Expert warns vaccine studies are useless

For Immediate Release (June 5, 2003)

Dr. Thomas Jefferson, board member of the European Programme for Improved Vaccine Safety Surveillance and head of the vaccine division of the prestigious Cochrane Collaboration has announced that most safety studies on childhood vaccines are useless. "There is some good research, but it is overwhelmed by the bad," he stated. "The public has been let down because proper studies have not been done." Dr. Jefferson, who has been funded by the European Commission, said that vaccines were the "Cinderella" of public health research and that Government officials had not made it a high priority.

"In more than 200 years of vaccine use, there has been increasing evidence of the harm that vaccines have caused our children," says Meryl Dorey, President of the Australian Vaccination Network, a national health lobby group. "Dr. Jefferson's announcement is a wake-up call to everyone involved in this issue that before yet more vaccines are added to our already overloaded schedule, the proper ground-work needs to be done to prove that they are actually not doing more harm than good.." According to Dr. Jefferson, the information available on the safety of vaccines that are routinely given to babies and children was "simply inadequate".

Fifteen years ago, children received18 vaccines by age 5.Today, they receive 40. The vaccine train keeps rolling on despite the fact that these medical procedures have not been properly tested. There is an epidemic of auto-immune diseases which once were rare but now are common among Australian children. Conditions such as Asthma, Diabetes, and certain forms of Cancer have all been linked with vaccine use. Our children are our future and they deserve the safest possible vaccines. The government must show that they are committed to this goal by putting money towards independent vaccine safety research and by legislating to require that all health professionals report vaccine adverse reactions when they occur.

 

· Pichichero's work has been cited in 21 vaccine patent applications He was involved in the recommendation for the Wyeth rotavirus vaccine and failed to anticipate its risks. (4) This vaccine was withdrawn soon after licensure due to adverse reactions.   A substantial proportion of Dr. Pichichero's work involves vaccines. Safe Minds conducted a simple Medline search of publications listing M Pichichero as an author.(5) A breakdown of these publications by subject area shows that many focus on vaccines, especially those which contained thimerosal.

·         161 publications

·         23 DPT

·         7 Hib

·         1 HepB

·         1 Polio

·         3 Pneumococcal Conjugate

·         3 Rotavirus

·         4 New combination vaccines or general vaccine discussions

·         The remainder deal with otitis media and use of antibiotics

·         Note some articles were counted more than once because they addressed more than one vaccine

 Similarly, the University of Rochester web site provides biographical information on Dr. Pichichero, which describes his focus on vaccine research. (6) It describes him as an immunologist, not a toxicologist. None of his work involves safety assessment of a heavy metal or other toxicant. One paragraph cites his work on the Haemophilus influenzae type B vaccine, one of the thimerosal-containing vaccines that was added to the CDC/AAP-recommended infant schedule in 1991, nearly doubling the thimerosal load.

John Treanor, another author, has also conducted substantial research into thimerosal-containing vaccines, and the University of Rochester is one of a few sites designated by NIH for evaluating new vaccines. Investigators at the University of Rochester helped develop the Haemophilus influenzae B vaccine. Per its web site, "Rochester has become a national model...in ensuring that as many people as possible are immunized." (7)

STUDY DESIGN ISSUES

Sample

· The sample size was small. Although the overall sample size was stated as 61 infants, there were only 33 exposed children who were used for the blood mercury assessment upon which the safety conclusions were made.  One major shortcoming of a small sample size is the low chance of including infants who are especially sensitive to mercury's effects, or who may have detoxification difficulties. We know from the mercury literature that there is wide variability in the population in regard to mercury sensitivity and clearance. Since vaccines are given to virtually all infants, even if 1% retained mercury to a much greater degree than the "norm", this would represent a large number of injured children.

·         In the Pichichero study, there is one infant blood level out of the 17 2-month old blood samples (12%) which was 20.55 nMol/L, or 4.1 ppb. This infant had its blood drawn at day 5, received 37.5 mcg/Hg, and weighed 5.3 kg.

·         a) Day 5 is past the peak value in blood, meaning that at days 1-3, levels would be much      higher.

·         b) A 37.5 mcg dose is (conservatively) 60% of what a typical 1990s infant may have received (37.5/62.5=60%).

·         c) A 5.3 kg infant is at the 95th percentile of weight for a 2 month old, that is, a large, heavy baby. Since blood Hg concentrations are in part dependent on weight, a child with a lower weight than this infant (that is, 95% of the 2 month old population) would have had a higher blood level than this infant.

·         The implications of points a, b, and c are that (1) if the study infant's blood were taken at 1-3 days, it is more than likely that the Hg levels would have exceeded 6 ppb; (2) it is likely that the peak levels of more than 12% of 2 month old children children given the full 62.5 mcg of mercury would exceed 6 ppb; and (3) a larger percentage of smaller infants - but still those of "normal" weight - would be likely to have blood levels exceeding 6 ppb.

·         In addition, there were two other 2 year olds with mercury levels at between 10 and 15 nMol/L. These values are with 1/2-1/3 of the EPA margin of safety, with blood draws on days 6-7.

·         For these reasons alone, the results of the Pichichero study are anything but "reassuring" to parents whose children were exposed to thimerosal as infants.

LEARNING FROM THE STUDY

·         Despite its many limitations, the Pichichero study does provide new or confirming information about the pharmacokinetics of ethylmercury injected into infants.

· The half life of ethymercury in infants appears to be shorter than methytlmercury, approximately 6-7 days. Pharmacologically, this period would be considered a very long half life and a long time for a toxic substance to be circulating in the body. In fact, the single blood draw after 20 days for which mercury quantitation could be made showed mercury being circulated at about 5 nMol/L. In a developing brain a few days are significant time periods for an agent that interferes with cell division and organization.

· The control group had no detectable mercury, indicating that the mercury in the exposed group was due to the thimerosal in the vaccines

SUMMARY

·         The Pichichero is a small-scale descriptive study with many design limitations, which has moderate value in advancing understanding of ethylmercury pharmacokinetics. It has little if no value as a safety assessment of thimerosal from vaccines, and its conclusions are overreaching, perhaps reflecting a bias on the part of its lead author towards absolving lisenced vaccines of any adverse effects.

References

·         (1) Mercury concentrations and metabolism in infants receiving vaccines containing thiomersal: a descriptive study, by Michael E Pichichero, Elsa Cernichiari, Joseph Lopreiato, John Treanor. The Lancet. November 30, 2002.

·         (2) UpToDate.com web site. Accessed 11/29/02. http//www.utdol.com/application/help/conflict.asp

·         (3) Acute Otitis Media Part I. Improving Diagnostic Accuracy, by Michael E. Pichichero, M.D. American Academy of Family Physicians newsletter, April 2000. Site accessed 11-29-02. http://www.aafp.org/afp/20000401/2051.html

·         (4) Rotavirus vaccines and vaccination in Latin America, by A. C. Linhares and J. S. Bresee. Pan Am J Public Health. 8(5) 2000. Accessed 11-30-02. http://www.paho.org/english/dbi/es/ARTI--Linares.pdf

·         (5) Pichichero Publications based on Medline Search of November 30, 2002, by Safe Minds

·         (6) Biographical Information on M. Pichichero, University of Rochester web site. Accessed 11-29-02. http://www.urmc.rochester.edu/gebs/faculty/Michael_Pichichero.htm

·         (7) Vaccine Technology Takes Center Stage in Rochester, University of Rochester press release, October 8, 1998. Accessed 11-30-02. http://www.rochester.edu/pr/releases/med/vaccines.htm

·         (8) Development of Methylmercury Reference Dose, by Dr. Kathryn Mahaffey, Office of Prevention, Pesticides and Toxic Substances, U.S. Environmental Protection Agency. Site accessed November 30, 2002. http://www.masgc.org/mercury/

http://www.medscape.com/viewarticle/445538

Medscape Medical News
Mercury in Vaccines: A Newsmaker Interview With Michael E. Pichichero, MD

Laurie Barclay, MD


Dec. 3, 2002  Editor's Note: There has been much debate about the safety of thimerosal, which is used as a preservative in childhood vaccines and also in adult influenza vaccines. Although studies generally have shown that mercury levels after vaccination are not a problem, the American Academy of Pediatrics (AAP) successfully lobbied to have thimerosal removed from all childhood vaccines. The first detailed analysis of blood, stool, and urine mercury levels in 61 infants who received vaccines containing thimerosal, published in the Nov. 30 issue of The Lancet, indicates that blood levels of mercury in children are well below current safety limits established by the Environmental Protection Agency (EPA). Surprisingly, the elimination of mercury in these children was much faster than predicted from studies of mercury toxicity from seafood. Based in part on these findings, the World Health Organization (WHO) put forth guidelines saying that thimerosal is safe and should continue to be used.

To clarify these findings and their implications, Medscape's Laurie Barclay interviews lead author and lead investigator of The Lancet article, Michael E. Pichichero, MD, a professor of microbiology, immunology, pediatrics, and medicine at the University of Rochester Medical Center in New York.

Medscape: Please summarize your Lancet study results and their implications for the safety of vaccines containing thimerosal.

Dr. Pichichero: We looked at the [blood] level of mercury in children who received thimerosal-containing vaccines. Not a single child had a blood mercury level approaching the lower safety limit established by the EPA. Former predictions of possible pediatric problems with mercury in vaccines, which led to removal of thimerosal from U.S. vaccines, were based on the notion that metabolism of ethyl mercury in the vaccine was the same as that of methyl mercury in fish. But our study showed that elimination of ethyl mercury from the vaccine was about six times as fast as that of methyl mercury. The rapid metabolism probably accounts for the very low blood levels in the children we studied.

Medscape: Could blood levels of mercury be misleading in that blood levels could be low even while mercury is accumulating in bone or in organs?

Dr. Pichichero: We accounted for virtually all the mercury contained in the vaccine in the stool of these children, with not much excretion in the urine. So there really is no evidence that there is any mercury unaccounted for which could be accumulating in bone or elsewhere, although this study was not a toxicity study and did not examine this issue directly.

Medscape: Although these results appear to be reassuring, are there any study limitations to consider in interpreting the findings? 

Dr. Pichichero: This was a small study of 61 children: 20 two-month-olds who got thimerosal, 20 six-month-olds who got thimerosal, and 21 controls. Because we didn't anticipate the rapid clearance of ethyl mercury with half-life of only six to seven days, we predicted the sampling times on the basis of an assumed 45-day half-life.

Medscape: On what basis did the EPA set public safety limits for mercury levels?

Dr. Pichichero: The EPA levels were largely based on studies from the Faroe Islands which looked at the toxicity of methyl mercury ingestion from whale blubber. Mild neurodevelopmental problems occurred at blood levels of 200 to 300 ng/mL, and the mildest detectable neurodevelopmental toxicity occurred at blood levels of 58 ng/mL. So the EPA decided they'd add in a safety factor of 10, and they reasoned that levels should not exceed 5.8 ng/mL to be totally safe. In our study, most children had levels of 1 to 2 ng/mL; two had levels of 2-3 ng/mL, and one had a level of 4 ng/mL. No child approached the EPA safety limit.

Medscape: Do you think that the Faroe Islands studies form an adequate basis on which the EPA can determine safe blood levels as they pertain to infants who receive vaccines containing thimerosal?

Dr. Pichichero: Actually, it's not an adequate basis because the situations are not strictly comparable. First of all, the Faroe Islands study looked at levels of mercury in fetal cord blood when mothers ingested mercury from whale blubber. If anything, the fetus has been shown in human studies to be more susceptible to the toxic effects of mercury than are infants, because mercury easily penetrates into the fetal brain and kidneys and causes damage.

The other issue is that the Faroe Islands study looked at methyl mercury exposure, but thimerosal contains ethyl mercury. The FDA [Food and Drug Administration] assumed that metabolism of these two organic forms of mercury was closely correlated, but this was not validated by our study. We now know that the two forms are metabolized and eliminated differently. But our data are very reassuring in that the metabolism of ethyl mercury appears to be six times faster than that of methyl mercury.

An editorial accompanying the Lancet paper suggests that another study will soon be published comparing the effects of ethyl and methyl mercury. But from a toxicity point of view, once mercury is freed from its organic bonds, mercury is mercury, and it's the free form that enters the brain and kidneys and can cause damage. Our study did not examine toxicity, but we measured blood levels of free mercury, not of ethyl mercury.

Medscape: Why did the AAP urge vaccine manufacturers to remove thimerosal from U.S. vaccines? Do you think that this recommendation should be changed or updated?

Dr. Pichichero: It's very reassuring for America's children that the hypothetical concerns which led to thimerosal removal were not validated by our study. The AAP and the FDA are not likely to reverse their decision based on our findings, now that thimerosal has been replaced with other preservatives. Although this drove up the cost of vaccines, we as a wealthy nation have absorbed this cost. But the FDA and the AAP should be very pleased with our findings, which speak to the millions of children who have already received vaccines containing thimerosal. Our findings were also pivotal in the WHO's recommendation that thimerosal will remain in all vaccines provided by them to other countries.

Medscape: What are the advantages of using thimerosal in vaccines?

Dr. Pichichero: Cost is a major issue. If you don't use preservatives at all, you have to dispense vaccine in single-dose vials, which is not only more expensive but which may lead to more errors in administration. In underdeveloped countries where millions of children die of whooping cough, tetanus and measles, switching to a thimerosal-free vaccine would raise the price so high that millions of children would not be vaccinated.

The potential toxicity of using newer preservatives, as we now do in the U.S., is unknown, so we're trading the very small, known risk of thimerosal for an unknown one. The new preservatives in U.S. vaccines are presumed to be safe, but I'm not an expert on vaccine preservatives, and I don't know the extent of background research supporting this presumption. 

Medscape: Is any additional research planned to clarify safety issues for
thimerosal?

Dr. Pichichero: We are collaborating with a laboratory in Seattle to look at nonhuman primate models to study possible mercury accumulation and other potential toxicity of thimerosal in vaccines. We're also doing a large follow-up in Buenos Aires, Argentina, in which we'll more carefully examine and quantitate these findings in larger numbers of children. 

Medscape: Please comment on the provision in the Homeland Security Bill that protects pharmaceutical manufacturers from lawsuits related to adverse effects of childhood vaccines.

Dr. Pichichero: The three major manufacturers of thimerosal-containing vaccines are GlaxoSmithKline, Aventis-Pasteur, and Wyeth. The Childhood Vaccine Protection Act is a long-standing piece of legislation which protects the pharmaceutical manufacturers against lawsuits involving vaccines recommended by the government. This legislation came into effect about a decade ago because all the lawsuits led to vaccine shortages. I'm not aware of any specific provisions in the Homeland Security Act dealing with this issue, but I haven't studied it specifically.

Lancet. 2002;360:1711-1712, 1737-1741

Reviewed by Gary D. Vogin, MD

 

Vaccine Science Review #2

Official site: http://www.freedom2think.com/vaccinescience

by Helen Tucker

Article reviewed:
Pichichero, M. et. al. 2002. "Mercury concentrations and metabolism in infants receiving vaccines containing thiomersal: a descriptive study." The Lancet 360: 1737 - 1741.

[A free copy can be obtained from http://www.thelancet.com/ .]

Review abstract:

Pichichero et. al. studied samples taken from infants given thimerosal* vaccines and infants given thimerosal-free vaccines. Mercury was found more frequently and in higher levels, in the blood, urine, and stool of thimerosal exposed children. The authors concluded that "Administration of vaccines containing thiomersal does not seem to raise blood concentrations of mercury above safe values in infants," but referenced a mouse study for these "safe values." They also estimated that the half-life of ethylmercury was around 7 days and "eliminated from the blood rapidly via the stools," even though they took samples only once per subject.

*(also spelled thiomersal, mostly in UK and commonwealth countries)

A. What did the authors do?

The authors took samples from:

a) 40 infants who had received vaccines containing thimerosal,

b) 21 infants who had received thimerosal-free vaccines,

c) their mothers, and

d) 9 additional infants who had not received any vaccines containing thimerosal who provided stool samples.

The vaccines included DPT, Hepatitis B, and Hib in both the exposure group and the control group, but an unspecified number of infants did not receive the Hib. It is therefore unknown exactly how much mercury each infant was exposed to from vaccines.

The samples were taken between 3-28 days after vaccination, taken on different days for different subjects. Samples included blood, urine, stool, maternal hair, and maternal breastmilk, but were not taken consistently from all subjects. Cold vapor atomic absorption was used to measure mercury levels in these samples.

Seven thimerosal-exposed and six control blood samples were excluded because insufficient blood was drawn. Only 33 thimerosal-explosed and 15 control blood samples were measured for mercury. Out of this number, only 21 thimerosal-exposed and 1 control blood sample were defined to be within the "range of reliable quantitation." Only the data from these 22 blood samples were included in calculations.

Urine samples were taken from 27 thimerosal-exposed children and 14 of the control children. Stool samples were taken from 22 thimerosal-exposed children. No stool samples were taken from the control group. Rather, they took stool samples from a second control group of 9 aged-matched children who had not received thimerosal-containing vaccines, who were not mentioned in the abstract and whose data was not included in the table of results.

Maternal hair samples were taken from all mothers of the 61 thimerosal-exposed and control infants. Breastmilk samples were taken from 8 mothers (no information given on whose mothers).

A simplistic mathematical model was used to estimate the half-life of ethylmercury based on the distribution of blood mercury levels in 21 blood samples taken on different days from 21 different children.

B. What did the authors find?

1. Out of the 21 blood samples from thimerosal-exposed children, the average mercury concentration was 8.20 nmol/L (SD=4.85) for two month olds, and 5.15 nmol/L (SD=1.20) for six month olds. (It is unknown if this difference is statistically significant.)

2. The only data for the control group came from one blood sample from a two month old child. It showed 4.90 nmol/L.

3. Mercury was detected in urine samples in only 4 out of 27 thimerosal-exposed children, and none of 14 control children. (It is unknown if this difference is statistically significant.)

4. For the 4 urine samples with detectable mercury from the exposure group, the values were 3.8 nmol/L for a two month old, and 5.75 nmol/L (SD=1.05) for 3 six month olds. (It is unknown if this difference is statistically significant.)

5. Out of the 22 stool samples from thimerosal-exposed children, the average mercury concentration was 81.8 ng/g dry weight (SD=40.3) for two month olds, and 58.3 ng/g dry weight (SD=21.2) for six month olds. (It is unknown if this difference is statistically significant.)

6. The average mercury concentration in stool samples taken from the 9 children in the second control group was 22 ng/g (SD=16). These 9 children had significantly lower levels of mercury in their stool (p=0.002) than the exposure group.

7. Maternal hair values were 0.45 :g/g for the exposure group and 0.32 :g/g for the control group. Mercury concentrations in maternal hair were not significantly different between the exposure group and the control group.

8. Breastmilk from 8 unidentified mothers averaged 0.30 :g/g (range 0.24-0.42 :g/g) of mercury.

C. What were the flaws of the study?

1. Unknown mercury exposure. Without knowing how much mercury exposure the subjects had, and how much of this total exposure came from vaccines, no conclusion can be drawn on the effects of vaccines on mercury levels found.

a. No samples were taken from the subjects before vaccination. This would have been the easiest way to control for other sources of mercury exposure. Without taking a comparison sample, how could the authors have known if blood concentrations of mercury were "raised" after vaccination, let alone determine how much they were raised and that any amount raised was safe?

Omitting a pre-vaccination sample from the design effectively rendered any connection with the subject of vaccines indefensible. Any conclusion that mentioned vaccines, such as "thiomersal in routine vaccines poses very little risk to full-term infants," is completely unsupported by the information available in this study.

b. The authors did not say how many children did not receive all three vaccines. We do not even know exactly how much mercury was injected into each child.

c. It is unknown how much mercury the children were exposed to from other sources such as diet (e.g. tuna fish) and air pollution.

The authors tried to address this problem by studying mercury levels in a control group. However, the only control data came from ONE blood sample in the entire study and 9 stool samples from children who were not formally part of the study. This does not provide adequate comparison to determine how much mercury exposure existed outside of vaccines.

The authors also tried taking maternal hair and breastmilk samples. Those samples showed that, indeed, the mothers have been exposed to mercury. But it is unknown if maternal mercury levels came from mercury exposure that is shared by their children (e.g. if their exposure came from their vaccines or drugs or came from past residence in a polluted area). Even if one assumes that the mothers' mercury exposure is shared by their children, we still do not know how much. For example, maternal hair mercury does not translate into a specific amount of mercury concentration in the blood of their children.

2. Invalid sampling within the study population. There is an overwhelming number of questionable exclusions in an already small sample size.

The authors claimed to have studied 61 children. The small initial sample size of this study means any conclusion, even if all 61 children were used to provide data, would have to be interpreted with extreme caution.

In reality, they studied data from only 21 blood samples, 31 stool samples, and 27 urine samples from separate children. There is no information on how many of these samples were from the same children. There is no information on why stool and urine samples were not taken from all subjects. No one knows if these samples were excluded objectively or because they would have provided data the authors did not like. Without objective evidence to explain why some children were excluded from providing stool and urine samples, none of the stool and urine concentration results have any scientific meaning.

Although they did try to take blood samples from all 61 children, they excluded almost 2/3rds of those blood samples for two dubious and poorly defined reasons. The first reason was insufficient blood volume, which can only be interpreted as stupefying incompetence. If insufficient blood was drawn because the infant was not able to participate properly, the subject should have been dismissed from the study.

The second was mercury levels falling outside the "range of reliable quantitation." The authors did not explain this criterion, except to say that that mercury levels found below the range of 2.5 to 7.5 nmol/L, depending on blood volume, were excluded. However, they showed a data plot (Figure 1) where 17 out of 21 other samples with levels within that range were included. The only factor that could have excluded these samples would again be blood volume, which was not defined. No one knows if these samples were excluded objectively or because they provided data the authors did not like. The authors fail to present sufficient objective evidence to explain how these exclusions were not subjective and arbitrary. Without such evidence, none of the blood concentration results have any scientific meaning.

3. Ridiculous calculations of half-life:
The authors admitted that this was not a formal pharmokinetic study, where the same subject would be tested repeatedly for mercury at regular intervals after exposure. However, they felt that taking single samples from 21 children at "various time points after exposure" could suggest a "half-life of less than 10 days." In other words, they could estimate the half-life by pretending all 21 samples were from the same person. Given the extremely small sample size used, this assumption is nothing but ridiculous.

The mathematical model they used for calculation half-life was simple, but it did require at least two samples from the same subject to be able to calculate any change in that subject. Without using at least two values from the same person, this model is meaningless. Taking two samples from two different children and pretending their difference is a change in mercury level in the same child is ludicrous.
(Under Unconscionable Conclusions)

4.  "Assessment of these samples suggested that the blood half-life of ethylmercury in infants might differ from the 40-50 day half-life of methylmercury (range 20-70 days) in adults and breastfeeding infants.  The concentrations of blood mercury 2-3 weeks after vaccination noted in our study were not consistent with such a long half-life, but suggested of a half-life of less than 10 days."

Half-life is a function of change within the same subject.  It is not the difference between Child #1 on Day 1 and Child #2 on Day 2.   Any calculation of half-life based on the difference in concentrations taken from 2 different children is fraudulent. 

4. Unconscionable conclusions by the authors.


1. "Administration of vaccines containing thiomersal does not seem to raise blood concentrations of mercury above safe values in infants."


They have no scientific data in this study to support any statement about the effects of vaccines on increased blood levels. As explained above, since only one sample per child was taken, there is no basis to determine that there was even an increase, let alone attribute an "increase" to vaccines. They also had no basis to make any statement about blood concentrations of mercury, given that samples could have been excluded subjectively. No reference or any other justification is provided for the authors' definition of "safe values in infants." This problem is explained below.

2. "However, no children had a concentration of blood mercury exceeding 29 nmol/L (parts per billion), which is the concentration thought to be safe in cord blood; (18) this value was set at ten times below the lower 95% CI limit of the minimal cord blood concentration associated with an increase in the prevalence of abnormal scores on cognitive function tests in children. " [no reference provided.]

It is incredible, but the reference (footnoted #18) provided for 29 nmol/L as" the concentration thought to be safe in cord blood," is titled:

18. Nielsen JB, Andersen O, Grandjean P. Evaluation of mercury in hair, blood, and muscle as biomarkers for methylmercury exposure in male and female mice. Arch Toxicol 1994; 68: 317-21.

I have read Nielsen's mouse paper in full, and have found no data or information that be construed as defining safe levels of mercury in human cord blood. The second half of the sentence did not even have a reference. Without references, the reader cannot know what these "safe values" are and where they came from, let alone determine if those values are valid. It is mind-boggling that the authors would fail to present ANY evidence whatsoever to justify the safe levels of mercury used for comparison.

I have written Dr. Pichichero, the principal author, on February 20, 2003 asking for correct references, and will update this review if correct references are given. (Although no reference was given for the second statement, I did find one of the references to be on the correlations between cord blood mercury concentrations and cognitive deficits. After reading it, I have not found any data to support the number cited in this paper either.)

3. "Ethylmercury seems to be eliminated from blood rapidly via the stools after parenteral administration of thiomersal in vaccines."


Elimination means a decrease in mercury levels obtained at two different times from the same child. Since only one sample was taken per child, there is no basis for determining there was a decrease in anything. Again, this conclusion required pretending 21 children were really the same child over the period of 28 days and the small sample size does not allow this pretense. Because they did not take a pre-vaccination sample and no immediate post-vaccination sample, there was absolutely no evidence in this study to conclude that mercury concentrations in blood came from thimerosal in vaccines. For all the evidence presented in this study, vaccine mercury could have traveled in the blood in the first 3 days to be stored in brain tissue, to never be eliminated or to be eliminated very slowly over years, and the mercury found in stools came from previous dietary mercury exposure. This study has no data to prove or disprove this hypothesis anymore than it has data to prove the conclusion that vaccine mercury is eliminated quickly.

D. What can be concluded from this study?

1. Mothers of infants in this study were exposed to mercury, source unknown. There was no significant difference between the hair mercury levels in mothers of subjects in the exposure and the control group.

2. Mercury is more prevalent in the stool samples than in the urine samples of some infants in this study, although this prevalence could have been an artifact of subjective exclusion.

3. Stool concentrations of mercury, source unknown, were significantly higher in exposure subjects than in 9 subjects used as controls, but who were not formally part of the study.

Because the paper fails to provide objective evidence meeting minimal scientific standards (or even normal common sense), no other conclusion is justified. In fact, this paper dangerously borders intellectual fraud from imagining relationships between data where none exist.
------------------------------------

The author would like to thank the Vaccine Science discussion list for their input and feedback.

http://groups.yahoo.com/group/VaccineScience/

Permission is granted to forward or reprint this article on the condition that it is reproduced in its entirety without any changes (everything between and including the 2 asterisk lines). If this article is reprinted on another website, the author would appreciate a note with the link to the site. Her email address is list@freedom2think.com.

You know, I found the data on how much mercury each study subject received from vaccines. I was mistaken. They did include that information, but only in the abstract, which I had apparently overlooked. (Who puts data in the abstract, but not in the body of the paper?)

Anyway, the mean mercury doses that these kids received were 45.6 :g for 2 month olds, and 111.3 :g for 6 month olds. 111.3 :g! That is actually 111,300 ng of mercury. When they tested blood samples, they found a mean of 5.15 nmol/L for 6 month olds. Now, follow along with me here.

1 mole of mercury = 200.8 grams.
1 nmol = 200.8 ng
5.15 nmol x 200.8 ng/nmol = 1034.12 ng
The average blood concentration was 1034.12 ng/L.

Blood volume is about 8% of infant's bodyweight.
6 month old boy average weight is 8 kg = .64 kg blood = .64 L blood.
1034.12 ng/L x .64 L blood = 654.08 ng of mercury in the blood of the 6 month old baby

What I want to know is, where did the rest of the 111,300 ng of mercury go, if it isn't in the blood?

To say that it was eliminated in the stools, they really needed to take entire stool samples before vaccination, and every day after vaccination for about 30 days. That way they know how many total grams of stool is passed per day and what concentration mercury there is in the stool every day. Then they can calculate how many total ng of mercury actually came out of the baby in 30 days. Short of this, they can't tell me that the mercury isn't still in the baby. I mean, we know for a fact the mercury went in. We don't know for a fact that all of it came out.

Vaccine Science Review #1

Official site:  http://www.freedom2think.com/vaccinescience

by Helen Tucker

Article reviewed:
Barlow, W. et. al.  2001.  "The Risk of Seizures after Receipt of Whole-Cell Pertussis or Measles, Mumps, and Rubella Vaccine," New England Journal of Medicine 345: 656-661

[A free copy can be obtained from http://www.nejm.org/ .]

Review abstract:

Barlow et. al. studied data from four HMO's on the west coast to assess the risk of seizures and neurobehavioral disorders after receiving the DTP and MMR vaccines.  They reviewed 624 medical records out of an undisclosed number of children using undisclosed methods and misleading control groups to calculate meaningless risk coefficients.  They then concluded there were only small, "transient" seizure risks associated with DTP and MMR which "do not appear to be associated with any long-term, adverse consequences."

A.  What did the study do?

The authors said they studied nearly 680,000 children aged 0 - 7 who were enrolled at these HMO's during the observation period, which was different at each HMO, but ranged between 1/91 to 9/93, with some follow-up data extending to 1998.

The authors concluded that there was a slightly increased risk of febrile seizures on the day of vaccination with DTP, which is estimated to mean 6 to 9 additional febrile seizures for 100,000 children.  They also found a slightly increased risk of febrile seizures in the second week after the MMR, which is estimated to mean 25 to 34 additional febrile seizures for 100,000 children.  They concluded there was no increased risk of  nonfebrile seizures, subsequent seizures after the first febrile seizure, and neurobehavioral disorders for children receiving the DTP and MMR.

B.  What were the flaws of the study?

1.  Meaningless sample:  The authors failed to provide sufficient evidence that their sample was valid and representative of the population they were studying. 

Although the study started out with almost 680,000, the authors excluded an unknown number of children, without a clear explanation.  The sample size was narrowed by at least 42,000 at the beginning to about 638,000 "person-years of observation," (i.e. persons per year of observation) which means the number of unique children could be even smaller.  It was also narrowed by 13.7%--of which number, they never said--because of disenrollment from the HMO's. 

From whatever figure they ended up with, they found 2281 possible seizures from highly variable sources depending on the HMO, anywhere from hospitalization records to neurology referrals.  They never explained how many seizures came from each source.    From the 2281, they sampled 1094 for risk analysis.  Because sampling proportions varied from HMO to HMO, the authors weighted the data from some random samples to make them comparable to the rest.  They did not say how many seizures came from each HMO and how many cases were weighted.  The authors admitted the sample was somewhat biased toward severe, hospitalized cases, but failed to present information necessary to objectively assess the extent of the bias. 

From the 1094, they whittled the final sample down to 624 children on which they presented results of their analysis.  They excluded children because seizures happened outside of the study period or before the inception of a vaccination database, but never defined those dates.  They excluded children because of specific infections or injuries, but never defined them.   They presented a category of neonatal seizures, but never discussed them in the analysis, so it was even unclear who exactly were excluded.  Without the objective criteria by which subjects were excluded, there is insufficient evidence to determine that the sample was not further biased.  It was the authors' responsibility to justify their sample as valid and representative, and they failed.

2.  Meaningless and Misleading Control Group:  The authors compared children who were recently vaccinated to children who were not recently vaccinated to conclude that the risk of vaccines over the "absence of vaccination" was small.

To assess the risk of seizures among children who had received the DTP and MMR, the authors needed to compare children "exposed" to DTP and MMR to children who were "unexposed."  The exposed group was defined as children who had had either the DTP, the MMR, or both vaccines concomittantly in 30 days preceding the first seizure episode.  The unexposed group was defined as children who had not had either vaccine in the last 30 days.   The authors implied, but never explicitly stated, that the "unexposed" group was also unexposed to any other vaccine in the last 30 days before seizure.  The control situation was referred to as "absence of vaccination."

The authors did not provide evidence that a 30 day difference between the exposure to vaccines in the two groups is sufficient time to meaningfully distinguish between presence of vaccination and "absence of vaccination," exposure and "nonexposure."  The authors needed to carefully qualify that their risk calculations were only for children who were recently vaccinated with DTP/MMR compared to children who were not recently vaccinated.  They needed to qualify that they were in all likelihood comparing vaccinated children to vaccinated children.  They did neither.

The authors also wanted to assess the seizure risks of DTP and MMR separately.   The fact that some children received both DTP and MMR in the last 30 days before their seizures confounds the risks attributed to either vaccine individually.  The extent to which the variables were confounded is unknown because the authors did not say how many received both vaccines. 

Finally, the authors admitted that vaccination status was not always accurate.  They did not explain how many were inaccurately identified as vaccinated or unvaccinated, and how they resolved disagreements.

3.  Meaningless and Unreliable Risk Calculations:  The authors failed to present data and justification for their calculations and used invalid background rates as the foundation of all their conclusions.

The authors concluded that certain risks were small and other risks were non-existent.  The only evidence provided to support these conclusions were calculations of "relative risk."  The authors said they used the "stratified Cox proportional-hazards analysis" and "standard methods" to calculate these numbers, but did not define what these methods were, provide equations, provide literature references, or present any other information that would validate these calculations.  They curiously did not present results such as how many did not get seizures vs. the numbers who did.  Without these numbers, the accuracy of their calculations cannot be gauged. Furthermore, these relative risks were calculated after "adjustments" for selected variables.  Although they defined some of these variables, others were unclear and how the calculations were "adjusted" was not explained.  Because there is insufficient proof that these statistical methods were applicable to the data collected, their results of those methods are meaningless.  Because there is no presentation of most of the data used in these calculations, their results are meaningless.

The only numbers presented was each "relative risk" and its 95% confidence interval, such as "5.70 (95% CI, 1.98 to 16.42)."  The confidence intervals they did provide showed that these calculations were highly unreliable.  For example, the risk of "5.70 (95% CI, 1.98 to 16.42)" translates to mean that 95 times out of a 100, their calculation could range anywhere from 2 to 16. 

In addition, these relative risks were compared to two "background rates" of febrile seizures to determine how many additional seizures per 100,000 children can be attributed to DTP or MMR.  One of the background rates came from the same data as the risk calculations, so it is not surprising that there was only minimal difference between the two.  The other background rate came from a 1969 published study of one of the participating HMO's, with data more than 20 years old.  The absence of more current and broader background rates makes the number of additional seizures attributed to DTP/MMR meaningless.

4.  Meaningless Follow Up.  The authors followed whichever children they wanted, for only the diagnoses they wanted, then calculated meaningless numbers after "adjusting" the data, to yield the conclusion that the vaccines were not associated with "long-term, adverse consequences."

Out of the 74 children who had febrile seizures within 30 days of vaccination, the authors followed only 40 to study any increased risk for subsequent seizures.  For the DTP, they followed only children who had febrile seizures in the first 7 days.  For the MMR, they followed only children who had febrile seizures within 7 - 21 days.  They did not explain why they followed only these children and not all of them.  They did not follow any children with nonfebrile seizures after vaccination because the authors believed there was no association between the two events.  The control group consisted of 521 children who had febrile seizures in the "absence of vaccination," that is, no DTP/MMR in the preceding 30 days.   The authors did not explain how long these children were followed, though they suggested that some of the children were followed for at least 2 years.  Nonetheless, they concluded the 40 exposed children were no more likely to have subsequent seizures than the 521 "nonexposed" children. 

Out of the 561 children followed for subsequent seizures, 273 were followed for neurobehavioral diagnoses.  Again, the authors do not explain how the 273 were followed, for how long they were followed, and why they excluded the rest.  The diagnoses they flagged included:

"ADD, learning disorders, mental retardation, speech disturbances, emotional disturbance, personality disorder, repetitive-movement disorder, obsessive-compulsive disorder, infantile autism, childhood type schizophrenia, and psychoses of early childhood."

Notably, with the exception of infantile autism, they did not include any of the Pervasive Developmental Disorders considered to be in the autism spectrum. 

The authors concluded that the risk of these conditions did not differ between exposed and unexposed children, after an "adjustment" for age at the time of the seizure.  This implies that there was a difference between exposed and unexposed without the adjustment. The only evidence cited to support this conclusion was again, one "relative risk" number.  Again, the enigmatic sampling, poorly defined control group, narrow selection of long-term consequences, and meaningless risk numbers provide insufficient justification to give these conclusions any meaning or validity.

C.  What can be concluded from this study?

The only results that can be credibly presented are the tabulation of incidences. 

1.  Out of an unknown number of children, at least 42 who received the DTP vaccination had febrile seizures within 30 days, and at least 10 had nonfebrile seizures.

2.  Out of an unknown number of children, at least 32 who received the MMR vaccination had febrile seizures within 30 days, and at least 3 had nonfebrile seizures.

3.  Out of an unknown number of children, at least 413 who had febrile seizures did not receive either the DTP or MMR in the preceding 30 days.  At least 124 children who had nonfebrile seizures did not receive either the DTP or MMR in the preceding 30 days.

Because this paper fails to meet minimum scientific standards for the presentation of objective evidence, no other conclusions are defensible. 

------------------------------------

Originally posted on 12/8/02 (Revised 12/11/02).

The author would like to thank the Vaccine Science discussion list for their input and feedback.

http://groups.yahoo.com/group/VaccineScience/

Cervical Cancer Vaccine -- A Shameful Example of How Medical Research is Taking Dangerous Short-Cuts
By Nicholas Regush  http://www.mercola.com/2002/dec/11/cervical_cancer.htm


Whenever you see or hear the word "breakthrough" in a medical news report, duck for cover. Chances are someone’s imagination is hard at work.

The latest medical frenzy involved a vaccine aimed at cervical cancer.  The study was published in the November 21 issue of The New England Journal of Medicine (NEJM).

The Reuters News Agency provided this lead: "A vaccine against a cervical cancer-causing virus can protect young women from infection - a success researchers hope will eventually allow them to prevent many cases of cervical cancer."

The virus referred to is the human papillomavirus (HPV).

Reuters quoted Dr.  Christopher P.  Crum of Brigham and Women’s Hospital in Boston as saying: "This is a great study."

Let’s move on.

CBSNews.com’s headline asked the question: "Major Cancer Breakthrough?"

Then the report proceeded to quote researchers in this manner: "It’s really the first time that a vaccine has been shown to prevent directly a pre-cancerous condition and indirectly a cancerous condition." That quote was attributed to Dr. Carol Brown, a gynacologic oncologist at Memorial Sloan Kettering Cancer Center in New York.

Over at the New York Times, at least the headline was more circumspect: "Experimental Vaccine Appears To Prevent Cervical Cancer." The "deck" or the line underneath the main headline might have read this way:
"Appearances Can Be Deceiving." However, the Times chose to report: "The vaccine works by making people immune to a sexually transmitted virus [human papillomavirus] that causes many cases of the disease."

The Times quoted Dr.  Laura A.  Koutsky of the University of Washington in Seattle, the study’s director, as saying: "These are tremendous results."

The Chicago Tribune bought the study too.  Its lead paragraph referred to the fact that "after decades of failure," scientists showed early success in preventing human papilloma infection, "which is linked to cervical cancer."

Really?

First, Some Background And A Question Raised Cervical cancer, arising in the lining of the cervix, affects about 13,000 women in the U.S.  each year.  About 4,000 die.  Worldwide, a half million get the disease and 225,000 die.

Back in the 1970s, herpes simplex virus (HSV) was proposed as the sexually-transmitted cause of cervical cancer, based mostly on population studies that showed a correlation of the disease with HSV DNA.  That approach shifted to HPV in the 1980s, and over the years population studies set the pace for the now well-accepted view that cervical cancer is strongly related to the transmission of HPV.

This is a group of more than 100 viruses, about 30 of which are said to be linked to cervical cancer. Of these 30 or so, HPV-16 is said to be found in 50 percent of cervical cancers.  HPV-18 accounts for another 20 percent.

In addition to the population studies that link HPV to cervical cancer, there is, for example, research showing that HPV viral DNA can be found integrated in the genetic structure of cervical cancers.

Back in 1992, however, a question was raised about the dominant and increasingly entrenched theory that HPV causes cervical cancer.  It came from Peter Duesberg and Jody Schwartz, molecular biologists at the University of California at Berkeley.

Among the various issues they raised about the acceptance of HPV as the cause of cervical cancer was their fundamental concern that there was a lack of consistent HPV DNA sequences and consistent HPV gene expression in tumors that were HPV-positive.  They instead suggested that "rare spontaneous or chemically induced chromosome abnormalities which are consistently observed in both HPV and HSV DNA-negative and positive cervical cancers induce cervical cancer."

In short, Duesberg and Schwartz were pointing to the possibility that "carcinogens may be primary inducers of abnormal cell proliferation rather than HPV or HSV." And here’s the key point: "Since proliferating cells [cancer cells dividing wildly] would be more susceptible to infection than resting cells, the viruses would just be indicators rather than causes of abnormal proliferation."

The concept they raised back in 1992 is still relevant today; only science has gone on to assume that causation of cervical cancer has been well established.  Even the National Cancer Institute (NCI) says that "direct" causation has not been demonstrated; however, the NCI and just about everyone else works with the principle that it has been established.  Lip service is paid to other possible factors that may be involved in cervical cancer such as environmental conditions, including smoking.  Even dietary factors -- particularly low levels of Vitamin A and folate -- have been suggested as associated with a risk for cervical cancer.

But once a vaccine to prevent HPV infection is raised as a weapon to prevent cervical cancer, then it’s pretty clear that the medical Establishment has gone all the way in accepting a theory.  And it’s also quite evident in some of the comments listed above that have been made to reporters.

The headline to the accompanying editorial to the study in the NEJM screams out:

"The Beginning of the End for Cervical Cancer?" This editorial is more or less an ode to the research published. But the published research doesn’t necessarily deserve any praise.  Why?  Because the study is a disgrace. A Worthless Study When I first reviewed the study, I couldn’t believe the NEJM was putting this research on such a high footing -- and that includes the embarrassing editorial.

Essentially this is what the study is about: Of 2,392 young women who were entered into the study, 859 were excluded from the final data analysis -- some for technical reasons and the vast majority because they were actually found to be infected with HPV-16 before getting the vaccine. Of 1,533 women who remained, half were given the vaccine and half the placebo shot.

The results were as follows: No one who was vaccinated developed an HPV-16 infection or a precancerous growth.  Of those who received the placebo shot, 41 women became infected with HPV-16, and nine of them had precancerous cervical growths. On the surface, at least interesting for an early study.  But those results became the focus of great jubilation.

But I’ll tell you this: It doesn’t take a rocket scientist to see that the study’s methodology is flawed to such a degree that it doesn’t even deserve to be published in some throwaway journal.  But then again, the NEJM has, of late, become a depository for bad science.

Still, given that the entire world of health journalism seems to have piled on the bravos for this study and just about every vaccine specialist has come out of the woodwork to applaud yet another vaccine effort, I figured that I would seek out someone who has the guts to face up to the bilge that masquerades as science.  I therefore got hold of Howard Urnovitz, who is a scientist dealing in molecular issues and a regular contributor to redflagsweekly.com.

His first reply was that "this is a poorly designed study that fits all-too-well into the legacy of medical incompetence called vaccine research." Here is what Urnovitz had to say, pretty well reaching the same conclusions that I reached upon careful review of this study:

"These investigators initially enrolled 2,392 women to take part in the study.  Immediately, 36 percent were disqualified primarily because they had detectable HPV markers, according to the study’s authors, who determined HPV-detectability by either antibody or PCR testing.  In other words, the study selected for women who showed some sort of robust natural immunity that kept them from expressing the HPV markers.

Then the study used a cancer detection method which is known to be inaccurate, with a rate of false negative test results that ranges from 1 percent to 93 percent, despite the fact that it is the only test currently available in the United States to screen women for signs of cervical cancer.  (A false negative result means that women who have cervical cancer or precancerous tissues are not being identified when they have a Pap smear.)"

The women in this study are only monitored for HPV infection if they show a positive Pap smear. But since even the CDC recognizes that the Pap test produces a wide range of false negative results, the HPV study’s foundation -- the Pap test -- is so unreliable that the rest of the study is rendered highly suspect.

"Also, the HPV test is poorly designed.  A positive result was defined as any PCR signal that exceeded the background PCR level associated with an HPV-negative sample of human DNA.  This is a risky protocol because PCR tests are plagued with false positive reactions (a positive signal that is not a true detection of the target). Since the authors show no data or reference to data on a secondary test that confirms the gene sequence of a positive signal, they cannot conclude that they are measuring HPV." So here is what the study really amounts to.  Again, I’ll defer to Urnovitz because he lays it very cleanly on the line:

"The proper conclusion of this study should be: Administration of this HPV-16 vaccine reduced the incidence of an uncharacterized PCR signal from a poorly defined cohort which was strongly biased toward a natural immunity.

Finally, press suggestions or those from the authors that young girls will soon be given a vaccine to prevent cervical cancer are ridiculously premature.

As an aside (make of it what you will), given the great new honesty in medicine these days, it was noted in the NEJM that "some co-authors on the study are with Merck Research Laboratories which developed the vaccine and provided the funding."

Red Flags Weekly November 25, 2002

DR.  MERCOLA'S COMMENT:


Wouldn’t it be nice if we could just get a shot, or in the future just eat a plant that is reengineered to contain a vaccine that would rid of us cancer?  Of course it would.

Unfortunately that is not the way our bodies were designed.  Cancer prevention is not as simplistic as taking a vaccination.  Maintaining a high level of immune integrity is the key, and this is done through the basics of emotional balancing, optimized nutrition, avoidance of toxins, proper sleep, exercise and hydration.

This research is clearly another deceptive ploy by Merck to generate revenue for their vaccine division in exchange for the delusional hope that a vaccine will reduce the risk of cancer.

Nicholas Regush writes an excellent review on this topic, which he is quite familiar with as a result of his review of the literature on HHV6 for his worthwhile book The Virus Within.

 

Parents fear possible vaccine link to autism

Monday, December 30, 2002

By MARK PERKISS

Sharon Oberleitner is facing a parent's nightmare.

She's convinced her two children developed autism because of vaccines they received and believes that having them immunized against smallpox will make their conditions worse. "I'm hoping there's not a war with Iraq and that there isn't any use of biological weapons," said the Princeton Township resident.

"I don't want to have to make a decision on whether to vaccinate my children and put them at risk, but I don't want them to get smallpox either. It's very scary," she said.

President Bush's move toward resurrecting wholesale smallpox inoculations for the first time since the 1970s comes as the nation's vaccination program is under increasing questioning - mostly from parents of autistic children. Questions abound whether the vaccines themselves or thimerosal, a mercury-containing preservative used in many of them from the 1930s until 1999, may be a cause of autism, a neurological disorder that can leave children unable to communicate with or relate to other people.

The debate rages in scientific circles, courtrooms and the halls of Congress, where lawmakers last month mysteriously slipped into the homeland security bill signed by Bush a provision protecting Eli Lilly & Co., the maker of thimerosal, from lawsuits.

But the head of the Eden Family of Services in West Windsor, one of the nation's leading treatment centers for autistic children, said parents' concerns about vaccines are unfounded and that the benefits of inoculations far outweigh any risk they may present.

"There are a lot of myths out there about vaccines and autism," said Eden President David Holmes.

"You have parents who are desperately searching for answers as to why and how their children have autism," he said. "There is a small, but vocal faction that sees vaccines as a culprit. "They were focused on the MMR (measles-mumps-rubella) vaccine as a cause, but scientific studies have shown there is no link. Now they're focused on the thimerosal, and so far the studies are showing there's not an autism link there either," Holmes said. "You can't help but feel for them. They're clutching for whatever they can, but there's a much larger consideration."  Recent studies, including one of 500,000 children in Denmark published in the New England Journal of Medicine last month, have found no link between the MMR vaccine and a dramatic rise in autism cases in the United States.
 

And a small, but groundbreaking study of infants who received vaccines containing thimerosal published in a British medical journal earlier this month found the levels of mercury in their blood was within federal safety limits. Parents and some scientists have theorized that a buildup of mercury from vaccines may have led to children developing autism. Holmes said the question of the effect of mercury in vaccines needs to be explored further but said he is looking at the larger picture.
 

"You have to look at the millions and millions of children in the United States who have been saved from a slew of devastating or fatal diseases because of our vaccination program," Holmes said. "That's a far larger number than any children who have had bad reactions from the vaccines. "There are always questions when you talk about vaccines, and those should be investigated and answered to make the program safer, but the overwhelming benefit of these medications far exceeds any risk there may be." Holmes said he is not concerned about the prospect of the United States resuming a smallpox inoculation program. "There's a legitimate threat from biological weapons, and we should be prepared," he said. "Children who already have autism aren't going to become worse if they are vaccinated for smallpox," Holmes said. "Autism doesn't get worse." 

Smallpox has not been seen for decades, but officials fear it could be used in defense by hostile countries or as part of a terrorist attack. The last U.S. case was in 1949, and the last anywhere else in the world was in 1977. The disease was declared eradicated globally in 1980. Routine smallpox vaccinations for children in the United States ended in 1972. So far, Bush has ordered about 500,000 military members in high-risk areas to receive the smallpox vaccine and has said vaccinations will be made available to about 500,000 health care workers around the country.

While he is not yet calling for all Americans to receive the vaccine, Bush has said those who want it will be able to get inoculated in 2003. The move to restart the smallpox vaccination program coupled with questions by parents and researchers about the possible link of thimerosal and autism has been music to the ears of trial lawyers, who have filed lawsuits against Eli Lilly and other manufacturers and are looking to drum up additional clients for what they see as billions of dollars in damage claims.  "What we have at the moment is a temporal correlation, which is enough for us to look to find potential plaintiffs," said John Sakson, the co-managing partner at Stark & Stark in Lawrence, which is working with a Texas law firm and earlier this year ran television ads seeking parents of autistic children as clients for possible lawsuits.

Stark & Stark signed up hundreds of potential clients but has not yet filed any lawsuits. "We need to make sure the science is correct for us to make a claim, and then there's the matter of the lawsuit protection that Congress put in for Eli Lilly," Sakson said. "That will have to be tested first."  Under the legislation, thimerosal claims would be limited to the federal Vaccine Injury Compensation Program, which limits damages and severely restricts who can sue vaccine manufacturers. Members of Congress are working to lift the litigation protection that was included in the homeland security legislation. "We've had a number of meetings with parents groups and with other members of Congress to see what we can do about it," said Nick Manetto, a spokesman for Rep. Chris Smith, R-Washington Township. Smith voted in favor of the legislation but was unaware of the provision that was included in the bill at the last minute, Manetto said. All of the legal and political maneuvering doesn't solve the pending dilemma for Oberleitner, the Princeton Township mother. "Vaccines are scary. My children are suffering because of them," she said. "Smallpox is scary also. "If it actually gets to our shores, I don't know what to do. I thought I was protecting my children with the vaccines they've already had, and look what happened."

NOTE: Contact Mark Perkiss at mperkiss@njtimes.com or at (609) 943-5727.

Copyright 2003 NJ.com. All Rights Reserved.

The Danish MMR-Study- a critical analysis

http://content.nejm.org/cgi/content/abstract/347/19/1477?ijkey=p4J.EJxP2/wIk

A Population-Based Study of Measles, Mumps, and Rubella Vaccination and Autism
Kreesten Meldgaard Madsen, M.D., Anders Hviid, M.Sc., Mogens Vestergaard, M.D., Diana Schendel, Ph.D., Jan Wohlfahrt, M.Sc., Poul Thorsen, M.D., Jørn Olsen, M.D., and Mads Melbye, M.D.

ABSTRACT

Background It has been suggested that vaccination against measles, mumps, and rubella (MMR) is a cause of autism.

Methods We conducted a retrospective cohort study of all children born in Denmark from January 1991 through December 1998. The cohort was selected on the basis of data from the Danish Civil Registration System, which assigns a unique identification number to every live-born infant and new resident in Denmark. MMR-vaccination status was obtained from the Danish National Board of Health. Information on the children's autism status was obtained from the Danish Psychiatric Central Register, which contains information on all diagnoses received by patients in psychiatric hospitals and outpatient clinics in Denmark. We obtained information on potential confounders from the Danish Medical Birth Registry, the National Hospital Registry, and Statistics Denmark.

Results Of the 537,303 children in the cohort (representing 2,129,864 person-years), 440,655 (82.0 percent) had received the MMR vaccine. We identified 316 children with a diagnosis of autistic disorder and 422 with a diagnosis of other autistic-spectrum disorders. After adjustment for potential confounders, the relative risk of autistic disorder in the group of vaccinated children, as compared with the unvaccinated group, was 0.92 (95 percent confidence interval, 0.68 to 1.24), and the relative risk of another autistic-spectrum disorder was 0.83 (95 percent confidence interval, 0.65 to 1.07). There was no association between the age at the time of vaccination, the time since vaccination, or the date of vaccination and the development of autistic disorder.

Conclusions This study provides strong evidence against the hypothesis that MMR vaccination causes autism.

BMJ 2002;325:1134 ( 16 November )

News

MMR vaccine is not linked with autism, says Danish study

r

537,304 children in the study, 8 cohorts
 

The underlined figures indicate when vaccination normally takes place as part of the vaccination programme. The figures in italics indicate the point in time when autism is usually diagnosed in that age group: i.e. the fifth year of life - 1996 for children born in 1991 etc. This point is only reached by the three oldest cohorts. Children born in 1994 and later did not reach the age when autism is usually diagnosed before the study was concluded.

SOURCE OF ERROR # 1: Children did not have time to become autistic as a result of MMR vaccination before being excluded from the study

537,303 children multiplied by 12 years equals a total of 6.5 million person-years for children born between 1991 and 1998. Only 2.1 person-years have been taken into account, however. Younger children were only studied from the time of birth until the study was concluded. As a result, the oldest children contribute considerably more person-years to the study than the youngest children. The average age for the entire population studied is 2.1/6.5 * 12 = approximately 4 person-years. As a result, observation of the subjects was discontinued long before the age when autism is normally diagnosed (4.25 - 5.25 years according to the study itself). Moreover, a second MMR vaccination is normally given during the fourth year of life.

The youngest cohorts have only just managed to get the MMR vaccine before they are discarded from the study. As a result, they contribute to the numbers of vaccinated children, but have little or no chance of being diagnosed with autism as a result of the vaccines they were given. Children diagnosed with autism before they were old enough to be given the MMR vaccine may then have been included in the study as "unvaccinated autistic children".

This is a systematic and uncontrolled source of error. As a result, the possible role of the MMR vaccine as a cause of autism is consistently underestimated.

SOURCE OF ERROR #2: Cases of congenital autism and cases of autism as a result of previous vaccinations with other vaccines also obscure the issue and reduce the effect of those few cases of autism caused by the MMR vaccine that are nonetheless detected.

Many experts on autism believe that some cases of autism are not caused by vaccination, but are congenital. These cases are usually diagnosed in the first year of life and often before the first MMR vaccine is administered. Moreover, the Danish study also seems to presume that only the MMR vaccine may cause autism, whereas numerous studies have shown that any vaccine is in fact capable of doing so. Books such as Dr Viera Scheibner's "Behavioural Problems in Childhood - The Link to Vaccination", Greg Wilson's "Vaccination and Behavioural Disorders - A Review of the Controversy", Harris Coulter's "Vaccination: Social Violence and Criminality, The Assault on the American Brain" and Karen Seroussi's "Unravelling the Mystery of Autism" examine the subject in great detail. The first two of these books alone cite over 500 relevant medical papers between them. However, it does not seem to have occurred to the authors of the Danish study that cases of autism caused by the MMR vaccine can hardly be diagnosed before the vaccine has been administered. Not only that: any cases of autism caused by the second MMR vaccine, which is normally administered in the fourth year of life, are unlikely to be detected by this study, since most of the older children are no longer included in the study by this time. Indeed, children in the later age cohorts no longer form part of the study before the effects of even the first MMR vaccine can be detected.

Most cases of congenital autism and many cases of autism caused by other vaccines will be detected by this study, but very few cases of autism caused by the MMR vaccine will show up. As a result, the significance of any such cases that are in fact found will be obscured by the cases of congenital autism and autism caused by other vaccines. The statistical effect of this is that groups that have received the MMR vaccine and those that have not will tend to exhibit a similar incidence of autism

This is a systematic source of error that makes it practically impossible to detect any cases of autism caused by the MMR vaccine

SOURCE. OF ERROR #3: Autistic children may have systematically been classified as unvaccinated.

According to the study, 18% of the children were unvaccinated, while 82% were vaccinated. Only by the age of three were children deemed, with certainty, to have been vaccinated. The average age when the MMR vaccine was given can be estimated as 1.5 years. It is not clear how the study categorised children who were diagnosed with autism before the age of three, but who were given the MMR vaccine after they were diagnosed. Similarly, it is unclear how children who were given the MMR vaccine for the first time after the age of three were classified. As for the reason why 18% of the children did not receive the MMR vaccine, this is neither studied nor commented upon. Contraindications to vaccination include poor health, lowered immunity, immunological processes, neurological diseases and neurological disturbances: in other words the very conditions indicative of the gastro-intestinal autism syndrome.

It is obvious that such cases must have existed. The fact that they are not commented upon can only indicate that the authors of the report have either not realised what the statistical effect would be or are deliberately seeking to conceal the effects of the MMR vaccine.

If doctors or parents have refrained from vaccinating for health reasons, whether real or suspected, these children will have been classified as "unvaccinated" and the conclusions of the report will be completely misleading.

SOURCE OF ERROR #4: The effect of relevant data has been diluted by irrelevant data.

If the intention is to compare the effects of vaccines on children, it is appropriate to compare vaccinated with unvaccinated children only AFTER vaccination. Mixing such data with data concerning children prior to vaccination only serves to obscure the issue and make any effects much harder to detect. At the same time the impression is given that the study is based on far more observations than is in fact the case.

Of the 2.1 million person-years studied, 537,303 * 1.5 = 0.8 million years represent unvaccinated children below 1.5 years of age (whether or not they were subsequently vaccinated). Of the remaining years (2.1 - 0.8 = 1.3 million person-years), 82%, or approximately 1.1 million person-years represent children older than 1.5 years who received the MMR vaccine. Only approximately 0.2 million person-years represent children over the age of 1.5 years who did not receive the MMR vaccine. Only in this group would it be possible to find a relevant control group to compare with those who did receive the MMR vaccine. It is this limited group that must form the basis for statistical evaluations of safety and level of incidence.

According to the study, 738 cases of autism were found that could be assigned to the population studied. All cases of autism diagnosed before the age at which the MMR vaccine was administered must naturally be discarded in order for any comparison to be meaningful. Generally speaking this would be 0.8/2.1 = 38% of the 738 cases reported (i.e. 280 cases). Of the remaining 458 cases, assuming the risk is the same for both vaccinated and unvaccinated children, 18% (82 cases) will be unvaccinated children older than 1.5 years. This represents 10 cases per year for the whole of Denmark.

SOURCE OF ERROR #5: The design of the study makes it extremely sensitive to any changes that take place over time. It is well known that vaccines are not stable: both their quality and their contents are continually changing. An analysis of the studies conducted by Kayes and Taylor in England, for example, show that the introduction of the Jeryl Lynn* vaccine in 1992 was followed by a sudden and rapid increase in the incidence of autism. It is reasonable to assume that in Denmark as well there were changes in the characteristics of the vaccines used. Such changes are neither mentioned nor accounted for.

The design of the study means that the older cohorts (1992-1995) contribute far more person-years to the study. This means that just as in the English studies, any increase in the risk of autism over time is practically impossible to detect. In addition, no information is given about how the unvaccinated group is distributed over the years 1991-1998. This in itself can seriously affect or distort the study.

TO SUM UP: The data presented in the study provides no basis whatsoever for the conclusions drawn by the authors. The study tries to give the appearance of an exhaustive investigation of all children born in Denmark from 1991 to 1998. In reality only one third of the person-years attributable to these groups of children have been studied. Many of the person-years that have been studied are of no relevance whatsoever. Most of the person-years that would have provided the most valuable information have been excluded from the study, perhaps due to lack of time or other reasons. However, a more detailed examination of the oldest cohorts, which might have compensated for this shortcoming, has not been provided. Important questions remain unanswered, such as whether children diagnosed with autism at an early age were classified as vaccinated or not, and whether or not the original decision to vaccinate or not vaccinate children is in itself a source of systematic error. In the final analysis, the conclusions drawn by the authors of the study are based on a mere 10 cases per year. Given the numerous sources of error and the unclear definitions of the concepts used, this is totally inadequate.
 

All the sources of error identified in the study distort it in the same direction: obscuring the role of the MMR vaccine and exonerating it from any suspicion that it may cause autism. This strongly indicates deliberate fraud. The reason is not hard to guess. Most of the authors of the report are medical doctors and it is safe to assume that they are - or have been - ardent pro-vaccinators. By now they should be well aware of the many scientific studies of the injuries caused by vaccines. They will know that there is now an autism epidemic, that only the vaccinated are affected and that autism always occurs after vaccination and not before. In other words the authors of this report are people with blood on their hands, who fear the retribution of parents, whose children they have killed, mutilated and rendered autistic. People who are prepared to kill and injure helpless children for money will hardly hesitate to lie and cheat if it will keep them out of jail and enable them to avoid paying compensation to their victims. This report is a desperate and despicable attempt by child abusers to remove the noose that is tightening around their necks. Their report (and this one) belongs in the hands of the prosecutor.

Ulf Brånell

Alan Rees +46 40 163930 rees <rees@pp.sbbs.se>

* Jeryl Lynn was earlier in this paper wrongly named Urabe, this was corrected 02 11 27.

Dear Dr. Holmes,
  Thank you for your recent contribution to the news article concerning vaccines and autism. http://www.nj.com/news/times/index.ssf?/base/news-0/1041246051125321.xml

As a leading authority on autism spectrum disorders, your comments will help to put many minds at ease, including my own. It's important for everyone to remember that a variety of factors may contribute to autism other than vaccines. As you mentioned, a small but vocal group of people believe that their children became autistic after receiving one or more vaccinations. A recent study at the University of California, Davis, recorded approximately one third of the parents who participated were convinced that vaccinations played a role in their child's autism. This number is closer to 90% among the hundreds of parents of autistic children I know. I'm certain your assurances will be welcome to these parents.   Before I can be completely at ease with subjecting my autistic child to additional vaccines, including the dreaded smallpox, I wonder if you would mind clarifying a few points of confusion.

1) Where did you complete your education in immunology and neurology?

2) Would you mind briefly explaining the mechanisms of acquired immunity including vaccination, antigen presentation, phage display, T-cell differentiation, molecular mimicry, viral receptors, chemotaxis, the function of adjuvant, and anything else that you feel may help me to better understand the intricacies of the human immune system?

3) Many autistic individuals seem to suffer from coincidental gastrointestinal disorders and multiple sensitivities to dietary proteins. Do you support the concept of a gut-brain connection? Which were you speaking from or should we consider another region of the GI tract?

4) Are you aware of any interactions between the immune system and the CNS? If so, how can we be sure that the permanent and irreversible medical procedure designed to modify the immune system, commonly known as vaccination, will not result in neurological manifestations?

5) If children who suffer adverse reactions from vaccines are contributing to the greater good, why aren't they recognized as heroes? Who is the omnipotent individual that decides who will be spared from devastating and fatal disease, and who will be punished with lifelong disabilities? I thought that position was occupied.

If you are unable to answer any or all of the above questions, might I suggest that you exercise restraint and comment only on matters that you are qualified to speak. In exchange, if I ever over hear two medical doctors debating the merits of Freud vs. Jung, I will offer the same advice. Although that may be interpreted as an aversive reinforcer by some.

Sincerely,

Steve
 

From: ALAN REES
GINSTGATAN 7
230 44 BUNKEFLOSTRAND
SWEDEN
Home tel +46 40 163930
Office tel/fax +46 40 158883
mailto:rees@pp.sbbs.se
17 February 2003

This is an open letter to the authors of the notorious ”Danish MMR Study” but it is also intended for vaccine victims and their families, journalists and the mass media. I would ask all recipients to use the power of the net and disseminate this as widely as possible.

To: Kreesten Meldgaard Madsen, M.D., Anders Hviid, M.Sc., Mogens
Vestergaard, M.D.,
Diana Schendel, Ph.D., Jan Wohlfahrt, M.Sc., Poul Thorsen, M.D., Jørn
Olsen, M.D., and
Mads Melbye, M.D. Copy to "Kåre Mølbak" KRM@ssi.dk and others.

Addresses for some of the authors

Kreesten Meldgaard Madsen Mailto:kmm@dadlnet.dk
Anders Hviid, M.Sc., mailto:aii@ssi.dk
Mads Melbye, M.D. mailto:serum@ssi.dk
Mads & Anders telephone: +45-32683163
Poul Thorsen mailto:pct9@cdc.gov>
Diana Schendel,  telephone  770 488-7359
I trust that those recipients will inform the others.

I must refer, once again to the infamous “Danish MMR study” of which you are the wretched authors. The criticism of it, by Ulf Brånell and myself can be read at:
http://www.motgift.nu/Div/SIEM/MMRE2E.html
http://www.whale.to/a/branell.html

This criticism was sent to you in December. You were invited to comment on it and contact me. Not one of you has done so, despite e-mails and phone calls (don’t you listen to your answering machine, Diana?). I managed to phone Anders Hviid and a truly bizarre conversation ensued. He first claimed that he did not know who I was, then he remembered but said he had been unable to understand our criticism because he could not read Swedish! Apart from the fact that our criticism is available in both Swedish and English, Anders is the first Dane I have encountered who cannot read Swedish (I can read Danish so what is his problem?) Anders did not want to talk about the study (indeed, he seemed incapable of doing so) and said I should speak to the principal author, Anders Meldgaard.

Me: What is his phone number?
Anders: I don’t know. I don’t have it.
Me: Then how the hell do you communicate? Carrier pigeons?
Anders: He rings me when he wants something.
Me: Then I’ll talk to you.
Anders:  I can’t. You must talk to the principal author.
Me: But your name is on the report.
Anders: I can’t comment on that. You must talk to the principal author.

There was much more to this hilarious conversation. You can read the rest when I write my book. If this is the way you operate, no wonder your report is such a disaster. I also asked Anders if he had the courage of his convictions and was willing to let me vaccinate him. “I would have to ask my colleagues.” Apparently an employee of the Danish Serum Institute has to ask permission to be vaccinated. Extraordinary! He said he would consult with his colleagues and ring me “in a couple of days”. He never did.

I therefore arrived at the Serum Institute with my vaccine-injured son on Friday February 7 and asked to speak to Anders Hviid and Mads Melbye (who also works there). I was told that they would not speak to me and that they were calling the police to have me removed from the premises. I said that was fine by me, but did the Serum Institute really want the publicity that would ensue from chucking a vaccine victim, a helpless child, into the snow? Suddenly Kåre Möllbak was available to talk to me. Now there you have a true believer. Even though his own son suffered convulsions after vaccination, he still thinks vaccines are great and that the benefits outweigh the risks. He said it was a pleasure to talk to me and we agreed that a meeting should be arranged. I would therefore like you all to meet me on Friday 7 March at 16.30 at:

Statens Serum Institut
Artillerivej 5 2300 Copenhagen S
Denmark
Telephone: +45-32683163
Fax: +45 3268 3868

and we shall have a seminar together. I suggest we conclude around 20.30. We shall go through your study and the criticism of it. We shall also go through a number of scientific studies on the injuries caused by vaccines and discuss the level of compensation victims should receive as well as treatment modalities and the legal aspects, including the possible liability of people such as yourselves and the various pending lawsuits. We need an appropriate room with an overhead projector, a copying machine and an on-line computer with a projector attachment. My vaccine-injured son will be with me and you can all take turns looking after him. This will be a salutary and educational experience for you all. You cheerfully admit that vaccines cause injuries, brain damage and deaths (it says so on the product insert – why is this never shown to us?) but do everything in your power to avoid meeting a victim (see above). This will be a great opportunity for you to see what vaccines do. For my son you should supply a mattress, pillow, blankets and suitable playthings, bottled spring water, gluten-free crispbread (made by the Vasa company), organically-grown fruit (bananas and apples) and hummous.

My fee for the seminar will be GBP 1000. This is to compensate me to some extent for the costs and loss of income I have incurred because of you. When your article was published I was contacted by outraged vaccine victims from around the world. They pointed out that  your study was financed by the CDC (ardent pro-vaccinators) and the NAAR (who receive funding from vaccine manufacturers). I was told that your study was blatant fraud and an attempt to write an alibi for yourselves and your colleagues now that autism has reached epidemic proportions. They begged me to write a rebuttal, which Ulf Brånell and I duly did. I had to take time of work to do so and to write letters such as this. Meanwhile you get paid for your trouble. The injustice and unfairness of this is appalling. You seem to think this is a game. You are given vast sums of money to conduct a study (some must have been set aside for follow-up, so my fee should be no problem) and you do a lousy job. You seem unable to answer your critics and appear to be trying to silence them, presumably hoping that your study will look good on your CVs and that nobody will notice. You should be ashamed of yourselves. You should publish a retraction in the medical journals and urge them to print our criticism, which they have so far refused to do.

To all other recipients of this message: other vaccine victims and their families may wish to attend the seminar. Please spread the word, especially to families in southern Sweden and the Copenhagen area. Please bring your vaccine-injured children if you are able to. The Serum Institute is a 10-minute cycle ride from the central station. It would be courteous if those attending the seminar were to inform the Serum Institute. You might also like to inform the media: In southern Sweden: the newspaper Sydsvenska Dagbladet: mailto:sydsvenskan@sydsvenskan.se
In Denmark the newspaper Politiken mailto:indland@pol.dk
then there is the television of course:
http://www.tv2.dk
http://www.dif.dk/

It is also possible that the authors will once again threaten to call the police and ask them to throw us out. It would save a lot of time if someone tells the police we are coming: http://www.politi.dk/
and asks them if the authors of the report are guilty of manslaughter and causing actual bodily harm. It is well documented that vaccines cause death and injury to perfectly healthy people, the authors are all vaccinators and promote vaccines, so do they not have a case to answer?

For those attending the seminar, please acquire, read and bring to the meeting the following publications in addition to the article by Brånell and myself:

Book: Vaccination, by Viera Scheibner. (ISBN 0 646 15124 X)
Book: Behavioural problems in childhood - the link to vaccination Viera
Scheibner (ISBN 0-9578007-0-3)
Book: Vaccination, social violence and criminality, by Harris Coulter
:(ISBN 1-55643-103-1).
Book: Vaccination, a parent's dilemma by Greg Beattie
(ISBN1-876308-00-1)
And all the books by Neil Z. Miller
Print out, read and bring with you the following articles by Viera
Scheibner.
http://www.nexusmagazine.com/shakenbaby.html
http://www.whale.to/vaccine/sch.html or
http://66.70.140.217/vaccine/sch.html

similarly this article:
Voices of Safety International (VOSI) is a Standards Development Organization (SDO) which is recognized by the National Institute of Standards & Technology. See http://www.voicesofsafety.com  home page "About VOSI". Click on "Public Health".
Click on the V50.2 standard and read the associated Research Report that PROVES  that children are 12 times more likely to become autistic after being vaccinated compared to never having been vaccinated.

You should also familiarise yourselves with the following sites and material on the net:
The founder and president of the Autism Research Institute, Bernard Rimland, is of the opinion that vaccines cause autism. Here is an article he wrote on the subject:
http://www.autism.com/ari/editorials/explosion.html

http://www.whale.to/vaccines.html or  http://66.70.140.217/vaccines.html

http://www.informedparent.co.uk

We shall also discuss treatments that can be used to treat and detoxify
those injured by vaccines:
International Child Development Resource Center – Dr Jeff Bradstreet
http://www.icdrc.org/

http://www.azavenue.com/kelly/organizations.htm
http://www.vaccinationnews.com/default.htm
For more information about monkey virus SV40 in vaccines:
http://www.rense.com/health/salk.htm
http://www.vaccine-info.com
http://www.vran.org
http://www.kessick.demon.co.uk/2commonspr.html
http://www.whale.to/vaccines/horwin.html
http://www.pnc.com.au/~cafmr/
This site is important. Conventional medicine is built on a foundation of fraud. 85% of medical and surgical procedures are scientifically unproven (British Medical Journal October 1991)
Only one in 24,000 drug reactions is ever reported by the doctor (British Journal of Clinical Pharmacology 1997; 43:177-181). Drug reactions are now the world's fourth major killer. They cause more than 100,000 deaths in the USA every year. Only heart disease, cancer and stroke are more dangerous than drugs
(JAMA 1998; 279 1200-05) Few people are aware of how endemic and widespread fraud is in medicine.

For an in-depth study, read the book The Betrayers of Truth by Broad & Wade, or order The Pharmaceutical Drug racket" from the Vaccination Information site below.
http://www.vaccinfo.karoo.net
http://www.ias.org.nz
http://www.avn.org.au
http://www.empiricaltherapies.com
http://www.new-atlantean.com/global/vaccine.html
Neil Z. Miller's site. Neil is the author of several books on vaccines.
http://www.cco.net/~trufax/vaccine/vacindex.html
http://www.unc.edu/~aphillip/www/chf/index.htm
http://www.909shot.com
http://unc.edu/~aphillip/www/vaccine/informed.htm
http://www.ias.org.nz/
http://www.jabs.org.uk
http://www.iahf.com/index1.html
http://home.san.rr.com/via
http://vaccines.net/risks.htm
http://www.doctorsaredangerous.com/
http://www.mercola.com/
Dr Mercola writes:  lot of people ask me where to find good articles on the subject of vaccination. I recommend http://www.redflagsweekly.com and http://www.vaccinationnews.com
http://www.whale.to/m/haley.html "A single vaccine given to a six-pound newborn is the equivalent of giving a 180 lb. adult 30 vaccinations on the same day. Include in this the toxic effects of high levels of aluminum and formaldehyde contained in some vaccines, and the synergist toxicity could be increased to
unknown levels. Further, it is very well known that infants do not produce significant levels of bile or have adult renal capacity for several months after birth. Bilary transport is the major biochemical route by which mercury is removed from the body, and infants cannot do this very well. They also do not possess the renal (kidney) capacity to remove aluminum. Additionally, mercury is a well-known inhibitor of kidney function." - Boyd Haley Ph.D.

The following study shows that bcg vaccine increases the risk of tb:
http://www.birthworks.org/primalhealth/databank.phtml?study=122
http://www.vaclib.org/index.htm
http://www.VaccineInfo.net
http://www.nccn.net/~wwithin/vaccine.htm
http://www.sickofdoctors.com


See you all in Copenhagen!

Alan Rees
 

Here is another study done by the pharmaceutical company GlaxoSmithKline. Kind of like grading your own homework.

Vaccine, Vol. 21 (11-12) (2003) pp. 1256-1267
© 2002 Elsevier Science Ltd. All rights reserved.
PII: S0264-410X(02)00431-0

http://www.allergyimmunolinx.com/theaarts.cfm?artid=501110&specid=21&ok=yes


The cost-effectiveness of routine childhood varicella vaccination in Germany
¤

K. Banz a * kurt.banz@outcomes.ch , S. Wagenpfeil b, A. Neiss b, A. Goertz c,
U. Staginnus c 1 , J. Vollmar c and P. Wutzler da Outcomes International,
Malzgasse 9, CH-4052 Basel, Switzerland b Institute for Medical Statistics and Epidemiology, Technical University of Munich, Munich, Germany  GlaxoSmithKline, Munich, Germany  Institute for Antiviral Chemotherapy, University of Jena, Jena, Germany Received 23 October 2001; received in revised form 1 August 2002; accepted 19 August 2002


Abstract

This study explores the economic value of a routine varicella vaccination program for Germany. An age-structured decision analytic model was used to assess the benefits, costs and cost-effectiveness of an immunization program for a period of 30 years. Three interventions were compared with no vaccination: universal vaccination of around 15 months old healthy children, vaccination of susceptible adolescents (11-12 years of age), and the combined strategy. The analysis was conducted from both the societal perspective and the payers', i.e. sickness funds, perspective. Input data were mainly derived from a retrospective survey (analyzed were1334 patient records) and from a seroprevalence study (n=4602 sera). Using a coverage rate of 85% and a vaccine efficacy rate of 86% routine children vaccination could prevent
around 611,000 varicella cases and over 4700 major complications per year.  Average yearly cost savings for the society are 51.3 million Euro. The benefit-cost ratio (BCR) is 4.12. From the third-party payer's perspective, the BCR is 1.75 which is a consequence of significant reimbursement of parent's lost earnings by German sickness funds. The adolescent vaccination strategy has a favorable BCR ratio of 8.44 from the societal perspective, but clearly inferior medical effects. The combined vaccination strategy showed similar results as the children strategy. Routine childhood varicella vaccination appears to be a highly efficient strategy to reduce the burden of varicella and results in significant savings for both the society and the payers.

Keywords: Varicella; Vaccination; Cost-effectiveness*Corresponding author. Tel.: +41-61-227-72-55; fax: +41-61-227-72-27.1Former with GlaxoSmithKline
Biologicals, Rixensart, Belgium.

 

The pharmaceutical industry has shown its true colors on this one.

The goal of creating Pediarix, a new 3-in-one combination vaccine for diphtheria, tetanus, pertussis, hepatitis B and polio, is clearly stated in the GlaxoSmithKline (GSK) press release: “combination vaccines will allow more vaccines to be added to the ‘crowded’ pediatric vaccination schedule.” With more than 200 vaccines currently under development, it is certain that many more will be added to the childhood and adolescent vaccination schedules. To accommodate the new additions, many combination vaccines are in the pipeline, including:

MMR and Varivax
DTaP and IPV
DTaP and Hepatitis B (HepB)
DTaP, IPV and HiB (Pentavac)
DTaP, HepB and HiB
DTaP, IPV, HepB and HiB (Hexavac)
DTaP, IPV, HepB, HiB and Hepatitis A[1]

Scientifically, the D-T-aP is composed of three separate vaccines, and the polio vaccine contains three viruses, so it is actually three vaccines. After adding the projected number of antigens in the “combination vaccines,” the fictional vaccine Omnivax portrayed in Michael Palmer’s book "Fatal," which combined 30 vaccines into one shot, does not seem so “fictional.”

It is certainly disturbing for parents to see their babies receive five to seven separate vaccinations at the 2-, 4- and 6-month “well-baby visits.” However, reducing the total number of shots by combining them, rather than eliminating unnecessary shots from the schedule, is nothing more than a deceptive “placebo” for concerned parents.

Even when familiar vaccines are combined, the mixture is considered to be a new product. The vaccine must be subjected to “safety and efficacy” clinical trials as though it were brand-new.[2] After reviewing several of the studies that allowed this vaccine to come to market, similar investigational flaws were discovered for this vaccine trial as in all others: safety is not “proven” through the studies, and “effectiveness” is defined only as the presence of antibodies.

The design of all vaccine safety studies is seriously flawed. A scientifically sound safety study would compare the new vaccine to an inert substance, such as sterile water or saline. In addition, current vaccine safety studies compare a new vaccine to a vaccine with a “known side effect profile.” These flaws are bad enough, but the design of the Pediarix study coordinated by the UCLA Center for Vaccine Research, Research and Education Institute, was even more bizarre.

Various combinations of vaccines were given to 400 children who had been divided into four groups:
 

The conclusion? The researchers found that the antibody levels of each of the vaccines were nearly the same in all groups, therefore, “the use of the pentavalent combination vaccine will greatly reduce the number of required injections during the first 2 years of life, thereby simplifying the immunization schedule, enhancing compliance and facilitating acceptance of additional injections engendered by introduction of newer vaccines.”[3] That sounds like proving convenience, but not proving safety. If the [DTaP + HepB] vaccine looks unfamiliar to you, it is because it is. In this study, five licensed vaccines and two investigational combination vaccines (also manufactured by GSK) were evaluated simultaneously.[4] The FDA appears to be granting permission to compare one experimental vaccine to another. I wonder if the parents knew that their children were being used as truly “experimental subjects”? This type of “research” goes far beyond what can possibly be defended on scientific grounds and borders on being criminal. The same study further concluded that “there were no vaccine-related serious adverse events in any group after any vaccine dose.” But if the study is read carefully, evidence to the contrary exists:
 

Why is it that whenever an adverse event occurs during the course of a vaccine clinical trail, that “event” is never related to vaccination?

Every consumer should ask to read the package insert on every vaccine, but be sure to read this one carefully.[6] Here is a partial list of the additives, adjuvants and contaminants: VERO (monkey) cells -- potentially containing the SV40 virus incriminated in several different cancers, including leukemia. Bovine extract, bovine casein and calf (bovine) sera -- It is common knowledge that bovine blood products can be contaminated with viruses, and bovine viral diarrhea virus (BVDV) is the one most often contaminating fetal bovine serum.[7] Formaldehyde -- a chemical that has caused cancer in laboratory animals and may cause cancer in humans. There is no known threshold level below which cancer risk does not exist. The World Health Organization recommends that exposure should not exceed 0.05 ppm (parts per million).[8] Glutaraldehyde -- a toxic chemical that is used for cold sterilization of medical and dental equipment. There is no Occupational Safety and Health Administration (OSHA) permissible exposure limit. The National Institute for Occupational Safety and Health (NIOSH) recommends that exposure to glutaraldehyde be under 0.2 ppm.[9] (TOM: reference) 2-Phenoxyethanol -- the chemical name for antifreeze, the vaccine contains 2.5 mg of this compound. Thimerosal -- this mercury compound is used in the production of Energix, the hepatitis B fraction of the vaccine. It is used during the initial manufacturing process and then removed by a process using cystiene. However, up to 12.5ng (nanograms) remain.

The vaccine also contains these substances: neomycin, polymyxin B, polysorbate 80 and less than five percent yeast protein. The instructions on the package insert caution to “shake well before administering” and describe the vaccine as a “turbid white suspension” consisting of the many particles in the solution.

Is this something that you would want to have injected into your arm? Into your baby’s arm? Don’t bet on it. The long-term studies on combination vaccines will most likely prove that the biological warfare coming through a needle is just that: war -- on the immune system.
References:
 

Has Gillberg been caught cheating? Pass it on.

Headlines in the Swedish press yesterday. Professor Christoper Gillberg, the co-author of “The Biology of the Autistic Syndromes” is involved in yet another scandal. This time he has been accused of fraudulent scientific research and his critics have been granted a court order to force him to reveal his raw data - something he has previously refused to do (as have Roy Meadows and Brent Taylor before him). Gillberg is, of course, no stranger to controversy. He is already notorious for admitting to a number of people in private that he had not vaccinated his own offspring, while declaring in public that there is no link between vaccines and autism. He even conducted an epidemiological study in the Gothenburg region to prove there is no link. This study was roundly condemned as worthless and it was elegantly torn apart by David Thrower in his customary fashion. You can find David’s analysis of this  and many other vaccine studies at:
http://www.whale.to/vaccines.html or  http://66.70.140.217/vaccines.html

http://click.topica.com/maaaO5paaVN7Ga4JkBVb/
http://www.freewebz.com/schafer/URL/g.htm

Sloppy research is bad enough, but now he is being accused of actually cheating. The study  was a 15-year follow-up of 42 children diagnosed as having DAMP. On the basis of this study, 3,000 Swedish children have been prescribed amphetamines (Ritalin) and Gillberg and his colleagues argue that another 70,000 children are in need of it. Given the horrific effects of amphetamine, this is a very serious matter.

Leif Elinder, a paediatrician in Uppsala and Eva Kärfve, a sociologist at the University of Lund have pointed out a number of peculiar features of the study:

- Nearly all the patients turned time after time up for comprehensive examinations without receiving any diagnosis or treatment.

- Leif Elinder has commented that the dropout rate appears to be incredibly low, when it is usually quite large in studies such as these.

- Eva Kärfve has pointed out that the dropout rate seems to be not just low, but positively non-existent. Indeed, the number of participants appears to have actually increased over the course of the study! She has therefore accused the researchers of subsequently recruiting participants who did not belong to the original study.

- DAMP, like autism, affects far more boys than girls. However, while more than half of the control group consisted of girls, most of whom came from stable families and prosperous homes, 75% of the DAMP children were boys from dysfunctional families in run-down areas with poor housing.

And so on and so forth…

Gillberg was asked to produce his raw data. He refused on the grounds that the information was confidential. Since participants in such studies are usually only identified by numbers or codes and their identities are concealed, this is a remarkable objection and clearly one that did not impress the court. So now Gillberg must hand over his data. What will happen to him? Perhaps he will follow in the footsteps of his predecessor, Stephen Breuning, who also studied the effects of amphetamines on hyperactive children in the 1980’s. He was found to have faked his data and was sent to jail for fraud. That is exactly where a
lot of people think Christopher Gillberg belongs. After all, this study is one of many, and how many of them would stand up to close inspection? Just ask David Thrower. And how about the finances? This study received grants from a foundation (Allmänna Arvsfonden) but the money was not to be used for salaries or computers. According to a newspaper article the money was used for…um…salaries and computers. No legal action has been taken on this matter…yet.

Actually, the financing of these studies is a study in itself. It has been pointed out that Gillberg & colleagues all seem to sit on boards that vet research projects and approve grants. Some cynics have implied that they are in fact dishing money out to each other. Personally I think this is a monstrous libel, but why was all that money given to someone called Carina Gillberg? Could she possibly be related to Chris? One wonders.

Gillberg seems to consider himself misunderstood. He has said that he is being persecuted by Eva Kärfve. I am told he has even referred to me in less than complimentary terms. No doubt he will set the record straight. His mail address is:
mailto:christopher.gillberg@pediat.gu.se
Fax: +46 31 341 5545
Phone +46 31 341 6749

 

Study Finds Vaccine Doesn't Lead to Child Bacterial Infections

[By Donald G. McNeil Jr. in the NY Times.]
http://www.nytimes.com/2003/02/20/health/20VACC.html?ex=1046408400&en=bddc7b
68647cbbf3&ei=5062&partner=GOOGLE

There is no evidence that the measles, mumps and rubella vaccine overloads children's immune systems or makes them more vulnerable to bacteria infections, researchers in Britain have found. The researchers, from the British Public Health Laboratory Service,said they undertook their study because some British parents' groups contend that the M.M.R. vaccine gives children more viruses than they can cope with, weakening their immune systems. The findings were reported yesterday in The Archives of Disease in Childhood, a medical journal. British and American groups skeptical about vaccinations said yesterday that the study, which was largely paid for by vaccine companies, missed the point. Their contention is that the vaccine overwhelms defenses against viruses, particularly measles, and makes infants vulnerable to autism.

Vaccine experts in the United States dismissed that idea as scientifically unsound and said the study's conclusions made sense, although some were disappointed at how little data the researchers released. Fear of the M.M.R. vaccine in Britain is so great that immunization rates with it have dropped to 85 percent nationally since 1998, and much lower in some areas, despite strong government endorsement of immunization.

Even as he endorsed the M.M.R. vaccine, Prime Minister Tony Blair has refused to say whether his new son has had the shot, drawing loud criticism from editorialists. Small, local measles outbreaks across Britain have raised alarms. The vaccine, given in the second year of life, is made with live, but weakened, viruses. The viruses provoke the body to produce antibodies, without actually causing disease. The researchers looked at the medical records of all young children hospitalized in southern England for serious bacterial infections of the blood, brain stem and lungs between 1991 and 1995. It studied those who had had an M.M.R. inoculation in the previous three months and excluded those who had underlying immune system problems or had been hospitalized before. Researchers concluded that immunized children actually had less risk than average of being hospitalized for pneumonia, meningitis, septicemia or other infections.

The results should be "reassuring evidence for parents on the safety of M.M.R. vaccine," said Dr. Liz Miller, leader of the Public Health Laboratory Service immunization division and the lead author of the paper. "While there were already strong scientific arguments against the idea that the immune system could be overloaded, our study provides direct evidence that this does not occur." Dr. Neal Halsey, director of the Institute for Vaccine Safety at the Johns Hopkins School of Public Health, called the study "well done, with appropriate methods, by investigators who are well known."

Groups skeptical of the M.M.R. vaccine on both sides of the Atlantic demurred. Dr. Marcel Kinsbroune, a pediatric neurologist who advises the National Vaccine Information Center, which considers some vaccines unsafe, conceded that the study showed that vaccinated children's immune systems do not collapse, but argued that "the serious allegations against M.M.R. have nothing to do with bacterial infections — they have to do with intestinal inflammation and autism." "The smoking gun," he said, "is that measles vaccine is in the lining of your gut years later."

PEDIARIX, the new 5-in-1 vaccine will be showing up in syringes in front of unsuspecting parents in pediatrician offices around the country now that it is FDA approved. Dr. Sheri Tenpenny did this great write up of information on PEDIARIX that all parents should have to consider before going taking their child in to the pediatrician. This was published in Dr. Mercola's recent issue of his awesome Wellness newsletter and appears on his website at http://www.mercola.com/2003/jan/25/pediarix.htm.
If you know a mom whose baby may be due for shots soon, please pass this on. Thanks. Dawn]

From www.mercola.com January 25, 2003
Commentary on PEDIARIX by Dr. Sherri Tenpenny, D.O and nationally renowned and respected vaccine expert.

The pharmaceutical industry has shown its true colors on this one.

The goal of creating Pediarix, a new 5-in-one combination vaccine for diphtheria, tetanus, pertussis, hepatitis B and polio, is clearly stated in the GlaxoSmithKline (GSK) press release: “combination vaccines will allow more vaccines to be added to the ‘crowded’ pediatric vaccination schedule.” With more than 200 vaccines currently under development, it is certain that many more will be added to the childhood and adolescent vaccination schedules. To accommodate the new additions, many combination vaccines are in the pipeline, including:

MMR and Varivax
DTaP and IPV
DTaP and Hepatitis B (HepB)
DTaP, IPV and HiB (Pentavac)
DTaP, HepB and HiB
DTaP, IPV, HepB and HiB (Hexavac)
DTaP, IPV, HepB, HiB and Hepatitis A[1]

Scientifically, the D-T-aP is composed of three separate vaccines, and the polio vaccine contains three viruses, so it is actually three vaccines. After adding the projected number of antigens in the “combination vaccines,” the fictional vaccine Omnivax portrayed in Michael Palmer’s book "Fatal," which combined 30 vaccines into one shot, does not seem so “fictional.”

It is certainly disturbing for parents to see their babies receive five to seven separate vaccinations at the 2-, 4- and 6-month “well-baby visits.” However, reducing the total number of shots by combining them, rather than eliminating unnecessary shots from the schedule, is nothing more than a deceptive “placebo” for concerned parents.

Even when familiar vaccines are combined, the mixture is considered to be a new product. The vaccine must be subjected to “safety and efficacy” clinical trials as though it were brand-new.[2] After reviewing several of the studies that allowed this vaccine to come to market, similar investigational flaws were discovered for this vaccine trial as in all others: safety is not “proven” through the studies, and “effectiveness” is defined only as the presence of antibodies.

The design of all vaccine safety studies is seriously flawed. A scientifically sound safety study would compare the new vaccine to an inert substance, such as sterile water or saline. In addition, current vaccine safety studies compare a new vaccine to a vaccine with a “known side effect profile.” These flaws are bad enough, but the design of the Pediarix study coordinated by the UCLA Center for Vaccine Research, Research and Education Institute, was even more bizarre.

Various combinations of vaccines were given to 400 children who had been divided into four groups:

Group A received 3 doses of Pediarix + the HiB (H.flu) vaccine

Group B received 2 doses of Pediarix + HiB;

The third vaccine was [DTaP + HepB] + oral polio

Group C received 3 doses each of [DTaP + HepB], IPV (injectable polio), and HiB

Group D received 3 doses each of DTaP, HepB, HiB and oral polio

The conclusion? The researchers found that the antibody levels of each of the vaccines were nearly the same in all groups, therefore, “the use of the pentavalent combination vaccine will greatly reduce the number of required injections during the first 2 years of life, thereby simplifying the immunization schedule, enhancing compliance and facilitating acceptance of additional injections engendered by introduction of newer vaccines.”[3]

That sounds like proving convenience, but not proving safety.

If the [DTaP + HepB] vaccine looks unfamiliar to you, it is because it is. In this study, five licensed vaccines and two investigational combination vaccines (also manufactured by GSK) were evaluated simultaneously.[4] The FDA appears to be granting permission to compare one experimental vaccine to another. I wonder if the parents knew that their children were being used as truly “experimental subjects”? This type of “research” goes far beyond what can possibly be defended on scientific grounds and borders on being criminal.

The same study further concluded that “there were no vaccine-related serious adverse events in any group after any vaccine dose.” But if the study is read carefully, evidence to the contrary exists:

“Two subjects withdrew from the study because of serious adverse events that were determined by the safety monitor to be unrelated to vaccination. One subject in Group A was diagnosed with a seizure disorder 14 days after the first immunization. Another subject in Group B had a neuroblastoma detected 6 weeks after the first immunization. Six other reported serious adverse events involved hospitalizations for bronchiolitis/pneumonia (4), meningitis (1) and apnea (1) and were also determined to be unrelated to vaccination.”[5]

Why is it that whenever an adverse event occurs during the course of a vaccine clinical trail, that “event” is never related to vaccination?

Every consumer should ask to read the package insert on every vaccine, but be sure to read this one carefully.[6] Here is a partial list of the additives, adjuvants and contaminants:

VERO (monkey) cells -- potentially containing the SV40 virus incriminated in several different cancers, including leukemia.

Bovine extract, bovine casein and calf (bovine) sera -- It is common knowledge that bovine blood products can be contaminated with viruses, and bovine viral diarrhea virus (BVDV) is the one most often contaminating fetal bovine serum.[7]

Formaldehyde -- a chemical that has caused cancer in laboratory animals and may cause cancer in humans. There is no known threshold level below which cancer risk does not exist. The World Health Organization recommends that exposure should not exceed 0.05 ppm (parts per million).[8]

Glutaraldehyde -- a toxic chemical that is used for cold sterilization of medical and dental equipment. There is no Occupational Safety and Health Administration (OSHA) permissible exposure limit. The National Institute for Occupational Safety and Health (NIOSH) recommends that exposure to glutaraldehyde be under 0.2 ppm.[9] (TOM: reference)

2-Phenoxyethanol -- the chemical name for antifreeze, the vaccine contains 2.5 mg of this compound.

Thimerosal -- this mercury compound is used in the production of Energix, the hepatitis B fraction of the vaccine. It is used during the initial manufacturing process and then removed by a process using cystiene. However, up to 12.5ng (nanograms) remain.


The vaccine also contains these substances: neomycin, polymyxin B, polysorbate 80 and less than five percent yeast protein. The instructions on the package insert caution to “shake well before administering” and describe the vaccine as a “turbid white suspension” consisting of the many particles in the solution.

Is this something that you would want to have injected into your arm? Into your baby’s arm? Don’t bet on it. The long-term studies on combination vaccines will most likely prove that the biological warfare coming through a needle is just that: war -- on the immune system.

--------------------------------------------------------------------------------

References:

[1] http://www.keepkidshealthy.com/ newsletters.html

[2] New vaccine supply and financing: a case study of combined vaccines in developing countries. http://www.who.int/ vaccines-access/ vaccines/ Vaccine_Supply/ Vaccine_supply_index_documents/ combination_vaccines.pdf

[3] Sylvia H. Yeh, MD. et.al. Safety and immunogenicity of a pentavalent diphtheria, tetanus, pertussis, hepatitis B and polio combination vaccine in infants. Ped Inf. Dis. J. 2001;20:973-980.

[4] Ibid.

[5] Ibid.

[6] Pediarix package insert: http://us.gsk.com/ products/ assets/ us_pediarix.pdf

[7] European Commission on Health and Consumer Protection Directorate-General. Scientific Committed on Animal Health and Animal Welfare. Adopted 25 October, 2000. http://europa.eu.int/ comm/ food/ fs/ sc/ scah/ out50_en.pdf

[8] IAQ fact sheet: formaldehyde. http://www.nsc.org/ ehc/ indoor/ formald.htm

[9] FMSCME Fact sheet: glutaraldehyde. http://www.afscme.org/ health/ faq-glut.htm


http://www.guardian.co.uk/aids/story/0,7369,902039,00.html

One battle lost, but the Aids war goes on

The most advanced HIV vaccine trial so far has failed but left useful
medical leads to pursue, says Sarah Boseley

Sarah Boseley,
Monday February 24, 2003

The first Aids vaccine ever to complete all three stages of clinical trials is a failure. It is disappointing news, even though hardly anyone expected AidsVax, made by the Californian biotech company VaxGen, to be a runaway success. But it is vital that this setback does not in any way damage the hunt for an effective vaccine. More effort, more commitment and more money is needed - not less.  The need for a vaccine can hardly be understated. There are 40 million people infected with HIV in the world - almost 30 million of them in impoverished sub-Saharan Africa - and the numbers are rising exponentially. The pandemic has not yet peaked and is not expected to do so until perhaps 2050. Huge efforts have gone into prevention and a lot has been achieved in countries such as Uganda and Thailand, but even there, it does not look as
though the infection rate has permanently stopped rising. In many other countries, customs, traditions and cultural taboos have to be overturned before people can feel able to use condoms and practice safe sex with their partners.

So the need is pressing. All credit must go to VaxGen for pushing ahead with its vaccine trials, which are a lengthy and very expensive business. The phase-3 trial - the final test of whether a vaccine prevents HIV
infection in those most at risk of it - ran for three years in the United States, Canada, Puerto Rico and the Netherlands. The interim results had not been encouraging, but VaxGen pressed on, led by its determined founder, Dr Donald Francis, an epidemiologist and virologist who once worked for the Centres for Disease Control and Prevention in the US and has been involved in the fight against Aids from its alarming beginnings in the 1980s. 

Is the news from VaxGen completely disastrous? No. First, any mass trial produces data that will be useful for future attempts, and VaxGen has said it intends to carry on with the work on the vaccine. Second, there is a strange quirk to the results, in that, while there was no overall difference between the proportions of high-risk volunteers (over 5,000 men who have sex with men and 309 at-risk women) given the vaccine and those given placebo who became infected with HIV, there appeared to be a difference between ethnic groups. The vaccine seemed to have a protective effect among African-Americans (78% fewer infections) and other non-Hispanic minorities (67% fewer infections).

The big cautionary note to this is that the numbers of black and other ethnic minority volunteers were very small. Out of a total of 5009, there were 314 blacks and 498 from other minorities. While the scientists report that the findings in these groups were statistically significant, the analysis is based on just 13 infections among the black volunteers - four of whom had been given the vaccine and nine of whom had not.

IAVI (the International Aids Vaccine Initiative), set up to fund and promote trials, says that it is difficult to draw conclusions from these figures, which need to be further analysed. VaxGen took comfort from them,
though, and announced that it intended to head towards a licence, after conducting any necessary additional studies, for the vaccine in these particular ethnic groups.

The figures may represent a statistical blip or they may say something profound about different responses of the immune system to the virus or the vaccine which could help the hunt for prevention, treatment and even a cure. If the trials had not been done, the data would not exist. Even in failure, VaxGen has advanced the search for a vaccine.

There are quite a number of other potential vaccines, many based on different approaches, in the pipeline. One of the most promising is a collaboration between the Universities of Oxford and Nairobi and is based
on the observation that some Kenyan prostitutes who regularly had sex with HIV-positive truck drivers somehow did not themselves become infected. There may be a lot more failure in the years ahead, but scientists are convinced that it will be possible in the end to find a vaccine against HIV. IAVI says the world must put in a lot more money to make it happen and happen sooner rather than later. There could hardly be a more important scientific cause.

· Sarah Boseley is the Guardian's health editor


 

 Parents fear possible vaccine link to autism

Monday, December 30, 2002
By MARK PERKISS
Sharon Oberleitner is facing a parent's nightmare. She's convinced her two children developed autism because of vaccines they received and believes that having them immunized against smallpox will make their conditions worse. "I'm hoping there's not a war with Iraq and that there isn't any use of biological weapons," said the Princeton Township resident.


"I don't want to have to make a decision on whether to vaccinate my children and put them at risk, but I don't want them to get smallpox either. It's very scary," she said.  President Bush's move toward resurrecting wholesale smallpox inoculations for the first time since the 1970s comes as the nation's vaccination program is under increasing questioning - mostly from parents of autistic children. Questions abound whether the vaccines themselves or thimerosal, a mercury-containing preservative used in many of them from the 1930s until 1999, may be a cause of autism, a neurological disorder that can leave children unable to communicate with or relate to other people. The debate rages in scientific circles, courtrooms and the halls of Congress, where lawmakers last month mysteriously slipped into the homeland security bill signed by Bush a provision protecting Eli Lilly & Co., the maker of thimerosal, from lawsuits. But the head of the Eden Family of Services in West Windsor, one of the nation's leading treatment centers for autistic children, said parents' concerns about vaccines are unfounded and that the benefits of inoculations far outweigh any risk they may present.
 
"There are a lot of myths out there about vaccines and autism," said Eden President David Holmes. "You have parents who are desperately searching for answers as to why and how their children have autism," he said. "There is a small, but vocal faction that sees vaccines as a culprit. "They were focused on the MMR (measles-mumps-rubella) vaccine as a cause, but scientific studies have shown there is no link. Now they're focused on the thimerosal, and so far the studies are showing there's not an autism link there either," Holmes said. "You can't help but feel for them. They're clutching for whatever they can, but there's a much larger consideration." Recent studies, including one of 500,000 children in Denmark published in the New England Journal of Medicine last month, have found no link between the MMR vaccine and a dramatic rise in autism cases in the United States.

And a small, but groundbreaking study of infants who received vaccines containing thimerosal published in a British medical journal earlier this month found the levels of mercury in their blood was within federal safety limits. Parents and some scientists have theorized that a buildup of mercury from vaccines may have led to children developing autism. Holmes said the question of the effect of mercury in vaccines needs to be explored further but said he is looking at the larger picture. "You have to look at the millions and millions of children in the United States who have been saved from a slew of devastating or fatal diseases because of our vaccination program," Holmes said. "That's a far larger number than any children who have had bad reactions from the vaccines. "There are always questions when you talk about vaccines, and those should be investigated and answered to make the program safer, but the overwhelming benefit of these medications far exceeds any risk there may be."
 
Holmes said he is not concerned about the prospect of the United States resuming a smallpox inoculation program. "There's a legitimate threat from biological weapons, and we should be prepared," he said. "Children who already have autism aren't going to become worse if they are vaccinated for smallpox," Holmes said. "Autism doesn't get worse." Smallpox has not been seen for decades, but officials fear it could be used in defense by hostile countries or as part of a terrorist attack. The last U.S. case was in 1949, and the last anywhere else in the world was in 1977. The disease was declared eradicated globally in 1980. Routine smallpox vaccinations for children in the United States ended in 1972. So far, Bush has ordered about 500,000 military members in high-risk areas to receive the smallpox vaccine and has said vaccinations will be made available to about 500,000 health care workers around the country.

While he is not yet calling for all Americans to receive the vaccine, Bush has said those who want it will be able to get inoculated in 2003. The move to restart the smallpox vaccination program coupled with questions by parents and researchers about the possible link of thimerosal and autism has been music to the ears of trial lawyers, who have filed lawsuits against Eli Lilly and other manufacturers and are looking to drum up additional clients for what they see as billions of dollars in damage claims. "What we have at the moment is a temporal correlation, which is enough for us to look to find potential plaintiffs," said John Sakson, the co-managing partner at Stark & Stark in Lawrence, which is working with a Texas law firm and earlier this year ran television ads seeking parents of autistic children as clients for possible lawsuits. Stark & Stark signed up hundreds of potential clients but has not yet filed any lawsuits. "We need to make sure the science is correct for us to make a claim, and then there's the matter of the lawsuit protection that Congress put in for Eli Lilly," Sakson said. "That will have to be tested first."
 
Under the legislation, thimerosal claims would be limited to the federal Vaccine Injury Compensation Program, which limits damages and severely restricts who can sue vaccine manufacturers. Members of Congress are working to lift the litigation protection that was included in the homeland security legislation.
"We've had a number of meetings with parents groups and with other members of Congress to see what we can do about it," said Nick Manetto, a spokesman for Rep. Chris Smith, R-Washington Township. Smith voted in favor of the legislation but was unaware of the provision that was included in the bill at the last minute, Manetto said. All of the legal and political maneuvering doesn't solve the pending dilemma for Oberleitner, the Princeton Township mother. "Vaccines are scary. My children are suffering because of them," she said. "Smallpox is scary also. "If it actually gets to our shores, I don't know what to do. I thought I was protecting my children with the vaccines they've already had, and look what happened." NOTE: Contact Mark Perkiss at mperkiss@njtimes.com or at (609) 943-5727.
Copyright 2003 NJ.com. All Rights Reserved.

 

DOI: 10.1016/S0165-5728(02)00468-X
PII: S0165-5728(02)00468-X
Copyright © 2003 Elsevier Science B.V. All rights reserved. IL-1-dependent neurological effects of the whole cell pertussis vaccine: a role for IL-1-associated signalling components in vaccine reactogenicity

Michelle E. Armstronga, 1, Christine E. Loschera, 1, Marina A. Lynchb and Kingston H. G. Millsa, ,

a Immune Regulation Research Group, Department of Biochemistry, Trinity College, Dublin 2, Ireland
b Department of Physiology, Institute of Neuroscience, Trinity College, Dublin 2, Ireland

Received 3 July 2002; revised 12 December 2002; accepted 13 December 2002. ; Available online 30 January 2003.

Abstract
Immunization with the whole cell pertussis vaccine (Pw), but not the acellular pertussis vaccine (Pa), is associated with a number of neurological side effects. Previously, we have demonstrated a role for interleukin-1 (IL-1) in Pw reactogenicity. Here we report that parenteral Pw administration resulted in a concomitant increase IL-1 type I receptor (IL-1RI) mRNA and a decrease in IL-1 type II receptor (IL-1RII) mRNA expression in the murine hypothalamus. These Pw-induced changes were accompanied by an increase in caspase-1 and interleukin-1 (IL-1), and were associated with increased activity of the stress-activated kinase, p38. In contrast, immunization with Pa failed to activate pro-inflammatory IL-1 responses but resulted in increased IL-1 receptor antagonist (IL-1ra) production. These results suggest that the neurological effects of Pw are associated with central activation of IL-1 and IL-1-associated signalling components.

Author Keywords: Pertussis vaccines; IL-1; IL-1 receptors;
Stress-activated kinases; IL-1ra; Hypothalamus

Corresponding author. Tel.: +353-1-608-3573; fax: +353-1-677-2086.

1 These authors contributed equally to this work.

Journal of Neuroimmunology
Volume 136, Issues 1-2, March 2003, Pages 25-33

 

Dear Mr. Guzzardo:

NAAR maintains that there is "no scientific evidence" for a vaccine-autism connection.

In 1995, James Oleske, MD did an immune panel test on our son and he found that Eric had the highest measles antibody titers he had ever encountered as well as abnormal T-cell readings.Vijendra Singh, PhD found that Eric tested positive for myelin basic problem antibodies indicating an immune dysregulation. Eric was born normal on January 17, 1985 and after receiving the MMR vaccine on April 28, 1986, he regressed into autism. We have the medical records and videotape of Eric for those years up to the present. Thousands of parents in the U.S., UK, Canada and other countries have found that their children had elevated measles antibody titers and/or measles in the gut.

The recent Danish study funded by NAAR and the CDC have flaws in it as cited by Dr. F. Edward Yazbak
at http://www.autismautoimmunityproject.org/upset.html and
http://www.autismautoimmunityproject.org/autism_debate.html

Also a critique by Alan Rees and Ulf Branell
http://www.motgift.nu/Div/SIEM/MMRE2E.html

The Danish Epidemiology Study was funded by the National Alliance for Autism Research (NAAR) and the Centers for Disease Control (CDC) and it came to the conclusion that the measles-mumps-rubella (MMR) vaccine and autism was NOT linked. The CDC promotes vaccines at the same time.

One of the scientific board members Of NAAR is Marshalyn Yeargin-Allsopp, MD. Dr. Yeargin-Allsopp is the Section Chief, Surveillance and Epidemiology, Division of Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention.
http://www.naar.org/sab.htm (Ironically, this url no longer works!)

Also, below is an item that NAAR received funding from Merck (who manufacturers the MMR vaccine in the US) from their own web site. One wonders how much they received from Merck and other vaccine companies over the years. To fund an epidemiology study and then come to the conclusion that the MMR vaccine is not linked to autism while having connections to the particular vaccine company that manufactures the vaccine in question is a conflict of interest. This was taken from http://www.naar.org/naarative6/naarrative6.pdf (This one also, no longer works!)


PAGE 14 under "PROGRESSIONS"
BRET SABERHAGEN DESIGNATES NAAR FOR 'HATS OFF' CHARITY CAMPAIGN
"Boston Red Sox pitcher Bret Saberhagen designated NAAR as his charity when he was asked to participate in Merck's Hats Off Charity Campaign. Saberhagen, the uncle of a child with autism and a member of NAAR's Honorary Board, was participating with several other baseball players in a contest to determine which player would most benefit from the use of the Merck medication, Propecia.

NAAR received $25,000 from Merck for Bret Saberhagen's participation. The designated charity of the player who enjoys the most hair growth will receive an additional $25,000. We're all keeping our fingers crossed!."

From: NAARRATIVE, Number 6, Summer 2000 * Newsletter of the National Alliance for Autism Research * 1-888-777-NAAR

At an autism meeting in Long Island, New York, Selma Krinsky, grandmother to Mark Krinsky who is on NAAR's board(see http://www.naar.org/about/boardbio.htm), told parents that NAAR was only funded $240,000.00 by vaccine companies. I find it troubling when an autism research organization is funded by pharmaceutical and vaccine companies. Especially when they fund studies that say there is no link between autism and vaccines. I also find troubling that Eric London who is founder of NAAR, ridicules and laughs at parents who link vaccines to autism
(see http://www.autism.com/ari/editorials/garbagescience.html).

If NAAR truly wants to find an answer to the autism epidemic they should fund independent researchers like Dr. Vijendra Singh, Dr. Andrew Wakefield, Dr. Jim Oleske and Dr. Harumi Jyonouchi, and Dr. Arthur Krigsman. By looking into the immunology/gastroenterology research and moving it forward we can stop the epidemic and develop treatments that will help the children already damaged.

Raymond Gallup, Founder
The Autism Autoimmunity Project

 

http://www.nytimes.com/2003/02/20/health/20VACC.html?tntemail1

Study Finds Vaccine Doesn't Lead to Child Bacterial Infections By DONALD G.
McNEIL Jr.


There is no evidence that the measles, mumps and rubella vaccine overloads children's immune systems or makes them more vulnerable to bacteria infections, researchers in Britain have found. The researchers, from the British Public Health Laboratory Service,said they undertook their study because some British parents' groups contend that the M.M.R. vaccine gives children more viruses than they can cope with, weakening their immune systems. The findings were reported yesterday in The Archives of Disease in Childhood, a medical journal.

British and American groups skeptical about vaccinations said yesterday that the study, which was largely paid for by vaccine companies, missed the point. Their contention is that the vaccine overwhelms defenses against viruses, particularly measles, and makes infants vulnerable to autism.

Vaccine experts in the United States dismissed that idea as scientifically unsound and said the study's conclusions made sense, although some were disappointed at how little data the researchers released. Fear of the M.M.R. vaccine in Britain is so great that immunization rates with it have dropped to 85 percent nationally since 1998, and much lower in some areas, despite strong government endorsement of immunization. Even as he endorsed the M.M.R. vaccine, Prime Minister Tony Blair has refused to say whether his new son has had the shot, drawing loud criticism from editorialists. Small, local measles outbreaks across Britain have raised alarms.

The vaccine, given in the second year of life, is made with live, but weakened, viruses. The viruses provoke the body to produce antibodies, without actually causing disease. The researchers looked at the medical records of all young children hospitalized in southern England for serious bacterial infections of the blood, brain stem and lungs between 1991 and 1995. It studied those who had had an M.M.R. inoculation in the previous three months and excluded those who had underlying immune system problems or had been hospitalized before. Researchers concluded that immunized children actually had less risk than average of being hospitalized for pneumonia, meningitis, septicemia or other infections.

The results should be "reassuring evidence for parents on the safety of M.M.R. vaccine," said Dr. Liz Miller, leader of the Public Health Laboratory Service immunization division and the lead author of the paper. "While there were already strong scientific arguments against the idea that  the immune system could be overloaded, our study provides direct evidence that this does not occur." Dr. Neal Halsey, director of the Institute for Vaccine Safety at the Johns Hopkins School of Public Health, called the study "well done, with appropriate methods, by investigators who are well known."

Groups skeptical of the M.M.R. vaccine on both sides of the Atlantic demurred. Dr. Marcel Kinsbroune, a pediatric neurologist who advises the National Vaccine Information Center, which considers some vaccines unsafe, conceded that the study showed that vaccinated children's immune systems do not collapse, but argued that "the serious allegations against M.M.R. have nothing to do with bacterial infections — they have to do with intestinal inflammation and autism."

"The smoking gun," he said, "is that measles vaccine is in the lining of your gut years later."
 

Subject: Study: Childhood Vaccines Linked to Autism, Heart Disease

Date: Thursday, March 27, 2003 10:37:38 AM EST

Content-Type: text/html

Contact: Kathryn Serkes, 202-333-3855 or kaserkes(At)att.net

Web: http://www.aapsonline.org

WASHINGTON, March 27 /U.S. Newswire/ -- A new study of mercury in childhood vaccines demonstrates that the doses are in excess of the Federal Safety Guidelines, and shows alarming evidence for a link between these excessive doses of mercury from thimerasol-containing vaccines and neurodevelopment disorders such as autism and speech disorders, as well as heart disease Those are the findings of the study published in the current issue of the peer-reviewed Journal of American Physicians and Surgeons (JP&S), authored by Mark Geier, M.D., Ph.D, President of The Genetic Centers of America, and David Geier. The authors also conclude that the U.S. should ban the use of thimerosal in all vaccines. "It is to be hoped that complete removal of thimerosal from all childhood vaccines will help to stem the tragic, apparently iatrogenic epidemic of autism and speech disorders that the United States is now facing," write the authors. The authors point to exploding rates of autism since introduction of thimerosal in vaccines. In less than 20 years, the rate increased by more than 800 percent, from one in about 2,500 children in the mid-1980s to one in about 300 children in 1996. "Many in the scientific community have, initially, been highly skeptical that thimerosal, an ethylmercury preservative in childhood vaccines, could be associated with neurodevelopment disorders," write the Geiers.

BACKGROUND:

In 2001, the Institute of Medicine concluded that exposure to mercury in vaccines and neurodevelopment disorders could not be linked because of indirect and incomplete information, but that the link was biologically possible. This study now confirms that, showing that there was a 2 to 6-fold increased incidence of neurodevelopment disorders following an additional 75-100 microgram dosage of mercury from thimerosal-containing vaccines compared to thimerosal-free vaccines.

METHODOLOGY:

The authors evaluated the doses of mercury that children received from thimerosal-containing vaccines, as part of routine US childhood immunization schedule. Those doses were compared to the US Federal Safety Guidelines for the oral ingestion of methylmercury. Secondly, in order to analyze the effects of thimerosal in vaccine recipients, they analyzed the incidence rates of neurodevelopment disorders and heart disease reported following thimerosal-containing vaccines in comparison to thimerosal-free vaccines. The data used was from the government's Vaccine Adverse Events Reporting System (VAERS). Vaccines compared were Diptheria-Tetanus-whole-cell-Pertussis and Diptheria-Tetanus-acellur-Pertussis.

Also, the authors analyzed data from the US Department of Education on the number of children of various ages in US schools who were reported with various types of disabilities in comparison to the mercury dose that children received from thimerosal in their vaccines.

CONCLUSION:

"In light of voluminous literature supporting the biologic mechanisms for mercury-induced adverse reactions, the presence of amounts of mercury in thimerosal-containing childhood vaccines exceeding Federal Safety Guidelines for the oral ingestion of mercury, and previous epidemiological studies showing adverse reactions to such vaccines, a causal relationship between thimerosal-containing childhood vaccines and neurodevelopment disorders and heart disease appears to be confirmed," write the authors. http://www.usnewswire.com

 

Article reviewed:
Barlow, W. et. al. 2001. "The Risk of Seizures after Receipt of Whole-Cell Pertussis or Measles, Mumps, and Rubella Vaccine," New England Journal of Medicine 345: 656-661

[A free copy can be obtained from http://www.nejm.org/ .]



Review abstract:

Barlow et. al. studied data from four HMO's on the west coast to assess the risk of seizures and neurobehavioral disorders after receiving the DTP and MMR vaccines. They reviewed 624 medical records out of an undisclosed number of children using undisclosed methods and misleading control groups to calculate meaningless risk coefficients. They then concluded there were only small, "transient" seizure risks associated with DTP and MMR which "do not appear to be associated with any long-term, adverse consequences."



A. What did the study do?



The authors said they studied nearly 680,000 children aged 0 - 7 who were enrolled at these HMO's during the observation period, which was different at each HMO, but ranged between 1/91 to 9/93, with some follow-up data extending to 1998.



The authors concluded that there was a slightly increased risk of febrile seizures on the day of vaccination with DTP, which is estimated to mean 6 to 9 additional febrile seizures for 100,000 children. They also found a slightly increased risk of febrile seizures in the second week after the MMR, which is estimated to mean 25 to 34 additional febrile seizures for 100,000 children. They concluded there was no increased risk of nonfebrile seizures, subsequent seizures after the first febrile seizure, and neurobehavioral disorders for children receiving the DTP and MMR.

B. What were the flaws of the study?

1. Meaningless sample: The authors failed to provide an unequivocal sample size and sufficient evidence that their sample was valid and representative of the population they were studying.

Although the study started out with almost 680,000, the authors excluded an unknown number of children, without a clear explanation. In the abstract, the authors described, "We calculated the relative risks...among 679,942 children...." This is patently false, since they excluded 13.7% because of disenrollment from the HMO's, and they said their data came from around 638,000 person-years (i.e. persons studied x years of observation). They never said which figure the 13.7% came from, but whichever number it was, the loss is substantial and could mean as many as 93,000 were excluded. Because they used person-years, the number of unique children studied is unknown, but likely to be less than 638,000. The absence of an unequivocal number for their total sample size is inexcusable, since it constitutes the backbone of all their subsequent calculations.

From whatever figure they ended up with, they found 2281 possible seizures from highly variable sources depending on the HMO, anywhere from hospitalization records to neurology referrals. They never explained how many seizures came from each source. From the 2281, they sampled 1094 for risk analysis. Because sampling proportions varied from HMO to HMO, the authors weighted the data from some random samples to make them comparable to the rest. They did not say how many seizures came from each HMO and how many cases were weighted. The authors admitted the sample was somewhat biased toward severe, hospitalized cases, but failed to present information necessary to objectively assess the extent of the bias.

From the 1094, they whittled the final sample down to 624 children on which they presented results of their analysis. They excluded children because seizures happened outside of the study period or before the inception of a vaccination database, but never defined those dates. They excluded children because of specific infections or injuries, but never defined them. They presented a category of neonatal seizures, but never discussed them in the analysis, so it was even unclear who exactly were excluded. Without the objective criteria by which subjects were excluded, there is insufficient evidence to determine that the sample was not further biased. It was the authors' responsibility to justify their sample as valid and representative, and they failed.

2. Meaningless and Misleading Control Group: The authors compared children who were recently vaccinated to children who were not recently vaccinated to conclude that the risk of vaccines over the "absence of vaccination" was small.

To assess the risk of seizures among children who had received the DTP and MMR, the authors needed to compare children "exposed" to DTP and MMR to children who were "unexposed." The exposed group was defined as children who had had either the DTP, the MMR, or both vaccines concomittantly in 30 days preceding the first seizure episode. The unexposed group was defined as children who had not had either vaccine in the last 30 days. The authors implied, but never explicitly stated, that the "unexposed" group was also unexposed to any other vaccine in the last 30 days before seizure. The control situation was referred to as "absence of vaccination."

The authors did not provide evidence that a 30 day difference between the exposure to vaccines in the two groups is sufficient time to meaningfully distinguish between presence of vaccination and "absence of vaccination," exposure and "nonexposure." The authors needed to carefully qualify that their risk calculations were only for children who were recently vaccinated with DTP/MMR compared to children who were not recently vaccinated. They needed to qualify that they were in all likelihood comparing vaccinated children to vaccinated children. They did neither.

The authors also wanted to assess the seizure risks of DTP and MMR separately. The fact that some children received both DTP and MMR in the last 30 days before their seizures confounds the risks attributed to either vaccine individually. The extent to which the variables were confounded is unknown because the authors did not say how many received both vaccines.

Finally, the authors admitted that vaccination status was not always accurate. They did not explain how many were inaccurately identified as vaccinated or unvaccinated, and how they resolved disagreements.

3. Meaningless and Unreliable Risk Calculations: The authors failed to present data and justification for their calculations and used invalid background rates as the foundation of all their conclusions.

The authors concluded that certain risks were small and other risks were non-existent. The only evidence provided to support these conclusions were calculations of "relative risk." The authors said they used the "stratified Cox proportional-hazards analysis" and "standard methods" to calculate these numbers, but did not define what these methods were, provide equations, provide literature references, or present any other information that would validate these calculations. They curiously did not present results such as how many did not get seizures vs. the numbers who did. Without these numbers, the accuracy of their calculations cannot be gauged. Furthermore, these relative risks were calculated after "adjustments" for selected variables. Although they defined some of these variables, others were unclear and how the calculations were "adjusted" was not explained. Because there is insufficient proof that these statistical methods were applicable to the data collected, their results of those methods are meaningless. Because there is no presentation of most of the data used in these calculations, their results are meaningless.

The only numbers presented was each "relative risk" and its 95% confidence interval, such as "5.70 (95% CI, 1.98 to 16.42)." The confidence intervals they did provide showed that these calculations were highly unreliable. For example, the risk of "5.70 (95% CI, 1.98 to 16.42)" translates to mean that 95 times out of a 100, their calculation could range anywhere from 2 to 16.

In addition, these relative risks were compared to two "background rates" of febrile seizures to determine how many additional seizures per 100,000 children can be attributed to DTP or MMR. One of the background rates came from the same data as the risk calculations, so it is not surprising that there was only minimal difference between the two. The other background rate came from a 1969 published study of one of the participating HMO's, with data more than 20 years old. The absence of more current and broader background rates makes the number of additional seizures attributed to DTP/MMR meaningless.

4. Meaningless Follow Up. The authors followed whichever children they wanted, for only the diagnoses they wanted, then calculated meaningless numbers after "adjusting" the data, to yield the conclusion that the vaccines were not associated with "long-term, adverse consequences."

Out of the 74 children who had febrile seizures within 30 days of vaccination, the authors followed only 40 to study any increased risk for subsequent seizures. For the DTP, they followed only children who had febrile seizures in the first 7 days. For the MMR, they followed only children who had febrile seizures within 7 - 21 days. They did not explain why they followed only these children and not all of them. They did not follow any children with nonfebrile seizures after vaccination because the authors believed there was no association between the two events. The control group consisted of 521 children who had febrile seizures in the "absence of vaccination," that is, no DTP/MMR in the preceding 30 days. The authors did not explain how long these children were followed, though they suggested that some of the children were followed for at least 2 years. Nonetheless, they concluded the 40 exposed children were no more likely to have subsequent seizures than the 521 "nonexposed" children.

Out of the 561 children followed for subsequent seizures, 273 were followed for neurobehavioral diagnoses. Again, the authors do not explain how the 273 were followed, for how long they were followed, and why they excluded the rest. The diagnoses they flagged included:

"ADD, learning disorders, mental retardation, speech disturbances, emotional disturbance, personality disorder, repetitive-movement disorder, obsessive-compulsive disorder, infantile autism, childhood type schizophrenia, and psychoses of early childhood."

Notably, with the exception of infantile autism, they did not include any of the Pervasive Developmental Disorders considered to be in the autism spectrum.

The authors concluded that the risk of these conditions did not differ between exposed and unexposed children, after an "adjustment" for age at the time of the seizure. This implies that there was a difference between exposed and unexposed without the adjustment.The only evidence cited to support this conclusion was again, one "relative risk" number. Again, the enigmatic sampling, poorly defined control group, narrow selection of long-term consequences, and meaningless risk numbers provide insufficient justification to give these conclusions any meaning or validity.

C. What can be concluded from this study?

The only results that can be credibly presented are the tabulation of incidences.

1. Out of an unknown number of children, at least 42 who received the DTP vaccination had febrile seizures within 30 days, and at least 10 had nonfebrile seizures.

2. Out of an unknown number of children, at least 32 who received the MMR vaccination had febrile seizures within 30 days, and at least 3 had nonfebrile seizures.

3. Out of an unknown number of children, at least 413 who had febrile seizures did not receive either the DTP or MMR in the preceding 30 days. At least 124 children who had nonfebrile seizures did not receive either the DTP or MMR in the preceding 30 days.

Because this paper fails to meet minimum scientific standards for the presentation of objective evidence, no other conclusions are defensible.
------------------------------------

Originally posted on 12/8/02 (Revised 12/11/02).

The author would like to thank the Vaccine Science discussion list for their input and feedback.

http://groups.yahoo.com/group/VaccineScience/

Permission is granted to forward or reprint this article on the condition that it is reproduced in its entirety without any changes (everything between and including the 2 asterisk lines). If this article is reprinted on another website, the author would appreciate a note with the link to the site. Her email address is list@freedom2think.com.

 

(AUTISM RESEARCH CAMPAIGN for HEALTH) 23JUNE 2003

  NEW STUDY SHOWS MMR/AUTISM LINK

  A new study, published in Pediatric Neurology, Vol. 28, No. 4, is expected to show that MMR and autism are linked, despite the denials  of the UK Department of Health and the recent court judgement that ordered two girls to receive the controversial MMR vaccine.   World-renowned autism researcher Dr. Vijendra Singh, at the Utah  State University, and fellow-researcher Ryan Jensen have announced  that their latest study," Elevated Levels of Measles Antibodies in
  Children with Autism", points directly to an MMR/autism link.

  Singh and Jensen analysed samples from 52 autistic children, all of whom had had the MMR vaccination, and 30 normal children, plus a further 15 siblings of autistic children.  They showed that measles antibody levels, a sign of an immune reaction to measles virus, were significantly greater in children with autism compared with the non-autistic children. Levels of mumps  and rubella antibodies were not different from the non-autistic children.

  Strikingly, they found that 43 out of the 52 (83%) of the autistic children had antibodies to the measles vaccine virus. None of the 30 normal children, and none of the 15 siblings, had these antibodies.  Singh and Jensen have concluded that the antibody results show that  many autistic children have suffered an abnormal response to the measles element of the MMR vaccine, causing them to develop "inappropriate" antibodies.

  Singh and Jensen were testing a hypothesis that, as viruses are common trigger agents for autoimmune diseases, where the human body attacks itself, then autism could involve a virus-induced autoimmune response, in turn leading to autism. The study looked at 88 autistic children, all of whom had a firm  diagnosis of autism. Not all children were tested for all the three
  viruses, of measles, mumps or rubella. In those children tested, the level of mumps or rubella antibodies did not attain statistical significance, leaving the researchers to focus upon the measles  element of MMR. None of the autistic children had any history of  measles rash or wild-type natural measles infection.

  This points to the source of the measles antibody as being vaccine strain. The researchers are undertaking further study work on this crucial aspect.  If the new research by Singh and Jensen is correct, then it backs up  the claims of many families who have reported that their children   became autistic after MMR. It also confirms the validity of the1998 study by Dr. Andrew Wakefield and other researchers in the UK, and a number of other studies published since that time.

  Over 1,000 cases of autism following MMR are being brought before the High Court in London in April 2004. If the claims are upheld, it will have dramatic implications for vaccine policy worldwide, and will throw a spotlight on the way vaccines arelicensed and regulated.


  BACKGROUND
  ARCH - Autism Research Campaign for Health - is a group of parents campaigning for more research into the causes and treatment of autism. It was set up in response to the departure of Dr Andrew  Wakefield from the Royal Free Hospital - which ARCH viewed as a sign  that medical scientists were no longer free to follow their own lines of enquiry. We are profoundly worried that medical science is now dictated by government, the medical establishment and the  pharmaceutical industry who between them control the vast sums of research money and determine which topics are legitimate researchand which are not. This state of affairs is unacceptable to the  growing number of children and parents who must live with the  painful consequences of autism, and with the lack of research into the alarming increase in the prevalence of autism in many countries across the world.

  ARCH believes that there is mounting evidence that suggests MMR is unsafe. It calls on the UK Government to fund clinical research into the effects of MMR vaccine on the immune system of autistic children and its role in the onset of regressive autism, epilepsy and bowel  disease.

 Visit ARCH on www.autism-arch.org

 

Unintended events following immunization with MMR: a systematic review

Tom Jefferson, , Deirdre Price, Vittorio Demicheli, Elvira Bianco and For the European Research Program for Improved Vaccine Safety Surveillance (EUSAFEVAC) Project1

Reparto Epidemiologia Clinica, Istituto Superiore di Sanità, Viale Regina Elena, 299-00161, Rome, Italy

Received 4 April 2003; accepted 6 April 2003. ; Available online 26 April 2003.

Abstract
Public debate over the safety of the trivalent measles, mumps and rubella (MMR) vaccine and the drop in vaccination rates in several countries persists despite its almost universal use and accepted effectiveness. We carried out a systematic review to assess the evidence of unintended effects (beneficial or harmful) associated with MMR and the applicability of systematic reviewing methods to the field of safety evaluation. Eligible studies were comparative prospective or retrospective on healthy individuals up to 15 years of age, carried out or published by 2003.

We identified 120 articles satisfying our inclusion criteria and included 22. MMR is associated with a lower incidence of upper respiratory tract infections, a higher incidence of irritability, similar incidence of other adverse effects compared to placebo and is likely to be associated with benign thrombocytopenic purpura (TP), parotitis, joint and limb complaints and aseptic meningitis (mumps Urabe strain-containing MMR). Exposure to MMR is unlikely to be associated with Crohn's disease, ulcerative colitis, autism or aseptic meningitis (mumps Jeryl–Lynn strain-containing MMR). The design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate. The evidence of adverse events following immunization with MMR cannot be separated from its role in preventing the target diseases.

Author Keywords: Measles, mumps and rubella (MMR); Randomized controlled trials (RCTs); CCTs

 

Retinal Hemorrhages Following CPR: Is it Child Abuse or Resuscitation?
Edwin Wortham, M.D., Brad Schwartz, M.D., Ali Tabassian, M.D., Laura Kim
Ophthalmologists are frequently asked to testify in cases of suspected child abuse, namely the shaken baby syndrome, which is characterized by retinal hemorrhages and intracranial injury Recently, defendants have claimed CPR led to the development of retinal hemorrhages This defense has confounded the significance of retinal hemorrhages in suspected child abuse cases In this limited study we attempt to determine the role of CPR in the development of retinal hemorrhages
Methods: Seven patients between the ages of 1 month and 13 years were studied All of these children had well-documented chest compression by trained personnel during resuscitation, no historical or physical evidence of preceding trauma, no history of conditions known to be associated with retinal hemorrhage (seizure disorders, hypertension, bleeding diatheses, etc ), and dilated retinal examination within 24 hours of CPR Most of the patients had cardiopulmonary arrest secondary to presumed sudden infant death syndrome and did not survive CPR

Results Retinal hemorrhages were noted in two of the cases These were clearly not characteristic of the hemorrhages seen in the shaken baby syndrome By transmitting intrathoracic to intraocular vascular pressure, chest compressions could have caused the retinal hemorrhages by increasing the intravascular pressure at the level of the eyes The paucity of ocular findings in cases associated with prolonged CPR should be noted

Conclusion Based on this limited prospective study, extensive retinal hemorrhages as seen in the shaken baby syndrome should not be attributed to the mechanical effects of CPR

(If it happened one time I don't think it should be ruled out to not happen again.IMHO)
 

Vaccines expert warns studies are useless

By Lorraine Fraser, Medical Correspondent
(Filed: 27/10/2002)www.telegraph.co.uk ...Most safety studies on childhood vaccines have not been conducted thoroughly enough to tell whether the jabs cause side effects, a leading authority on vaccine research has warned. Dr Thomas Jefferson, who has been funded to investigate vaccine safety by the European Commission, said that the issue was the "Cinderella" of public health research and that Government officials had failed to make it a high priority. Dr Jefferson is the head of the vaccine division of the Cochrane Collaboration, an organisation of scientists that aims to make accurate information about the effects of treatments available worldwide and promotes high standards in research. He is also a board member of the European Programme for Improved Vaccine Safety Surveillance, set up by the commission. He said: "There is some good research, but it is overwhelmed by the bad. The public has been let down because the  proper studies have not been done." His outspoken and unprecedented comments will anger public health officials in Britain and elsewhere, who fear that any discussion will undermine parents' confidence in national vaccination programmes. Officials at the Department of Health are already alarmed by the number of parents shunning the triple measles, mumps and rubella jab (MMR) after claims that it is linked with autism and bowel disease. Although Dr Jefferson emphasised  that there was no evidence to suggest that any vaccine now in use was dangerous, he said that there was a "dearth" of sound studies on the risks and benefits. As a result, the information available on the safety of vaccines that are routinely given to babies and toddlers was "simply inadequate".Dr Jefferson also disclosed plans for a Europe-wide electronic register of children's vaccine exposure that would allow scientists to investigate the risks and benefits of inoculations using data on thousands of participants. Pilot schemes will start soon in Sweden and Finland."We need such a system urgently," he said. "Governments are reluctant to accept this but in my view they owe it to future generations to back this idea."He was especially concerned, he said, because future  vaccination programmes were likely to involve giving children "five, six, even seven vaccines all at once".A vaccine designed to protect children against measles, mumps, rubella and chickenpox in one shot is already under development."For people like me, it is becoming more and more difficult to tease out what problems may be due to an individual vaccine," said Dr Jefferson."It is almost becoming impossible to do this. We have to think very carefully about how we will monitor these vaccines."We have a responsibility to these children - they are our future. It is no use having a situation where someone suggests a possible harm and everyone runs around frantically trying to find bits of evidence. What is required is good-quality information that has been systematically  collated and assessed."
20 October 2002: US study blames 'unknown factor' on rise in autism 6 October 2002: Measles virus is found in boy's brain after MMR 1 September 2002: Disabled children sue over triple diphtheria vaccine 25 August 2002: Parents unhappy with MMR safety experts' links to drug firms  http://www.telegraph.co.uk/news/main.jhtml?xml=/news/2002/10/27/nvacc27.xml& sSheet=/news/2002/10/27/ixhome.html
   
 

BL Fisher Note:

Unfortunately, the common myth that vaccines are harmless, that doctors are infallible and that medical researchers are seldom unethical contributed to the blind trust that caused this tragedy. The "sacred cow" status of vaccines must be replaced with a more realistic understanding that every
experimental or licensed vaccine, like every experimental or licensed drug, can carry significant risks for individuals. The right to informed consent to taking a risk with a medical intervention, such as vaccination, should be considered a human right because each human being has the moral right to
voluntarily choose what they are willing to die for.

http://www.kfor.com/Global/story.asp?S=1539828
KFOR-TV, OK

November 25, 2003


Patients: Oklahomans used as human 'guinea pigs'
A cancer research project may have used Oklahomans as human guinea pigs.

ALI MEYER reports


In late 1996 a Tulsa doctor concocted a vaccine designed to fight deadly skin cancer. Sources close to the doctor say he believed in his research. He tested it on about 100 people, mostly Oklahomans, some of whom now believe that research nearly killed them.

Five years ago, Jeff Teel was diagnosed with deadly skin cancer. Doctors gave him a 20 percent chance of survival. "I mean, I was petrified," he said, "thinking I was going to die." Surgeons removed a portion of Jeff's arm, but the likelihood of a cancer comeback was high and Jeff thought his best chance was an investigational new drug. A public service announcement aired on local TV in Tulsa and starred Dr.
Michael McGee, principal investigator for the melanoma cancer project at OUHealth Sciences-Tulsa. McGee believes his research could help cure melanoma cancer.

"They're told that this is a vaccine designed with a purpose to fight tumors and keep tumors from coming back once they've been removed," said   Attorney Robert Seacat, who is representing some of McGee's patients in a lawsuit. In 1998 Teel signed up for McGee's melanoma study. According to the consent form, Saint John Medical Center and OU Health Sciences are working together. McGee had an office in the basement of Saint John's, the factory for his experimental vaccine.

"He said he had a very high success rate," Teel said. "That there were minimal side effects. I was hooked right there." But, Jeff and Paige Teel soon realized minimal side-effects meant something very different. "It was like the worst flu you've ever had in your life times 10 and it was guaranteed," he said. "It was like he was being poisoned," Paige said. "Like his body was fighting the poison in his system." Despite being violently ill, Jeff endured the poison. At first, the treatments were weekly, then monthly for two years. "He told me because of my illness, my body was fighting it off. That's what was supposed to happen," Teel said.

But while Jeff and about 100 others continued on Dr. McGee's experimental injections, a whistle-blower inside the melanoma project was reporting allegations of faulty research to the federal government. Attorney Robert Seacat is representing some of McGee's former patients in an ongoing lawsuit.

"The rats and the monkeys in cages in laboratories have better, adhered to anyway, regulations and standards of care than what we have in some research projects," he said. According to a Food and Drug Administration inspection, a laundry-list of violations were found. They included: failure to report side effects, failure to properly store vaccine, failure to control how vaccine is administered.

"One of my clients, he [Dr. McGee] literally gave her a box of the vaccine. Told her to go home and put it in the refrigerator. So she could self-inject at home," Seacat said. Four years after it started, the FDA closed the doors on doctor mc-gee's melanoma research. Subsequent reports from the Office of Human Research Protection show the violations extend beyond Dr. McGee all the way up to senior officials.

"It's a shorter conversation to talk about what they did right than what they did wrong," Seacat said.

Now, patients such as Jeff, are finally learning the real reason for Dr. McGee's research. Even though some of the researchers believed the vaccine had the potential to ward of cancer, McGee's study was not a test for the effectiveness of the melanoma vaccine.

"The reality is, his study was simply to study toxicity levels," Seacat said. "To see whether it made you sick and how sick it made you. These people all thought they were getting on a study that would give them some hope for living. When, in reality, he was just using them as human guinea pigs."

Volunteers relying on a miracle were left wondering if an Oklahoma researcher put their lives on the line. "He's a Dr. Frankenstein, as far as I'm concerned," Paige Teel said.

The University of Oklahoma settled the lawsuit with the former patients and issued a statement about their human testing programs. They say they've completed all the corrective actions spelled out by the Office of Human Research Protections and fired the board of administrators supervising Dr. McGee. They now have mandatory certification for researchers, including education on the ethical principals for protecting patients.

Lawyers for Dr. McGee said: "the safety of the study participants was never compromised." They say an independent audit showed, "no notable pattern of adverse experiences." They say "the vast majority of the problems were administrative in nature, and could've been remedied had the university provided adequate resources." Those lawyers also point out, several patients sued to continue taking the experimental vaccine. We're told they're still taking that vaccine, with FDA approval. As for Dr. McGee's supervisors, their attorneys said they were used as scapegoats to protect OU's reputation. Dr. McGee is still practicing. He's a general surgeon operating in Tulsa.
The FDA suspended him from further research.
 

The Washington Times
www.washingtontimes.com

Researchers fake AIDS study data
By Robert Stacy McCain
THE WASHINGTON TIMES
Published December 5, 2003

    Three Maryland researchers have admitted fabricating interviews with teenagers for a study on AIDS prevention that received more than $1 million in federal funds.  Lajuane Woodard, Sheila Blackwell and Khalilah Creek were employed by the University of Maryland at Baltimore's department of pediatrics as researchers on the study, funded by a grant from the National Institutes of Health (NIH).

    The three admitted they made up interviews with teenagers, which they had claimed took place from May to August 2001, for the study on preventing the transmission of HIV, the virus that causes AIDS. The fabrication was first reported in the journal Research USA.  The study was designed to evaluate the impact of "safe sex" counseling on black teens in Baltimore housing developments. Congressional staffers said the study, titled "Effectiveness of Standard Versus Embellished HIV Prevention," received more than $1 million in NIH funds in 1999.

    "It is terribly troubling that federally funded research on a topic as sensitive and important as HIV prevention for children, some as young as 13, would be intentionally manipulated," said Rep. Mark Souder, Indiana Republican and chairman of the House subcommittee on criminal justice, drug policy and human resources. "If not caught, the lives of countless children may have been put at risk by ineffective, perhaps dangerous, prevention messages developed from this fabricated research."    Results of the Baltimore study were published in January in the journal Pediatrics by a group of nine researchers led by Ying Wu of West Virginia University.

    The study's objective was to determine whether enhancing an existing AIDS prevention program called Focus on Kids by adding "parental monitoring" would have an effect on the children involved.     Editors of Pediatrics said yesterday they were investigating the reported fabrications.  The study involved "817 black youths aged 12 to 16 years," and found that youth whose families participated in the enhanced Focus on Kids program showed "significantly lower rates" for a variety of risk behaviors, including sex without condoms and use of cigarettes and alcohol.  The Focus on Kids program is a widely used "safe sex" curriculum advertised by its publisher, ETR Associates, as "proven effective."  "We would not comment on this," said Constance Burr, spokeswoman for the
National Institute for Mental Health, the NIH division which funded the study. Officials at the Office of Research Integrity had no response to the report.

    In the past year, House Republicans have repeatedly criticized NIH funding of sex research projects, including a $147,000 grant to a Northwestern University professor who paid women to watch pornography while measuring their sexual arousal.  In July, the House rejected on a 212-210 vote a measure sponsored by Rep. Patrick J. Toomey, Pennsylvania Republican, that would have eliminated federal funding for five sex studies. But investigation of federally funded sex research has come under fire by critics, including Rep. Henry A. Waxman, California Democrat. In October, responding to a list of research grants questioned by some House Republicans, Mr. Waxman wrote to Health and Human Services Secretary Tommy G. Thompson: "I urge you in the strongest possible terms to denounce this scientific McCarthyism. Imposing ideological shackles on this research would be a serious public health mistake."

    More recently, the New England Journal of Medicine denounced congressional probes of research grants. Such scrutiny risks turning sex research into a "political football," warned the journal's editor, Dr. Jeffrey Drazen.  "Science should have oversight from Congress but it ought not to be at the level of specific grants," Dr. Drazen told United Press International.   But Mr. Souder said the admissions of fabrication in the Baltimore HIV study show the importance of congressional oversight.  "This scandal underscores the need for oversight of all federal programs -- even NIH -- to ensure taxpayer dollars are not misspent and science is not manipulated," the congressman said.


Copyright © 2003 News World Communications, Inc. All rights reserved.

 

They don't tell the truth

[Federal Register: April 19, 2002 (Volume 67, Number 76)]
[Notices]
[Page 19438]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19ap02-64]

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Findings of Scientific Misconduct
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.

SUMMARY: Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case:

Joao Carlos deSales, San Francisco Department of Public Health: Based on the report of an investigation conducted by the San Francisco Department of Public Health (SFDPH) and additional analysis conducted by ORI in its oversight review, the U.S. Public Health Service (PHS) found that Joao Carlos deSales, former study counselor at SFDPH, engaged in scientific misconduct by falsifying data supported under National Institutes of Health subcontract SFP-N01-A1-35176-HMEISTERI-94 to SFDPH under National Institute of Allergy and Infectious Diseases (NIAID), NIH, contract 5-N01-AI35176-019, "Domestic Master Contract for HIV Vaccine Efficacy Trials,'' awarded to ABT Associates, Inc.

Specifically, from April through September of 1999, Mr. deSales switched randomization assignments on four pairs of subjects and subsequently altered the research records to conceal his conduct. Mr. deSales' switching of the randomization assignments, if undetected, could have biased the study so as to invalidate the conclusions on the effectiveness of intensive counseling sessions on reducing the rate of new HIV infections.

Mr. deSales has entered into a Voluntary Exclusion Agreement in which he has voluntarily agreed for a period of three (3) years, beginning on April 4, 2002:

(1) to exclude himself from serving in any advisory capacity to PHS, including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant; and

(2) that any institution that submits an application for PHS support for a research project on which Mr. deSales' participation is proposed or which uses him in any capacity on PHS supported research, or that submits a report of PHS-funded research in which Mr. deSales is involved, must concurrently submit a plan for supervision of his duties to the funding agency for approval. The supervisory plan must be designed to ensure the scientific integrity of his research contribution. A copy of the supervisory plan must also be submitted to ORI by the institution.

FOR FURTHER INFORMATION CONTACT: Director, Division of Investigative
Oversight, Office of Research Integrity, 5515 Security Lane, Suite 700,
Rockville, MD 20852. (301) 443-5330.

Chris B. Pascal,
Director, Office of Research Integrity.
[FR Doc. 02-9620 Filed 4-18-02; 8:45 am]
BILLING CODE 4150-31-P

 

Below is a series of articles regarding the vaccination link to sudden infant death syndrome (SIDS). The first article is by Harris L. Coulter, PhD, where he criticises two official studies that purport to refute the vaccination/SIDS link. Following this is a two-part debate between Coulter and Lon Morgan, DC.

Harris L. Coulter:
Two studies by teams of epidemiologists headed by Marie R. Griffin represent  perhaps the absolute worst I have encountered in many years of reading this literature (Marie R. Griffin, Wayne A. Ray, John R. Livengood, and William Schaffner, "Risk of Sudden Infant Death Syndrome after Immunization with the Diphtheria-Tetanus-Pertussis Vaccine." NEJM 319:10 [Sept. 8, 1988], 618-622. Marie R. Griffin, Wayne A. Ray, Edward A. Mortimer, Gerald M. Fenichel, and William Schaffner, "Risk of Seizures and Encephalopathy After Immunization with the Diphtheria-Tetanus-Pertussis Vaccine." JAMA 263:12 [March 23/30, 1990], 1641-1645). For those who are still interested I will attempt to show the reasons for my conclusion.

The first article, on "sudden infant death," was presumably written to refute the conclusion reached earlier by Alexander Walker et al.: "we found the SIDS mortality rate in the period zero to three days following DTP to be 7.3 times that in the period beginning 30 days after immunization...only a small proportion of SIDS cases in infants with birthweights greater than 2500 grams could be associated with DTP" ("Diphtheria-Tetanus-Pertussis Immunization and Sudden Infant Death Syndrome." American Journal of Public Health 77:8 [1987], 945-951).
So Walker et al. did find that the DPT shot was apparently causing "sudden infant death." And these deaths were not associated with just the first DPT shot, but with each succeeding shot.

Griffin et al. set out to refute this conclusion - not, indeed, by visiting these children and their parents but, in the new style, by leafing through computerized immunization records for children born between 1974 and 1984 in the state of Tennessee, "augmented through linkage of records with state vital statistics and Medicaid files."

The major problem with an epidemiologic study is always that of ensuring that the sample picked is representative of the larger group. It is logistically difficult to include all children, despite the availability of computerized records. Therefore, how the sample is selected is of paramount importance.

Griffin et al. found that, out of 280,000 children born in four Tennessee cities between 1974 and 1984, 180,000 had records in Public Health clinics. Oddly enough, for over 41,000 of these 180,000 children no immunizations had ever been recorded. But instead of looking into SIDS incidence in this sizable group, Griffin et al. simply excluded them from the study.

Another 3000 children were excluded because their immunization records were confused.

This left 130,000 children in the cohort. And it is legitimate to ask if these 130,000 were truly representative of the 180,000 with public health service records. And, even more to the point, are they representative of the 280,000 children born in these same cities who did not have Public health clinic records?

Next they found that 204 children had died during days 29 to 365 of life. But they excluded 95 of the 204 because "a cause of death was listed [on the death certificate] that was clearly not SIDS." But what were these causes that were clearly not SIDS? Griffin et al. do not vouchsafe us that information, even though causes of death on death certificates are not necessarily reliable. At the very least, the chronological relationship between these deaths and a preceding vaccination should have been provided. Two of the 95 deaths had actually been coded SIDS by the attending physicians, but Griffin et al. knew better and changed the diagnoses: one baby had pneumonia (as if there is no connection between pneumonia and a vaccine reaction), while the other had heart disease (as if babies with congenital heart disease are never vaccinated).

By this time the SIDS sample has been so restricted as to be entirely unrepresentative of anything, and we are not surprised to find that Griffin et al. found the incidence of SIDS to be identical with the expected background incidence ("marginal rate of SIDS for that age group," as it is called).

As we might expect, no published references are given in support of the concept of "marginal rate of SIDS for that age group."

Griffin et al. dismiss the results of the Alexander Walker study above (7.3 times as many SIDS deaths in the first 3 days after vaccination as 30+ days after vaccination) as follows: "Since the first DTP immunization is usually given near the age when the incidence of SIDS peaks, the results of such case-series analyses are biased toward finding an apparent association between SIDS and
DTP immunization." But Walker had found that SIDS was clustered not only around the first DPT shot, but around each succeeding shot. So Griffin et al. are hypothesizing that the background incidence of SIDS "peaks" every two months (!!).

It is amazing that such a study could be accepted by a reputable scientific journal. The reason was doubtless that the study was funded by the CDC and the FDA, and that two of the coauthors (Griffin and Ray) were at the time "Burroughs Wellcome Scholars in pharmacoepidemiology" (whatever that is). Burroughs-Wellcome is, of course, a major producer of the pertussis vaccine. Have these people never heard of conflict of interest?

The second article by this same group of authors is equally typical of the kind of epidemiologic research conducted by those who work with government funding. Marie Griffin et al., "Risk of Seizures and Encephalopathy after Immunization with the Diphtheria-Tetanus-Pertussis Vaccine" is a retrospective analysis of 38,171 Tennessee children enrolled in Medicaid who received DPT
immunizations during the first 3 years of life.

These constituted 29% of all children immunized in the public sector and 12% of all children born in the area during the study years, so the problem of "representativeness" of the sample is just as significant here as in the earlier study.

The "event" monitored was the "first nonneonatal seizure or episode of encephalopathy that resulted in a Medicaid reimbursement for a medical encounter, between the first DPT immunization" and the child's attainment of 36 months of age.

Griffin et al. found that 1187 study children had a potential "outcome of interest," meaning a seizure, but hold on, we can't just throw all these cases into the hopper, as it might lead us to the wrong (right!) conclusion. So Griffin et al. started whittling down the sample.

Records were "unavailable" for 359 (30%!!), and they were excluded! Just like that! And even though half of these, in the authors' estimation, would have met their criteria for inclusion! How about some good old shoe-leather epidemiology? Sorry, that's not how we do things these days.

Of the remaining 828 children 470 more (43%!!) were excluded as not meeting the "case definition." Ultimately, only 358 of the children remained in the study - 30% of the initial number!!

The 470 excluded cases consisted of: 34 seizures in the first 30 days of life ("neonatal"), 150 cases of chronic preexisting neurological abnormality without seizures, 18 "spells" "that were not clearly seizures," 82 diagnoses of "failure to thrive," 121 other nonneurological events, and 65 miscoded records. There is no way in the world that Griffin et al. could reliably conclude that these cases were unrelated to vaccination merely by examining Medicaid records and without interviewing the families. We must take these exclusions on faith, and such faith or confidence in the conclusions reached by government-funded epidemiologic surveys of vaccine damage is today in pretty short supply.

Griffin et al. conclude: "no child had the onset of encephalopathy, epilepsy, or other serious neurological disease in the first week following DPT immunization." But this is entirely disingenuous, since the "event" of interest has been defined as a neurological illness resulting in a medical encounter. The parents would have had to take the child rather quickly to the "medical encounter" to qualify under the terms of this study. If a parent left the baby in peace for a few days, just to see what was happening, or if the parents just did not notice a seizure in the baby (seizures are not very evident in small babies), this would not qualify as an "event" worth reporting.

Furthermore, the authors seem to assume that a seizure must occur within three days after vaccination to qualify as vaccination-related. There is no evidence for this anywhere in the vaccination literature. But it allows them to ignore a few unpleasant, and even potentially disastrous, outcomes, viz.: "Four children who were previously normal and had no prior seizures developed some neurological or developmental abnormality following the index seizure. In only one was the index event a febrile seizure, and this occurred more than 30 days following immunization. The other 3 occurred after acute symptomatic seizures. An additional 11 children who were previously normal developed epilepsy. One of these children had an initial afebrile seizure in the 8-14 days following immunization; the initial seizures for the other 10 were all in the period 30 or more days after immunization." Or: "Two children were hospitalized with encephalopathy between their first DTP immunization and 36 months of age. The 2 children with encephalopathy both had their onset of illness more than 2 weeks following DPT immunization, and neither had permanent sequelae. These 2 children will not be considered further." (??) Or, "There were six febrile seizures in the 0-3 days following immunization... Other events in the 0- to 3-day interval following DTP immunization included one afebrile seizure, zero symptomatic seizures, and six potential seizures, with no evidence for an increased rate of occurrence compared with the control period of 30 or more days following DPT immunization."

Amazingly, the authors think that seizures or other neurological events occurring more than 30 days after a vaccination are unrelated to the vaccination and part of the "background incidence." Hence the period commencing 30 days after vaccination is apparently used as a "control period," allowing the authors to conclude that the incidence of afebrile seizures in the 3 days following vaccination was no greater than in the "control period."

They do find, however, that the incidence of febrile seizures (generally thought to be less serious than the afebrile ones) is 50% higher in the period 0-3 days after vaccination than in the period 30+ days following vaccination.

The inherent difficulty of making sense of this article is due in part to the authors' tendency to contradict themselves from one paragraph to the next. For instance, after stating that afebrile seizures are 50% more common in the period 0-3 days post vaccination, they then say: "Indeed, there was no significant increase in febrile, afebrile, or acute symptomatic seizures in the early  post-immunization period, compared with the control period of 30 or more days following DTP immunization."

In sum, this article eliminates 70% of the cases which initially presented, without giving any justification for such elimination. The authors then excuse the neurologic illnesses and disabilities which occurred on the ground that they are part of a background incidence (whose existence and magnitude in an unvaccinated population has never been demonstrated). And this article appeared in the "peer-reviewed" Journal of the American Medical Association!

These kinds of articles bring the Public Health Service, the CDC, the FDA, the "peer-reviewed" journals, and the rest of the medical-industrial-government complex into disrepute. Physicians can swallow this garbage if they want, since they make their living from it, but parents who expect at least elementary honesty from those who call themselves "scientists," and whose children are being maimed and crippled by the very vaccines which are proclaimed innocuous by authors such as Griffin et al. are already taking steps to put this invalid out of its misery.

The relations between the public and the vaccine establishment are surely going to get a lot worse before they start getting any better. (Harris L. Coulter, PhD, June 11, 1996, hlcoulter@msn.com)
Lon Morgan's response to Harris Coulter - Part I:

1) A recent posting by Harris Coulter reviewed his assertion of a connection between DPT immunization and SIDS. He attacked studies by Griffen, et.al., published in JAMA and NEJM, which severely challenged this assertion.

2) Coulter's primary basis for his claim of a DPT/SIDS association is a study done by Walker in the August, 1987 AJPH. (1) Coulter systematically clings to this one, nearly 10 year old study, and purposefully ignores numerous studies done since then that seriously challenge his conclusions.

3) Since Coulter has made the 1987 study by Walker his 'end-all, be-all' for an alleged DPT/SIDS connection, a systematic examination of this study to examine the legitimacy of Coulter's position is in order.

BACKGROUND:
4) The AJPH study examined SIDS mortality over a period of eleven years, from 1972 to 1983, of some 26,500 infants born in the Puget Sound area. SIDS was defined as any death without discernable cause in a normal birthweight baby. A total of 29 cases of SIDS were identified. Six of the SIDS cases had not received pertussis vaccine.

5) Coulter's claim:
"we found the SIDS mortality rate in the period zero to three days following DTP to be 7.3 times that in the period beginning 30 days after immunization....", and also, "So Walker et al. did find that the DPT shot was apparently causing "sudden infant death."

6) REALITY CHECK:
Coulter conveniently, and obviously very deliberately, omitted the very next sentence in the AJPH study, which reads: "The mortality rate of NON-IMMUNIZED infants was 6.5 times that of IMMUNIZED infants of the same age." (emphasis added)

7) What does this mean? The study itself noted:
"Delay in immunization of high-risk infants might lead both to an elevated risk in the never-immunized and to a foreshortening of the interval between immunization and SIDS in the immunized. Both phenomenon could operate in the absence of any causal connection between immunization and risk of SIDS death..."

8) This phenomenon was further observed in another English study wherein the risk of SIDS was 2.4 times GREATER in NON-IMMUNIZED children. (2)

9) It was further noted that SIDS rates in the UK did NOT rise or fall when pertussis vaccination was discontinued. (3)

10) SUMMARY: The AJPH study that Coulter is so fond of lends basically NO support to his theories. It states quite clearly that "...only a small proportion of SIDS cases...could be associated with DTP," and that "The relatively small number of SIDS cases in the present study also admits the possibility of substantial random error."

11) Coulter's claim:
"These kinds of articles bring the Public Health Service, the CDC, the FDA, the "peer-reviewed" journals, and the rest of the medical-industrial-government complex into disrepute. Physicians can swallow this garbage if they want, since they make their living from it,"

12) REALITY CHECK:
Given Coulter's wholesale bastardization and misrepresentation of the professional literature, it is the ultimate in hypocrisy that he would presume to question the integrity of PHS, or anyone else. Are his motives financial? He does make his living peddling anti-vaccine literature, and disclosure of his inept research might well threaten his income.

13) Is he merely incompetent, or jealous that the scientific community ignores him? An examination of his background reveals ZERO training in the health sciences, and ZERO research experience. Yet he presumes to stand in high judgement of all the world's science! Incredible!

14) Part II of our review will examine why Coulter is so upset with the pertussis studies done by Griffin. (Lon Morgan DC, July 15, 1996, lmorgan@primenet.com)
REFERENCES:
1. Diptheria-Tetanus-Pertussis Immunization and Sudden Infant Death Syndrome,
Walker, AJPH, August, 1987, Vol. 77, No. 8.

2. Possible temporal association..., Ped. Infect Dis, 1983; 2:7-11.

3. Effect of low pertussis vaccination uptake on a large community. BMJ, 1981;282:23-26.
Harris L. Coulter responds:
I have made several contributions lately to VIA criticizing various government-funded and industry-funded epidemiologic studies of vaccine damage. The point I have been making is that the raw data are carelessly and inadequately gathered, the conclusions are not supported by the data, and, often enough, the articles are so slanted in favor of the government/industry position as to verge on the fraudulent.

Now we have a response by Lon Morgan, DC, which ignores my criticisms and quotes, or misquotes, an article back at me as if I had never written the critique in the first place.

I am happy to engage in controversy. We all need more light on these issues, and the sparks of controversy often cast that sort of light, but I am not willing just to waste my time (and the readers' time as well). Responding to Dr. Morgan's supposed critique of my articles comes close to being a simple waste of time, but I will try to show what I mean, going through Dr. Morgan's contribution paragraph by paragraph.

This following should be read and compared with my initial contribution(s).

1) Marie Griffin's name is misspelled.

2) I do not "systematically cling" to the Walker study. It was the fifth
article cited by me, four of which supported a vaccine-SIDS connection.

3) Again, it is not my "end-all, be-all" (for the reasons given above in 2).

4) Dr. Morgan accepts the raw data on SIDS. I do not: very many deaths were excluded from the survey without the reader being told the reason. It is a matter of common knowledge that only 10% of vaccine reactions are reported by physicians. And it is ludicrous to think that the authors of the study could get a true picture of SIDS by scrutinizing death certificates, hospital discharge data, and pharmacy use. The article does not state that the families of the babies concerned were interviewed. But even with these defects and exclusions, the SIDS incidence after vaccination was uncomfortably high, as the authors admit.

5) "We found the SIDS mortality in the period zero to three days following DPT to be 7.3 times that in the period beginning 30 days after immunization" is not "Coulter's claim," but is taken from the article Abstract. "So Walker et al. did find that the DPT shot was apparently causing 'sudden infant death'" was my paraphrase of the article Abstract.

6) I did not "conveniently" and "deliberately" omit mention of SIDS mortality in non-immunized infants. I have never held that all SIDS is from vaccinations. In DPT: A Shot in the Dark Barbara Loe Fisher and I estimated that 13% of all SIDS cases were from vaccination. So the fact that six unvaccinated babies in a population of 26,500 apparently died of SIDS is of no significance at all. What the study was measuring was the time interval between vaccination and SIDS.

7) This is pure hypothesis, of the sort with which we are too lamentably familiar in SIDS epidemiologic studies. The authors themselves state "might" and "could," and Dr. Morgan elevates these suppositions to the level of fact.

8) This paragraph is unintelligible. Dr. Morgan seems to be discussing an English study, but his reference is to a study conducted in Los Angeles, California. The article ("Possible Temporal Association, etc.), however, does state: "Both the efficacy and safety of pertussis vaccine have been questioned recently, particularly in the United Kingdom."

9) This 1981 British study is too old and too obscure to be cited as a reference for anything. And it is inappropriate to try to disprove my conclusions by citing references which suffer from the same defects as those being criticized.

10) Walker et al. mention the "possibility of substantial random error," and Dr. Morgan elevates this second supposition to the level of fact. Of course, the random error could just as well operate in the opposite sense, i.e., reinforcing the authors' conclusion about a connection between vaccination and SIDS, a point which Dr. Morgan may not fully appreciate. The conclusion of Walker
et all. That "a small proportion of SIDS cases...could be associated with DPT" is the important element in this article, and to state that it "lends basically no support" to my position is just silly.

11) I stand by this conclusion.

12) I only wish I made as much money "peddling anti-vaccine literature" as the average CDC/PHS operative does peddling vaccines. But it does help keep me independent of government- or pharmaceutical-industry-handouts ("grants," "funding," etc.) and enables me to tell the truth as I see it rather than have to support an official line.

13) I have never claimed to be anything but a historian and writer. But a cat can look at a queen and a historian can look at scientific data. I wouldn't want to be associated with the kind of "research" which Dr. Morgan seems to admire so much. Furthermore, the scientific community has not been ignoring me at all. DPT: A Shot in the Dark sparked passage of the "National Childhood
Vaccine Injury Act" of 1986 together with three studies of vaccine damage by the National Academy of Sciences Institute of Medicine, all of which make specific mention of this book. My second book, Vaccination, Social Violence, and Criminality (North Atlantic Books, 1990) has also had its share of attention, both official and professional. Someone out there may be "jealous," but it isn't me.

14) I will take up Part II of Dr. Morgan's review in my next communication. (Harris L. Coulter, PhD, July 22, 1996, hlcoulter@msn.com) Lon Morgan's response to Harris Coulter - Part II: In a recent posting Harris Coulter attacked studies done by Marie Griffin, M.D., et.al., which examined for any connection between DPT immunization and SIDS or seizures. These studies were published in NEJM and JAMA. (1)(2). For the sake of brevity, I'll confine my comments to Coulter's handling of the JAMA study, although it would be similar in both cases.

1) Coulter claims the purpose of the Griffin study is to 'refute' a prior study by Walker. (3) Coulter has ZERO evidence to support this claim. As demonstrated in a prior post (7/15/97) on this topic, despite Coulter's attempts at distortion, the Walker study is highly supportive of DPT immunization.

2) Coulter claims the cohort sample of 29% of children immunized in the public sector and 12% born in the area has a problem with "representativeness."This is incredible. National election polls can predict outcomes very accurately with only a fraction of one percent of the population polled. And Coulter thinks 29% of a population is not representative enough?!

3) Coulter makes the claim that: "the authors seem to assume that a seizure must occur with three days after vaccination to qualify as vaccination-related." Coulter's confusion and befuddlement is pathetic. All Coulter had to do was read the seizure classification used in the study, which was similar to that of Hauser and Kurland, and which clearly stated the seizure types that were examined:
Neonatal: occurring in the first 28 days of life
Febrile: seizures with fever, no acute neurological illness
Afebrile: no fever, no neurological illness
Symptomatic: having neurological illness
Encephalopathies: acute or subacute
Follow-up continued for 36 months of life.

4) Is that too difficult for anyone to understand? Apparently it was for Coulter. One could go on at length, but his wearisome pattern of distortion and misrepresentation remains the same.

5) Since it is obvious that nothing honest or candid regarding this study will be forthcoming from the Coulter camp, a summary follows: The risk of seizures and other neurological occurrences following DPT immunization was followed in 38,171 children who received 107,154 DPT immunizations in their first three years of life. There was NO evidence of an increase in seizures.

6) So why is Coulter so upset with this study? Probably because it, like a steadily increasing number of other DPT studies, blows holes a mile wide right through the middle of his insipid theories.

7) EXAMPLES OF OTHER DPT STUDIES:
A. Walker found NO cases of unexplained encephalopathy or seizure disorders following 106,000 DPT vaccinations. (4) B. Danish investigators found NO change in the age at onset of epilepsy or infantile spasms when age at pertussis immunization was changed. (5) C. The British National Childhood Encephalopathy Study could only estimate one serious neurological problem per 110,000 immunizations. (6)

8) Many more studies from all over the world could be cited - all with a similar finding: The risk of serious neurological problems, or SIDS, from DPT immunization is infintisimal. But Coulter considers these studies to be all part of a worldwide "medical-industrial-government" conspiracy.

9) So why does Coulter continue with his paranoid charade? He has obviously staked his reputation, such as it is, on the outcome. He further derives a substantial portion of his personal income peddling anti-vaccination pulp-fiction. (Can you say "C-O-N-F-L-I-C-T O-F I-N-T-E-R-E-S-T"?)

10) All this from "the premier medical historian of our time." (Lon Morgan DC, July 16, 1996, lmorgan@primenet.com)
REFERENCES:
1. "Risk of Sudden Infant Death Syndrome after Immunization with the Diphtheria-Tetanus-Pertussis Vaccine." NEJM 319:10 [Sept. 8, 1988], 618-622.

2. "Risk of Seizures and Encephalopathy After Immunization with the Diphtheria-Tetanus-Pertussis Vaccine." JAMA 263:12 [March 23/30, 1990], 1641-1645).

3. "Diptheria-Tetanus-Pertussis Immunization and Sudden Infant Death Syndrome." AMJH 77:8, 1987, 945-951.

4. "Neurologic events following diptheria-tetanus-pertussis immunization." Pediatrics. 1988;81:345-349.

5. "Relationship of pertussis immunization to the onset of neurologic disorders." J. Pediatrics. 1988;113:801-805.

6. "Pertussis immunization and serious acute neurological illness in children. BMJ. 1981;282:1595-1599. Harris L. Coulter's response:
I have written several articles lately criticizing various government-funded and industry-funded epidemiologic studies of vaccine damage. The point I have been making is that the raw data are carelessly and inadequately gathered, the conclusions are not supported by the data, and, often enough, the articles are so slanted in favor of the government/industry position as to verge on the
fraudulent.

Now we have another response by Lon Morgan, DC, which commits the same errors as his earlier one, indeed, the very errors I have been criticizing. I will respond in the same way as I did to his earlier critique, going through Dr. Morgan's contribution paragraph by paragraph.

1) I did not claim that the purpose of this study was to "refute" the prior study by Walker. I made that claim for the other Griffin study, the one published in NEJM (ref. 1 below), because Griffin et al. referred to it specifically in paragraph l of that article. Does Dr. Morgan know which article he is
critiquing? In any case, the Walker study (ref. 3 below) does find a connection between SIDS and DPT immunization (Dr. Morgan is getting off to a shaky start!).

2) I was concerned about the representativeness of the study population and, even more, by the small size and representativeness of the case group: 358 out of a population of 38,171 children immunized, or less than 1 in 100.

3) and 4) Dr. Morgan is simply confused here. My point is that Griffin et al. seem to consider seizures occurring more than 3 days after a vaccination is not vaccine-related but, as it were, part of a (never demonstrated) "background incidence" of seizures

5) and 6) Dr. Morgan quotes against me the conclusions of the very study I have criticized as methodologically defective. A little elementary logic is called for: before he can cite the article in his favor, he must deal with my criticism of it.

7) Again, he quotes studies whose methodology I have criticized. Dr. Morgan does not seem to understand that criticism of a study's methodology cannot be refuted by citing the conclusions of the same study.

To be specific: the Walker study he mentions (ref. 4), while suffering from all the methodological defects I have mentioned, does, even so, note one very disturbing case: "The single seizure that occurred within three days of a DPT was in an 11-month old white girl who suffered a 2 ½ hour generalized tonic-clonic seizure on the evening of her third DPT-oral poliovirus vaccination. Her temperature during the seizure was 39 degrees C. (102.2 degrees F.). Results of CSF studies were normal. There was a transient left hemiparesis and right sixth-nerve paresis. She was treated with phenobarbitol. At 6 years of age, while still taking phenobarbitol, she was experiencing rare focal left-sided seizures in the absence of fever and continued to have abnormal EEG tracings." So Dr. Morgan's "NO cases of unexplained encephalopathy or seizure disorders" seems  to be a transparent lie. This girl will suffer from afebrile seizures for the rest of her life.

Dr. Morgan's depiction of the conclusions of the Danish study (ref. 5) is also erratic and incorrect. When the age of vaccination was changed, there was a concomitant change in the pattern of central nervous system infections, febrile convulsions (sometimes associated with long-term seizures), and central nervous system illnesses generally. My critique of that study may be found at: www.healthy.net/clinic/familyhealthcenter/children/vaccination.

His reference to the National Childhood Encephalopathy Study is also tendentious (ref. 6). The contribution made by this study and its followups has been to demonstrate that vaccinations do cause acute reactions and long-term neurologic sequelae. The authors suggested a low figure of 1:100,000 for the incidence of these conditions, but does anyone really believe that figure? Maybe Dr. Morgan does, but everyone else knows the figure is going to go up. My own estimate is 1:5-1:10.

8) I don't think I have ever used the word "conspiracy" in any of my writings. However, being a political scientist and historian by training, I know that social and professional groups usually work together to pursue common goals and to benefit themselves at the expense of society as a whole. This is what is happening in medicine today.In a society which expends $1 trillion every year on what are mistakenly called "health services," those who control these expenditures do so in such a way as to benefit themselves first and foremost. Pediatricians make about half their income from giving shots; hence they will defend shots to their dying day (may it come soon!) and are simply uninterested in data showing vaccinations to be dangerous. If this were a "conspiracy" against  the public health, meaning that pediatricians gave vaccines deliberately in full awareness of their riskiness, they would not be vaccinating their own children.

9) I do a lot of other things besides criticizing vaccinations. And Dr. Morgan, with his usual silliness, doesn't even understand the concept of conflict of interest. If Barbara Fisher went on the Oprah Winfrey show to promote sales of DPT: A Shot in the Dark, would she be in "conflict of interest?" As I stated earlier, trying to answer Dr. Morgan is just a waste of time.
 

This completely netural clinical "control"factor-it was funded by Merck, the lab testing was performed at Merck Labs.....
   
MEDSCAPE
http://www.medscape.com/viewarticle/472539?src=mp

From The Pediatric Infectious Disease Journal®

Concomitant Administration of a Bivalent Haemophilus Influenzae Type B-Hepatitis B Vaccine, Measles-Mumps-Rubella Vaccine and Varicella Vaccine: Safety, Tolerability and Immunogenicity

Posted 04/14/2004

Teresa M. Hesley, MPH; Keith S. Reisinger, MD; Bradley J. Sullivan, MD; Erin
H. Jensen, MS; Susan Stasiorowski, BS; Cathy D. Meechan, RN, BSN; Christina
Y. Chan, MD; David J. West, PhD; the HIB-Hb Vaccine Study Group

Abstract and Introduction
Abstract
Background: The study was done to verify that concomitant administration of a bivalent Haemophilus influenzae type b-hepatitis B vaccine (Comvax), measles-mumps-rubella vaccine (M-M-RII) and varicella vaccine (Varivax) would be well-tolerated and suitably immunogenic with respect to all vaccine antigens. Methods: We randomized 822 healthy 12- to 15-month-old children (1:1) to receive concomitant injections of Comvax, M-M-RII and Varivax (concomitant group) or Comvax followed 6 weeks later by injections of M-M-RII and Varivax (nonconcomitant group). Blood samples taken before and 6 weeks after vaccination were tested for antibodies to all vaccine antigens. Results: Vaccinations were generally well-tolerated. Children in the concomitant and nonconcomitant treatment groups were similar with respect to the safety endpoint of primary interest (16.1 and 19.5%, respectively, had a fever >/=103°F rectally at any time within 14 days after either of two clinic visits). Fifteen serious adverse events were reported (eight in the concomitant group and seven in the nonconcomitant group); all resolved. Elements of two serious adverse events (fever, fever and measles-like rash; both in concomitant group children) were considered possibly related to vaccination. One child was withdrawn from the study because of a nonserious adverse event subsequently judged to be unrelated to vaccination. Similar proportions of vaccinees in the concomitant and nonconcomitant groups developed satisfactory antibody responses to the H. influenzae polysaccharide, polyribosylribitol phosphate (97.8 to 98.7%), hepatitis B surface antigen (99.2 to 100%), measles virus (99.4 to 99.6%), mumps virus (98.4 to 99.2%), rubella virus (100%) and varicella virus (93.2 to 94.6%). Conclusion: Concomitant administration of Comvax, M-M-RII and VARIVAX at the 12- or 15-month clinic visit is one satisfactory way of delivering some of the multiple vaccines indicated during the second year of life.
Introduction
All currently recommended pediatric vaccines are formulated for administration by injection, with as many as eight that could be given at 12 to 15 months of age. These include: (1) the final dose (usually the third) of hepatitis B vaccine (recommended at 6 to 18 months of age); (2) the fourth dose of diphtheria-tetanus-acellular pertussis vaccine (recommended at 15 to 18 months of age, but may be given as early as 12 months provided 6 months have elapsed since the third dose and the child is unlikely to return at 15 to 18 months); (3) a final dose (third or fourth depending on the manufacturer) of Haemophilus influenzae type b vaccine (recommended at 12 to 15 months of age); (4) a third dose of inactivated polio vaccine (recommended at 6 to 18 months of age); (5) the fourth dose of pneumococcal conjugate vaccine (recommended at 12 to 15 months of age); (6) a dose of measles-mumps-rubella vaccine (recommended at 12 to 15 months of age); (7) a dose of varicella vaccine (recommended at 12 to 18 months of age); and (8) a dose of influenza vaccine (where indicated, recommended annually for children at least 6 months of age).[1] No child is likely to receive all eight injectable vaccines at once, but there are multiple permutations for the vaccines (usually 2 to 4 per visit) that could be given concomitantly at 12 or 15 months of age. It is imperative that the selected vaccines be well-tolerated and not interact to diminish significantly the immune response to any vaccine antigen.

In this article we report the results of a study designed to assess the safety and immunogenicity of concurrent vaccination with a bivalent H.influenzae type b (Hib)-hepatitis B vaccine (Comvax), measles-mumps-rubella vaccine (M-M-RII) and varicella vaccine (Varivax).

Materials and Methods
The study was conducted at 14 sites in the United States under a protocol developed by Merck Research Laboratories. The protocol and subject consent forms were reviewed and approved by an institutional review board at each study site. Written informed consent was obtained from a parent or guardian for each child enrolled.

Study Population
The study was open to healthy children 12 to 15 months of months of age, who had previously received two or three doses of a hepatitis B vaccine and a two-dose primary series of the polyribosylribitol phosphate-meningococcal outer membrane protein type of Hib vaccine (PedvaxHIB), a three-dose primary series of a polyribosylribitol phosphate-tetanus (PRP-T) type of Hib vaccine (ActHIB or OmniHIB), a diphtheria CRM197 (CRM, cross-reactive material) protein conjugate (HbOC) type of Hib vaccine (HibTITER or Tetramune) or a mixture of the PRP-T and HbOC vaccines, but had not yet been given any M-M-RII or Varivax. Children were excluded from participating if any of the following conditions applied: hypersensitivity to a component of any study vaccine; receipt of immunoglobulin or any other blood product within the previous 2 months; recent household, day-care or school exposure (<14 days) to invasive Hib disease, hepatitis B, measles, mumps, rubella or varicella, or a previous history of having had any of these diseases; any immunodeficiency, neoplastic disease or depressed immunity including those resulting from corticosteroid or other immunosuppressive therapy; a history of anaphylactic or other immediate reactions subsequent to egg ingestion or to neomycin; a personal history of seizure disorder; or a recent (<72 h) history of febrile illness (>101°F orally) or underlying medical problems.

Vaccines
The vaccines utlized in this study, Comvax [Haemophilus b conjugate
(meningococcal protein conjugate) and hepatitis B (recombinant) vaccine],
M-M-RII (measles, mumps and rubella virus vaccine, live) and Varivax
[varicella virus vaccine live (Oka/Merck)] are products of Merck & Co.,
Inc., Whitehouse Station, NJ.

Study Design and Procedures
This was an open, randomized, multicenter study with subjects assigned (1:1) to a concomitant treatment group or nonconcomitant treatment group. Children in the concomitant treatment group received concomitant doses of Comvax (0.5-ml im injection in the right thigh), M-M-RII (0.5-ml subcutaneous injection in the left deltoid) and Varivax (0.5-ml subcutaneous injection in the right deltoid) at Visit 1 but no vaccinations at Visit 2, scheduled 6 weeks later. Children in the nonconcomitant treatment group were given a dose of Comvax at Visit 1 followed by doses of M-M-RII and Varivax 6 weeks later at Visit 2. Vaccinees in both groups were monitored for systemic adverse events (AEs) during a 6-week period after both Visit 1 and Visit 2 so as to compensate for a time of observation bias that would otherwise exist between the treatment groups if surveillance occurred only after the visit(s) during which vaccines were given. Blood samples (2 to 5 ml) for the measurement of antibodies to all vaccine antigens were to be obtained before and 6 weeks after each vaccination.

Assessment of Vaccine Safety
All vaccinees were observed for at least 15 min after each injection for evidence of any immediate reaction. Parents of children vaccinated in the study were given a Vaccination Report Card and asked to record any injection site AE (i.e. pain/soreness, swelling/hardness, redness, other) that was
observed 4 to 6 h after injection and daily thereafter at the same time for 5 days. The child's rectal temperature was also to be recorded daily for 14 days after both Visit 1 and Visit 2. Systemic AEs were recorded for 42 days after both Visit 1 and Visit 2. Parents were instructed to notify the study
physician immediately if their child experienced any unexpected or serious AE.

Measurement of Antibody Titers
Sera were tested at the Merck Research Laboratories (West Point, PA) to determine the titers of antibodies to the polysaccharide of H. influenzae (anti-PRP) (Farr-type radioimmunoassay protocol with a standard provided by the US Food and Drug Administration),[2] hepatitis B virus surface antigen (anti-HBs) [AUSAB; radioimmunoassay (Abbott Laboratories, North Chicago, IL)], measles virus (IgG antibody detected by enzyme immunoassay with reagents from the Measelisa II kit; Whittaker Bioproducts, Inc., Walkersville, MD), mumps virus (enzyme immunoassay method described by Shehab),[3] rubella virus (with a modified Rubazyme kit; Abbott Laboratories, North Chicago, IL) and varicella virus (anti-VZV) (gpELISA procedure).[4] Endpoints of primary interest were the proportions of vaccinees developing >1.0 µg/ml anti-PRP (a titer thought to ensure long term protection against invasive Hib disease),[5-7] >/=10 milli-International Units (mIU)/ml anti-HBs (associated with protected against clinically significant HBV infection),[8-10] >/=5 gpELISA units of
anti-VZV (correlated with a low likelihood of breakthrough infection and disease)[11] and the proportions of baseline seronegative vaccinees seroconverting for antibodies to measles, mumps and rubella viruses.

Study Objectives, Hypotheses and Statistical Analyses
The primary safety hypothesis was that the proportion of children in the concomitant treatment group experiencing a high fever (>/=103°F rectally or >/=102°F axillary) at any time during the 14-day periods of observation after Visits 1 and 2 would be similar (<15 percentage points higher) to the proportion with such a fever in the nonconcomitant treatment group. This was addressed by testing a null hypothesis of the form h0: p1 - p0 >/= 0.15 against the alternative hypothesis, H1: p1 - p0 < 0.15 (where p0 and p1 are the proportions of children with a high fever in the nonconcomitant and the concomitant treatment groups, respectively). The concomitant and nonconcomitant treatment groups were also compared with respect to the occurrence of any injection site AE within 5 days of Visit 1 or Visit 2 and to systemic AEs occurring at a frequency of at least 1% during the 6-week periods of observation after Visits 1 and 2, with rejection of a null hypothesis of no difference (two sided test, P </= 0.050) taken as an indication that there was a difference between the treatment groups. These analyses included all vaccinees for whom safety data were obtained.

The primary hypothesis regarding immunogenicity was that the proportion of vaccinees in the concomitant treatment group developing a critical titer of antibody to each vaccine antigen (i.e. >1 µg/ml anti-PRP, >/=10 mIU/ml anti-HBs, seroconversion for antibodies to measles, mumps and rubella viruses and >/=5 gpELISA units anti-VZV) 6 weeks postvaccination would be similar (<10 percentage points lower) than the proportion of vaccinees developing such titers in the nonconcomitant treatment group. The method of Farrington and Manning[12] was used to test a null hypothesis of the form H0: p0 - p1 >/= 0.10 against the alternative hypothesis, H1: p0 -p1 <0.10
for each antibody (where p0 and p1 are the proportions of children responding in the nonconcomitant and the concomitant treatment groups, respectively). A one sided test with P </= 0.025 rejects the null hypothesis and implies that the antibody responses of children in the concomitant and nonconcomitant treatment groups were similar for a given vaccine antigen. For each antibody this analysis included all vaccinees for whom baseline and postvaccination test data were obtained.

Antibody responses of secondary interest [i.e. the proportions of vaccinees with >0.15 µg/ml anti-PRP, seropositive for anti-HBs and seropositive foranti-VZV, as well as the geometric mean titer (GMT) for every antibody] were not targeted for formal statistical comparisons between the concomitant and nonconcomitant treatment groups, but 95% confidence intervals were calculated for each endpoint within each treatment group.

Results
Study Population
The study comprised 822 enrolled children (mean age, 12.9 months; 54.9% female; 71.5% Caucasian). Children in the concomitant treatment group (n =410) and nonconcomitant treatment group (n = 412) were similar with respectto vaccinee age, gender and race/ethnicity.

Safety and Tolerability
Clinical follow-up was obtained for 812 (98.8%) of the study participants. Vaccination was generally well-tolerated. A single child discontinued the study subsequent to an episode of otitis media that responded to treatment with amoxicillin. The physician determined that this event was not related to the study vaccine, but the child's parents decided to withdraw him from the study.

Fifteen children had events classified as serious AEs (eight in the concomitant treatment group, seven in the nonconcomitant treatment group). Two serious AEs (both in concomitant treatment group vaccinees) were considered possibly related to vaccination.

Case 1. A 12-month-old boy with a history of reactive airway disease was hospitalized 1 day after vaccination with fever (105.1°F rectally), reactive airway disease, nausea, vomiting, oral thrush and diaper rash. On admission a chest radiogram revealed right lower lobe streaking. There was no known varicella or measles exposure. The child recovered and was discharged 3 days later. The investigator felt that the high fever might be attributable to vaccination but that the other features of the illness were not.

Case 2. A 13-month-old boy developed upper respiratory symptoms with profuse clear nasal discharge and fever (up to 105°F, rectal) 8 days after vaccination. Two days later he also developed a morbilliform fine papular rash over his abdomen, with no known measles or varicella exposure. At that time he was hospitalized to rule out sepsis. On admission he had a clear chest examination. Blood culture, urine culture and nasopharyngeal swab for respiratory syncytial virus were all negative; a measles antibody titer was positive. The child was discharged 3 days later with a diagnosis of pneumonia and viral exanthem. The investigator considered that the fever, but not the pneumonia, might have been related to vaccination and that the  measles-like rash might have been specifically related to receipt of M-M-RII. The same child was rehospitalized 5 days later, this time with left periorbital cellulitis of the upper eyelid, oral thrush and diaper rash. Blood cultures were negative, but no culture of the eye was obtained. Thechild was treated with iv antibiotics and nystatin and was discharged 2 days later in good condition. The investigator felt that none of the features of the illness associated with the second hospitalization was related to vaccination.

Table 1 shows by treatment group the reported rates of injection site AEs within 5 days of Visit 1 or Visit 2, common systemic AEs (frequency, >/=5%) occurring any time during the 6-week observation periods after Visits 1 and 2 and an elevated temperature occurring any time during the 14-day periods after Visits 1 and 2. There was statistical evidence (P </= 0.025) that the frequency of a high fever (>/= 103°F, rectally or >/= 102°F axillary) among children in the concomitant treatment group was similar to that among those in the nonconcomitant treatment group (Table 1, bold type). Nearly every child reported at least one AE. There was no significant difference between treatment groups in the proportion of vaccinees reporting any AE, although vaccinees in the nonconcomitant group were marginally more likely to have an AE rated as possibly, probably or certainly related to vaccination (P = 0.048). Slightly less than one-half of the vaccinees in each group had at least one local injection site AE within a 5-day period after vaccination, whereas just over 90% had one or more systemic AEs at some time during the 6-week observation periods after Visits 1 and 2. The treatment groups differed little with respect to commonly reported systemic AEs, although children in the nonconcomitant treatment group reported significantly higher rates of rhinorrhea (P = 0.021) and rash (P = 0.015). There were no significant differences between treatment groups in the reported rates of less common systemic AEs (frequencies, 1 to 4.9%; data not shown).

Antibody Responses
Table 2 shows the antibody responses of children in the concomitant and nonconcomitant treatment groups to Comvax, M-M-RII and Varivax, with bold text identifying the responses of primary clinical interest. Comvax completed the Hib and hepatitis B vaccination of children previously given priming doses of other Hib vaccines (records showed that 92.2 to 92.9% had received a three dose series of PRP-T, HbOC or a mixture of PRP-T and HbOC Hib vaccines) and hepatitis B vaccines (78.4 to 81.0% had received three doses of a recombinant hepatitis B vaccine). As shown by the pre- and postinjection GMTs, this dose of Comvax induced substantial secondary increases in both anti-PRP and anti-HBs, and nearly all vaccinees developed >1.0 µg/ml anti-PRP and >/= 10 mIU/ml anti-HBs. Similarly almost all baseline-seronegative children in both treatment groups (98.4 to 100%) seroconverted for antibodies against measles, mumps and rubella in response to M-M-RII, whereas 93.2 to 94.6% achieved >/=5 gpELISA units of anti-VZV after a dose of Varivax.

Because almost all children in the study had previously received a three dose primary series of H. influenzae type b vaccine, it was unnecessary to control on Hib vaccination history (i.e. two vs. three doses); therefore the analysis of immune responses was performed adjusting only for geographic region (study centers combined in three regions: East, Midwest, West). There was statistical evidence (P </= 0.025) that the proportion of children in the concomitant treatment group achieving a critical titer of antibody to each vaccine antigen was similar to the proportion among children in the
nonconcomitant treatment group (Table 2, bold type). Confidence intervals on the point estimates shown in Table 2 also attest to the similarity of antibody responses to each vaccine antigen among children in the two treatment groups.

Discussion
This study was specifically designed to test whether concomitant administration of Comvax, M-M-RII and Varivax would be comparably well-tolerated and as immunogenic as staggered administration of Comvax followed 6 weeks later by M-M-RII and Varivax. The report cards completed by parents showed that children in both treatment groups experienced similar AEs at similar frequencies. In particular follow-up data supported the safety hypothesis of primary interest (i.e. the proportion of children in the concomitant group experiencing a high fever at any time after either  study visit would be similar to that in the nonconcomitant treatment group).

Children assigned to both treatment groups developed satisfactory antibody responses to all vaccine antigens similar to or greater than those observed in previous studies of Comvax[13] and of M-M-RII + Varivax.[14, 15] Furthermore statistical analysis found similarity between the concomitant
and nonconcomitant treatment groups in the proportion of children developing a critical titer of antibody to each of the vaccine antigens.

Health care providers must decide which of the many vaccines recommended during the second year of life to administer at a given clinic visit. The results of this study support concomitant administration of Comvax, M-M-RII and Varivax as one option that should be well-tolerated and can be expected to induce satisfactory titers of antibodies to all of the constituent vaccine antigens.

Preliminary summaries of this study have been presented in abstract form.
[16, 17]
Acknowledgements

We thank Charles Liss for helping to organize and interpret the results of statistical analyses. We also thank Pamela Burke and Beverly Rich for performing the serologic assays.
Funding Information

This study was supported by a grant from the Merck Research Laboratories.

 

And another lie bites the dust.................

next vaccines, statins, pitocin, rhogam in pregnancy, and so much more

    It Was Medical Gospel, but It Wasn't True

By GINA KOLATA
http://www.nytimes.com/2004/05/30/weekinreview/30kola.html

OUR nanograms of prostate specific antigen, or P.S.A., per milliliter. For more than a decade, that has been the line between normal and abnormal on a common annual blood test used to screen for prostate cancer. Above four and you need a biopsy of your prostate to look for cancer. Below four and you go home. But a new study, published last week in The New England Journal of Medicine, showed that no matter how low his P.S.A. level, a man could have prostate cancer.

In addition, it has long been known that men whose prostates are enlarged, a normal consequence of aging, can also have P.S.A. levels indistinguishable from those with early prostate cancer. So the question arises: How did four become the standard? Even some leading urologists say they aren't sure. Dr. E. David Crawford, the head of urologic oncology at the University of Colorado Health Sciences Center, says a 1986 paper by a test maker, Hybritech (now part of Beckman Coulter), proposed that number as the divider between normal and abnormal P.S.A. levels. But Dr. William Catalona, director of the prostate cancer program at Northwestern University, said he was primarily responsible for generating interest in using the P.S.A. as a screening tool, first advocating its use at a 1988 meeting of the National Cancer Institute.

The test finds a protein, the prostate specific antigen, that is released by prostate cells. Its levels go up slightly early in the course of cancer, but also when the prostate grows larger as a man ages. When cancer is advanced, P.S.A. levels soar into the thousands, but the test is looking at levels where only a biopsy could tell whether or not cancer was present. Dr. Catalona knew that, but, he said, given the seriousness of the disease, "we were willing to pay that price."

Not everyone agreed. "I was howled down," at the cancer institute, he said. "They were looking for something like a pregnancy test; when it was positive you always had cancer and when it was negative you never did." Unfazed, Dr. Catalona began his own P.S.A. study with the support of Hybritech, in which any test result over four nanograms was considered abnormal. But that cutoff, the same as in the Hybritech paper, was adopted "just sort of arbitrarily" he said.

The usual sort of study to validate a screening test would determine how likely the test is to miss a cancer that is there and how many times it points to cancer when none is present. But Dr. Catalona's test instead asked only how often cancers were found and how the men fared after treatment. In 1991, his findings appeared in The New England Journal of Medicine. That, said Dr. Peter Albertsen, chief of urology at the University of Connecticut, convinced urologists. Four became the standard. But some say it has resulted in way too much testing and way too many biopsies. Dr. H. Gilbert Welch, a professor of medicine at Darmouth College and at the Department of Veterans Affairs Medical Center in White River Junction, Vt., attributes the appeal of the number four to "digit preference." Doctors, he said, like whole numbers, they like clear results.

Unfortunately, he said, cancer, and prostate cancer in particular, is not like that. "If the P.S.A. gets very high, it is telling us something," he said. But lower levels, certainly levels below 10, lead to the discovery of microscopic cancers that no one understands. Most are harmless and will never grow. Some are dangerous, but there is no way of distinguishing between the two. "We just don't know what it means," Dr. Welch said. Prostate cancer is so common that virtually every man gets it if he lives long enough, said Dr. Thomas A. Stamey, a professor of urology at Stanford. Yet only rarely is it life-threatening. Screening, Dr. Stamey said, fueled by a false sense of confidence in what is normal and what is not, has led to far too many biopsies, far too many discoveries of cancers that pose no danger, far too many prostates removed or destroyed.

Dr. Catalona is of the opposite camp. He says he has moved his cutoff down a notch, to 2.5. He has seen too many men, he says, who ended up with deadly cancers because they waited for their P.S.A. levels to creep above four before having a biopsy. But Dr. Stamey said, "I have some smart colleagues who are very proud of the fact that they used to stand up at meetings and say, 'I never had a P.S.A. test in my life, and I don't plan to have one.' " Given the new study, he said, "it looks like they were very insightful."
 

http://www.pharmacytimes.com/newsfeed.cfm?id=15868

Conflicts of Interest in Biomedical Research Harm Children With and Without Disabilities
Source: Journal of Disability Policy Studies

Children have been exposed to unjustifiable risks that in some cases amount to research abuse. Powerful, financially interconnected stakeholders control all facets of research, including the approval process. Physician investigators, their academic institutions, and institutional review boards (IRBs) all come under the influence of funding sponsors, whose interests conflict with the best interest of children. Children cannot rely on IRBs or on any of the existing research oversight agencies to protect them, for research too often takes inordinate risks in the name of the greater good.

Medical research, by its nature, involves risks. Infants and children cannot assess those risks; neither can they exercise the adult human right to refuse consent to research. They are thus particularly vulnerable to experiments involving pain, discomfort, and risks of medical, physical, and psychological harm. Children are vulnerable to exploitation in "heroic" experimentsventures whose risks arc not justified by any evidence of foreseeable benefits to the subjects (Anas, 1985; Bailey, Nehlsen, Sandra, Concepcion, & Jolley, 1985; Kushner & Belliotti, 1985; Moss, 1996). History demonstrates that the welfare of vulnerable persons-such as individuals with mental retardation, minorities, economically disadvantaged persons, and children from poor families-has been compromised and their rights violated, even when codified ethical standards for the protection of individual rights exist (Advisory Commission on Human Radiation Experiments [ACHRE], 1995).

The absence of an effective system of protection for human subjects is a serious defect in the biomedical research enterprise. Federal oversight agencies-the Office of Human Research Protection (OHRP), the U.S. General Accounting Office (1996, 2001), me Office of the Inspector General of the U.S. Department of Health and Human Services (1998,2000)-and the National Biocthics Advisory Committee (2001 ) and the Institute of Medicine (IOM; 2002) of the National Academies have all reported systemic weakness and ethical violations in the conduct of human research. The IOM report concluded:

The evidence is abundant regarding the significant strains and weaknesses of the current system, and this committee has reached the conclusion that major reforms are in order. . . . The existing
regulatory framework . . . cannot adequately respond to the complex and ever-changing research environment, with weaknesses related to gaps in authority, structure, and resources, (p. ES-3-ES-4)

Federal regulations restrict the use of children in research of greater than minimal risk. The regulations define minimal risk as risk on a par with activities ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (45 C.F.R. 46.102(i)). Institutional review boards (IRBs) may approve research involving "greater than minimal
risk" for children only if the research presents the prospect of direct benefit and evidence of a favorable risk/benefit ratio. If there is a "minor increase" over minimal risk and no prospect of direct benefit for child subjects, investigators must provide compelling evidence that the research "is likely" to provide essential knowledge that is of "vital importance" for "the subjects' disorder or condition" (45 C.F.R. 46.406).

The regulations, unfortunately, do not define risk, greater than minimal risk, condition, or benefit. The life safety of human subjects may be undermined by inconsistent and widely disparate interpretations of these regulations (Glantz, 1998). Powerful institutions whose interests conflict with those of research subjects control all facets of research, including the approval process (Angell, 2000; Bodenhcimer, 2000; Kassirer, 2001; Relman & Angell, 2002). Failure to review research proposals from the perspective of the child's best interest, failure to examine alternative treatments
to minimize the exposure of children to research risks, failure to set limits on the level of risk and pain to which a child may legitimately be exposed-all stem from pervasive conflicts of interest. Absence of accountability, dependable enforcement mechanisms, and meaningful penalties invite noncompliance with safety requirements.

Those who have argued that clinical trials involving greater than minimal risk for children are approvable, even without a prospect of direct benefit, claim that failure to test drugs in children harms other children who are prescribed drugs off-label (American Academy of Pediatrics, 1995; Milne, 2001 ). Freedman, Fuks, and Wejer (1993) claimed that "a prohibition on such research involvement would be to the long-term detriment of children, just as a prohibition on new experiences is harmful to children over the long term." Others disagree, pointing out that those making such claims fail to explain why a particular child not participating in nontherapeutic research would be harmed (Ross, 2003). Furthermore, few who claim that the benefits to be gained for all children outweigh the risks for the child subjects ("The Need to Test," 2002) are themselves free of conflicts of interest.

The federal government, through its several advisory panels, such as the National Human Research Protections Advisory Committee (NHRPAC), set about to deconstruct federal regulatory restrictions that were enacted to protect children from exposure to undue risk of harm (Sharav, 2003a). For example, the Children's Workgroup of NHRPAC recommended that the minimal-risk category be broadened: "IRBs need not limit the tests or procedures in the research to those actually used in routine physical or psychological evaluations" (Fleischman, 2002, p. 2). Instead, the work group, composed largely of academic stakeholders-with the exception of one dissenting community representative-favored giving IRBs greater latitude to interpret minimal risk based on their notion of an indeterminate concept they called "equivalence of risk."

Another recommendation would waive parental permission by elevating children's "assent" to the level of informed consent (NHRPAC, 2001). But children who are enrolled in clinical research are not legally authorized to volunteer for experimental research (45 C.F.R. 46.116,408). Children, by definition, are nonconsensual human subjects who require added protections (U.S. Department of Health, Education, and Welfare, 1973). Efforts to circumvent parental authority by elevating the validity of children's assent for research would abrogate the basic legal doctrine of informed consent, which may be exercised by adults only. Substituting assent for parental permission would shift to children the burden of adult responsibility for decisions judged to be in the best interest of the individual child.

The rationale for exposing children to research risks is based on utilitarian ethics, which holds that the sacrifices of the few are necessary to promote the greatest good for the greatest number. The
unanswered question is who has the moral or legal authority to relegate a child to bear the burden of risks posed by toxic drugs for science or for the benefit of others.

Incentives to Experiment on Children

The Food and Drug Administration Modernization Act (FDAMA) of 1997, extended in 2002 by the Better Pharmaceuticals for Children Act, provides enormous financial incentives to pharmaceutical companies, who reap a lucrative 6-month extension of patent exclusivity if they test patented drugs in children. For example, a 6-month patent extension for the antipsychotic drug Zyprexa (sales $3.5 billion) can mean a billion dollars for Eli Lilly ("Eli Lilly," 2003). FDAMA has also stimulated the expansion of pediatrie drug trials at academic institutions (Steinbrook, 2002; Vitiello, 2001). But Congress failed to balance these financial incentives for stakeholders in the drug industry with improved safeguards to protect children, who are not autonomous, from the increased financial pressure to make use of them. Clinical research is a highly profitable venture, as demonstrated by the 600% increase in the number of physicians engaged in clinical drug trials in 1998 compared to a decade earlier (Morin, 2002, p. 78). Physicians who specialize in clinical trials are handsomely rewarded, earning more than $1 million annually. Some have earned as much as $10 million dollars (Eichenwald & Kolatoc, 1999; Steklow & Johannes, 1997; Wilson & Heath, 2001). Contrary to a prohibition in the ethics code of the American Medical Association ( 1994,2000-2001 ), physicians commonly earn fees of $2,000 to $5,000 per child they refer for clinical trials (Dembncr, 2000). Lind (
1990) questioned whether offering financial incentives of such magnitude is ethical.

Since the passage of FDAMA, the number of child research subjects has grown, from about 16,000 in 1997 to about 45,000 in 2001 (Dembner, 2001). The Food and Drug Administration (FDA) acknowledged that before it adopted the Pediatrie Rule (U.S. Food and Drug Administration, 1998), Phase 1 trials in children "had been primarily limited to life-threatening diseases and children who had the disease for which the new drug was being proposed" (U.S. Food and Drug Administration). Since the rule was adopted, child subjects with and without disabilities have been incr\easingly exposed to pain and risk of harm in experiments that may undermine their welfare. The welfare of children-and adults as well-is also undermined by the current IRB system, for it is riddled by conflict of interests (Eichenwald & Kolata, 1999; Kaufman & ju lien, 2000; Lemmens & Miller, in press; Sharav, 2002, 2003a; Whitaker, 1998; Wilson & Heath, 2002). A recent survey by Harvard's Health Policy Institute concluded, "The fact that almost half of all faculty IRB members serve as consultants to industry raises potential conflicts of interest" (Campbell et al., 2003, p. 836).

Even parents may have interests that conflict with those of their children, so their consent does not protect children in the way that an adult's informed consent protects the adult. The radiation commission (ACHRE, 1995) recognized the potential conflict, as did a U.S. Supreme Court ruling: "Parents may be free to become martyrs themselves. But it does not follow that they are free, in identical circumstances, to make martyrs of their children" (Prince v. Maassachusetts, 1944). Recently, two court decisions followed suit (Grimes v. Kennedy Krieger Institute, 2001; TD v. NYSOMMH, 1995). In the Grimes case, the researchers argued that protective standards prohibiting the use of children in greater-than-minimal-risk experiments will deprive children of "an advantage," and that a prohibition on nontherapeutic experiments will be a "lost opportunity to cure a disease"(Maryland Court of Appeals, 200Ia). The court rejected their lost opportunity argument and their hypothesized claim oi future benefits as spurious. Indeed, new drugs are not eliminating diseases-nor are many of them an improvement over older and cheaper drugs (ABC, 2002; Burton, 2002). Expert critics have pointed out that randomized, controlled trials (RCTs) are not designed to prove a drug's safety or effectiveness or to inform clinicians about what is the best treatment at what dose. Healy (2002) has shown that RCTs in pediatrie testing of psychotropic drugs, for example, do not even address scientifically valuable questions. Furthermore, restrictive criteria for selecting human research subjects ("cherry picking") invalidate the generalizability of the findings (Zimmerman, Mattia, & Posternak, 2002). The short duration of most trials and the reliance on self- reporting of adverse effects result in failure to detect uncommon but potentially deadly adverse effects. Widespread failure to report all findings-including negative findings-renders suspect many reports of positive results (Harris, 2003; Klassen, 2002). Drug trials are designed and controlled by sponsors for the purpose of obtaining FDA approval, which requires merely the demonstration of an
effect greater than that of a placebo-which is not necessarily better than an existing treatment. It can be argued that most clinical trials for which children are currently being recruited, then randomized to an experimental treatment or placebo, will not improve their health. Indeed, those who serve as test subjects are at increased risk of harm and discomfort, as documented in a Boston
Globe series reporting how many children suffered and died in unethical clinical trials (Dembner, 2001). Five case examples are presented to illustrate the nature of the ethical dilemmas that surround biomedical research on children.

Case Examples

Case 1: Assessing Lead Abatement

In the first case, investigators at the Kennedy Krieger Institute (KKI) tested the effectiveness of varying degrees of lead abatement to reduce the risks of brain damage "for future generations of children" by exposing 140 infants and children, ranging from 6 months to 4 years of age, to lead dust in partially contaminated houses (U.S. Environmental Protection Agency, 1996). Successful lead abatement was measured by the extent of lead detected in the blood of children from largely African American mothers on welfare. The researchers ignored their own findings from a prior study showing
that even "low levels of blood lead in the range seen in many impoverished inner-city children cause structural alterations" in children's brains. (Wilson, Johnson, Goldstein, & Blue, 2000, p. 5545). The investigators, the Johns Hopkins University (JHU) IRB, and state and federal government agencies justified the risks of lead exposure for these children by invoking a utilitarian rationale, claiming that sacrifices were necessary for the so- called "greater good" (Young, 2001). That rationale failed to persuade the judiciary. In August 2001, the Maryland Court of Appeals (Grimes v. Kennedy Krieger Institute, 2001) issued a landmark decision that both criticized the experimental design and rejected current IRB practices geared more toward accommodating the needs of the researchers than toward protecting the best interests of the child subjects.

The Court's decision cited the Nuremberg Code (1947), the Declaration of Helsinki (1964), and the prevailing "best interest of the child" legal standard. The court went beyond the ambiguously defined
regulatory standards (45 C.F.R. 46) that IRBs had used to justify the experiment. Officials of KKI and IHU argued that the focus of the research was to study buildings, not children; that neither the
researchers nor the institutions had a duty to warn parents of the presence of lead dust in the homes; and that they had no duty to warn parents about the danger of increased lead levels in the children's blood during the 2-year experiment (Roig-Franzia, 2001). The Maryland Court of Appeals summarily rejected all these arguments and sharply rebuked the researchers, the sponsoring institutions, and the IRBs for their failure to abide by the "best interest of the child" standard when they exposed little children to the brain-damaging consequences of increased lead levels in their blood. The court unambiguously criticized "the very inappropriateness of the research itself" (p. 7), a criticism never made by the federal Office of Human Research Protection (OHRP). The court reminded researchers, institutions, and IRBs that they have a "duty of care" for vulnerable  human subjects, such as children and people with mental illness, and ruled that "consent of the parents, or any consent surrogates, in our view, cannot make the research appropriate or the actions of the researchers and the |IRB] proper" (Grimes, 2001, p. 8). The court rejected out of hand the often- invoked rationalization that parental permission absolves researchers and institutions of responsibility for harmful effects suffered by child subjects and criticized the practice of giving enticements such as "trinkets, food stamps, money" to parents. The court set standards for consent and limits on proxy consent and on parental authority to consent for research that places children "in potentially hazardous nontherapeutic research surroundings." Finally, the court nullified the absolute authority of researchers "and their science-based review boards," which, the court noted, are not "sufficiently objective in the sense that they are as sufficiently concerned with the cthicality of the experiments they review as they are with the success of the experiments" (p. 11).

The hostile reaction of the research community to the decision underscores the extreme vulnerability of children in the prevailing biomedical research culture (Maryland Court of Appeals, 200Ia). Indeed, the Maryland Court compared the deliberate exposure of children to lead dust to sending "canaries in the mines" (p. 3) to detect the presence of toxic gases. Only one organization, the Alliance for Human Research Protection, filed an amicus curiae brief in support of the Court of Appeal's decision (Maryland Court of Appeals, 200Ib).

Case 2: Diabetes Prevention Experiments

These trials subject healthy children to invasive, painful glucose tolerance tests before there is evidence of disease or a proven medical intervention in order to prevent diabetes. OHRP (2000) suspended an experiment conducted at the National Institute of Child and Adolescent Human Development (NICAHD) after determining that there was no justification for exposing healthy children to such testing. Although all previous prevention experiments failed, they continue to be conducted. At this stage, diabetes screening tests involve high risk and no foreseeable benefit. In an article titled "Brave New World," Couzin (2003) reported that whereas European scientists are retreating from diabetes prevention experiments, some American clinicians are forging ahead with ever more aggressive experimental strategies that expose children to increased risks without any certainty that these children will even develop diabetes. At Columbia University, children are being exposed experimentally to immunosuppressant therapy (Couzin, 2003)-an extremely risky exploratory intervention that can be justified only for those whose autoimmune system is so overactive as to cause an immune disorder. But the children being exposed to such a radical intervention may, as a result, suffer the consequences of a compromised immune system, which would make them vulnerable to acute infection and to debilitating chronic illness during their entire lives.

These "diabetes prevention" experiments are generating furious debate among immunologists, endocrinologiste, and pediatricians. "How much risk," they ask, "should we tolerate in trying to prevent or stall a disease that may not threaten life for many decades?" "How well must we understand autoimmunity, or a drug's potential hazards, before treating an 8-year-old?" (Couzin, 2003, p. 1162). Dr. Carla Greenbaum, who directs diabetes clinical research warns, "We can't be cowboys on this" (p. 1162). Proponents of radical interventions in children seem oblivious to the sobering lessons to be learned from the hormone replacement therapy debacle (Altman, 2003). Who will bear responsibility for the children subjected to radical exper\imentation who suffer unintended yet predictable harm as a result of diabetes prevention therapies? The approval of these risky experiments lends support to the strict interpretation of existing federal regulations to set limits on the level of risk to which children should be exposed. Additional safeguards are needed to ensure that pediatrie research demonstrates a favorable risk/ benefit ratio with empirical data before approval.

Case 3: Preschool Psychostimulant Drug Trials

Dr. Lawrence Diller (2000) described a case involving a 29-month- olci toddler named Simon. "I was flabbergasted when I later learned from his mother that Simon saw a highly respected child psychiatrist [who prescribed] Lithium, Zoloft, and Risperdal, three psychiatric drugs at once.... I didn't know who felt crazier, Simon or I" (p. A21). Public concern about the increasing number of American children being diagnosed with loosely defined psychiatric disorders, for which 6 million are prescribed a variety of psychoactive drugs (Safer, Zito, & Fine, 1996; Zito et al., 2000; Zito et al, 2003), led to a
series of high-level conferences in 2000 (Sharav, 2003a, 2003b). At a workshop convened by the National Institute of Mental Health (NIMH) and the FDA, the director of the Child and Adolescent Treatment and Preventive Interventions Research Branch of NIMH acknowledged the "diagnostic uncertainty [that] surrounds most manifestations of psychopathology in early childhood" (Vitiello, 2001, p. 983). he also acknowledged that "the impact of psychotropics on the developing brain is largely unknown, and possible long-term effects of early exposure to these drugs have not been investigated" (p. 983).

Inasmuch as objective diagnostic tools in psychiatry do not exist, experts do not agree about the criteria for diagnosing children's behavioral disorders. The rating scales and checklists used do not
qualify as scientifically reliable diagnostic tools. Critics-among them, pediatricians, neurologists, clinical psychologists, and a minority of psychiatrists-suggest that children are often labeled with a psychiatric "disorder," such as attention- deficit/hyperactivity disorder (ADHD), when their behavior may be within the normal range. Not surprisingly, experts do not agree about either the diagnostic criteria or the best method for treating children's behavior disorders (National Institutes of Health, 1998; Sharav, 2003a).

Psychostimulant drugs that are prescribed for ADHD, such as methylphenidate (Ritalin) and amphetamine (Adderall, Concerta), carry risks that go well beyond appetite suppression and sleep disturbance. Stimulants are linked to growth retardation, anxiety, and induced psychotic behavioral episodes in some children (Ravenel, 2002). A recent retrospective study found that 6% of 98 children treated with Ritalin developed psychotic symptoms during treatment (Cherland & Fitzpatrick, 1999). These included paranoia, visual and auditory hallucinations, and bizarre behavior. None were diagnosed with any other psychiatric disorder before or after treatment with Ritalin, and the psychotic symptoms resolved following the discontinuation of stimulant drugs. Some children developed obsessive-compulsive disorder (OCD); others had explosive behavioral outbursts (Kouris,
1998). These problematic behaviors were of sufficient severity to discontinue the drug, whereupon they gradually and completely resolved over 2 to 3 months, with no recurrence of OCD behaviors off
drugs at 1-year follow-up. A case report described a 7-ycar-old boy who developed both explosive episodes of aggressive and violent behavior and OCD behavioral symptoms (Adrian, 2001) coincident with treatment widi Rilalin. When Ritalin was stopped, both the explosive and the OCD behaviors resolved. Doctors reporting these cases stated that behavioral problems were induced by Ritalin rather than being a feature of the underlying clinical disorder. Finally, psychostimulants arc controlled Schedule II drugs that carry a serious risk of addiction (Hyman & Nestler, 1996; Lambert & Hartsough, 1998; U.S. Drug Enforcement Agency, 2000).

Despite the concerns about known and foreseeable serious risks and the absence of scientific diagnostic tools, a controversial experiment was launched in 2000 at the 47th annual meeting of the
American Academy of Child and Adolescent Psychiatry at a session titled "Mew Frontiers in Pediatrie Psychopharmacology" (Greenhill, 2000). The experimental pre-school ADHD treatment study (PATS), a dose tolerance test, is being conducted on children 2 to 5 years old at six academic research centers with NlMH funding. Given the risks, one wonders about the justification that led the IRBs at those centers to approve PATS. Did they consider that the experiment may be used to legitimixe 167% increased stimulant drug prescription for children rather than to improve the children's mental health? (Dobbs,2003).

Cose 4: Spinal Taps

This experiment provides a glimpse into the darker side of current psychiatric research practices involving children who were subjected to pain and risks of spinal taps for nontherapcutic experimental purposes. In 1996, Castellanos et al. reported the results of a 9-week, crossover, multiple-drug experiment replicating their previous research (Castellanos et al., 1994). The 45 boys, ages 6 to 11, had been diagnosed with ADHD and other, equally controversial behavioral disorders, including conduct disorder, oppositional disorder, and mild overanxious disorder. The purpose of the experiment was to test the effect of stimulant drugs (methylphenidate, dextroamphetamine, and placebo) on the ccrebrospinal fluid (CSF) levels of dopamine, norepinephrine, and serotonin in children. The investigators speculated that they might find a correlation between dopamine levels
and hyperactive behavior. However, they admitted that there were no criteria for evaluating whether "high" dopaminc levels in some children were within the normal range of CSP dopamine levels-thus
invalidating possible conclusions.

Castellanos et al. (1996) reported that originally 54 children had been enrolled in the experiment, but 2 who initially agreed later refused the lumbar puncture. Furthermore, 2 children who had previously undergone lumbar puncture "could not be located for rcanalysis" (p. 126) and 4 were omitted from the analysis because CSF was "unobtainable" from them (p. 126). One wonders how many times the children were subjected to the pain of needle jabs in their spine in an effort to obtain CSF, and how the children were prevailed upon to "assent"? Without explanation, the investigators stated, "some subjects worsened on medication compared to placebo" (p. 128). One would want to know how many worsened, in what way, and whether they recovered. It is unclear why the children were subjected to lumbar punctures, because dopamine is excreted in urine and could have been measured without any pain.

This nonthcrapcutic experiment and numerous others like it present serious ethical, methodological, and interpretive problems (Sharav, 2003a). Young children were exposed to considerable pain and unjustifiable risks to test a speculative hypothesis, not a potential therapeutic treatment to help them. The investigators failed to demonstrate that the information they sought was in the children's
best interest or "unprocurable by other means," as required by the Nuremberg Code (1947).

Case 5: Antidepressants

Since their introduction, antidepressant drugs of the selective serotonin re-uptake inhibitor (SSRIs) class have generated controversy. case reports linked these drugs to severe adverse effects, including "restlessness, extreme agitation and self- destructive impulses and behaviors" (Anderson, Segman, & King, 1995, p. 48). Industry and institutional psychiatry vehemently denied the drugs' hazards for some patients, dismissing reports of suicidal behavior in adults (Crcaney, Murray, & Healy, 1991; Teichcr, Glod, & Cole, 1991; Wirshing et al., 1992) and children (King et al., 1991) as anecdotal. They proclaimed these drugs to be safe and effective, with few side effects (Cowley, Springen, Leonard, Robins, & Gordon, 1990), and declared the suicides a consequence of depression, not the drugs. Aggressive marketing of these "magic bullets" has generated $12 billion in SSRl sales in 2002, a 73% increase since 1998 (Dobbs, 2003).

However, recent independent analyses of unpublished company data submitted to the PDA during the licensure process that had been concealed from published reports (Boseley, 2003) have contradicted those efficacy claims. In controlled clinical trials, SSRIs failed to demonstrate greater efficacy than placebo or older antidcpressants (Geddes, Freemantle, Mason, Eccles, & Boynton, 2000). The high 33% to 85% dropout rate during short-term trials suggests that subjects experienced intolerable adverse effects (Healy, 2003). The unpublished evidence confirms earlier case reports of drug-induced severe adverse effects in adults and children (Healy, 1997b, 2000; Moore, 1997; Pfizer, 1997). Some suffered prolonged, severe drug withdrawal symptoms (Black, Shea, Dursun, & Kutcher, 2000), others became violent or driven to suicidal acts (Boseley, 2003; GlaxoSmithKline, 2003; Khan, Warner, & Brown, 2000; Kirsch, Moore, Scoboria, & Nicholls, 2002; U.K. Department of Health, 2003)-even patients who had not previously shown suicidal tendencies (Healy,2000).

Critics who analyzed the clinical trial data submitted to the PDA concluded that SSRIs are "among the most toxic drugs in widespread use as measured by the number, variety, and severity of adverse
effects" (Moore, 1997). Indeed, a recently published study from Yale suggests that up to 8% of patients admitted to psychiatric emergency facilities may suffer from SSRI-induced mania or psychosis (Preda, MacLean, Maxure, & Bowers, 2001). But the public and physicians have been grossly misled to believe that SSRIs ar\e completely safe and effective, leading doctors to prescribe them widely not just for depression but also for an array of nonmedical "conditions," such as shyness (Glenmullen, 2000; Healy, 1997a). Even irritable babies are prescribed antideprcssants (Grinfeld, 1998).

Pharmaceutical companies, PDA officials, and the investigators who had access to the data must have known that clinical trials failed to demonstrate the effectiveness of SSRIs when compared to placebo. Dr.Robert Temple, director of the Office of Drug Evaluation at the FDA, acknowledged "the preponderance of negative studies of antidepressants in pediatrie populations" (U.S. Food and Drug Administration, 2000). All but one pediatrie study resulted in negative findings. That much publicized study by Emslie et al. (1997) claimed that "fluoxetine treatment was superior to placebo in
relieving depressive symptoms" (p. 1031). However, the differential between fluoxetine (Prozac) and placebo for complete remission was only 8%. Emslie ct al.'s claim that "side effects, as a reason for
discontinuation, were minimal, affecting only 4 patients who were receiving fluoxetine" (p. 1033) does not account for the 37.5% dropout rate. Furthermore, those 4 children (8.3%) suffered "manic
symptoms" and "severe rash" (Cohen, in press), not minor effects.

FDA officials also knew that despite efforts to exclude suicidal patients from clinical trials, suicide preoccupation, attempts, and completion among patients testing the drugs occurred with disturbing
frequency, far exceeding the incidence in patients on placebo. Healy (2000) reported that the risk of suicide existed whether the test subjects were depressed or not-even healthy volunteers became suicidal after taking an SSRI for only 2 to 3 weeks. Khan et al. (2000), for example, found that among 19,639 patients tested on seven SSRIs, 34 patients had committed suicide and 130 attempted suicide. Of these, only 2 patients who committed suicide were in the placebo arm, as were 15 of the 130 suicide attempters.

In june 2003, the public learned about concealed evidence from nine pediatrie trials of paroxetine (Paxil) in 1,000 children revealing that the drug was of no benefit for depressed children but posed a
two- to threefold increased suicide risk compared to placebo. Public disclosure of these findings prompted the British government to ban Paxil for use in children under 18 (Bosley 2003; U.K. Department of Health, 2003), the FDA issued a warning about the potential risk on its Web site, and GlaxoSmithKline (2003), Paxil manufacturer, then Wyeth (2003), manufacturer of venflaxamine (Effexor), issued letters of warning to physicians acknowledging the suicide risk and lack of drug efficacy in children. Revelations such as these raise serious doubts about the veracity of clinical trial reports relating to SSRIs and possibly other psychotropic drugs.

Unpublished reports to the FDA reveal that dose tolerance ("forced titration") tests pushed children's endurance, triggering severe adverse events (SAE), including suicidal behavior. A Pfizer (1997) report about sertraline (Zoloft) forced titration tests defined SAEs as "events which were fatal; life-threatening or potentially life- threatening; resulted in permanent disability; required hospitalization or prolongation of hospitalization .. . a drug overdose or suggested significant hazard to the patient" (p. 27). The report described a 51-day open-label forced titration study in 61 children (ages 6-12 ) and adolescents (ages 13-17) who were recruited to test the pharmacokinetics of and tolerance to Zoloft after single and multiple doses. Of these 61 children, 44 were diagnosed with depression and 17 with obsessive-compulsive disorder (OCD). During the first 4 weeks of the trial, the children's dose was increased to 200 nag-a dose higher than was tested in adult trials. Pfizer reported, "the mean maximum daily dose of sertraline was considerably higher in the paediatric studies (185 mg) than in the adult OCD studies (148 mg) ... due to the design of the paediatric studies" (p. 31). In healthy adult volunteers, a 200-mg dose induced nausea, vomiting, diarrhea, giddiness, restlessness, tremor, and lockjaw, producing marked "deterioration" (p. 241) in their cognitive function and emotional stability (Saletu, Grunberger, & Linzmayer, 1986). The rationale for exposing children to a higher dose and, hence, to greater risks than adults remains unclear.

Pfizer (1996) reported to the FDA that among the group of 44 depressed children testing Zoloft, 4 attempted suicide-a rate of 9%. Among these, an 8-year-old boy (Patient 4) who had been in the trial
for 36 days "was hospitalized for a suicide gesture, and dropped from the study. The patient #4 mutilated himself by cutting his feet with a razor blade and tying a tie around his neck" (p. 23, Table 1). Pfizer's report acknowledged no previous history of self- mutilation or suicidality, and "the event was attributed to study drug by the investigator" (p. 23). The published report declared, "Despite forced titration to 200 mg/day... sertraline was well tolerated by both child and adolescent patients." (Alderman, Wolkow, Chung, & Johnston, 1998, p. 393).

The rationale given for testing psychotropic drugs on children is their widespread overprescription by physicians without evidence of their safety in children. Arguably, the solution for overprescription is not to expose additional children to the very drugs that pose risk of harm-especially in the absence of credible evidence demonstrating beneficial effects greater than placebo. In fact, compelling clinical evidence from a recent chart review of Massachusetts General Hospital clinics shows that 74% of children prescribed any one of the popular SSRIs had suffered an adverse effect. Wilens et al. (2003) found that 22% of children had suffered severe psychiatric adverse effects (PAE), and 44% suffered an additional PAE when re-exposed to the drug after withdrawal. Even those who promote these drugs acknowledge the absence of outcome data following long-term exposure. The possibility that antidepressant drugs produce permanent neurological damage with long- term use is especially troubling as regards children, whose brains are still developing (Coyle, 1997, 2000).

A front-page article in the New York Times on August 7, 2003, reported that the safety of SSRIs was once again being debated and that 7 out of the 10 experts who in 1991 served on PDA's advisory panel that cleared SSRIs of triggering suicide said they would now reconsider their decision (Harris, 2003). Dr. Robert Fricdman (2003), director of the psychopharmacology clinic at Cornell University conceded that drug company manipulation resulted in "publication bias," which "has a profound impact on medical practice," giving doctors a "distorted impression about the safety and efficacy of new medications." Friedman further acknowledged that "government approval is not a guarantee of safety" (p. A-17).

Conclusion and Recommendations

The weight of the evidence supports the thesis of this article. Unchecked pharmaceutical industry influence has undermined the integrity of academic medical research, the integrity of PDA's drug review and approval process, and the integrity of the scientific literature on which clinicians have relied to guide their practice. Prior to FDAMA, children were protected under federal regulations prohibiting their recruitment for experiments that were not in their best interest. The financial incentives of FDAMA have generated an explosion of pediatrie clinical drug trials, but the direct beneficiaries of these experiments are not the children who served as human subjects. Child subjects arc often risk bearers rather than beneficiaries. Undoubtedly, those who benefit are drug manufacturers and the research stakeholders whom they finance.

The following recommendations would protect children with and without disabilities from exposure to unjustifiable risk of harm in experiments that jeopardize their best interest:

1. Restrict the use of children in medical experiments involving greater than minimal risk unless the potential benefit to them or their condition justifies the risk. Thus, only children whose currently diagnosed medical conditions could be helped should be recruited to test drugs or other medical devices or procedures.

2. Establish independent Child Protection Committees to monitor recruitment, assess the reasonableness of their parents' permission, assess the adequacy of disclosure in the informed consent process, and monitor the child's continued willingness to participate, thereby ensuring that child subjects are not exploited.

3. Identify specific, scientifically demonstrable risk factors as likely predictors of disease in the children being recruited, ensuring that current best medical practice standards of treatment will be compared to any new or experimental treatment.

4. Prohibit conflicts of interest, such as recruitment fees to physicians or parents.

5. Establish a registry of all pediatrie clinical trials, requiring mandatory reporting of serious adverse effects, and mandate long-term monitoring for adverse effects.

6. Ensure that selection of child subjects does not place an unfair burden on disadvantaged fami lies who do not have healthcare coverage.

7. Impose stiff penalties when foreseeable risks have not been disclosed or informed consent requirements have been violated.

8. Ensure every child subject protection by nofault insurance coverage against possible harm arising from or in the course of research.

9. Prohibit the use of children in trials of treatments not intended for children.

10. Require licensure of researchers who conduct research on human subjects, including specialization in pediatrie research, to ensure their proficiency in both medical ethics and standards of medical practice.

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Vera H. Sharav, Alliance for Human Research Protection

ABOUT THE AUTHOR

VERA H. SHARAV, MLS, is a professional law librarian turned public advocate for human rights. She is the founder and president of the Alliance for Human Research Protection (AHRP), which serves as a public interest watchdog organization to protect the life safety of human subjects in biomedical and behavioral research. The AHRP database, which tracks ethical violations in research, is used extensively by researchers and investigative reporters. Address: Vera H. Sharav, 142 West End Ave., Apt. 28P, New York, NY 10023.

 

Contact: Julio Licinio
licinio@ucla.edu
310-825-7113
Molecular Psychiatry
Thimerosal, found in childhood vaccines, can increase the risk of autism-like damage in miceA new study indicates that postnatal exposure to thimerosal, a mercury preservative commonly used in a number of childhood vaccines, can lead to the development of autism-like damage in autoimmune disease susceptible mice. This animal model, the first to show that the administration of low-dose ethylmercury can lead to behavioral and neurological changes in the developing brain, reinforces previous studies showing that a genetic predisposition affects risk in combination with certain environmental triggers. The study was conducted by researchers at the Jerome L. and Dawn Greene Infectious Disease Laboratory at the Mailman School of Public Health, Columbia University.
Over the past 20 years, there has been a striking increase--at least ten-fold since 1985--in the number of children diagnosed with autism spectrum disorders. Genetic factors alone cannot account for this rise in prevalence. Researchers at the Mailman School, led by Dr. Mady Hornig, created an animal model to explore the relationship between thimerosal (ethylmercury) and autism, hypothesizing that the combination of genetic susceptibility and environmental exposure to mercury in childhood vaccines may cause neurotoxicity. Cumulative mercury burden through other sources, including in utero exposures to mercury in fish or vaccines, may also lead to damage in susceptible hosts. Timing and quantity of thimerosal dosing for the mouse model were developed using the U.S. immunization schedule for children, with doses calculated for mice based on 10th percentile weight of U.S. boys at age two, four, six, and twelve months.

The researchers found the subset of autoimmune disease susceptible mice with thimerosal exposure to express many important aspects of the behavioral and neuropathologic features of autism spectrum disorders, including:

Abnormal response to novel environments;
Behavioral impoverishment (limited range of behaviors and decreased exploration of environment);
Significant abnormalities in brain architecture, affecting areas subserving emotion and cognition;
Increased brain size.

These findings have relevance for identification of autism cases relating to environmental factors; design of treatment strategies; and development of rational immunization programs. The use of thimerosal in vaccines has been reduced over the past few years, although it is still present in some influenza vaccines. Identifying the connection between genetic susceptibility and an environmental trigger for autism--in this case thimerosal exposure--is important because it may promote discovery of effective interventions for and limit exposure in a specific population, stated the lead author Dr. Mady Hornig. Because the developing brain can be exposed to toxins that are long gone by the time symptoms appear, clues gathered in these animal models can then be evaluated through prospective human birth cohorts--providing a powerful to tool to dissect the interaction between genes and the environment over time.


Citation source: Molecular Psychiatry 2004 Volume 9, advance on line publication doi:10.1038/sj.mp.4001529
For further information on this work, please contact Mady Hornig, MD, Columbia University, Mailman School of Public Health, Greene Infectious Disease Laboratory, 722 W 168th St, New York, New York 10032, United States of America, phone: 212-342-9036; FAX: 949-824-1229; e-mail: mh2092@columbia.edu
ARTICLE: "Neurotoxic effects of postnatal thimerosal are mouse strain-dependent"
M Hornig, D Chian, W. I. Lipkin
Greene Infectious Disease Laboratory, Mailman School of Public Health, Columbia University, 722 W 168th St, New York, New York 10032
----------------------------------------
Molecular Psychiatry is published by the Nature Publishing Group.
http://www.nature.com/mp
Editor: Julio Licinio, M.D.; phone: 310-825-7113; FAX: 310-206-6715; e-mail: licinio@ucla.edu
----------------------------------------
 

"Robert Cohen"
Subject: How Dairy Lies Become Truth

Time morphs dairy lies into myths based upon biased research. Dairy dollars become print advertisements and television commercials distorting truth to a trusting and naive public.

Here is a prime example. Why does dairy consumption prevent diabetes and obesity? The Journal of the American Medical Association (JAMA) let this biased and statistically distorted paper slip through their review process. Perhaps Elsie the Cow did the actual peer-reviewing in the April 24, 2002 issue of JAMA. On page 2059 of that same issue, the journal lists their ethical objectives:

"The Journal has a social responsibility to improve the total human condition and to promote the integrity of science."

"To report American Medical Association policy, as appropriate, while maintaining editorial independence, objectivity, and responsibility."  The severely flawed JAMA study in question was funded by General Mills, who conveniently owns Haagen Dazs Ice Cream, Yoplait Yogurt, and Wheaties and Cheerios. Conflicts of interest? You decide. I've discovered an enormous and unbelievable flaw in this so-called research.

A sample of 3,157 males were included in the study. Diets were compared to diabetes rates. In order to assess an association between disease and dairy consumption, the authors placed restrictive guidelines that compromised their conclusions. The study is so flawed that it is laughable.
When I read the author's words on page 2082, I wanted to cry:

"We identified dairy products as any items reported during the diet history interview that were either 100% dairy (eg, milk) or included dairy as one of the main ingredients (eg, dips made with sour cream). We did not include mixed dishes."

I was astounded.

When I spoke with the senior author (Pereira), I asked:

"You did not include pizza?"

He responded:

"No."

"Macaroni and cheese?"

"No."

"Milk and cereal?

"No. The grains would have compromised the glycemic index."

"Don't you realize that half of the 170 billion pounds of milk produced in America go towards making pizza?"

He was surprised.

"I didn't know that."

I told Pereira that in 1970, the average American ate ten pounds of cheese, and that last year, the average American ate 31 pounds. It takes ten pounds of milk to produce one  pound of hard cheese.

"Cheeseburgers?"

"No."

"Chicken parmagiana?"

"No."

"Cakes, cream cheese on bagels, milkshakes, cream sauce, cheese sauce, milk chocolate?"

"No, no, no, no, no, no!"

The terrible thing is that the media reports just one thing, because reporters are spoon-fed lies at press conferences:

"Dairy prevents obesity and diabetes."

The terrible thing is that those dairy products which cause obesity and diabetes were not even taken into account by the well-funded biased scientists.

Here's obesity information:

http://www.notmilk.com/f.html

Here's diabetes information:

http://www.notmilk.com/d.html

The dairy industry does everything in their power to promote lies and distortions. They spend millions of dollars on advertising, supported by friendly newspapers and magazines who nurture and spread the lies with dairy-supplied fertilizer. Stories are written and delivered in press kits. You read the same stories and become well meaning authorities of the lie.

Robert Cohen
http://www.notmilk.com
201-967-7001