products before 1961 and later. Stan Kops, an attorney who successfully sued those companies for causing polio in vaccinees, alleged at the meeting that Lederle continued to sell SV40-tainted oral polio vaccine until 1999.
Attorney Donald MacLachlan, representing five families who claim the vaccine caused cancer, told Reuters Health that a federal judge in Los Angeles recently allowed a case against Wyeth to proceed. Scientists have tried to unravel whether SV40 is prevalent in humans, and if the polio vaccine caused infection, or if SV40 had been in humans previously. In the 1970s, SV40 was isolated in human tumors, especially brain and bone cancers, and, more recently, in mesotheliomas, a rare lung cancer found mostly in people over age 50, and primarily in men with occupational exposure to asbestos.
Michele Carbone of Loyola University in Chicago, Illinois has linked SV40 to mesothelioma. He called SV40 a "potent human carcinogen," capable of transforming cells and inhibiting the p53 gene that normally keeps cancer cells in check. But he added that the virus is not likely to act alone, and that co-factors--like asbestos--lead to cancer. In 2002, several researchers found SV40 in non-Hodgkin's lymphoma (NHL). Janet Butel, a Baylor College of Medicine virologist, isolated SV40 in NHL and has sequenced SV40 genomes. In three NHL samples, the SV40 strain was the same as one found in samples of a polio vaccine used in the 1950s, she said. SV40 "seems to be established in humans," and "it is causing infection," said Butel.
"Perhaps it was there before the polio vaccine, I don't know," she said, adding that widespread vaccine use may have broadly distributed SV40 in humans. The virus has been found in many nations. Erik Engels of the National Cancer Institute is conducting a study in northern India, where monkeys and humans live in close proximity, to see if--and how--SV40 might be jumping species or being transmitted from human-to-human.
Another researcher, Jeffrey Kopp of the National Institute of Diabetic, Digestive and Kidney Diseases, said a small study he and colleagues recently completed found SV40 in blood and urine of both healthy people and kidney disease patients, and that "argues for relatively common infection in the general population." Kopp's study will be published in September's Journal of the American Society of Nephrology. There were several nay-sayers, including long-time SV40 researcher Keerti Shah of Johns Hopkins University Bloomberg School of Public Health. Shah has been unable to isolate SV40 in human urine, and said that lab studies have been so inconsistent that they do not prove causality.
Howard Strickler, an epidemiologist at the Albert Einstein College of Medicine in New York, presented several studies he has conducted, all showing no association between SV40 and cancer incidence, he said. In a 1998 study in The Journal of the American Medical Association, Strickler and colleagues found no link between SV40 exposure and a type of cancer called ependymoma. Strickler also analyzed mesothelioma rates and said that incidence has remained at a steady 3% a year. It is very rare and not rising in women, said Strickler, which he said argued against the possibility that the cancer is being driven by polio vaccine exposure. Also, rates have only increased among people over 50, who were least likely to have been vaccinated, he said.
That was disputed by Carbone, who said a large number of people aged 20 to 45 were vaccinated in the 1960s, and that age group is having more mesothelioma. Susan Fisher, chief of the division of epidemiology at the University of Rochester, conducted a cohort study, comparing people born between 1955-1959 who were likely exposed to vaccine to those born between 1961-1965, and documented cancer incidence in that group from 1973 to 1993. In the vaccine-exposed group, there was a 178% increase in mesothelioma, and an increased incidence of ependymoma and osteosarcoma. But, because the cancers are rare, the differences between the exposed and unexposed group were not statistically significant, said Fisher.
For history of SV40 contaminating polio vaccine - see my website
http://www.nccn.net/~wwithin/polio.htm
http://tinyurl.com/demi
Simian virus 40 in human cancers
The American Journal of Medicine
Volume 114, Issue 8 , 1 June 2003, Pages 675-684
Background
Many studies have reported the presence of simian virus 40 (SV40) deoxyribonucleic acid (DNA) or protein in human brain tumors and bone cancers, malignant mesothelioma, and non-Hodgkin's lymphoma. However, the small samples and lack of control groups in some reports have made it difficult to assess their
reliability.
Methods
Studies were included in this analysis if they met the following criteria: original studies of patients with primary brain tumors and bone cancers, malignant mesothelioma, or non-Hodgkin's lymphoma; the investigation of SV40 was performed on primary cancer specimens; the analysis included a control group; and the same technique was used for cases and controls. Included reports were published from 1975 to 2002.
Results
Thirteen studies fulfilled the criteria for the investigation of primary brain cancers (661 tumors and 482 control samples). Specimens from patients with brain tumors were almost four times more likely to have evidence of SV40 infection than were those from controls (odds ratio [OR] = 3.9; 95% confidence interval [CI]: 2.6 to 5.8). The association was even stronger for mesothelioma (OR = 17; 95% CI: 10 to 28; based on 15 studies with 528 mesothelioma samples and 468 control samples) and for bone cancer (OR = 25; 95% CI: 6.8 to 88; based on four studies with 303 cancers and 121 control samples). SV40 DNA was also more frequent in samples from patients with non-Hodgkin's lymphoma (OR = 5.4; 95% CI: 3.1 to 9.3; based on three studies with 301 cases and 578 control samples) than from controls.
Conclusion
These results establish that SV40 is associated significantly with brain tumors, bone cancers, malignant mesothelioma, and non-Hodgkin's lymphoma. Studies are needed to assess current prevalence of SV40 infections.
http://news.bmn.com/news/story?day=030718&story=2
SV40: an emerging pathogen that's been around for fifty years
17 July 2003 8:00 GMTby Tabitha M. Powledge
Washington DC - Evidence mounts that the monkey virus that contaminated early polio vaccines causes human cancer - sometimes in people who never got the vaccine. Janet Butel has worked on SV40 for much of her long career, but to her the monkey virus is an emerging pathogen. She argues that researchers are in the midst of a changing paradigm for SV40, which contaminated certain polio vaccines nearly half a century ago and is suspected of leaving behind a legacy of cancer.
The idea that the virus is present in some characteristic tumors is no longer controversial, says Butel, who chairs the department of molecular virology and microbiology at Baylor College of Medicine in Houston. The next step is to demonstrate unequivocally that the virus causes those tumors.
Butel, who was speaking at the annual meeting of the American Association for Cancer Research (AACR) here in Washington, wants to understand the interaction of SV40 with its human host.
"Specifically we need to know the details of the immune response to an SV40 infection, both humoral immunity and cellular immunity," she said. She also wants to know which tissues get infected, how the virus is distributed in different cells around the body, and whether it is produced or just goes into a latent phase. "I hope that funding agencies will support these types of studies because it's important for scientists and public health officials to know what risk is posed by SV40 infections," she told BioMedNet News.
SV40 is, no question, a powerful cancer virus. In the hamster, the model animal for SV40 infection, the virus causes tumors of brain and bone as well as lymphomas and mesotheoliomas - exactly the same as cancers seen in people with SV40-positive tumors.
In a metaanalysis published just last month in the American Journals of Medicine, Butel and her colleagues report that in 13 studies, specimens from patients with brain tumors were almost four times more likely to have evidence of SV40 infection than were those from controls. The association was even stronger for 15 mesothelioma papers and four studies on bone cancer. SV40 DNA was also more frequent in three studies of samples from patients with non-Hodgkin's lymphoma.
The strong association with mesotheliomas turns up despite some negative studies. SV40 has important effects on mesosthelial cells in vitro, Butel says; transformation frequency is a thousand times higher than the rate reported for other cells. "It's very important that we study the correct target cells," she urged.
Butel's lab has also described several different SV40 strains, which she says is a relatively new concept. The researchers have sequenced about a dozen genomes so far. "We can tell each lab strain apart," she notes - crucial for establishing that the sequences found in human tumors are not lab strains. A key finding is that some human tumor-associated strains are the same as SV40 from early polio vaccines. The vaccine strains are found in brain tumors and non-Hodgkins lymphoma.
Alarmingly, some patients whose tumors contain the polio vaccine strains are too young to have received the contaminated vaccine. How the patients got exposed to these viruses is a mystery. One possibility, Butel suggests, is that the virus may be transmitted in urine. Studies on immunocompromised patients suggest that route of transmission, and one old study has reported that infected infants shed SV40 in their stools. "A student in my lab has shown that it can be transmitted in utero in hamsters," she added. That's a theoretical possibility in people, although there is no evidence for it. "We don't know; there are several possibilities," she said.
What are the biological differences among these strains, and do they differ in oncogenic potential? Unpublished work from her lab suggests the answer is yes, at least in syrian hamsters.
Butel notes that there are some negative reports arguing no association between SV40 and particular tumors. She speculates that the explanation is geography. SV40 tends to be found in particular US tumors, but not detected in those same tumors in Finland, Turkey, and Austria. "We need to sort this out to see what it's telling us," she said. One explanation may be that contaminated polio vaccine was never used in these countries, Butel speculates.
http://antonio.ingentaselect.com/vl=2542244/cl=80/nw=1/rpsv/cgi-bin/linker?ini=tandf&reqidx=/catchword/tandf/00015555/v83n3/s12/p202
By Facsimile
Letter to Demand a Congressional Investigation and Hearing on the Introduction of Simian Virus 40 (SV40), a Cancer-Causing Monkey Virus, into the American Population From Contaminated Polio Vaccines
Dear Representative Burton:
I am writing this letter on June 7, 2003. Exactly seven years ago, on June 7, 1996, my son Alexander was born. He would die in my arms 30 months later in a little motel room in Houston, Texas as we, his parents, tried desperately to safe his life. This letter is written in commemoration of Alexander’s short life and the injustice that befell him and the cause of the brain tumor (medulloblastoma) that killed him.
This letter is also the result of four long years of struggle by myself and my husband to find out why our beautiful healthy young son would be stricken by cancer. Now, our lawsuit against the manufacturer of the oral polio vaccine, American Home Products, (i.e. Lederle), has come to a close. As a result, much of the information that has been under a protective order for over three years has been entered into the public record through our legal documents filed with the Federal Court for the Central District of California in Los Angeles. What happened to Alexander is not an
isolated event. We contend that his death was caused by a Public Health Disaster that has befallen others and will continue to kill children until
it is addressed.
On August 12, 1999, we wrote you when you where Chairman of the Committee on House Government Reform in support of your investigations into pediatric vaccines - Vaccines; Finding the Balance Between Public Safety and Personal Choice. In this letter we described how various childhood vaccines contain known carcinogens and yet not a single vaccine is tested for carcinogenicity. While shampoos and cosmetics are tested to see if they cause cancer, incredibly, biological substances that are squirted or injected into healthy infants and children have never been tested.
On June 7, 2000, My husband and I also appeared before your Committee to discuss the FDA’s control of effective non-toxic pediatric cancer therapies in Cancer Care for The New Millenium - Integrative Oncology. During our sworn testimony we described how Alexander suffered enormously and unnecessarily as a result of the administration of four toxic but ineffective chemotherapy drugs (vincristine, cytoxan, etoposide, and cisplatin - Protocol CCG 9921). We described how the FDA would not allow our son to have access to a non-toxic cancer therapy that offered him the best chance of saving his life. We presented photographs to your Committee that demonstrated how Alexander struggled to stay alive and then suffered a horrific death.
From your own considerable effort in investigating vaccine production, testing, and safety you know that childhood vaccines contain formaldehyde (i.e. formalin), mercury (i.e. thimerosal), aluminum, and other toxic substances. In addition, vaccines can also contain animal viruses -contaminants from the animal substrates upon which the vaccines are manufactured. One of these viruses, a monkey virus called Simian Virus 40 is carcinogenic and found its way into the oral polio vaccine (OPV) and the inactivated polio vaccine (IPV) in the late 1950's and early 1960's. Such an event was not surprising because monkey kidneys contain a multitude of simian viruses and the polio vaccine is grown on monkey kidney cells.
The oral polio vaccine is a "live" trivalent vaccine which means that it contains three strains of poliovirus - Types I, II, and III, and each strain is attenuated (i.e. weakened). Dr. Albert Sabin, who was responsible for the creation of the licensed OPV, had to passage his poliovirus strains through a myriad of animals and animal host cells in order to attain the right virulence-strong enough to illicit an immune response, but sufficiently attenuated so as to not cause polio in the
recipient. For example, Type I has the following lineage:
In 1941, Drs. Francis and Mack isolated the Mahoney poliovirus "from the pooled feces of three healthy children in Cleveland." Dr. Salk then passed this strain through fourteen living monkeys and two cultures of monkey testicular cultures. In 1954, the strain (now called Monk14 T2) was given to Drs. Li and Schaeffer who subjected the virus to nine more passages through monkey testicular cultures. Next, the strain (now called Monk14 T11) underwent fifteen more passages in monkey testicular cultures, eighteen passages in monkey kidney cells, two passages through living rhesus monkeys skin, and additional passages through African Green monkey skin and monkey kidney cell cultures. This strain was now called MS10 T43 and LS-c. In 1956, Dr. Sabin took this virus and passaged it through seven cultures of African Green Monkey kidney cells. That same year, the pharmaceutical company, Merck, Sharp & Dohme, passed the strain (now called LS-c, 2ab/KP2) through a rhesus monkey kidney cell culture. The resulting material was called Sabin Original Merck (SOM) and was provided to Lederle in 1960 as the seed material to manufacture its polio vaccine.
Types II and III were created in a similar fashion.
Once the strains were isolated, the pharmaceutical companies needed a method to propagate the viruses in order to produce the vast quantities of vaccine needed for nation-wide immunization campaigns. This required a substrate upon which the poliovirus could be efficiently grown and harvested. Kidney cells from rhesus monkeys were chosen because they were found to be an effective growth medium. A small quantity of poliovirus could be added to the minced kidneys removed from these monkeys and within a few days, large quantities of poliovirus could then be harvested from these same monkey cells.
Between 1959 and 1960, Bernice Eddy, Ph.D., of the National Institute of Health (NIH) examined minced rhesus monkey kidney cells under a microscope. These were the cells of the same species of monkeys used to create and produce the oral polio vaccine. Dr. Eddy discovered that the cells would die without any apparent cause. She then took suspensions of the cellular material from these kidney cell cultures and injected them into hamsters. Cancers grew in the hamsters. Within a few months, the virus responsible for creating these cancers would be isolated and identified by Dr. Eddy and other scientists. Because it was the 40th simian virus found it was named simian virus 40 (SV40).
According to the FDA:
The discovery in 1960 that a DNA tumor virus, designated simian virus 40(SV40), was an inadvertent contaminant of rhesus monkey cells, and consequently the poliovirus and adenovirus vaccines that were made in these cells, was a watershed event in vaccine development…"
By 1960, the Salk injectable polio vaccine (IPV) had been administered to about 98 million American children and adults, and Sabin’s oral polio vaccine (OPV) had been administered to about 10,000 Americans and millions in the USSR where the clinical trials had been conducted. It was estimated that 10% to 30% of the vaccines contained live SV40. The federal agency in charge of vaccine licensing and safety at the time was the Division of Biologics Standards (DBS) of the National Institute of Health (NIH). Incredibly, this agency did not order a recall of any of the SV40-contaminated vaccines. The tainted vaccines continued to be administered until 1963 when they were all used and replaced by allegedly SV40-free vaccines as required by the new federal regulations promulgated in 1961.
In 1961, federal regulations were implemented to ensure that SV40 would no longer contaminate the polio vaccine. Despite these regulations, we contend that the OPV has been sporadically contaminated with SV40 for the last four decades. As a result, we allege that some of the children who have been administered the contaminated vaccines have been stricken with cancer and others are at risk. The main points are summarized below:
1) SV40 (Simian Virus Number 40) is a cancer causing monkey virus found in the kidney cells of Rhesus and African Green Monkeys. The kidney cells of these two species of monkeys comprise the substrate that has been used to create poliovirus strains and manufacture the oral polio vaccine for four decades.
2) SV40 is a human carcinogen for brain cancer and mesothelioma and it is a suspected carcinogen in osteosarcomas (bone cancers) and Non-Hodgkin’s Lymphomas.
3) Alexander was administered the OPV in November 1997. He was diagnosed with a brain tumor in August 1998. Alexander died on January 31, 1999.
4) Four independent laboratories using DNA testing and laser micro-dissection found SV40 in Alexander’s brain tumor.
5) SV40 has been found in the cancers of many other children. Pediatric brain tumors and other childhood cancers including osteosarcomas (bone cancer) and Non-Hodgkins Lymphomas have been found to contain SV40.
6) When Alexander was born on June 7th, 1996, I had his cord blood saved and stored by a private laboratory. The cord blood was the blood shared by Alexander and myself at the time of Alexander's birth. We had this blood tested for SV40. This marked the very first time the cord blood of a child with an SV40 positive brain tumor would be tested for SV40. To the astonishment of the scientists it was negative for SV40. This suggestedthat at the time Alexander was born he had not been exposed to SV40.
7) It is known that SV40 can be spread through contaminated blood so my husband and myself underwent a battery of tests from 2000 to 2001. Using a variety of sophisticated DNA tests to isolate the genetic fingerprint of the SV40 virus including Polymerase Chain Reaction (PCR), the scientists checked blood, urine and semen multiple times looking for any trace of SV40 (even antibodies). The scientists were once again surprised. Despite the repeated tests by leading SV40 laboratories both in the United States and Europe, we had absolutely no trace of SV40.
8) The scientists concluded that Alexander did not get SV40 from his parents, nor did he give SV40 to us.
9) The original oral polio vaccine (OPV) seed stocks created by Dr. Albert
Sabin and used to make OPV since 1961 were known to be contaminated with
SV40. In fact, SV40 was isolated from Sabin's OPV seeds - the original material used to make OPV for four decades.
10) Dr. Sabin had admitted that OPV seeds were contaminated with SV40 in a peer-reviewed scientific publication. Dr. Sabin wrote, "The three types of the large lots produced by Merck, Sharp and Dohme in rhesus monkey kidney cell cultures contained SV40."
11) Lederle, the sole American manufacturer of OPV for many years, received their OPV seeds from Merck, Sharp and Dohme. There is no evidence that Lederle ever tested their seeds for SV40 nor discarded their presumably contaminated seed stocks.
12) There are Lederle documents (not under a protective order) that demonstrate that their early OPV vaccines were contaminated with SV40.
13) Lederle did not use the SV40-neutralization procedures recommended by Dr. Sabin.
14) Monkeys used to produce OPV were not tested for SV40 by Lederle because of economic considerations.
15) After reviewing all of the Lederle records and the Lederle systems in place, our expert concluded that the contamination detected in the OPV material ultimately administered to Alexander was SV40.
16) The medical literature is unequivocal - the pediatric brain cancer rate in the U.S. has been climbing at a rate of approximately 3% for the last four decades.
17) A recent study has demonstrated that 11% of Americans are currently infected or have been infected with SV40.
SV40 is not only responsible for causing the cancer, but also for making these particular cancers incurable. Orthodox cancer therapies such as chemotherapy and radiation can not cure an SV40 positive cancer. Pediatric brain cancers and other solid cancers have been found to contain SV40. SV40 binds with the tumor suppressor genes p53 and RB and stops tumor cells from undergoing apoptosis (programmed cell death). Apoptosis is what radiation and chemo depend on to work in order to trigger the cancer cell to die. Exposing SV40 positive cancer cells to chemo and radiation does not kill the cells but simply creates more genetic mutations - making the cancer more aggressive. The bottom-line is that SV40 causes human cancer, stops orthodox cancer therapies (i.e. chemo and radiation) from providing any benefit, and can make the cancer even more aggressive.
Despite these facts, children diagnosed with cancer are not given a choice of whether they should undergo debilitating and toxic chemo and radiation. Alexander should have been tested for SV40 upon his diagnosis, not after he died. He should not have been administered ineffective and unnecessary chemotherapy which provided no benefit and only made him suffer. Children with SV40 positive cancers (or p53 mutations) should not be used as guinea pigs and profit centers for pediatric oncologists, hospitals, and pharmaceutical companies.
A Congressional Hearing should be immediately convened to examine how a federally policed vaccine program has introduced a deadly monkey virus into countless American men, women and children for the past 45 years and what the public health consequences have been of this tragedy.
This government investigation should demand to know:
Why a vaccine manufacturer was allowed to use vaccine seed stocks for four decades that came from a source contaminated with SV40? Why did this manufacturer violate federal regulations and allowed contaminated vaccines to be released? Why weren't sophisticated tests to detect SV40 during OPV production and to eliminate the virus ever required by the federal government? Why aren't children with cancer tested for SV40 when they are diagnosed, not when they are dead, because an SV40 positive cancer means that chemo and radiation will be ineffective? Why is there a significant percentage of Americans (children and adults) walking around with evidence of having had an SV40 infection and what does that mean for their risk of cancer and chances for a successful treatment?
Like our son, many children are already dead, victims of this virus, and many adults will be stricken later. Time is of the essence, not for our beloved Alexander anymore, but for other children who are infected with this cancer causing virus.
Sincerely,
Raphaele Moreau-Horwin M.A., M.F.S. Michael
Horwin, M.A., J.D.
http://www.ouralexander.org
cc: Barbara Loe Fisher, Co-Founder & President of the National Vaccine
Information Center
53rd Meeting of the Advisory Commission
On Childhood Vaccines (ACCV)
and Conference Call
December 4, 2002
Minutes
Members Present
Elizabeth J. Noyes, MA
Lois Ann Swartzlander, RN
Thomas P. Gallagher, J.D.
John R. Schreiber, M.D.
Eileen Seemayer
Barry R. Sugarman, J.D.
Public Participants Present
David Blake/Department of Justice
Amanda Buxbaum/National Vaccine Information Center
Greg Chernick/Wilmer, Cutler & Pickering
Dack Dalrymple/ Dalrymple & Associates
Adam Eckstein/The Pink Sheet
Jeff Francer/Arnold & Porter
Arnold Gale, M.D./Stanford University
Claire Hannan/Association of State and Territorial Health Officials
Sam Kanji
Bronwen Kaye, Wyeth
Raymond MacDougall/Sabin Vaccine Institute
Peter Meyers/George Washington University School of Law
Michael Milmoe/Department of Justice
Geoffrey Peterson/Aventis Pasteur
Bruce Roberts/Robertson Roberts
Carol Ruppel/Every Child By Two
Charlene Shapiro/Wilmer, Cutler & Pickering
Mary Sherrett/ASA
Paul Strain/Venable, Baetjer & Howard, LLP
Ex Officio Members Present
Norman Baylor, Ph.D.
Barbara Mulach, Ph.D. for
Carol A. Heilman, Ph.D.
Ben Schwartz, M.D.
Executive Secretary
Thomas E. Balbier, Jr., Director, Division of Vaccine Injury Compensation (DVIC), Office of Special Programs (OSP), Health Resources and Services Administration (HRSA)
Principal Staff Liaison
Cheryl A. Lee, DVIC, OSP, HRSA
Introduction and Opening Remarks
Ms. Elizabeth Noyes welcomed the members to the 53rd quarterly meeting. The minutes of the September 4, 2002 meeting were approved.
Institute of Medicine's Report, SV40 Contamination of Polio Vaccine and Cancer, Kathleen Stratton, Ph.D.
On October 22, the Immunization Safety Review Committee (Committee) released its fifth report, entitled, SV40 Contamination of Polio Vaccine and Cancer.The Committee examined the hypothesis that exposure to polio vaccine contaminated with simian virus 40 (SV40) causes certain types of cancer. The Committee's charge was to assess both the scientific evidence regarding the hypotheses under review and the significance of these issues for society.
Some of the polio vaccine administered from 1955 - 1963 was contaminated with SV40. The virus came from the monkey kidney cell cultures used to produce the vaccine. Most, but not all, of the contamination was in the inactivated polio vaccine (IPV). Once the contamination was recognized, steps were taken to eliminate it from future vaccines. Between 1959 - 1961, experimental lots of oral polio vaccine (OPV) contaminated with SV40 were administered to about 10,000 people participating in clinical trials. Tests of stored samples of the IPV that had been administered in the United States from May through July in 1955 found varied levels of SV40 contamination with some vaccine showing no contamination. From this data, it is estimated that 10% - 30% of IPV contained live SV40 and that similar percentages of the approximately 98 million Americans who had been vaccinated by 1961 were exposed to SV40.
The Committee reviewed the epidemiologic evidence on the association between exposure to polio vaccines containing SV40 and the subsequent development of cancer. Upon this review, the Committee found studies examining cancer incidence or mortality. Also included in the Committee's review were studies of cancer occurring in children who may have had a prenatal exposure to SV40 through vaccination of their mothers.
The Committee reviewed the studies in the following three categories: cancer incidence, cancer mortality, and cancers following prenatal exposure to SV40-containing vaccine. For cancer incidence, the Committee reviewed five ecologic studies and two controlled studies. The five ecologic studies were: Fisher et al., 1999; Geissler, 1990; Olin and Giesecke, 1998; Strickler
et al., 1998; and Strickler et al., 1999. The two controlled studies were Innis, 1968 and Stewart and Hewitt, 1965.
For cancer mortality, the Committee reviewed the following two ecologic studies: Fraumeni et al., 1963, and Strickler et al., 1998. They reviewed one uncontrolled study (Carroll-Pankhurst et al., 2001), and two follow-ups to the study--Fraumeni et al., 1970; and Mortimer et al., 1981.
All of the studies that the Committee reviewed concerning cancer incidence or cancer mortality and exposure to polio vaccine containing SV40 have substantial limitations. Many of theses studies were ecologic in design. In an ecologic study, the unit of analysis is a group. Because the joint distribution of the study factors and disease within each group are unknown, it is difficult to make causal inferences regarding the association between an exposure and disease at the individual level.
Most of the epidemiologic studies on polio vaccine containing SV40 and cancer are subject to misclassification bias because of a lack of detailed and specific information about the level of SV40 contamination in individual vaccine doses. These studies were also limited by the rarity of the tumors thought to be associated with exposure to SV40.
Studies of cancer mortality are confusing due to improvements over time in the effectiveness of treatments, which may produce a decline in mortality rates that is unrelated to the incidence of the cancer. If the associations suggested by some studies in this body of weak epidemiological evidence are true, the absolute risks for additional cancer cases or deaths are small and cannot necessarily be attributed solely to exposure to SV40-contaminated polio vaccine. Based on these limitations, the Committee concluded that the evidence is inadequate to accept or reject a causal relationship between SV40-containing polio vaccines and cancer.
The Committee focused on reviewing the biological evidence with an eye toward additional research that might be needed to better understand the putative role that exposure to SV40 from polio vaccines might have in cancer. The Committee reviewed the evidence on biological mechanisms related to this hypothesis through the following three key questions: (1) Is SV40 a transforming virus; (2) Can SV40 cause cancer in humans under conditions of natural exposure; and (3) Is contamination of the polio vaccine with SV40 responsible for SV40 infection in humans?
The first question was, "Is SV40 a transforming virus?" Evidence suggested that SV40 could produce oncogenic transformation of cells that comes from four sources: rodents, nonhuman primates, cell culture studies, and humans. The earliest studies of SV40 were conducted with rodents and showed that administration to neonatal and weanling hamsters causes cancers. A seminal study (Eddy et al, 1961) demonstrated that injection of extracts of rhesus monkey kidney-cell cultures into newborn hamsters was followed by the occurrence of neoplasms in approximately 70% of the animals. Despite the limitations in their applicability to humans, these animal systems are notable in that the tumors were seen, and the human cancers were associated with the presence of SV40 or viral fragments in rodents.
Cells transformed by SV40 have been shown to grow in humans and become tumors. In a study by Jensen and colleagues (1964), persons terminally ill with cancer received implants of either homologous or autologous tissue via subcutaneous injection. When cells transformed by SV40 were implanted, nodules of undifferentiated tumor cells developed. This study provides evidence from contrived clinical conditions that cells transformed by SV40 can develop into undifferentiated tumors in a human host. Therefore, the Committee concluded that the biological evidence is strong that SV40 is a transforming virus.
The second question was, "Can SV40 cause cancer in humans under conditions of natural exposure?" There is a theoretical basis for the existence of mechanisms by which SV40 could cause cancer in humans. The principal lines of evidence for the operation of specific mechanisms are that SV40 acts in ways consistent with tumorigenesis and that DNA sequences consistent with SV40 have been detected in several types of human tumors.
Data on the association between SV40 and human tumors are inconsistent. A growing body of clinical studies reported the detection of SV40 DNA in several types of tumors. The most notable and well studied of these is mesothelioma. In addition, SV40 DNA has been detected in bone cancers, and in non-Hodgkin's lymphoma. However, other studies report an inconsistency or absence of SV40 in mesotheliomas, osteosarcomas, and brain tumors.
The conflicting results in the detection of SV40 have led to questions about technical aspects of the detection of the virus. There are questions as to whether positive findings are the result of overly sensitive, but nonspecific tests that are detecting other viruses or SV40 from laboratory contamination, or whether negative findings arise from a lack of sensitivity in the detection methods used.
The detection of SV40 in tumors does not demonstrate a causal relationship. SV40 could be a passenger virus, infecting the cells, but causing no pathology. Findings from studies examining SV40 in mesothelioma demonstrate a great deal of variability which precludes the ability at present to draw conclusions regarding the frequency with which SV40 can be detected in specific neoplasms and/or normal tissues in humans. Therefore, the Committee concluded that the biological evidence is of moderate strength that SV40 exposure could lead to cancer in humans under natural conditions.
The third question was, "Is contamination of the polio vaccine with SV40 responsible for SV40 infection in humans?" In the United States, potentially contaminated IPV was administered between 1955 and 1963. Because the process for inactivating the live polio virus could be expected to kill some of the SV40, some vaccines were likely exposed to a mixture of the live and killed virus while others were exposed only to killed SV40. Thus, exposure to IPV between 1955 and 1963 cannot be equated with exposure to live SV40 or, by extension, to infection with SV40.
There is additional uncertainty about the possible contribution of vaccine-based SV40 exposure to SV40 infection and carcinogenesis because of the age of which vaccines were exposed. Because the incidence of ependymomas is highest in children under age 5 and osteocarcoma is most common in adolescents, contemporary evidence of SV40 in such tumors does not provide a direct link to exposure to contaminated IPV between 1955 and 1963. But with the long latency period for mesothelioma, exposure to contaminated IPV remains a possibility.
Other sources of exposure to SV40 may also exist. A limited number of people have been exposed to SV40 through other vaccines, including an experimental live-virus vaccine against respiratory syncytial virus and a licensed inactivated adenovirus vaccine that was administered to military recruits.
The measures of infection remain problematic. The serology data is unclear, in part, because of concerns about cross-reactivity with certain viruses. The Committee concluded that the biological evidence is of moderate strength that SV40 exposure from the polio vaccine is related to SV40 infection in humans.
The Committee concluded that the evidence is inadequate to accept or reject a causal relationship between SV40-containing polio vaccines and cancer. The Committee also concluded that concerns about exposure to SV40 through inadvertent contamination of polio vaccines are significant because of the seriousness of cancers as the possible adverse health outcomes and because of the continuing need to ensure and protect public trust in the nation's immunization program.
The Committee does not recommend a policy review of polio vaccine by any of the national or federal vaccine advisory bodies, on the basis of concerns about cancer risks that might be associated with exposure to SV40, because the vaccine in current use is free of SV40. The Committee does recommend that appropriate Federal agencies develop a Vaccine Contamination Prevention and Response Plan. The Committee also recommends the development and use of sensitive and specific standardized techniques for SV40 detection.
The Committee further recommends that once there is agreement in the scientific community as to the best detection methods and protocols, pre-1955 samples of human tissues should be analyzed for presence or absence of SV40 in rigorous, multi-center studies. The Committee recommends further study of the transmissibility of SV40 in humans.
Until some of the technical issues are resolved, the Committee does not recommend additional epidemiological studies of people potentially exposed to the contaminated polio vaccine.
Discussion of VICP Provisions in the Homeland Security Act of 2002:
Emily Marcus Levine, J.D.
Ms. Emily Marcus Levine, J.D. presented an overview of sections 1714-1717 in the Homeland Security Act of 2002 (P.L. 107-296) affecting the National Vaccine Injury Compensation Program (VICP) and on section 304 which provides liability protection to health care providers administering the smallpox vaccine under certain circumstances.
On November 25, 2002, the President signed into law the Homeland Security Act (HSA). There are two vaccine liability issues in the HSA that affect the VICP. The first issue is modifications to the National Childhood Vaccine Injury Act of 1986 (Act), as amended, which incorporates several sections of the March 21 version of, "Improved Vaccine Affordability and Availability Act" (S. 2053), introduced by Senator William Frist, (R-TN). The second issue is smallpox liability.
Prior to the enactment of the HSA, the Act's definition of manufacturers extended only to manufacturers of vaccines on the Vaccine Injury Table (Table). This definition did not include manufacturers of components of ingredients in these vaccines.
In HSA, Section 1714, "The Clarification of Definition of Manufacturer," amends the definition of manufacturer to include manufacturer of any components or ingredients of vaccines on the Table. This change extended the Act to allow liability protection for vaccine-related claims against manufacturers of thimerosal.
In HSA, Section 1715, "Clarification of Definition of Vaccine-Related Injury or Death," clarifies the definition of "vaccine-related injury or death." It states that a preservative that was intentionally used as a component of a vaccine is not an adulterant or contaminant. It also states that any component or ingredient that is listed in a vaccine's product license application and product label is not an adulterant or contaminant. Therefore, thimerosal would be not considered an adulterant or contaminant of a covered vaccine under the Act. In the Department's view, this section was a mere clarification of preexisting law.
Prior to the enactment of the HSA, the Act did not provide a definition for a vaccine. Section 1716 of HSA, "Clarification of Definition of Vaccine," provides the following definition of a vaccine, "any preparation or suspension, including but not limited to a preparation or suspension containing an attenuated or inactive microorganism or subunit there of or toxin, developed or administered to produce or enhance the body's immune response to a disease or diseases and includes all components and ingredients listed in the vaccine's product license application and product label." This provision makes it explicit that a preservative listed in a vaccine's product license and product label is included in the definition of a covered vaccine. This provision requires claims alleging injuries from a thimerosal component of a covered vaccine to be pursued initially through the VICP before other civil litigation can be pursued.
Several proposals in S. 2053 that would affect thimerosal civil actions were included in the HSA. For example, in section 203, "Jurisdiction to Dismiss Actions Improperly Brought," would have prohibited awards in civil actions for claims where an individual had not proved that any physical injury had occurred. In Section 202, "Equitable Relief," would have extended the Act to apply claims seeking equitable relief.
There are other proposals in S. 2053 that were not specifically targeted to addressing thimerosal claims, but were targeted toward making the VICP more efficient and generous. First, Section 207, "Increase in Award in the Case of a Vaccine-Related Death and for Pain and Suffering, " would have increased the $250,000 award for death and the $250,000 award for pain and suffering to $350,000. Second, Section 212, "Extension of Statute of Limitation," would have extended the statute of limitations for a vaccine-related injury from 36 months to 6 years, and upon death, extended from 48 months to 6 years after the onset of the first symptoms or significant aggravation of the injury from which death resulted.
The enactment of the HSA did not affect the Act or state law statute of limitations provisions. The Act has two statute of limitation provisions that may affect thimerosal claims. One provision states that the date the civil action was dismissed would be considered the date the VICP petition was filed for purposes of calculating the statute of limitations under the Act. This gives petitioners the benefit of this time period, so long as the petition is filed within one year from the date that the civil action was dismissed.
Under the Act, the statute of limitation provision specifies that the state law statute of limitations provision will be tolled during the pendency of the VICP claim. If a proper VICP petition is filed, the limitations period under state law will be stayed with respect to the civil action brought for the same injury/death claim from the date the VICP petition is filed, and until the date the VICP petitioner elects to reject the VICP judgment.
The HSA provisions apply to all actions or proceedings pending on or after the date of enactment, unless a court of competent jurisdiction has entered judgment (regardless of whether the time for appeal has expired).
Smallpox Liability
In HSA, Section 304, "Conduct of Certain Public Health-Related Activities," includes smallpox liability protection and countermeasures. It also includes the Secretary of Health and Human Services' (HHS) obligations, along with the Secretary of Homeland Security, to set priorities and develop strategies for research and development relating to counter measures against terrorist threats.
Section 304 authorizes the Secretary of HHS to issue a declaration for a set period of time to administer smallpox countermeasures to a group of individuals. The declaration has to be published in the Federal Register, and once it is finalized, it will provide liability protection to healthcare providers administering the smallpox vaccine. This group of individuals would be deemed "covered persons" and "employees of the Public Health Service." If an individual sustains an injury they believe resulted from the smallpox vaccine, they would be able to bring a lawsuit under the U.S. Federal Tort Claim Act (FTCA). This would be the only lawsuit an injured could file for an injury from smallpox vaccine.
If the Secretary of HHS does not issue a declaration and someone received the smallpox vaccine, or if the person were not covered by the declaration, the injured person would have the rights he/she would normally have under current law to seek legal redress.
Under HSA, a "covered person" includes the following four categories of individuals: manufacturers and distributors of a covered countermeasure; healthcare entities under whose auspices countermeasures were administered; a qualified person who administered the counter- measure (this would be a licensed healthcare professional/other person authorized to administer countermeasure under State law where administered); and any agent/employee of any person in the above categories. These covered persons are shielded from liability because they would be protected under FTCA, which is the exclusive remedy for seeking damages for smallpox vaccine related injuries and deaths.
The U.S. is liable for a claim arising from the administration of a covered countermeasure, including the smallpox vaccine, if certain requirements are met. The countermeasure had to be administered by a qualified person. It had to be administered for the purpose of preventing or treating smallpox. It also had to be administered during the effective period of the Secretary of HHS' declaration, and the injured person had to be within the category of person that the Secretary of HHS recommended receive the countermeasure.
The HSA also covers liability for non-vaccine recipients. If someone suffers an injury by being in close contact with someone who received the smallpox vaccine, then for the purposes of the HSA, he/she is treated as if he/she received the smallpox vaccine. The non-vaccine recipient would have to contract vaccinia during the effective period of the Secretary of HHS declaration or within 30 days thereafter. In the alternative, the injured person would have to reside with a vaccine recipient or reside with a vaccine recipient who was a covered person under the Secretary of HHS declaration, and the non-vaccine recipient would have to contract vaccinia after that date. Under certain circumstances, the U.S. can oppose or deny a claim.
The HSA makes clear that in order for a legal action to proceed against the U.S. under the FTCA, the U.S. Attorney General would have to make a certification that the action was filed against a covered person, and that action was based on a claim alleging injury/death arising from administration of covered countermeasure. This certification would establish facts for determining certain jurisdictional issues.
The HSA does not specifically impose any limitations on damages under the FTCA, or under state law. The FTCA incorporates state law provisions on damages, but punitive damages would not be allowable.
Update on Thimerosal Litigation: Luke Sobota, J.D., Wilmer, Cutler & Pickering
Luke Sobota is an associate attorney with the firm of Wilmer, Cutler and Pickering. Mr. Sobota stated that he is not the counsel of record in any of the thimerosal related lawsuits and that his discussion would not reflect the positions of any party in these lawsuits.
In June, there were 67 thimerosal lawsuits filed. Currently, there are 190 thimerosal related lawsuits filed in state and Federal courts. Out of these cases, there are 12 putative class actions, which purport to represent 175 million individuals who have received a vaccine containing the preservative thimerosal. None of these putative class actions lawsuits have been certified.
These lawsuits have been filed against vaccine manufacturers, manufacturers and distributors of thimerosal, and doctors and other administrators of the vaccines.
The complaints filed in these lawsuits fall into three categories. First, children alleging autism or other neurodevelopmental disorders that they claim were caused by thimerosal. Second, children who have received a vaccine containing thimerosal, but do not currently have an injury. These plaintiffs are seeking future medical monitoring of their health. Third, parents and other third parties alleging injuries arising out of the child's vaccine related injury or death (derivative claims).
Most of the courts have been willing to permit these derivative claims filed by parents to continue in state court notwithstanding the VICP. Although the remedies available differ among the state courts, they have recognized that parents might be eligible to receive compensation for loss of consortium, loss of services of the child, lost wages, and medical expenses.
On November 5, Federal Judge Sarah Vance permitted a derivative claim filed by a vaccinated child's parents to go forward under state law. The parents in that case alleged that the manufacturers of vaccines and thimerosal were negligent in failing to adequately test the vaccines, in failing to consider alternatives to thimerosal as a preservative, and in failing to adequately warn of potential dangers.
The court's ruling that the claims could go forward was interesting in two respects. First, the child never filed a petition with the VICP, and sought no relief in this case. The only claims filed in this case were the parents' derivative claim for loss of consortium, intentional infliction of emotional distress, and lost wages. The court held that the parents' claims for loss of consortium and lost wages could go forward.
Second, the court held that there was no need to wait for the child to file a petition with the VICP, even though the VICP would ordinarily decide whether or not the vaccines caused the child's alleged injuries. The court instead held that it would independently make that causal determination in the process of resolving the merits of the parents' derivative claims.
Other courts have ruled that the parents' derivative claims should be stayed until the VICP has resolved the child's underlying petition. These courts have noted that parallel claims could result in inconsistent decisions and could frustrate the Act's purpose of sparing the vaccine industry from the expenses of duplicative litigation.
All of the courts addressing direct cases filed by children alleging thimerosal related injuries have held that they must first be brought under the VICP before going into state or Federal court. These courts have rejected the plaintiff's argument that thimerosal is not covered under the Act because it is an "adulterant or contaminant" intentionally added to the vaccine. However, these decisions do not mean that these cases will be filed with the VICP. Plaintiffs have developed other theories to keep their cases in state court and out of the VICP.
In Leroy v. HHS, the U.S. Court of Federal Claims held that thimerosal is antithetical to an "adulterant or contaminant" because it prevents corruption of the vaccine. The court further held that thimerosal is a constituent part of the vaccine's suspension or preparation; and therefore, covered by the VICP.
Even though the state and Federal courts appear to agree that thimerosal is a constituent part of a vaccine and therefore, covered by the VICP, it does not mean that these cases will now be filed in the VICP. These court decisions only address one of several bases that plaintiffs have asserted for not filing under the VICP.
For example, some courts have held that parents' derivative claims can continue in state court notwithstanding the VICP. These derivative claims often present the same legal issues and sometimes even seek the same type of damages that the VICP would address with respect to the underlying petition. In addition, plaintiffs have amended their complaints to evade the VICP by seeking damages of less than $1,000 or by seeking medical monitoring.
The vast majority of courts in the thimerosal lawsuits have not addressed these issues and the decisions that were made by some courts are subject to further appellate review.
Report on the Division of Vaccine Injury Compensation (DVIC): Thomas E. Balbier, Jr.
On October 18, DVIC moved from the Parklawn Building in Rockville, Maryland to the East-West Towers Building in Bethesda, Maryland. Our new mailing address is 5600 Fishers Lane, Room 16C-17, Rockville, Maryland, 20857 and our phone and fax numbers will remain the same.
There has been a huge influx of cases filed. In Fiscal Year (FY) 2002, there were 953 claims filed. This increase is due to thimerosal and autism cases being filed. In FY 2003, 160 claims have been filed thus far.
The annual total for awards paid for post-1988 cases has changed over the years. In FY 2001, the total paid was almost $84 million. In FY 2002, the total was $56.9 million, and so far in FY 2003, $12.2 million has been paid.
Beginning in January 1999, DVIC developed an initiative in partnership with the Office of the General Counsel (OGC), Department of Justice (DOJ), and the U.S. Court of Federal Claims (the Court) to expedite the adjudication of the remaining pre-1988 claims. As of November 18, only 6 claims remain to be adjudicated.
The Vaccine Injury Compensation Trust Fund (Trust Fund) balance is $1.8 billion. The amount of money received in the Trust Fund from October 1, 2001 through September 30, 2002 was $176 million. The interest income earned was $74 million, and the excise tax collected was $102 million.
On October 3 and 4, the VICP held a Strategic Planning Retreat (the Retreat) at the Hyatt Regency Hotel in Bethesda, Maryland. The Retreat was facilitated by the Vantage Human Resources Services, Incorporated (Vantage). Approximately, 55 VICP stakeholders attended the Retreat. The stakeholders in attendance were: 15 staff from the Health Resources and Services Administration; 2 staff from the Office of the General Counsel; 7 members of the ACCV; 5 parents of children who had filed claims under the VICP; 7 attorneys representing petitioners and vaccine companies; 3 representatives of vaccine companies, 9 individuals representing medical organizations; 5 representatives of parent or consumer interest groups; and 1 individual from the Clerk's Office of the U.S. Court of Federal Claims.
The participants provided valuable comments on the draft strategic plan, and on the draft implementation and communication plans for the strategic plan. The VICP Strategic Planning Workgroup (the Workgroup) developed the strategic plan. Comments received from the participants stated that the Retreat provided an opportunity for a frank discussion of issues and challenges facing the VICP, as well as a forum for presenting potential solutions to these challenges. All the participants expressed an interest in continuing their involvement in the strategic planning process until its completion in December. The participants also expressed sincere hopes that some positive changes will occur as a result of their efforts.
The next major activities of the Workgroup will be to obtain comments on the draft plan from the ACCV members and other participants this afternoon, and review and incorporate appropriate comments into the final strategic plan.
There has been lots of legislative activity. On September 5, Ms. Elizabeth J. Noyes, ACCV Chair, sent a letter to Tommy Thompson, Secretary of Health and Human Services
(the Secretary) recommending changes in various provisions in the "Improved Vaccine Affordability and Availability Act" (H.R. 5282). This bill is the House version of S. 2053, and was introduced by Representatives Jim Greenwood (R-PA) and Edolphus Towns (D-NY).
On September 18, the House Committee on Government Reform held a hearing titled "Continuing Oversight of the National Vaccine Injury Compensation Program." Chairman Dan Burton conducted this hearing as a follow-up to the VICP hearings held on November 1 and December 12, 2001. The purpose of the hearing was to discuss the cases of petitioners, Ms. Janet Zuhlke and Mr. Thad Rogers. The hearing consisted of two panels. The first panel consisted of Ms. Zuhlke and Mr. Rogers. They testified about their experiences in seeking
compensation through the VICP. Mr. Ron Homer, an attorney representing Mr. Rogers was also a member of this panel. The second panel consisted of Mr. Paul Clinton Harris, Jr., Deputy Associate Attorney General, DOJ, and Mr. William Hobson, Director, Office of Special Programs, HRSA. They were asked their views on the "National Vaccine Injury Compensation Improvement Act of 2002" (H.R. 3741).
On September 18, Daniel J. Bryant, Assistant Attorney General, DOJ, sent a letter to Rep. Dan Burton (R-IN), Chairman of the House Committee on Government Report, expressing DOJ's views on the "National Vaccine Injury Compensation Program Improvement Act of 2002" (H.R. 3741).
On November 25, the President signed into law the Homeland Security Act of 2002 (HSA), which established the Department of Homeland Security. The HSA includes provisions from the "Improved Vaccine Affordability and Availability Act," a bill introduced by Senator William Frist (R-TN) on March 21, 2002. Sections 1714 -1717 revise the definition of a manufacturer, clarify the definition of a vaccine-related injury or death, and adds the definition of a vaccine. These sections would require future and pending civil lawsuits to first be filed with the VICP. Presumably, this would remove from the state courts future and pending individual and class action lawsuits alleging that thimerosal and/or covered vaccines caused autism.
In HSA, Section 304 provides liability protection to health care providers and hospitals administering the smallpox vaccine, and the manufacturers of this vaccine through the Federal Tort Claims Act if the Secretary issues a declaration that a bioterrorist threat makes it advisable to implement a countermeasure, such as administration of the smallpox vaccine. Under this section, the only recourse for individuals filing claims or actions alleging injuries from the smallpox vaccine would be to sue the U.S. in Federal court although State laws would apply. This section would not allow claims alleging injuries or deaths from the smallpox vaccine to be filed with the VICP.
In September, the U.S. General Accounting Office released a report entitled, "Ensuring an Adequate Supply Poses Continuing Challenges." This report addresses the following issues: the recent childhood vaccine shortages; what factors have contributed to the vaccine shortages; and what strategies are Federal agencies considering to help mitigate disruptions in the vaccine supply.
On October 8-9, Dr. Geoffrey Evans, Medical Director, represented the Health Resources and Services Administration (HRSA) at the National Vaccine Advisory Committee (NVAC) meeting in Washington, D.C. Agenda topics included: payment rates by Medicare for vaccine administration, vaccine supply shortages, and smallpox vaccine policy. In addition, Dr. Evans co-chaired the Subcommittee on Vaccine Safety and Communications, and reviewed the Centers for Disease Control and Prevention's (CDC) smallpox vaccine communication plan and future topics for the Institute of Medicine Immunization Safety Review Committee. Ms. Noyes, ACCV liaison to NVAC, provided a briefing on the VICP Strategic Planning Retreat, and an update thimerosal-related litigation.
On October 16-17, Dr. Evans attended the CDC's Advisory Committee on Immunization Practices meeting in Atlanta, Georgia, and provided an update on the VICP.
On November 8, Commander Carol L. Konchan presented an overview of the VICP to approximately 225 participants at the Annual Kansas Immunization Conference in Topeka, Kansas. The conference was sponsored by the Kansas State Nurses' Association. The presentation included the history of the VICP, as well as the general process of filing a claim with the VICP.
On September 23, Ms. Elizabeth Rezai-zadeh joined the VICP as a HRSA Scholar. She has completed a B.S. degree in Microbiology and a M.P.H. in Epidemiology at the University of South Florida in Tampa.
On October 21, Lieutenant Nichole Chamberlain joined the VICP as a Program Analyst in the Policy Analysis Branch. She has a Bachelors degree in Nursing. Formerly, she worked in HRSA's Office of Peer Review as a Program Analyst.
Effective November 17, Ms. Doris Cooper, Program Analyst, Program Operations Branch, was promoted from a Grade 9 to a Grade 11.
On November 13, the 20th Annual 2002 HRSA Awards Ceremony was held and two VICP staff received distinguished awards. Mr. Ward Sorensen, Chief, Program Operations Branch, received the Administrator's Award for Excellence for his extraordinary contributions over a decade of development, implementation, and evolution of the VICP. Ms. Carole Marks, Management Analyst, Program Operations Branch, received the Administrator's Special Citation Award for extraordinary contributions in the design, conversion, and implementation of the VICP's internal data system.
On November 29, Ms. Judy Ceresa left the VICP after 8 years of invaluable service to join HRSA's Office of Rural Health as a coordinator of grants.
Report of the Department of Justice (DOJ): Mark Rogers, J.D., Acting Deputy Director for the Torts Branch, Civil Division
Mr. Mark Rogers gave an update on autism and other cases currently being handled at DOJ.
DOJ has been working on an ongoing initiative to review all the 1997 and older docket number cases (hereinafter referred to as "Project 97"). DOJ is looking at various methods to complete the adjudications of these cases. These methods include: working with the Special Masters to reconsider the possibility of settlement in these cases; locating additional medical records, and encouraging petitioner's counsel to respond more quickly.
At the start of Project 97, there were 70 such cases at DOJ. In the past 8 months, 41 cases were resolved, with 29 cases still pending. Thirteen of these cases are awaiting attorney's fees, and fifteen cases are pending resolution before the Special Master.1
DOJ has been focusing on settling cases fairly and quickly. Over the past 18 months, 71 cases have been settled. This number represents over half of the cases compensated during this period. Forty percent of the cases were settled within a year of being filed; 21 percent were settled within two years of filing; and 25 percent were settled within three years of filing. The average time to process the settlement of a case is approximately 11 weeks, and DOJ has been working with the Special Masters to ensure that the process takes no more than 15 weeks.
DOJ has also been resolving cases using Alternative Dispute Resolution (ADR). This method is being used instead of litigation to resolve a case. A Special Master who is not assigned to the case acts as a mediator between the parties to resolve the case. Over the past 18 months, DOJ has participated in 18 ADR resolutions. This is compared to just 17 ADRs in the first ten years of the Program.
In the past year and a half, DOJ has had only 5 hearings on the amount of damages that should be awarded. There are 5 cases on appeal to the U.S. Court of Federal Claims (Court), and one of these cases was appealed by DOJ. Currently, there are no appeals pending at the U.S. Court of Appeals for the Federal Circuit.
Currently, there are approximately, 1,000 petitions filed alleging injuries due to thimerosal. These cases are currently moving on the track of an omnibus autism proceeding. This proceeding gives anyone who has a claim alleging autism the opportunity to opt into the proceeding, and consolidates the cases for purposes of processing. Most of these cases are being filed without medical record documentation.
The specific inquiry in individual cases will be stayed until the general questions are answered.
Currently, the autism cases are in the discovery phase. This phase involves producing relevant documents to support a position in the case. DOJ developed a Motion For Protective Order to clarify the rules for production of documents submitted to a Special Master. A party in a Vaccine Act proceeding may not disclose information to a person who is not a party in the proceeding without the express written consent of the person submitting the information. The Motion for a Protective Order sought to have this ordinary protection extend to the Omnibus proceedings.
Mr. Rogers stated that the number of autism cases will stress the VICP's capability to handle these cases, and that DOJ will move these cases along as fairly and less litigiously as possible.
Update from the U.S. Court of Federal Claims: Gary Golkiewicz, J.D., Special Master
Chief Special Master Golkiewicz reported that he would give a broad overview of activities of the U.S. Court of Federal Claims (Court).
The Special Masters have been working diligently to resolve the pre-1988 cases. The Court is down to one pre-1988 case, and it is currently tied up with Medicaid issues.
The use of ADR in resolving cases has been successful as parties in the case become more comfortable with the process. The Court has encouraged parties to utilize ADR for more than just settling cases. ADR can be used to assist parties in closing communication gaps, gathering information, narrowing issues, resolving collateral issues, and preparing the case for trial.
Last spring, a Process Committee (the Committee) was formed by the Court to review, evaluate, and suggest changes in the litigation process. The Committee consists of Court representatives, DOJ representatives, Petitioners' Counsel, Chief Special Master Gary Golkiewicz, Thomas Gallagher, J.D., Vito Caserta, M.D., Deborah Harris, J.D., and Emily Marcus Levine, J.D. The Committee's views on the litigation process will be taken into consideration for changes in the Court's procedural guidelines.
In 2000, there were 350 hepatitis B cases filed. The Court has categorized these cases into ten groups. Four of these groups represent approximately 100 cases. The remaining six groups of cases are stayed until supporting documentation can be found. Special Master Golkiewicz stated that his priority at the Court would be to monitor the progress of both groups of cases.
The Court has formed another committee to discuss the best methods for handling autism cases. Chief Special Master Golkiewicz established two governing principles at the start of the committee that will affect the handling of autism claims. The first principle is the Court cannot litigate thousands of cases individually. There are insufficient resources available to review the individual petitions and medical issues. Second, the causation issue will be determined to be decided in two years.
Chief Special Master Golkiewicz issued the "Autism General Order #1" (the Order), as a result of the tremendous efforts from this committee. This order discusses the process and timeframes for procedures leading to a decision in an autism case.
The autism proceedings started on July 3, 2002 and a decision will be issued no later than July 3, 2004. Special Master George Hastings is overseeing the autism proceedings. Chief Special Master Golkiewicz is assisting by working with attorneys to work out disagreements, accepting new ideas for better case strategy, and listening to complaints. Most importantly, Chief Special Master Golkiewicz is working to see what cases or categories of cases are candidates for settlements.
The autism cases will also be assisted by medical experts, who will provide scientific information and medical theories to help the Court understand the litigative risks, and determine if settlement is a possibility.
There have been several difficulties in processing the autism claims. First, the Respondents have challenged the Order relating to the completeness of a petition. They have moved to dismiss the case based on an incomplete petition. The National Childhood Vaccine Injury Act of 1986, as amended (the Act), states that petitioners shall file a complete petition. A ruling on a response to this motion will be issued later this month.
Second, the Act states that Special Masters must issue a decision on a petition no later than 240 days. At the close of this period, the petitioner has the option to continue in the VICP or withdraw their petition. If a petitioner elects to continue in the VICP, but later withdraws their petition, a question arises if they have a right to do so, or is it irrevocable that they continue in the VICP. The Act is silent on this issue.
Lastly, the biggest issue the Court is facing is causation. This issue dictates how much information is needed, defines the nature of the proceedings, and whether a case can be decided based upon medical records, witnesses, doctors, or medical experts. The Act does not provide help in defining "causation." The Act states that it must be shown that the vaccine caused the injury. The Appellate Court has dealt with some causation-in-fact issues, but there is no case, which presents the issue of standards to be applied in a causation-in-fact case.
Chief Special Master Golkiewicz stated that when the VICP started 14 years ago, virtually all the cases were litigated as vaccine injury Table cases. These types of cases were easy to decide because the proof of injury was a straightforward factual determination. Now, virtually all cases are litigated as causation-in-fact cases. These cases raise many issues and petitioners must prove their injury using traditional tort standards that the vaccine in fact caused the injury. He stated that the change in how causation is determined impacts every facet of litigation in the VICP.
Discussion on the National Vaccine Injury Compensation Program's Revised Draft Strategic Plan: Ana Rodriquez, Ed.D.
Ms. Ana Rodriquez, Ed.D. has a doctoral degree in organizational development from the University of Massachusetts. She has advised other programs in the Federal government in organizational development. She has been extremely involved with the VICP in developing their Strategic Plan. Ms. Rodriquez requested comments on the VICP's strategic themes and objectives from the ACCV and other participants. The comments received are provided below.
Theme 1 - Develop a consistent standard for determining off-Table cases.
Mr. Barry Sugarman, J.D. commented that using a term to imply a relaxed standard for determining off-Table cases would be a benefit to petitioners.
Dr. Arnold Gale commented that it would be easier to establish a standard that would make it easier for the VICP to be understood by all parties, i.e. Special Masters and attorneys.
Mr. Peter Meyers, J.D. reiterated that the standard should be a somewhat relaxed standard to create a more generous type of compensation program.
Ms. Deborah Harris, J.D. commented that the standard needs to be changed to be more consistent and specific.
Mr. Thomas Gallagher, J.D. stated that the increase in causation-in-fact cases have occurred because the guides to interpretation have been changed for Table cases. The causation-in-fact cases have a more difficult burden of proof, and this defeats the intent of Congress to compensate individuals in a fair manner.
Dr. Rodriquez stated that after considering the comments on Theme 1, it might be changed to: "Develop a more relaxed and consistent standard for determining off-Table cases."
Objective 1.5 - Establish limits of legal discovery
Mr. Sugarman commented that it would be unfair to limit discovery to petitioners with non-Table case injuries because it would limit their rights, and they carry the burden of proof in proving their case.
Ms. Jackie Noyes stated that legal discovery should be limited, but not less restrictive than what is currently set.
Theme 2 - Structure the National Vaccine Injury Compensation Program (VICP) to be responsive to evolving science, medicine, and policy actions.
Ms. Noyes stated that the word "structure" in Theme 2 could be replaced with "assure." She stated that keeping "structure" in the sentence implies that the VICP is not responsive to evolving science, etc.
Objective 2.3 - Advocate for the exploration of other funding options for research into vaccine-related injuries.
Dr. John Schreiber suggested that it might be useful to request research funds for the National Institute for Allergies and Infectious Diseases at the National Institute for Health to conduct research on vaccine related injuries.
Objective 2.1 - Decrease the number of claims that are not brought on a "reasonable" basis, perhaps by establishing a more specific definition of "reasonable."
Ms. Noyes stated that this objective was negative, and implied that claims should be reduced.
Dr. Schreiber stated that this objective should be changed to: "Establish a more specific definition of "reasonable."
Mr. Gallagher stated that language in objective 2.1 needs to refer to bringing a case on a good faith basis after an examination of the medical records, and after consultation with physician, and if there is a reasonable basis to believe that there is an injury associated with a vaccine.
Dr. Rodriquez reported that objective 2.1 might be changed to, "Increase the number of cases that are based upon a reasonable basis, as long as they are meritorious and based upon a scientific basis."
Theme 3 - Simplify the process sufficiently enough to make it understandable to the claimants, attorneys, physicians, special masters and others.
Ms. Noyes stated that this theme implies that the information that is sent out on the VICP is not understandable or sufficient enough. She stated that this theme indicates that some sort of measure is needed to indicate how well the VICP is understood. She further stated that simple language is needed for people to understand it.
Dr. Gale stated that since he was a part of the VICP Draft Strategic Planning Workgroup, they discussed that communication can always be improved to explain the VICP and let the public know that the VICP is here to serve them.
Objective 3.1 - Identify key indicators of a lack of knowledge of misinformation regarding how the VICP functions.
Mr. Sugarman stated that this objective should be deleted in its entirety because it overlaps with Theme 4. He stated that a marketing research strategy could be done to identify the key problems in publicizing the VICP.
Dr. Rodriquez stated that Theme 3 might be changed to, "Streamline the process to make it more user friendly or understandable to the claimants, attorneys, physicians, and special masters." She stated that objective 3.1 may be deleted, and that objectives 3.2 and 3.3 may also be deleted because they are very similar.
Theme 4 - Increase knowledge about the VICP among all stakeholders. The Strategic Planning Workgroup acknowledges that communication about the existence of the VICP, while necessary, is potentially frightening to people. It is vitally important to communicate to the public the message that, while vaccines are essentially safe, the VICP's goal is to compensate the small number of people who suffer a significant adverse event to covered vaccines.
Ms. Lois Swartzlander commented that she objected to the phrase "small number of people" because the numbers of vaccine-injured people are growing, and some parents might be offended by this phrase.
Dr. Schreiber stated that "potentially frightening" should be removed. He said that it could be implied that the VICP is frightening. He stated that is important to make parents aware of the VICP, as well as to make them aware of the effects of the diseases if vaccines are not administered.
Ms. Eileen Seemayer stated that it is important that physicians communicate to new parents the existence of the VICP, especially during the child's first year of life.
Objective 4.2.2 - Partnering with healthcare providers, advocacy groups, government agencies, and public organizations to assure vaccine benefits and risks and information about the VICP ("who to turn to on those rare occasions when something goes wrong)" are given to parents, or those adults taking a vaccine, all the time the vaccine is being considered/administered, and to increase and improve the distribution of the Vaccine Information Statements to vaccine recipients or their parents in the case of a minor child.
Dr. Schreiber stated that the bar associations need to be listed in this objective because they need to be made more aware of the existence of the VICP.
Ms. Swartzlander stated that the word "rare occasions" should be deleted because when a vaccine injury occurs it does not feel like a rare occasion at the time.
Dr. Rodriquez stated that Theme 4 might be changed to: "Increase knowledge about the VICP among all the stakeholders. The Strategic Planning Workgroup acknowledges that it is vitally important to communicate to the public that while vaccines are essentially safe, the VICP's goal is to compensate people who suffer a significant adverse event to covered vaccines." She stated in Objective 4.2.2 "state and local bar associations" may be added to the partnering groups. Also in this objective, the word "rare" may be deleted.
Theme 5 - Recognize and address the growing threat posed by bioterrorism.
Ms. Noyes asked if this theme was in place because someday the bioterrorist drugs will be covered under the VICP. She also stated that Theme 5 should be moved to the end of the theme list because the Homeland Security Act of 2002 addresses smallpox liability, and the VICP is not mentioned in the bill.
Ms. Tamara Overby stated that Theme 5 was created in case the VICP would someday have to cover bioterrorist drugs.
Dr. Schreiber asked if someday the VICP would be engaged to assist with smallpox liability. He stated that the VICP was designated to compensate children injured by childhood vaccines. He added that smallpox injuries could deplete the Trust Fund.
Ms. Bronwen Kaye stated that a smallpox compensation program could be modeled after the VICP. She stated that the VICP personnel could assist with the smallpox claims because of their expertise, and this new program could have a different funding source.
Mr. Dack Dalrymple, J.D. commented that another possibility for a smallpox compensation program would be that the President could create an emergency compensation program if a smallpox outbreak were to occur, and base it upon how many people are injured and an appropriate economic response.
Ms. Carol Ruppel suggested deleting Theme 5. She stated this theme is misleading, and that the strategic plan is meant to strengthen the issues in the VICP.
Objective 5.2 - Define the risks posed by a potential bioterrorism attack.
Objective 5.3 - Collect, maintain and analyze data regarding such vaccines, reported adverse events, and the infections themselves. Utilize appropriate data.
Dr. Schreiber stated that objectives 5.2 and 5.3 should be deleted because 5.2 defines the risk posed by a potential bioterrorism attack and the VICP should not be involved. He stated that objective 5.3 deals with analyzing and collecting data vaccines and adverse events, and that the VICP is not a data collection agency that follows adverse events.
Dr. Rodriquez reported that Theme 5 may be moved to the end as Theme 9, and that Theme 5 may be change to: "Recognize and address the potential role of the VICP and the growing threat posed by bioterrorism." She also reported that the objectives under Theme 5 need to be reviewed to possibly be change and more generalized.
Theme 6 - Encourage the continued preservation of the Vaccine Injury Compensation Trust Fund to ensure funds are available to pay awards to claimants who have been found to be eligible for compensation.
Ms. Seemayer commented that the word "encourage" needs to be deleted from Theme 6.
Ms. Overby stated that the word "encourage" is used because most people do not know that the Department of Treasury controls the Trust Fund. She stated that the use of funds in the Trust Fund must be monitored by the VICP to keep track of the balance and to ensure that it is being used as intended by Congress.
Mr. Balbier stated the word "preservation" in Theme 6 implies that the goal would be not to pay out funds. He stated that the VICP has no control over the collections and investments in the Trust Fund, but the VICP does provide input to the Department of Treasury on investments.
Mr. Gallagher stated he did not agree with "preservation" either. He stated that the Trust Fund should continue to be used to compensate legitimate claims.
Dr. Rodriquez stated that Theme 6 might be changed to "Maintain the integrity of the vaccine injury compensation Trust Fund."
Theme 7 - Streamline administrative handling of the claims to facilitate a less time consuming process.
Ms. Noyes questioned if Theme 7 should be combined with Theme 3 since the topic matters are similar. Dr. Schreiber concurred.
Ms. Overby commented that Theme 7 could be an objective under Theme 3. She stated that Theme 7 relates to the process of the claim, whereas Theme 3 deals with all the steps involved in processing a claim.
Dr. Rodriquez noted that Theme 7 would be reviewed by the Workgroup to give it a new title to distinguish it from Theme 3.
Objective 8.1 - Convene a conference, sponsored by the ACCV and attended by all stakeholders, to consider, based on an improved VICP, whether:
Ms. Noyes asked if a workgroup should be formed to review and discuss the current vaccine litigation issues (e.g., thimerosal cases).
Dr. Schreiber commented that he would be very interested in a conference or workgroup to address increases in civil litigation and thimerosal injuries, and send suggestions to the Secretary of HHS.
Mr. Balbier stated that he did not agree it was necessary to have a conference over a particular vaccine issue when workgroups of the ACCV have been formed to hash out difficult and contentious issues.
Dr. Schreiber stated that in Theme 8, the phrase "thimerosal-related injuries" should be deleted. He said that there is no data that supports injuries related to thimerosal.
Dr. Rodriquez stated that there are no changes to Theme 8. Objective 8.1 will be further discussed and maybe reworded at a later time. She also stated that forming a workgroup would be considered.
Objective 8.1.1 - it would be more beneficial to all stakeholders, as a national health policy, to eliminate all civil litigation based on vaccines
Mr. Gallagher commented that Objective 8.1 and its subcategories are unconstitutional. He stated that it would be unfair to take away the right of the individual to sue a vaccine manufacturer if they are not satisfied with the VICP award.
Mr. Sugarman concurred with Mr. Gallagher's comment that is unconstitutional to take away a right of an individual to seek other legal remedies. He stated the mission of the VICP is not to legislate the due process in other U.S. courts.
Ms. Kaye stated that the purpose of the objective is to convene a group and discuss the different themes, while deciding what to keep and what to change.
Dr. Schreiber stated that it is not the VICP's purview to change the process of civil litigation. He further stated that the purview of the VICP should be to maintain vaccine supply and protect children against diseases.
Objective 9.2 - Extend the statute of limitations to at least six years.
Ms. Noyes stated that objective 9.2 has already been addressed by the ACCV, and is part of the legislative proposals.
Ms. Overby stated that they are looking at processes that have not taken place yet under the VICP, so it can be included as a strategic objective.
Objective 9.3 - With input from the ACCV, consider restructuring the entire claims process so that the determination of whether an injury is vaccine related is an entirely administrative process.
Ms. Overby gave an example of administratively processing claims. She stated the Veterans' Affairs uses guidelines to determine if someone is entitled to compensation.
Dr. Geoffrey Evans stated the Veterans Affairs uses an administrative process for processing Agent Orange Program claims. He stated that this program is streamlined and less adversarial with a large number of individuals being compensated using a relaxed standard.
Ms. Seemayer commented that she would rather have a lawyer handle a claim instead of an administrative process of filling out paper work.
Mr. Sugarman stated it is important to have a lawyer litigating on the claimants' behalf because they have a right for their story to be told and tried by a judge. He said the administrative process takes that right away.
Dr. Rodriquez stated that objective 9.3 may be reconsidered at a later time, and Objective 9.2 may be either eliminated or restated to ensure it meets the need of the VICP. She also stated that objective 9.7 would be reconsidered.
Ms. Overby stated the next steps of the Strategic Workgroup would be to review the suggestions from the ACCV members and participants, and revise the strategic plan accordingly. The revised plan will then be sent out to the ACCV, participants at the Strategic Planning Retreat, and other interested parties in the VICP for review.
Nomination of ACCV Vice-Chair
On December 31, Ms. Swartzlander's term will expire. Ms. Noyes called for nominations to replace Ms. Swartzlander as Vice-Chair. Ms. Swartzlander nominated Dr. Schreiber, and the ACCV voted all in favor of Dr. Schreiber as the newly appointed Vice-Chair. His first meeting in this capacity will be March 5, 2003.
Elizabeth J. Noyes, M.A.
ACCV Chair
Lois Ann Swartzlander, RN
ACCV Vice-Chair
Thomas E. Balbier, Jr.
Executive Secretary, ACCV
http://news.bmn.com/news/story?day=030718&story=2
SV40: an emerging pathogen that's been around for fifty years
17 July 2003 8:00 GMTby Tabitha M. Powledge
Washington DC - Evidence mounts that the monkey virus that contaminated early polio vaccines causes human cancer - sometimes in people who never got the vaccine. Janet Butel has worked on SV40 for much of her long career, but to her the monkey virus is an emerging pathogen. She argues that researchers are in the midst of a changing paradigm for SV40, which contaminated certain polio vaccines nearly half a century ago and is suspected of leaving behind a legacy of cancer.
The idea that the virus is present in some characteristic tumors is no longer controversial, says Butel, who chairs the department of molecular virology and microbiology at Baylor College of Medicine in Houston. The next step is to demonstrate unequivocally that the virus causes those tumors. Butel, who was speaking at the annual meeting of the American Association for Cancer Research (AACR) here in Washington, wants to understand the interaction of SV40 with its human host.
"Specifically we need to know the details of the immune response to an SV40 infection, both humoral immunity and cellular immunity," she said. She also wants to know which tissues get infected, how the virus is distributed in different cells around the body, and whether it is produced or just goes into a latent phase. "I hope that funding agencies will support these types of studies
because it's important for scientists and public health officials to know what risk is posed by SV40 infections," she told BioMedNet News.
SV40 is, no question, a powerful cancer virus. In the hamster, the model animal for SV40 infection, the virus causes tumors of brain and bone as well as lymphomas and mesotheoliomas - exactly the same as cancers seen in people with SV40-positive tumors.
In a metaanalysis published just last month in the American Journals of Medicine, Butel and her colleagues report that in 13 studies, specimens from patients with brain tumors were almost four times more likely to have evidence of SV40 infection than were those from controls. The association was even stronger for 15 mesothelioma papers and four studies on bone cancer. SV40 DNA was also more frequent in three studies of samples from patients with non-Hodgkin's
lymphoma.
The strong association with mesotheliomas turns up despite some negative studies. SV40 has important effects on mesosthelial cells in vitro, Butel says; transformation frequency is a thousand times higher than the rate reported for other cells. "It's very important that we study the correct target cells," she urged.
Butel's lab has also described several different SV40 strains, which she says is a relatively new concept. The researchers have sequenced about a dozen genomes so far. "We can tell each lab strain apart," she notes - crucial for establishing that the sequences found in human tumors are not lab strains. A key finding is that some human tumor-associated strains are the same as SV40 from early polio vaccines. The vaccine strains are found in brain tumors and non-Hodgkins lymphoma.
Alarmingly, some patients whose tumors contain the polio vaccine strains are too young to have received the contaminated vaccine. How the patients got exposed to these viruses is a mystery. One possibility, Butel suggests, is that the virus may be transmitted in urine. Studies on immunocompromised patients suggest that route of transmission, and one old study has reported that infected infants shed SV40 in their stools. "A student in my lab has shown that it can be transmitted in utero in hamsters," she added. That's a theoretical possibility in people, although there is no evidence for it. "We don't know; there are several possibilities," she said.
What are the biological differences among these strains, and do they differ in oncogenic potential? Unpublished work from her lab suggests the answer is yes, at least in syrian hamsters.
Butel notes that there are some negative reports arguing no association between SV40 and particular tumors. She speculates that the explanation is geography. SV40 tends to be found in particular US tumors, but not detected in those same tumors in Finland, Turkey, and Austria. "We need to sort this out to see what it's telling us," she said. One explanation may be that contaminated polio vaccine was never used in these countries, Butel speculates.
Excerpts from the Summer 2002 Issue of Baylor Connections
Butel Discovers SV40 Virus in Non-Hodgkin Lymphoma
Since 1973, new cases of non-Hodgkin lymphoma have risen in the United States by more than 80 percent. A research team led by Janet S. Butel, Ph.D., '66, might have discovered a contributing factor in the increased incidence.
Recently, Butel's team found evidence of simian virus SV40 in 42 percent of 154 patients with non-Hodgkin lymphoma. This finding is significant because, between 1955 an 1963, millions of Americans and people around the world were exposed to SV40 through polio vaccines that were contaminated with the virus.
Raising additional concern is the fact that Butel has found some patients with SV40-positive tumors who were born after 1963 and would not have been exposed to the contaminated vaccine. Therefore, it appears that SV40 continues to spread among humans in ways that are not yet clear.
"SV40 has been linked to other cancers, but it has not generated the same level of interest because the cancers are rare," said Butel, who is Distinguished Service Professor and Chair of the Department of Molecular Virology & Microbiology at Baylor. "Non-Hodgkin lymphoma, on the other hand, is the fourth most common cancer in American women and the fifth most common cancer in U.S. men. The discovery that SV40 might play a role in these cancers opens up lines of investigation into possible new treatments and vaccines."
Butel's work with the SV40 virus goes back almost four decades to when she was a student at Baylor's fledgling Graduate School. She was drawn to Baylor from her home state of Kansas because the school offered one of only a few programs in the country devoted solely to viruses.
"My lifelong fascination with viruses began in an undergraduate course in soil microbiology," recalled Butel. "There was one lecture on viruses during the course, and I thought it was the most intriguing topic I had ever heard. At the time, there were not many women majoring in the sciences or in graduate school programs, but at the suggestion of one of my professors, I began to consider pursuing a Ph.D. Dr. Joseph Melnick had just started the virology program at Baylor, and I was thrilled to be accepted into the program."
Butel's graduate advisor was Fred Rapp, Ph.D., who was just starting some SV40 experiments when Butel joined his lab as a graduate student. "The experiments went well and a lot of new information was generated, so it was a very exciting time," said Butel. "I think the virus has been a wonderful model for DNA tumor viruses and for how viruses can affect the way cells grow and behave, leading to cancer. It has always stayed an interest of mine."
Now that the virus has been found in non-Hodgkin lymphoma tumors, Butel hopes to learn more about the role the virus plays in the development of the tumors and to create a small animal model to learn more about the early stages of the disease and to test new treatment approaches.
Excerpts from the Spring 2002 Issue of Baylor Connections
Distinguished Alumni and Faculty Award Winners
The Baylor Medical Alumni Association presented its highest awards at the 40th Annual Alumni Reunion Banquet on April 13. David Y. Graham, M.D., '66, and Joe C. Smith, M.D., '51, were honored with the 2002 Distinguished M.D. Alumnus Awards, and Janet S. Butel, Ph.D., '66, received the 2002 Distinguished Alumnus of The Graduate School of Biomedical Sciences Award.
Each year, the Alumni Association also honors two outstanding Baylor faculty members. This year's winners are Garrett Rush Lynch, M.D., '74, and Edward B. Singleton, M.D.
http://www.bcm.tmc.edu/alumni/newsletter/Archives/Ph_D_/ph_d_.html
by Geraldo Fuentes
Editor's Note:
When we first ran Geraldo's first story, SV-40, A Deadly Cure? we thought it was a bit on the conspiratory side, but it seemed well researched. We were pleased that many other journalists also investigated the material, proving the sad truth that Geraldo reported in ViewZone.
Research has now firmly linked many of today's cancers with tainted virus vaccinations given in the early 1950s. Could there be any more shocking and horrific revelations like this? We didn't think so - but we were wrong.
The latest horror story is posted HERE: SV40 Part Two for you to ponder. As you read it, also do not forget the Black Americans that were knowingly infected with Syphilis or the soldiers made to march through the fallout of our nuclear bomb tests...
But first, read Geraldo Fuentes original story. Also, important new information is at the end of this story.
If you received a polio vaccination in the 50's, you may have gotten more than you know...
It was 1956. I was only six years old and attended grade school in Springfield, Massachusetts. I was too young to recollect the first round of polio vaccinations, but I have a few memories. I remember that my first grade class was escorted to the school gymnasium. There was a peculiar smell in the air. I think it was probably rubbing alcohol. And some of the other kids were crying. The shot itself wasn't so bad. I didn't cry, but my best friend did. At the end of the ordeal we all got a lollipop.
A few years later, when we marched again to the gymnasium it was different. There was no crying and no alcohol odor. Instead, there were long tables bearing neat rows of small paper cups, filled about half way with a liquid that tasted like bitter orange juice. White clad Nurses watched as each child drank the vaccine. There was no lollipop and, after we handed back the cup, we simply returned to class.
The government had initiated the mandatory polio vaccination programs in 1955. Prior to this, polio had killed or crippled thousands of children and adults all over the world. Attacking the central nervous system, this viral infection was transmitted by human contact, sewage and even by contaminated milk. Victims who contracted polio would incubate the virus in their intestines, where it would multiply and enter the lymphatic system. Eventually the virus would penetrate the nerves and travel along nerve paths, destroying neurons and rendering the muscles connected to them paralyzed.
The polio epidemic reached its height in 1952. It turned thousands of victims into cripples and confined countless children to large pressure chambers called "iron lungs," which helped them to breath when their diaphragm muscles were stilled. There was and still is no treatment for polio. Aside from attempts to maintain life functions, the disease must run its course. And so, in 1955, just one year before I received it, Jonas Salk had performed no small miracle when he successfully mass-produced an effective polio vaccine by growing a form of the virus on the kidneys of rhesus monkeys. This virus would be harvested, killed, and given to healthy children like me, who would then develop antibodies which would kill any future invasion of the body by the polio virus.
This happy story of medical marvel has a deadly glitch. And it is especially deadly if, like me, you received your vaccinations in the 1950s, in certain states like Massachusetts.
In 1960, researchers discovered that the polio vaccine distributed to certain states was infected with another virus called "Simian Virus 40." SV-40 is a monkey virus that is not normally found in humans. Unknown at the time, it was present in hundreds of rhesus monkeys that were used to grow and harvest the polio vaccine. Injected into research animals, the SV-40 virus causes brain and lung cancers. Now, some forty years later, its effect on humans is just being investigated.
SV-40 has appeared in 61% of all new cancer patients -- patients too young to have received the contaminated vaccine being administered forty years ago!
Michele Carbone , Assistant Professor of Pathology at Loyola University in Chicago, has recently isolated fragments of the SV-40 virus in human bone cancers and in a lethal form of lung cancer called mesotheliomas. He found SV-40 in 33% of the osteosarcoma bone cancers studied, in 40% of other bone cancers, and in 60% of the mesotheliomas lung cancers. Dr. Carbone believes this
study explains why 50% of the current mesotheliomas being treated were no longer occurring in association with asbestos exposure, their traditional cause.
Researchers from the Institute of Histology and General Embryology of the University of Ferrara, lead by Dr. Fernanda Martini , discovered SV-40's presence in a variety other tumors. They found the rhesus monkey virus in 83% of choriod plexus papillomas, in 73% of ependymomas, in 47% of astrocytomas, in 50% of glioblastomas, and in 14% of meningiomas.
SV-40 also has been found in 23% of blood samples and 45% of sperm fluids taken from normal individuals! Researchers have determined the SV-40 virus can be transmitted sexually and through blood transfusions.
Even more shocking, SV-40 has appeared in 61% of all new cancer patients -- patients even too young to have received the contaminated vaccine being administered forty years ago! How could this happen?
My second vaccination was from a cup. This was the brainstorm of the FDA. Instead of getting the "dead" virus in an injection, the Federal vaccination policy mandated that children should be given the new live "oral polio vaccine" (OPV). This decision was based upon the belief that the OPV recipient would "shed" the virus through body contact with other non-vaccinated children and adults, thereby spreading the "live" virus throughout the population. Since the infection was extremely small, it would produce the desired antibodies while posing no threat of contracting polio. This, it was thought, would assure the total immunization of America and the eradication of the disease. The public was never informed that this national health strategy was being implemented, despite several cases of polio which were directly attributed to the vaccine.
By 1963, the estimated number of tainted polio vaccinations was estimated to be upwards of 98-million!
The SV-40 virus that contaminated the oral polio vaccine quickly spread from child to child and from child to adult, crossing state lines and national boundaries. By 1960, when the virus was first detected, it was already too late to prevent its dissemination throughout the population. The FDA quietly and gradually instituted a program to eliminate rhesus monkeys, who harbor the SV-40, and replace them with African Green monkeys that are free of the virus. By 1963 the monkeys had been replaced but the estimated number of tainted polio vaccinations was estimated to be 98-million!
According to the National Institutes of Health, high levels of SV-40 were identified in polio vaccines in Washington, Oregon, Wyoming, Utah, Minnesota, Iowa, Wisconsin, Illinois, Michigan, Pennsylvania, Washington DC, Maryland, Delaware, New York, Connecticut, Rhode Island, Massachusetts, Vermont and New Hampshire. Low levels of SV-40 were found in California, Arizona, New Mexico, Colorado, Texas, Kansas, Nebraska, North Dakota, Missouri, Louisiana, Georgia, Tennessee, Kentucky, Ohio, and West Virginia. Polio vaccines in the other states show no SV-40 present. This revelation has only recently come to public attention. Many people, like myself, were unaware that a potential for cancer had been implanted in their body. Researchers say that, by age fifteen, the virus stops shedding to others. I cannot but wonder how many people I contacted between the age of eight and fifteen... Did I shed the SV-40 virus to my mother, who eventually died of brain cancer? Will I contract brain, lung or bone cancer? Many other people in my age group are asking similar questions.
A number of public statements have been made by the National Cancer Institute in the past few months, attempting to put their spin on these disturbing revelations. In an statement published in the January (1999) New EnglandJournal of Medicine , the institute states that there is no evidence of an increase in humans of the types of cancers found in laboratory animals that have been injected with SV-40. But other researchers remind us that SV-40 has already been found in a wide variety of other tumors. It has been shown that individuals who received the tainted oral vaccine demonstrate a higher occurrence of these cancers.
For example: people who lived in Massachusetts and Illinois in the 1950s, and received identified lot numbers of the contaminated oral vaccine, are now contracting osteosarcoma bone tumors at a rate of ten times more than those who received the vaccine free of the SV-40. But the National Cancer Institute has been silent about these facts. There needs to be more demographic studies to explore the relationship of SV-40 to adult onset cancers. Not surprisingly, the US government and its agencies are reluctant to pursue this matter. In fact, requests to the National Institute for Health for grants to study the SIV and simian cyto-megalovirus (SCMV) were recently denied. Microbiologist Howard Urnovitz, Ph.D., may have an explanation as he stated in the Boston Globe :
"that almost 100 million Americans were exposed (to SV-40) through a government sponsored program, but for over 30 years, there has been virtually no government effort to see if anyone's been harmed by the exposure." He added, "The government will not fund science that makes it look culpable."
Another method used by the National Cancer Institute to divert public concern is to issue statements that "many of the cancers under suspicion were contracted by people who are too young to have received the tainted vaccine in the 1950s." This argument, although true, ignores the potential of spreading the live SV-40 by "shedding" through personal contact. The oral polio vaccine was designed to be transmitted to non-vaccinated individuals by this very method. In fact, this was the reason that OPV was preferred over injection. If SV-40 is still being spread by contact today it is not surprising that these cancers are now affecting younger people.
Regardless of blame, severe damage to world health has already been done by the unsavory practice of growing vaccination products in animals. An example of these horrors was presented by Dr. Urnovitz at the Eighth Annual Houston Conference on AIDS. Dr. Urnovitz revealed significant evidence that human immunodeficiency virus type 1 (HIV-1) is a monkey hybrid virus which was produced when 320,000 Africans were injected with polio virus contaminated with live simian immunodeficiency virus (SIV) in the late 1950's. Apparently, viral fragments combine easily with other viruses to produce these hybrids called "chimeras." Prior to this revelation, health officials were blaming AIDS on the habit of certain Africans to consume monkey flesh.
What can be done now? "Make it in anything but animals," said Barbara Loe Fisher of the National Vaccine Information Center, which criticizes vaccine safety. "We have the technology to make vaccines in human cell lines that are clean," said Dr. Michele Carbone of Loyola University Medical Center, one of the first to discover SV-40 inside human tumors.
Until then we can only hope that researchers continue their work, regardless of the repercussions. Millions of people are already infected with SV-40 and are in danger. Many cancers do not develop until mid-life. Future generations must be protected. We must prohibit any future contamination of the world population, whether for our own good or not, by well-meaning governmental agencies.
UPDATE: October-November 2002 -- The following article appeared in the NY
Times on October 22, 2002, partially quoted as follows:
Monkey Virus - Cancer Link Debated (THE ASSOCIATED PRESS)
WASHINGTON (AP) -- Despite years of study, there remains too little evidence to conclude a monkey virus that once tainted some polio vaccine can cause cancer in humans.
Still, the Institute of Medicine said Tuesday, although studies of people who received the vaccine have not shown increased cancer rates, a connection cannot be completely ruled out.
The institute, an arm of the National Academy of Sciences, recommended development of a federal response plan for dealing with contaminated vaccines and better tests for the monkey virus to determine how widespread it is.
The test in this article was to compare the group of people who got the original "live" virus in the 1950's, in school immunization programs, with the cancer rates of the general population. But, remember, the whole purpose of the mandatory "live" virus immunization program was to make sure that EVERYONE was exposed to the new batches of vaccine. This was done by having innoculated children "shed" the virus to others -- their parents, other children and virtually anyone that had contact with them after they were vaccinated. In other words, the entire American population was subjected to the SV-40 in either the original innoculation or from the shedding. So it is natural that the rates of cancer would be no different between the school children and anyone else that they infected.
On the whole, cancer rates have sky-rocketed, especially those rare forms related to the SV40, yet this type of misleading (i.e. lies) is typical of what the current administration and Federal offices are attempting to do with everything from the threat of Iraq to the infecting of its own population in the past.
If you want to get involved in a potential class action suit, you might want to contact a woman whose daughter contracted one of these rare forms of cancer (medulloblastoma), attributed to the SV40 contamination. Not only does she suffer from having her child impacted by this horrible governmental error, but she also has the uncertain guilt of possibly infecting her daughter from her own exposure to the live virus back in the 1950s.
Maybe you have had a similar experience. Are you angry? Then contact Sandy at bambitsg@winco.net . Remember the words of Mahatma Gandhi: "Even if you are a minority of one, the truth is still the truth."
by Geraldo Fuentes
Editor's Note:
When we first ran Geraldo's first story, SV-40, A Deadly Cure? we thought it was a bit on the conspiratory side, but it seemed well researched. We were pleased that many other journalists also investigated the material, proving the sad truth that Geraldo reported in ViewZone.
Research has now firmly linked many of today's cancers with tainted virus vaccinations given in the early 1950s. Could there be any more shocking and horrific revelations like this? We didn't think so - but we were wrong.
The latest horror story is posted HERE: SV40 Part Two for you to ponder. As you read it, also do not forget the Black Americans that were knowingly infected with Syphilis or the soldiers made to march through the fallout of our nuclear bomb tests...
But first, read Geraldo Fuentes original story. Also, important new information is at the end of this story.
If you received a polio vaccination in the 50's,
you may have gotten more than you know...
It was 1956. I was only six years old and attended grade school in Springfield, Massachusetts. I was too young to recollect the first round of polio vaccinations, but I have a few memories. I remember that my first grade class was escorted to the school gymnasium. There was a peculiar smell in the air. I think it was probably rubbing alcohol. And some of the other kids were crying. The shot itself wasn't so bad. I didn't cry, but my best friend did. At the end of the ordeal we all got a lollipop.
A few years later, when we marched again to the gymnasium it was different. There was no crying and no alcohol odor. Instead, there were long tables bearing neat rows of small paper cups, filled about half way with a liquid that tasted like bitter orange juice. White clad Nurses watched as each child drank the vaccine. There was no lollipop and, after we handed back the cup, we simply returned to class.
The government had initiated the mandatory polio vaccination programs in 1955. Prior to this, polio had killed or crippled thousands of children and adults all over the world. Attacking the central nervous system, this viral infection was transmitted by human contact, sewage and even by contaminated milk. Victims who contracted polio would incubate the virus in their intestines, where it would multiply and enter the lymphatic system. Eventually the virus would penetrate the nerves and travel along nerve paths, destroying neurons and rendering the muscles connected to them paralyzed.
The polio epidemic reached its height in 1952. It turned thousands of victims into cripples and confined countless children to large pressure chambers called "iron lungs," which helped them to breath when their diaphragm muscles were stilled. There was and still is no treatment for polio. Aside from attempts to maintain life functions, the disease must run its course.
And so, in 1955, just one year before I received it, Jonas Salk had performed no small miracle when he successfully mass-produced an effective polio vaccine by growing a form of the virus on the kidneys of rhesus monkeys. This virus would be harvested, killed, and given to healthy children like me, who would then develop antibodies which would kill any future invasion of the body by the polio virus.
This happy story of medical marvel has a deadly glitch. And it is especially deadly if, like me, you received your vaccinations in the 1950s, in certain states like Massachusetts.
In 1960, researchers discovered that the polio vaccine distributed to certain states was infected with another virus called "Simian Virus 40." SV-40 is a monkey virus that is not normally found in humans. Unknown at the time, it was present in hundreds of rhesus monkeys that were used to grow and harvest the polio vaccine. Injected into research animals, the SV-40 virus causes brain and lung cancers. Now, some forty years later, its effect on humans is just being investigated.
SV-40 has appeared in 61% of all new cancer patients -- patients too young to have received the contaminated vaccine being administered forty years ago!
Michele Carbone , Assistant Professor of Pathology at Loyola University in Chicago, has recently isolated fragments of the SV-40 virus in human bone cancers and in a lethal form of lung cancer called mesotheliomas. He found SV-40 in 33% of the osteosarcoma bone cancers studied, in 40% of other bone cancers, and in 60% of the mesotheliomas lung cancers. Dr. Carbone believes this study explains why 50% of the current mesotheliomas being treated were no longer occurring in association with asbestos exposure, their traditional cause.
Researchers from the Institute of Histology and General Embryology of the University of Ferrara, lead by Dr. Fernanda Martini , discovered SV-40's presence in a variety other tumors. They found the rhesus monkey virus in 83% of choriod plexus papillomas, in 73% of ependymomas, in 47% of astrocytomas, in 50% of glioblastomas, and in 14% of meningiomas.
SV-40 also has been found in 23% of blood samples and 45% of sperm fluids taken from normal individuals! Researchers have determined the SV-40 virus can be transmitted sexually and through blood transfusions.
Even more shocking, SV-40 has appeared in 61% of all new cancer patients -- patients even too young to have received the contaminated vaccine being administered forty years ago! How could this happen?
My second vaccination was from a cup. This was the brainstorm of the FDA. Instead of getting the "dead" virus in an injection, the Federal vaccination policy mandated that children should be given the new live "oral polio vaccine" (OPV). This decision was based upon the belief that the OPV recipient would "shed" the virus through body contact with other non-vaccinated children and adults, thereby spreading the "live" virus throughout the population. Since the infection was extremely small, it would produce the desired antibodies while posing no threat of contracting polio. This, it was thought, would assure the total immunization of America and the eradication of the disease. The public was never informed that this national health strategy was being implemented, despite several cases of polio which were directly attributed to the vaccine.
By 1963, the estimated number of tainted polio vaccinations was estimated to be upwards of 98-million!
The SV-40 virus that contaminated the oral polio vaccine quickly spread from child to child and from child to adult, crossing state lines and national boundaries. By 1960, when the virus was first detected, it was already too late to prevent its dissemination throughout the population. The FDA quietly and gradually instituted a program to eliminate rhesus monkeys, who harbor the SV-40, and replace them with African Green monkeys that are free of the virus. By 1963 the monkeys had been replaced but the estimated number of tainted polio vaccinations was estimated to be 98-million!
According to the National Institutes of Health, high levels of SV-40 were identified in polio vaccines in Washington, Oregon, Wyoming, Utah, Minnesota, Iowa, Wisconsin, Illinois, Michigan, Pennsylvania, Washington DC, Maryland, Delaware, New York, Connecticut, Rhode Island, Massachusetts, Vermont and New Hampshire. Low levels of SV-40 were found in California, Arizona, New Mexico, Colorado, Texas, Kansas, Nebraska, North Dakota, Missouri, Louisiana, Georgia, Tennessee, Kentucky, Ohio, and West Virginia. Polio vaccines in the other states show no SV-40 present.
This revelation has only recently come to public attention. Many people, like myself, were unaware that a potential for cancer had been implanted in their body. Researchers say that, by age fifteen, the virus stops shedding to others. I cannot but wonder how many people I contacted between the age of eight and fifteen... Did I shed the SV-40 virus to my mother, who eventually died of brain cancer? Will I contract brain, lung or bone cancer? Many other people in my age group are asking similar questions.
A number of public statements have been made by the National Cancer Institute in the past few months, attempting to put their spin on these disturbing revelations. In an statement published in the January (1999) New England Journal of Medicine , the institute states that there is no evidence of an increase in humans of the types of cancers found in laboratory animals that have been injected with SV-40. But other researchers remind us that SV-40 has already been found in a wide variety of other tumors. It has been shown that individuals who received the tainted oral vaccine demonstrate a higher occurrence of these cancers.
For example: people who lived in Massachusetts and Illinois in the 1950s, and received identified lot numbers of the contaminated oral vaccine, are now contracting osteosarcoma bone tumors at a rate of ten times more than those who received the vaccine free of the SV-40.
But the National Cancer Institute has been silent about these facts.
There needs to be more demographic studies to explore the relationship of SV-40 to adult onset cancers. Not surprisingly, the US government and its agencies are reluctant to pursue this matter. In fact, requests to the National Institute for Health for grants to study the SIV and simian cyto-megalovirus (SCMV) were recently denied. Microbiologist Howard Urnovitz, Ph.D., may have an explanation as he stated in the Boston Globe :
"that almost 100 million Americans were exposed (to SV-40) through a government sponsored program, but for over 30 years, there has been virtually no government effort to see if anyone's been harmed by the exposure." He added, "The government will not fund science that makes it look culpable."
Another method used by the National Cancer Institute to divert public concern is to issue statements that "many of the cancers under suspicion were contracted by people who are too young to have received the tainted vaccine in the 1950s." This argument, although true, ignores the potential of spreading the live SV-40 by "shedding" through personal contact. The oral polio vaccine was designed to be transmitted to non-vaccinated individuals by this very method. In fact, this was the reason that OPV was preferred over injection. If SV-40 is still being spread by contact today it is not surprising that these cancers are now affecting younger people.
Regardless of blame, severe damage to world health has already been done by the unsavory practice of growing vaccination products in animals. An example of these horrors was presented by Dr. Urnovitz at the Eighth Annual Houston Conference on AIDS.
Dr. Urnovitz revealed significant evidence that human immunodeficiency virus type 1 (HIV-1) is a monkey hybrid virus which was produced when 320,000 Africans were injected with polio virus contaminated with live simian immunodeficiency virus (SIV) in the late 1950's.
Apparently, viral fragments combine easily with other viruses to produce these hybrids called "chimeras." Prior to this revelation, health officials were blaming AIDS on the habit of certain Africans to consume monkey flesh.
What can be done now? "Make it in anything but animals," said Barbara Loe Fisher of the National Vaccine Information Center, which criticizes vaccine safety.
"We have the technology to make vaccines in human cell lines that are clean," said Dr. Michele Carbone of Loyola University Medical Center, one of the first to discover SV-40 inside human tumors.
Until then we can only hope that researchers continue their work, regardless of the repercussions. Millions of people are already infected with SV-40 and are in danger. Many cancers do not develop until mid-life. Future generations must be protected. We must prohibit any future contamination of the world population, whether for our own good or not, by well-meaning governmental agencies.
UPDATE: October-November 2002 -- The following article appeared in the NY Times on October 22, 2002, partially quoted as follows:
Monkey Virus - Cancer Link Debated (THE ASSOCIATED PRESS)
WASHINGTON (AP) -- Despite years of study, there remains too little evidence to conclude a monkey virus that once tainted some polio vaccine can cause cancer in humans.
Still, the Institute of Medicine said Tuesday, although studies of people who received the vaccine have not shown increased cancer rates, a connection cannot be completely ruled out.
The institute, an arm of the National Academy of Sciences, recommended development of a federal response plan for dealing with contaminated vaccines and better tests for the monkey virus to determine how widespread it is.
The test in this article was to compare the group of people who got the original "live" virus in the 1950's, in school immunization programs, with the cancer rates of the general population. But, remember, the whole purpose of the mandatory "live" virus immunization program was to make sure that EVERYONE was exposed to the new batches of vaccine. This was done by having innoculated children "shed" the virus to others -- their parents, other children and virtually anyone that had contact with them after they were vaccinated. In other words, the entire American population was subjected to the SV-40 in either the original innoculation or from the shedding. So it is natural that the rates of cancer would be no different between the school children and anyone else that they infected.
On the whole, cancer rates have sky-rocketed, especially those rare forms related to the SV40, yet this type of misleading (i.e. lies) is typical of what the current administration and Federal offices are attempting to do with everything from the threat of Iraq to the infecting of its own population in the past.
If you want to get involved in a potential class action suit, you might want to contact a woman whose daughter contracted one of these rare forms of cancer (medulloblastoma), attributed to the SV40 contamination. Not only does she suffer from having her child impacted by this horrible governmental error, but she also has the uncertain guilt of possibly infecting her daughter from her own exposure to the live virus back in the 1950s.
Maybe you have had a similar experience. Are you angry? Then contact Sandy at bambitsg@winco.net . Remember the words of Mahatma Gandhi: "Even if you are a minority of one, the truth is still the truth."
http://www.upi.com/view.cfm?StoryID=20030909-045736-9932r
United Press International
Polio vaccine might have carried virus
By Mark Benjamin
Investigations Editor
Published 9/9/2003 5:41 PM
WASHINGTON, Sept. 9 (UPI) -- Some of the polio vaccine given to millions of American children from 1962 until 2000 could have been contaminated with a monkey virus that shows up in some cancers, according to documents and testimony to be delivered to a House committee Wednesday. The vaccine manufacturer said such claims "don't have any validity," and the Centers for Disease Control and Prevention agrees. Some batches of the first polio vaccine used from 1955 until 1962 were contaminated with the monkey virus. The virus has also been found in some cancer in humans, although it has not been determined that the virus caused the cancer. Between 10 and 30 million Americans may have received a contaminated dose of that vaccine, according to the Centers for Disease Control and Prevention. The monkey virus is suspected of causing cancer in laboratory animals, including brain cancers, bone tumors and a usually fatal cancer in the membranes around the lungs called mesothelioma. But it has been widely assume that the replacement for the Salk vaccine, a live oral polio vaccine called the Sabin oral vaccine, was free of Simian Virus 40, or SV40. That vaccine was used from 1963 until 2000, when it too was replaced.
Documents set to be delivered to the House Subcommittee on Human Rights and Wellness appear to show that the original "seeds" used to produce the Sabin vaccine could have been tainted with SV40; that the company that manufactured the vaccine, Wyeth Lederle, may have used Rhesus monkeys -- which are more likely to carry the disease -- rather than the African Green monkeys it says it used, according to company documents; and that the company may not have performed all of the screening tests required. Stanley P. Kops, an attorney who represents clients he says were "paralyzed, killed and-or severely damaged" by the vaccine used until 2000, will present the documents. Kops alleges in his written testimony that the manufacturer and the FDA were negligent and failed to protect children.
"There is a history of negligence involving this vaccine manufacturer and the regulators," Kops says in his written testimony. "The vaccine safety tests were not submitted [to the FDA], the regulators did not look, and infants in the United States became paralyzed or died, and there are now clear instances of cancer reported in the children and individuals who received this product." A spokesperson for Wyeth Lederle, Natalie de Vane, said Kops is wrong. "These claims don't have any validity," said de Vane. "In response to allegations such as this, the FDA went back and tested batches that were released between 1976 and 1989 and using the most advanced methods of testing available, found no evidence of SV40. We have always conducted extensive screening and testing of our products. The FDA monitors this." A Food and Drug Administration spokesperson was unaware of the allegations. A CDC fact sheet says that "all of the current evidence indicates that polio vaccines have been free of SV40 since 1963." Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, will tell the committee that the polio vaccine story is particularly troubling. The center does not accept money from vaccine manufacturers. "At the hear of this tragic story is a violation of the public trust and the informed consent ethic," Fisher says in her testimony. Kops says his documents show the following:
-- A decades-old letter from Dr. Albert B. Sabin to Lederle Laboratories saying that the original "seed" used to make the Sabin vaccine may not be free of SV40 contamination. The letter says that Sabin "could not be certainthat there may not be a trace of SV40 virus in this material."
-- On Oct. 2, 2002, the Wyeth Lederle head of biological quality control said in a deposition that the company did not routinely perform blood tests on monkeys used to make the vaccine to make sure the monkeys did not carry SV40.
-- Company protocols show that a "cell batch" used to make vaccines might not be rejected even if SV40 is found in some test results.
-- Company documents describe the use of "rhesus" monkeys, apparently to make the vaccine. Wyeth Lederle says it did not use rhesus monkeys.
-- A Dec. 16, 1960, letter from Merck & Co. to the U.S. Public Health Service saying that company would not join the business of producing the oral vaccine because the risk of SV40 contamination was too high. The company told the government that it is "extremely difficult" to eliminate monkey viruses and "impossible to detect."
Morris County Daily Record
Thursday, September 11, 2003
Page A19
http://www.dailyrecord.com
Wyeth sued over polio vaccine said to cause cancer Federal panel hearing testimonies on possible dangers of various inoculations
by Ledyard King
Gannett News Service
Washington-For years Eileen Grebinski blamed the tumor that took half her son Mark's brain on nature forces. Today, she blames it on the makers of the polio vaccine Mark was given as a baby. "What I thought was an act of God I now learned was an act of man," the Brick woman told a House
Government Reform subcommittee Wednesday. "I am not a scientist or a lawyer. I'm just a mother,
and I feel cheated and robbed out of my life, my son's life and our entire family's life."The hearing is one of several that the panel's chairman, Rep. Dan Burton, R-Ind, has held on potential health dangers of different vaccines. Wednesday's session focused on an oral polio vaccine widely used from 1963 to 2000 that critics say contained a monkey virus, known as SV40, that has been linked to several forms of cancer.
Vaccine safety advocates and scientists who testified said independent studies have linked the virus to cancer in humans. But government researchers said their analysis has yet to prove the connection. "It remains an open question," said James J. Goedert, a senior investigator with the National Cancer Institute. Not for Grebinski, who has joined families from Virginia and California in a lawsuit against the maker of the vaccine, Wyeth Lederle, based in Madison, NJ. The case is pending in New Jersey state court. Wyeth spokeswoman Natalie de Vane would not comment on the lawsuit. But, she said the pharmaceutical company thoroughly tested its oral vaccine to make sure it did not
contain SV40. Food and Drug Administration spokesman Brad Stone said his agency tested samples of the vaccine administered between 1972 and 1989 when questions about side effects surfaced several years ago.
"We never found any evidence of SV40 in any of the lots we looked at, " Stone said. "There really shouldn't be any concern about being exposed to SV40 through the vaccine."Grebinski's son received the vaccine as an infant in 1968 and doctors discovered a tumor when he was about 2 and a half years old. Wheelchair-bound and wearing a protective helmet, Mark, now 35, sat quietly during the two-hour hearing and played with the stuffed dragons that have become his closest friends. "He gives his paintings and coloring pages to people he meets to show them he loves them, and he thinks they love him back," she said. "I can only hope that Mark's prayers to God will be answered by the scientists and maybe there is something that can be done to reverse his condition."
http://www.democratandchronicle.com/news/1010C521KID_Vax_news.shtml
Immunization debate airs in area
Livingston County activist enlists vaccine critic as speaker.
By Matt Leingang
Staff Writer
(October 10, 2003) — When her 17-year-old daughter died of Hodgkin’s disease five years ago, Sevaste Spaker went looking for answers. Spaker contends that she found what she was looking for after searching through her daughter’s medical records — a weakened immune system possibly induced by vaccines she received as a child. As an infant, Spaker’s daughter, Alexis, was allergic to the combined vaccination shot for diphtheria, pertussis and tetanus. She was also allergic to the shot for measles, mumps and rubella. It was shortly after she received the MMR vaccine that Alexis was diagnosed with Hodgkin’s.
“I blame myself for not being informed, for not protecting my child,” said Spaker, a former schoolteacher from Avon, Livingston County. Spaker, 55, has organized a conference on Saturday that explores the highly emotional debate about vaccine safety. Speakers include Dr. Richard Moskowitz, a Massachusetts doctor and outspoken critic of vaccines.
Spaker, who runs a Web site called KnowVaccines .com, said the purpose of the conference is not to push parents away from vaccinating their children. Rather, she believes that every parent should be empowered with enough information so that he or she can make educated decisions.
In 1980, infants were vaccinated against just four diseases — diphtheria, tetanus, pertussis and polio. But today American children are vaccinated against a much broader range of conditions, such as chickenpox, hepatitis, measles and mumps. As the immunization schedule has grown, so have parents’ fears. Most scientific studies show that vaccines are safe and effective, according to the American Academy of Pediatrics. Nevertheless, congressional hearings have focused on the issue, and Internet chat rooms are abuzz with anecdotes of alleged harm.
“Certainly I’m aware of parents that for reasons of personal choice have chosen not to vaccinate their children at all,” said Dr. Shellie Sasscer, a pediatrician in Rochester. Those parents may home-school their children as a way of avoiding immunization requirements set by many school districts, Sasscer said. Personally, Sasscer said, she believes in the benefits of vaccines and worries about a resurgence of infectious diseases should too many children go unvaccinated. But she makes a point of providing parents with pamphlets and videos that discuss the debate.
“I would rather have parents take several months to decide whether they are comfortable with vaccination rather than rushing them into something,” Sasscer said.
MLEINGAN@DemocratandChronicle.com
http://www.mercola.com/1999/aug/30/simian_virus_40_dna_found_in_us_children.htm
Simian Virus 40 DNA Found In US Children
Researchers in the US have uncovered molecular evidence of simian virus 40 (SV40) infections in tissue samples from four children born after 1982. Researchers used a polymerase chain reaction technique to identify SV40 DNA in archival tissue samples from the 13 antibody-positive children for whom tissue samples were available. The researchers discovered SV40 DNA in tissue samples from four children: three kidney transplant patients and one patient with Wilms' tumor. A sample from one of the kidney transplant patients also yielded human polyomavirus BK virus DNA products. Sequence analysis showed that the SV40 DNA strains did not arise from laboratory contamination, the team reports.
J Infect Disease September 1999;180:884-887
COMMENT (Dr. Thomas Stone) The Polyoma virus caused cancers in every animal receiving it! It was discovered that the Polyoma virus was IDENTICAL to the SV40 virus that grossly contaminated the polio vaccine prior to 1964 and continues to contaminate vaccines used by pediatricians today! Which vaccines are contaminated???"
"It was Bernice Eddy whose lab tests showed the Cutter vaccine had been inadequately treated. Eventually she lost her labs pursuing and espousing the truth. Her treatment scandalized the scientific community and resulted in a U.S. Senate investigation during which she warned legislators that unless the vaccine contamination problem was addressed, SLOW monkey viruses would simply deliver human cancer epidemics around the world.
And what has happened?? Are these cancer causing viruses the only contamination problem?
"Discovery of an atypical virus infecting humans linked to viral vaccines produced on monkey tissues In what could be one of the most important scientific discoveries of this decade, an award winning pathologist and immunologist at the University of Southern California, W. John Martin, M.D., Ph.D., has discovered an atypical virus infecting both children and adults who are exhibiting neurological, psychiatric and autoimmune disorder symptoms with diagnoses including chronic fatigue syndrome, fibromyalgia, depression, schizophrenia, anxiety disorder, seizures, developmental delays, autism, lupus, multiple sclerosis, Alzheimer's, Parkinson's, unexplained encephalopathy and chronic vegetative states.
Martin and his colleagues at USC's Infectious Diseases and Molecular Pathology Laboratories have been meticulously culturing out stealth viruses from patients for the past eight years and, in a stunning development earlier this year, successfully identified one of the viruses as being of African green monkey origin by using DNA sequence analysis. Kidney tissues from African green monkeys have been used to make the live oral polio vaccine OPV) as well as other viral vaccines during the past three decades."
We had better hope that the satanic spin-doctors are able to bury the significance of this SV40 discovery. How will we in the medical profession appear if the public discovers that we have been a major source of MANY types of CANCER with our MANDATED DIRTY vaccines?
Political and Economic Compromises Affecting Public Health:
Lessons from Contaminated Polio Vaccines
W. John Martin, MD, Ph.D.
There are growing health problems being faced by many Americans. The autism rate has doubled in California over the last 4 years and special educational needs of school children are soaring. Severe childhood behavioral problems necessitating residential care are financially forcing many parents to relinquish custody of their children to the state. In 2001 a sampling of only 19 mid-sized states revealed the astounding number of 12,700 children who were orphaned to the state because of their parents¡ inability to cover institutional costs. This heart rendering loss of legal custody does not even ensure medical therapy, but merely protective restraint. Nearly half of the elderly will experience the memory loss and emotional fragility of Alzheimer¡s disease. Published figures from the Centers for Disease Control and Prevention (CDC) confirm that nearly 20,000 patients are hospitalized each year with a brain illness diagnosed as encephalitis. Yet in over 60 percent of such patients, even detailed laboratory studies fail to reveal the underlying cause. Many more individuals who experience an alarming decline in brain function are not hospitalized. Some are driven to such tragedies as suicide or mindless criminal behaviors. It has become commonplace to hear of individuals with chronic fatigue syndrome, diabetes, arthritis and debilitating stress-related mental illnesses.
Individually, any of these increasingly prevalent diseases ought to trigger a serious investigation for the possibility of an infectious cause. When lumped together, and with the added knowledge of virus contaminated vaccines, it is difficult to comprehend the smug indifference of those entrusted with protecting the public health.
This article is written primarily to document lapses in public health decision making. It is also an effort to increase public awareness of one of the causes of our Nation¡s deteriorating health. The article is focused on events surrounding the development and testing of polio virus vaccines. It is a personal account prompted by my experiences with public health officials and their reactions to my repeated attempts to speak up on behalf of those afflicted with stealth-adapted viruses.
I have previously summarized the early history of polio as a disease entity and the subsequent development of both inactivated (Salk) and attenuated or weakened (Sabin) polio virus vaccines. This information has been available on the web site www.ccid.org since being presented at various public health conferences in 1995 and 1996. Primary cultures of Rhesus monkey kidney cells were initially chosen to grow polio virus for vaccine production. The decision to use freshly cultured cells was based on an understandable concern that established long term cell lines may have acquired some genetic changes leading towards the formation of cancer cells. The potential alternative risk that these monkeys might be carriers of cancer causing viruses was expressed by several prominent scientists but their concerns were dismissed. The 1960 finding that Rhesus monkeys were commonly contaminated with an animal cancer causing virus, termed SV40, should have been a wake up call, especially when it was realized that the formalin inactivation process used for Salk vaccine was essentially ineffective against this virus. Known contaminated polio vaccine lots of inactivated vaccines were never recalled. Instead, a rapid switch was made to the use of kidneys obtained from African green monkeys. Rather than reestablishing SV40-free polio viral stocks, use was made of an anti-SV40 animal antiserum (itself a potential source of contaminating viruses), as a way of clearing the contaminant.
The other major change in the early 1960¡s was the reluctant admission that the Salk vaccine was inferior to Dr. Sabin¡s live attenuated vaccine in the rapidity of providing immunity and cost. Moreover, the Sabin vaccine was transiently excreted by those who were vaccinated leading to secondary infection and presumed vaccination of others within the community. The omission of a formalin inactivation step should have led to a redoubling of efforts to screen the donor monkeys for unapparent infections. This was never done. Rather a political conflict arose over the Division of Biological Standards (a forerunner to the Bureau of Biologics component of the Food and Drug Administration, FDA) decision to license Dr. Sabin¡s vaccine. Lederle, a vaccine manufacturer was working with an attenuated polio virus developed by Dr. Hilary Koproski of the Wistar Research Institute. A rift had developed between Dr. Sabin and Dr. Koproski. Seemingly, Dr. Sabin had produced a better attenuated vaccine by employing Dr. Dubecco¡s plaque purification procedure. Thus there were persistent reports from field trials using Dr. Koprowski¡s vaccine of breakthrough infections. More serious was Dr. Sabin¡s concerns that Dr. Koprowski¡s vaccines had a contaminating virus that was not being openly addressed. A mention of this concern was published by Dr. Sabin and included in correspondence that led to a breakdown in any previous friendship enjoyed by these individuals. Lederle reportedly threatened to sue the government if they could not get their vaccine licensed at the same time as Dr. Sabin¡s vaccine. By appealing to Dr. Sabin, the government had him agree to forego patenting his vaccine virus and instead to freely, if reluctantly, provide it to Lederle.
Concerns regarding the possible contamination of polio vaccine grown in African green monkeys persisted throughout the 1960¡s. Up to half of all monkey kidney cultures were being rejected because of apparent viral contamination. Common sense suggestions such as screening the monkeys own serum for antibody reactivity against the cultured kidney cells were dismissed since it would undoubtedly lead to rejection of even more cultures. Dr. Leonard Hayflick, also working in the Wistar Research Institute, had successfully cultured a human lung derived cell line that lacked the longevity or chromosomal abnormalities of cancer cells. This cell line, designated WI-38, was a potential substitute for monkey kidney cells. Dr. Hayflick had provided the cells to Pfizer for successful polio vaccine production in England. Various arguments were raised by Lederle to justify the continued use of monkeys, including the need for monkeys in safety studies. Nevertheless, the issue of contamination was addressed by Lederle and the Bureau of Biologics in 1972. Kidneys from eleven monkeys were set aside from vaccine production to see what, if any, contaminating viruses might be present. All eleven monkeys grew out African green monkey simian cytomegalovirus (SCMV). Only four of the isolates would have been detected using the then mandated government screening tests. Lederle had a more sensitive indicator cell line, even better than WI-38. In Lederle¡s contingency plan, they argued that the Bureau of Biologics would not be willing to take their product off the market in favor of Pfizer¡s vaccine. They also argued how they could contest the findings; repeat the studies, etc., while continuing to make thousands of doses of the existing vaccine. Alternatively, they could begin to treat the monkeys with an anti-viral agent. Their main point of argument was that there had been no apparent illness resulting from the vaccine. Possibly, the contaminating virus was destroyed as it passed into the stomach from an oral administration! This silly argument was essentially repeated to me 5 years later by Dr. Harry Myer, the Director of the Bureau of Biologics, when he dismissed my report of finding foreign DNA in polio vaccine lots. Dr. Meyer was subsequently appointed a vice president of the company, American Cyanamid that had acquired Lederle.
A cell damaging (cytopathic) virus was isolated from a child named Colburn in 1973 by a pediatrician from Birmingham, Alabama, Dr. Charles Alford. It was subsequently shown to be SCMV. From my initial conversations with Dr. Alford, it was clear that he had been discouraged from suggesting a vaccine origin, but was rather pressured to suggest it may have been a laboratory contaminant. Much later I was told by a technician working at CDC that she recalled culturing a SCMV-like virus from a patient who had received an experimental rubella vaccine produced in kidney cells from African green monkeys. This vaccine was being promoted by Dr. Paul Parkman, Deputy Director of the Bureau of Biologics, in competition with industry alternative rubella vaccines, produced in kidney cells from ducks, dogs and other species. When I inquired of Dr. Parkman about my conversation with the CDC technologist, his surprise answer was is she still working there? A CDC researcher described their Director¡s response as proclaiming The shit has hit the fan and close the hatches, and no more mention of it. Sadly, the CDC technician complied.
I reported isolating an atypical virus from a patient with a chronic fatigue syndrome (CFS) illness in 1991. This isolate followed several years of suggestive culture findings and clearly apparent reactions using virus-reactive probes in a sensitive molecular based assay known as the polymerase chain reaction (PCR). Based on the foamy appearance of the cells developing in the viral cultures, I initially suspected a spumavirus (spuma is the Latin for foam). I communicated this opinion to the CFIDS Association of America. They substituted fact for opinion and claimed their success to the CDC. I soon found myself to be a pawn in infighting between various chronic fatigue syndrome support groups. I was also dismayed by opportunistic researchers claiming they too had isolated such a virus with at least one commercial laboratory began offering spumavirus testing. There was also conflict within CDC with Dr. Walter Gunn being erroneously overconfident that Dr. Folks from the CDC was also isolating spumaviruses and with Dr. Brian Mahy asking who my virologist was, as if I had no clue as to what I was doing. I agreed to a study organized by Dr. Gunn soon after he retired from CDC and had entered into a consultative agreement with the CFIDS Association. The study did not distinguish fatigued patients from poorly selected controls. Rather than focusing on why anyone should be testing positive, the conclusion was I had not provided the prized diagnostic test for CFS.
Early DNA analysis on the initially isolated virus indicated a herpes-like virus with portions clearly related to, but distinct from, human cytomegalovirus. By 1995, the cytomegalovirus-related sequences were unequivocally identified as being derived from SCMV, as was another virus isolated from a comatose patient with a history of a severe bi-polar illness. This second virus isolate was provided to the Los Angeles County Public Health laboratory in early 1972 which reportedly sent it onto the California State Health Department. Both laboratories dismissed it as a possible contaminant.
Having obtained unequivocal sequence data, published in July 1995, and having seen and published on the devastating effect of inoculating the virus into cats, I was ill prepared for the responses that I received. These included industry anger that I was invited to address an Institute of Medicine (IOM) meeting held in Washington in November 1995; flat out rejection of unsolicited proposals to both the Bureau of Biologics and CDC for collaborative studies; abrupt dismissal of all volunteers, including an unpaid technologist, and closure of my USC laboratory nine days after the IOM presentation. As was discussed at a closed executive session held the day after my IOM presentation, a panelist Dr. Robert Johnston was quoted as stating that confirmation of the data presented by Dr. Martin would require removal of the polio vaccine from the market. Without my approval, a lawyer filed suit immediately after the IOM meeting for my testing of the polio vaccine administered to his client. A court had previously approved, over the objection of Lederle and the FDA, PCR testing of the polio vaccine lot administered to a child with an unusual brain illness. The allowed testing, however, was specifically to be restricted only to human immunodeficiency virus (HIV), with the stipulation that no other viral testing be done. I had agreed to do this testing, and also to test the child's blood samples stealth viruses. If the child's blood was stealth virus positive, the approach would have been to reapply to the court for stealth virus testing on the polio vaccine lot. Within days of the IOM meeting, all of the patient donated funds in a USC gift account (over $20,000) were whisked away by Dr. Clive Taylor Chairman of the Pathology Department. This was done ostensibly in order to provide back pay and pay-in-lieu-of-notice to the medical technologist. I refused to sign an authorization for this payment, knowing all too well that Dr. Taylor's major source of research funding in prior years had been American Cyanamid, the parent company of Lederle. I took leave from USC when confronted in January 1996 with an additional $27,000 demand to cover additional costs before my laboratory could be reopened.
Instead, I personally financed an independent laboratory, with some income generated from doing fee-for-service viral cultures, very occasional large donations and a much appreciated steady $2,100 every 1-2 months from a Japanese donor whom I have yet to personally thank. That he would continue to provide support without acknowledgement has helped fuel my determination to stay the course whatever the personal or financial costs.
A series of memorable patients have also provided more than adequate motivation and justification. On the other hand, efforts to enlist support from those in authority have been unproductive. I challenged acquaintances at FDA as to why they did not disclose the 1972 results of the collaborative study with Lederle. They could not, I was told, because the results on all studies done on regulated products are essentially proprietary to the industry providing the product. This was also given as the excuse why I could not even view tissue sections of spinal cords inoculated with licensed lots of polio vaccines in routine safety studies. I described the problem to staff of the United States Government House and Senate Commerce Committees. A legal counsel for the House Committee was willing to insert a provision in an upcoming FDA Reform bill that would require Industry to agree to waive its proprietary restrictions in the event that a safety issue was identified on a regulated product and to allow the safety concern to be freely disseminated to the scientific committee. I was tasked with seeking support from the American Medical Association (AMA) and also advised to contact someone at the Hover Institute at Stanford University. The AMA political liaison officer in Washington, D.C., could see no advantage of the public learning that doctors were not in the knowledge loop. Senior FDA officials told the legislative counsel that to be a sieve of such information about competitor's products would lessen their prospects for high salaried post government service employment. The Hover Institute expert was unwilling to confront the Pharmaceutical Industry. Thus, the matter was dropped.
In another visit to Congress, I accompanied a delegation to discuss Gulf War syndrome. The morning presentations dealt with potential movement of toxic chemical clouds from Khamisiyah towards the troops. There were celebrations at lunch time for the group had secured a commitment of funds regarding low level chemical exposure. By the way John, they don't want to hear anything about viruses and we have agreed to pull you off the agenda for this afternoon. It was reminiscent of a tactic I had seen played out at the National Institutes of Health where dissident visiting guests were offered grants in return for their silence.
I had taken an interest in Gulf War syndrome because of the obvious clinical similarities with chronic fatigue syndrome. I was also informed by a conscientious administrator in the Office of Naval Research that I should look into the possibility that the gamma globulin injections provided to troops to reduce the risk of hepatitis A infection may have transmitted stealth viruses. She could not raise the issue internally because it would create a political ceiling restricting her career prospects. The potential of gamma globulin injections for transmitting hepatitis C was recognized at the time of the Gulf War but was only belatedly addressed by the Bureau of Biologics some years later. I had presented the issue to a meeting in the Oklahoma State House that was attended by a high ranking Government representative who had stated We will let no stone go unturned. When I subsequently asked for his help with the rejection of a formal grant application to the Department of Defense his sorry replies from Washington were You can't do anything in this town without someone looking over your shoulder; and I'm nearing retirement, I don't need to create controversies.
Yet I knew I was having some impact. The Bureau of Biologics was willing to fund a Johns Hopkins researcher if he could disprove my findings. In 1996, I was invited to attend a closed National Institutes of Health sponsored meeting on SCMV. I was barraged with contradictory assertions, all aimed at justifying official inaction. I could sense no concern or compassion for the patients that I was describing and showing brain biopsies and culture results. Yet I was being asked on the sidelines whether I thought formalin would inactivate the stealth virus. I learned of efforts by the National Vaccine Advisory Committee to switch back to formalin inactivated vaccines, purportedly because of the occasional case of vaccine-derived polio. As the Chairman of this committee told me, the switch will be done over a two year period to let the company use up their stocks. Because of further delays and industry protests, the use of live polio vaccine was only formally discontinued in the United States at the beginning of 2000.
Interesting medical cases and reports of family centered and even community wide outbreaks of complex illnesses kept coming to my attention. Dr. Donovan Anderson reported to me on over 100 patients he had seen in the spring of 1996, with an initial gastrointestinal disease. Many went on to develop a chronic neurological and fatiguing illness. He reported both the occurrence of the gastrointestinal symptoms and the subsequent neurological symptoms to the Arizona state health authorities. He told them that I had found many of his patients to be stealth virus infected. Not only were his reports dismissed by the Arizona State Public Health department, but he soon found himself the target of probes by both the Arizona State Medical Board and the Federal Drug Enforcement Agency.
A hairdresser in Joelton, TN, realized she, her two staff members and a number of her clients were experiencing general malaise, muscle aches and pains, and impaired brain function. When asked if she knew of other patients, she took the initiative of describing her illness in the local Shopper magazine. Well over 100 people responded. As soon as the issue of stealth viruses arose, the local health authorities, on advice from CDC, let the matter die. A lady from Peoria, IL has seen similar symptoms among many in her community. The scope of the problem has been masked by the tendency to separate patients into distinct disease entities. Diagnostic labeling and categorizing tends to obscure the shared features common to many chronic persisting illnesses. Narrowly focused patient support groups have sprung up that unfortunately seem to compete more than to cooperate. There is a greater willingness to ascribe illnesses to some known established microorganism than to embrace the concept of atypically structured, stealth-adapted viruses. No insurance company will pay for a stealth virus diagnosis, whereas they may pay for an illness presumptively caused by Borrelia burgdoferi (the bacteria that causes acute Lyme disease), Babesia (a parasite related to malaria) Mycoplasma fermentans (a postulated cause of the Gulf war syndrome), Streptococcus, human herpesvirus-6, etc. The internal discrepancies and inconsistencies in the laboratory testing for conventional types of infectious agents in patients with chronic, persisting neurological and neuropsychiatric illnesses are conveniently overlooked by some support group leaders and their show-cased lucrative clinicians. I have been offered a piece of their pie, but only in return for positioning stealth viruses as simply another co-infection.
I continued to publish on cases from the Mohave valley and elsewhere and to present the findings at various scientific conferences. I found it difficult to engage CDC researchers in open discussion. Subsequent e-mails would go unanswered. Offers to informally discuss the work were repeatedly refused. Two salient earlier comments from friends were You must be a masochist to persist and You¡re proven it John. It¡s up to them to disprove you, but they will never give you the platform.
The passive indifference gave way to a more active antagonism when I was told last year that my Clinical Laboratory license was coming up for early re-inspection. I was informed by the Head of the State Health Department¡s Field Services Division of the concerns she had received from CDC. It also became apparent that a complaining patient, believing she had Lyme disease, provided the appropriate cover for the inspection. Because of inexperience of the local inspector, I was informed that the Health Department had decided to send a senior inspector from the Berkeley office. My early expectation of a serious effort to understand the research soon gave way to disappointment that the clinical testing was being scrutinized with the foregone conclusion of non-compliance with Federal regulations. The essential premise was that since others had not confirmed the work, it must not be valid. I worked hard trying to formulate responsive letters that would promote an independent review of the body of research work, but to no avail. An inquiry to CDC at least provoked an apology from someone who had criticized the work. Still, there was not to be an invitation to present the research
The interruption in testing has allowed time for completing two important publications. They deal with a fascinating mechanism whereby stealth virus infected cells appear to derive cellular energy from mineral containing pigmented materials. These materials have been designated as alternative cellular energy pigments or ACE-pigments. Their identification has opened up interesting therapeutic possibilities especially within the medically suppressed fields of biophysics and energy-related technologies.
I have also had some time to contemplate whether AIDS has anything to do with the lack of Public Health support. I reported that unlike human and chimpanzee cytomegaloviruses, SCMV has multiple copies of a gene that provides a cell surface receptor for HIV. Rhesus CMV has a similar structure as SCMV. I argued that it was quite plausible that the experimental use of CMV contaminated polio vaccines in Africa promoted the transition of the chimpanzee simian immunodeficiency virus to HIV. Again, requests that CDC test stored sera collected from polio vaccine immunized Congolese children in 1958 for evidence that the vaccines were contaminated with CMV were never answered. Possibly without realizing its significance, a recent article from the Division of Biological Standards in England, did reveal the presence of DNA corresponding to Rhesus CMV in the CHAT vaccine lot used by Dr. Koprowski in Africa. Possibly this was the virus detected by Dr. Sabin in his criticism of Dr. Koprow ski¡s vaccine. The same English study revealed that approximately half of over 100 tested licensed polio vaccines had DNA corresponding to SCMV. The United States FDA also disclosed that 3 of 8 tested polio vaccines lots released in the 1970¡s had DNA from SCMV. Both the English and American authorities argued that their results did not pose a Public Health problem since they were unable to culture any live virus. I suspect they did not try very hard, and certainly did not approach the issue in other potentially telling ways.
The system is flawed. To hear that there is no known cause of the majority of the almost 20,000 hospitalizations each year for encephalitis is alarming. To be told by a Public Health official that they are pushing for a probable chemical cause, such as pesticide exposure, lest they have to deal with issues of patient confinement is more than disappointing. Similarly, to be told to back off suggesting that autism could be an infection since this might discourage teachers from working with these children is wrong. Certainly it offers little comfort to the ill healthcare worker or special education school teacher whose lives change dramatically with the onset of an occupationally acquired stealth virus illness. It is time for Public Health laboratories to do stealth virus testing and to provide the scientific, social and spiritual support for those with stealth virus associated illnesses.
Such an obvious conclusion is not as easy as it may sound. Public Health agencies are creatures of, and respond directly to, those who govern. These are the politicians who fight desperately to become elected and then quickly sense the power of ever growing political and personal coffers. The need for money can easily subdue the politicians¡ willingness to confront special interests. Those with money clearly influence political appointments and even the choices and behavior of those to be promoted within the health agencies. Pharmaceutical giants can help set agendas and raise such spurious arguments as: Questioning vaccine safety will result in non-compliance with public health policies and widespread outbreaks of infections. Massive law suits will bankrupt our industry and we will not be able to continue conquering diseases. That we inadvertently caused AIDS will undermine the claim that this is the greatest nation ever to have existed. It is little wonder that those in c ontrol have chosen to close ranks.
Yet there is hope for a change, especially since most politicians are parents and many are now beginning to also experience the ravages of the current epidemic. Increased public awareness will make it easier for such politicians to demand a full accounting of the past and current practices of those entrusted with the nation¡s health. Focused, well supported research will very likely provide therapeutic answers whereas continuing to ignore the issues will simply result in an ever increasing national and international tragedy. The Scientific, Social and Spiritual Support (S3Support) movement is designed to create awareness of the problems, support those in need, and promote the necessary research.
http://www.s3support.com/members/scientific/vaccine/political.htm
http://www.eurekalert.org/pub_releases/2004-03/uotm-mvm032604.php
Public release date: 29-Mar-2004
Contact: Julie Penne
jpenne@mdanderson.org
713-792-0655
University of Texas M. D. Anderson Cancer Center
Monkey virus may hold clue for development of common blood cancer
ORLANDO -- Examination of tumors in patients with newly diagnosed non-Hodgkin's lymphoma found that half of them show evidence of a monkey virus DNA that may have originated from contaminated polio vaccines. These findings suggest that Simian virus 40 (SV40) may "participate" in the development of the blood cancer, say researchers from The University of Texas M. D. Anderson Cancer Center, who presented their findings at the annual meeting of the American Association for Cancer Research.
There is no known etiology for most non-Hodgkin's lymphoma, which has doubled in incidence within the past 30 years, say the researchers. "We found a strong association between the monkey virus DNA and non-Hodgkin's lymphoma in this study, and now the question is whether the virus DNA is there as an innocent bystander, or if it has a role to play in causing the cancer," says the first author, Felipe Samaniego, M.D., assistant professor in the Department of Lymphoma/Myeloma.
There has been a debate as to whether SV40, which contaminated some batches of polio vaccine in the 1950s and 60s, could cause human cancer, especially after the virus was discovered in human tumors. Given that, the M. D. Anderson researchers looked to see if either DNA from the virus or associated antigens or antibodies could be found in non-Hodgkin's lymphoma.
One reason they looked for evidence of SV40 in non-Hodgkin's lymphoma is because other viruses have been commonly found in this form of lymphoma, including Epstein Barr virus. "The assumption has long been that if only some NHL cases showed signs of virus, the rest may have another virus
involved in the development of this lymphoma," says Samaniego. "Now we wonder, which one is most important?"
The research team, which included Suizhao Wang, M.D., Ph.D., and Shu Wang, M.D., both post doctoral fellows in the Department of Lymphoma/Myeloma, examined 55 tumors taken from patients newly diagnosed with the disease who had not yet been treated with chemotherapy. After isolating DNA from the genomes of the cancer cells, the researchers found that 33 of the tumors contained DNA sequences from the anitigen produced by the virus. And 30 of 57 tumors stained positive with antibody that recognizes the large T antigen of SV40.
There is no question that SV40 is a powerful cancer virus in some animals, says Samaniego. In a hamster, for example, the virus causes both lymphomas and mesotheolioma lung cancers, as well as tumors in the brain and bones. People may pick up the virus by association with infected animals, through a polio vaccine, or even though secretions, such as saliva, from a person already infected, he says. One study suggested that at least five percent of Americans have signs of infection with the monkey virus, says Samaniego.
But he theorizes that the body's immune system normally keeps the virus in check until "a transforming event, inflammation or other disease," says Samaniego. "Then the virus may reactivate and cause cancer." If SV40 does prove to play a role in development of non-Hodgkin's lymphoma, then treatment aimed at destroying the virus could help prevent its development, he says. "The virus could serve as a target in novel immune-based prevention and therapeutic strategies for non-Hodgkin's lymphoma," Samaniego says. "Although this cancer is quite treatable with a 60 percent cure rate, a new therapeutic strategy would be welcomed."
Are Vaccines Causing More Disease Than They Are Curing?
Copyright 1999 by Alan Cantwell, Jr., M.D.
(re-printed with permission of author)
Vaccines help keep us safe from infectious diseases. Smallpox and polio epidemics have been wiped out by mass vaccine programs. People rush to get flu shots every fall, and kids are bombarded with a barrage of 22 required vaccinations before the age of six. Even pets need their shots. The manufacture of vaccines is a giant industry and what you pay for inoculations and doctor visits is big business for pediatricians, family practitioners and veterinarians. So why are more and more people worried about vaccines, especially the ones for kids?
Vaccine-induced Illness
Barbara Loe Fisher, president of the National Vaccine Information Center, a consumer's group based in Vienna, Virginia, claims vaccines are responsible for the increasing numbers of children and adults who suffer from immune system and neurologic disorders, hyperactivity, learning disabilities, asthma, chronic fatigue syndrome, lupus, rheumatoid arthritis, multiple sclerosis, and seizure disorders. She calls for studies to monitor the long-term effects of mass vaccination and Fisher wants physicians to be absolutely sure these vaccines are safe and not harming people.
No one can deny the dangers of vaccines. The measles, mumps, rubella (German measles) and polio vaccines, all contain live but weakened viruses. Although health officials tell you that polio has been wiped out in the U.S. since 1979, they often fail to mention that all recorded cases of polio since that time are actually caused by the polio vaccine.
Vaccine investigator Neil Z. Miller questions whether we still need need the polio vaccine when it causes every new case of polio in this country. Before mass vaccinations programs began fifty years ago, Miller insists we didn't have cancer in epidemic numbers, that autoimmune ailments were barely known, and childhood autism did not exist.
Vaccine Contamination
There is also the problem of contamination that has always plagued vaccine makers. During World War II a yellow fever vaccine manufactured with human blood serum was unknowingly contaminated with hepatitis virus and given to the military. As a result, more than 50,000 cases of serum hepatitis broke out among American troops injected with the vaccine.
In the 1960s it was discovered that polio vaccines manufactured in monkey kidney tissue between 1955 and 1963 were contaminated with a monkey virus (Simian Virus, number 40). Although this virus causes cancer in experimental animals, health authorities insist it does not cause problems in humans. But evidence of SV40 genetic material has been popping up in human cancers and normal tissue. Researchers are now connecting SV40-contaminated polio vaccines to an increasing number of rare cancers of the lung (mesothelioma) and bone marrow (multiple myeloma). In a 1999 report, SV40 DNA was detected in tissue samples from four children born after 1982. Three were kidney transplant patients, and a fourth had a kidney tumor. Could SV40 be passed on from parents to their children?
No one knows for sure.
Covert Vaccine Experiments
Using kids as guinea pigs in potentially harmful vaccine experiments is every parents' worst nightmare. This actually happened in 1989-1991 when Kaiser Permanente of Southern California and the Centers for Disease Control (CDC) jointly conducted a measles vaccine experiment. Without proper parental disclosure, the Yugoslavian-made "high titre" Edmonston-Zagreb measles vaccine was tested on 1,500 poor, primarily black and Latino, inner city children in Los Angeles.
Highly recommended by the World Health Organization (WHO), the high-potency experimental vaccine was previously injected into infants in Mexico, Haiti, and Africa. It was discontinued in these countries when it was discovered that the children were dying in large numbers.
Unbelievably, the measles vaccine caused long-term suppression of the children's immune system for six months up to three years. As a result, the immunodepressed children died from other diseases in greater numbers than children who had never received the vaccine. Tragically, African girl babies in the experiment were given twice the dose of boys, and therefore suffered a higher death rate. The WHO pulled the vaccine off the market in 1992.
Ironically, the E-Z measles vaccine tested by Kaiser on minority babies was supposed to increase immunity in younger infants. Instead, the vaccine produced the opposite effect. A Los Angeles Times editorial (June 20, 1996) assured readers that "none of the 1,500 was injured by the unlicensed vaccine" and called upon the CDC to ensure that experiments like the E-Z measles vaccine could never occur again.
One wonders how many secret vaccine experiments are conducted by health authorities that never come to the attention of the public. During the two-year measles experiment I was employed by Kaiser and I never knew anything about it until I read the report in The Times five years later, in 1996.
In the poor inner cities across the country the number of asthma cases is exploding and health officials don't know why. According to the CDC, 5000 asthma deaths occur annually; and it is estimated that 17.3 million people (4.8 are children) suffer from the disease, up from 6.7 million in 1980. Asthma usually begins before age 6, and blacks are two to three times more likely to die from asthma than whites. In the Bronx and Harlem sections of New York City, the hospitalization rate for asthma is 21 times higher than in the more affluent areas of the city.
Could the sharp rise in asthma in poor children be connected with immunosuppression caused by a barrage of vaccines, as well as a lack of quality medical care and insurance, poor diet, and environmental factors? The possible connection of immunosuppressive vaccines to diseases like asthma has never been raised by health officials .
With vaccine experiments frequently performed in Africa and now on black Americans, no wonder one out of every four African-Americans believes AIDS was developed as a genocide program by the U.S. government to exterminate the black population.
But vaccine experiments in the 1990s have not been limited to blacks. Millions of female Mexicans, Nicaraguans and Filipinos have been duped into taking tetanus vaccines, some of which contained a female hormone that could cause miscarriage and sterilization. In 1995, a Catholic human rights organization called Human Life International accused the WHO of promoting a Canadian-made tetanus vaccine laced with a pregnancy hormone called human choriogonadotropic hormone (HCG). Suspicions were aroused when the tetanus vaccine was prescribed in the unusual dose of five multiple injections over a three month period, and recommended only to women of reproductive age.
When an unusual number of women experienced vaginal bleeding and miscarriages after the shots, a hormone additive was uncovered as the cause.
Apparently the WHO has been developing and testing anti-fertility vaccines for over two decades. Women receiving the laced tetanus shot not only developed antibodies to tetanus, but they also developed dangerous antibodies to the pregnancy hormone as well. Without this HCG hormone the growth of the fetus is impaired. Consequently, the laced vaccine served as a covert contraceptive device. Commissioned to analyze the vaccine, the Philippines Medical Association found that 20 percent of the WHO tetanus vaccines were contaminated with the hormone. Not surprisingly, the WHO has denied all accusations as "completely false and without basis," and the major media have never reported on the controversy. For further details on this issue, consult the Human Life International website (http://www.hli.org/).
Newly approved vaccines may also pose serious risks. In October 1999 a vaccine against "rotavirus" infection (which causes most cases of childhood diarrhea) was pulled off the market. One year after the RotaShield vaccine was inoculated into over a million infants, it was found to increase the risk of bowel obstruction. Almost 100 cases of bowel obstruction were reported to the government, and twenty infants developed bowel obstructions within one or two weeks after receiving the vaccine.
Vaccine Manufacture and Associated Dangers
Although the public has heard about side effects of vaccines, most people are clueless about the manufacture of vaccines. Few people know that viruses used in vaccine production need to be grown on animal parts like monkey kidneys, or in chicken embryos, or in human and fetal "cell lines."
Harvesting viruses in human cell-lines can be perilous because some human cell lines are derived from cancer cells.
In AIDS & The Doctors of Death I wrote about the development of the first human "HeLa" cell line - an "immortal" cell line used extensively in cancer and vaccine research for decades. Henrietta Lacks was a young black woman from Baltimore who died from a highly malignant cervical cancer in 1951. Small pieces of her tumor were donated to a laboratory specializing in tissue cell culture. In those days most attempts to grow human cells outside the body failed. But for some unknown reason Henrietta's cancer cells grew vigorously and became known as the first successful human tissue cell line in history - the now famous HeLa cell line commemorating the legendary HEnrietta LAcks.
Henrietta's cells were kept alive by feeding them a witches' brew of beef embryo extract (the ground-up remains of a three-week-old, unborn cattle embryo); fresh chicken plasma obtained from the blood of a live chicken heart; and blood from human placentas (the placenta is the sac that nurtures the developing fetus and contains powerful hormones).
It is now suspected that a sexually-transmitted papilloma virus is the cause of cervical cancer. And it is anybody's guess how many other chicken, cattle, and human viruses are incorporated into the HeLa cell line, but none of this possible viral contamination seems to bother scientists who have extensively used the cells in cancer research. What laboratory scientists did eventually discover was that HeLa cells proved so hardy that they frequently contaminated other tissue cell lines used in cancer and cancer virus research.
In the late 1960s when widespread HeLa cell contamination problems were uncovered, scientists were shocked and embarrassed to learn that millions of dollars worth of published cancer experiments were ruined. "Liver cells" and "monkey cells" that were used in cancer experiments turned out to be Henrietta's cancer cells in disguise. Benign cells which supposedly "spontaneously transformed" into malignant cells were found to be cells contaminated with cancerous HeLa cells.
The serious problem of HeLa cell contamination in cancer and vaccine research is revealed in Michael Gold's A Conspiracy of Cells: One Woman's Immortal Legacy and the Medical Scandal It Caused. Even Jonas Salk, who developed the legendary Salk polio vaccine, was fooled when HeLa cells contaminated his animal cell lines. He admitted this years later in 1978 before a stunned audience of cell biologists and vaccine makers. In experiments performed in the late 1950s on dying cancer patients, Salk tried injecting them with a cell line of monkey heart tissue - the same cell line he used to harvest polio virus for his famous vaccine. He hoped the monkey cell injections would stimulate the immune system to fight cancer. However, when abscesses developed at the site of injections Salk began to suspect that he might be injecting HeLa cells rather than monkey cells, and he stopped the experiment.
Mark Nelson-Rees, a HeLa cell expert and one of the 1978 conference attendees, offered to test Salk's line if it was still available. Salk graciously agreed and the monkey cells indeed proved to be HeLa cells which had invaded and taken over the monkey cell line. According to author Gold, Salk thought there were adequate ways to separate viruses from the tissue cell lines they were harvested in, so that it really didn't matter what kind of cells were used. Even if vaccines weren't filtered, and even if whole cancer cells were injected directly into a human, Salk believed they would be rejected by the body and cause no harm. In those days doctors didn't much believe in cancer-causing viruses. Nowadays, no researcher would dare try injecting cancer cells into a human being. But in the 1950s Salk had done it accidentally. He had injected HeLa cells into a few dozen patients and it hadn't bothered him a bit.
Is There a Vaccine Contamination Connection to AIDS?
Most people assume vaccines are "sterile" and germ free. But sterilizing a vaccine can destroy the necessary immunizing protein that makes it work. Thus, contaminating viruses or viral "particles" can sometime survive the vaccine process.
Animal viruses are also contained in fetal calf serum, a blood product commonly used as a laboratory nutrient to feed various tissue cell cultures. Vaccine contamination by fetal calf serum and its possible relationship to HIV was the subject of a letter by J. Grote, published in the Journal of the Royal (London) Society of Medicine in October 1988. Bovine visna virus (which looks similar to HIV) is a known contaminant of fetal calf serum used in vaccine production and virus-like particles have been detected in vaccines certified for clinical use. Grote warns that "It seems absolutely vital that all vaccines are screened for HIV prior to use, and that bovine visna virus is further investigated as to its relationship to HIV and its possible role in progression towards AIDS ."
Could virus-contaminated vaccines lie at the root of AIDS? A few researchers, including myself, who believe HIV was "introduced" into gays during the experimental hepatitis B vaccine trails when thousands of homosexuals were injected in Los Angeles, San Francisco, and New York, during the years 1978-1981.
The AIDS epidemic first erupted in gays living in those cities in 1981. In 1980, one year before, already 20% of the gays inoculated in Manhattan with the experimental vaccine were already HIV-positive. This was several years before definite AIDS cases were diagnosed in Africa. In the early 1970s the hepatitis B vaccine was developed in chimpanzees, now wildly accepted as the animal from which HIV supposedly evolved.
Hepatitis B vaccine was developed to protect people from the sexual spread of the hepatitis B virus. Now the government recommends that all newborn babies be given the vaccine. Such recommendations do not make sense to many parents. And people are still fearful of the hepatitis B vaccine because of its original connection to gay men and AIDS. The original experimental vaccine was made from the pooled blood serum of hepatitis-infected homosexuals and, as mentioned, serum-based vaccines cannot be sterilized.
Another theory of AIDS is that HIV originated from polio vaccines contaminated with chimp and monkey viruses, and administered to Africans in the late 1950s. In The River: A Journey to the Source of HIV and AIDS , published in 1999, Edward Hooper details how polio vaccine was made using monkey (and possibly chimp) kidneys and how the ancestor virus of HIV could have jumped species (via the vaccine) to produce the outbreak of AIDS in Africa. Hooper's well-researched book greatly expands the polio vaccine theory of AIDS first reported by Tom Curtis in Rolling Stone magazine in 1992, and The River is a must-read for anyone interested in the possible man-made origin of AIDS.
Other researchers think it more likely that the various WHO-sponsored vaccine programs (particularly the smallpox program) in Africa in the 1970s are responsible for unleashing AIDS in Africa in the 1980s. Hooper, who has worked as a United Nations official, has discounted the research pointing to AIDS as a man-made disease, as proposed by Dr. Leonard Horowitz in Emerging Viruses, and in my two books AIDS & The Doctors of Death: An Inquiry into the Origin of the AIDS Epidemic: and Queer Blood: The Secret AIDS Genocide Plot.
Horowitz and I both suspect contaminated smallpox vaccines as the source of HIV In Africa. Certainly the smallpox (vaccinia-cowpox) virus is an excellent virus to use for the genetic engineering of new, multipurpose vaccines. By splicing into the DNA genes of the vaccinia virus, scientists can add on parts of disease-producing viruses like influenza, hepatitis, and other viruses. The safety of this technique has not been fully evaluated, prompting one vaccine maker at a Vaccinia Virus Workshop in 1984 to ask if this could lead to another form of AIDS.
The Vaccine Connection to Gulf War Illness and Huntsville Mystery Illness
The cause of Gulf War Illness (GWI) is unknown. For years this debilitating illness (which now affects one-half of the Gulf War vets) has been ignored by Pentagon officials who claim the disease does not exist and that vets are simply reacting to stress. GWI is also thought to be contagious. Vets insist their disease has been passed on to spouses, other family members, and even pets.
Some people suspect multiple vaccines, particularly the experimental anthrax vaccine, are implicated in the disease. Currently, soldiers who refuse to take the mandatory anthrax vaccine are being court-martialed and dismissed from the service.
Researchers Dr. Garth Nicolson and his wife Nancy have found a tiny bacterial microbe (a "mycoplasma") in the blood of nearly half the ill vets with GWI. Amazingly, this infectious agent has a piece of HIV (the AIDS virus) attached to it. This microbe could never have occurred naturally. On the contrary, the composition of the microbe suggests a man-made and genetically-engineered biological warfare agent.
Garth Nicolson's scientific credentials are impeccable. For 16 years he was a professor of medicine at the University of Texas M.D. Anderson Cancer Center in Houston, as well as professor of pathology and laboratory medicine at the University of Texas Medical School, also in Houston. Nancy Nicolson, a molecular biophysicist, was on the faculty at Baylor College of Medicine.
Six months after returning home from the Gulf war, the Nicolson's daughter contracted GWI. Her mother Nancy had contracted a similar illness in 1987 when she was working with Mycoplasma incognitus in infectious disease research. Finally suspecting that this research had biowarfare implications, Nancy Nicolson became a whistle-blower and angered officials. As a result, she believes she was deliberately infected with the mycoplasma. After partial paralysis and a long illness, she finally regained her health with the antibiotic Doxycycline.
The Nicolson's discovery of a similar mycoplasma (but without the attachment of HIV) in a mysterious illness that erupted in the Huntsville, Texas area among prison guards and their families has all the drama of a The Movie of the Week. Although the Huntsville disease broke out in the late 1980s (shortly before the Gulf War), it has many of the same signs and symptoms of GWI. Many locals are convinced the sometimes deadly disease originally spread from prisoners incarcerated in several large prisons around Huntsville.
In experiments conducted during the 1970s and 80s, the prisoners were inoculated with flu vaccines containing genetically engineered viruses and mycoplasma . It is suspected that vaccines were being covertly developed and deployed as biological warfare weapons. Nobel prize winner James Watson, world famous for his discovery of the molecular structure of DNA and a leading researcher of the still ongoing Human Genome Project, was involved in these prison experiments. The guards are convinced the Huntsville mystery illness is intimately connected to these experiments, jointly conducted by the Medical School and the military. Like GWI, health officials deny the disease exists.
The Nicolsons continued to develop antibiotic treatments, which have helped some vets. But they have paid a heavy price for their controversial research and unprecedented discoveries. Garth Nicolson was forced to resign from M.D. Anderson in 1996. His career and reputation destroyed, the Nicolsons have since moved to California and head The Institute for Molecular Medicine in Huntington Beach.
Dangerous Animal and Human Cell Lines in Vaccine Manufacture
In an effort to quell concerns about the safety of vaccines, scientists are finally taking another look at the "non-infectious" particles of bird-cancer viruses (avian leukosis virus) in the mumps/measles/rubella vaccines routinely given to kids. Could this be the reason the FDA held a meeting in September, 1999, to reconsider using human tumor cell lines (like HeLa) rather than monkey kidneys and chicken embryos which are no longer guaranteed 100% safe?
Writing in Science, Gretchen Vogel admits public trust in vaccines is a bit shaky. In Wales anti-vaccine parents are holding "measles parties" to infect their children with the disease rather than vaccinate them. She cites the danger of using immortal cell lines for live vaccine production because cancer genes or other hazardous factors might be transferred to people receiving vaccines. But manufacturers also realize vaccine critics are becoming more wary of vaccines made in animal and bird tissue. And vaccine makers want to use immortal cell lines to grow their viruses because obviously viruses can't grow on their own.
The big question everyone seems to avoid is: Can vaccines cause cancer? There is certainly evidence connecting contaminated vaccines to AIDS. And HIV is a cancer-causing virus. Robert Gallo, the co-discoverer of HIV in 1984, has clearly stated AIDS is an epidemic of cancer.
Animal and avian viruses can contaminate vaccines and have all been studied as cancer-causing agents. And cancer and vaccine research would be much more difficult without the use of cell lines, some of which are derived from cancer.
Vaccines and Public Paranoia
Is the fear of vaccines justified? It is clear that vaccines can be dangerous. The contamination of vaccines is a reality, and vaccine experiments can be hazardous to one's health. AIDS, unknown two decades ago, is now an increasing worldwide epidemic with millions of death predicted for the next decade. Could vaccines contaminated with cancer-causing and immunosuppressive viruses unleash new plagues in the New Millennium? If so, the new plagues may be far worse than the diseases we eradicated by vaccine programs in the twentieth century.
References
"Anti-diarrheal vaccine for babies recalled," Los Angeles Times, October 16, 1999.
Butel JS, Arrington AS, Wong C, et al.: Molecular evidence of simian virus 40 infections in children. J Infect Dis 180:884-887, 1999.
Cantwell A: AIDS & the Doctors of Death. Aries Rising Press, Los Angeles, 1988.
Cantwell A: Queer Blood. Aries Rising Press, Los Angeles, 1993.
Gold M: A Conspiracy of Cells. State University of New York Press, Albany, 1986.
Hooper E: The River: A Journey to the Source of HIV and AIDS. Little, Brown and Company, Boston, 1999.
Horowitz L: Emerging Viruses: AIDS & Ebola. Tetrahedron, Inc, Rockport, MA, 1996.
Jaroff Leon: "Vaccine Jitters," TIME, September 13, 1999.
Likoudis P: "Gulf war illness probe to advance with new study," The Wanderer, January 21, 1999.
"Measles, government and trust " (Editorial), Los Angeles Times, June 20, 1996.
Miller NZ: Immunization: Theory vs Reality. New Atlantean Press, Santa Fe, 1996.
Miller NZ: Immunizations: The People Speak! New Atlantean Press, Santa Fe,
1996.
Quinnan GV: Vaccinia Viruses as Vectors for Vaccine Antigens. Elsevier, New York, 1985.
Stolberg SG: "Poor fight baffling surge in asthma," New York Times, October 18, 1999.
[Alan Cantwell is a physician and AIDS researcher. His book on the man-made epidemic of AIDS entitled AIDS & The Doctors of Death: An Inquiry into the Origin of the AIDS Epidemic, is available on the Internet through Amazon.com, Barnes and Noble, or through Book Clearing House at 1-800-431-1579]. [word count 3800]
http://www.sevendaysvt.com/-thisweek/feat/01.html
Bad Shot?
BY KEN PICARD
It’s never easy for a parent to challenge accepted medical wisdom about what’s best for a child’s health, particularly when it comes to early-childhood shots. Vaccines are now considered such an essential part of pediatric health care that the government recommends children receive 39 doses of 12 different vaccines by the age of 5. Refusing to vaccinate a child against debilitating and deadly diseases such as polio, smallpox, measles and rubella makes a parent seem negligent in many people’s eyes. Most public schools, colleges and universities won’t register a student who isn’t inoculated. In most places, in fact, not inoculating is illegal. Still, each year a small number of parents choose not to vaccinate their children because of religious, philosophical or health concerns — something the law permits in Vermont. In 1995, Burlington attorney Jim Schumacher was clerking for a law firm that represented a woman involved in a child-custody battle with her ex-husband over her refusal to vaccinate their children. She had heard horror stories about the possible consequences of vaccines, including autism, learning disabilities, diabetes and, in rare instances, brain damage and death.
Schumacher’s job was to summarize 40 articles supporting the ex-wife’s position. Among them was an obscure journal article claiming that, back in the 1950s and ’60s, the polio vaccine was widely contaminated with a potentially carcinogenic monkey virus. “I was just blown away,” Schumacher recalls today. “I came home and told this to [my wife] and said, ‘We should write about this. This is just incredible!’”
Over the next few years, Schumacher and his wife, investigative reporter Debbie Bookchin, delved into the history of the polio vaccine and the growing debate in the scientific community about the possible health effects of SV40, a little understood simian virus. Unwittingly, the Burlington couple had stumbled upon what they would later call “one of the biggest blunders in medical history.” Neither Bookchin nor Schu-macher is a scientist, though for a time, Schumacher considered following in his father’s footsteps and studied to become a physician. Bookchin, daughter of the internationally known author and social ecologist Murray Bookchin, has been a journalist since 1979 and spent much of the 1980s working for the Rutland Herald and the Vanguard Press. Since then, the award-winning writer has been published in numerous newspapers and magazines, including The New York Times, The Boston Globe, Boston Magazine, The Atlantic Monthly, The Nation and Utne Reader. Schumacher, who has also been published nationally, is an attorney and now works as a consultant for municipalities around the country. He and Bookchin met in the early 1990s while they were both working for Congressman Bernie Sanders.
The couple soon began piecing together the facts behind a frightening but irrefutable story: Between 1954 and 1963, roughly half of the U.S. population — nearly 100 million Americans and untold millions more worldwide — were given a polio vaccine that was contaminated with a cancer-causing monkey virus. For decades, this story remained virtually unknown outside of scientific circles.
Now, on the 50th anniversary of Jonas Salk’s test trials for the polio vaccine, Bookchin and Schumacher have released a meticulously researched and thoroughly documented book, The Virus and the Vaccine, tracing the development of the polio vaccine and the ensuing discovery of SV40. It’s a story eerily reminiscent of The Hot Zone, only more disturbing, considering the staggering number of people who were exposed to this carcinogenic agent.
But The Virus and the Vaccine is more than a fascinating history lesson. It’s also a cautionary tale about how the federal regulatory agencies that were supposed to safeguard consumer health not only allowed a dangerous contaminant to be given to millions of healthy children, but also kept quiet about it for years out of fear of disrupting the public’s faith in vaccines.
Worse, once the source of that contamination was identified — the cancer-causing virus was traced to rhesus monkey kidneys used to produce the polio vaccine — the government still refused to mandate a safer method of vaccine production, even though viable alternatives were being used successfully in other countries.
Perhaps most egregious, Book-chin and Schumacher said in a recent interview with Seven Days, newer polio vaccines may have been contaminated with SV40 as recently as January 2000, when the last vaccines produced using monkey kidneys were removed from the market. This potentially disastrous contamination occurred decades after vaccine manufacturers and the U.S. government claimed that the problem had been corrected.
In January 1997, Bookchin and Schumacher pitched the story to The Boston Globe and followed that article with another in The Atlantic Monthly in February 2000. Both pieces served as the basis for The Virus and the Vaccine, their first book together.
Though the 380-page volume is steeped in detailed and well-annotated science, it’s an accessible read. The pair has crafted a real page-turner that is part detective story, part government cover-up. And like any good exposé, it lays out the tangled web of bureaucratic stonewalling, scientific dogma and financial self-interest that for decades concealed a serious health risk from the public. The story’s colorful cast of characters includes powerful and egotistical men who refused to question
their own deeply entrenched beliefs, as well as unsung heroes who toiled in virtual anonymity and sacrificed their professional reputations and careers in the name of scientific truths.
“You really think of science as kind of a rarefied, disinterested pursuit based completely on facts and objective truths,” says Bookchin. “And the government in the United States is supposed to play a disinterested, activist role. But, as the story of SV40 shows, that hasn’t always worked the way it’s supposed to.”
The polio vaccine was,
literally, the shot felt around the world. Salk’s discovery all but eradicated — in the industrialized world, at least — a debilitating and deadly childhood disease. The U.S. government’s polio-eradication program laid the groundwork for the mass-inoculation programs that became the cornerstone of American public-health policy.
Many Americans today are too young to have known the fear and horror that once accompanied the annual start of “polio season.” At its peak in 1952, about 58,000 new cases of polio were diagnosed — one in every 3000 Americans — killing more children that year than any other infectious disease. “Polio was becoming America’s bête noire,” Bookchin and Schumacher write, “as dangerous as the Red Menace, and just as insidious — an unseen enemy within, a crippler and killer that seemed unstoppable, viciously cruel, with a penchant for young victims.”
Ironically, the wild poliovirus, which seemed to rage haphazardly through the population proved surprisingly difficult to grow in a laboratory. Unlike bacteria, viruses require a “substrate” of living cells to reproduce, and since laboratory rodents are unaffected by it, the next logical choice was the rhesus monkey. In 1950, Salk, then at the University of Pittsburgh, discovered that ground monkey kidneys could produce a high yield of the poliovirus in record time, and at a fraction of the cost of
earlier methods.
Salk’s choice of rhesus monkey kidneys proved to have monumental consequences. The kidney is a storehouse for all the microorganisms filtered from the blood. But for researchers at the time, the easy accessibility and cheap supply of rhesus monkey kidneys made them an ideal growth medium.
By the summer of 1952, Salk believed he had perfected the technique of “inactivating” the poliovirus and began conducting vaccine field trials. They were an unqualified success. Two years later, on April 26, 1954, a 6-year-old boy named Randy Kerr of Falls Church, Virginia, became America’s first “polio pioneer,” one of 2 million children in 44 states inoculated with the Salk vaccine or an identical-looking placebo. Salk was awarded the Nobel Prize in medicine for his development, and his name became synonymous with the polio cure.
However, less-publicized problems arose almost immediately. Previously unknown strains of simian viruses began contaminating batches of the vaccine. The first “SV1” was isolated in February 1954; the second, just months later. Initially, researchers didn’t worry much about these rogue viruses. Given the deadly scourge of polio, their attitude was “better the devil you know than the devil you don’t,” says Bookchin.
But soon a more urgent crisis shook America’s confidence in the Salk vaccine. In 1955, vaccine manufacturer Cutter Laboratories distributed a batch of vaccine that inadvertently contained live poliovirus. The so-called “Cutter incident” resulted in 260 people contracting polio, including 200 cases of paralysis and 11 deaths. Investigations revealed that other vaccine manufacturers were also having serious problems with rogue viruses contaminating their vaccines. But while the immediate problem may have been addressed, its underlying cause — the practice of using monkey kidneys — continued unabated. “Despite the Cutter deaths, the lesson — as far as the federal government was concerned — was that there was no need for increased surveillance of the manufacturers,” write Bookchin and Schumacher.
By 1960, tens of millions of Americans had received the vaccine, seemingly with no major problems. Meanwhile, simian viruses continued to crop up, though scientists considered them little more than a nuisance. But one researcher, Bernice Eddy, at the government’s newly formed Division of Biologic Standards, began investigating the new field of “viral oncology” — the relationship between viruses and cancer. Eddy had discovered that laboratory mammals injected with certain mouse viruses developed tumors. Would a monkey virus do the same thing in humans? And if it did, were any of the simian viruses that had contaminated early batches of the polio vaccine carcinogenic?
Eddy’s public suspicions about the safety of the polio vaccine not only impugned the reputation of her agency, but also proved to be professional suicide for her. Far from being commended by her bosses for her scientific curiosity, Eddy was effectively stripped of all her responsibilities in vaccine-control work and literally relegated to a former broom closet on the campus of the National Institutes of Health. “Millions of children would continue to receive live SV40 as part of their Salk injections,” write Bookchin and Schumacher. “As had been the case with the Cutter incident, the official conclusion was that the nation’s polio program was simply too important to interrupt, despite a known problem with the vaccine. But, unlike Cutter, this time the federal government would keep the news to itself.”
In 1963, a highly publicized epidemiological study conducted by the NIH’s Joseph Fraumeni concluded that people who had received doses of SV40-contaminated vaccines were no more likely to contract cancer than those who had not. As Schumacher and Bookchin found, that study was “deeply flawed.” Still, for the next three decades, it was a widely accepted medical “fact” that SV40 was harmless to humans.
Thirty years after Eddy’s findings, NIH scientist Michele Carbone discovered a link between SV40 and malignant mesothelioma, a deadly cancer of the lungs, heart and abdominal cavity that was virtually unknown before 1955 but now kills about 2500 Americans each year.
Although mesothelioma is usually tied to asbestos exposure, recent studies suggest that those who have SV40 in their bodies may be more susceptible to the disease. Scientists don’t yet understand why, though a researcher at the University of Vermont has been looking into the links between SV40 and cancer. Dr. Brooke Mossman is the director of UVM’s Environmental Pathology Department and an internationally renowned expert on mesothelioma. Next month, she plans to submit a multi-million-dollar grant request to the NCI with Dr. Carbone, now associate professor of pathology at Loyola University Medical School in Chicago. As Bookchin learned last week, their goal is to study how mesothelioma originates, its relationship to SV40 and genetics, and whether the simian virus makes the deadly cancer even more pernicious.
Today, certain facts about SV40 are undisputed. The U.S. Centers for Disease Control and Prevention (CDC) and the National Cancer Institute (NCI) admit that between 1955 and 1963, an unknown number of Salk vaccines were contaminated with SV40 and given to millions of Americans. Both agencies also acknowledge that SV40 has been shown to cause cancer in laboratory animals.
However, those same agencies also contend that once the SV40 contamination was confirmed, no further vaccines were contaminated and no one else was infected. For example, the CDC website notes, “The majority of evidence suggests there is no causal relationship between receipt of SV40-contaminated vaccine and cancer.” That webpage, Shumacher points out, hasn’t been updated for more than two years.
The NCI also seems to be clinging to outdated information. “Over the last four decades, an intensive research effort has been made to determine whether this route of exposure to SV40 has caused health problems in people, including cancer,” the NCI website notes. “Epidemiology studies involving decades of observations in the United States and Europe have failed to detect an increased risk in those likely to have been exposed to the virus.”
But even with a growing body of evidence linking SV40 to cancer, there has been very little public funding in the United States for SV40 research that could lead to cancer therapies. Just as importantly, Bookchin and Schumacher say, no one even knows if SV40 is spreading in the population, or if it is passed from parent to child.
Overseas, there is considerably more open-mindedness about SV40. Researchers in England, Italy, Japan, China and elsewhere have completed more than 90 peer-reviewed studies linking SV40 to at least four different types of human cancer. As Shumacher said last week, U.S. public-health officials’ unwillingness to revisit their own science about SV40 is “unconscionable and disgraceful,” especially since some virologists familiar with SV40 now estimate that as many as one in 10 Americans carries the virus.
Moreover, the U.S. government’s resistance to reopening the case on SV40 may be leaving government scientists behind the curve. Just a few weeks ago, for example, the M.D. Anderson Cancer Center in Houston announced that in a study of tumors removed from people newly diagnosed with non-Hodgkin’s lymphoma, about half showed evidence of SV40. Those researchers believe that SV40 “participates” in the development of the blood cancer, for which there is no other known cause, but whose incidence has doubled in the United States in the last 30 years.
Despite their findings, Bookchin and Schumacher are not blanket opponents of vaccination programs — their own daughter was vaccinated, they admit. “Ultimately, vaccines are critical public-health tools. They absolutely are,” Bookchin says emphatically. “What you want is a situation in which consumers feel they can rely on the judgment of a governmental agency that something is safe.”
She adds, however, “There’s a fear [in government] that if any vaccine is deemed unsafe, in particular the polio vaccine, which is the sacred cow of vaccines… that people may become reluctant or fearful in general about vaccines.”
This view is shared by Barbara Loe Fisher, cofounder and president of the National Vaccine Information Center, a Virginia-based consumer-advocacy group that’s pushing for more funding and research into vaccine safety. Fisher, whose own son was permanently injured by an adverse reaction to the DPT vaccine, was a prime mover behind a 1986 federal law known as the National Childhood Vaccine Injury Act. That legislation created a no-fault compensation system for families whose children have been injured or killed by reactions to vaccines. Since 1990, the program has paid out more than $1 billion to more than 1000 families nationwide.
In a recent phone interview from her home in Virginia, Fisher called The Virus and the Vaccine “a critically important work” that “exposes the true lapses in judgment and cavalier attitudes at the federal level toward vaccine safety in general.” Far too little research has been done, she says, to understand the impact that vaccines have on children’s immature immune systems. Each year, the CDC receives between 12,000 and 14,000 reports of adverse reactions to vaccines, a number, Fisher believes that reflects only a small fraction of the actual incidence. “It’s a tiny drop in the bucket of what’s occurring out there,” she says.
Fisher also argues that vaccines may be at least partly to blame for the dramatic rise in a variety of childhood illnesses and disorders. For example, the rates of learning disabilities, ADHD and childhood asthma in children in the United States have doubled in the last two decades. The rate of diabetes has tripled, and there’s a 200 to 600 percent increase in autism. The latter, some suspect, may be the result of the measles-mumps-rubella vaccine.
The lessons to be learned from The Virus and the Vaccine reach well beyond childhood vaccination programs. After 9/11 the Bush administration, fearing a biological weapons attack, tried to implement a nationwide smallpox vaccination program for all health-care workers. But when tens of thousands of medical professionals refused to subject themselves to the vaccine — saying, in effect, that it posed a greater health hazard than the risk of contracting smallpox in the wild — the program was scuttled.
Similar fears have arisen among U.S. military personnel and their families in light of the health problems experienced by returning Gulf War veterans. “We have talked to scientists who are absolutely convinced that the Gulf War Syndrome is, at least in part, due to the anthrax vaccine, along with 17 other vaccines that were given to soldiers in one day,” says Schumacher.
Meanwhile, deadly new diseases continue to crop up with alarming frequency — West Nile, SARS avian flu — forcing scientists to investigate how all these animal viruses are jumping the species barrier. “That’s why dismissing SV40 out of hand just doesn’t make any scientific sense,” Shumacher says. “Even if it turns out after years and years of good research that the conclusion is that it’s basically okay, given the millions of people who were exposed, why wouldn’t we want to know for sure?”
Polio Vaccine Might Have Carried Virus
NewsMax.com Wires
Wednesday, Sept. 10, 2003
WASHINGTON -- Some of the polio vaccine given to millions of American children from 1962 until 2000 could have been contaminated with a monkey virus that shows up in some cancers, according to documents and testimony to be delivered to a House committee Wednesday. The vaccine manufacturer said such claims "don't have any validity," and the Centers for Disease Control and Prevention agrees.
Some batches of the first polio vaccine used from 1955 until 1962 were contaminated with the monkey virus. The virus has also been found in some cancer in humans, although it has not been determined that the virus caused the cancer. Between 10 and 30 million Americans may have received a contaminated dose of that vaccine, according to the Centers for Disease Control and Prevention.
The monkey virus is suspected of causing cancer in laboratory animals, including brain cancers, bone tumors and a usually fatal cancer in the membranes around the lungs called mesothelioma.
But it has been widely assume that the replacement for the Salk vaccine, a live oral polio vaccine called the Sabin oral vaccine, was free of Simian Virus 40, or SV40. That vaccine was used from 1963 until 2000, when it too was replaced.
Documents set to be delivered to the House Subcommittee on Human Rights and Wellness appear to show that the original "seeds" used to produce the Sabin vaccine could have been tainted with SV40; that the company that manufactured the vaccine, Wyeth Lederle, may have used Rhesus monkeys -- which are more likely to carry the disease -- rather than the African Green monkeys it says it used, according to company documents; and that the company may not have performed all of the screening tests required.
Stanley P. Kops, an attorney who represents clients he says were "paralyzed, killed and-or severely damaged" by the vaccine used until 2000, will present the documents. Kops alleges in his written testimony that the manufacturer and the FDA were negligent and failed to protect children.
"There is a history of negligence involving this vaccine manufacturer and the regulators," Kops says in his written testimony. "The vaccine safety tests were not submitted [to the FDA], the regulators did not look, and infants in the United States became paralyzed or died, and there are now clear instances of cancer reported in the children and individuals who received this product."
A spokesperson for Wyeth Lederle, Natalie de Vane, said Kops is wrong.
No Validity
"These claims don't have any validity," said de Vane. "In response to allegations such as this, the FDA went back and tested batches that were released between 1976 and 1989 and using the most advanced methods of testing available, found no evidence of SV40. We have always conducted extensive screening and testing of our products. The FDA monitors this."
A Food and Drug Administration spokesperson was unaware of the allegations. A CDC fact sheet says that "all of the current evidence indicates that polio vaccines have been free of SV40 since 1963."
Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, will tell the committee that the polio vaccine story is particularly troubling. The center does not accept money from vaccine manufacturers.
"At the hear of this tragic story is a violation of the public trust and the informed consent ethic," Fisher says in her testimony.
Kops says his documents show the following:
-- A decades-old letter from Dr. Albert B. Sabin to Lederle Laboratories saying that the original "seed" used to make the Sabin vaccine may not be free of SV40 contamination. The letter says that Sabin "could not be certain that there may not be a trace of SV40 virus in this material."
Their lawsuit is continuing. More info on that in November, hopefully.
Raphaele says......
"We wish that we could say more at this time, but the information in the 4 page letter is still important for parents. (check out the footnotes) "
******
July 29, 2002
Immunization Safety Review Committee:
Marie McCormick, M.D., Sc.D. (Chair), Ronald Bayer, Ph.D., Alferd Berg, M.D., M.P.H., Rosemary Casey, M.D., Joshua Cohen, Ph.D., Betsy Foxman, Ph.D., Constantine Gatsonis, Ph.D., Steven Goodman, M.D., M.H.S., Ph.D., Ellen (Abby) Horak, M.S.N., Michael Kaback, M.D., Gerald Medoff, M.D., Rebecca Parkin, Ph.D., Bennett Shaywitz, M.D., Christopher Wilson, M.D., Richard B. Johnston, Jr., M.D.
Dear Members of the Immunization Safety Review Committee:
This letter is written regarding the public meeting on SV40 Contamination of Polio Vaccine and Cancer that took place on July 11, 2002 and we ask that it be added to the record.
Our lives were full of joy when on June 7, 1996 our first and only child was born. We named him Alexander Roy Horwin and he grew tall and strong. He could speak French and English by the age of two. He loved the ocean and wanted nothing more than to grow up, go to school, and see the world with his mommy and daddy.
We were a hard working happy family building our future. But everything came apart on August 10th, 1998. On that day, we were told that Alexander had a pediatric brain tumor called medulloblastoma. The next six months became a race against time to try to understand the disease, find the appropriate treatment, and save Alexander. However, despite two operations and three rounds of “state-of-the-art” chemotherapy Alexander died on January 31, 1999, six months after being diagnosed. He was not yet three years old.
After he died, we were told that there was monkey virus in Alexander’s brain called SV40. We visited medical libraries and discovered a vast body of literature on this virus. There were numerous studies performed at reputable universities that demonstrated that the existence of this virus has been known for forty years. Other studies from leading virologists, microbiologists, and pathologists reported how the virus had been found in human cancers, including pediatric brain tumors, using a variety of technologies. In addition, there were literally thousands of articles that described how SV40 was the “gold standard” to transform (i.e. turn malignant) normal human cells in vitro.
Despite this body of knowledge, we discovered that the federal government had decided that SV40 was not a virus that deserved serious concern. Now, your committee has a rare opportunity to change this long-standing position. This opportunity may never present itself again. An objective report from your committee will be a significant step towards defeating this deadly virus.
The Evidence
We ask you to consider the evidence - objectively. Compare SV40 with other known human carcinogens. Consider which human carcinogen can:
A) transform a variety of human somatic cells on contact in vitro;
B) create tumors/cancers in animal models with regularity;
C) be found in the same human cancers that it creates in animals in vivo?
We challenge you to find another known human carcinogen that is as carcinogenic as SV40.
If you are perplexed about the uncertainty of the epidemiology, consider that there is no unexposed cohort. Documents now conclusively prove that SV40 was never removed from the vaccine stocks after 1963. The contaminated oral polio vaccine seeds from Dr. Sabin were so full of SV40 that they were used as the source of SV40 by the early virologists. These SV40 contaminated seeds were never thrown away, but instead have been used to make Oral Polio Vaccine (OPV) for millions of children over the last four decades. Moreover, despite their assertion to the contrary, the manufacturer of OPV continued to use Rhesus Monkeys after 1963 as a substrate for the manufacture of the vaccine.
Err on the Side of Caution
Being a member of this IOM committee comes with a serious responsibility - not to gamble with the public health. That means that you must focus on the ramifications of your decisions and must err on the side of caution. Why is this important? Consider what happens when an authority labels an agent as a carcinogen or pathogen. Serious efforts are made to understand the agent’s etiology and epidemiology. Funding is made available to discover ways to treat individuals who carry the agent. And newer, more rational therapies are employed to attend those who have a disease process related to the agent. If you think the data regarding SV40 and human cancers is not 100% perfect be cautious with what you decide. How many more people will have to die with SV40 positive cancers before the data is flawless?
More rational therapies are needed for SV40 positive cancers right now. For example, there is no orthodox treatment for medulloblastoma in young children. The following quotations come from reputable medical journals:
“[In] medulloblastoma, the most common primary tumor of the CNS [central nervous system] in childhood. . .[t]he role of adjuvant chemotherapy is unclear. . .virtually no cures are reported.” “Aggressive treatment of medulloblastoma, the most common pediatric brain tumor, has not improved survival.” “[T]he absolute benefit of chemotherapy for the treatment of medulloblastoma in childhood is, as yet, not proven.” “The median time to progression [return of the tumor] was 6 months.” “For many years, chemotherapy has been utilized for the treatment of malignant brain tumors with minimal success.” “The outcome for the majority of children with malignant brain tumors remains poor, despite surgery, irradiation and conventional chemotherapy.”
Various studies have found that medulloblastoma can contain SV40. Moreover, the biological mechanisms of SV40’s oncogenic potential is well understood - the virus binds to p53 and RB. As you know p53 is a tumor suppressor gene. It drives a damaged cell towards apoptosis. As you may also know, cytotoxic cancer therapies (i.e. radiation and chemo) rely on an intact tumor suppressor system because these agents cause point mutations, strand breaks, and other disturbances to a cell’s DNA. Without a working p53 gene, chemo and radiation do nothing more than to take a transformed cell and create more mutations. However, children are only permitted to be treated with surgery, chemo and radiation. Greater focus on the role of SV40 in these cancers will lead to more rationale therapies. This is another example of the type of progress your committee can facilitate right now.
The Role of the Federal Government
Given all that we already know about SV40, why does the federal government report the virus is not yet a serious concern? Why has the federal government refused to spend $.01 to investigate why a monkey virus that is considered the “gold standard” in creating human cancers in vitro (including brain cancers) is often found in pediatric brain tumors? The rhetoric from government scientists at the 1997 SV40 Conference in Bethesda is the same rhetoric from these same scientists at the IOM Committee meeting on July 11, 2002. In the intervening five years how many children have died of SV40 positive cancers? How much farther has SV40 spread throughout the U.S. and the world?
The federal government has ostensibly mandated a product (OPV) for consumption by millions of American children for forty years. During these four decades, the federal government was in charge of ensuring the safety of this vaccine. But, it was misled by at least one vaccine manufacturer. A product the government thought was pure and safe was contaminated and potentially deadly. Now, the government is faced with potential embarrassment and liability resulting from this deception.
Each one of you has been chosen to participate in this committee because of your outstanding scientific achievements. But, most of you owe your careers to some extent to the funding you have received from the federal government. As recipients of tax money, you can demonstrate that scientists who receive NIH funding act responsibly and independently despite the less than stellar record of the government’s earlier decisions. In addition, most of the universities that each of you are affiliated with receive substantial contributions and grants from vaccine manufacturers including the corporation responsible for the contaminated OPV. An objective and unbiased investigation from your committee will proclaim to the American people that decisions that affect millions of lives especially children’s lives are not for sale.
Conclusion
Our son, Alexander was not the first child to die from a SV40 positive brain cancer and, unfortunately, he was not the last. SV40 concerns all children, yours included. Do your children or grandchildren harbor SV40 in their blood? Is there a deadly tumor that will be born out of the joining of a SV40 virion and a cell somewhere in their body? What happens if they were diagnosed with a SV40 positive cancer? Statistically, there is no cure. And, unfortunately, the probability of such an occurrence is increasing. Cancer is now the leading cause of death by disease in children and pediatric brain tumors have been increasing steadily at a rate of about 3% a year. As you reflect on your roles as vanguards of the public health, consider also your own children and your children’s children.
History will judge the wisdom of your decisions.
Sincerely,
Michael Horwin M.A., J.D. Raphaele Horwin M.A., MFS
Alexander
More from his father:
http://www.mindspring.com/~chiroken/health_news.htm Editorial Reply Re: Congressional Hearings on Vaccines and Autism
Mandating Vaccines: Government Practicing Medicine Without a License?
Editorial Reply Re: Congressional Hearings on Vaccines and Autism
- GCN - NEWS @ 8:31 am PST
From: Dawn Richardson PROVE
This is a phenomenal letter written by a parent of a vaccine injured child in response to an editorial comment published on WebMD. It clearly illustrates the incestuous ties some of those who make vaccine decisions for our children have with drug companies. These are the very people who are critical of the parents and elected representatives who are doing such a great job shedding light on some of the dangers of vaccines because of the threat the truth poses to their pocketbooks. The internet (source of all this information) is a wonderful thing.
In Reply to Editorial Comment from: Wayne L. Pines Re: Congressional Hearings on Vaccines and Autism
Wayne L. Pines, you belittle Congressman Burton as an "angry grandfather" when his goal is to make vaccines safer for children. Your feeble attempt to undermine Congressman Burton's efforts made sense only after your ties to the vaccine manufacturers and drug companies were revealed. This is a day in your life Wayne L. Pines. Let's see who you really are and then people will understand that your words are meaningless because they are motivated by avarice.
You started your career in Washington as the associate editor for The Pink Sheet a pharmaceutical trade magazine. Then you went to work at the FDA for 10 years from 1972 to 1982. Your next job was with the PR firm Burson-Marsteller. After that, you got a job with APCO Associates. Then you joined a company called Therametrix (1). In between you became involved with various pharmaceutical trade groups such as the Food and Drug Law Institute (2), the Drug Information Association (3), and the Internet Healthcare Coalition (4).
Now let's start connecting the dots to see why you would not want a public discussion about how to improve the safety of our children's vaccines. We'll pick-up your career after you leave the FDA. You immediately landed a job with the PR firm Burson-Marsteller (a subsidiary of the advertising agency Young & Rubicam). Your title there was executive vice president. Marsteller clients include Monsanto and their bio-engineere foods and Dow-Corning and their silicon breast implants. In addition, Marsteller has several large drug companies as clients including Eli Lilly. Lilly produces the drug Prozac which has accumulated more adverse reaction reports than any substance (besides vaccines) in the history of the FDA's adverse drug reporting system. Documents released under the Freedom of Information Act challenged the veracity of Prozac's clinical trials that led to FDA approval. Lilly's PR firm Burson-Marsteller was called in to do damage control. There, according to the Campaign Against Fraudulent Medical Research, it was reported that you helped Lilly get past its troubles by exploiting your contacts with current FDA officials (5).
You then became president of the Health Care Practice of APCO Associates a "communications consulting firm." According to PR Watch, APCO Associates specializes in setting up front groups and coalitions for the tobacco and insurance companies (6). In fact, APCO's website boasts that "excellence in public affairs and public relations, like excellence in art, is about the power of communication" (7). No it's not. Excellence in public affairs is about honest communication and adding substance to the public discourse. It's what Congressman Burton is doing. It's not about ridiculous, crude and poorly veiled attempts to protect and further your client base. You may think excellence in public affairs and public relations is about power, but power won't help you when it comes to our children. As much as it may disturb your plans, parents will not sacrifice the health and lives of their children in order to drive up the stock prices of your drug company clients.
Next you joined Therametrix whose website gloats that "Wayne L.Pines is a world-renowned health care consultant (who) has consulted for virtually all of the major pharmaceutical companies..."(1). It also states that Therametrix is a "medical marketing research agency that serves the pharmaceutical, biotechnology, medical device and consumer health products industries" (8). Your clients are listed as including: Abbot Laboratories, Bayer, Bristol-Myers Squibb, Du Pont
Pharmaceuticals, Eli Lilly, Glaxo Wellcome, Novartis
Pharmaceuticals, Pharacia & Upjohn, Procter & Gamble
Pharmaceuticals, Roche Laboratories, Schering-Plough, Triangle
Pharmaceuticals and Warner Lambert - all of them drug and vaccine
manufacturers (9). Your company's mission statement declares, "We see nothing more important than meeting our client's needs" (9). I don't doubt it.
You are also on the marketing and advertising committee of the Drug Information Association which describes itself as a "member-driven scientific association with a membership of over 22,000 primarily from the regulatory agencies, academia, contract service organizations, pharmaceutical, biological and device industry, and from other health care organizations" (10). Who are some of the
other committee members in the Drug Information Association? They include Dr. R. Venkataraghaven of Lederle Laboratories (3)manufacturer of Orimune, Tetramune and other vaccines, Dr. Elizabeth B. D'Angelo of AstraZeneca (3), and Dr. John F. Bedard of Bristol-Myers Squibb (3). The board of directors include Stuart W. Cummings of Merck, Sharp & Dohme manufacturer of the vaccines associated with autism - MMR, MR Vax, Meruvax II, Mumpsvax, Varivax and others, Francoise de Cremiers of Wyeth-Ayerst another major vaccine manufacturer, Charles C. Depew of SmithKline Beecham, Brenton James of Glaxo Wellcome, Murray Lumpkin of the FDA, and Irwin G. Martin of Parke-Davis (11).
In addition, you are a member of the Food and Drug Law Institute which describes itself "as a private organization, not affiliated with the FDA.(but our) mission, however, does relate to the activities, policies and procedures of the FDA..."(12). As a participant in this institute you work with the other members, and in fact, you are scheduled to moderate one of the institute's conferences on medical technology, drugs and biologics (i.e. vaccines) in June of this year (2). Nearly every drug company including the major vaccine manufacturers is a member of this organization. The list includes: American Home Products (i.e.Lederle), Bayer, Medeva Pharmaceuticals, Merck & Co., Organon Teknika, and SmithKline Beecham.
I could go on and on about your affiliations with vaccine manufacturers and drug companies but I believe the point has been made ad nauseam.
One of Congressman Burton's assertions is that an inherent conflict of interest may exist amongst the people who decide what gets injected into our children's veins. The Congressman understands that many of the individuals in our halls of government who make health decisions affecting our children get money from the very drug companies they are supposed to be regulating. During the hearings, when Coleen Boyle of the CDC was asked if she thought there was anything wrong with such a conflict she was literally speechless. Wayne L. Pines your behavior is a text book example of what Congressman Burton and tens of thousands of parents disdain.
As a former employee of the FDA you use your clout to influence what should be a scientifically sound, reasonable and objective decision making process. But even with all of your industry's money and consultants and PR firms and communication experts and doctors on payrolls you are still missing one key ingredient - the truth. The truth can't be bought, spun, manipulated, or turned into a sound bite. Parents know the truth when they watch their children become ill, disabled and die. So despite your supreme efforts to sell more vaccines, we will not allow some greedy industry to decide what is safe and to dictate to us what should be put into our children's bodies.
Wayne L. Pines go back to your "medical marketing research agency" and your "communications consulting firm," shut up, and leave our children alone.
Sincerely,
Michael Horwin Father of Alexander - a vaccine injured child who passed away at the age of 2 ½ years old
Footnotes:
1) http://www.therametrix.com/staff.html
http://www.therametrix.com/wayne.html
2) http://www.fdli.org/conf/medsymagd.htm
3) http://www.diahome.org/dhp2d12.htm
4) http://www.ihealthcoalition.org/content/fda_1.html
5) http://www.pnc.com.au/~cafmr/newsl/prozac.html
6) http://www.prwatch.org/prw_issues/1996-Q3/index.html
7) http://www.apcoassoc.com/gallery/gallery.html
8) http://www.therametrix.com/company.html
9) http://www.therametrix.com/clients.html
10) http://www.diahome.org/
11) http://www.diahome.org/dhp2c.htm
12) http://www.fdli.org/about/index.html
VITAL info here as MUCH cannot be revealed as court required gag June 7, 2003 - ALL TO BE SECRET
Child who was born in 1996 - did not have SV40 in cord blood but did later after vaccine and parents do not have
But you can figure out much from below...........still contaminated vaccine
They lost their case due to the judge and he defendant asked for and was granted a Protective Order. As a result, all of its production documents cannot be quoted directly or shared with Congress, the media, or health authorities. However, our motions and pleadings are in the Court Record and have not been put under a Protective Order. Therefore, we are able to cite our own arguments set-out in these papers. We believe this Protective Order should be lifted because public health interests should take precedence over the interests of pharmaceutical companies
*******
Letter sent to The Honorable Dan Burton, Chairman of the House Government Reform Subcommittee on Human Right and Wellness, to Demand a Congressional Investigation and Hearing on the Introduction of Simian Virus 40 (SV40), a Cancer-Causing Monkey Virus, into the American Population From Contaminated Polio Vaccines
1. 2 issues here - SV40 in polio vaccine found in Alexander's tumor (it was not in his cord blood & parents did not have so did not inherit from them). He got polio vaccine (see point by point below)
2. An SV40 positive cancer means that chemo and radiation will be ineffective and they did not know this & accepted this type of treatment for Alexander.......and not allowed the treatment they wanted. - the FDA would not allow our son to have access to a non-toxic cancer therapy that offered him the best chance of saving his life.
SV40 is not only responsible for causing the cancer, but also for making these particular cancers incurable. Orthodox cancer therapies such as chemotherapy and radiation can not cure an SV40 positive cancer. Pediatric brain cancers and other solid cancers have been found to contain SV40. SV40 binds with the tumor suppressor genes p53 and RB and stops tumor cells from undergoing apoptosis (programmed cell death). Apoptosis is what radiation and chemo depend on to work in order to trigger the cancer cell to die. Exposing SV40 positive cancer cells to chemo and radiation does not kill the cells but simply creates more genetic mutations - making the cancer more aggressive. The bottom-line is that SV40 causes human cancer, stops orthodox cancer therapies (i.e. chemo and radiation) from providing any benefit, and can make the cancer even more aggressive.
http://www.ouralexander.org/BurtonSV40%20Letter%20(2003).doc
June 7, 2003
The Honorable Dan Burton
Chairman of the House Government Reform
Subcommittee on Human Rights and Wellness
U.S. House of Representatives
2157 Rayburn House Office Building
Washington, DC 20515
By Facsimile
Letter to Demand a Congressional Investigation and Hearing on the Introduction of Simian Virus 40 (SV40), a Cancer-Causing Monkey Virus, into the American Population From Contaminated Polio Vaccines
Dear Representative Burton:
I am writing this letter on June 7, 2003. Exactly seven years ago, on June 7, 1996, my son Alexander was born. He would die in my arms 30 months later in a little motel room in Houston, Texas as we, his parents, tried desperately to safe his life. This letter is written in commemoration of Alexander's short life and the injustice that befell him and the cause of the brain tumor (medulloblastoma) that killed him.
This letter is also the result of four long years of struggle by myself and my husband to find out why our beautiful healthy young son would be stricken by cancer. Now, our lawsuit against the manufacturer of the oral polio vaccine, American Home Products, (i.e. Lederle), has come to a close.
As a result, much of the information that has been under a protective order for over three years has been entered into the public record through our legal documents filed with the Federal Court for the Central District of California in Los Angeles. What happened to Alexander is not an isolated event. We contend that his death was caused by a Public Health Disaster that has befallen others and will continue to kill children until it is addressed.
On August 12, 1999, we wrote you when you where Chairman of the Committee on House Government Reform in support of your investigations into pediatric vaccines - Vaccines; Finding the Balance Between Public Safety and Personal Choice. In this letter we described how various childhood vaccines contain known carcinogens and yet not a single vaccine is tested for carcinogenicity. While shampoos and cosmetics are tested to see if they cause cancer, incredibly, biological substances that are squirted or injected into healthy infants and children have never been tested.
On June 7, 2000, My husband and I also appeared before your Committee to discuss the FDA's control of effective non-toxic pediatric cancer therapies in Cancer Care for The New Millenium - Integrative Oncology. During our sworn testimony we described how Alexander suffered enormously and unnecessarily as a result of the administration of four toxic but ineffective chemotherapy drugs (vincristine, cytoxan, etoposide, and cisplatin - Protocol CCG 9921). We described how the FDA would not allow our son to have access to a non-toxic cancer therapy that offered him the best chance of saving his life. We presented photographs to your Committee that demonstrated how Alexander struggled to stay alive and then suffered a horrific death.
From your own considerable effort in investigating vaccine production, testing, and safety you know that childhood vaccines contain formaldehyde (i.e. formalin), mercury (i.e. thimerosal), aluminum, and other toxic substances. In addition, vaccines can also contain animal viruses - contaminants from the animal substrates upon which the vaccines are manufactured. One of these viruses, a monkey virus called Simian Virus 40 is carcinogenic and found its way into the oral polio vaccine (OPV) and the inactivated polio vaccine (IPV) in the late 1950's and early 1960's. Such an event was not surprising because monkey kidneys contain a multitude of simian viruses and the polio vaccine is grown on monkey kidney cells.
The oral polio vaccine is a "live" trivalent vaccine which means that it contains three strains of poliovirus - Types I, II, and III, and each strain is attenuated (i.e. weakened). Dr. Albert Sabin, who was responsible for the creation of the licensed OPV, had to passage his poliovirus strains through a myriad of animals and animal host cells in order to attain the right virulence-strong enough to illicit an immune response, but sufficiently attenuated so as to not cause polio in the recipient. For example, Type I has the following lineage:
In 1941, Drs. Francis and Mack isolated the Mahoney poliovirus "from the pooled feces of three healthy children in Cleveland." Dr. Salk then passed this strain through fourteen living monkeys and two cultures of monkey testicular cultures. In 1954, the strain (now called Monk14 T2) was given to Drs. Li and Schaeffer who subjected the virus to nine more passages through monkey testicular cultures. Next, the strain (now called Monk14 T11) underwent fifteen more passages in monkey testicular cultures, eighteen passages in monkey kidney cells, two passages through living rhesus monkeys skin, and additional passages through African Green monkey skin and monkey kidney cell cultures. This strain was now called MS10 T43 and LS-c. In 1956, Dr. Sabin took this virus and passaged it through seven cultures of African Green Monkey kidney cells. That same year, the pharmaceutical company, Merck, Sharp & Dohme, passed the strain (now called LS-c, 2ab/KP2) through a rhesus monkey kidney cell culture. The resulting material was called Sabin Original Merck (SOM) and was provided to Lederle in 1960 as the seed material to manufacture its polio vaccine.
Types II and III were created in a similar fashion.
Once the strains were isolated, the pharmaceutical companies needed a method to propagate the viruses in order to produce the vast quantities of vaccine needed for nation-wide immunization campaigns. This required a substrate upon which the poliovirus could be efficiently grown and harvested. Kidney cells from rhesus monkeys were chosen because they were found to be an effective growth medium. A small quantity of poliovirus could be added to the minced kidneys removed from these monkeys and within a few days, large quantities of poliovirus could then be harvested from these same monkey cells.
Between 1959 and 1960, Bernice Eddy, Ph.D., of the National Institute of Health (NIH) examined minced rhesus monkey kidney cells under a microscope. These were the cells of the same species of monkeys used to create and produce the oral polio vaccine. Dr. Eddy discovered that the cells would die without any apparent cause. She then took suspensions of the cellular material from these kidney cell cultures and injected them into hamsters. Cancers grew in the hamsters. Within a few months, the virus responsible for creating these cancers would be isolated and identified by Dr. Eddy and other scientists. Because it was the 40th simian virus found it was named simian virus 40 (SV40).
According to the FDA:
The discovery in 1960 that a DNA tumor virus, designated simian virus 40 (SV40), was an inadvertent contaminant of rhesus monkey cells, and consequently the poliovirus and adenovirus vaccines that were made in these cells, was a watershed event in vaccine development…"
By 1960, the Salk injectable polio vaccine (IPV) had been administered to about 98 million American children and adults, and Sabin's oral polio vaccine (OPV) had been administered to about 10,000 Americans and millions in the USSR where the clinical trials had been conducted. It was estimated that 10% to 30% of the vaccines contained live SV40. The federal agency in charge of vaccine licensing and safety at the time was the Division of Biologics Standards (DBS) of the National Institute of Health (NIH). Incredibly, this agency did not order a recall of any of the SV40-contaminated vaccines. The tainted vaccines continued to be administered until 1963 when they were all used and replaced by allegedly SV40-free vaccines as required by the new federal regulations promulgated in 1961.
In 1961, federal regulations were implemented to ensure that SV40 would no longer contaminate the polio vaccine. Despite these regulations, we contend that the OPV has been sporadically contaminated with SV40 for the last four decades. As a result, we allege that some of the children who have been administered the contaminated vaccines have been stricken with cancer and others are at risk. The main points are summarized below:
1) SV40 (Simian Virus Number 40) is a cancer causing monkey virus found in the kidney cells of Rhesus and African Green Monkeys. The kidney cells of these two species of monkeys comprise the substrate that has been used to create poliovirus strains and manufacture the oral polio vaccine for four decades.
2) SV40 is a human carcinogen for brain cancer and mesothelioma and it is a suspected carcinogen in osteosarcomas (bone cancers) and Non-Hodgkin's Lymphomas.
3) Alexander was administered the OPV in November 1997. He was diagnosed with a brain tumor in August 1998. Alexander died on January 31, 1999. 4) Four independent laboratories using DNA testing and laser micro-dissection found SV40 in Alexander's brain tumor.
5) SV40 has been found in the cancers of many other children. Pediatric brain tumors and other childhood cancers including osteosarcomas (bone cancer) and Non-Hodgkins Lymphomas have been found to contain SV40.
6) When Alexander was born on June 7th, 1996, I had his cord blood saved and stored by a private laboratory. The cord blood was the blood shared by Alexander and myself at the time of Alexander's birth. We had this blood tested for SV40. This marked the very first time the cord blood of a child
with an SV40 positive brain tumor would be tested for SV40. To the astonishment of the scientists it was negative for SV40. This suggested that at the time Alexander was born he had not been exposed to SV40.
7) It is known that SV40 can be spread through contaminated blood so my husband and myself underwent a battery of tests from 2000 to 2001. Using a variety of sophisticated DNA tests to isolate the genetic fingerprint of the SV40 virus including Polymerase Chain Reaction (PCR), the scientists checked blood, urine and semen multiple times looking for any trace of SV40 (even antibodies). The scientists were once again surprised. Despite the repeated tests by leading SV40 laboratories both in the United States and Europe, we had absolutely no trace of SV40.
8) The scientists concluded that Alexander did not get SV40 from his parents, nor did he give SV40 to us.
9) The original oral polio vaccine (OPV) seed stocks created by Dr. Albert Sabin and used to make OPV since 1961 were known to be contaminated with SV40. In fact, SV40 was isolated from Sabin's OPV seeds - the original material used to make OPV for four decades.
10) Dr. Sabin had admitted that OPV seeds were contaminated with SV40 in a peer-reviewed scientific publication. Dr. Sabin wrote, "The three types of the large lots produced by Merck, Sharp and Dohme in rhesus monkey kidney cell cultures contained SV40."
11) Lederle, the sole American manufacturer of OPV for many years, received their OPV seeds from Merck, Sharp and Dohme. There is no evidence that Lederle ever tested their seeds for SV40 nor discarded their presumably contaminated seed stocks.
12) There are Lederle documents (not under a protective order) that demonstrate that their early OPV vaccines were contaminated with SV40.
13) Lederle did not use the SV40-neutralization procedures recommended by Dr. Sabin.
14) Monkeys used to produce OPV were not tested for SV40 by Lederle because of economic considerations.
15) After reviewing all of the Lederle records and the Lederle systems in place, our expert concluded that the contamination detected in the OPV material ultimately administered to Alexander was SV40.
16) The medical literature is unequivocal - the pediatric brain cancer rate in the U.S. has been climbing at a rate of approximately 3% for the last four decades.
17) A recent study has demonstrated that 11% of Americans are currently infected or have been infected with SV40.
SV40 is not only responsible for causing the cancer, but also for making these particular cancers incurable. Orthodox cancer therapies such as chemotherapy and radiation can not cure an SV40 positive cancer. Pediatric brain cancers and other solid cancers have been found to contain SV40.
SV40 binds with the tumor suppressor genes p53 and RB and stops tumor cells from undergoing apoptosis (programmed cell death). Apoptosis is what radiation and chemo depend on to work in order to trigger the cancer cell to die. Exposing SV40 positive cancer cells to chemo and radiation does not kill the cells but simply creates more genetic mutations - making the cancer more aggressive. The bottom-line is that SV40 causes human cancer, stops orthodox cancer therapies (i.e. chemo and radiation) from providing any benefit, and can make the cancer even more aggressive.
Despite these facts, children diagnosed with cancer are not given a choice of whether they should undergo debilitating and toxic chemo and radiation. Alexander should have been tested for SV40 upon his diagnosis, not after he died. He should not have been administered ineffective and unnecessary chemotherapy which provided no benefit and only made him suffer. Children with SV40 positive cancers (or p53 mutations) should not be used as guinea pigs and profit centers for pediatric oncologists, hospitals, and pharmaceutical companies.
A Congressional Hearing should be immediately convened to examine how a federally policed vaccine program has introduced a deadly monkey virus into countless American men, women and children for the past 45 years and what the public health consequences have been of this tragedy.
This government investigation should demand to know:
· Why a vaccine manufacturer was allowed to use vaccine seed stocks for four decades that came from a source contaminated with SV40? · Why did this manufacturer violate federal regulations and allowed contaminated vaccines to be released? · Why weren't sophisticated tests to detect SV40 during OPV production and to eliminate the virus ever required by the federal government? · Why aren't children with cancer tested for SV40 when they are diagnosed, not when they are dead, because an SV40 positive cancer means that chemo and radiation will be ineffective? · Why is there a significant percentage of Americans (children and adults) walking around with evidence of having had an SV40 infection and what does that mean for their risk of cancer and chances for a successful treatment?
Like our son, many children are already dead, victims of this virus, and many adults will be stricken later. Time is of the essence, not for our beloved Alexander anymore, but for other children who are infected with this cancer causing virus.
Sincerely,
Raphaele Moreau-Horwin M.A., M.F.S. Michael
Horwin, M.A., J.D.
www.ouralexander.org
Footnotes
1 The case was Horwin v. American Home Products, American Cyanamid Company, Lederle Laboratories, Case No. CV00-04523 WJR (EX), United States District Court for the Central District of California originally filed on January 31, 2000. The District Court Judge decided that the testimony of the plaintiffs' experts on the issue of whether SV40 caused Alexander's tumor was admissible under the Daubert standard. (United States District Court Central District of California Tentative Ruling Case No. CV00-04523 WJR (EX), Daubert Motion, Thursday May 8, 2003.) Nonetheless, the judge excluded critical evidence related to the source of SV40 because it believed that it could require that all exhibits used to qualify a witness under Daubert be identified in a FRCP Rule 26(a)(2) disclosure. After excluding critical evidence, the court decided that since there was no
direct evidence that the dose of Orimune administered to Alexander was contaminated that the expert's opinion was inadmissible under Daubert. As a result, the judge granted the defendant's (Lederle's) motion for summary judgement.
2 The defendant asked for and was granted a Protective Order. As a result, all of its production documents cannot be quoted directly or shared with Congress, the media, or health authorities. However, our motions and pleadings are in the Court Record and have not been put under a Protective Order. Therefore, we are able to cite our own arguments set-out in these papers. We believe this Protective Order should be lifted because public health interests should take precedence over the interests of pharmaceutical companies
3 Passage is defined as the introduction of infectious material into an experimental animal or culture medium followed by recovery of the infectious agent. Dorland's Medical Dictionary, 25th edition, page 1146. 4 A.B. Sabin, A.B. & L. Boulger, History of Sabin Attenuated Poliovirus Oral Live Vaccine Strains. 1 J. BIOL. STAND. 115, 115-18 (1973). The Mahoney virus was isolated in 1941 by Drs. Fancis and Mack.
5 Id.
6 Id.
7 Id
8 Id
9 Id
10 Id.
11 M.R. Hilleman, Discovery of Simian Virus (SV40) and its Relationship to Poliomyelitis Virus Vaccines, in SIMIAN VIRUS 40 (SV40): A POSSIBLE HUMAN POLYOMAVIRUS, 94 DEV. BIOL. STAND. 183-90 (F. Brown & A.M. Lewis eds., 1998).
12 Bernice E. Eddy, Tumors Produced in Hamsters by SV40, 21 FED'N PROC 930, 930-35 (1962) [hereinafter Eddy I]; Bernice E. Eddy et al., Identification of the Oncogenic Substance in Rhesus Monkey Kidney Cell Cultures as Simian Virus 40, 17 VIROLOGY 65-75 (1962) [hereinafter Eddy et
al. II]; EDWARD SHORTER, THE HEALTH CENTURY 195-99 (1987).
13 Eddy I, supra note 34, at 930; Eddy et al. II, supra note 34, at 65.
14 Simian Virus 40 (SV40): A Possible Human Polyomavirus, Developments in Biological Standardization Vol. 94, 1998.
15 INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES, IMMUNIZATION SAFETY REVIEW: SV40 CONTAMINATION OF POLIO VACCINE AND CANCER 4, 21 (Kathleen Stratton et al. eds., 2002), http://www.nap.edu/books/0309086108/html (last visited May 26, 2003) [hereinafter IMMUNIZATION SAFETY REVIEW].
16 Id.
17 National Institutes of Health (NIH) Division of Biologics Standards (DBS) was a forerunner of today's Center for Biologics Evaluation and Research (CBER). Paul Parkman, Harry Meyer, Jr., MD Lecture, CBER Centennial-Slide Presentation (Sept. 23-24, 2002), at http://www.fda.gov/cber/summaries/cent092302pp.htm (last visited May 26,
2003). "The transfer of DBS to the Food and Drug Administration took place in 1972." Id. The DBS became the FDA's Bureau of Biologics (BoB). Id. "Later incarnations of this organization included the Center for Drugs and Biologics (CDB) and finally, the present day Center for Biologics
Evaluation and Research (CBER)." Id.
18 Immunization Safety Review, supra note 45, at 21.
19 Id.
20 A.B. Sabin, A.B. & L. Boulger, History of Sabin Attenuated Poliovirus Oral Live Vaccine Strains. 1 J. Biol. Stand. 115, 115-18 (1973).
21Adi F. Gazdar et al., SV40 and Human Tumours: Myth, Association or Causality?, 2 Nat. Rev. Cancer 957, 957-64 (2002). In addition, in July 2002, the National Academy of Science Institute of
Medicine (IOM) Immunization Safety Committee convened a study into SV40 and cancer which culminated in a report published in October 2002. According to the IOM report "SV40 Contamination of Polio Vaccine and Cancer": The committee concludes that the biological evidence is strong that SV40 is a transforming [i.e., cancer-causing] virus, . . . that the biological evidence is of moderate strength that SV40 exposure could lead to cancer in humans under natural conditions, [and] that the biological evidence is of moderate strength that SV40 exposure from the polio vaccine is related to SV40 infection in humans. See Immunization Safety Review: SV40 Contamination of Polio Vaccine and Cancer.
22John A. Lednicky and Janet S. Butel, Simian virus 40 regulatory region structural diversity and the association of viral archetypal regulatory regions with human brain tumors, Semin Cancer Biol. 2001 Feb;11(1):39-47. Bharat Jasani, et al., Association of SV40 with human tumours, Semin Cancer Biol. 2001 Feb;11(1):49-61.
23 See Sara Stinebaugh and Joseph Melnick, Plaque Formation by Vacuolating Virus SV40, Virology Vol. 16, March 1962 ("The strain of virus (SV40) used was isolated from Sabin's lot of type 2 oral poliomyelitis vaccine . . . ."); Asaria Ashkenazi and Joseph L. Melnick, Induced Latent Infection of Monkeys with Vacuolating SV40 Papova Virus: Virus in Kidneys and Urine, Proceedings of the Society for Experimental Biology and Medicine, Vol. 111, October-December 1962 ("The [SV40] virus used was isolated from Sabin's seed stock of type 3 oral polio-vaccine. . . .")
24A.B. Sabin, A.B. & L. Boulger, History of Sabin Attenuated Poliovirus Oral Live Vaccine Strains. 1 J. BIOL. STAND. 115, 115-18 (1973).
25 Id.
26 These documents are attached as exhibits to the Declaration of Stanley P. Kops in Support of Plaintiff's Motion For Reconsideration (Case No. CV-00-04523 WJR (Ex) Pending in the U.S. District Court for the Central District of California.)
27 Declaration of Stanley P. Kops in Support of Plaintiff's Motion For Reconsideration (Case No. CV-00-04523 WJR (Ex) Pending in the U.S. District Court for the Central District of California.)
28 From Brown v. Lederle; Civil Action 73-1920. Deposition of Dr. Ronald Vallancourt of July 24, 1975. Dr. Vallancourt, the responsible head of American Cyanamid, testified that the reason for the lack of testing of the monkey sera for SV40 was based on economic considerations. 29 Declaration of Stanley P. Kops in Support of Plaintiff's Motion For Reconsideration (Case No. CV-00-04523 WJR (Ex) Pending in the U.S. District Court for the Central District of California.)
30 D.E. Rollison, et al., Serum Antibodies to JC Virus, BK Virus, Simian Virus 40, and the Risk of Incident Adult Astrocytic Brain Tumors, Cancer Epidemiol Biomarkers Prev. 2003 May;12(5):460-3.
31 S.D. Conzen, et al, Identification of a novel antiapoptotic functional domain in simian virus 40 large T antigen, J Virol. 1997 Jun;71(6):4536-43; J.W. Ludlow, Interactions between SV40 large-tumor antigen and the growth suppressor proteins pRB and p53,FASEB J. 1993 Jul;7(10):866-71; Michele Carbone, et al., The pathogenesis of mesothelioma, Semin Oncol. 2002 Feb;29(1):2-17.
32 THE CHEMOTHERAPY SOURCE BOOK 4 (Michael C. Perry ed., 3d ed. 2001). One tumor gene in particular, p53 is designed to kill cells through apoptosis or "cell suicide" so that mutated cells to not lead to cancer through uncontrolled multiplication and metastasis. Chemotherapy and
radiation depend, to a large degree, on p53. Id.
Following is the transcript of Savini's report, "Vaccine Virus."
Dave Savini: At age two and a half, Stacey Girardi and Tim Brennan battled the same brain cancer -- an ependymoma. Both had tumors removed. Years later, Tim is doing well.
(Addressing Tim) You feel good now?
Tim: Yeah.
Savini: But part of Stacey's tumor remains, and she suffers from side effects.
Stacey: Made me lose the back of my hair and my hearing.
Savini: Mark Moreno had the same kind of tumor removed when he was two and a half years old, too. His surgery left him permanently disabled, and he now wears a helmet to protect his head. What connects these three people is a fear over what was found in Moreno's case, inside his tumor: a virus typically not found in humans but in monkeys -- Simian Virus 40 or SV-40.
It's a virus that's also been found in a contaminated vaccine: the polio vaccine. Scientists used monkeys to grow the polio vaccine in the late 1950s and early 1960s. They later learned the monkeys were infected with SV40, and an unknown number of people were given the vaccine that contained the virus.
(Addressing a physician) You believe SV40 causes cancer?
Dr. Michele Carbone (Loyola Medical Center): SV40 is a virus that is capable of causing cancer.
Savini: Mark Moreno's SV40 was found when his tumor was tested for it. That type of testing is uncommon, and neither Stacey nor Tim's tumors were tested. But their parents want to know if that's what caused their rare cancers, and they want the government to fund more studies.
Melony Girardi (Stacey's Mother): If they are indeed doing research on ependymomas and finding that there is SV40 in them, everyone diagnosed with ependymoma -- their tumor, their specimen of that tumor should be tested.
Eileen Brennan (son had cancer): I don't understand why they won't unless somewhere out there somebody is trying to cover something up.
Savini: There is now growing concern that the polio vaccine that was given to millions may also have exposed people to cancer. Dozens of medical research studies are now confirming the link between the monkey virus and some tumors. There's new concern that the virus can spread, but researchers are not sure how. Meanwhile, lawsuits are being filed claiming that more recent polio vaccines have been infected with the same virus.
Stacey and Tim were too young to have received the original batch of contaminated vaccine.
The same is true for Moreno, who lives in New Jersey. So how did he get infected? Moreno's mother filed a lawsuit claiming that later versions of the polio vaccine also were contaminated. Their lawsuit claims that drug manufacturers did not get rid of the SV40 when the government ordered it (to be done) in 1961.
Loyola doctors Michele Carbone and John Lednicky, both of Loyola Medical Center, have been researching SV40 for years. They fear young people are testing positive for SV40 because, somehow, the virus is spreading. One discovery that leads them to believe this is that, in 1997, Carbone tested an unused vial of the 40-year-old tainted polio vaccine. It was the only one known to exist, and it tested positive for SV40.
An identical strain of SV40 was found in tumors of non-Hodgkins Lymphoma patients, in Texas. All the patients were too young to have received the originally contaminated vaccines from teh 1950s and early 1960s.
Carbone: At least some of the virus came from the vaccine, yes, no question.
Lednicky: Some people would say that it was a smoking gun.
Savini: It's a smoking gun to researchers who are trying to find out if the virus is spreading, and how. Is it spread from a parents who were vaccinated to their children? Or is it spread from person to person?
Researchers are hoping for more funding to study this, along with SV40's link to cancer.
Melony Girardi: It needs to be stopped. It needs to be checked.
Savini: It's important to know that even if you have SV40 in your system, that does not mean you will get cancer -- just like so many of us spend time in the sun but never get skin cancer.
SV40 experts, including Dr. Carbone, say that the benefits of the polio vaccine far outweight any potential risks, and even he made sure he was vaccinated.
With regards to the lawsuits, at least four have been filed.
Drug manufacturers and some medical researchers say the polio vaccine has been free of the monkey virus for decades, and that includes the vaccine on the market today. Today the polio vaccine is tested to ensure it is free of the virus. But the link between the virus and tumors remains a medical mystery, and many researchers are urging that more funding be provided to study SV40.
http://www.eurekalert.org/pub_releases/2002-12/jotn-etc122002.php
Public release date: 31-Dec-2002
Contact: Linda Wang
jncimedia@oupjournals.org
301-841-1287
Journal of the National Cancer Institute
Exposure to contaminated poliovirus vaccine not likely linked to rare cancer
The poliovirus vaccine used in mass immunization programs in the late 1950s and early 1960s was contaminated with the monkey virus SV40, which has been detected in some human tumors, particularly pleural mesothelioma. However, the rise in incidence of pleural mesothelioma between 1975 and 1997 is not likely the result of immunization with the SV40-contaminated vaccine, according to an analysis in the January 1 issue of the Journal of the National Cancer Institute.
SV40, or simian virus 40, can cause tumors in rodents when injected at high levels. However, most epidemiologic studies of people who were immunized as children with poliovirus vaccine that was potentially contaminated with SV40 have not found an association between SV40-contaminated poliovirus vaccine and the risk of cancer--even more than 30 years after exposure. Still, the presence of SV40 in some tumors raises the possibility that there may be an association.
To determine whether immunization with the contaminated poliovirus vaccine had any affect on the incidence of pleural mesothelioma, a rare cancer of the membrane that covers the lungs, Howard D. Strickler, M.D., of the Albert Einstein College of Medicine in New York, and his colleagues used cancer incidence data from the National Cancer Institute's Surveillance, Epidemiology, and End Results Program to estimate age- and sex-specific incidence rates of pleural mesothelioma from 1975 through 1997. They then compared trends in mesothelioma incidence with prevalence of exposure to SV40-contaminated poliovirus vaccine.
The authors found that incidence rates increased the most among males who were age 75 or older, the age group least likely to have been exposed to the contaminated poliovirus vaccine. Incidence rates among males in the age groups most heavily exposed to SV40-contaminated poliovirus vaccine (between ages 25 and 54) remained stable or decreased from 1975 through 1997.
Similar trends were seen among females. The authors point out that even though women had similar exposure to SV40 contaminated vaccine, female pleural mesothelioma remained very rare, and the few female cases that did occur were mainly among the elderly who were unlikely to have ever received any poliovirus vaccine. In addition, statistical assessment of trends in pleural mesothelioma incidence did not reveal any increases in rates of the disease that could be attributed to SV40-contaminated poliovirus vaccine in males or females.
"Thus, after almost 40 years of follow-up, U.S. cancer incidence data have not shown an increased incidence of pleural mesothelioma among the birth cohorts that were exposed to SV40-contaminated poliovaccine," the authors conclude. However, they note that "continued surveillance of all vaccine-exposed cohorts is needed, in view of conflicting reports on the detection of SV40 genomic DNA sequences in mesothelioma tumor samples."
Contact: Abe Habenstreit, Albert Einstein College of Medicine, 718-430-3101; fax: 718-430-3703, habenstr@aecom.yu.edu
Strickler H, Goedert J, Devesa S, Lahey J, Fraumeni J, Rosenberg P. Trends in U.S. pleural mesothelioma incidence rates following simian virus 40 contamination of early poliovirus vaccines. J Natl Cancer Inst
2003;95:38–45.
Note: The Journal of the National Cancer Institute is published by Oxford University Press and is not affiliated with the National Cancer Institute. Attribution to the Journal of the National Cancer Institute is requested in all news coverage.
http://www.viewzone.com/sv40.html
SV-40 - A deadly Cure
by Geraldo Fuentes
Editor's Note:
When we first ran Geraldo's first story, SV-40, A Deadly Cure? we thought it was a bit on the conspiratory side, but it seemed well researched. We were pleased that many other journalists also investigated the material, proving the sad truth that Geraldo reported in ViewZone. Research has now firmly linked many of today's cancers with tainted virus vaccinations given in the early 1950s. Could there be any more shocking and horrific revelations like this? We didn't think so - but we were wrong.
The latest horror story is posted HERE: SV40 Part Two for you to ponder. As you read it, also do not forget the Black Americans that were knowingly infected with Syphilis or the soldiers made to march through the fallout of our nuclear bomb tests... But first, read Geraldo Fuentes original story. Also, important new information is at the end of this story.
PART I
If you received a polio vaccination in the 50's, you may have gotten more than you know...
It was 1956. I was only six years old and attended grade school in Springfield, Massachusetts. I was too young to recollect the first round of polio vaccinations, but I have a few memories. I remember that my first grade class was escorted to the school gymnasium. There was a peculiar smell in the air. I think it was probably rubbing alcohol. And some of the other kids were crying. The shot itself wasn't so bad. I didn't cry, but my best friend did. At the end of the ordeal we all got a lollipop.
A few years later, when we marched again to the gymnasium it was different. There was no crying and no alcohol odor. Instead, there were long tables bearing neat rows of small paper cups, filled about half way with a liquid that tasted like bitter orange juice. White clad Nurses watched as each child drank the vaccine. There was no lollipop and, after we handed back the cup, we simply returned to class.
The government had initiated the mandatory polio vaccination programs in 1955. Prior to this, polio had killed or crippled thousands of children and adults all over the world. Attacking the central nervous system, this viral infection was transmitted by human contact, sewage and even by contaminated milk. Victims who contracted polio would incubate the virus in their intestines, where it would multiply and enter the lymphatic system. Eventually the virus would penetrate the nerves and travel along nerve paths, destroying neurons and rendering the muscles connected to them paralyzed.
The polio epidemic reached its height in 1952. It turned thousands of victims into cripples and confined countless children to large pressure chambers called "iron lungs," which helped them to breath when their diaphragm muscles were stilled. There was and still is no treatment for polio. Aside from attempts to maintain life functions, the disease must run its course.
And so, in 1955, just one year before I received it, Jonas Salk had performed no small miracle when he successfully mass-produced an effective polio vaccine by growing a form of the virus on the kidneys of rhesus monkeys. This virus would be harvested, killed, and given to healthy children like me, who would then develop antibodies which would kill any future invasion of the body by the polio virus.
This happy story of medical marvel has a deadly glitch. And it is especially deadly if, like me, you received your vaccinations in the 1950s, in certain states like Massachusetts. In 1960, researchers discovered that the polio vaccine distributed to certain states was infected with another virus called "Simian Virus 40." SV-40 is a monkey virus that is not normally found in humans. Unknown at the time, it was present in hundreds of rhesus monkeys that were used to grow and harvest the polio vaccine. Injected into research animals, the SV-40 virus causes brain and lung cancers. Now, some forty years later, its effect on humans is just being investigated.
SV-40 has appeared in 61% of all new cancer patients -- patients too young to have received the contaminated vaccine being administered forty years ago! Michele Carbone, Assistant Professor of Pathology at Loyola University in Chicago, has recently isolated fragments of the SV-40 virus in human bone cancers and in a lethal form of lung cancer called mesotheliomas. He found SV-40 in 33% of the osteosarcoma bone cancers studied, in 40% of other bone cancers, and in 60% of the mesotheliomas lung cancers. Dr. Carbone believes this study explains why 50% of the current mesotheliomas being treated were no longer occurring in association with asbestos exposure, their traditional cause.
Researchers from the Institute of Histology and General Embryology of the University of Ferrara, lead by Dr. Fernanda Martini, discovered SV-40's presence in a variety other tumors. They found the rhesus monkey virus in 83% of choriod plexus papillomas, in 73% of ependymomas, in 47% of astrocytomas, in 50% of glioblastomas, and in 14% of meningiomas.
SV-40 also has been found in 23% of blood samples and 45% of sperm fluids taken from normal individuals! Researchers have determined the SV-40 virus can be transmitted sexually and through blood transfusions. Even more shocking, SV-40 has appeared in 61% of all new cancer patients -- patients even too young to have received the contaminated vaccine being administered forty years ago! How could this happen?
My second vaccination was from a cup. This was the brainstorm of the FDA. Instead of getting the "dead" virus in an injection, the Federal vaccination policy mandated that children should be given the new live "oral polio vaccine" (OPV). This decision was based upon the belief that the OPV recipient would "shed" the virus through body contact with other non-vaccinated children and adults, thereby spreading the "live" virus throughout the population. Since the infection was extremely small, it would produce the desired antibodies while posing no threat of contracting polio. This, it was thought, would assure the total immunization of America and the eradication of the disease. The public was never informed that this national health strategy was being implemented, despite several cases of polio which were directly attributed to the vaccine.
By 1963, the estimated number of tainted polio vaccinations was estimated to be upwards of 98-million!
The SV-40 virus that contaminated the oral polio vaccine quickly spread from child to child and from child to adult, crossing state lines and national boundaries. By 1960, when the virus was first detected, it was already too late to prevent its dissemination throughout the population. The FDA quietly and gradually instituted a program to eliminate rhesus monkeys, who harbor the SV-40, and replace them with African Green monkeys that are free of the virus. By 1963 the monkeys had been replaced but the estimated number of tainted polio vaccinations was estimated to be 98-million!
According to the National Institutes of Health, high levels of SV-40 were identified in polio vaccines in Washington, Oregon, Wyoming, Utah, Minnesota, Iowa, Wisconsin, Illinois, Michigan, Pennsylvania, Washington DC, Maryland, Delaware, New York, Connecticut, Rhode Island, Massachusetts, Vermont and New Hampshire. Low levels of SV-40 were found in California, Arizona, New Mexico, Colorado, Texas, Kansas, Nebraska, North Dakota, Missouri, Louisiana, Georgia, Tennessee, Kentucky, Ohio, and West Virginia. Polio vaccines in the other states show no SV-40 present. This revelation has only recently come to public attention. Many people, like myself, were unaware that a potential for cancer had been implanted in their body. Researchers say that, by age fifteen, the virus stops shedding to others. I cannot but wonder how many people I contacted between the age of eight and fifteen... Did I shed the SV-40 virus to my mother, who eventually died of brain cancer? Will I contract brain, lung or bone cancer? Many other people in my age group are asking similar questions.
A number of public statements have been made by the National Cancer Institute in the past few months, attempting to put their spin on these disturbing revelations. In a statement published in the January (1999) New England Journal of Medicine, the institute states that there is no evidence of an increase in humans of the types of cancers found in laboratory animals that have been injected with SV-40. But other researchers remind us that SV-40 has already been found in a wide variety of other tumors. It has been shown that individuals who received the tainted oral vaccine demonstrate a higher occurrence of these cancers. For example: people who lived in Massachusetts and Illinois in the 1950s, and received identified lot numbers of the contaminated oral vaccine, are now contracting osteosarcoma bone tumors at a rate of ten times more than those who received the vaccine free of the SV-40. But the National Cancer Institute has been silent about these facts.
There needs to be more demographic studies to explore the relationship of SV-40 to adult onset cancers. Not surprisingly, the US government and its agencies are reluctant to pursue this matter. In fact, requests to the National Institute for Health for grants to study the SIV and simian cyto-megalovirus (SCMV) were recently denied. Microbiologist Howard Urnovitz, Ph.D., may have an explanation as he stated in the Boston Globe:
"that almost 100 million Americans were exposed (to SV-40) through a government sponsored program, but for over 30 years, there has been virtually no government effort to see if anyone's been harmed by the exposure." He added, "The government will not fund science that makes it look culpable."
Another method used by the National Cancer Institute to divert public concern is to issue statements that "many of the cancers under suspicion were contracted by people who are too young to have received the tainted vaccine in the 1950s." This argument, although true, ignores the potential of spreading the live SV-40 by "shedding" through personal contact. The oral polio vaccine was designed to be transmitted to non-vaccinated individuals by this very method. In fact, this was the reason that OPV was preferred over injection. If SV-40 is still being spread by contact today it is not surprising that these cancers are now affecting younger people.
Regardless of blame, severe damage to world health has already been done by the unsavory practice of growing vaccination products in animals. An example of these horrors was presented by Dr. Urnovitz at the Eighth Annual Houston Conference on AIDS. Dr. Urnovitz revealed significant evidence that human immunodeficiency virus type 1 (HIV-1) is a monkey hybrid virus which was produced when 320,000 Africans were injected with polio virus contaminated with live simian immunodeficiency virus (SIV) in the late 1950's. Apparently, viral fragments combine easily with other viruses to produce these hybrids called "chimeras." Prior to this revelation, health officials were blaming AIDS on the habit of certain Africans to consume monkey flesh.
What can be done now? "Make it in anything but animals," said Barbara Loe Fisher of the National Vaccine Information Center, which criticizes vaccine safety. "We have the technology to make vaccines in human cell lines that are clean," said Dr. Michele Carbone of Loyola University Medical Center, one of the first to discover SV-40 inside human tumors.
Until then we can only hope that researchers continue their work, regardless of the repercussions. Millions of people are already infected with SV-40 and are in danger. Many cancers do not develop until mid-life. Future generations must be protected. We must prohibit any future contamination of the world population, whether for our own good or not, by well-meaning governmental agencies.
UPDATE: October-November 2002 -- The following article appeared in the NY Times on October 22, 2002, partially quoted as follows:
Monkey Virus - Cancer Link Debated (THE ASSOCIATED PRESS)
WASHINGTON (AP) -- Despite years of study, there remains too little evidence to conclude a monkey virus that once tainted some polio vaccine can cause cancer in humans. Still, the Institute of Medicine said Tuesday, although studies of people who received the vaccine have not shown increased cancer rates, a connection cannot be completely ruled out. The institute, an arm of the National Academy of Sciences, recommended development of a federal response plan for dealing with contaminated vaccines and better tests for the monkey virus to determine how widespread it is.
The test in this article was to compare the group of people who got the original "live" virus in the 1950's, in school immunization programs, with the cancer rates of the general population. But, remember, the whole purpose of the mandatory "live" virus immunization program was to make sure that EVERYONE was exposed to the new batches of vaccine. This was done by having innoculated children "shed" the virus to others -- their parents, other children and virtually anyone that had contact with them after they were vaccinated. In other words, the entire American population was subjected to the SV-40 in either the original innoculation or from the shedding. So it is natural that the rates of cancer would be no different between the school children and anyone else that they infected.
On the whole, cancer rates have sky-rocketed, especially those rare forms related to the SV40, yet this type of misleading (i.e. lies) is typical of what the current administration and Federal offices are attempting to do with everything from the threat of Iraq to the infecting of its own population in the past.
If you want to get involved in a potential class action suit, you might want to contact a woman whose daughter contracted one of these rare forms of cancer (medulloblastoma), attributed to the SV40 contamination. Not only does she suffer from having her child impacted by this horrible governmental error, but she also has the uncertain guilt of possibly infecting her daughter from her own exposure to the live virus back in the 1950s.
Maybe you have had a similar experience. Are you angry? Then contact Sandy at bambitsg@winco.net. Remember the words of Mahatma Gandhi: "Even if you are a minority of one, the truth is still the truth."
Monkey virus in humans may trigger cancer: experts
Last Updated: 2002-07-12 10:01:08 -0400 (Reuters Health)
By Alicia Ault
WASHINGTON (Reuters Health) - Though there is still no clear consensus, a majority of researchers told a quasi-governmental health panel Thursday that simian virus 40 (SV40) has become established in humans, and that it plays a role in causing cancer, including in people who had virus-contaminated polio vaccines in the 1950s and 1960s.
The experts addressed the Institute of Medicine's (IOM) Immunization Safety Committee, which met to hear the latest epidemiologic and lab data on SV40. In 2 to 3 months, the committee will issue a report, along with recommendations based on their assessment of the data. SV40's role in cancer has been debated since the early 1960s, when it was discovered that inactivated polio vaccine contained the naturally occurring monkey virus. Monkey kidney cells were fingered as the source; they were used to grow polio for the shot. In 1961, scientists discovered SV40 caused cancer in rodents. The government required all future polio vaccine to be SV40-free.
Even so, some contaminated vaccine still on shelves may have been used, and as many as 98 million children had already been exposed during the government's Mass Immunization Program from 1955 until early 1963. Several attorneys alleged that the three polio vaccine makers--Wyeth, Lederle and Pfizer--knowingly distributed contaminated products before 1961 and later. Stan Kops, an attorney who successfully sued those companies for causing polio in vaccinees, alleged at the meeting that Lederle continued to sell SV40-tainted oral polio vaccine until 1999.
Attorney Donald MacLachlan, representing five families who claim the vaccine caused cancer, told Reuters Health that a federal judge in Los Angeles recently allowed a case against Wyeth to proceed. Scientists have tried to unravel whether SV40 is prevalent in humans, and if the polio vaccine caused infection, or if SV40 had been in humans previously. In the 1970s, SV40 was isolated in human tumors, especially brain and bone cancers, and, more recently, in mesotheliomas, a rare lung cancer found mostly in people over age 50, and primarily in men with occupational exposure to asbestos.
Michele Carbone of Loyola University in Chicago, Illinois has linked SV40 to mesothelioma. He called SV40 a "potent human carcinogen," capable of transforming cells and inhibiting the p53 gene that normally keeps cancer cells in check. But he added that the virus is not likely to act alone, and that co-factors--like asbestos--lead to cancer. In 2002, several researchers found SV40 in non-Hodgkin's lymphoma (NHL). Janet Butel, a Baylor College of Medicine virologist, isolated SV40 in NHL and has sequenced SV40 genomes. In three NHL samples, the SV40 strain was the same as one found in samples of a polio vaccine used in the 1950s, she said. SV40 "seems to be established in humans," and "it is causing infection," said Butel.
"Perhaps it was there before the polio vaccine, I don't know," she said, adding that widespread vaccine use may have broadly distributed SV40 in humans. The virus has been found in many nations. Erik Engels of the National Cancer Institute is conducting a study in northern India, where monkeys and humans live in close proximity, to see if--and how--SV40 might be jumping species or being transmitted from human-to-human.
Another researcher, Jeffrey Kopp of the National Institute of Diabetic, Digestive and Kidney Diseases, said a small study he and colleagues recently completed found SV40 in blood and urine of both healthy people and kidney disease patients, and that "argues for relatively common infection in the general population." Kopp's study will be published in September's Journal of the American Society of Nephrology. There were several nay-sayers, including long-time SV40 researcher Keerti Shah of Johns Hopkins University Bloomberg School of Public Health. Shah has been unable to isolate SV40 in human urine, and said that lab studies have been so inconsistent that they do not prove causality.
Howard Strickler, an epidemiologist at the Albert Einstein College of Medicine in New York, presented several studies he has conducted, all showing no association between SV40 and cancer incidence, he said. In a 1998 study in The Journal of the American Medical Association, Strickler and colleagues found no link between SV40 exposure and a type of cancer called ependymoma. Strickler also analyzed mesothelioma rates and said that incidence has remained at a steady 3% a year. It is very rare and not rising in women, said Strickler, which he said argued against the possibility that the cancer is being driven by polio vaccine exposure. Also, rates have only increased among people over 50, who were least likely to have been vaccinated, he said.
That was disputed by Carbone, who said a large number of people aged 20 to 45 were vaccinated in the 1960s, and that age group is having more mesothelioma. Susan Fisher, chief of the division of epidemiology at the University of Rochester, conducted a cohort study, comparing people born between 1955-1959 who were likely exposed to vaccine to those born between 1961-1965, and documented cancer incidence in that group from 1973 to 1993. In the vaccine-exposed group, there was a 178% increase in mesothelioma, and an increased incidence of ependymoma and osteosarcoma. But, because the cancers are rare, the differences between the exposed and unexposed group were not statistically significant, said Fisher.
For history of SV40 contaminating polio vaccine - see my website
http://www.nccn.net/~wwithin/polio.htm
http://tinyurl.com/demi
Simian virus 40 in human cancers
The American Journal of Medicine
Volume 114, Issue 8 , 1 June 2003, Pages 675-684
Background
Many studies have reported the presence of simian virus 40 (SV40) deoxyribonucleic acid (DNA) or protein in human brain tumors and bone cancers, malignant mesothelioma, and non-Hodgkin's lymphoma. However, the small samples and lack of control groups in some reports have made it difficult to assess their
reliability.
Methods
Studies were included in this analysis if they met the following criteria: original studies of patients with primary brain tumors and bone cancers, malignant mesothelioma, or non-Hodgkin's lymphoma; the investigation of SV40 was performed on primary cancer specimens; the analysis included a control group; and the same technique was used for cases and controls. Included reports were published from 1975 to 2002.
Results
Thirteen studies fulfilled the criteria for the investigation of primary brain cancers (661 tumors and 482 control samples). Specimens from patients with brain tumors were almost four times more likely to have evidence of SV40 infection than were those from controls (odds ratio [OR] = 3.9; 95% confidence interval [CI]: 2.6 to 5.8). The association was even stronger for mesothelioma (OR = 17; 95% CI: 10 to 28; based on 15 studies with 528 mesothelioma samples and 468 control samples) and for bone cancer (OR = 25; 95% CI: 6.8 to 88; based on four studies with 303 cancers and 121 control samples). SV40 DNA was also more frequent in samples from patients with non-Hodgkin's lymphoma (OR = 5.4; 95% CI: 3.1 to 9.3; based on three studies with 301 cases and 578 control samples) than from controls.
Conclusion
These results establish that SV40 is associated significantly with brain tumors, bone cancers, malignant mesothelioma, and non-Hodgkin's lymphoma. Studies are needed to assess current prevalence of SV40 infections.
http://news.bmn.com/news/story?day=030718&story=2
SV40: an emerging pathogen that's been around for fifty years
17 July 2003 8:00 GMTby Tabitha M. Powledge
Washington DC - Evidence mounts that the monkey virus that contaminated early polio vaccines causes human cancer - sometimes in people who never got the vaccine. Janet Butel has worked on SV40 for much of her long career, but to her the monkey virus is an emerging pathogen. She argues that researchers are in the midst of a changing paradigm for SV40, which contaminated certain polio vaccines nearly half a century ago and is suspected of leaving behind a legacy of cancer.
The idea that the virus is present in some characteristic tumors is no longer controversial, says Butel, who chairs the department of molecular virology and microbiology at Baylor College of Medicine in Houston. The next step is to demonstrate unequivocally that the virus causes those tumors.
Butel, who was speaking at the annual meeting of the American Association for Cancer Research (AACR) here in Washington, wants to understand the interaction of SV40 with its human host.
"Specifically we need to know the details of the immune response to an SV40 infection, both humoral immunity and cellular immunity," she said. She also wants to know which tissues get infected, how the virus is distributed in different cells around the body, and whether it is produced or just goes into a latent phase. "I hope that funding agencies will support these types of studies because it's important for scientists and public health officials to know what risk is posed by SV40 infections," she told BioMedNet News.
SV40 is, no question, a powerful cancer virus. In the hamster, the model animal for SV40 infection, the virus causes tumors of brain and bone as well as lymphomas and mesotheoliomas - exactly the same as cancers seen in people with SV40-positive tumors.
In a metaanalysis published just last month in the American Journals of Medicine, Butel and her colleagues report that in 13 studies, specimens from patients with brain tumors were almost four times more likely to have evidence of SV40 infection than were those from controls. The association was even stronger for 15 mesothelioma papers and four studies on bone cancer. SV40 DNA was also more frequent in three studies of samples from patients with non-Hodgkin's lymphoma.
The strong association with mesotheliomas turns up despite some negative studies. SV40 has important effects on mesosthelial cells in vitro, Butel says; transformation frequency is a thousand times higher than the rate reported for other cells. "It's very important that we study the correct target cells," she urged.
Butel's lab has also described several different SV40 strains, which she says is a relatively new concept. The researchers have sequenced about a dozen genomes so far. "We can tell each lab strain apart," she notes - crucial for establishing that the sequences found in human tumors are not lab strains. A key finding is that some human tumor-associated strains are the same as SV40 from early polio vaccines. The vaccine strains are found in brain tumors and non-Hodgkins lymphoma.
Alarmingly, some patients whose tumors contain the polio vaccine strains are too young to have received the contaminated vaccine. How the patients got exposed to these viruses is a mystery. One possibility, Butel suggests, is that the virus may be transmitted in urine. Studies on immunocompromised patients suggest that route of transmission, and one old study has reported that infected infants shed SV40 in their stools. "A student in my lab has shown that it can be transmitted in utero in hamsters," she added. That's a theoretical possibility in people, although there is no evidence for it. "We don't know; there are several possibilities," she said.
What are the biological differences among these strains, and do they differ in oncogenic potential? Unpublished work from her lab suggests the answer is yes, at least in syrian hamsters.
Butel notes that there are some negative reports arguing no association between SV40 and particular tumors. She speculates that the explanation is geography. SV40 tends to be found in particular US tumors, but not detected in those same tumors in Finland, Turkey, and Austria. "We need to sort this out to see what it's telling us," she said. One explanation may be that contaminated polio vaccine was never used in these countries, Butel speculates.
http://antonio.ingentaselect.com/vl=2542244/cl=80/nw=1/rpsv/cgi-bin/linker?ini=tandf&reqidx=/catchword/tandf/00015555/v83n3/s12/p202
By Facsimile
Letter to Demand a Congressional Investigation and Hearing on the Introduction of Simian Virus 40 (SV40), a Cancer-Causing Monkey Virus, into the American Population From Contaminated Polio Vaccines
Dear Representative Burton:
I am writing this letter on June 7, 2003. Exactly seven years ago, on June 7, 1996, my son Alexander was born. He would die in my arms 30 months later in a little motel room in Houston, Texas as we, his parents, tried desperately to safe his life. This letter is written in commemoration of Alexander’s short life and the injustice that befell him and the cause of the brain tumor (medulloblastoma) that killed him.
This letter is also the result of four long years of struggle by myself and my husband to find out why our beautiful healthy young son would be stricken by cancer. Now, our lawsuit against the manufacturer of the oral polio vaccine, American Home Products, (i.e. Lederle), has come to a close. As a result, much of the information that has been under a protective order for over three years has been entered into the public record through our legal documents filed with the Federal Court for the Central District of California in Los Angeles. What happened to Alexander is not an
isolated event. We contend that his death was caused by a Public Health Disaster that has befallen others and will continue to kill children until
it is addressed.
On August 12, 1999, we wrote you when you where Chairman of the Committee on House Government Reform in support of your investigations into pediatric vaccines - Vaccines; Finding the Balance Between Public Safety and Personal Choice. In this letter we described how various childhood vaccines contain known carcinogens and yet not a single vaccine is tested for carcinogenicity. While shampoos and cosmetics are tested to see if they cause cancer, incredibly, biological substances that are squirted or injected into healthy infants and children have never been tested.
On June 7, 2000, My husband and I also appeared before your Committee to discuss the FDA’s control of effective non-toxic pediatric cancer therapies in Cancer Care for The New Millenium - Integrative Oncology. During our sworn testimony we described how Alexander suffered enormously and unnecessarily as a result of the administration of four toxic but ineffective chemotherapy drugs (vincristine, cytoxan, etoposide, and cisplatin - Protocol CCG 9921). We described how the FDA would not allow our son to have access to a non-toxic cancer therapy that offered him the best chance of saving his life. We presented photographs to your Committee that demonstrated how Alexander struggled to stay alive and then suffered a horrific death.
From your own considerable effort in investigating vaccine production, testing, and safety you know that childhood vaccines contain formaldehyde (i.e. formalin), mercury (i.e. thimerosal), aluminum, and other toxic substances. In addition, vaccines can also contain animal viruses -contaminants from the animal substrates upon which the vaccines are manufactured. One of these viruses, a monkey virus called Simian Virus 40 is carcinogenic and found its way into the oral polio vaccine (OPV) and the inactivated polio vaccine (IPV) in the late 1950's and early 1960's. Such an event was not surprising because monkey kidneys contain a multitude of simian viruses and the polio vaccine is grown on monkey kidney cells.
The oral polio vaccine is a "live" trivalent vaccine which means that it contains three strains of poliovirus - Types I, II, and III, and each strain is attenuated (i.e. weakened). Dr. Albert Sabin, who was responsible for the creation of the licensed OPV, had to passage his poliovirus strains through a myriad of animals and animal host cells in order to attain the right virulence-strong enough to illicit an immune response, but sufficiently attenuated so as to not cause polio in the
recipient. For example, Type I has the following lineage:
In 1941, Drs. Francis and Mack isolated the Mahoney poliovirus "from the pooled feces of three healthy children in Cleveland." Dr. Salk then passed this strain through fourteen living monkeys and two cultures of monkey testicular cultures. In 1954, the strain (now called Monk14 T2) was given to Drs. Li and Schaeffer who subjected the virus to nine more passages through monkey testicular cultures. Next, the strain (now called Monk14 T11) underwent fifteen more passages in monkey testicular cultures, eighteen passages in monkey kidney cells, two passages through living rhesus monkeys skin, and additional passages through African Green monkey skin and monkey kidney cell cultures. This strain was now called MS10 T43 and LS-c. In 1956, Dr. Sabin took this virus and passaged it through seven cultures of African Green Monkey kidney cells. That same year, the pharmaceutical company, Merck, Sharp & Dohme, passed the strain (now called LS-c, 2ab/KP2) through a rhesus monkey kidney cell culture. The resulting material was called Sabin Original Merck (SOM) and was provided to Lederle in 1960 as the seed material to manufacture its polio vaccine.
Types II and III were created in a similar fashion.
Once the strains were isolated, the pharmaceutical companies needed a method to propagate the viruses in order to produce the vast quantities of vaccine needed for nation-wide immunization campaigns. This required a substrate upon which the poliovirus could be efficiently grown and harvested. Kidney cells from rhesus monkeys were chosen because they were found to be an effective growth medium. A small quantity of poliovirus could be added to the minced kidneys removed from these monkeys and within a few days, large quantities of poliovirus could then be harvested from these same monkey cells.
Between 1959 and 1960, Bernice Eddy, Ph.D., of the National Institute of Health (NIH) examined minced rhesus monkey kidney cells under a microscope. These were the cells of the same species of monkeys used to create and produce the oral polio vaccine. Dr. Eddy discovered that the cells would die without any apparent cause. She then took suspensions of the cellular material from these kidney cell cultures and injected them into hamsters. Cancers grew in the hamsters. Within a few months, the virus responsible for creating these cancers would be isolated and identified by Dr. Eddy and other scientists. Because it was the 40th simian virus found it was named simian virus 40 (SV40).
According to the FDA:
The discovery in 1960 that a DNA tumor virus, designated simian virus 40(SV40), was an inadvertent contaminant of rhesus monkey cells, and consequently the poliovirus and adenovirus vaccines that were made in these cells, was a watershed event in vaccine development…"
By 1960, the Salk injectable polio vaccine (IPV) had been administered to about 98 million American children and adults, and Sabin’s oral polio vaccine (OPV) had been administered to about 10,000 Americans and millions in the USSR where the clinical trials had been conducted. It was estimated that 10% to 30% of the vaccines contained live SV40. The federal agency in charge of vaccine licensing and safety at the time was the Division of Biologics Standards (DBS) of the National Institute of Health (NIH). Incredibly, this agency did not order a recall of any of the SV40-contaminated vaccines. The tainted vaccines continued to be administered until 1963 when they were all used and replaced by allegedly SV40-free vaccines as required by the new federal regulations promulgated in 1961.
In 1961, federal regulations were implemented to ensure that SV40 would no longer contaminate the polio vaccine. Despite these regulations, we contend that the OPV has been sporadically contaminated with SV40 for the last four decades. As a result, we allege that some of the children who have been administered the contaminated vaccines have been stricken with cancer and others are at risk. The main points are summarized below:
1) SV40 (Simian Virus Number 40) is a cancer causing monkey virus found in the kidney cells of Rhesus and African Green Monkeys. The kidney cells of these two species of monkeys comprise the substrate that has been used to create poliovirus strains and manufacture the oral polio vaccine for four decades.
2) SV40 is a human carcinogen for brain cancer and mesothelioma and it is a suspected carcinogen in osteosarcomas (bone cancers) and Non-Hodgkin’s Lymphomas.
3) Alexander was administered the OPV in November 1997. He was diagnosed with a brain tumor in August 1998. Alexander died on January 31, 1999.
4) Four independent laboratories using DNA testing and laser micro-dissection found SV40 in Alexander’s brain tumor.
5) SV40 has been found in the cancers of many other children. Pediatric brain tumors and other childhood cancers including osteosarcomas (bone cancer) and Non-Hodgkins Lymphomas have been found to contain SV40.
6) When Alexander was born on June 7th, 1996, I had his cord blood saved and stored by a private laboratory. The cord blood was the blood shared by Alexander and myself at the time of Alexander's birth. We had this blood tested for SV40. This marked the very first time the cord blood of a child with an SV40 positive brain tumor would be tested for SV40. To the astonishment of the scientists it was negative for SV40. This suggestedthat at the time Alexander was born he had not been exposed to SV40.
7) It is known that SV40 can be spread through contaminated blood so my husband and myself underwent a battery of tests from 2000 to 2001. Using a variety of sophisticated DNA tests to isolate the genetic fingerprint of the SV40 virus including Polymerase Chain Reaction (PCR), the scientists checked blood, urine and semen multiple times looking for any trace of SV40 (even antibodies). The scientists were once again surprised. Despite the repeated tests by leading SV40 laboratories both in the United States and Europe, we had absolutely no trace of SV40.
8) The scientists concluded that Alexander did not get SV40 from his parents, nor did he give SV40 to us.
9) The original oral polio vaccine (OPV) seed stocks created by Dr. Albert
Sabin and used to make OPV since 1961 were known to be contaminated with
SV40. In fact, SV40 was isolated from Sabin's OPV seeds - the original material used to make OPV for four decades.
10) Dr. Sabin had admitted that OPV seeds were contaminated with SV40 in a peer-reviewed scientific publication. Dr. Sabin wrote, "The three types of the large lots produced by Merck, Sharp and Dohme in rhesus monkey kidney cell cultures contained SV40."
11) Lederle, the sole American manufacturer of OPV for many years, received their OPV seeds from Merck, Sharp and Dohme. There is no evidence that Lederle ever tested their seeds for SV40 nor discarded their presumably contaminated seed stocks.
12) There are Lederle documents (not under a protective order) that demonstrate that their early OPV vaccines were contaminated with SV40.
13) Lederle did not use the SV40-neutralization procedures recommended by Dr. Sabin.
14) Monkeys used to produce OPV were not tested for SV40 by Lederle because of economic considerations.
15) After reviewing all of the Lederle records and the Lederle systems in place, our expert concluded that the contamination detected in the OPV material ultimately administered to Alexander was SV40.
16) The medical literature is unequivocal - the pediatric brain cancer rate in the U.S. has been climbing at a rate of approximately 3% for the last four decades.
17) A recent study has demonstrated that 11% of Americans are currently infected or have been infected with SV40.
SV40 is not only responsible for causing the cancer, but also for making these particular cancers incurable. Orthodox cancer therapies such as chemotherapy and radiation can not cure an SV40 positive cancer. Pediatric brain cancers and other solid cancers have been found to contain SV40. SV40 binds with the tumor suppressor genes p53 and RB and stops tumor cells from undergoing apoptosis (programmed cell death). Apoptosis is what radiation and chemo depend on to work in order to trigger the cancer cell to die. Exposing SV40 positive cancer cells to chemo and radiation does not kill the cells but simply creates more genetic mutations - making the cancer more aggressive. The bottom-line is that SV40 causes human cancer, stops orthodox cancer therapies (i.e. chemo and radiation) from providing any benefit, and can make the cancer even more aggressive.
Despite these facts, children diagnosed with cancer are not given a choice of whether they should undergo debilitating and toxic chemo and radiation. Alexander should have been tested for SV40 upon his diagnosis, not after he died. He should not have been administered ineffective and unnecessary chemotherapy which provided no benefit and only made him suffer. Children with SV40 positive cancers (or p53 mutations) should not be used as guinea pigs and profit centers for pediatric oncologists, hospitals, and pharmaceutical companies.
A Congressional Hearing should be immediately convened to examine how a federally policed vaccine program has introduced a deadly monkey virus into countless American men, women and children for the past 45 years and what the public health consequences have been of this tragedy.
This government investigation should demand to know:
Why a vaccine manufacturer was allowed to use vaccine seed stocks for four decades that came from a source contaminated with SV40? Why did this manufacturer violate federal regulations and allowed contaminated vaccines to be released? Why weren't sophisticated tests to detect SV40 during OPV production and to eliminate the virus ever required by the federal government? Why aren't children with cancer tested for SV40 when they are diagnosed, not when they are dead, because an SV40 positive cancer means that chemo and radiation will be ineffective? Why is there a significant percentage of Americans (children and adults) walking around with evidence of having had an SV40 infection and what does that mean for their risk of cancer and chances for a successful treatment?
Like our son, many children are already dead, victims of this virus, and many adults will be stricken later. Time is of the essence, not for our beloved Alexander anymore, but for other children who are infected with this cancer causing virus.
Sincerely,
Raphaele Moreau-Horwin M.A., M.F.S. Michael
Horwin, M.A., J.D.
http://www.ouralexander.org
cc: Barbara Loe Fisher, Co-Founder & President of the National Vaccine
Information Center
53rd Meeting of the Advisory Commission
On Childhood Vaccines (ACCV)
and Conference Call
December 4, 2002
Minutes
Members Present
Elizabeth J. Noyes, MA
Lois Ann Swartzlander, RN
Thomas P. Gallagher, J.D.
John R. Schreiber, M.D.
Eileen Seemayer
Barry R. Sugarman, J.D.
Public Participants Present
David Blake/Department of Justice
Amanda Buxbaum/National Vaccine Information Center
Greg Chernick/Wilmer, Cutler & Pickering
Dack Dalrymple/ Dalrymple & Associates
Adam Eckstein/The Pink Sheet
Jeff Francer/Arnold & Porter
Arnold Gale, M.D./Stanford University
Claire Hannan/Association of State and Territorial Health Officials
Sam Kanji
Bronwen Kaye, Wyeth
Raymond MacDougall/Sabin Vaccine Institute
Peter Meyers/George Washington University School of Law
Michael Milmoe/Department of Justice
Geoffrey Peterson/Aventis Pasteur
Bruce Roberts/Robertson Roberts
Carol Ruppel/Every Child By Two
Charlene Shapiro/Wilmer, Cutler & Pickering
Mary Sherrett/ASA
Paul Strain/Venable, Baetjer & Howard, LLP
Ex Officio Members Present
Norman Baylor, Ph.D.
Barbara Mulach, Ph.D. for
Carol A. Heilman, Ph.D.
Ben Schwartz, M.D.
Executive Secretary
Thomas E. Balbier, Jr., Director, Division of Vaccine Injury Compensation (DVIC), Office of Special Programs (OSP), Health Resources and Services Administration (HRSA)
Principal Staff Liaison
Cheryl A. Lee, DVIC, OSP, HRSA
Introduction and Opening Remarks
Ms. Elizabeth Noyes welcomed the members to the 53rd quarterly meeting. The minutes of the September 4, 2002 meeting were approved.
Institute of Medicine's Report, SV40 Contamination of Polio Vaccine and Cancer, Kathleen Stratton, Ph.D.
On October 22, the Immunization Safety Review Committee (Committee) released its fifth report, entitled, SV40 Contamination of Polio Vaccine and Cancer.The Committee examined the hypothesis that exposure to polio vaccine contaminated with simian virus 40 (SV40) causes certain types of cancer. The Committee's charge was to assess both the scientific evidence regarding the hypotheses under review and the significance of these issues for society.
Some of the polio vaccine administered from 1955 - 1963 was contaminated with SV40. The virus came from the monkey kidney cell cultures used to produce the vaccine. Most, but not all, of the contamination was in the inactivated polio vaccine (IPV). Once the contamination was recognized, steps were taken to eliminate it from future vaccines. Between 1959 - 1961, experimental lots of oral polio vaccine (OPV) contaminated with SV40 were administered to about 10,000 people participating in clinical trials. Tests of stored samples of the IPV that had been administered in the United States from May through July in 1955 found varied levels of SV40 contamination with some vaccine showing no contamination. From this data, it is estimated that 10% - 30% of IPV contained live SV40 and that similar percentages of the approximately 98 million Americans who had been vaccinated by 1961 were exposed to SV40.
The Committee reviewed the epidemiologic evidence on the association between exposure to polio vaccines containing SV40 and the subsequent development of cancer. Upon this review, the Committee found studies examining cancer incidence or mortality. Also included in the Committee's review were studies of cancer occurring in children who may have had a prenatal exposure to SV40 through vaccination of their mothers.
The Committee reviewed the studies in the following three categories: cancer incidence, cancer mortality, and cancers following prenatal exposure to SV40-containing vaccine. For cancer incidence, the Committee reviewed five ecologic studies and two controlled studies. The five ecologic studies were: Fisher et al., 1999; Geissler, 1990; Olin and Giesecke, 1998; Strickler
et al., 1998; and Strickler et al., 1999. The two controlled studies were Innis, 1968 and Stewart and Hewitt, 1965.
For cancer mortality, the Committee reviewed the following two ecologic studies: Fraumeni et al., 1963, and Strickler et al., 1998. They reviewed one uncontrolled study (Carroll-Pankhurst et al., 2001), and two follow-ups to the study--Fraumeni et al., 1970; and Mortimer et al., 1981.
All of the studies that the Committee reviewed concerning cancer incidence or cancer mortality and exposure to polio vaccine containing SV40 have substantial limitations. Many of theses studies were ecologic in design. In an ecologic study, the unit of analysis is a group. Because the joint distribution of the study factors and disease within each group are unknown, it is difficult to make causal inferences regarding the association between an exposure and disease at the individual level.
Most of the epidemiologic studies on polio vaccine containing SV40 and cancer are subject to misclassification bias because of a lack of detailed and specific information about the level of SV40 contamination in individual vaccine doses. These studies were also limited by the rarity of the tumors thought to be associated with exposure to SV40.
Studies of cancer mortality are confusing due to improvements over time in the effectiveness of treatments, which may produce a decline in mortality rates that is unrelated to the incidence of the cancer. If the associations suggested by some studies in this body of weak epidemiological evidence are true, the absolute risks for additional cancer cases or deaths are small and cannot necessarily be attributed solely to exposure to SV40-contaminated polio vaccine. Based on these limitations, the Committee concluded that the evidence is inadequate to accept or reject a causal relationship between SV40-containing polio vaccines and cancer.
The Committee focused on reviewing the biological evidence with an eye toward additional research that might be needed to better understand the putative role that exposure to SV40 from polio vaccines might have in cancer. The Committee reviewed the evidence on biological mechanisms related to this hypothesis through the following three key questions: (1) Is SV40 a transforming virus; (2) Can SV40 cause cancer in humans under conditions of natural exposure; and (3) Is contamination of the polio vaccine with SV40 responsible for SV40 infection in humans?
The first question was, "Is SV40 a transforming virus?" Evidence suggested that SV40 could produce oncogenic transformation of cells that comes from four sources: rodents, nonhuman primates, cell culture studies, and humans. The earliest studies of SV40 were conducted with rodents and showed that administration to neonatal and weanling hamsters causes cancers. A seminal study (Eddy et al, 1961) demonstrated that injection of extracts of rhesus monkey kidney-cell cultures into newborn hamsters was followed by the occurrence of neoplasms in approximately 70% of the animals. Despite the limitations in their applicability to humans, these animal systems are notable in that the tumors were seen, and the human cancers were associated with the presence of SV40 or viral fragments in rodents.
Cells transformed by SV40 have been shown to grow in humans and become tumors. In a study by Jensen and colleagues (1964), persons terminally ill with cancer received implants of either homologous or autologous tissue via subcutaneous injection. When cells transformed by SV40 were implanted, nodules of undifferentiated tumor cells developed. This study provides evidence from contrived clinical conditions that cells transformed by SV40 can develop into undifferentiated tumors in a human host. Therefore, the Committee concluded that the biological evidence is strong that SV40 is a transforming virus.
The second question was, "Can SV40 cause cancer in humans under conditions of natural exposure?" There is a theoretical basis for the existence of mechanisms by which SV40 could cause cancer in humans. The principal lines of evidence for the operation of specific mechanisms are that SV40 acts in ways consistent with tumorigenesis and that DNA sequences consistent with SV40 have been detected in several types of human tumors.
Data on the association between SV40 and human tumors are inconsistent. A growing body of clinical studies reported the detection of SV40 DNA in several types of tumors. The most notable and well studied of these is mesothelioma. In addition, SV40 DNA has been detected in bone cancers, and in non-Hodgkin's lymphoma. However, other studies report an inconsistency or absence of SV40 in mesotheliomas, osteosarcomas, and brain tumors.
The conflicting results in the detection of SV40 have led to questions about technical aspects of the detection of the virus. There are questions as to whether positive findings are the result of overly sensitive, but nonspecific tests that are detecting other viruses or SV40 from laboratory contamination, or whether negative findings arise from a lack of sensitivity in the detection methods used.
The detection of SV40 in tumors does not demonstrate a causal relationship. SV40 could be a passenger virus, infecting the cells, but causing no pathology. Findings from studies examining SV40 in mesothelioma demonstrate a great deal of variability which precludes the ability at present to draw conclusions regarding the frequency with which SV40 can be detected in specific neoplasms and/or normal tissues in humans. Therefore, the Committee concluded that the biological evidence is of moderate strength that SV40 exposure could lead to cancer in humans under natural conditions.
The third question was, "Is contamination of the polio vaccine with SV40 responsible for SV40 infection in humans?" In the United States, potentially contaminated IPV was administered between 1955 and 1963. Because the process for inactivating the live polio virus could be expected to kill some of the SV40, some vaccines were likely exposed to a mixture of the live and killed virus while others were exposed only to killed SV40. Thus, exposure to IPV between 1955 and 1963 cannot be equated with exposure to live SV40 or, by extension, to infection with SV40.
There is additional uncertainty about the possible contribution of vaccine-based SV40 exposure to SV40 infection and carcinogenesis because of the age of which vaccines were exposed. Because the incidence of ependymomas is highest in children under age 5 and osteocarcoma is most common in adolescents, contemporary evidence of SV40 in such tumors does not provide a direct link to exposure to contaminated IPV between 1955 and 1963. But with the long latency period for mesothelioma, exposure to contaminated IPV remains a possibility.
Other sources of exposure to SV40 may also exist. A limited number of people have been exposed to SV40 through other vaccines, including an experimental live-virus vaccine against respiratory syncytial virus and a licensed inactivated adenovirus vaccine that was administered to military recruits.
The measures of infection remain problematic. The serology data is unclear, in part, because of concerns about cross-reactivity with certain viruses. The Committee concluded that the biological evidence is of moderate strength that SV40 exposure from the polio vaccine is related to SV40 infection in humans.
The Committee concluded that the evidence is inadequate to accept or reject a causal relationship between SV40-containing polio vaccines and cancer. The Committee also concluded that concerns about exposure to SV40 through inadvertent contamination of polio vaccines are significant because of the seriousness of cancers as the possible adverse health outcomes and because of the continuing need to ensure and protect public trust in the nation's immunization program.
The Committee does not recommend a policy review of polio vaccine by any of the national or federal vaccine advisory bodies, on the basis of concerns about cancer risks that might be associated with exposure to SV40, because the vaccine in current use is free of SV40. The Committee does recommend that appropriate Federal agencies develop a Vaccine Contamination Prevention and Response Plan. The Committee also recommends the development and use of sensitive and specific standardized techniques for SV40 detection.
The Committee further recommends that once there is agreement in the scientific community as to the best detection methods and protocols, pre-1955 samples of human tissues should be analyzed for presence or absence of SV40 in rigorous, multi-center studies. The Committee recommends further study of the transmissibility of SV40 in humans.
Until some of the technical issues are resolved, the Committee does not recommend additional epidemiological studies of people potentially exposed to the contaminated polio vaccine.
Discussion of VICP Provisions in the Homeland Security Act of 2002:
Emily Marcus Levine, J.D.
Ms. Emily Marcus Levine, J.D. presented an overview of sections 1714-1717 in the Homeland Security Act of 2002 (P.L. 107-296) affecting the National Vaccine Injury Compensation Program (VICP) and on section 304 which provides liability protection to health care providers administering the smallpox vaccine under certain circumstances.
On November 25, 2002, the President signed into law the Homeland Security Act (HSA). There are two vaccine liability issues in the HSA that affect the VICP. The first issue is modifications to the National Childhood Vaccine Injury Act of 1986 (Act), as amended, which incorporates several sections of the March 21 version of, "Improved Vaccine Affordability and Availability Act" (S. 2053), introduced by Senator William Frist, (R-TN). The second issue is smallpox liability.
Prior to the enactment of the HSA, the Act's definition of manufacturers extended only to manufacturers of vaccines on the Vaccine Injury Table (Table). This definition did not include manufacturers of components of ingredients in these vaccines.
In HSA, Section 1714, "The Clarification of Definition of Manufacturer," amends the definition of manufacturer to include manufacturer of any components or ingredients of vaccines on the Table. This change extended the Act to allow liability protection for vaccine-related claims against manufacturers of thimerosal.
In HSA, Section 1715, "Clarification of Definition of Vaccine-Related Injury or Death," clarifies the definition of "vaccine-related injury or death." It states that a preservative that was intentionally used as a component of a vaccine is not an adulterant or contaminant. It also states that any component or ingredient that is listed in a vaccine's product license application and product label is not an adulterant or contaminant. Therefore, thimerosal would be not considered an adulterant or contaminant of a covered vaccine under the Act. In the Department's view, this section was a mere clarification of preexisting law.
Prior to the enactment of the HSA, the Act did not provide a definition for a vaccine. Section 1716 of HSA, "Clarification of Definition of Vaccine," provides the following definition of a vaccine, "any preparation or suspension, including but not limited to a preparation or suspension containing an attenuated or inactive microorganism or subunit there of or toxin, developed or administered to produce or enhance the body's immune response to a disease or diseases and includes all components and ingredients listed in the vaccine's product license application and product label." This provision makes it explicit that a preservative listed in a vaccine's product license and product label is included in the definition of a covered vaccine. This provision requires claims alleging injuries from a thimerosal component of a covered vaccine to be pursued initially through the VICP before other civil litigation can be pursued.
Several proposals in S. 2053 that would affect thimerosal civil actions were included in the HSA. For example, in section 203, "Jurisdiction to Dismiss Actions Improperly Brought," would have prohibited awards in civil actions for claims where an individual had not proved that any physical injury had occurred. In Section 202, "Equitable Relief," would have extended the Act to apply claims seeking equitable relief.
There are other proposals in S. 2053 that were not specifically targeted to addressing thimerosal claims, but were targeted toward making the VICP more efficient and generous. First, Section 207, "Increase in Award in the Case of a Vaccine-Related Death and for Pain and Suffering, " would have increased the $250,000 award for death and the $250,000 award for pain and suffering to $350,000. Second, Section 212, "Extension of Statute of Limitation," would have extended the statute of limitations for a vaccine-related injury from 36 months to 6 years, and upon death, extended from 48 months to 6 years after the onset of the first symptoms or significant aggravation of the injury from which death resulted.
The enactment of the HSA did not affect the Act or state law statute of limitations provisions. The Act has two statute of limitation provisions that may affect thimerosal claims. One provision states that the date the civil action was dismissed would be considered the date the VICP petition was filed for purposes of calculating the statute of limitations under the Act. This gives petitioners the benefit of this time period, so long as the petition is filed within one year from the date that the civil action was dismissed.
Under the Act, the statute of limitation provision specifies that the state law statute of limitations provision will be tolled during the pendency of the VICP claim. If a proper VICP petition is filed, the limitations period under state law will be stayed with respect to the civil action brought for the same injury/death claim from the date the VICP petition is filed, and until the date the VICP petitioner elects to reject the VICP judgment.
The HSA provisions apply to all actions or proceedings pending on or after the date of enactment, unless a court of competent jurisdiction has entered judgment (regardless of whether the time for appeal has expired).
Smallpox Liability
In HSA, Section 304, "Conduct of Certain Public Health-Related Activities," includes smallpox liability protection and countermeasures. It also includes the Secretary of Health and Human Services' (HHS) obligations, along with the Secretary of Homeland Security, to set priorities and develop strategies for research and development relating to counter measures against terrorist threats.
Section 304 authorizes the Secretary of HHS to issue a declaration for a set period of time to administer smallpox countermeasures to a group of individuals. The declaration has to be published in the Federal Register, and once it is finalized, it will provide liability protection to healthcare providers administering the smallpox vaccine. This group of individuals would be deemed "covered persons" and "employees of the Public Health Service." If an individual sustains an injury they believe resulted from the smallpox vaccine, they would be able to bring a lawsuit under the U.S. Federal Tort Claim Act (FTCA). This would be the only lawsuit an injured could file for an injury from smallpox vaccine.
If the Secretary of HHS does not issue a declaration and someone received the smallpox vaccine, or if the person were not covered by the declaration, the injured person would have the rights he/she would normally have under current law to seek legal redress.
Under HSA, a "covered person" includes the following four categories of individuals: manufacturers and distributors of a covered countermeasure; healthcare entities under whose auspices countermeasures were administered; a qualified person who administered the counter- measure (this would be a licensed healthcare professional/other person authorized to administer countermeasure under State law where administered); and any agent/employee of any person in the above categories. These covered persons are shielded from liability because they would be protected under FTCA, which is the exclusive remedy for seeking damages for smallpox vaccine related injuries and deaths.
The U.S. is liable for a claim arising from the administration of a covered countermeasure, including the smallpox vaccine, if certain requirements are met. The countermeasure had to be administered by a qualified person. It had to be administered for the purpose of preventing or treating smallpox. It also had to be administered during the effective period of the Secretary of HHS' declaration, and the injured person had to be within the category of person that the Secretary of HHS recommended receive the countermeasure.
The HSA also covers liability for non-vaccine recipients. If someone suffers an injury by being in close contact with someone who received the smallpox vaccine, then for the purposes of the HSA, he/she is treated as if he/she received the smallpox vaccine. The non-vaccine recipient would have to contract vaccinia during the effective period of the Secretary of HHS declaration or within 30 days thereafter. In the alternative, the injured person would have to reside with a vaccine recipient or reside with a vaccine recipient who was a covered person under the Secretary of HHS declaration, and the non-vaccine recipient would have to contract vaccinia after that date. Under certain circumstances, the U.S. can oppose or deny a claim.
The HSA makes clear that in order for a legal action to proceed against the U.S. under the FTCA, the U.S. Attorney General would have to make a certification that the action was filed against a covered person, and that action was based on a claim alleging injury/death arising from administration of covered countermeasure. This certification would establish facts for determining certain jurisdictional issues.
The HSA does not specifically impose any limitations on damages under the FTCA, or under state law. The FTCA incorporates state law provisions on damages, but punitive damages would not be allowable.
Update on Thimerosal Litigation: Luke Sobota, J.D., Wilmer, Cutler & Pickering
Luke Sobota is an associate attorney with the firm of Wilmer, Cutler and Pickering. Mr. Sobota stated that he is not the counsel of record in any of the thimerosal related lawsuits and that his discussion would not reflect the positions of any party in these lawsuits.
In June, there were 67 thimerosal lawsuits filed. Currently, there are 190 thimerosal related lawsuits filed in state and Federal courts. Out of these cases, there are 12 putative class actions, which purport to represent 175 million individuals who have received a vaccine containing the preservative thimerosal. None of these putative class actions lawsuits have been certified.
These lawsuits have been filed against vaccine manufacturers, manufacturers and distributors of thimerosal, and doctors and other administrators of the vaccines.
The complaints filed in these lawsuits fall into three categories. First, children alleging autism or other neurodevelopmental disorders that they claim were caused by thimerosal. Second, children who have received a vaccine containing thimerosal, but do not currently have an injury. These plaintiffs are seeking future medical monitoring of their health. Third, parents and other third parties alleging injuries arising out of the child's vaccine related injury or death (derivative claims).
Most of the courts have been willing to permit these derivative claims filed by parents to continue in state court notwithstanding the VICP. Although the remedies available differ among the state courts, they have recognized that parents might be eligible to receive compensation for loss of consortium, loss of services of the child, lost wages, and medical expenses.
On November 5, Federal Judge Sarah Vance permitted a derivative claim filed by a vaccinated child's parents to go forward under state law. The parents in that case alleged that the manufacturers of vaccines and thimerosal were negligent in failing to adequately test the vaccines, in failing to consider alternatives to thimerosal as a preservative, and in failing to adequately warn of potential dangers.
The court's ruling that the claims could go forward was interesting in two respects. First, the child never filed a petition with the VICP, and sought no relief in this case. The only claims filed in this case were the parents' derivative claim for loss of consortium, intentional infliction of emotional distress, and lost wages. The court held that the parents' claims for loss of consortium and lost wages could go forward.
Second, the court held that there was no need to wait for the child to file a petition with the VICP, even though the VICP would ordinarily decide whether or not the vaccines caused the child's alleged injuries. The court instead held that it would independently make that causal determination in the process of resolving the merits of the parents' derivative claims.
Other courts have ruled that the parents' derivative claims should be stayed until the VICP has resolved the child's underlying petition. These courts have noted that parallel claims could result in inconsistent decisions and could frustrate the Act's purpose of sparing the vaccine industry from the expenses of duplicative litigation.
All of the courts addressing direct cases filed by children alleging thimerosal related injuries have held that they must first be brought under the VICP before going into state or Federal court. These courts have rejected the plaintiff's argument that thimerosal is not covered under the Act because it is an "adulterant or contaminant" intentionally added to the vaccine. However, these decisions do not mean that these cases will be filed with the VICP. Plaintiffs have developed other theories to keep their cases in state court and out of the VICP.
In Leroy v. HHS, the U.S. Court of Federal Claims held that thimerosal is antithetical to an "adulterant or contaminant" because it prevents corruption of the vaccine. The court further held that thimerosal is a constituent part of the vaccine's suspension or preparation; and therefore, covered by the VICP.
Even though the state and Federal courts appear to agree that thimerosal is a constituent part of a vaccine and therefore, covered by the VICP, it does not mean that these cases will now be filed in the VICP. These court decisions only address one of several bases that plaintiffs have asserted for not filing under the VICP.
For example, some courts have held that parents' derivative claims can continue in state court notwithstanding the VICP. These derivative claims often present the same legal issues and sometimes even seek the same type of damages that the VICP would address with respect to the underlying petition. In addition, plaintiffs have amended their complaints to evade the VICP by seeking damages of less than $1,000 or by seeking medical monitoring.
The vast majority of courts in the thimerosal lawsuits have not addressed these issues and the decisions that were made by some courts are subject to further appellate review.
Report on the Division of Vaccine Injury Compensation (DVIC): Thomas E. Balbier, Jr.
On October 18, DVIC moved from the Parklawn Building in Rockville, Maryland to the East-West Towers Building in Bethesda, Maryland. Our new mailing address is 5600 Fishers Lane, Room 16C-17, Rockville, Maryland, 20857 and our phone and fax numbers will remain the same.
There has been a huge influx of cases filed. In Fiscal Year (FY) 2002, there were 953 claims filed. This increase is due to thimerosal and autism cases being filed. In FY 2003, 160 claims have been filed thus far.
The annual total for awards paid for post-1988 cases has changed over the years. In FY 2001, the total paid was almost $84 million. In FY 2002, the total was $56.9 million, and so far in FY 2003, $12.2 million has been paid.
Beginning in January 1999, DVIC developed an initiative in partnership with the Office of the General Counsel (OGC), Department of Justice (DOJ), and the U.S. Court of Federal Claims (the Court) to expedite the adjudication of the remaining pre-1988 claims. As of November 18, only 6 claims remain to be adjudicated.
The Vaccine Injury Compensation Trust Fund (Trust Fund) balance is $1.8 billion. The amount of money received in the Trust Fund from October 1, 2001 through September 30, 2002 was $176 million. The interest income earned was $74 million, and the excise tax collected was $102 million.
On October 3 and 4, the VICP held a Strategic Planning Retreat (the Retreat) at the Hyatt Regency Hotel in Bethesda, Maryland. The Retreat was facilitated by the Vantage Human Resources Services, Incorporated (Vantage). Approximately, 55 VICP stakeholders attended the Retreat. The stakeholders in attendance were: 15 staff from the Health Resources and Services Administration; 2 staff from the Office of the General Counsel; 7 members of the ACCV; 5 parents of children who had filed claims under the VICP; 7 attorneys representing petitioners and vaccine companies; 3 representatives of vaccine companies, 9 individuals representing medical organizations; 5 representatives of parent or consumer interest groups; and 1 individual from the Clerk's Office of the U.S. Court of Federal Claims.
The participants provided valuable comments on the draft strategic plan, and on the draft implementation and communication plans for the strategic plan. The VICP Strategic Planning Workgroup (the Workgroup) developed the strategic plan. Comments received from the participants stated that the Retreat provided an opportunity for a frank discussion of issues and challenges facing the VICP, as well as a forum for presenting potential solutions to these challenges. All the participants expressed an interest in continuing their involvement in the strategic planning process until its completion in December. The participants also expressed sincere hopes that some positive changes will occur as a result of their efforts.
The next major activities of the Workgroup will be to obtain comments on the draft plan from the ACCV members and other participants this afternoon, and review and incorporate appropriate comments into the final strategic plan.
There has been lots of legislative activity. On September 5, Ms. Elizabeth J. Noyes, ACCV Chair, sent a letter to Tommy Thompson, Secretary of Health and Human Services
(the Secretary) recommending changes in various provisions in the "Improved Vaccine Affordability and Availability Act" (H.R. 5282). This bill is the House version of S. 2053, and was introduced by Representatives Jim Greenwood (R-PA) and Edolphus Towns (D-NY).
On September 18, the House Committee on Government Reform held a hearing titled "Continuing Oversight of the National Vaccine Injury Compensation Program." Chairman Dan Burton conducted this hearing as a follow-up to the VICP hearings held on November 1 and December 12, 2001. The purpose of the hearing was to discuss the cases of petitioners, Ms. Janet Zuhlke and Mr. Thad Rogers. The hearing consisted of two panels. The first panel consisted of Ms. Zuhlke and Mr. Rogers. They testified about their experiences in seeking
compensation through the VICP. Mr. Ron Homer, an attorney representing Mr. Rogers was also a member of this panel. The second panel consisted of Mr. Paul Clinton Harris, Jr., Deputy Associate Attorney General, DOJ, and Mr. William Hobson, Director, Office of Special Programs, HRSA. They were asked their views on the "National Vaccine Injury Compensation Improvement Act of 2002" (H.R. 3741).
On September 18, Daniel J. Bryant, Assistant Attorney General, DOJ, sent a letter to Rep. Dan Burton (R-IN), Chairman of the House Committee on Government Report, expressing DOJ's views on the "National Vaccine Injury Compensation Program Improvement Act of 2002" (H.R. 3741).
On November 25, the President signed into law the Homeland Security Act of 2002 (HSA), which established the Department of Homeland Security. The HSA includes provisions from the "Improved Vaccine Affordability and Availability Act," a bill introduced by Senator William Frist (R-TN) on March 21, 2002. Sections 1714 -1717 revise the definition of a manufacturer, clarify the definition of a vaccine-related injury or death, and adds the definition of a vaccine. These sections would require future and pending civil lawsuits to first be filed with the VICP. Presumably, this would remove from the state courts future and pending individual and class action lawsuits alleging that thimerosal and/or covered vaccines caused autism.
In HSA, Section 304 provides liability protection to health care providers and hospitals administering the smallpox vaccine, and the manufacturers of this vaccine through the Federal Tort Claims Act if the Secretary issues a declaration that a bioterrorist threat makes it advisable to implement a countermeasure, such as administration of the smallpox vaccine. Under this section, the only recourse for individuals filing claims or actions alleging injuries from the smallpox vaccine would be to sue the U.S. in Federal court although State laws would apply. This section would not allow claims alleging injuries or deaths from the smallpox vaccine to be filed with the VICP.
In September, the U.S. General Accounting Office released a report entitled, "Ensuring an Adequate Supply Poses Continuing Challenges." This report addresses the following issues: the recent childhood vaccine shortages; what factors have contributed to the vaccine shortages; and what strategies are Federal agencies considering to help mitigate disruptions in the vaccine supply.
On October 8-9, Dr. Geoffrey Evans, Medical Director, represented the Health Resources and Services Administration (HRSA) at the National Vaccine Advisory Committee (NVAC) meeting in Washington, D.C. Agenda topics included: payment rates by Medicare for vaccine administration, vaccine supply shortages, and smallpox vaccine policy. In addition, Dr. Evans co-chaired the Subcommittee on Vaccine Safety and Communications, and reviewed the Centers for Disease Control and Prevention's (CDC) smallpox vaccine communication plan and future topics for the Institute of Medicine Immunization Safety Review Committee. Ms. Noyes, ACCV liaison to NVAC, provided a briefing on the VICP Strategic Planning Retreat, and an update thimerosal-related litigation.
On October 16-17, Dr. Evans attended the CDC's Advisory Committee on Immunization Practices meeting in Atlanta, Georgia, and provided an update on the VICP.
On November 8, Commander Carol L. Konchan presented an overview of the VICP to approximately 225 participants at the Annual Kansas Immunization Conference in Topeka, Kansas. The conference was sponsored by the Kansas State Nurses' Association. The presentation included the history of the VICP, as well as the general process of filing a claim with the VICP.
On September 23, Ms. Elizabeth Rezai-zadeh joined the VICP as a HRSA Scholar. She has completed a B.S. degree in Microbiology and a M.P.H. in Epidemiology at the University of South Florida in Tampa.
On October 21, Lieutenant Nichole Chamberlain joined the VICP as a Program Analyst in the Policy Analysis Branch. She has a Bachelors degree in Nursing. Formerly, she worked in HRSA's Office of Peer Review as a Program Analyst.
Effective November 17, Ms. Doris Cooper, Program Analyst, Program Operations Branch, was promoted from a Grade 9 to a Grade 11.
On November 13, the 20th Annual 2002 HRSA Awards Ceremony was held and two VICP staff received distinguished awards. Mr. Ward Sorensen, Chief, Program Operations Branch, received the Administrator's Award for Excellence for his extraordinary contributions over a decade of development, implementation, and evolution of the VICP. Ms. Carole Marks, Management Analyst, Program Operations Branch, received the Administrator's Special Citation Award for extraordinary contributions in the design, conversion, and implementation of the VICP's internal data system.
On November 29, Ms. Judy Ceresa left the VICP after 8 years of invaluable service to join HRSA's Office of Rural Health as a coordinator of grants.
Report of the Department of Justice (DOJ): Mark Rogers, J.D., Acting Deputy Director for the Torts Branch, Civil Division
Mr. Mark Rogers gave an update on autism and other cases currently being handled at DOJ.
DOJ has been working on an ongoing initiative to review all the 1997 and older docket number cases (hereinafter referred to as "Project 97"). DOJ is looking at various methods to complete the adjudications of these cases. These methods include: working with the Special Masters to reconsider the possibility of settlement in these cases; locating additional medical records, and encouraging petitioner's counsel to respond more quickly.
At the start of Project 97, there were 70 such cases at DOJ. In the past 8 months, 41 cases were resolved, with 29 cases still pending. Thirteen of these cases are awaiting attorney's fees, and fifteen cases are pending resolution before the Special Master.1
DOJ has been focusing on settling cases fairly and quickly. Over the past 18 months, 71 cases have been settled. This number represents over half of the cases compensated during this period. Forty percent of the cases were settled within a year of being filed; 21 percent were settled within two years of filing; and 25 percent were settled within three years of filing. The average time to process the settlement of a case is approximately 11 weeks, and DOJ has been working with the Special Masters to ensure that the process takes no more than 15 weeks.
DOJ has also been resolving cases using Alternative Dispute Resolution (ADR). This method is being used instead of litigation to resolve a case. A Special Master who is not assigned to the case acts as a mediator between the parties to resolve the case. Over the past 18 months, DOJ has participated in 18 ADR resolutions. This is compared to just 17 ADRs in the first ten years of the Program.
In the past year and a half, DOJ has had only 5 hearings on the amount of damages that should be awarded. There are 5 cases on appeal to the U.S. Court of Federal Claims (Court), and one of these cases was appealed by DOJ. Currently, there are no appeals pending at the U.S. Court of Appeals for the Federal Circuit.
Currently, there are approximately, 1,000 petitions filed alleging injuries due to thimerosal. These cases are currently moving on the track of an omnibus autism proceeding. This proceeding gives anyone who has a claim alleging autism the opportunity to opt into the proceeding, and consolidates the cases for purposes of processing. Most of these cases are being filed without medical record documentation.
The specific inquiry in individual cases will be stayed until the general questions are answered.
Currently, the autism cases are in the discovery phase. This phase involves producing relevant documents to support a position in the case. DOJ developed a Motion For Protective Order to clarify the rules for production of documents submitted to a Special Master. A party in a Vaccine Act proceeding may not disclose information to a person who is not a party in the proceeding without the express written consent of the person submitting the information. The Motion for a Protective Order sought to have this ordinary protection extend to the Omnibus proceedings.
Mr. Rogers stated that the number of autism cases will stress the VICP's capability to handle these cases, and that DOJ will move these cases along as fairly and less litigiously as possible.
Update from the U.S. Court of Federal Claims: Gary Golkiewicz, J.D., Special Master
Chief Special Master Golkiewicz reported that he would give a broad overview of activities of the U.S. Court of Federal Claims (Court).
The Special Masters have been working diligently to resolve the pre-1988 cases. The Court is down to one pre-1988 case, and it is currently tied up with Medicaid issues.
The use of ADR in resolving cases has been successful as parties in the case become more comfortable with the process. The Court has encouraged parties to utilize ADR for more than just settling cases. ADR can be used to assist parties in closing communication gaps, gathering information, narrowing issues, resolving collateral issues, and preparing the case for trial.
Last spring, a Process Committee (the Committee) was formed by the Court to review, evaluate, and suggest changes in the litigation process. The Committee consists of Court representatives, DOJ representatives, Petitioners' Counsel, Chief Special Master Gary Golkiewicz, Thomas Gallagher, J.D., Vito Caserta, M.D., Deborah Harris, J.D., and Emily Marcus Levine, J.D. The Committee's views on the litigation process will be taken into consideration for changes in the Court's procedural guidelines.
In 2000, there were 350 hepatitis B cases filed. The Court has categorized these cases into ten groups. Four of these groups represent approximately 100 cases. The remaining six groups of cases are stayed until supporting documentation can be found. Special Master Golkiewicz stated that his priority at the Court would be to monitor the progress of both groups of cases.
The Court has formed another committee to discuss the best methods for handling autism cases. Chief Special Master Golkiewicz established two governing principles at the start of the committee that will affect the handling of autism claims. The first principle is the Court cannot litigate thousands of cases individually. There are insufficient resources available to review the individual petitions and medical issues. Second, the causation issue will be determined to be decided in two years.
Chief Special Master Golkiewicz issued the "Autism General Order #1" (the Order), as a result of the tremendous efforts from this committee. This order discusses the process and timeframes for procedures leading to a decision in an autism case.
The autism proceedings started on July 3, 2002 and a decision will be issued no later than July 3, 2004. Special Master George Hastings is overseeing the autism proceedings. Chief Special Master Golkiewicz is assisting by working with attorneys to work out disagreements, accepting new ideas for better case strategy, and listening to complaints. Most importantly, Chief Special Master Golkiewicz is working to see what cases or categories of cases are candidates for settlements.
The autism cases will also be assisted by medical experts, who will provide scientific information and medical theories to help the Court understand the litigative risks, and determine if settlement is a possibility.
There have been several difficulties in processing the autism claims. First, the Respondents have challenged the Order relating to the completeness of a petition. They have moved to dismiss the case based on an incomplete petition. The National Childhood Vaccine Injury Act of 1986, as amended (the Act), states that petitioners shall file a complete petition. A ruling on a response to this motion will be issued later this month.
Second, the Act states that Special Masters must issue a decision on a petition no later than 240 days. At the close of this period, the petitioner has the option to continue in the VICP or withdraw their petition. If a petitioner elects to continue in the VICP, but later withdraws their petition, a question arises if they have a right to do so, or is it irrevocable that they continue in the VICP. The Act is silent on this issue.
Lastly, the biggest issue the Court is facing is causation. This issue dictates how much information is needed, defines the nature of the proceedings, and whether a case can be decided based upon medical records, witnesses, doctors, or medical experts. The Act does not provide help in defining "causation." The Act states that it must be shown that the vaccine caused the injury. The Appellate Court has dealt with some causation-in-fact issues, but there is no case, which presents the issue of standards to be applied in a causation-in-fact case.
Chief Special Master Golkiewicz stated that when the VICP started 14 years ago, virtually all the cases were litigated as vaccine injury Table cases. These types of cases were easy to decide because the proof of injury was a straightforward factual determination. Now, virtually all cases are litigated as causation-in-fact cases. These cases raise many issues and petitioners must prove their injury using traditional tort standards that the vaccine in fact caused the injury. He stated that the change in how causation is determined impacts every facet of litigation in the VICP.
Discussion on the National Vaccine Injury Compensation Program's Revised Draft Strategic Plan: Ana Rodriquez, Ed.D.
Ms. Ana Rodriquez, Ed.D. has a doctoral degree in organizational development from the University of Massachusetts. She has advised other programs in the Federal government in organizational development. She has been extremely involved with the VICP in developing their Strategic Plan. Ms. Rodriquez requested comments on the VICP's strategic themes and objectives from the ACCV and other participants. The comments received are provided below.
Theme 1 - Develop a consistent standard for determining off-Table cases.
Mr. Barry Sugarman, J.D. commented that using a term to imply a relaxed standard for determining off-Table cases would be a benefit to petitioners.
Dr. Arnold Gale commented that it would be easier to establish a standard that would make it easier for the VICP to be understood by all parties, i.e. Special Masters and attorneys.
Mr. Peter Meyers, J.D. reiterated that the standard should be a somewhat relaxed standard to create a more generous type of compensation program.
Ms. Deborah Harris, J.D. commented that the standard needs to be changed to be more consistent and specific.
Mr. Thomas Gallagher, J.D. stated that the increase in causation-in-fact cases have occurred because the guides to interpretation have been changed for Table cases. The causation-in-fact cases have a more difficult burden of proof, and this defeats the intent of Congress to compensate individuals in a fair manner.
Dr. Rodriquez stated that after considering the comments on Theme 1, it might be changed to: "Develop a more relaxed and consistent standard for determining off-Table cases."
Objective 1.5 - Establish limits of legal discovery
Mr. Sugarman commented that it would be unfair to limit discovery to petitioners with non-Table case injuries because it would limit their rights, and they carry the burden of proof in proving their case.
Ms. Jackie Noyes stated that legal discovery should be limited, but not less restrictive than what is currently set.
Theme 2 - Structure the National Vaccine Injury Compensation Program (VICP) to be responsive to evolving science, medicine, and policy actions.
Ms. Noyes stated that the word "structure" in Theme 2 could be replaced with "assure." She stated that keeping "structure" in the sentence implies that the VICP is not responsive to evolving science, etc.
Objective 2.3 - Advocate for the exploration of other funding options for research into vaccine-related injuries.
Dr. John Schreiber suggested that it might be useful to request research funds for the National Institute for Allergies and Infectious Diseases at the National Institute for Health to conduct research on vaccine related injuries.
Objective 2.1 - Decrease the number of claims that are not brought on a "reasonable" basis, perhaps by establishing a more specific definition of "reasonable."
Ms. Noyes stated that this objective was negative, and implied that claims should be reduced.
Dr. Schreiber stated that this objective should be changed to: "Establish a more specific definition of "reasonable."
Mr. Gallagher stated that language in objective 2.1 needs to refer to bringing a case on a good faith basis after an examination of the medical records, and after consultation with physician, and if there is a reasonable basis to believe that there is an injury associated with a vaccine.
Dr. Rodriquez reported that objective 2.1 might be changed to, "Increase the number of cases that are based upon a reasonable basis, as long as they are meritorious and based upon a scientific basis."
Theme 3 - Simplify the process sufficiently enough to make it understandable to the claimants, attorneys, physicians, special masters and others.
Ms. Noyes stated that this theme implies that the information that is sent out on the VICP is not understandable or sufficient enough. She stated that this theme indicates that some sort of measure is needed to indicate how well the VICP is understood. She further stated that simple language is needed for people to understand it.
Dr. Gale stated that since he was a part of the VICP Draft Strategic Planning Workgroup, they discussed that communication can always be improved to explain the VICP and let the public know that the VICP is here to serve them.
Objective 3.1 - Identify key indicators of a lack of knowledge of misinformation regarding how the VICP functions.
Mr. Sugarman stated that this objective should be deleted in its entirety because it overlaps with Theme 4. He stated that a marketing research strategy could be done to identify the key problems in publicizing the VICP.
Dr. Rodriquez stated that Theme 3 might be changed to, "Streamline the process to make it more user friendly or understandable to the claimants, attorneys, physicians, and special masters." She stated that objective 3.1 may be deleted, and that objectives 3.2 and 3.3 may also be deleted because they are very similar.
Theme 4 - Increase knowledge about the VICP among all stakeholders. The Strategic Planning Workgroup acknowledges that communication about the existence of the VICP, while necessary, is potentially frightening to people. It is vitally important to communicate to the public the message that, while vaccines are essentially safe, the VICP's goal is to compensate the small number of people who suffer a significant adverse event to covered vaccines.
Ms. Lois Swartzlander commented that she objected to the phrase "small number of people" because the numbers of vaccine-injured people are growing, and some parents might be offended by this phrase.
Dr. Schreiber stated that "potentially frightening" should be removed. He said that it could be implied that the VICP is frightening. He stated that is important to make parents aware of the VICP, as well as to make them aware of the effects of the diseases if vaccines are not administered.
Ms. Eileen Seemayer stated that it is important that physicians communicate to new parents the existence of the VICP, especially during the child's first year of life.
Objective 4.2.2 - Partnering with healthcare providers, advocacy groups, government agencies, and public organizations to assure vaccine benefits and risks and information about the VICP ("who to turn to on those rare occasions when something goes wrong)" are given to parents, or those adults taking a vaccine, all the time the vaccine is being considered/administered, and to increase and improve the distribution of the Vaccine Information Statements to vaccine recipients or their parents in the case of a minor child.
Dr. Schreiber stated that the bar associations need to be listed in this objective because they need to be made more aware of the existence of the VICP.
Ms. Swartzlander stated that the word "rare occasions" should be deleted because when a vaccine injury occurs it does not feel like a rare occasion at the time.
Dr. Rodriquez stated that Theme 4 might be changed to: "Increase knowledge about the VICP among all the stakeholders. The Strategic Planning Workgroup acknowledges that it is vitally important to communicate to the public that while vaccines are essentially safe, the VICP's goal is to compensate people who suffer a significant adverse event to covered vaccines." She stated in Objective 4.2.2 "state and local bar associations" may be added to the partnering groups. Also in this objective, the word "rare" may be deleted.
Theme 5 - Recognize and address the growing threat posed by bioterrorism.
Ms. Noyes asked if this theme was in place because someday the bioterrorist drugs will be covered under the VICP. She also stated that Theme 5 should be moved to the end of the theme list because the Homeland Security Act of 2002 addresses smallpox liability, and the VICP is not mentioned in the bill.
Ms. Tamara Overby stated that Theme 5 was created in case the VICP would someday have to cover bioterrorist drugs.
Dr. Schreiber asked if someday the VICP would be engaged to assist with smallpox liability. He stated that the VICP was designated to compensate children injured by childhood vaccines. He added that smallpox injuries could deplete the Trust Fund.
Ms. Bronwen Kaye stated that a smallpox compensation program could be modeled after the VICP. She stated that the VICP personnel could assist with the smallpox claims because of their expertise, and this new program could have a different funding source.
Mr. Dack Dalrymple, J.D. commented that another possibility for a smallpox compensation program would be that the President could create an emergency compensation program if a smallpox outbreak were to occur, and base it upon how many people are injured and an appropriate economic response.
Ms. Carol Ruppel suggested deleting Theme 5. She stated this theme is misleading, and that the strategic plan is meant to strengthen the issues in the VICP.
Objective 5.2 - Define the risks posed by a potential bioterrorism attack.
Objective 5.3 - Collect, maintain and analyze data regarding such vaccines, reported adverse events, and the infections themselves. Utilize appropriate data.
Dr. Schreiber stated that objectives 5.2 and 5.3 should be deleted because 5.2 defines the risk posed by a potential bioterrorism attack and the VICP should not be involved. He stated that objective 5.3 deals with analyzing and collecting data vaccines and adverse events, and that the VICP is not a data collection agency that follows adverse events.
Dr. Rodriquez reported that Theme 5 may be moved to the end as Theme 9, and that Theme 5 may be change to: "Recognize and address the potential role of the VICP and the growing threat posed by bioterrorism." She also reported that the objectives under Theme 5 need to be reviewed to possibly be change and more generalized.
Theme 6 - Encourage the continued preservation of the Vaccine Injury Compensation Trust Fund to ensure funds are available to pay awards to claimants who have been found to be eligible for compensation.
Ms. Seemayer commented that the word "encourage" needs to be deleted from Theme 6.
Ms. Overby stated that the word "encourage" is used because most people do not know that the Department of Treasury controls the Trust Fund. She stated that the use of funds in the Trust Fund must be monitored by the VICP to keep track of the balance and to ensure that it is being used as intended by Congress.
Mr. Balbier stated the word "preservation" in Theme 6 implies that the goal would be not to pay out funds. He stated that the VICP has no control over the collections and investments in the Trust Fund, but the VICP does provide input to the Department of Treasury on investments.
Mr. Gallagher stated he did not agree with "preservation" either. He stated that the Trust Fund should continue to be used to compensate legitimate claims.
Dr. Rodriquez stated that Theme 6 might be changed to "Maintain the integrity of the vaccine injury compensation Trust Fund."
Theme 7 - Streamline administrative handling of the claims to facilitate a less time consuming process.
Ms. Noyes questioned if Theme 7 should be combined with Theme 3 since the topic matters are similar. Dr. Schreiber concurred.
Ms. Overby commented that Theme 7 could be an objective under Theme 3. She stated that Theme 7 relates to the process of the claim, whereas Theme 3 deals with all the steps involved in processing a claim.
Dr. Rodriquez noted that Theme 7 would be reviewed by the Workgroup to give it a new title to distinguish it from Theme 3.
Objective 8.1 - Convene a conference, sponsored by the ACCV and attended by all stakeholders, to consider, based on an improved VICP, whether:
Ms. Noyes asked if a workgroup should be formed to review and discuss the current vaccine litigation issues (e.g., thimerosal cases).
Dr. Schreiber commented that he would be very interested in a conference or workgroup to address increases in civil litigation and thimerosal injuries, and send suggestions to the Secretary of HHS.
Mr. Balbier stated that he did not agree it was necessary to have a conference over a particular vaccine issue when workgroups of the ACCV have been formed to hash out difficult and contentious issues.
Dr. Schreiber stated that in Theme 8, the phrase "thimerosal-related injuries" should be deleted. He said that there is no data that supports injuries related to thimerosal.
Dr. Rodriquez stated that there are no changes to Theme 8. Objective 8.1 will be further discussed and maybe reworded at a later time. She also stated that forming a workgroup would be considered.
Objective 8.1.1 - it would be more beneficial to all stakeholders, as a national health policy, to eliminate all civil litigation based on vaccines
Mr. Gallagher commented that Objective 8.1 and its subcategories are unconstitutional. He stated that it would be unfair to take away the right of the individual to sue a vaccine manufacturer if they are not satisfied with the VICP award.
Mr. Sugarman concurred with Mr. Gallagher's comment that is unconstitutional to take away a right of an individual to seek other legal remedies. He stated the mission of the VICP is not to legislate the due process in other U.S. courts.
Ms. Kaye stated that the purpose of the objective is to convene a group and discuss the different themes, while deciding what to keep and what to change.
Dr. Schreiber stated that it is not the VICP's purview to change the process of civil litigation. He further stated that the purview of the VICP should be to maintain vaccine supply and protect children against diseases.
Objective 9.2 - Extend the statute of limitations to at least six years.
Ms. Noyes stated that objective 9.2 has already been addressed by the ACCV, and is part of the legislative proposals.
Ms. Overby stated that they are looking at processes that have not taken place yet under the VICP, so it can be included as a strategic objective.
Objective 9.3 - With input from the ACCV, consider restructuring the entire claims process so that the determination of whether an injury is vaccine related is an entirely administrative process.
Ms. Overby gave an example of administratively processing claims. She stated the Veterans' Affairs uses guidelines to determine if someone is entitled to compensation.
Dr. Geoffrey Evans stated the Veterans Affairs uses an administrative process for processing Agent Orange Program claims. He stated that this program is streamlined and less adversarial with a large number of individuals being compensated using a relaxed standard.
Ms. Seemayer commented that she would rather have a lawyer handle a claim instead of an administrative process of filling out paper work.
Mr. Sugarman stated it is important to have a lawyer litigating on the claimants' behalf because they have a right for their story to be told and tried by a judge. He said the administrative process takes that right away.
Dr. Rodriquez stated that objective 9.3 may be reconsidered at a later time, and Objective 9.2 may be either eliminated or restated to ensure it meets the need of the VICP. She also stated that objective 9.7 would be reconsidered.
Ms. Overby stated the next steps of the Strategic Workgroup would be to review the suggestions from the ACCV members and participants, and revise the strategic plan accordingly. The revised plan will then be sent out to the ACCV, participants at the Strategic Planning Retreat, and other interested parties in the VICP for review.
Nomination of ACCV Vice-Chair
On December 31, Ms. Swartzlander's term will expire. Ms. Noyes called for nominations to replace Ms. Swartzlander as Vice-Chair. Ms. Swartzlander nominated Dr. Schreiber, and the ACCV voted all in favor of Dr. Schreiber as the newly appointed Vice-Chair. His first meeting in this capacity will be March 5, 2003.
Elizabeth J. Noyes, M.A.
ACCV Chair
Lois Ann Swartzlander, RN
ACCV Vice-Chair
Thomas E. Balbier, Jr.
Executive Secretary, ACCV
http://news.bmn.com/news/story?day=030718&story=2
SV40: an emerging pathogen that's been around for fifty years
17 July 2003 8:00 GMTby Tabitha M. Powledge
Washington DC - Evidence mounts that the monkey virus that contaminated early polio vaccines causes human cancer - sometimes in people who never got the vaccine. Janet Butel has worked on SV40 for much of her long career, but to her the monkey virus is an emerging pathogen. She argues that researchers are in the midst of a changing paradigm for SV40, which contaminated certain polio vaccines nearly half a century ago and is suspected of leaving behind a legacy of cancer.
The idea that the virus is present in some characteristic tumors is no longer controversial, says Butel, who chairs the department of molecular virology and microbiology at Baylor College of Medicine in Houston. The next step is to demonstrate unequivocally that the virus causes those tumors. Butel, who was speaking at the annual meeting of the American Association for Cancer Research (AACR) here in Washington, wants to understand the interaction of SV40 with its human host.
"Specifically we need to know the details of the immune response to an SV40 infection, both humoral immunity and cellular immunity," she said. She also wants to know which tissues get infected, how the virus is distributed in different cells around the body, and whether it is produced or just goes into a latent phase. "I hope that funding agencies will support these types of studies
because it's important for scientists and public health officials to know what risk is posed by SV40 infections," she told BioMedNet News.
SV40 is, no question, a powerful cancer virus. In the hamster, the model animal for SV40 infection, the virus causes tumors of brain and bone as well as lymphomas and mesotheoliomas - exactly the same as cancers seen in people with SV40-positive tumors.
In a metaanalysis published just last month in the American Journals of Medicine, Butel and her colleagues report that in 13 studies, specimens from patients with brain tumors were almost four times more likely to have evidence of SV40 infection than were those from controls. The association was even stronger for 15 mesothelioma papers and four studies on bone cancer. SV40 DNA was also more frequent in three studies of samples from patients with non-Hodgkin's
lymphoma.
The strong association with mesotheliomas turns up despite some negative studies. SV40 has important effects on mesosthelial cells in vitro, Butel says; transformation frequency is a thousand times higher than the rate reported for other cells. "It's very important that we study the correct target cells," she urged.
Butel's lab has also described several different SV40 strains, which she says is a relatively new concept. The researchers have sequenced about a dozen genomes so far. "We can tell each lab strain apart," she notes - crucial for establishing that the sequences found in human tumors are not lab strains. A key finding is that some human tumor-associated strains are the same as SV40 from early polio vaccines. The vaccine strains are found in brain tumors and non-Hodgkins lymphoma.
Alarmingly, some patients whose tumors contain the polio vaccine strains are too young to have received the contaminated vaccine. How the patients got exposed to these viruses is a mystery. One possibility, Butel suggests, is that the virus may be transmitted in urine. Studies on immunocompromised patients suggest that route of transmission, and one old study has reported that infected infants shed SV40 in their stools. "A student in my lab has shown that it can be transmitted in utero in hamsters," she added. That's a theoretical possibility in people, although there is no evidence for it. "We don't know; there are several possibilities," she said.
What are the biological differences among these strains, and do they differ in oncogenic potential? Unpublished work from her lab suggests the answer is yes, at least in syrian hamsters.
Butel notes that there are some negative reports arguing no association between SV40 and particular tumors. She speculates that the explanation is geography. SV40 tends to be found in particular US tumors, but not detected in those same tumors in Finland, Turkey, and Austria. "We need to sort this out to see what it's telling us," she said. One explanation may be that contaminated polio vaccine was never used in these countries, Butel speculates.
Excerpts from the Summer 2002 Issue of Baylor Connections
Butel Discovers SV40 Virus in Non-Hodgkin Lymphoma
Since 1973, new cases of non-Hodgkin lymphoma have risen in the United States by more than 80 percent. A research team led by Janet S. Butel, Ph.D., '66, might have discovered a contributing factor in the increased incidence.
Recently, Butel's team found evidence of simian virus SV40 in 42 percent of 154 patients with non-Hodgkin lymphoma. This finding is significant because, between 1955 an 1963, millions of Americans and people around the world were exposed to SV40 through polio vaccines that were contaminated with the virus.
Raising additional concern is the fact that Butel has found some patients with SV40-positive tumors who were born after 1963 and would not have been exposed to the contaminated vaccine. Therefore, it appears that SV40 continues to spread among humans in ways that are not yet clear.
"SV40 has been linked to other cancers, but it has not generated the same level of interest because the cancers are rare," said Butel, who is Distinguished Service Professor and Chair of the Department of Molecular Virology & Microbiology at Baylor. "Non-Hodgkin lymphoma, on the other hand, is the fourth most common cancer in American women and the fifth most common cancer in U.S. men. The discovery that SV40 might play a role in these cancers opens up lines of investigation into possible new treatments and vaccines."
Butel's work with the SV40 virus goes back almost four decades to when she was a student at Baylor's fledgling Graduate School. She was drawn to Baylor from her home state of Kansas because the school offered one of only a few programs in the country devoted solely to viruses.
"My lifelong fascination with viruses began in an undergraduate course in soil microbiology," recalled Butel. "There was one lecture on viruses during the course, and I thought it was the most intriguing topic I had ever heard. At the time, there were not many women majoring in the sciences or in graduate school programs, but at the suggestion of one of my professors, I began to consider pursuing a Ph.D. Dr. Joseph Melnick had just started the virology program at Baylor, and I was thrilled to be accepted into the program."
Butel's graduate advisor was Fred Rapp, Ph.D., who was just starting some SV40 experiments when Butel joined his lab as a graduate student. "The experiments went well and a lot of new information was generated, so it was a very exciting time," said Butel. "I think the virus has been a wonderful model for DNA tumor viruses and for how viruses can affect the way cells grow and behave, leading to cancer. It has always stayed an interest of mine."
Now that the virus has been found in non-Hodgkin lymphoma tumors, Butel hopes to learn more about the role the virus plays in the development of the tumors and to create a small animal model to learn more about the early stages of the disease and to test new treatment approaches.
Excerpts from the Spring 2002 Issue of Baylor Connections
Distinguished Alumni and Faculty Award Winners
The Baylor Medical Alumni Association presented its highest awards at the 40th Annual Alumni Reunion Banquet on April 13. David Y. Graham, M.D., '66, and Joe C. Smith, M.D., '51, were honored with the 2002 Distinguished M.D. Alumnus Awards, and Janet S. Butel, Ph.D., '66, received the 2002 Distinguished Alumnus of The Graduate School of Biomedical Sciences Award.
Each year, the Alumni Association also honors two outstanding Baylor faculty members. This year's winners are Garrett Rush Lynch, M.D., '74, and Edward B. Singleton, M.D.
http://www.bcm.tmc.edu/alumni/newsletter/Archives/Ph_D_/ph_d_.html
by Geraldo Fuentes
Editor's Note:
When we first ran Geraldo's first story, SV-40, A Deadly Cure? we thought it was a bit on the conspiratory side, but it seemed well researched. We were pleased that many other journalists also investigated the material, proving the sad truth that Geraldo reported in ViewZone.
Research has now firmly linked many of today's cancers with tainted virus vaccinations given in the early 1950s. Could there be any more shocking and horrific revelations like this? We didn't think so - but we were wrong.
The latest horror story is posted HERE: SV40 Part Two for you to ponder. As you read it, also do not forget the Black Americans that were knowingly infected with Syphilis or the soldiers made to march through the fallout of our nuclear bomb tests...
But first, read Geraldo Fuentes original story. Also, important new information is at the end of this story.
If you received a polio vaccination in the 50's, you may have gotten more than you know...
It was 1956. I was only six years old and attended grade school in Springfield, Massachusetts. I was too young to recollect the first round of polio vaccinations, but I have a few memories. I remember that my first grade class was escorted to the school gymnasium. There was a peculiar smell in the air. I think it was probably rubbing alcohol. And some of the other kids were crying. The shot itself wasn't so bad. I didn't cry, but my best friend did. At the end of the ordeal we all got a lollipop.
A few years later, when we marched again to the gymnasium it was different. There was no crying and no alcohol odor. Instead, there were long tables bearing neat rows of small paper cups, filled about half way with a liquid that tasted like bitter orange juice. White clad Nurses watched as each child drank the vaccine. There was no lollipop and, after we handed back the cup, we simply returned to class.
The government had initiated the mandatory polio vaccination programs in 1955. Prior to this, polio had killed or crippled thousands of children and adults all over the world. Attacking the central nervous system, this viral infection was transmitted by human contact, sewage and even by contaminated milk. Victims who contracted polio would incubate the virus in their intestines, where it would multiply and enter the lymphatic system. Eventually the virus would penetrate the nerves and travel along nerve paths, destroying neurons and rendering the muscles connected to them paralyzed.
The polio epidemic reached its height in 1952. It turned thousands of victims into cripples and confined countless children to large pressure chambers called "iron lungs," which helped them to breath when their diaphragm muscles were stilled. There was and still is no treatment for polio. Aside from attempts to maintain life functions, the disease must run its course. And so, in 1955, just one year before I received it, Jonas Salk had performed no small miracle when he successfully mass-produced an effective polio vaccine by growing a form of the virus on the kidneys of rhesus monkeys. This virus would be harvested, killed, and given to healthy children like me, who would then develop antibodies which would kill any future invasion of the body by the polio virus.
This happy story of medical marvel has a deadly glitch. And it is especially deadly if, like me, you received your vaccinations in the 1950s, in certain states like Massachusetts.
In 1960, researchers discovered that the polio vaccine distributed to certain states was infected with another virus called "Simian Virus 40." SV-40 is a monkey virus that is not normally found in humans. Unknown at the time, it was present in hundreds of rhesus monkeys that were used to grow and harvest the polio vaccine. Injected into research animals, the SV-40 virus causes brain and lung cancers. Now, some forty years later, its effect on humans is just being investigated.
SV-40 has appeared in 61% of all new cancer patients -- patients too young to have received the contaminated vaccine being administered forty years ago!
Michele Carbone , Assistant Professor of Pathology at Loyola University in Chicago, has recently isolated fragments of the SV-40 virus in human bone cancers and in a lethal form of lung cancer called mesotheliomas. He found SV-40 in 33% of the osteosarcoma bone cancers studied, in 40% of other bone cancers, and in 60% of the mesotheliomas lung cancers. Dr. Carbone believes this
study explains why 50% of the current mesotheliomas being treated were no longer occurring in association with asbestos exposure, their traditional cause.
Researchers from the Institute of Histology and General Embryology of the University of Ferrara, lead by Dr. Fernanda Martini , discovered SV-40's presence in a variety other tumors. They found the rhesus monkey virus in 83% of choriod plexus papillomas, in 73% of ependymomas, in 47% of astrocytomas, in 50% of glioblastomas, and in 14% of meningiomas.
SV-40 also has been found in 23% of blood samples and 45% of sperm fluids taken from normal individuals! Researchers have determined the SV-40 virus can be transmitted sexually and through blood transfusions.
Even more shocking, SV-40 has appeared in 61% of all new cancer patients -- patients even too young to have received the contaminated vaccine being administered forty years ago! How could this happen?
My second vaccination was from a cup. This was the brainstorm of the FDA. Instead of getting the "dead" virus in an injection, the Federal vaccination policy mandated that children should be given the new live "oral polio vaccine" (OPV). This decision was based upon the belief that the OPV recipient would "shed" the virus through body contact with other non-vaccinated children and adults, thereby spreading the "live" virus throughout the population. Since the infection was extremely small, it would produce the desired antibodies while posing no threat of contracting polio. This, it was thought, would assure the total immunization of America and the eradication of the disease. The public was never informed that this national health strategy was being implemented, despite several cases of polio which were directly attributed to the vaccine.
By 1963, the estimated number of tainted polio vaccinations was estimated to be upwards of 98-million!
The SV-40 virus that contaminated the oral polio vaccine quickly spread from child to child and from child to adult, crossing state lines and national boundaries. By 1960, when the virus was first detected, it was already too late to prevent its dissemination throughout the population. The FDA quietly and gradually instituted a program to eliminate rhesus monkeys, who harbor the SV-40, and replace them with African Green monkeys that are free of the virus. By 1963 the monkeys had been replaced but the estimated number of tainted polio vaccinations was estimated to be 98-million!
According to the National Institutes of Health, high levels of SV-40 were identified in polio vaccines in Washington, Oregon, Wyoming, Utah, Minnesota, Iowa, Wisconsin, Illinois, Michigan, Pennsylvania, Washington DC, Maryland, Delaware, New York, Connecticut, Rhode Island, Massachusetts, Vermont and New Hampshire. Low levels of SV-40 were found in California, Arizona, New Mexico, Colorado, Texas, Kansas, Nebraska, North Dakota, Missouri, Louisiana, Georgia, Tennessee, Kentucky, Ohio, and West Virginia. Polio vaccines in the other states show no SV-40 present. This revelation has only recently come to public attention. Many people, like myself, were unaware that a potential for cancer had been implanted in their body. Researchers say that, by age fifteen, the virus stops shedding to others. I cannot but wonder how many people I contacted between the age of eight and fifteen... Did I shed the SV-40 virus to my mother, who eventually died of brain cancer? Will I contract brain, lung or bone cancer? Many other people in my age group are asking similar questions.
A number of public statements have been made by the National Cancer Institute in the past few months, attempting to put their spin on these disturbing revelations. In an statement published in the January (1999) New EnglandJournal of Medicine , the institute states that there is no evidence of an increase in humans of the types of cancers found in laboratory animals that have been injected with SV-40. But other researchers remind us that SV-40 has already been found in a wide variety of other tumors. It has been shown that individuals who received the tainted oral vaccine demonstrate a higher occurrence of these cancers.
For example: people who lived in Massachusetts and Illinois in the 1950s, and received identified lot numbers of the contaminated oral vaccine, are now contracting osteosarcoma bone tumors at a rate of ten times more than those who received the vaccine free of the SV-40. But the National Cancer Institute has been silent about these facts. There needs to be more demographic studies to explore the relationship of SV-40 to adult onset cancers. Not surprisingly, the US government and its agencies are reluctant to pursue this matter. In fact, requests to the National Institute for Health for grants to study the SIV and simian cyto-megalovirus (SCMV) were recently denied. Microbiologist Howard Urnovitz, Ph.D., may have an explanation as he stated in the Boston Globe :
"that almost 100 million Americans were exposed (to SV-40) through a government sponsored program, but for over 30 years, there has been virtually no government effort to see if anyone's been harmed by the exposure." He added, "The government will not fund science that makes it look culpable."
Another method used by the National Cancer Institute to divert public concern is to issue statements that "many of the cancers under suspicion were contracted by people who are too young to have received the tainted vaccine in the 1950s." This argument, although true, ignores the potential of spreading the live SV-40 by "shedding" through personal contact. The oral polio vaccine was designed to be transmitted to non-vaccinated individuals by this very method. In fact, this was the reason that OPV was preferred over injection. If SV-40 is still being spread by contact today it is not surprising that these cancers are now affecting younger people.
Regardless of blame, severe damage to world health has already been done by the unsavory practice of growing vaccination products in animals. An example of these horrors was presented by Dr. Urnovitz at the Eighth Annual Houston Conference on AIDS. Dr. Urnovitz revealed significant evidence that human immunodeficiency virus type 1 (HIV-1) is a monkey hybrid virus which was produced when 320,000 Africans were injected with polio virus contaminated with live simian immunodeficiency virus (SIV) in the late 1950's. Apparently, viral fragments combine easily with other viruses to produce these hybrids called "chimeras." Prior to this revelation, health officials were blaming AIDS on the habit of certain Africans to consume monkey flesh.
What can be done now? "Make it in anything but animals," said Barbara Loe Fisher of the National Vaccine Information Center, which criticizes vaccine safety. "We have the technology to make vaccines in human cell lines that are clean," said Dr. Michele Carbone of Loyola University Medical Center, one of the first to discover SV-40 inside human tumors.
Until then we can only hope that researchers continue their work, regardless of the repercussions. Millions of people are already infected with SV-40 and are in danger. Many cancers do not develop until mid-life. Future generations must be protected. We must prohibit any future contamination of the world population, whether for our own good or not, by well-meaning governmental agencies.
UPDATE: October-November 2002 -- The following article appeared in the NY
Times on October 22, 2002, partially quoted as follows:
Monkey Virus - Cancer Link Debated (THE ASSOCIATED PRESS)
WASHINGTON (AP) -- Despite years of study, there remains too little evidence to conclude a monkey virus that once tainted some polio vaccine can cause cancer in humans.
Still, the Institute of Medicine said Tuesday, although studies of people who received the vaccine have not shown increased cancer rates, a connection cannot be completely ruled out.
The institute, an arm of the National Academy of Sciences, recommended development of a federal response plan for dealing with contaminated vaccines and better tests for the monkey virus to determine how widespread it is.
The test in this article was to compare the group of people who got the original "live" virus in the 1950's, in school immunization programs, with the cancer rates of the general population. But, remember, the whole purpose of the mandatory "live" virus immunization program was to make sure that EVERYONE was exposed to the new batches of vaccine. This was done by having innoculated children "shed" the virus to others -- their parents, other children and virtually anyone that had contact with them after they were vaccinated. In other words, the entire American population was subjected to the SV-40 in either the original innoculation or from the shedding. So it is natural that the rates of cancer would be no different between the school children and anyone else that they infected.
On the whole, cancer rates have sky-rocketed, especially those rare forms related to the SV40, yet this type of misleading (i.e. lies) is typical of what the current administration and Federal offices are attempting to do with everything from the threat of Iraq to the infecting of its own population in the past.
If you want to get involved in a potential class action suit, you might want to contact a woman whose daughter contracted one of these rare forms of cancer (medulloblastoma), attributed to the SV40 contamination. Not only does she suffer from having her child impacted by this horrible governmental error, but she also has the uncertain guilt of possibly infecting her daughter from her own exposure to the live virus back in the 1950s.
Maybe you have had a similar experience. Are you angry? Then contact Sandy at bambitsg@winco.net . Remember the words of Mahatma Gandhi: "Even if you are a minority of one, the truth is still the truth."
by Geraldo Fuentes
Editor's Note:
When we first ran Geraldo's first story, SV-40, A Deadly Cure? we thought it was a bit on the conspiratory side, but it seemed well researched. We were pleased that many other journalists also investigated the material, proving the sad truth that Geraldo reported in ViewZone.
Research has now firmly linked many of today's cancers with tainted virus vaccinations given in the early 1950s. Could there be any more shocking and horrific revelations like this? We didn't think so - but we were wrong.
The latest horror story is posted HERE: SV40 Part Two for you to ponder. As you read it, also do not forget the Black Americans that were knowingly infected with Syphilis or the soldiers made to march through the fallout of our nuclear bomb tests...
But first, read Geraldo Fuentes original story. Also, important new information is at the end of this story.
If you received a polio vaccination in the 50's,
you may have gotten more than you know...
It was 1956. I was only six years old and attended grade school in Springfield, Massachusetts. I was too young to recollect the first round of polio vaccinations, but I have a few memories. I remember that my first grade class was escorted to the school gymnasium. There was a peculiar smell in the air. I think it was probably rubbing alcohol. And some of the other kids were crying. The shot itself wasn't so bad. I didn't cry, but my best friend did. At the end of the ordeal we all got a lollipop.
A few years later, when we marched again to the gymnasium it was different. There was no crying and no alcohol odor. Instead, there were long tables bearing neat rows of small paper cups, filled about half way with a liquid that tasted like bitter orange juice. White clad Nurses watched as each child drank the vaccine. There was no lollipop and, after we handed back the cup, we simply returned to class.
The government had initiated the mandatory polio vaccination programs in 1955. Prior to this, polio had killed or crippled thousands of children and adults all over the world. Attacking the central nervous system, this viral infection was transmitted by human contact, sewage and even by contaminated milk. Victims who contracted polio would incubate the virus in their intestines, where it would multiply and enter the lymphatic system. Eventually the virus would penetrate the nerves and travel along nerve paths, destroying neurons and rendering the muscles connected to them paralyzed.
The polio epidemic reached its height in 1952. It turned thousands of victims into cripples and confined countless children to large pressure chambers called "iron lungs," which helped them to breath when their diaphragm muscles were stilled. There was and still is no treatment for polio. Aside from attempts to maintain life functions, the disease must run its course.
And so, in 1955, just one year before I received it, Jonas Salk had performed no small miracle when he successfully mass-produced an effective polio vaccine by growing a form of the virus on the kidneys of rhesus monkeys. This virus would be harvested, killed, and given to healthy children like me, who would then develop antibodies which would kill any future invasion of the body by the polio virus.
This happy story of medical marvel has a deadly glitch. And it is especially deadly if, like me, you received your vaccinations in the 1950s, in certain states like Massachusetts.
In 1960, researchers discovered that the polio vaccine distributed to certain states was infected with another virus called "Simian Virus 40." SV-40 is a monkey virus that is not normally found in humans. Unknown at the time, it was present in hundreds of rhesus monkeys that were used to grow and harvest the polio vaccine. Injected into research animals, the SV-40 virus causes brain and lung cancers. Now, some forty years later, its effect on humans is just being investigated.
SV-40 has appeared in 61% of all new cancer patients -- patients too young to have received the contaminated vaccine being administered forty years ago!
Michele Carbone , Assistant Professor of Pathology at Loyola University in Chicago, has recently isolated fragments of the SV-40 virus in human bone cancers and in a lethal form of lung cancer called mesotheliomas. He found SV-40 in 33% of the osteosarcoma bone cancers studied, in 40% of other bone cancers, and in 60% of the mesotheliomas lung cancers. Dr. Carbone believes this study explains why 50% of the current mesotheliomas being treated were no longer occurring in association with asbestos exposure, their traditional cause.
Researchers from the Institute of Histology and General Embryology of the University of Ferrara, lead by Dr. Fernanda Martini , discovered SV-40's presence in a variety other tumors. They found the rhesus monkey virus in 83% of choriod plexus papillomas, in 73% of ependymomas, in 47% of astrocytomas, in 50% of glioblastomas, and in 14% of meningiomas.
SV-40 also has been found in 23% of blood samples and 45% of sperm fluids taken from normal individuals! Researchers have determined the SV-40 virus can be transmitted sexually and through blood transfusions.
Even more shocking, SV-40 has appeared in 61% of all new cancer patients -- patients even too young to have received the contaminated vaccine being administered forty years ago! How could this happen?
My second vaccination was from a cup. This was the brainstorm of the FDA. Instead of getting the "dead" virus in an injection, the Federal vaccination policy mandated that children should be given the new live "oral polio vaccine" (OPV). This decision was based upon the belief that the OPV recipient would "shed" the virus through body contact with other non-vaccinated children and adults, thereby spreading the "live" virus throughout the population. Since the infection was extremely small, it would produce the desired antibodies while posing no threat of contracting polio. This, it was thought, would assure the total immunization of America and the eradication of the disease. The public was never informed that this national health strategy was being implemented, despite several cases of polio which were directly attributed to the vaccine.
By 1963, the estimated number of tainted polio vaccinations was estimated to be upwards of 98-million!
The SV-40 virus that contaminated the oral polio vaccine quickly spread from child to child and from child to adult, crossing state lines and national boundaries. By 1960, when the virus was first detected, it was already too late to prevent its dissemination throughout the population. The FDA quietly and gradually instituted a program to eliminate rhesus monkeys, who harbor the SV-40, and replace them with African Green monkeys that are free of the virus. By 1963 the monkeys had been replaced but the estimated number of tainted polio vaccinations was estimated to be 98-million!
According to the National Institutes of Health, high levels of SV-40 were identified in polio vaccines in Washington, Oregon, Wyoming, Utah, Minnesota, Iowa, Wisconsin, Illinois, Michigan, Pennsylvania, Washington DC, Maryland, Delaware, New York, Connecticut, Rhode Island, Massachusetts, Vermont and New Hampshire. Low levels of SV-40 were found in California, Arizona, New Mexico, Colorado, Texas, Kansas, Nebraska, North Dakota, Missouri, Louisiana, Georgia, Tennessee, Kentucky, Ohio, and West Virginia. Polio vaccines in the other states show no SV-40 present.
This revelation has only recently come to public attention. Many people, like myself, were unaware that a potential for cancer had been implanted in their body. Researchers say that, by age fifteen, the virus stops shedding to others. I cannot but wonder how many people I contacted between the age of eight and fifteen... Did I shed the SV-40 virus to my mother, who eventually died of brain cancer? Will I contract brain, lung or bone cancer? Many other people in my age group are asking similar questions.
A number of public statements have been made by the National Cancer Institute in the past few months, attempting to put their spin on these disturbing revelations. In an statement published in the January (1999) New England Journal of Medicine , the institute states that there is no evidence of an increase in humans of the types of cancers found in laboratory animals that have been injected with SV-40. But other researchers remind us that SV-40 has already been found in a wide variety of other tumors. It has been shown that individuals who received the tainted oral vaccine demonstrate a higher occurrence of these cancers.
For example: people who lived in Massachusetts and Illinois in the 1950s, and received identified lot numbers of the contaminated oral vaccine, are now contracting osteosarcoma bone tumors at a rate of ten times more than those who received the vaccine free of the SV-40.
But the National Cancer Institute has been silent about these facts.
There needs to be more demographic studies to explore the relationship of SV-40 to adult onset cancers. Not surprisingly, the US government and its agencies are reluctant to pursue this matter. In fact, requests to the National Institute for Health for grants to study the SIV and simian cyto-megalovirus (SCMV) were recently denied. Microbiologist Howard Urnovitz, Ph.D., may have an explanation as he stated in the Boston Globe :
"that almost 100 million Americans were exposed (to SV-40) through a government sponsored program, but for over 30 years, there has been virtually no government effort to see if anyone's been harmed by the exposure." He added, "The government will not fund science that makes it look culpable."
Another method used by the National Cancer Institute to divert public concern is to issue statements that "many of the cancers under suspicion were contracted by people who are too young to have received the tainted vaccine in the 1950s." This argument, although true, ignores the potential of spreading the live SV-40 by "shedding" through personal contact. The oral polio vaccine was designed to be transmitted to non-vaccinated individuals by this very method. In fact, this was the reason that OPV was preferred over injection. If SV-40 is still being spread by contact today it is not surprising that these cancers are now affecting younger people.
Regardless of blame, severe damage to world health has already been done by the unsavory practice of growing vaccination products in animals. An example of these horrors was presented by Dr. Urnovitz at the Eighth Annual Houston Conference on AIDS.
Dr. Urnovitz revealed significant evidence that human immunodeficiency virus type 1 (HIV-1) is a monkey hybrid virus which was produced when 320,000 Africans were injected with polio virus contaminated with live simian immunodeficiency virus (SIV) in the late 1950's.
Apparently, viral fragments combine easily with other viruses to produce these hybrids called "chimeras." Prior to this revelation, health officials were blaming AIDS on the habit of certain Africans to consume monkey flesh.
What can be done now? "Make it in anything but animals," said Barbara Loe Fisher of the National Vaccine Information Center, which criticizes vaccine safety.
"We have the technology to make vaccines in human cell lines that are clean," said Dr. Michele Carbone of Loyola University Medical Center, one of the first to discover SV-40 inside human tumors.
Until then we can only hope that researchers continue their work, regardless of the repercussions. Millions of people are already infected with SV-40 and are in danger. Many cancers do not develop until mid-life. Future generations must be protected. We must prohibit any future contamination of the world population, whether for our own good or not, by well-meaning governmental agencies.
UPDATE: October-November 2002 -- The following article appeared in the NY Times on October 22, 2002, partially quoted as follows:
Monkey Virus - Cancer Link Debated (THE ASSOCIATED PRESS)
WASHINGTON (AP) -- Despite years of study, there remains too little evidence to conclude a monkey virus that once tainted some polio vaccine can cause cancer in humans.
Still, the Institute of Medicine said Tuesday, although studies of people who received the vaccine have not shown increased cancer rates, a connection cannot be completely ruled out.
The institute, an arm of the National Academy of Sciences, recommended development of a federal response plan for dealing with contaminated vaccines and better tests for the monkey virus to determine how widespread it is.
The test in this article was to compare the group of people who got the original "live" virus in the 1950's, in school immunization programs, with the cancer rates of the general population. But, remember, the whole purpose of the mandatory "live" virus immunization program was to make sure that EVERYONE was exposed to the new batches of vaccine. This was done by having innoculated children "shed" the virus to others -- their parents, other children and virtually anyone that had contact with them after they were vaccinated. In other words, the entire American population was subjected to the SV-40 in either the original innoculation or from the shedding. So it is natural that the rates of cancer would be no different between the school children and anyone else that they infected.
On the whole, cancer rates have sky-rocketed, especially those rare forms related to the SV40, yet this type of misleading (i.e. lies) is typical of what the current administration and Federal offices are attempting to do with everything from the threat of Iraq to the infecting of its own population in the past.
If you want to get involved in a potential class action suit, you might want to contact a woman whose daughter contracted one of these rare forms of cancer (medulloblastoma), attributed to the SV40 contamination. Not only does she suffer from having her child impacted by this horrible governmental error, but she also has the uncertain guilt of possibly infecting her daughter from her own exposure to the live virus back in the 1950s.
Maybe you have had a similar experience. Are you angry? Then contact Sandy at bambitsg@winco.net . Remember the words of Mahatma Gandhi: "Even if you are a minority of one, the truth is still the truth."
http://www.upi.com/view.cfm?StoryID=20030909-045736-9932r
United Press International
Polio vaccine might have carried virus
By Mark Benjamin
Investigations Editor
Published 9/9/2003 5:41 PM
WASHINGTON, Sept. 9 (UPI) -- Some of the polio vaccine given to millions of American children from 1962 until 2000 could have been contaminated with a monkey virus that shows up in some cancers, according to documents and testimony to be delivered to a House committee Wednesday. The vaccine manufacturer said such claims "don't have any validity," and the Centers for Disease Control and Prevention agrees. Some batches of the first polio vaccine used from 1955 until 1962 were contaminated with the monkey virus. The virus has also been found in some cancer in humans, although it has not been determined that the virus caused the cancer. Between 10 and 30 million Americans may have received a contaminated dose of that vaccine, according to the Centers for Disease Control and Prevention. The monkey virus is suspected of causing cancer in laboratory animals, including brain cancers, bone tumors and a usually fatal cancer in the membranes around the lungs called mesothelioma. But it has been widely assume that the replacement for the Salk vaccine, a live oral polio vaccine called the Sabin oral vaccine, was free of Simian Virus 40, or SV40. That vaccine was used from 1963 until 2000, when it too was replaced.
Documents set to be delivered to the House Subcommittee on Human Rights and Wellness appear to show that the original "seeds" used to produce the Sabin vaccine could have been tainted with SV40; that the company that manufactured the vaccine, Wyeth Lederle, may have used Rhesus monkeys -- which are more likely to carry the disease -- rather than the African Green monkeys it says it used, according to company documents; and that the company may not have performed all of the screening tests required. Stanley P. Kops, an attorney who represents clients he says were "paralyzed, killed and-or severely damaged" by the vaccine used until 2000, will present the documents. Kops alleges in his written testimony that the manufacturer and the FDA were negligent and failed to protect children.
"There is a history of negligence involving this vaccine manufacturer and the regulators," Kops says in his written testimony. "The vaccine safety tests were not submitted [to the FDA], the regulators did not look, and infants in the United States became paralyzed or died, and there are now clear instances of cancer reported in the children and individuals who received this product." A spokesperson for Wyeth Lederle, Natalie de Vane, said Kops is wrong. "These claims don't have any validity," said de Vane. "In response to allegations such as this, the FDA went back and tested batches that were released between 1976 and 1989 and using the most advanced methods of testing available, found no evidence of SV40. We have always conducted extensive screening and testing of our products. The FDA monitors this." A Food and Drug Administration spokesperson was unaware of the allegations. A CDC fact sheet says that "all of the current evidence indicates that polio vaccines have been free of SV40 since 1963." Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, will tell the committee that the polio vaccine story is particularly troubling. The center does not accept money from vaccine manufacturers. "At the hear of this tragic story is a violation of the public trust and the informed consent ethic," Fisher says in her testimony. Kops says his documents show the following:
-- A decades-old letter from Dr. Albert B. Sabin to Lederle Laboratories saying that the original "seed" used to make the Sabin vaccine may not be free of SV40 contamination. The letter says that Sabin "could not be certainthat there may not be a trace of SV40 virus in this material."
-- On Oct. 2, 2002, the Wyeth Lederle head of biological quality control said in a deposition that the company did not routinely perform blood tests on monkeys used to make the vaccine to make sure the monkeys did not carry SV40.
-- Company protocols show that a "cell batch" used to make vaccines might not be rejected even if SV40 is found in some test results.
-- Company documents describe the use of "rhesus" monkeys, apparently to make the vaccine. Wyeth Lederle says it did not use rhesus monkeys.
-- A Dec. 16, 1960, letter from Merck & Co. to the U.S. Public Health Service saying that company would not join the business of producing the oral vaccine because the risk of SV40 contamination was too high. The company told the government that it is "extremely difficult" to eliminate monkey viruses and "impossible to detect."
Morris County Daily Record
Thursday, September 11, 2003
Page A19
http://www.dailyrecord.com
Wyeth sued over polio vaccine said to cause cancer Federal panel hearing testimonies on possible dangers of various inoculations
by Ledyard King
Gannett News Service
Washington-For years Eileen Grebinski blamed the tumor that took half her son Mark's brain on nature forces. Today, she blames it on the makers of the polio vaccine Mark was given as a baby. "What I thought was an act of God I now learned was an act of man," the Brick woman told a House
Government Reform subcommittee Wednesday. "I am not a scientist or a lawyer. I'm just a mother,
and I feel cheated and robbed out of my life, my son's life and our entire family's life."The hearing is one of several that the panel's chairman, Rep. Dan Burton, R-Ind, has held on potential health dangers of different vaccines. Wednesday's session focused on an oral polio vaccine widely used from 1963 to 2000 that critics say contained a monkey virus, known as SV40, that has been linked to several forms of cancer.
Vaccine safety advocates and scientists who testified said independent studies have linked the virus to cancer in humans. But government researchers said their analysis has yet to prove the connection. "It remains an open question," said James J. Goedert, a senior investigator with the National Cancer Institute. Not for Grebinski, who has joined families from Virginia and California in a lawsuit against the maker of the vaccine, Wyeth Lederle, based in Madison, NJ. The case is pending in New Jersey state court. Wyeth spokeswoman Natalie de Vane would not comment on the lawsuit. But, she said the pharmaceutical company thoroughly tested its oral vaccine to make sure it did not
contain SV40. Food and Drug Administration spokesman Brad Stone said his agency tested samples of the vaccine administered between 1972 and 1989 when questions about side effects surfaced several years ago.
"We never found any evidence of SV40 in any of the lots we looked at, " Stone said. "There really shouldn't be any concern about being exposed to SV40 through the vaccine."Grebinski's son received the vaccine as an infant in 1968 and doctors discovered a tumor when he was about 2 and a half years old. Wheelchair-bound and wearing a protective helmet, Mark, now 35, sat quietly during the two-hour hearing and played with the stuffed dragons that have become his closest friends. "He gives his paintings and coloring pages to people he meets to show them he loves them, and he thinks they love him back," she said. "I can only hope that Mark's prayers to God will be answered by the scientists and maybe there is something that can be done to reverse his condition."
http://www.democratandchronicle.com/news/1010C521KID_Vax_news.shtml
Immunization debate airs in area
Livingston County activist enlists vaccine critic as speaker.
By Matt Leingang
Staff Writer
(October 10, 2003) — When her 17-year-old daughter died of Hodgkin’s disease five years ago, Sevaste Spaker went looking for answers. Spaker contends that she found what she was looking for after searching through her daughter’s medical records — a weakened immune system possibly induced by vaccines she received as a child. As an infant, Spaker’s daughter, Alexis, was allergic to the combined vaccination shot for diphtheria, pertussis and tetanus. She was also allergic to the shot for measles, mumps and rubella. It was shortly after she received the MMR vaccine that Alexis was diagnosed with Hodgkin’s.
“I blame myself for not being informed, for not protecting my child,” said Spaker, a former schoolteacher from Avon, Livingston County. Spaker, 55, has organized a conference on Saturday that explores the highly emotional debate about vaccine safety. Speakers include Dr. Richard Moskowitz, a Massachusetts doctor and outspoken critic of vaccines.
Spaker, who runs a Web site called KnowVaccines .com, said the purpose of the conference is not to push parents away from vaccinating their children. Rather, she believes that every parent should be empowered with enough information so that he or she can make educated decisions.
In 1980, infants were vaccinated against just four diseases — diphtheria, tetanus, pertussis and polio. But today American children are vaccinated against a much broader range of conditions, such as chickenpox, hepatitis, measles and mumps. As the immunization schedule has grown, so have parents’ fears. Most scientific studies show that vaccines are safe and effective, according to the American Academy of Pediatrics. Nevertheless, congressional hearings have focused on the issue, and Internet chat rooms are abuzz with anecdotes of alleged harm.
“Certainly I’m aware of parents that for reasons of personal choice have chosen not to vaccinate their children at all,” said Dr. Shellie Sasscer, a pediatrician in Rochester. Those parents may home-school their children as a way of avoiding immunization requirements set by many school districts, Sasscer said. Personally, Sasscer said, she believes in the benefits of vaccines and worries about a resurgence of infectious diseases should too many children go unvaccinated. But she makes a point of providing parents with pamphlets and videos that discuss the debate.
“I would rather have parents take several months to decide whether they are comfortable with vaccination rather than rushing them into something,” Sasscer said.
MLEINGAN@DemocratandChronicle.com
http://www.mercola.com/1999/aug/30/simian_virus_40_dna_found_in_us_children.htm
Simian Virus 40 DNA Found In US Children
Researchers in the US have uncovered molecular evidence of simian virus 40 (SV40) infections in tissue samples from four children born after 1982. Researchers used a polymerase chain reaction technique to identify SV40 DNA in archival tissue samples from the 13 antibody-positive children for whom tissue samples were available. The researchers discovered SV40 DNA in tissue samples from four children: three kidney transplant patients and one patient with Wilms' tumor. A sample from one of the kidney transplant patients also yielded human polyomavirus BK virus DNA products. Sequence analysis showed that the SV40 DNA strains did not arise from laboratory contamination, the team reports.
J Infect Disease September 1999;180:884-887
COMMENT (Dr. Thomas Stone) The Polyoma virus caused cancers in every animal receiving it! It was discovered that the Polyoma virus was IDENTICAL to the SV40 virus that grossly contaminated the polio vaccine prior to 1964 and continues to contaminate vaccines used by pediatricians today! Which vaccines are contaminated???"
"It was Bernice Eddy whose lab tests showed the Cutter vaccine had been inadequately treated. Eventually she lost her labs pursuing and espousing the truth. Her treatment scandalized the scientific community and resulted in a U.S. Senate investigation during which she warned legislators that unless the vaccine contamination problem was addressed, SLOW monkey viruses would simply deliver human cancer epidemics around the world.
And what has happened?? Are these cancer causing viruses the only contamination problem?
"Discovery of an atypical virus infecting humans linked to viral vaccines produced on monkey tissues In what could be one of the most important scientific discoveries of this decade, an award winning pathologist and immunologist at the University of Southern California, W. John Martin, M.D., Ph.D., has discovered an atypical virus infecting both children and adults who are exhibiting neurological, psychiatric and autoimmune disorder symptoms with diagnoses including chronic fatigue syndrome, fibromyalgia, depression, schizophrenia, anxiety disorder, seizures, developmental delays, autism, lupus, multiple sclerosis, Alzheimer's, Parkinson's, unexplained encephalopathy and chronic vegetative states.
Martin and his colleagues at USC's Infectious Diseases and Molecular Pathology Laboratories have been meticulously culturing out stealth viruses from patients for the past eight years and, in a stunning development earlier this year, successfully identified one of the viruses as being of African green monkey origin by using DNA sequence analysis. Kidney tissues from African green monkeys have been used to make the live oral polio vaccine OPV) as well as other viral vaccines during the past three decades."
We had better hope that the satanic spin-doctors are able to bury the significance of this SV40 discovery. How will we in the medical profession appear if the public discovers that we have been a major source of MANY types of CANCER with our MANDATED DIRTY vaccines?
Political and Economic Compromises Affecting Public Health:
Lessons from Contaminated Polio Vaccines
W. John Martin, MD, Ph.D.
There are growing health problems being faced by many Americans. The autism rate has doubled in California over the last 4 years and special educational needs of school children are soaring. Severe childhood behavioral problems necessitating residential care are financially forcing many parents to relinquish custody of their children to the state. In 2001 a sampling of only 19 mid-sized states revealed the astounding number of 12,700 children who were orphaned to the state because of their parents¡ inability to cover institutional costs. This heart rendering loss of legal custody does not even ensure medical therapy, but merely protective restraint. Nearly half of the elderly will experience the memory loss and emotional fragility of Alzheimer¡s disease. Published figures from the Centers for Disease Control and Prevention (CDC) confirm that nearly 20,000 patients are hospitalized each year with a brain illness diagnosed as encephalitis. Yet in over 60 percent of such patients, even detailed laboratory studies fail to reveal the underlying cause. Many more individuals who experience an alarming decline in brain function are not hospitalized. Some are driven to such tragedies as suicide or mindless criminal behaviors. It has become commonplace to hear of individuals with chronic fatigue syndrome, diabetes, arthritis and debilitating stress-related mental illnesses.
Individually, any of these increasingly prevalent diseases ought to trigger a serious investigation for the possibility of an infectious cause. When lumped together, and with the added knowledge of virus contaminated vaccines, it is difficult to comprehend the smug indifference of those entrusted with protecting the public health.
This article is written primarily to document lapses in public health decision making. It is also an effort to increase public awareness of one of the causes of our Nation¡s deteriorating health. The article is focused on events surrounding the development and testing of polio virus vaccines. It is a personal account prompted by my experiences with public health officials and their reactions to my repeated attempts to speak up on behalf of those afflicted with stealth-adapted viruses.
I have previously summarized the early history of polio as a disease entity and the subsequent development of both inactivated (Salk) and attenuated or weakened (Sabin) polio virus vaccines. This information has been available on the web site www.ccid.org since being presented at various public health conferences in 1995 and 1996. Primary cultures of Rhesus monkey kidney cells were initially chosen to grow polio virus for vaccine production. The decision to use freshly cultured cells was based on an understandable concern that established long term cell lines may have acquired some genetic changes leading towards the formation of cancer cells. The potential alternative risk that these monkeys might be carriers of cancer causing viruses was expressed by several prominent scientists but their concerns were dismissed. The 1960 finding that Rhesus monkeys were commonly contaminated with an animal cancer causing virus, termed SV40, should have been a wake up call, especially when it was realized that the formalin inactivation process used for Salk vaccine was essentially ineffective against this virus. Known contaminated polio vaccine lots of inactivated vaccines were never recalled. Instead, a rapid switch was made to the use of kidneys obtained from African green monkeys. Rather than reestablishing SV40-free polio viral stocks, use was made of an anti-SV40 animal antiserum (itself a potential source of contaminating viruses), as a way of clearing the contaminant.
The other major change in the early 1960¡s was the reluctant admission that the Salk vaccine was inferior to Dr. Sabin¡s live attenuated vaccine in the rapidity of providing immunity and cost. Moreover, the Sabin vaccine was transiently excreted by those who were vaccinated leading to secondary infection and presumed vaccination of others within the community. The omission of a formalin inactivation step should have led to a redoubling of efforts to screen the donor monkeys for unapparent infections. This was never done. Rather a political conflict arose over the Division of Biological Standards (a forerunner to the Bureau of Biologics component of the Food and Drug Administration, FDA) decision to license Dr. Sabin¡s vaccine. Lederle, a vaccine manufacturer was working with an attenuated polio virus developed by Dr. Hilary Koproski of the Wistar Research Institute. A rift had developed between Dr. Sabin and Dr. Koproski. Seemingly, Dr. Sabin had produced a better attenuated vaccine by employing Dr. Dubecco¡s plaque purification procedure. Thus there were persistent reports from field trials using Dr. Koprowski¡s vaccine of breakthrough infections. More serious was Dr. Sabin¡s concerns that Dr. Koprowski¡s vaccines had a contaminating virus that was not being openly addressed. A mention of this concern was published by Dr. Sabin and included in correspondence that led to a breakdown in any previous friendship enjoyed by these individuals. Lederle reportedly threatened to sue the government if they could not get their vaccine licensed at the same time as Dr. Sabin¡s vaccine. By appealing to Dr. Sabin, the government had him agree to forego patenting his vaccine virus and instead to freely, if reluctantly, provide it to Lederle.
Concerns regarding the possible contamination of polio vaccine grown in African green monkeys persisted throughout the 1960¡s. Up to half of all monkey kidney cultures were being rejected because of apparent viral contamination. Common sense suggestions such as screening the monkeys own serum for antibody reactivity against the cultured kidney cells were dismissed since it would undoubtedly lead to rejection of even more cultures. Dr. Leonard Hayflick, also working in the Wistar Research Institute, had successfully cultured a human lung derived cell line that lacked the longevity or chromosomal abnormalities of cancer cells. This cell line, designated WI-38, was a potential substitute for monkey kidney cells. Dr. Hayflick had provided the cells to Pfizer for successful polio vaccine production in England. Various arguments were raised by Lederle to justify the continued use of monkeys, including the need for monkeys in safety studies. Nevertheless, the issue of contamination was addressed by Lederle and the Bureau of Biologics in 1972. Kidneys from eleven monkeys were set aside from vaccine production to see what, if any, contaminating viruses might be present. All eleven monkeys grew out African green monkey simian cytomegalovirus (SCMV). Only four of the isolates would have been detected using the then mandated government screening tests. Lederle had a more sensitive indicator cell line, even better than WI-38. In Lederle¡s contingency plan, they argued that the Bureau of Biologics would not be willing to take their product off the market in favor of Pfizer¡s vaccine. They also argued how they could contest the findings; repeat the studies, etc., while continuing to make thousands of doses of the existing vaccine. Alternatively, they could begin to treat the monkeys with an anti-viral agent. Their main point of argument was that there had been no apparent illness resulting from the vaccine. Possibly, the contaminating virus was destroyed as it passed into the stomach from an oral administration! This silly argument was essentially repeated to me 5 years later by Dr. Harry Myer, the Director of the Bureau of Biologics, when he dismissed my report of finding foreign DNA in polio vaccine lots. Dr. Meyer was subsequently appointed a vice president of the company, American Cyanamid that had acquired Lederle.
A cell damaging (cytopathic) virus was isolated from a child named Colburn in 1973 by a pediatrician from Birmingham, Alabama, Dr. Charles Alford. It was subsequently shown to be SCMV. From my initial conversations with Dr. Alford, it was clear that he had been discouraged from suggesting a vaccine origin, but was rather pressured to suggest it may have been a laboratory contaminant. Much later I was told by a technician working at CDC that she recalled culturing a SCMV-like virus from a patient who had received an experimental rubella vaccine produced in kidney cells from African green monkeys. This vaccine was being promoted by Dr. Paul Parkman, Deputy Director of the Bureau of Biologics, in competition with industry alternative rubella vaccines, produced in kidney cells from ducks, dogs and other species. When I inquired of Dr. Parkman about my conversation with the CDC technologist, his surprise answer was is she still working there? A CDC researcher described their Director¡s response as proclaiming The shit has hit the fan and close the hatches, and no more mention of it. Sadly, the CDC technician complied.
I reported isolating an atypical virus from a patient with a chronic fatigue syndrome (CFS) illness in 1991. This isolate followed several years of suggestive culture findings and clearly apparent reactions using virus-reactive probes in a sensitive molecular based assay known as the polymerase chain reaction (PCR). Based on the foamy appearance of the cells developing in the viral cultures, I initially suspected a spumavirus (spuma is the Latin for foam). I communicated this opinion to the CFIDS Association of America. They substituted fact for opinion and claimed their success to the CDC. I soon found myself to be a pawn in infighting between various chronic fatigue syndrome support groups. I was also dismayed by opportunistic researchers claiming they too had isolated such a virus with at least one commercial laboratory began offering spumavirus testing. There was also conflict within CDC with Dr. Walter Gunn being erroneously overconfident that Dr. Folks from the CDC was also isolating spumaviruses and with Dr. Brian Mahy asking who my virologist was, as if I had no clue as to what I was doing. I agreed to a study organized by Dr. Gunn soon after he retired from CDC and had entered into a consultative agreement with the CFIDS Association. The study did not distinguish fatigued patients from poorly selected controls. Rather than focusing on why anyone should be testing positive, the conclusion was I had not provided the prized diagnostic test for CFS.
Early DNA analysis on the initially isolated virus indicated a herpes-like virus with portions clearly related to, but distinct from, human cytomegalovirus. By 1995, the cytomegalovirus-related sequences were unequivocally identified as being derived from SCMV, as was another virus isolated from a comatose patient with a history of a severe bi-polar illness. This second virus isolate was provided to the Los Angeles County Public Health laboratory in early 1972 which reportedly sent it onto the California State Health Department. Both laboratories dismissed it as a possible contaminant.
Having obtained unequivocal sequence data, published in July 1995, and having seen and published on the devastating effect of inoculating the virus into cats, I was ill prepared for the responses that I received. These included industry anger that I was invited to address an Institute of Medicine (IOM) meeting held in Washington in November 1995; flat out rejection of unsolicited proposals to both the Bureau of Biologics and CDC for collaborative studies; abrupt dismissal of all volunteers, including an unpaid technologist, and closure of my USC laboratory nine days after the IOM presentation. As was discussed at a closed executive session held the day after my IOM presentation, a panelist Dr. Robert Johnston was quoted as stating that confirmation of the data presented by Dr. Martin would require removal of the polio vaccine from the market. Without my approval, a lawyer filed suit immediately after the IOM meeting for my testing of the polio vaccine administered to his client. A court had previously approved, over the objection of Lederle and the FDA, PCR testing of the polio vaccine lot administered to a child with an unusual brain illness. The allowed testing, however, was specifically to be restricted only to human immunodeficiency virus (HIV), with the stipulation that no other viral testing be done. I had agreed to do this testing, and also to test the child's blood samples stealth viruses. If the child's blood was stealth virus positive, the approach would have been to reapply to the court for stealth virus testing on the polio vaccine lot. Within days of the IOM meeting, all of the patient donated funds in a USC gift account (over $20,000) were whisked away by Dr. Clive Taylor Chairman of the Pathology Department. This was done ostensibly in order to provide back pay and pay-in-lieu-of-notice to the medical technologist. I refused to sign an authorization for this payment, knowing all too well that Dr. Taylor's major source of research funding in prior years had been American Cyanamid, the parent company of Lederle. I took leave from USC when confronted in January 1996 with an additional $27,000 demand to cover additional costs before my laboratory could be reopened.
Instead, I personally financed an independent laboratory, with some income generated from doing fee-for-service viral cultures, very occasional large donations and a much appreciated steady $2,100 every 1-2 months from a Japanese donor whom I have yet to personally thank. That he would continue to provide support without acknowledgement has helped fuel my determination to stay the course whatever the personal or financial costs.
A series of memorable patients have also provided more than adequate motivation and justification. On the other hand, efforts to enlist support from those in authority have been unproductive. I challenged acquaintances at FDA as to why they did not disclose the 1972 results of the collaborative study with Lederle. They could not, I was told, because the results on all studies done on regulated products are essentially proprietary to the industry providing the product. This was also given as the excuse why I could not even view tissue sections of spinal cords inoculated with licensed lots of polio vaccines in routine safety studies. I described the problem to staff of the United States Government House and Senate Commerce Committees. A legal counsel for the House Committee was willing to insert a provision in an upcoming FDA Reform bill that would require Industry to agree to waive its proprietary restrictions in the event that a safety issue was identified on a regulated product and to allow the safety concern to be freely disseminated to the scientific committee. I was tasked with seeking support from the American Medical Association (AMA) and also advised to contact someone at the Hover Institute at Stanford University. The AMA political liaison officer in Washington, D.C., could see no advantage of the public learning that doctors were not in the knowledge loop. Senior FDA officials told the legislative counsel that to be a sieve of such information about competitor's products would lessen their prospects for high salaried post government service employment. The Hover Institute expert was unwilling to confront the Pharmaceutical Industry. Thus, the matter was dropped.
In another visit to Congress, I accompanied a delegation to discuss Gulf War syndrome. The morning presentations dealt with potential movement of toxic chemical clouds from Khamisiyah towards the troops. There were celebrations at lunch time for the group had secured a commitment of funds regarding low level chemical exposure. By the way John, they don't want to hear anything about viruses and we have agreed to pull you off the agenda for this afternoon. It was reminiscent of a tactic I had seen played out at the National Institutes of Health where dissident visiting guests were offered grants in return for their silence.
I had taken an interest in Gulf War syndrome because of the obvious clinical similarities with chronic fatigue syndrome. I was also informed by a conscientious administrator in the Office of Naval Research that I should look into the possibility that the gamma globulin injections provided to troops to reduce the risk of hepatitis A infection may have transmitted stealth viruses. She could not raise the issue internally because it would create a political ceiling restricting her career prospects. The potential of gamma globulin injections for transmitting hepatitis C was recognized at the time of the Gulf War but was only belatedly addressed by the Bureau of Biologics some years later. I had presented the issue to a meeting in the Oklahoma State House that was attended by a high ranking Government representative who had stated We will let no stone go unturned. When I subsequently asked for his help with the rejection of a formal grant application to the Department of Defense his sorry replies from Washington were You can't do anything in this town without someone looking over your shoulder; and I'm nearing retirement, I don't need to create controversies.
Yet I knew I was having some impact. The Bureau of Biologics was willing to fund a Johns Hopkins researcher if he could disprove my findings. In 1996, I was invited to attend a closed National Institutes of Health sponsored meeting on SCMV. I was barraged with contradictory assertions, all aimed at justifying official inaction. I could sense no concern or compassion for the patients that I was describing and showing brain biopsies and culture results. Yet I was being asked on the sidelines whether I thought formalin would inactivate the stealth virus. I learned of efforts by the National Vaccine Advisory Committee to switch back to formalin inactivated vaccines, purportedly because of the occasional case of vaccine-derived polio. As the Chairman of this committee told me, the switch will be done over a two year period to let the company use up their stocks. Because of further delays and industry protests, the use of live polio vaccine was only formally discontinued in the United States at the beginning of 2000.
Interesting medical cases and reports of family centered and even community wide outbreaks of complex illnesses kept coming to my attention. Dr. Donovan Anderson reported to me on over 100 patients he had seen in the spring of 1996, with an initial gastrointestinal disease. Many went on to develop a chronic neurological and fatiguing illness. He reported both the occurrence of the gastrointestinal symptoms and the subsequent neurological symptoms to the Arizona state health authorities. He told them that I had found many of his patients to be stealth virus infected. Not only were his reports dismissed by the Arizona State Public Health department, but he soon found himself the target of probes by both the Arizona State Medical Board and the Federal Drug Enforcement Agency.
A hairdresser in Joelton, TN, realized she, her two staff members and a number of her clients were experiencing general malaise, muscle aches and pains, and impaired brain function. When asked if she knew of other patients, she took the initiative of describing her illness in the local Shopper magazine. Well over 100 people responded. As soon as the issue of stealth viruses arose, the local health authorities, on advice from CDC, let the matter die. A lady from Peoria, IL has seen similar symptoms among many in her community. The scope of the problem has been masked by the tendency to separate patients into distinct disease entities. Diagnostic labeling and categorizing tends to obscure the shared features common to many chronic persisting illnesses. Narrowly focused patient support groups have sprung up that unfortunately seem to compete more than to cooperate. There is a greater willingness to ascribe illnesses to some known established microorganism than to embrace the concept of atypically structured, stealth-adapted viruses. No insurance company will pay for a stealth virus diagnosis, whereas they may pay for an illness presumptively caused by Borrelia burgdoferi (the bacteria that causes acute Lyme disease), Babesia (a parasite related to malaria) Mycoplasma fermentans (a postulated cause of the Gulf war syndrome), Streptococcus, human herpesvirus-6, etc. The internal discrepancies and inconsistencies in the laboratory testing for conventional types of infectious agents in patients with chronic, persisting neurological and neuropsychiatric illnesses are conveniently overlooked by some support group leaders and their show-cased lucrative clinicians. I have been offered a piece of their pie, but only in return for positioning stealth viruses as simply another co-infection.
I continued to publish on cases from the Mohave valley and elsewhere and to present the findings at various scientific conferences. I found it difficult to engage CDC researchers in open discussion. Subsequent e-mails would go unanswered. Offers to informally discuss the work were repeatedly refused. Two salient earlier comments from friends were You must be a masochist to persist and You¡re proven it John. It¡s up to them to disprove you, but they will never give you the platform.
The passive indifference gave way to a more active antagonism when I was told last year that my Clinical Laboratory license was coming up for early re-inspection. I was informed by the Head of the State Health Department¡s Field Services Division of the concerns she had received from CDC. It also became apparent that a complaining patient, believing she had Lyme disease, provided the appropriate cover for the inspection. Because of inexperience of the local inspector, I was informed that the Health Department had decided to send a senior inspector from the Berkeley office. My early expectation of a serious effort to understand the research soon gave way to disappointment that the clinical testing was being scrutinized with the foregone conclusion of non-compliance with Federal regulations. The essential premise was that since others had not confirmed the work, it must not be valid. I worked hard trying to formulate responsive letters that would promote an independent review of the body of research work, but to no avail. An inquiry to CDC at least provoked an apology from someone who had criticized the work. Still, there was not to be an invitation to present the research
The interruption in testing has allowed time for completing two important publications. They deal with a fascinating mechanism whereby stealth virus infected cells appear to derive cellular energy from mineral containing pigmented materials. These materials have been designated as alternative cellular energy pigments or ACE-pigments. Their identification has opened up interesting therapeutic possibilities especially within the medically suppressed fields of biophysics and energy-related technologies.
I have also had some time to contemplate whether AIDS has anything to do with the lack of Public Health support. I reported that unlike human and chimpanzee cytomegaloviruses, SCMV has multiple copies of a gene that provides a cell surface receptor for HIV. Rhesus CMV has a similar structure as SCMV. I argued that it was quite plausible that the experimental use of CMV contaminated polio vaccines in Africa promoted the transition of the chimpanzee simian immunodeficiency virus to HIV. Again, requests that CDC test stored sera collected from polio vaccine immunized Congolese children in 1958 for evidence that the vaccines were contaminated with CMV were never answered. Possibly without realizing its significance, a recent article from the Division of Biological Standards in England, did reveal the presence of DNA corresponding to Rhesus CMV in the CHAT vaccine lot used by Dr. Koprowski in Africa. Possibly this was the virus detected by Dr. Sabin in his criticism of Dr. Koprow ski¡s vaccine. The same English study revealed that approximately half of over 100 tested licensed polio vaccines had DNA corresponding to SCMV. The United States FDA also disclosed that 3 of 8 tested polio vaccines lots released in the 1970¡s had DNA from SCMV. Both the English and American authorities argued that their results did not pose a Public Health problem since they were unable to culture any live virus. I suspect they did not try very hard, and certainly did not approach the issue in other potentially telling ways.
The system is flawed. To hear that there is no known cause of the majority of the almost 20,000 hospitalizations each year for encephalitis is alarming. To be told by a Public Health official that they are pushing for a probable chemical cause, such as pesticide exposure, lest they have to deal with issues of patient confinement is more than disappointing. Similarly, to be told to back off suggesting that autism could be an infection since this might discourage teachers from working with these children is wrong. Certainly it offers little comfort to the ill healthcare worker or special education school teacher whose lives change dramatically with the onset of an occupationally acquired stealth virus illness. It is time for Public Health laboratories to do stealth virus testing and to provide the scientific, social and spiritual support for those with stealth virus associated illnesses.
Such an obvious conclusion is not as easy as it may sound. Public Health agencies are creatures of, and respond directly to, those who govern. These are the politicians who fight desperately to become elected and then quickly sense the power of ever growing political and personal coffers. The need for money can easily subdue the politicians¡ willingness to confront special interests. Those with money clearly influence political appointments and even the choices and behavior of those to be promoted within the health agencies. Pharmaceutical giants can help set agendas and raise such spurious arguments as: Questioning vaccine safety will result in non-compliance with public health policies and widespread outbreaks of infections. Massive law suits will bankrupt our industry and we will not be able to continue conquering diseases. That we inadvertently caused AIDS will undermine the claim that this is the greatest nation ever to have existed. It is little wonder that those in c ontrol have chosen to close ranks.
Yet there is hope for a change, especially since most politicians are parents and many are now beginning to also experience the ravages of the current epidemic. Increased public awareness will make it easier for such politicians to demand a full accounting of the past and current practices of those entrusted with the nation¡s health. Focused, well supported research will very likely provide therapeutic answers whereas continuing to ignore the issues will simply result in an ever increasing national and international tragedy. The Scientific, Social and Spiritual Support (S3Support) movement is designed to create awareness of the problems, support those in need, and promote the necessary research.
http://www.s3support.com/members/scientific/vaccine/political.htm
http://www.eurekalert.org/pub_releases/2004-03/uotm-mvm032604.php
Public release date: 29-Mar-2004
Contact: Julie Penne
jpenne@mdanderson.org
713-792-0655
University of Texas M. D. Anderson Cancer Center
Monkey virus may hold clue for development of common blood cancer
ORLANDO -- Examination of tumors in patients with newly diagnosed non-Hodgkin's lymphoma found that half of them show evidence of a monkey virus DNA that may have originated from contaminated polio vaccines. These findings suggest that Simian virus 40 (SV40) may "participate" in the development of the blood cancer, say researchers from The University of Texas M. D. Anderson Cancer Center, who presented their findings at the annual meeting of the American Association for Cancer Research.
There is no known etiology for most non-Hodgkin's lymphoma, which has doubled in incidence within the past 30 years, say the researchers. "We found a strong association between the monkey virus DNA and non-Hodgkin's lymphoma in this study, and now the question is whether the virus DNA is there as an innocent bystander, or if it has a role to play in causing the cancer," says the first author, Felipe Samaniego, M.D., assistant professor in the Department of Lymphoma/Myeloma.
There has been a debate as to whether SV40, which contaminated some batches of polio vaccine in the 1950s and 60s, could cause human cancer, especially after the virus was discovered in human tumors. Given that, the M. D. Anderson researchers looked to see if either DNA from the virus or associated antigens or antibodies could be found in non-Hodgkin's lymphoma.
One reason they looked for evidence of SV40 in non-Hodgkin's lymphoma is because other viruses have been commonly found in this form of lymphoma, including Epstein Barr virus. "The assumption has long been that if only some NHL cases showed signs of virus, the rest may have another virus
involved in the development of this lymphoma," says Samaniego. "Now we wonder, which one is most important?"
The research team, which included Suizhao Wang, M.D., Ph.D., and Shu Wang, M.D., both post doctoral fellows in the Department of Lymphoma/Myeloma, examined 55 tumors taken from patients newly diagnosed with the disease who had not yet been treated with chemotherapy. After isolating DNA from the genomes of the cancer cells, the researchers found that 33 of the tumors contained DNA sequences from the anitigen produced by the virus. And 30 of 57 tumors stained positive with antibody that recognizes the large T antigen of SV40.
There is no question that SV40 is a powerful cancer virus in some animals, says Samaniego. In a hamster, for example, the virus causes both lymphomas and mesotheolioma lung cancers, as well as tumors in the brain and bones. People may pick up the virus by association with infected animals, through a polio vaccine, or even though secretions, such as saliva, from a person already infected, he says. One study suggested that at least five percent of Americans have signs of infection with the monkey virus, says Samaniego.
But he theorizes that the body's immune system normally keeps the virus in check until "a transforming event, inflammation or other disease," says Samaniego. "Then the virus may reactivate and cause cancer." If SV40 does prove to play a role in development of non-Hodgkin's lymphoma, then treatment aimed at destroying the virus could help prevent its development, he says. "The virus could serve as a target in novel immune-based prevention and therapeutic strategies for non-Hodgkin's lymphoma," Samaniego says. "Although this cancer is quite treatable with a 60 percent cure rate, a new therapeutic strategy would be welcomed."
Are Vaccines Causing More Disease Than They Are Curing?
Copyright 1999 by Alan Cantwell, Jr., M.D.
(re-printed with permission of author)
Vaccines help keep us safe from infectious diseases. Smallpox and polio epidemics have been wiped out by mass vaccine programs. People rush to get flu shots every fall, and kids are bombarded with a barrage of 22 required vaccinations before the age of six. Even pets need their shots. The manufacture of vaccines is a giant industry and what you pay for inoculations and doctor visits is big business for pediatricians, family practitioners and veterinarians. So why are more and more people worried about vaccines, especially the ones for kids?
Vaccine-induced Illness
Barbara Loe Fisher, president of the National Vaccine Information Center, a consumer's group based in Vienna, Virginia, claims vaccines are responsible for the increasing numbers of children and adults who suffer from immune system and neurologic disorders, hyperactivity, learning disabilities, asthma, chronic fatigue syndrome, lupus, rheumatoid arthritis, multiple sclerosis, and seizure disorders. She calls for studies to monitor the long-term effects of mass vaccination and Fisher wants physicians to be absolutely sure these vaccines are safe and not harming people.
No one can deny the dangers of vaccines. The measles, mumps, rubella (German measles) and polio vaccines, all contain live but weakened viruses. Although health officials tell you that polio has been wiped out in the U.S. since 1979, they often fail to mention that all recorded cases of polio since that time are actually caused by the polio vaccine.
Vaccine investigator Neil Z. Miller questions whether we still need need the polio vaccine when it causes every new case of polio in this country. Before mass vaccinations programs began fifty years ago, Miller insists we didn't have cancer in epidemic numbers, that autoimmune ailments were barely known, and childhood autism did not exist.
Vaccine Contamination
There is also the problem of contamination that has always plagued vaccine makers. During World War II a yellow fever vaccine manufactured with human blood serum was unknowingly contaminated with hepatitis virus and given to the military. As a result, more than 50,000 cases of serum hepatitis broke out among American troops injected with the vaccine.
In the 1960s it was discovered that polio vaccines manufactured in monkey kidney tissue between 1955 and 1963 were contaminated with a monkey virus (Simian Virus, number 40). Although this virus causes cancer in experimental animals, health authorities insist it does not cause problems in humans. But evidence of SV40 genetic material has been popping up in human cancers and normal tissue. Researchers are now connecting SV40-contaminated polio vaccines to an increasing number of rare cancers of the lung (mesothelioma) and bone marrow (multiple myeloma). In a 1999 report, SV40 DNA was detected in tissue samples from four children born after 1982. Three were kidney transplant patients, and a fourth had a kidney tumor. Could SV40 be passed on from parents to their children?
No one knows for sure.
Covert Vaccine Experiments
Using kids as guinea pigs in potentially harmful vaccine experiments is every parents' worst nightmare. This actually happened in 1989-1991 when Kaiser Permanente of Southern California and the Centers for Disease Control (CDC) jointly conducted a measles vaccine experiment. Without proper parental disclosure, the Yugoslavian-made "high titre" Edmonston-Zagreb measles vaccine was tested on 1,500 poor, primarily black and Latino, inner city children in Los Angeles.
Highly recommended by the World Health Organization (WHO), the high-potency experimental vaccine was previously injected into infants in Mexico, Haiti, and Africa. It was discontinued in these countries when it was discovered that the children were dying in large numbers.
Unbelievably, the measles vaccine caused long-term suppression of the children's immune system for six months up to three years. As a result, the immunodepressed children died from other diseases in greater numbers than children who had never received the vaccine. Tragically, African girl babies in the experiment were given twice the dose of boys, and therefore suffered a higher death rate. The WHO pulled the vaccine off the market in 1992.
Ironically, the E-Z measles vaccine tested by Kaiser on minority babies was supposed to increase immunity in younger infants. Instead, the vaccine produced the opposite effect. A Los Angeles Times editorial (June 20, 1996) assured readers that "none of the 1,500 was injured by the unlicensed vaccine" and called upon the CDC to ensure that experiments like the E-Z measles vaccine could never occur again.
One wonders how many secret vaccine experiments are conducted by health authorities that never come to the attention of the public. During the two-year measles experiment I was employed by Kaiser and I never knew anything about it until I read the report in The Times five years later, in 1996.
In the poor inner cities across the country the number of asthma cases is exploding and health officials don't know why. According to the CDC, 5000 asthma deaths occur annually; and it is estimated that 17.3 million people (4.8 are children) suffer from the disease, up from 6.7 million in 1980. Asthma usually begins before age 6, and blacks are two to three times more likely to die from asthma than whites. In the Bronx and Harlem sections of New York City, the hospitalization rate for asthma is 21 times higher than in the more affluent areas of the city.
Could the sharp rise in asthma in poor children be connected with immunosuppression caused by a barrage of vaccines, as well as a lack of quality medical care and insurance, poor diet, and environmental factors? The possible connection of immunosuppressive vaccines to diseases like asthma has never been raised by health officials .
With vaccine experiments frequently performed in Africa and now on black Americans, no wonder one out of every four African-Americans believes AIDS was developed as a genocide program by the U.S. government to exterminate the black population.
But vaccine experiments in the 1990s have not been limited to blacks. Millions of female Mexicans, Nicaraguans and Filipinos have been duped into taking tetanus vaccines, some of which contained a female hormone that could cause miscarriage and sterilization. In 1995, a Catholic human rights organization called Human Life International accused the WHO of promoting a Canadian-made tetanus vaccine laced with a pregnancy hormone called human choriogonadotropic hormone (HCG). Suspicions were aroused when the tetanus vaccine was prescribed in the unusual dose of five multiple injections over a three month period, and recommended only to women of reproductive age.
When an unusual number of women experienced vaginal bleeding and miscarriages after the shots, a hormone additive was uncovered as the cause.
Apparently the WHO has been developing and testing anti-fertility vaccines for over two decades. Women receiving the laced tetanus shot not only developed antibodies to tetanus, but they also developed dangerous antibodies to the pregnancy hormone as well. Without this HCG hormone the growth of the fetus is impaired. Consequently, the laced vaccine served as a covert contraceptive device. Commissioned to analyze the vaccine, the Philippines Medical Association found that 20 percent of the WHO tetanus vaccines were contaminated with the hormone. Not surprisingly, the WHO has denied all accusations as "completely false and without basis," and the major media have never reported on the controversy. For further details on this issue, consult the Human Life International website (http://www.hli.org/).
Newly approved vaccines may also pose serious risks. In October 1999 a vaccine against "rotavirus" infection (which causes most cases of childhood diarrhea) was pulled off the market. One year after the RotaShield vaccine was inoculated into over a million infants, it was found to increase the risk of bowel obstruction. Almost 100 cases of bowel obstruction were reported to the government, and twenty infants developed bowel obstructions within one or two weeks after receiving the vaccine.
Vaccine Manufacture and Associated Dangers
Although the public has heard about side effects of vaccines, most people are clueless about the manufacture of vaccines. Few people know that viruses used in vaccine production need to be grown on animal parts like monkey kidneys, or in chicken embryos, or in human and fetal "cell lines."
Harvesting viruses in human cell-lines can be perilous because some human cell lines are derived from cancer cells.
In AIDS & The Doctors of Death I wrote about the development of the first human "HeLa" cell line - an "immortal" cell line used extensively in cancer and vaccine research for decades. Henrietta Lacks was a young black woman from Baltimore who died from a highly malignant cervical cancer in 1951. Small pieces of her tumor were donated to a laboratory specializing in tissue cell culture. In those days most attempts to grow human cells outside the body failed. But for some unknown reason Henrietta's cancer cells grew vigorously and became known as the first successful human tissue cell line in history - the now famous HeLa cell line commemorating the legendary HEnrietta LAcks.
Henrietta's cells were kept alive by feeding them a witches' brew of beef embryo extract (the ground-up remains of a three-week-old, unborn cattle embryo); fresh chicken plasma obtained from the blood of a live chicken heart; and blood from human placentas (the placenta is the sac that nurtures the developing fetus and contains powerful hormones).
It is now suspected that a sexually-transmitted papilloma virus is the cause of cervical cancer. And it is anybody's guess how many other chicken, cattle, and human viruses are incorporated into the HeLa cell line, but none of this possible viral contamination seems to bother scientists who have extensively used the cells in cancer research. What laboratory scientists did eventually discover was that HeLa cells proved so hardy that they frequently contaminated other tissue cell lines used in cancer and cancer virus research.
In the late 1960s when widespread HeLa cell contamination problems were uncovered, scientists were shocked and embarrassed to learn that millions of dollars worth of published cancer experiments were ruined. "Liver cells" and "monkey cells" that were used in cancer experiments turned out to be Henrietta's cancer cells in disguise. Benign cells which supposedly "spontaneously transformed" into malignant cells were found to be cells contaminated with cancerous HeLa cells.
The serious problem of HeLa cell contamination in cancer and vaccine research is revealed in Michael Gold's A Conspiracy of Cells: One Woman's Immortal Legacy and the Medical Scandal It Caused. Even Jonas Salk, who developed the legendary Salk polio vaccine, was fooled when HeLa cells contaminated his animal cell lines. He admitted this years later in 1978 before a stunned audience of cell biologists and vaccine makers. In experiments performed in the late 1950s on dying cancer patients, Salk tried injecting them with a cell line of monkey heart tissue - the same cell line he used to harvest polio virus for his famous vaccine. He hoped the monkey cell injections would stimulate the immune system to fight cancer. However, when abscesses developed at the site of injections Salk began to suspect that he might be injecting HeLa cells rather than monkey cells, and he stopped the experiment.
Mark Nelson-Rees, a HeLa cell expert and one of the 1978 conference attendees, offered to test Salk's line if it was still available. Salk graciously agreed and the monkey cells indeed proved to be HeLa cells which had invaded and taken over the monkey cell line. According to author Gold, Salk thought there were adequate ways to separate viruses from the tissue cell lines they were harvested in, so that it really didn't matter what kind of cells were used. Even if vaccines weren't filtered, and even if whole cancer cells were injected directly into a human, Salk believed they would be rejected by the body and cause no harm. In those days doctors didn't much believe in cancer-causing viruses. Nowadays, no researcher would dare try injecting cancer cells into a human being. But in the 1950s Salk had done it accidentally. He had injected HeLa cells into a few dozen patients and it hadn't bothered him a bit.
Is There a Vaccine Contamination Connection to AIDS?
Most people assume vaccines are "sterile" and germ free. But sterilizing a vaccine can destroy the necessary immunizing protein that makes it work. Thus, contaminating viruses or viral "particles" can sometime survive the vaccine process.
Animal viruses are also contained in fetal calf serum, a blood product commonly used as a laboratory nutrient to feed various tissue cell cultures. Vaccine contamination by fetal calf serum and its possible relationship to HIV was the subject of a letter by J. Grote, published in the Journal of the Royal (London) Society of Medicine in October 1988. Bovine visna virus (which looks similar to HIV) is a known contaminant of fetal calf serum used in vaccine production and virus-like particles have been detected in vaccines certified for clinical use. Grote warns that "It seems absolutely vital that all vaccines are screened for HIV prior to use, and that bovine visna virus is further investigated as to its relationship to HIV and its possible role in progression towards AIDS ."
Could virus-contaminated vaccines lie at the root of AIDS? A few researchers, including myself, who believe HIV was "introduced" into gays during the experimental hepatitis B vaccine trails when thousands of homosexuals were injected in Los Angeles, San Francisco, and New York, during the years 1978-1981.
The AIDS epidemic first erupted in gays living in those cities in 1981. In 1980, one year before, already 20% of the gays inoculated in Manhattan with the experimental vaccine were already HIV-positive. This was several years before definite AIDS cases were diagnosed in Africa. In the early 1970s the hepatitis B vaccine was developed in chimpanzees, now wildly accepted as the animal from which HIV supposedly evolved.
Hepatitis B vaccine was developed to protect people from the sexual spread of the hepatitis B virus. Now the government recommends that all newborn babies be given the vaccine. Such recommendations do not make sense to many parents. And people are still fearful of the hepatitis B vaccine because of its original connection to gay men and AIDS. The original experimental vaccine was made from the pooled blood serum of hepatitis-infected homosexuals and, as mentioned, serum-based vaccines cannot be sterilized.
Another theory of AIDS is that HIV originated from polio vaccines contaminated with chimp and monkey viruses, and administered to Africans in the late 1950s. In The River: A Journey to the Source of HIV and AIDS , published in 1999, Edward Hooper details how polio vaccine was made using monkey (and possibly chimp) kidneys and how the ancestor virus of HIV could have jumped species (via the vaccine) to produce the outbreak of AIDS in Africa. Hooper's well-researched book greatly expands the polio vaccine theory of AIDS first reported by Tom Curtis in Rolling Stone magazine in 1992, and The River is a must-read for anyone interested in the possible man-made origin of AIDS.
Other researchers think it more likely that the various WHO-sponsored vaccine programs (particularly the smallpox program) in Africa in the 1970s are responsible for unleashing AIDS in Africa in the 1980s. Hooper, who has worked as a United Nations official, has discounted the research pointing to AIDS as a man-made disease, as proposed by Dr. Leonard Horowitz in Emerging Viruses, and in my two books AIDS & The Doctors of Death: An Inquiry into the Origin of the AIDS Epidemic: and Queer Blood: The Secret AIDS Genocide Plot.
Horowitz and I both suspect contaminated smallpox vaccines as the source of HIV In Africa. Certainly the smallpox (vaccinia-cowpox) virus is an excellent virus to use for the genetic engineering of new, multipurpose vaccines. By splicing into the DNA genes of the vaccinia virus, scientists can add on parts of disease-producing viruses like influenza, hepatitis, and other viruses. The safety of this technique has not been fully evaluated, prompting one vaccine maker at a Vaccinia Virus Workshop in 1984 to ask if this could lead to another form of AIDS.
The Vaccine Connection to Gulf War Illness and Huntsville Mystery Illness
The cause of Gulf War Illness (GWI) is unknown. For years this debilitating illness (which now affects one-half of the Gulf War vets) has been ignored by Pentagon officials who claim the disease does not exist and that vets are simply reacting to stress. GWI is also thought to be contagious. Vets insist their disease has been passed on to spouses, other family members, and even pets.
Some people suspect multiple vaccines, particularly the experimental anthrax vaccine, are implicated in the disease. Currently, soldiers who refuse to take the mandatory anthrax vaccine are being court-martialed and dismissed from the service.
Researchers Dr. Garth Nicolson and his wife Nancy have found a tiny bacterial microbe (a "mycoplasma") in the blood of nearly half the ill vets with GWI. Amazingly, this infectious agent has a piece of HIV (the AIDS virus) attached to it. This microbe could never have occurred naturally. On the contrary, the composition of the microbe suggests a man-made and genetically-engineered biological warfare agent.
Garth Nicolson's scientific credentials are impeccable. For 16 years he was a professor of medicine at the University of Texas M.D. Anderson Cancer Center in Houston, as well as professor of pathology and laboratory medicine at the University of Texas Medical School, also in Houston. Nancy Nicolson, a molecular biophysicist, was on the faculty at Baylor College of Medicine.
Six months after returning home from the Gulf war, the Nicolson's daughter contracted GWI. Her mother Nancy had contracted a similar illness in 1987 when she was working with Mycoplasma incognitus in infectious disease research. Finally suspecting that this research had biowarfare implications, Nancy Nicolson became a whistle-blower and angered officials. As a result, she believes she was deliberately infected with the mycoplasma. After partial paralysis and a long illness, she finally regained her health with the antibiotic Doxycycline.
The Nicolson's discovery of a similar mycoplasma (but without the attachment of HIV) in a mysterious illness that erupted in the Huntsville, Texas area among prison guards and their families has all the drama of a The Movie of the Week. Although the Huntsville disease broke out in the late 1980s (shortly before the Gulf War), it has many of the same signs and symptoms of GWI. Many locals are convinced the sometimes deadly disease originally spread from prisoners incarcerated in several large prisons around Huntsville.
In experiments conducted during the 1970s and 80s, the prisoners were inoculated with flu vaccines containing genetically engineered viruses and mycoplasma . It is suspected that vaccines were being covertly developed and deployed as biological warfare weapons. Nobel prize winner James Watson, world famous for his discovery of the molecular structure of DNA and a leading researcher of the still ongoing Human Genome Project, was involved in these prison experiments. The guards are convinced the Huntsville mystery illness is intimately connected to these experiments, jointly conducted by the Medical School and the military. Like GWI, health officials deny the disease exists.
The Nicolsons continued to develop antibiotic treatments, which have helped some vets. But they have paid a heavy price for their controversial research and unprecedented discoveries. Garth Nicolson was forced to resign from M.D. Anderson in 1996. His career and reputation destroyed, the Nicolsons have since moved to California and head The Institute for Molecular Medicine in Huntington Beach.
Dangerous Animal and Human Cell Lines in Vaccine Manufacture
In an effort to quell concerns about the safety of vaccines, scientists are finally taking another look at the "non-infectious" particles of bird-cancer viruses (avian leukosis virus) in the mumps/measles/rubella vaccines routinely given to kids. Could this be the reason the FDA held a meeting in September, 1999, to reconsider using human tumor cell lines (like HeLa) rather than monkey kidneys and chicken embryos which are no longer guaranteed 100% safe?
Writing in Science, Gretchen Vogel admits public trust in vaccines is a bit shaky. In Wales anti-vaccine parents are holding "measles parties" to infect their children with the disease rather than vaccinate them. She cites the danger of using immortal cell lines for live vaccine production because cancer genes or other hazardous factors might be transferred to people receiving vaccines. But manufacturers also realize vaccine critics are becoming more wary of vaccines made in animal and bird tissue. And vaccine makers want to use immortal cell lines to grow their viruses because obviously viruses can't grow on their own.
The big question everyone seems to avoid is: Can vaccines cause cancer? There is certainly evidence connecting contaminated vaccines to AIDS. And HIV is a cancer-causing virus. Robert Gallo, the co-discoverer of HIV in 1984, has clearly stated AIDS is an epidemic of cancer.
Animal and avian viruses can contaminate vaccines and have all been studied as cancer-causing agents. And cancer and vaccine research would be much more difficult without the use of cell lines, some of which are derived from cancer.
Vaccines and Public Paranoia
Is the fear of vaccines justified? It is clear that vaccines can be dangerous. The contamination of vaccines is a reality, and vaccine experiments can be hazardous to one's health. AIDS, unknown two decades ago, is now an increasing worldwide epidemic with millions of death predicted for the next decade. Could vaccines contaminated with cancer-causing and immunosuppressive viruses unleash new plagues in the New Millennium? If so, the new plagues may be far worse than the diseases we eradicated by vaccine programs in the twentieth century.
References
"Anti-diarrheal vaccine for babies recalled," Los Angeles Times, October 16, 1999.
Butel JS, Arrington AS, Wong C, et al.: Molecular evidence of simian virus 40 infections in children. J Infect Dis 180:884-887, 1999.
Cantwell A: AIDS & the Doctors of Death. Aries Rising Press, Los Angeles, 1988.
Cantwell A: Queer Blood. Aries Rising Press, Los Angeles, 1993.
Gold M: A Conspiracy of Cells. State University of New York Press, Albany, 1986.
Hooper E: The River: A Journey to the Source of HIV and AIDS. Little, Brown and Company, Boston, 1999.
Horowitz L: Emerging Viruses: AIDS & Ebola. Tetrahedron, Inc, Rockport, MA, 1996.
Jaroff Leon: "Vaccine Jitters," TIME, September 13, 1999.
Likoudis P: "Gulf war illness probe to advance with new study," The Wanderer, January 21, 1999.
"Measles, government and trust " (Editorial), Los Angeles Times, June 20, 1996.
Miller NZ: Immunization: Theory vs Reality. New Atlantean Press, Santa Fe, 1996.
Miller NZ: Immunizations: The People Speak! New Atlantean Press, Santa Fe,
1996.
Quinnan GV: Vaccinia Viruses as Vectors for Vaccine Antigens. Elsevier, New York, 1985.
Stolberg SG: "Poor fight baffling surge in asthma," New York Times, October 18, 1999.
[Alan Cantwell is a physician and AIDS researcher. His book on the man-made epidemic of AIDS entitled AIDS & The Doctors of Death: An Inquiry into the Origin of the AIDS Epidemic, is available on the Internet through Amazon.com, Barnes and Noble, or through Book Clearing House at 1-800-431-1579]. [word count 3800]
http://www.sevendaysvt.com/-thisweek/feat/01.html
Bad Shot?
BY KEN PICARD
It’s never easy for a parent to challenge accepted medical wisdom about what’s best for a child’s health, particularly when it comes to early-childhood shots. Vaccines are now considered such an essential part of pediatric health care that the government recommends children receive 39 doses of 12 different vaccines by the age of 5. Refusing to vaccinate a child against debilitating and deadly diseases such as polio, smallpox, measles and rubella makes a parent seem negligent in many people’s eyes. Most public schools, colleges and universities won’t register a student who isn’t inoculated. In most places, in fact, not inoculating is illegal. Still, each year a small number of parents choose not to vaccinate their children because of religious, philosophical or health concerns — something the law permits in Vermont. In 1995, Burlington attorney Jim Schumacher was clerking for a law firm that represented a woman involved in a child-custody battle with her ex-husband over her refusal to vaccinate their children. She had heard horror stories about the possible consequences of vaccines, including autism, learning disabilities, diabetes and, in rare instances, brain damage and death.
Schumacher’s job was to summarize 40 articles supporting the ex-wife’s position. Among them was an obscure journal article claiming that, back in the 1950s and ’60s, the polio vaccine was widely contaminated with a potentially carcinogenic monkey virus. “I was just blown away,” Schumacher recalls today. “I came home and told this to [my wife] and said, ‘We should write about this. This is just incredible!’”
Over the next few years, Schumacher and his wife, investigative reporter Debbie Bookchin, delved into the history of the polio vaccine and the growing debate in the scientific community about the possible health effects of SV40, a little understood simian virus. Unwittingly, the Burlington couple had stumbled upon what they would later call “one of the biggest blunders in medical history.” Neither Bookchin nor Schu-macher is a scientist, though for a time, Schumacher considered following in his father’s footsteps and studied to become a physician. Bookchin, daughter of the internationally known author and social ecologist Murray Bookchin, has been a journalist since 1979 and spent much of the 1980s working for the Rutland Herald and the Vanguard Press. Since then, the award-winning writer has been published in numerous newspapers and magazines, including The New York Times, The Boston Globe, Boston Magazine, The Atlantic Monthly, The Nation and Utne Reader. Schumacher, who has also been published nationally, is an attorney and now works as a consultant for municipalities around the country. He and Bookchin met in the early 1990s while they were both working for Congressman Bernie Sanders.
The couple soon began piecing together the facts behind a frightening but irrefutable story: Between 1954 and 1963, roughly half of the U.S. population — nearly 100 million Americans and untold millions more worldwide — were given a polio vaccine that was contaminated with a cancer-causing monkey virus. For decades, this story remained virtually unknown outside of scientific circles.
Now, on the 50th anniversary of Jonas Salk’s test trials for the polio vaccine, Bookchin and Schumacher have released a meticulously researched and thoroughly documented book, The Virus and the Vaccine, tracing the development of the polio vaccine and the ensuing discovery of SV40. It’s a story eerily reminiscent of The Hot Zone, only more disturbing, considering the staggering number of people who were exposed to this carcinogenic agent.
But The Virus and the Vaccine is more than a fascinating history lesson. It’s also a cautionary tale about how the federal regulatory agencies that were supposed to safeguard consumer health not only allowed a dangerous contaminant to be given to millions of healthy children, but also kept quiet about it for years out of fear of disrupting the public’s faith in vaccines.
Worse, once the source of that contamination was identified — the cancer-causing virus was traced to rhesus monkey kidneys used to produce the polio vaccine — the government still refused to mandate a safer method of vaccine production, even though viable alternatives were being used successfully in other countries.
Perhaps most egregious, Book-chin and Schumacher said in a recent interview with Seven Days, newer polio vaccines may have been contaminated with SV40 as recently as January 2000, when the last vaccines produced using monkey kidneys were removed from the market. This potentially disastrous contamination occurred decades after vaccine manufacturers and the U.S. government claimed that the problem had been corrected.
In January 1997, Bookchin and Schumacher pitched the story to The Boston Globe and followed that article with another in The Atlantic Monthly in February 2000. Both pieces served as the basis for The Virus and the Vaccine, their first book together.
Though the 380-page volume is steeped in detailed and well-annotated science, it’s an accessible read. The pair has crafted a real page-turner that is part detective story, part government cover-up. And like any good exposé, it lays out the tangled web of bureaucratic stonewalling, scientific dogma and financial self-interest that for decades concealed a serious health risk from the public. The story’s colorful cast of characters includes powerful and egotistical men who refused to question
their own deeply entrenched beliefs, as well as unsung heroes who toiled in virtual anonymity and sacrificed their professional reputations and careers in the name of scientific truths.
“You really think of science as kind of a rarefied, disinterested pursuit based completely on facts and objective truths,” says Bookchin. “And the government in the United States is supposed to play a disinterested, activist role. But, as the story of SV40 shows, that hasn’t always worked the way it’s supposed to.”
The polio vaccine was,
literally, the shot felt around the world. Salk’s discovery all but eradicated — in the industrialized world, at least — a debilitating and deadly childhood disease. The U.S. government’s polio-eradication program laid the groundwork for the mass-inoculation programs that became the cornerstone of American public-health policy.
Many Americans today are too young to have known the fear and horror that once accompanied the annual start of “polio season.” At its peak in 1952, about 58,000 new cases of polio were diagnosed — one in every 3000 Americans — killing more children that year than any other infectious disease. “Polio was becoming America’s bête noire,” Bookchin and Schumacher write, “as dangerous as the Red Menace, and just as insidious — an unseen enemy within, a crippler and killer that seemed unstoppable, viciously cruel, with a penchant for young victims.”
Ironically, the wild poliovirus, which seemed to rage haphazardly through the population proved surprisingly difficult to grow in a laboratory. Unlike bacteria, viruses require a “substrate” of living cells to reproduce, and since laboratory rodents are unaffected by it, the next logical choice was the rhesus monkey. In 1950, Salk, then at the University of Pittsburgh, discovered that ground monkey kidneys could produce a high yield of the poliovirus in record time, and at a fraction of the cost of
earlier methods.
Salk’s choice of rhesus monkey kidneys proved to have monumental consequences. The kidney is a storehouse for all the microorganisms filtered from the blood. But for researchers at the time, the easy accessibility and cheap supply of rhesus monkey kidneys made them an ideal growth medium.
By the summer of 1952, Salk believed he had perfected the technique of “inactivating” the poliovirus and began conducting vaccine field trials. They were an unqualified success. Two years later, on April 26, 1954, a 6-year-old boy named Randy Kerr of Falls Church, Virginia, became America’s first “polio pioneer,” one of 2 million children in 44 states inoculated with the Salk vaccine or an identical-looking placebo. Salk was awarded the Nobel Prize in medicine for his development, and his name became synonymous with the polio cure.
However, less-publicized problems arose almost immediately. Previously unknown strains of simian viruses began contaminating batches of the vaccine. The first “SV1” was isolated in February 1954; the second, just months later. Initially, researchers didn’t worry much about these rogue viruses. Given the deadly scourge of polio, their attitude was “better the devil you know than the devil you don’t,” says Bookchin.
But soon a more urgent crisis shook America’s confidence in the Salk vaccine. In 1955, vaccine manufacturer Cutter Laboratories distributed a batch of vaccine that inadvertently contained live poliovirus. The so-called “Cutter incident” resulted in 260 people contracting polio, including 200 cases of paralysis and 11 deaths. Investigations revealed that other vaccine manufacturers were also having serious problems with rogue viruses contaminating their vaccines. But while the immediate problem may have been addressed, its underlying cause — the practice of using monkey kidneys — continued unabated. “Despite the Cutter deaths, the lesson — as far as the federal government was concerned — was that there was no need for increased surveillance of the manufacturers,” write Bookchin and Schumacher.
By 1960, tens of millions of Americans had received the vaccine, seemingly with no major problems. Meanwhile, simian viruses continued to crop up, though scientists considered them little more than a nuisance. But one researcher, Bernice Eddy, at the government’s newly formed Division of Biologic Standards, began investigating the new field of “viral oncology” — the relationship between viruses and cancer. Eddy had discovered that laboratory mammals injected with certain mouse viruses developed tumors. Would a monkey virus do the same thing in humans? And if it did, were any of the simian viruses that had contaminated early batches of the polio vaccine carcinogenic?
Eddy’s public suspicions about the safety of the polio vaccine not only impugned the reputation of her agency, but also proved to be professional suicide for her. Far from being commended by her bosses for her scientific curiosity, Eddy was effectively stripped of all her responsibilities in vaccine-control work and literally relegated to a former broom closet on the campus of the National Institutes of Health. “Millions of children would continue to receive live SV40 as part of their Salk injections,” write Bookchin and Schumacher. “As had been the case with the Cutter incident, the official conclusion was that the nation’s polio program was simply too important to interrupt, despite a known problem with the vaccine. But, unlike Cutter, this time the federal government would keep the news to itself.”
In 1963, a highly publicized epidemiological study conducted by the NIH’s Joseph Fraumeni concluded that people who had received doses of SV40-contaminated vaccines were no more likely to contract cancer than those who had not. As Schumacher and Bookchin found, that study was “deeply flawed.” Still, for the next three decades, it was a widely accepted medical “fact” that SV40 was harmless to humans.
Thirty years after Eddy’s findings, NIH scientist Michele Carbone discovered a link between SV40 and malignant mesothelioma, a deadly cancer of the lungs, heart and abdominal cavity that was virtually unknown before 1955 but now kills about 2500 Americans each year.
Although mesothelioma is usually tied to asbestos exposure, recent studies suggest that those who have SV40 in their bodies may be more susceptible to the disease. Scientists don’t yet understand why, though a researcher at the University of Vermont has been looking into the links between SV40 and cancer. Dr. Brooke Mossman is the director of UVM’s Environmental Pathology Department and an internationally renowned expert on mesothelioma. Next month, she plans to submit a multi-million-dollar grant request to the NCI with Dr. Carbone, now associate professor of pathology at Loyola University Medical School in Chicago. As Bookchin learned last week, their goal is to study how mesothelioma originates, its relationship to SV40 and genetics, and whether the simian virus makes the deadly cancer even more pernicious.
Today, certain facts about SV40 are undisputed. The U.S. Centers for Disease Control and Prevention (CDC) and the National Cancer Institute (NCI) admit that between 1955 and 1963, an unknown number of Salk vaccines were contaminated with SV40 and given to millions of Americans. Both agencies also acknowledge that SV40 has been shown to cause cancer in laboratory animals.
However, those same agencies also contend that once the SV40 contamination was confirmed, no further vaccines were contaminated and no one else was infected. For example, the CDC website notes, “The majority of evidence suggests there is no causal relationship between receipt of SV40-contaminated vaccine and cancer.” That webpage, Shumacher points out, hasn’t been updated for more than two years.
The NCI also seems to be clinging to outdated information. “Over the last four decades, an intensive research effort has been made to determine whether this route of exposure to SV40 has caused health problems in people, including cancer,” the NCI website notes. “Epidemiology studies involving decades of observations in the United States and Europe have failed to detect an increased risk in those likely to have been exposed to the virus.”
But even with a growing body of evidence linking SV40 to cancer, there has been very little public funding in the United States for SV40 research that could lead to cancer therapies. Just as importantly, Bookchin and Schumacher say, no one even knows if SV40 is spreading in the population, or if it is passed from parent to child.
Overseas, there is considerably more open-mindedness about SV40. Researchers in England, Italy, Japan, China and elsewhere have completed more than 90 peer-reviewed studies linking SV40 to at least four different types of human cancer. As Shumacher said last week, U.S. public-health officials’ unwillingness to revisit their own science about SV40 is “unconscionable and disgraceful,” especially since some virologists familiar with SV40 now estimate that as many as one in 10 Americans carries the virus.
Moreover, the U.S. government’s resistance to reopening the case on SV40 may be leaving government scientists behind the curve. Just a few weeks ago, for example, the M.D. Anderson Cancer Center in Houston announced that in a study of tumors removed from people newly diagnosed with non-Hodgkin’s lymphoma, about half showed evidence of SV40. Those researchers believe that SV40 “participates” in the development of the blood cancer, for which there is no other known cause, but whose incidence has doubled in the United States in the last 30 years.
Despite their findings, Bookchin and Schumacher are not blanket opponents of vaccination programs — their own daughter was vaccinated, they admit. “Ultimately, vaccines are critical public-health tools. They absolutely are,” Bookchin says emphatically. “What you want is a situation in which consumers feel they can rely on the judgment of a governmental agency that something is safe.”
She adds, however, “There’s a fear [in government] that if any vaccine is deemed unsafe, in particular the polio vaccine, which is the sacred cow of vaccines… that people may become reluctant or fearful in general about vaccines.”
This view is shared by Barbara Loe Fisher, cofounder and president of the National Vaccine Information Center, a Virginia-based consumer-advocacy group that’s pushing for more funding and research into vaccine safety. Fisher, whose own son was permanently injured by an adverse reaction to the DPT vaccine, was a prime mover behind a 1986 federal law known as the National Childhood Vaccine Injury Act. That legislation created a no-fault compensation system for families whose children have been injured or killed by reactions to vaccines. Since 1990, the program has paid out more than $1 billion to more than 1000 families nationwide.
In a recent phone interview from her home in Virginia, Fisher called The Virus and the Vaccine “a critically important work” that “exposes the true lapses in judgment and cavalier attitudes at the federal level toward vaccine safety in general.” Far too little research has been done, she says, to understand the impact that vaccines have on children’s immature immune systems. Each year, the CDC receives between 12,000 and 14,000 reports of adverse reactions to vaccines, a number, Fisher believes that reflects only a small fraction of the actual incidence. “It’s a tiny drop in the bucket of what’s occurring out there,” she says.
Fisher also argues that vaccines may be at least partly to blame for the dramatic rise in a variety of childhood illnesses and disorders. For example, the rates of learning disabilities, ADHD and childhood asthma in children in the United States have doubled in the last two decades. The rate of diabetes has tripled, and there’s a 200 to 600 percent increase in autism. The latter, some suspect, may be the result of the measles-mumps-rubella vaccine.
The lessons to be learned from The Virus and the Vaccine reach well beyond childhood vaccination programs. After 9/11 the Bush administration, fearing a biological weapons attack, tried to implement a nationwide smallpox vaccination program for all health-care workers. But when tens of thousands of medical professionals refused to subject themselves to the vaccine — saying, in effect, that it posed a greater health hazard than the risk of contracting smallpox in the wild — the program was scuttled.
Similar fears have arisen among U.S. military personnel and their families in light of the health problems experienced by returning Gulf War veterans. “We have talked to scientists who are absolutely convinced that the Gulf War Syndrome is, at least in part, due to the anthrax vaccine, along with 17 other vaccines that were given to soldiers in one day,” says Schumacher.
Meanwhile, deadly new diseases continue to crop up with alarming frequency — West Nile, SARS avian flu — forcing scientists to investigate how all these animal viruses are jumping the species barrier. “That’s why dismissing SV40 out of hand just doesn’t make any scientific sense,” Shumacher says. “Even if it turns out after years and years of good research that the conclusion is that it’s basically okay, given the millions of people who were exposed, why wouldn’t we want to know for sure?”
Polio Vaccine Might Have Carried Virus
NewsMax.com Wires
Wednesday, Sept. 10, 2003
WASHINGTON -- Some of the polio vaccine given to millions of American children from 1962 until 2000 could have been contaminated with a monkey virus that shows up in some cancers, according to documents and testimony to be delivered to a House committee Wednesday. The vaccine manufacturer said such claims "don't have any validity," and the Centers for Disease Control and Prevention agrees.
Some batches of the first polio vaccine used from 1955 until 1962 were contaminated with the monkey virus. The virus has also been found in some cancer in humans, although it has not been determined that the virus caused the cancer. Between 10 and 30 million Americans may have received a contaminated dose of that vaccine, according to the Centers for Disease Control and Prevention.
The monkey virus is suspected of causing cancer in laboratory animals, including brain cancers, bone tumors and a usually fatal cancer in the membranes around the lungs called mesothelioma.
But it has been widely assume that the replacement for the Salk vaccine, a live oral polio vaccine called the Sabin oral vaccine, was free of Simian Virus 40, or SV40. That vaccine was used from 1963 until 2000, when it too was replaced.
Documents set to be delivered to the House Subcommittee on Human Rights and Wellness appear to show that the original "seeds" used to produce the Sabin vaccine could have been tainted with SV40; that the company that manufactured the vaccine, Wyeth Lederle, may have used Rhesus monkeys -- which are more likely to carry the disease -- rather than the African Green monkeys it says it used, according to company documents; and that the company may not have performed all of the screening tests required.
Stanley P. Kops, an attorney who represents clients he says were "paralyzed, killed and-or severely damaged" by the vaccine used until 2000, will present the documents. Kops alleges in his written testimony that the manufacturer and the FDA were negligent and failed to protect children.
"There is a history of negligence involving this vaccine manufacturer and the regulators," Kops says in his written testimony. "The vaccine safety tests were not submitted [to the FDA], the regulators did not look, and infants in the United States became paralyzed or died, and there are now clear instances of cancer reported in the children and individuals who received this product."
A spokesperson for Wyeth Lederle, Natalie de Vane, said Kops is wrong.
No Validity
"These claims don't have any validity," said de Vane. "In response to allegations such as this, the FDA went back and tested batches that were released between 1976 and 1989 and using the most advanced methods of testing available, found no evidence of SV40. We have always conducted extensive screening and testing of our products. The FDA monitors this."
A Food and Drug Administration spokesperson was unaware of the allegations. A CDC fact sheet says that "all of the current evidence indicates that polio vaccines have been free of SV40 since 1963."
Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, will tell the committee that the polio vaccine story is particularly troubling. The center does not accept money from vaccine manufacturers.
"At the hear of this tragic story is a violation of the public trust and the informed consent ethic," Fisher says in her testimony.
Kops says his documents show the following:
-- A decades-old letter from Dr. Albert B. Sabin to Lederle Laboratories saying that the original "seed" used to make the Sabin vaccine may not be free of SV40 contamination. The letter says that Sabin "could not be certain that there may not be a trace of SV40 virus in this material."
Scand J Infect Dis. 2001;33(8):630-1.
Polio vaccine virus-associated meningoencephalitis in an infant with transient hypogammaglobulinemia.
Inaba H, Hori H, Ito M, Kuze M, Ishiko H, Asmar BI, Komada Y.Author information AbstractThe case of an infant with transient hypogammaglobulinemia who developed meningoencephalitis, retinitis and sensorineural hearing loss is presented. The neurovirulent variant of the Sabin type 2 oral poliovirus vaccine was detected in cerebrospinal fluid and stool.
PMID:11525363 [PubMed - indexed for MEDLINE]
Publication Types, MeSH Terms, Substances
Polio vaccine virus-associated meningoencephalitis in an infant with transient hypogammaglobulinemia.
Inaba H, Hori H, Ito M, Kuze M, Ishiko H, Asmar BI, Komada Y.Author information AbstractThe case of an infant with transient hypogammaglobulinemia who developed meningoencephalitis, retinitis and sensorineural hearing loss is presented. The neurovirulent variant of the Sabin type 2 oral poliovirus vaccine was detected in cerebrospinal fluid and stool.
PMID:11525363 [PubMed - indexed for MEDLINE]
Publication Types, MeSH Terms, Substances
Beyond Breach of Trust
About two years ago, the CDC removed from its website a page about SV40, a monkey virus known to be carcinogenic in lab animals, found in batches of the polio vaccine in 1960. (1) They no longer wanted the information that easily available to you - both the fact that it was indeed discovered, and that in the 80's pathologists began detecting markers for the virus in human carcinomas.
That the virus was found in the vaccine is historical fact, undisputed. The manufacturers were required to test the vaccine for 14 days to determine which batches were contaminated, but, inexcusably, though contaminated batches were indeed discovered, the government has refused to respond when asked whether they were ever recalled. We must assume they remained on the shelves, and in some instances continued to be used.
More insidious, we don't know whether some or all of the polio vaccine administered through the years, down to today, is contaminated. Janine Roberts is an intrepid researcher. In her book, Fear of the Invisible, she mentions evidence she'd discovered that had the assigned test period for the vaccine been longer, more contaminated batches would likely have been found, and that government officials were well aware of it. To the point, had the test period been six or eight weeks instead of two, all batches of the vaccine might have been found contaminated.
Stanley Kops is an attorney with much experience investigating the issue of SV40. In 2000 he published an article in the journal, Anticancer Research, in which he stated, based on a bevy of legal documents he procured through discovery motions:
"Whether SV40 was removed from Sabin Oral Polio Virus strains remains a serious and unanswered question.'' (2).
Moreover, in a conversation with Mr. Kops almost two years ago, he corroborated Janine Roberts' statement - that yes, his research showed that the government knew full well that a longer test period could have resulted in the detection of SV40 contamination in several or many more batches of the vaccine, possibly all of them.
The threats to our health are ubiquitous, from genetically modified foods to the macabre clouds that slowly integrate behind the trails left by planes doggedly implementing global geoengineering, but vaccinations are in a realm all by themselves, with parents lining up eagerly to get their kids their shots, blinded to the reality of the threat by the constant, purposeful mainstream of misinformation and disinformation. (3) The fact that vaccine legislation slowly but surely is becoming more restrictive, shutting down avenues of refusal or expanding the number of insisted vaccines or reassigning parental consent rights to kids, with no reasonable end in sight, makes inescapable the conclusion that in the balconies of the vaccine paradigm sit those whose goal it is to inflict the damage.
1. http://web.archive.org/web/20120508130224/http://www.cdc.gov/vaccinesafety/updates/archive/polio_and_cancer_factsheet.htm
2. http://mesothel.com/asbestos-cancer/exposure/sv40/sv40_vac.htm
3. http://www.vaccinationcouncil.org/2013/09/19/disinformed-consent-by-shawn-siegel/
About two years ago, the CDC removed from its website a page about SV40, a monkey virus known to be carcinogenic in lab animals, found in batches of the polio vaccine in 1960. (1) They no longer wanted the information that easily available to you - both the fact that it was indeed discovered, and that in the 80's pathologists began detecting markers for the virus in human carcinomas.
That the virus was found in the vaccine is historical fact, undisputed. The manufacturers were required to test the vaccine for 14 days to determine which batches were contaminated, but, inexcusably, though contaminated batches were indeed discovered, the government has refused to respond when asked whether they were ever recalled. We must assume they remained on the shelves, and in some instances continued to be used.
More insidious, we don't know whether some or all of the polio vaccine administered through the years, down to today, is contaminated. Janine Roberts is an intrepid researcher. In her book, Fear of the Invisible, she mentions evidence she'd discovered that had the assigned test period for the vaccine been longer, more contaminated batches would likely have been found, and that government officials were well aware of it. To the point, had the test period been six or eight weeks instead of two, all batches of the vaccine might have been found contaminated.
Stanley Kops is an attorney with much experience investigating the issue of SV40. In 2000 he published an article in the journal, Anticancer Research, in which he stated, based on a bevy of legal documents he procured through discovery motions:
"Whether SV40 was removed from Sabin Oral Polio Virus strains remains a serious and unanswered question.'' (2).
Moreover, in a conversation with Mr. Kops almost two years ago, he corroborated Janine Roberts' statement - that yes, his research showed that the government knew full well that a longer test period could have resulted in the detection of SV40 contamination in several or many more batches of the vaccine, possibly all of them.
The threats to our health are ubiquitous, from genetically modified foods to the macabre clouds that slowly integrate behind the trails left by planes doggedly implementing global geoengineering, but vaccinations are in a realm all by themselves, with parents lining up eagerly to get their kids their shots, blinded to the reality of the threat by the constant, purposeful mainstream of misinformation and disinformation. (3) The fact that vaccine legislation slowly but surely is becoming more restrictive, shutting down avenues of refusal or expanding the number of insisted vaccines or reassigning parental consent rights to kids, with no reasonable end in sight, makes inescapable the conclusion that in the balconies of the vaccine paradigm sit those whose goal it is to inflict the damage.
1. http://web.archive.org/web/20120508130224/http://www.cdc.gov/vaccinesafety/updates/archive/polio_and_cancer_factsheet.htm
2. http://mesothel.com/asbestos-cancer/exposure/sv40/sv40_vac.htm
3. http://www.vaccinationcouncil.org/2013/09/19/disinformed-consent-by-shawn-siegel/
