By David Brown
Washington Post Staff Writer
Wednesday, June 19, 2002; Page A01
Antibiotic prescriptions for children fell by 40 percent over the course of the 1990s, reversing an upward trend that had fueled the emergence of hard-to-treat, drug-resistant bacteria, researchers reported yesterday. The dramatic reversal was seen across the spectrum of common ailments of childhood, including ear infections, sore throats, bronchitis and miscellaneous respiratory infections. It was seen in all ways that drug prescribing is gauged -- total number of prescriptions, prescriptions per child and prescriptions per trip to the doctor.
The change follows numerous public health campaigns aimed at doctors and parents, widespread media coverage of "super-bugs" and a few documented examples of death from bacterial infections that once would have been easily cured. "It's a dramatic decline," said Linda F. McCaig, an epidemiologist at the National Center for Health Statistics, the organization that regularly surveys the prescribing behavior of American physicians. "It's encouraging that parents and physicians may be getting the message about how to use antibiotics appropriately."
The national survey results appear in today's Journal of the American Medical Association. Accompanying them is a report on a successful 1997 campaign to lower antibiotics use in Knoxville, Tenn., the American city with the highest per capita use of prescription drugs in the country. That campaign featured a number of strategies, including lectures to doctors and handouts to parents of newborns. It produced a drop in antibiotic prescription-writing over the next two years that was more than double that seen in three other Tennessee cities -- 19 percent vs. 8 percent.
"We think this can serve as a model for community-wide interventions in other places," said Allen S. Craig, Tennessee's state epidemiologist. Neither the national nor the local study measured the effects on children's health -- good or bad, or none at all -- from the decline in antibiotic use. However, in Knox County (Knoxville and its suburbs), there was no increase in serious infections from Streptococcus pneumoniae -- the most common bacterial pathogen in young children -- said Stephanie Hall, the county health officer. There also wasn't a decrease in the prevalence of drug-resistant strains of the bacterium, although that is likely to take longer to occur.
Most antibiotics used in the United States are prescribed in doctor's offices. Usually they are for infections for which the practitioner isn't certain what microbe is responsible. The proliferation of antibiotics, and the cultural perception that taking them is the safer course in situations of uncertainty, has led to a steady rise in their use over the last 30 years, peaking in 1992. At that time, American children under age 15 got, on average, one antibiotic prescription a year. Many studies have shown, however, that when definitive diagnostic tests are performed, most upper respiratory infections are caused by viruses, not bacteria. Viruses are not killed by antibiotics.
Several experts said it is unclear whether the decline seen in the two studies will last. "We know from the experience in other countries that when you are on top of things, you can control prescribing," said Stuart B. Levy, a physician at Tufts University School of Medicine, who founded the Alliance for Prudent Use of Antibiotics in 1981. "But once you leave, there's a great temptation to go back to the old behavior. So, reminders will be needed."
In the National Ambulatory Medical Care Survey, about 3,000 office practitioners are asked to record patient visits, and what they prescribe, for a week. The sample is chosen to represent the country statistically.
In the 1989-1990 survey, the average annual number of antimicrobial drugs prescribed in offices to children under age 15 was 45.5 million. In 1999-2000, it was 30.3 million. The rate of prescription per 1,000 visits fell from 838 to 503 -- a decrease of 40 percent. The rate at which trips to the doctor by children resulted in antibiotic prescriptions fell from 330 per 1,000 visits to 234 per 1,000 visits -- a decrease of 29 percent.
This last measure is the best window on what is happening in the doctor's office -- where a complicated interaction of the patient's ailment, the physician's judgment and knowledge, and the parent's expectation determines behavior, McCaig said. The Knoxville campaign began after three children in a day-care center in nearby Morristown developed meningitis caused by multi-drug-resistant S. pneumoniae in one week in 1996. One died.
A physician from the Centers for Disease Control and Prevention was invited to talk to 150 key physicians in Knox County. Prescribing guidelines were sent to 250 doctors, 40,000 pamphlets were given to parents of toddlers and young grade-schoolers, and 53,000 pamphlets were handed out to pharmacy customers.
© 2002 The Washington Post Company
Think about this:
a. The number of physicians in the US is 700,000.
b. Accidental deaths caused by Physicians per year is 120,000.
c. Accidental deaths per physician is 0.171. (US Dept. of Health & Human Services)
Then think about this:
a. The number of gun owners in the US is 80,000,000.
b. The number of accidental gun deaths per year (all age groups) is 1,500.
c. The number of accidental deaths per gun owner is .0000188.
Statistically, doctors are approximately 9,000 times more dangerous than
FACT: NOT EVERYONE HAS A GUN, BUT ALMOST EVERYONE HAS AT LEAST ONE DOCTOR.
When Modern Medicine Fails
By Charles Krauthammer
Friday, July 12, 2002; Page A21
In "Sleeper," Woody Allen wakes up a couple of hundred years in the future to discover, among other things, that scientists have found that tobacco is actually good for you. Well, not quite yet. But how about eggs? After years of egg phobia, we have learned that eggs may not be bad for you after all. And that butter is healthier than stick margarine. Every month, it seems, some accepted nutritional fact is overturned.
We have come to expect that diet fashions, though promulgated with scientific authority, change like the seasons. What we do not expect is a change in hormone fashions. Hence the shock this week when a massive study of hormone replacement therapy in postmenopausal women had to be halted three years early because the estrogen-progestin combination appeared to cause an alarming increase in invasive breast cancer, blood clots, strokes and heart attacks.
With that, the decades-old medical axiom about the protective powers of hormonal therapy was overturned in a flash. The reverberations were immediate. The company whose pill was being tested, Wyeth Pharmaceutical, lost 24 percent of its value in one day. Millions of women are now frantically calling their doctors for advice on whether to continue.
Most shocking, perhaps, is the simple reminder of how contingent are the received truths of modern medicine. We know how pre-modern medicine got it wrong, from centuries of leeching and bleeding to the lobotomies and shock therapies that destroyed the lives of so many psychiatric patients in the mid-20th century. But we think of modern science as infinitely more enlightened and more solid.
Not so. Less than a century ago, the most exalted scientific theory, Newtonian mechanics, was overthrown. Today its successors, general relativity and quantum mechanics, have yet to be fully reconciled. Thirty years ago, the scientific consensus was that we were headed for global cooling. Today it is global warming. The only thing I feel reasonably sure about is that 30 years from now meteorological science will have delivered yet a new theory, a new threat, a new thrall.
The problem is that even the most sophisticated scientific studies are limited by method, by modeling, by sampling and by an inevitable margin of error. Hence error and revision. In medicine, because its solemn pronouncements are so widely propagated and so ingrained in people's lives, these revisions are particularly shocking. Yet common. When I was a kid, everyone got a tonsillectomy. It was a rite of passage. We now know that this was unnecessary surgery, indeed, worse than useless. We also routinely were given antibiotics for earaches. It now turns out that this did not hasten recovery, and in fact may have made us, and the population in general, more resistant to antibiotics.
For decades, breast cancer was treated with radical mastectomy, a disfiguring and deeply invasive surgery. The idea that many patients should instead be treated with lumpectomy was ridiculed for decades. It is now accepted medical practice. My favorite myth is 98.6. If there was anything solid in my medical education, it was that mean body temperature was 98.6 F. Well, in 1992 the Journal of the American Medical Association published a study that actually measured it. It turns out to be 98.2 degrees. Where did the 98.6 come from? From the German doctor, Carl Wunderlich. In 1868. No
one had bothered to check it since then.
The myths go on and on. That infectious diseases had been conquered. (Then came HIV.) That asthma is a psychological condition. That ulcers are caused by stress or stomach acid. For decades at mid-century, at the height of the psychoanalytic fad, the cream of the New York intelligentsia was sending its healthy children to five-day-a-week psychoanalysis.
So much nonsense. So much damage. Yet science has a hard time with humility. The rage today is regenerative medicine. Stem cells. Cloning. The growing, essentially, of replacement parts. It sounds wonderful, and it may yet turn out to be.
It is well to remember, however, that this is not the first panacea to be peddled. Yesterday, it was fetal tissue transplants for degenerative diseases and angiogenesis inhibitors for the cure of cancer. All of which looked wonderful on paper but have not panned out. This is not to say that this embryonic research will not pan out. It is only to say that when you hear Sen. Dianne Feinstein tell you that the research cloning her bill would promote will do wonders for your suffering Aunt Sarah, hold on to your wallet. She's talking about the speculative benefits from the most speculative of new technologies --at a time when, until yesterday, science could not tell us the effects of existing postmenopausal hormone therapy on known medical conditions. For now, I'll put my money on Woody Allen. "Sleeper" discovers that hot-fudge sundaes turn out to be good for you too.
© 2002 The Washington Post
NEW YORK (Reuters Health) Oct 07 - One in 10 children who are treated in the emergency department (ED) may get the wrong dose of medicine or be given medication at the incorrect frequency, new study findings suggest. Children seen between 4 AM and 8 AM, children with severe disease and those seen on weekends were between 1.5 and 2.5 times more likely to experience a medication prescribing error than others, lead author Dr. Eran Kozer, from the Hospital for Sick Children in Toronto, and colleagues note.
In their paper in the October issue of Pediatrics, Dr. Kozer and colleagues note that between 44,000 and 98,000 people die each year in the US as a result of medical errors. And prescribing errors, they note, occur most frequently in pediatric patients and EDs.
Dr. Kozer's team reviewed the medical records of 1532 children treated in the ED of a pediatric hospital. Two pediatricians independently decided whether a medication error had occurred and gave errors a numerical severity score.
"Prescribing errors were identified in 10.1% of the charts," the researchers report.
"The most common types of prescribing errors were dosing errors, followed by drugs given with incorrect frequency," they add.
Drugs most commonly implicated in prescribing errors included acetaminophen, antibiotics, asthma medications and antihistamines.
"Our findings suggest that errors are more common among seriously ill patients and that trainees are more likely to make medical errors, particularly at the beginning of the academic year," the authors write.
"Future research should focus on the development and evaluation of strategies to reduce medication errors in the pediatric emergency department," they conclude.
Annu. Rev. Public Health 2002. 23:135-150.
MORBIDITY AND MORTALITY FROM MEDICAL ERRORS: An
Increasingly Serious Public Health Problem
David P. Phillips and Charlene C. Bredder
From 1983 to 1998, U.S. fatalities from acknowledged prescription errors increased by 243%, from 2,876 to 9,856. This percentage increase was greater than for almost any other cause of death, and far outpaced the increase in the number of prescriptions. Many nonfatal prescription errors also occur, but estimates of the frequency of these errors vary widely, because various definitions, geographic settings, and institutions have been used. Efforts to reduce fatal and nonfatal prescription errors have encountered perceptual, legal, medical, and cultural barriers. It may be possible to reduce prescription errors by instituting a central agency responsible for collecting, analyzing, and reporting harmful or potentially harmful drug events, and for issuing recommendations and directives.
GANGSTERS IN MEDICINE
By Thomas Smith
December 23, 2002
The Journal of the American Medical Association recently reported that as many as 106,000 deaths occur annually in US hospitals due to adverse reactions to prescription drugs that are properly prescribed by physicians that use them as directed by the drug companies. Even worse, the National Council for Patient Information and Education reported that an additional 125,000 deaths occur annually due to adverse reactions to drugs that the physician never should have prescribed. In these deaths the doctor did not follow the instructions on proper administration of the drugs. For example, Glucophage, a diabetic oral hypoglycemic, should never be prescribed for patients with Kidney disease or Congestive Heart Failure because it can cause fatal Lactic Acidosis in these patients. A warning label is prominently placed on the medication container to warn of this potential misuse.
However, JAMA reported that almost 1/4 of the patients who had been prescribed Glucophage had Kidney damage or Congestive Heart failure or both. The annual death toll from synthetic prescription drugs, both from the correctly prescribed and the incorrectly prescribed, amounts to about 231,000 deaths every year. To put this into perspective, this is the equivalent of a world trade center disaster every week for over a year and a half or the crash of two fully loaded 747 aircraft every day of the year.
No information was reported on the number of outpatient and doctor's office deaths caused by these very same drugs when prescribed by these very same doctors. The reported figures alone, however, make drug deaths caused by physicians the third leading cause of death in the US. It is far ahead of accidents, drunk driving, homicides, airline accidents, as well as all other disease with the sole exceptions of cancer and heart disease. Many of these drugs responsible for the death statistics cited are diabetic drugs. None of these drugs cure or even were intended to cure diabetes.
During the time a patient is on the drugs his body is suffering great damage due to the uncontrolled progress of the disease. This is in addition to the risk and damage caused by the drug itself.
According to Dr. Mendelsohn, author of "Confessions of a Medical Heretic", 2.4 million unnecessary operations are performed every year and they cost over 12,000 lives. When the records of six New York hospitals were examined it was found that 43% of the Hysterectomies that were performed were medically unnecessary. No one should ever submit to any surgical procedure without first obtaining several unrelated medical opinions, at least not here in the United States. Women are particularly vulnerable to this type of victimization.
Disease in America
According to the World Health Report 2000 the United States ranks twelfth, that is second from the bottom, in their thirteen country survey of sixteen available health indicators. We are dead last for low birth weight and neonatal and infant mortality. We rank between ninth and twelfth for all life expectancy categories between one year and 40 years. Another study ranked the United States as fifteenth in the twenty-five industrialized countries studied.
Diabetes, Hypoglycemia, Hyperinsulinemia are so widespread in the United States that it is estimated that over half the population exhibits one or more symptoms of these life destroying diseases. Symptoms of Adult onset diabetes are now being routinely noted in six year old children. Obesity and it's related Endocrine dysfunction are commonly observed in teenagers. Heart Failure, a symptom of advanced Type II Diabetes, remains in the top three killer diseases in the Westernized countries. Although the cause and cure for Type II Diabetes and related endocrine failure has been increasingly well understood in the scientific community for the last forty years, this disease is not being cured by todays orthodox treatment regimens. In order to find a cure it is necessary to seek alternative medical approaches to this disease.
Some of the economics of Medicine
A large part of this medical disaster that the United States currently experiences is due to the way our medical community is organized. Basically it is not organized to heal and to cure disease; the medical community, particularly at its upper levels, is a commercial venture organized to make money for its practitioners.
Although the record of the United States Medical community in the cure of disease is deplorable, the same cannot be said for its ability to produce income and profit. For example, for the top fifteen pharmaceutical companies, including such names as Abbot, Wyeth, Hoffman-La Roche, Merck and others, the second quarter revenue for 2002 was reported as $63,520.6 million and the corresponding reported income was 11,731.8 million respectively. This is second only to the defense industry in the United States. In 1997, the latest year for which we have the figures, the earnings of physicians were reported by Broad as averaging around $200,000 per year. The lowest reporting specialty, Rheumatology reported $158,500 and the highest, cardiovascular surgeon, reported $363,300. When examining the numbers, we noted that the high salaries seemed to be concentrated in members of the AMA. Those belonging to less powerful trade unions did not fare nearly so well even though they did most of the actual patient care work. For example, the median staff salary of registered nurses was $35,256
The Cardiac surgeon, for example, does nothing whatsoever to cure cardiac disease. Three to five percent of the heart surgery patients die on the operating table. Cardiac surgery provides no better three year survival rate than no treatment at all. A Harvard survival study of 200,000 patients revealed that the long term survival rate of patients subjected to surgery was no better than the survival rate of those that had no surgery. Of course, your cardiac surgeon will not tell you this when you need to make a decision on whether or not to elect cardiac surgery. Never in history have so many accumulated so much wealth for providing their customers or clients or patients with so little real benefit.
Exceptions to the rule
Many doctors of integrity are as much victims of the system as are their patients. Todays doctor is not free to treat disease as his conscience dictates. He is forced to administer approved protocols whether they are known to work or not. To deviate from these approved protocols invites law suits, peer criticism and censure from State medical licensing boards. This writer knows of two local doctors who tried to buck the establishment and really help their patients. Both lost their license to practice medicine. One is currently working as an administrator in a California hospital and the other has started a nutritional clinic.
Takeover of the American medical Association
This sad state of affairs is directly traceable to the takeover of the American Medical Association by the Carnegie and Rockefeller foundations in the early part of the twentieth century. At the turn of the century the medical community was in a sad state of disrepair. There were no qualifications to become a doctor. If one wanted to be a doctor it was only necessary to hang out a shingle and start the practice of medicine. Medical schools were poorly financed, often taught contradictory medical philosophies and had little impact on the practice of medicine. In 1910 the American Medical Association, todays AMA, was on the verge of bankruptcy. Few doctors belonged to it and even fewer paid any attention to it. Quackery of all kinds was rampant. The market was flooded with fake cancer cures and 80 proof liver tonic.
It was in this environment that Rockefeller and Carnegie moved in and bought the AMA and then used it to take control of the entire United States medical establishment. In 1910, Henry Prichard president of the Carnegie foundation, bought control of the AMA for the sum of $10,000. He then financed the publication of the Flexner report, as it was then called, to gain popular support for the changes that were to be made in the medical community. With public backing secured by the publication of the Flexner report, Carnegie and Rockefeller commenced a major upgrade in medical education by financing only those medical schools that taught what they wanted taught. Predictably, those schools that had the financing churned out the better doctors.
In return for the financing, the schools were required to teach course material that was exclusively drug oriented. That is why today our doctors are so heavily biased toward synthetic drug therapy and know little or nothing about nutrition. Dr. David Edsall, former dean of Harvard medical school, said "I was, for a period, a professor of Therapeutics and Pharmacology, [at Harvard] and I knew from experience that students were obliged then by me and by others to learn about an interminable number of drugs, many of which were valueless, many of them useless, some probably even harmful...."
For a time, these changes actually improved the practice of medicine in the United States. Then, as the distorted medical curriculum began to churn out doctors whose only concern was prescribing synthetic drugs, things began to deteriorate into what we see today. Today the average medical doctor receives 3 hours or less training on nutrition despite the fact that our bodies are constructed entirely of what we eat and drink. Todays doctor receives much of his ongoing education from detail men. The detail man is the drug company salesman whose job it is to teach the doctor how to use the latest drugs.
Treatment instead of cure
Even with all of this history the medical doctor retained a great deal of his autonomy through the 1930's and into the late 1940's. In 1949 another major change took place in the medical community that set the stage for the disaster we see today. It was in 1949 that the medical community reorganized itself into the competing medical specialty groups we see today. Prior to 1949 a doctor was a doctor; he dealt with all disease and injury. After 1949 this was not so. The reorganization established many of the specialties that we know today. It was then that the Cardiac Specialist, the Endocrinologist, the Hepatic and Biliary Specialist and many other professional specialty groups were formed. The symptoms of the then raging epidemic of Type II Diabetes were divided among the specialty groups so that each group had their own set of proprietary symptoms.
The story given out for the reorganization was that it would help to focus more attention on the then current Diabetes epidemic. However, in practice it caused the entire medical community to treat their own proprietary symptom set and nobody focused on curing the disease anymore. This was the origin of the "treat the symptom" and "ignore the cause" philosophy that now dominates the entire medical community. This was the turning point event that led to the removal of the word "cure" from the medical vocabulary. Today, if you mention the "c" word around your doctor he will usually glaze over and pretend not to hear you. He only responds to the word "treatment".
Under the Rockefeller and Carnegie influence their pharmaceutical firms started to pour out the vast array of synthetic drugs that the doctors trained to their medical school standards now prescribed almost to the exclusion of any other remedies. Among the first drugs to be marketed this way were the oral hypoglycemic agents. They were deliberately designed to treat the symptom while not curing the disease.
Since the name of the medical game was money, a means had to be devised to provide the patient with money that could only be used to pay for approved medical treatment. Enter the insurance company concept. Today employees have, as an important part of their remuneration for their work, a health insurance policy. This health insurance policy does not pay for all health related needs; it only pays for those health related services that are approved. These, of course, are the synthetic drug therapies that are known to work poorly, if at all. In order to secure effective medical treatment from the alternative sector ofthe economy the patient must pay for it himself; insurance companies specifically exclude virtually all alternative treatment. One wonders why so many continue to pay for an insurance program that cannot, even in principle, be of any real benefit to them.
Government coercion in medical practice
In the ordinary course of events, good medicine would eventually drive out bad medicine. As more and more people discover ways to maintain and improve their health, without drug therapy, they will simply abandon bad medicine and resort to alternative therapies. Indeed, this is happening. Also happening is a concerted government effort to discredit and declare unlawful those effective therapies that represent the greatest threat to orthodox medicine. In the last fifty years many effective cures have been developed for many of the major killer diseases that we have. In each instance the developer has been branded a quack, his business has been ruined and in some cases he has been sent to jail.
Even with outright governmental attacks on those that would promote effective therapies in America, the tide is turning. More and more Americans are waking up to the reality of our medical community. More and more they are finding it to be a fraud and they are turning to less conventional treatments and modalities. Informed Americans that require effective medical treatment for anything more serious than a head cold are turning away from orthodox drug quackery in droves. The medical community is trying hard to make it illegal to refuse their treatment. A major effort is currently underway (Codex) to severely restrict the availability of nutritional supplements to those that use them throughout the world. Our government is seriously considering mandatory vaccination programs.
Many believe that our Food and Drug Administration, FDA, represents the American people and that the FDA acts to insure that our food and drugs are safe and effective. Nothing could be further from the truth. The FDA acts entirely to restrain and manage competition between and among those that manufacture our food and drugs. They do this only for the purpose of minimizing competition in business. Rockefeller is famous for proclaiming the only sin is competition. Willy Ley, a former head of the FDA, said it best when he said "What the Food and Drug Administration does and what the public thinks that it does are a different as night and day".
Today in America the practice of medicine is not free. It is one of the most tightly controlled commercial enterprises in the world. That is why it produces such extraordinary income for it's favored and such misery, disease and death for its victims.
What to do
Given the growth of the medical monster that ate the United States, what can we who live here do to effectively manage our own health. Perhaps the single most important thing that we all must do is to recognize that our health is our most important possession. We have no choice but to accept total responsibility for our own health. To leave such an important consideration to someone who clearly has much to gain by lying to us just does not make sense. Typically, we buy our cars and houses with a great deal more wisdom than we bring to the doctor's office when we go there. The modern orthodox medical community treats symptoms; they do not cure disease. When you visit the doctor, it is perfectly in order for you to ask bluntly whether or not the treatment he wants to give you will cure the disease you have. Some years ago, when I had a serious case of Type II Diabetes, I asked my doctor that question about the treatment he offered me. First he pretended he did not hear me. When I persisted and made eye contact and repeated the question he replied "this is the prescribed treatment". Such an evasive answer to such a direct question sent me to the library where I did the research to get a better answer. I quickly discovered that the drug he offered me would not only not cure the disease, but that it was guaranteed to put me on the road to becoming an invalid long before my time. Fortunately I rejected his treatment. I went on to search the scientific literature where I quickly found what I needed. It had nothing to do with synthetic drugs. It took me about 3 1/2 months to fully reverse my diabetes. That was seven years ago. The disease remains in full remission to this day.
There is one important caveat that must be mentioned at this point. If you are currently under a doctors care and are dissatisfied with the results you are getting, do not just stop taking the prescribed medication. Get your doctor, or another doctor if yours will not cooperate, to help weanyou off prescription drugs and to help you to devise a workable alternative therapy. Many of these synthetic drugs will produce serious side effects if they are abruptly discontinued. When I had the problem I had not yet taken prescription medication.
After accepting full responsibility for your own health, the second most important consideration is to do your homework and learn about the disease or disability that you have. Buy books, attend seminars, subscribe to newsletters, search the internet, learn about what it takes to actually reverse the disease that afflicts you. Investigate alternative medical practitioners. Many Naturopaths and Chiropractors can be of great help in actually curing disease. Do not fall for the idea that only doctors are smart enough to understand these things. Look for that unusual doctor that will risk really trying to help you; and, realize that he is taking a substantial risk when he does so. In other words, do the best you can to find something better for yourself than what your doctor offers. Help each other. If you discover something important, don't be afraid to share the information. Be vocal when government organizations attempt to restrict or deny your access to natural nutritional supplements.
If you are fortunate to find a doctor with this kind of integrity, understand the importance of what you have found and give him all of the support that you can give. There is a medical doctor in California, we will call him Doctor Q, that refused to compromise his integrity in his practice of medicine. He ended up in jail, put there by his fellow doctors. His patients got together, got him out of jail and had a special bill passed in the State legislature to protect his practice of medicine. Today he still runs a flourishing practice where he ministers to patients from all over this country. He is actually curing disease not just treating it.
Third, after accepting responsibility for your own health and becoming informed, recognize that medicine is a business. Your doctor is a paid consultant just like your electrician or plumber and he is listed in the same yellow pages. You have every right to get the information for which you are paying. When your doctor retreats into arrogance and refuses to provide direct answers to direct questions, consider getting another doctor. There really are many safe and effective therapies that go far beyond drugs. However, we must demand them on the firing line, in the doctor's office, when we need them.
© 2002 Thomas Smith - All Rights Reserved
Thomas Smith is a reluctant medical investigator having been forced into seeking a cure for his own Diabetes because it was obvious that his doctor would not or could not cure it. He has published the results of his successful Diabetes investigation in his special report entitled "Insulin: Our Silent Killer" written for the layman but also widely valued by the medical practitioner. This report may be purchased by sending $25.00 US to him at PO Box 7685 Loveland, Colorado 80537. He has also posted a great deal of useful information about this disease on his web page www.Healingmatters.com He can be reached by telephone at: 1 (970) 669-9176 E-Mail: Valley@healingmatters.com
Surgery Tools Left in 1,500 People a Year
Wed Jan 15, 5:09 PM ET Add Health - AP to My Yahoo!
By JEFF DONN, Associated Press Writer
BOSTON - Surgical teams accidentally leave clamps, sponges and other tools inside about 1,500 patients nationwide each year, according to the biggest study of the problem yet. The mistakes largely result not from surgeon fatigue, but from the stress arising from emergencies or complications discovered on the operating table, the researchers reported. It also happens more often to fat patients, simply because there is more room inside them to lose equipment, according to the study.
Both the researchers and several other experts agreed that the number of such mistakes is small compared with the roughly 28 million operations a year in the United States. "But no one in any role would say it's acceptable," said Dr. Donald Berwick, president of the Boston-based nonprofit Institute for Healthcare Improvement. The study was done by researchers at Brigham and Women's Hospital and Harvard School of Public Health, both in Boston. It was published in Thursday's New England Journal of Medicine (news - web sites).
The researchers checked insurance records from about 800,000 operations in Massachusetts for 16 years ending in 2001. They counted 61 forgotten pieces of surgical equipment in 54 patients. From that, they calculated a national estimate of 1,500 cases yearly. A total of $3 million was paid out in the Massachusetts cases, mostly in settlements.
Two-thirds of the mistakes happened even though the equipment was counted before and after the procedure, in keeping with the standard practice. Most lost objects were sponges, but also included were metal clamps and electrodes. In two cases, 11-inch retractors — metal strips used to hold back tissue — were forgotten inside patients. In another operation, four sponges were left inside someone.
The lost objects were usually lodged around the abdomen or hips but sometimes in the chest, vagina or other cavities. They often caused tears, obstructions or infections. One patient died of complications, but the researchers withheld details for reasons of privacy.
Most patients needed additional surgery to remove the object, but sometimes it came out by itself or in a doctor's office. In other cases, patients were not even aware of the object, and it turned up in later surgery for other problems. The study found that emergency operations are nine times more likely to lead to such mistakes, and operating-room complications requiring a change in procedure are four times more likely. A rise of one point in body-mass index, a measure of weight relative to height, raises the chances of such a mistake by 10 percent.
The length of the operation or the hour of day does not appear to make a difference, suggesting that fatigue does not cause such mistakes. "It tends to be in unpredictable situations," said lead author Dr. Atul Gawande of Brigham and Women's Hospital. Some other researchers said fatigue could promote such mistakes in a way undetected by this study.
The Boston research team suggested that more X-ray checks be done right after those operations where such errors are most likely. Metal instruments and radiologically tagged sponges show up in such checks. Eventually, wands similar to supermarket bar-code readers might be developed to detect missing equipment, researchers said. Dr. Sidney Wolfe, health research director of the public-interest lobby group Public Citizen, said the real number of lost instruments may be even higher, because hospitals are not required to report such mistakes to public agencies. He said they should be. However, some others said such mistakes are so rare — occurring about 50 times in 1 million operations — that figuring out how to prevent them could be difficult.
"Something has to be done about this. It's just a very tough balance to decide. Do we really want to add this hoop for every patient to jump through?" said Dr. Kaveh Shojania, author of a 2001 federal study on medical mistakes. Lori Bartholomew, research director at the Physician Insurers Association of America, said: "I find it's going to be difficult to make much more improvement, because some of the risk factors are things that are hard to control." The Rockville, Md., group represents medical malpractice insurers.
ST. PAUL, Minn. (Jan. 18) - A hospital apologized for a laboratory mistake that resulted in the amputation of a healthy woman's breasts after she was mistakenly told she had an aggressive form of cancer.
Dr. Daniel Foley, medical director of United Hospital, told KARE-TV in the Twin Cities that the St. Paul hospital had made changes so ''this kind of mixup would never happen again.'' Linda McDougal, 46, said she was diagnosed with cancer in May 2002 after her doctor had a biopsy performed when a suspicious spot appeared on her mammogram.
McDougal said she was told the cancer was so aggressive that a double mastectomy, chemotherapy and radiation were her only chances for survival. In June, she had the surgery. Two days later, she was recovering when her doctor visited. ''She had bad news,'' McDougal said. ''She didn't know how to tell us other than to just tell us, and immediately I thought I was dying, and she told me I didn't have cancer.''
After finding no malignancy in the amputated breast tissue, McDougal said her doctor discovered a mistake in United's laboratory. Tissue from McDougal's biopsy was switched with tissue from another woman. Foley said the woman who actually had the cancer has been contacted and treated. He would not identify the pathologist at fault, but said the doctor remains with United.
''If you're right 99.9999 percent of the time, you don't want to be that .01 percent because the consequences are serious and we have to be right 100 percent of the time,'' Foley said. An attorney representing United's pathologists said the group's insurance company has paid McDougal's medical expenses and lost wages, and will continue to do so. McDougal said she is fighting several infections and must still undergo several reconstructive surgeries before she decides whether to sue for malpractice.
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16 Quotes on Pharmaceutical Drugs
1. "The cause of most disease is in the poisonous drugs physicians superstitiously give in order to effect a cure."
Charles E. Page, M.D.
2. "Medicines are of subordinate importance because of their very nature they can only work symptomatically."
Hans Kusche, M.D.
3. "If all the medicine in the world were thrown into the sea, it would be bad for the fish and good for humanity"
O.W. Holmes, (Prof. of Med. Harvard University)
4. "Drug medications consists in employing, as remedies for disease, those things which produce disease in well persons. Its materia medica is simply a lot of drugs or chemicals or dye-stuffs in a word poisons. All are incompatible with vital matter; all produce disease when brought in contact in any manner with the living; all are poisons." R.T. TraIl, M.D., in a two and one half hour lecture to members of congress and the medical profession, delivered at the Smithsonian Institute in Washington D.C.
5. "Every drug increases and complicates the patients condition."
Robert Henderson, M.D.
6. "Drugs never cure disease. They merely hush the voice of nature's protest, and pull down the danger signals she erects along the pathway of transgression. Any poison taken into the system has to be reckoned with later on even though it palliates present symptoms. Pain may disappear, but the patient is left in a worse condition, though unconscious of it at the time."
Daniel. H. Kress, M.D.
7. "The greatest part of all chronic disease is created by the suppression of acute disease by drug poisoning." Henry Lindlahr, M.D.
8. "Every educated physician knows that most diseases are not appreciably helped by medicine." Richard C. Cabot, M.D. (Mass. Gen. Hospital)
9. "Medicine is only palliative, for back of disease lies the cause, and this cause no drug can reach." Wier Mitchel, M.D.
10. "The person who takes medicine must recover twice, once from the disease and once from the medicine." William Osler, M.D.
11. "Medical practice has neither philosophy nor common sense to recommend it. In sickness the body is already loaded with impurities. By taking drug - medicines more impurities are added, thereby the case is further embarrassed and harder to cure." Elmer Lee, M.D., Past Vice President, Academy of Medicine.
12. "Our figures show approximately four and one half million hospital admissions annually due to the adverse reactions to drugs. Further, the average hospital patient has as much as thirty percent chance, depending how long he is in, of doubling his stay due to adverse drug reactions."
Milton Silverman, M.D. (Professor of Pharmacology, University of California)
13. "Why would a patient swallow a poison because he is ill, or take that which would make a well man sick." L.F. Kebler, M.D.
14. "What hope is there for medical science to ever become a true science when the entire structure of medical knowledge is built around the idea that there is an entity called disease which can be expelled when the right drug is found?" John H. Tilden, M.D.
15. "The necessity of teaching mankind not to take drugs and medicines, is a duty incumbent upon all who know their uncertainty and injurious effects; and the time is not far distant when the drug system will be abandoned." Charles Armbruster, M. D.
16. "We are prone to thinking of drug abuse in terms of the male population and illicit drugs such as heroin, cocaine, and marijuana. It may surprise you to learn that a greater problem exists with millions of women dependent on legal prescription drugs." Robert Mendelsohn, M.D
A draconian medical malpractice and medical device liability bill - H.R. 5 - has been introduced in the House. This bill devastates patients' rights by capping non-economic damages, protecting makers of faulty medical devices and shortening statutes of limitation, among other things. There may be congressional votes on this legislation between the end of February and mid-March. It is URGENT that you - and your friends, neighbors and co-workers call your U.S. Senators and Representatives today to OPPOSE this effort to punish patients in order to subsidize the insurance industry. Tell your representatives that insurance companies and the drug company lobbyist already have too much control over our healthcare system. All members of Congress can be reached by calling: 202-224-3121.
The Administration's attacks on the jury system are nothing more than a desperate attempt to change the subject away from the fact that the insurance industry is receiving special treatment from its friends in the Administration. President Bush and the Republican leadership in Congress appear to be beholden to corporate special interests in Washington and are trying to give the insurance industry and other big campaign contributors (Remember Eli Lilly!!!!!!) more legal rights than injured patients and American families have. Source: The Center for Responsive Politics, President George W. Bush, Contributions by Sector,
Our top priority in reforming America's health-care system should be reducing the shameful number of preventable medical errors that kill nearly 100,000 hospital patients a year - the equivalent of three fatal plane crashes every two days. The day before President Bush attacked juries as the cause of high malpractice insurance premiums for doctors, the New England Journal of Medicine reported that surgical teams leave clamps, sponges and other tools inside about 1,500 patients nationwide each year. Source: AP, 1/15/03 President Bush is blaming the American jury system for rising medical insurance rates but skyrocketing rates are a problem around the world in countries that do not have a jury system like ours. Obstetricians in France - which has strict limits on malpractice lawsuits and no juries - recently threatened to walk off the job because of soaring malpractice premiums. Source: The Guardian, 1/2/03 President Bush's "solutions" to the health-care crisis are being driven by Washington special interests at the expense of states' rights. A one-size-fits-all federal mandate that limits patients' rights in medical malpractice cases would step on states' rights by wiping out existing state laws and eliminating the authority of state Legislatures to control their own court systems.
This is a message from Pedtalk - a message board for pediatricians. This dr. won't buy thimerosal-free because of money (the date of this message is 3/5/03!!). this doctor should be in jail.
"We got the same pricing.
We've made the decision to only order the old-fashioned thimerasol laced vaccine. Even at that, we will be LOSING $$ with some of the managed care plans. I don't feel that we can justify the additional cost of the thimerasol-free vaccine. I guess if some parents insist on it, I'll give them a script and have them buy it at a pharmacy."
All the more this doc. should know better than to take the risk of using thimerosql containing vaccines. I would suggest he attend a DAN (Defeat Autism Now) conference. The speakers are mostly medical docs. and some have children who are on the spectrum. The vast majority of the research done by these docs. shows that our kids have been damaged by thimerosal.
This doc. clearly needs to look at all the research that has been done. Not only the thimerosal issue, but vaccines themselves. However, I think some docs., maybe most, are too concerned about losing their license to practice if he/she becomes involved or leaning toward the anti-vax side.
This is tragic. I wonder if he vaccinated his grandchild? Dr. Usman, a DAN doc., said she vaccinated her own child w/o the knowledge of thimerosal and that child is autistic (vaccine damaged). Interesting enough, she said publicly that her last child is completely vaccine free! I guess some docs get it and some don't. I find it hard to believe that he could be so closed minded. And you would think as a doc. he would understand more concerning the vaccine issue. It sounds like it is all about $ for this fellow.
A Free Ride for Bad Doctors (HRG Publication #1655)
This Op-Ed by Sidney Wolfe, M.D. appeared in the March 4, 2003 edition of the New York Times
A Free Ride for Bad Doctors
The death of Jésica Santillán, the 17-year-old given a heart and lung transplant last month from an incompatible donor, has become the latest argument in Congress against President Bush's plan to limit malpractice damage awards. With doctors in several states staging work stoppages to protest the soaring costs of premiums, the plan to put caps on pain-and-suffering payouts had been picking up steam.
Yet in all the discussion of tragic cases and dollar amounts, a major cause of the malpractice problem is ignored: the failure of state medical boards to discipline doctors.
The fact is, only a small percentage of doctors account for most of the money paid out in malpractice cases. From 1990 to 2002, just 5 percent of doctors were involved in 54 percent of the payouts — including jury awards and out-of-court settlements — according to the National Practitioner Data Bank of the Department of Health and Human Services. (The data bank allows hospitals and medical boards to see the records of individual doctors but, thanks to pressure from the American Medical Association, Congress forbids it to release information to doctors or the public.)
Of the 35,000 doctors with two or more payouts during that period, only 8 percent were disciplined by state medical boards. Among the 2,774 doctors who had made payments in five or more cases, only 463 — one out of six — had been disciplined.
Is it any coincidence that the states least likely to discipline doctors are among those with insurance crises? Pennsylvania — where the governor had to intervene to keep doctors from going out on strike over malpractice insurance costs — has disciplined only 5 percent of the 512 doctors who had made payments in malpractice suits five or more times, the lowest percentage of any state. (Arizona, for example, has disciplined nearly half of the doctors in this category.)
And while Pennsylvania has 5.3 percent of the doctors in the United States, they make up 18.5 percent of American doctors with five or more malpractice payments. One doctor there paid 24 claims between 1993 and 2001 totaling more than $8 million (one was for operating on the wrong part of the body; another was for leaving a "foreign body" in the patient) yet was never disciplined by Pennsylvania authorities.
The state with the next highest overrepresentation of doctors with five or more payouts is West Virginia, where doctors went on strike last month. It has 0.57 percent of the country's physicians, but they make up 1.69 percent of American doctors who have had made malpractice payments five or more times. Only one-quarter of the state's doctors with five or more payouts has been disciplined by the medical board.
In New York, another state with a pending malpractice crisis, the number of doctors who have had five or more malpractice payments is two and one-half times higher than would be expected from the number of doctors licensed. Yet only 15 percent of these 698 doctors have been disciplined by the state board.
Amid the uproar about malpractice premium increases, there is a deadly silence from physicians' groups on the crisis of inadequate doctor discipline. The problem is not the compensation paid to injured patients, but an epidemic of medical errors. If medical boards, which are state agencies, areunwilling to seriously discipline doctors who repeatedly pay for malpractice — including revoking medical licenses from the worst offenders — then legislatures must step in and change the way the boards operate.
Congress should also rethink the secrecy surrounding the practitioner data bank. While a few states release some data to the public, most Americans have no way of finding out their doctors' backgrounds. What patient would not like to discover the malpractice history of a potential doctor, especially if he is among the 2,774 in the United States who have had five or more payouts?
Parents of Dead Child Sue Over Transplant
Parents of Dead Child Sue Doctors, Hospitals Over Blood-Type Mistake in Liver Transplant
The Associated Press
DALLAS March 12 —
The parents of a 17-month-old girl who died last summer after receiving a transplanted liver that didn't match her blood type are suing two Dallas hospitals and three surgeons who were involved. The lawsuit alleges that doctors mistakenly gave Jeanella Aranda a liver transplant from her father instead of from her mother. The mother and child had type O blood; the father is type A.
The case recalls the death last month of Jesica Santillan, the teenager who underwent two heart-lung transplants in North Carolina. As with Jeanella, Jesica's first transplanted organs had been the wrong blood type and her body rejected them. Her parents have not said if they will sue. According to the lawsuit filed Monday in Texas, a surgeon at Children's Medical Center severed the blood veins and arteries around Jeanella's liver, causing uncontrollable bleeding. Hospital officials told the girl's parents she needed a transplant and recommended they be tested as possible donors.
A laboratory that performed the blood typing for Jeanella and her parents mixed up the blood types of the parents and incorrectly identified the father as a suitable donor of a partial liver. Partial liver donations are becoming more common because livers regenerate quickly in donor and recipient alike. The father went to Baylor University Medical Center, where surgeons removed part of his liver and sent it to Children's Medical Center. It was transplanted into Jeanella in July.
After the transplant, the girl developed a blood disorder, fever, kidney problems, lung hemorrhages and jaundice. But the blood type mismatch was not detected until 19 days after the surgery, when the mother noticed that Jeanelle's transfusions were type O, and asked whether the transplant had been a mismatch.
Doctors realized she was correct. The girl died the next day. The parents, Cesar and Alicia Aranda, are suing both hospitals and the doctors who operated on Jeanella and Cesar Aranda, claiming both hospitals should have double-checked the blood types. The physicians named in the lawsuit are Dr. Robert Goldstein, Dr. Philip Guzzetta and Dr. Jay Roden, who were involved in the operations. In statements issued Tuesday, both hospitals said they understood the father's blood type to be a match, The Dallas Morning News reported Wednesday.
"An exhaustive review of the care Jeanella received at our hospital has been conducted, and Children's believes it acted appropriately, based on the information provided to us by an external laboratory," the hospital's statement read in part
Patient Dies in VA Medical Study
Patient Dies As Result of Medical Error in Veterans Affairs Medical
Study, Prompting Review
The Associated Press
WASHINGTON March 12 —
At least one patient died recently as a result of a medical error in a study at a Veterans Affairs hospital, prompting a review of the agency's entire human research effort, according to a memo released Wednesday. The memo, signed by two deputy undersecretaries for health and dated March 6, called for an intensive 90-day review at all VA medical centers of procedures used to monitor human research. Current projects will continue and patients will still be enrolled in new ones, the memo said.
The memo referred to the death "of one or more patients at one site," but did not describe the human experiments or offer any details. A House VA committee staffer said, however, the memo refers to a cancer patient who died last year during a drug trial conducted at a VA medical center in Albany, N.Y. The staffer said the death was being investigated by federal authorities, including the FBI. He said the investigation has shown that at least one researcher in the study had falsified credentials and did not hold a valid medical license.VA spokeswoman Karen Fedele said the agency would not comment further, citing an investigation by the VA's inspector general.
Dr. Jonathan B. Perlin and Laura J. Miller, the deputy undersecretaries who signed the memo, were not available for comment and a receptionist referred all questions to Louise Van Diepen, an associate in their office. She refused to discuss the memo. The Perlin-Miller memo said recent incidents in VA center human research studies "have had the potential to put research subjects at risk."
Among the incidents cited:
Falsification of individual patient data "contributed" to the death of at least one patient. Overdosing of a patient in a drug study project at another center.
An experimental procedure was conducted without the prior approval of the Institutional Review Board or the Research and Development Committee panels that have the formal responsibility of monitoring human research. A drug study was conducted without a researcher who had clinical privileges permitting the prescribing of the study medication. Failure of a review board "to meet even the minimal standards required."
Perlin and Miller ordered the 90-day review "to ensure we are doing all that is possible to ensure the protection of human subjects and the ethical conduct of research." The memo directed that directors and other officials at VA centers are to review the operations of review boards and R&D committees to assure they are "functioning at least at the minimum level required."
The memo required that all researchers and the members of the oversight boards complete training courses on the protection of human research subjects. It also called for new procedures to assure that all researchers have the proper credentials and licenses. Finally, the memo warned that principle researchers at the VA centers "will be held responsible for ethical breaches in the conduct of their research."
Half of all hospital drug injections are wrong
00:01 28 March 03 NewScientist.com news service
Half of all drug injections given intravenously in hospitals are done wrongly, a new study reveals, with third of these being potentially dangerous.
British researchers uncovered the disturbing level of errors when they examined drugs given intravenously by nurses in two hospitals in the UK. They believe the rate of mistakes they found is likely to be representative of practice across Europe and the US.
Nick Barber and Katja Taxis, at the School of Pharmacy, London, tracked the preparation and administration of over 400 intravenous (IV) doses given to patients on 10 different wards in the hospitals. "We were surprised about how commonly errors occurred," say Barber. "But not all of these were serious."
However, the error rate they calculated from their data predicts one serious error every day in every hospital in the UK, which is a concern, he says. The most common mistakes were injecting doses of concentrated drugs too rapidly and preparing drugs incorrectly, by either using the wrong dose or dissolving them in the wrong solution. All could be fatal in certain circumstances.
For some drugs, the speed at which it enters the body is crucial, Barber explains. If they are injected too fast, they can induce anaphylaxis - a life-threatening allergic reaction. "This is because there is a load of potent foreign chemical shooting around your body - if it hits the brain or heart it can have a marked effect," he said. But injecting a drug slowly, for example, over three minutes can be physically difficult for health care staff.
One of the three "potentially severe" errors Barber and Taxis in their study was of this type - with the antibiotic vancomycin being given too quickly. However, a pharmacist observer for the study intervened before any harm was done.
Nick Barber, School of Pharmacy, London National Patient Safety Agency, UK British Medical Journal The second severe error occurred when a patient was nearly injected with an IV preparation containing five times the correct dose of heparin - which stops the blood clotting. "Wrong dose errors are the ones most likely to cause harm," notes Barber. The third potentially lethal error was when an intensive care team infusing a patient with adrenalin ran out of the drug and had not prepared a second infusion in time. Barber says the key to tackling such errors was to improve nurse training. He says there would also be a role for companies to develop a simple pump to help nurses administer drugs slowly.
Journal reference: British Medical Journal (vol 326, p 684)
Schools shift rules on pelvic procedure
Exams often done without consent
By David B. Caruso
Published March 12, 2003
PHILADELPHIA -- Some of the nation's leading medical schools have abandoned a little-known, decades-old practice of letting students perform pelvic exams on women without their consent while they are under anesthesia.
The institutions that have recently implemented policies of asking for permission routinely brought in students--sometimes as many as three or four--to conduct pelvic exams on unconscious women just before their gynecological surgeries, often without their consent. Changes in that practice have taken place over the past five years after complaints from students who felt the exams without consent were unethical. "My problem was that if they found out about it, they might be really upset, and it was really only being done for my benefit," said Dr. Ari Silver-Isenstadt, who refused to examine anesthetized women as a student at
the University of Pennsylvania.
Students also raised objections in the mid-1990s at Harvard Medical School.Dr. Daniel Federman, senior dean for clinical teaching at Harvard, said the complaints led to a new policy under which surgical patients had to give consent for a pelvic exam for training purposes. In addition, the students had to be part of the medical team. "Very few patients decline," Federman said. "And when they do, we honor it." At the University of California-San Francisco, complaints by medical students in the late 1990s led to a line being added to patient consent forms, specifically noting that women having gynecological surgery may be given a pelvic exam while they are under anesthesia.
Typically, the surgeon performing the operation conducts an exam to confirm the problem to be corrected by surgery. Dr. Patricia Robertson, director of UCSF's obstetrics and gynecology clerkship, said students also have been directed to meet the patient before each operation and explain how they will be involved in their care. "The students, I think, were most upset because they felt there were students lining up in the operating room doing pelvic exams who really had nothing to do with the patient," she said.
Most medical students today learn basics of the pelvic exam by practicing on paid volunteers. Anesthetized women are the perfect subjects, doctors said, because they are unable to feel the sometimes painful mistakes of novice examiners. Consent is still far from a universal practice. At the Washington University School of Medicine in St. Louis, for instance, patients are told that students will be part of their care team, but aren't specifically told the treatment could include a pelvic exam for educational purposes.
"I don't think any of us even think about it," said Dr. Jessica Bienstock, residency program director at Johns Hopkins University. "It's just so standard as to how you train medical students." Many students, however, appear to disagree: 70 percent surveyed at Philadelphia-area hospitals in 1995 before they completed an obstetrics and gynecology clerkship said it was important to ask women for consent, according to a study published last month in the American Journal of Obstetrics and Gynecology.
Dr. Michael Gregory, a Boston public health physician who objected to the exams when he was a third-year student at Tufts University School of Medicine, said that while studies show most women will give their consent, doctors are afraid to ask. "It's this paternalistic, patronizing view that the doctors know best. ... We underestimate people's incredible charity, and their willingness to let us train," he said. "But I think that at a gut level, doctors understand that if they actually told patients that this was happening without their consent, people would be outraged."
Patient safety is a top priority in the Nation today. The Institute of Medicine (IOM) report entitled "To Err is Human", (in ref. 9) estimated that between 44,000 and 98,000 people die each year in hospitals from medical errors. The majority of these errors are a result of systemic problems rather than poor performance by individual providers. Although, the United States provides some of the best health care in the world, the number of patients that are being harmed as a result of the process of health care is unacceptably high. In response to the IOM report, the Quality Interagency Coordination Task Force (QuIC), which is composed of Federal members representing the Departments of Health and Human Services (DHHS), Labor (DoL), Defense (DoD), Veterans Affairs (VA), and Commerce; Office of Management and Budget (OMB); Office of Personnel Management (OPM); U.S. Coast Guard, Federal Bureau of Prisons (BoP); National Highway Transportation and Safety Administration; and the Federal Trade Commission (FTC), issued a report in February 2000 "Doing What Counts for Patient Safety, Federal Action to Reduce Medical Errors and Their Impact". (See ref. 10)
The Soft Science of Dietary Fat by Gary Taubes Science magazine Mainstream nutritional science has demonized dietary fat, yet 50 years and hundreds of millions of dollars of research have failed to prove that eating a low-fat diet will help you live longer When the U.S. Surgeon General's Office set off in 1988 to write the definitive report on the dangers of dietary fat, the scientific task appeared straightforward. Four years earlier, the National Institutes of Health (NIH) had begun advising every American old enough to walk to restrict fat intake, and the president of the American Heart Association (AHA) had told Time magazine that if everyone went along, "we will have [atherosclerosis] conquered" by the year 2000. The Surgeon General's Office itself had just published its 700-page landmark "Report on Nutrition and Health," declaring fat the single most unwholesome component of the American diet.
All of this was apparently based on sound science. So the task before the project officer was merely to gather that science together in one volume, have it reviewed by a committee of experts, which had been promptly established, and publish it. The project did not go smoothly, however. Four project officers came and went over the next decade. "It consumed project officers," says Marion Nestle, who helped launch the project and now runs the nutrition and food studies department at New York University (NYU). Members of the oversight committee saw drafts of an early chapter or two, criticized them vigorously, and then saw little else.
Finally, in June 1999, 11 years after the project began, the Surgeon General's Office circulated a letter, authored by the last of the project officers, explaining that the report would be killed. There was no other public announcement and no press release. The letter explained that the relevant administrators "did not anticipate fully the magnitude of the additional external expertise and staff resources that would be needed." In other words, says Nestle, the subject matter "was too complicated." Bill Harlan, a member of the oversight committee and associate director of the Office of Disease Prevention at NIH, says "the report was initiated with a preconceived opinion of the conclusions," but the science behind those opinions was not holding up. "Clearly the thoughts of yesterday were not going to serve us very well."
During the past 30 years, the concept of eating healthy in America has become synonymous with avoiding dietary fat. The creation and marketing of reduced-fat food products has become big business; over 15,000 have appeared on supermarket shelves. Indeed, an entire research industry has arisen to create palatable nonfat fat substitutes, and the food industry now spends billions of dollars yearly selling the less-fat-is-good-health message. The government weighs in as well, with the U.S. Department of Agriculture's (USDA's) booklet on dietary guidelines, published every 5 years, and its ubiquitous Food Guide Pyramid, which recommends that fats and oils be eaten "sparingly." The low-fat gospel spreads farther by a kind of societal osmosis, continuously reinforced by physicians, nutritionists, journalists, health organizations, and consumer advocacy groups such as the Center for Science in the Public Interest, which refers to fat as this "greasy killer." "In America, we no longer fear God or the communists, but we fear fat," says David Kritchevsky of the Wistar Institute in Philadelphia, who in 1958 wrote the first textbook on cholesterol.
As the Surgeon General's Office discovered, however, the science of dietary fat is not nearly as simple as it once appeared. The proposition, now 50 years old, that dietary fat is a bane to health is based chiefly on the fact that fat, specifically the hard, saturated fat found primarily in meat and dairy products, elevates blood cholesterol levels. This in turn raises the likelihood that cholesterol will clog arteries, a condition known as atherosclerosis, which then increases risk of coronary artery disease, heart attack, and untimely death. By the 1970s, each individual step of this chain from fat to cholesterol to heart disease had been demonstrated beyond reasonable doubt, but the veracity of the chain as a whole has never been proven. In other words, despite decades of research, it is still a debatable proposition whether the consumption of saturated fats above recommended levels (step one in the chain) by anyone who's not already at high risk of heart disease will increase the likelihood of untimely death (outcome three). Nor have hundreds of millions of dollars in trials managed to generate compelling evidence that healthy individuals can extend their lives by more than a few weeks, if that, by eating less fat (see sidebar on p. 2538). To put it simply, the data remain ambiguous as to whether low-fat diets will benefit healthy Americans. Worse, the ubiquitous admonishments to reduce total fat intake have encouraged a shift to high-carbohydrate diets, which may be no better--and may even be worse--than high-fat diets.
Since the early 1970s, for instance, Americans' average fat intake has dropped from over 40% of total calories to 34%; average serum cholesterol levels have dropped as well. But no compelling evidence suggests that these decreases have improved health. Although heart disease death rates have dropped--and public health officials insist low-fat diets are partly responsible--the incidence of heart disease does not seem to be declining, as would be expected if lower fat diets made a difference. This was the conclusion, for instance, of a 10-year study of heart disease mortality published in The New England Journal of Medicine in 1998, which suggested that death rates are declining largely because doctors are treating the disease more successfully. AHA statistics agree: Between 1979 and 1996, the number of medical procedures for heart disease increased from 1.2 million to 5.4 million a year. "I don't consider that this disease category has disappeared or anything close to it," says one AHA statistician.
Meanwhile, obesity in America, which remained constant from the early 1960s through 1980, has surged upward since then--from 14% of the population to over 22%. Diabetes has increased apace. Both obesity and diabetes increase heart disease risk, which could explain why heart disease incidence is not decreasing. That this obesity epidemic occurred just as the government began bombarding Americans with the low-fat message suggests the possibility, however distant, that low-fat diets might have unintended consequences--among them, weight gain. "Most of us would have predicted that if we can get the population to change its fat intake, with its dense calories, we would see a reduction in weight," admits Harlan. "Instead, we see the exact opposite."
In the face of this uncertainty, skeptics and apostates have come along repeatedly, only to see their work almost religiously ignored as the mainstream medical community sought consensus on the evils of dietary fat. For 20 years, for instance, the Harvard School of Public Health has run the Nurses' Health Study and its two sequelae--the Health Professionals Follow-Up Study and the Nurses' Health Study II--accumulating over a decade of data on the diet and health of almost 300,000 Americans. The results suggest that total fat consumed has no relation to heart disease risk; that monounsaturated fats like olive oil lower risk; and that saturated fats are little worse, if at all, than the pasta and other carbohydrates that the Food Guide Pyramid suggests be eaten copiously. (The studies also suggest that trans fatty acids are unhealthful. These are the fats in margarine, for instance, and are what many Americans started eating when they were told that the saturated fats in butter might kill them.) Harvard epidemiologist Walter Willett, spokesperson for the Nurses' Health Study, points out that NIH has spent over $100 million on the three studies and yet not one government agency has changed its primary guidelines to fit these particular data. "Scandalous," says Willett. "They say, 'You really need a high level of proof to change the recommendations,' which is ironic, because they never had a high level of proof to set them."
Indeed, the history of the national conviction that dietary fat is deadly, and its evolution from hypothesis to dogma, is one in which politicians, bureaucrats, the media, and the public have played as large a role as the scientists and the science. It's a story of what can happen when the demands of public health policy--and the demands of the public for simple advice--run up against the confusing ambiguity of real science.
Fear of fat During the first half of the 20th century, nutritionists were more concerned about malnutrition than about the sins of dietary excess. After World War II, however, a coronary heart disease epidemic seemed to sweep the country (see sidebar on p. 2540). "Middle-aged men, seemingly healthy, were dropping dead," wrote biochemist Ancel Keys of the University of Minnesota, Twin Cities, who was among the first to suggest that dietary fats might be the cause. By 1952, Keys was arguing that Americans should reduce their fat intake to less than 30% of total calories, although he simultaneously recognized that "direct evidence on the effect of the diet on human arteriosclerosis is very little and likely to remain so for some time." In the famous and very controversial Seven Countries Study, for instance, Keys and his colleagues reported that the amount of fat consumed seemed to be the salient difference between populations such as those in Japan and Crete that had little heart disease and those, as in Finland, that were plagued by it. In 1961, the Framingham Heart Study linked cholesterol levels to heart disease, Keys made the cover of Time magazine, and the AHA, under his influence, began advocating low-fat diets as a palliative for men with high cholesterol levels. Keys had also become one of the first Americans to consciously adopt a heart-healthy diet: He and his wife, Time reported, "do not eat 'carving meat'--steaks, chops, roasts--more than three times a week."
Nonetheless, by 1969 the state of the science could still be summarized by a single sentence from a report of the Diet-Heart Review Panel of the National Heart Institute (now the National Heart, Lung, and Blood Institute, or NHLBI): "It is not known whether dietary manipulation has any effect whatsoever on coronary heart disease." The chair of the panel was E. H. "Pete" Ahrens, whose laboratory at Rockefeller University in New York City did much of the seminal research on fat and cholesterol metabolism.
Whereas proponents of low-fat diets were concerned primarily about the effects of dietary fat on cholesterol levels and heart disease, Ahrens and his panel--10 experts in clinical medicine, epidemiology, biostatistics, human nutrition, and metabolism--were equally concerned that eating less fat could have profound effects throughout the body, many of which could be harmful. The brain, for instance, is 70% fat, which chiefly serves to insulate neurons. Fat is also the primary component of cell membranes. Changing the proportion of saturated to unsaturated fats in the diet changes the fat composition in these membranes. This could conceivably change the membrane permeability, which controls the transport of everything from glucose, signaling proteins, and hormones to bacteria, viruses, and tumor-causing agents into and out of the cell. The relative saturation of fats in the diet could also influence cellular aging as well as the clotting ability of blood cells.
Whether the potential benefits of low-fat diets would exceed the potential risks could be settled by testing whether low-fat diets actually prolong life, but such a test would have to be enormous. The effect of diet on cholesterol levels is subtle for most individuals--especially those living in the real world rather than the metabolic wards of nutrition researchers--and the effect of cholesterol levels on heart disease is also subtle. As a result, tens of thousands of individuals would have to switch to low-fat diets and their subsequent health compared to that of equal numbers who continued eating fat to alleged excess. And all these people would have to be followed for years until enough deaths accumulated to provide statistically significant results. Ahrens and his colleagues were pessimistic about whether such a massive and expensive trial could ever be done. In 1971, an NIH task force estimated such a trial would cost $1 billion, considerably more than NIH was willing to spend. Instead, NIH administrators opted for a handful of smaller studies, two of which alone would cost $255 million. Perhaps more important, these studies would take a decade. Neither the public, the press, nor the U.S. Congress was willing to wait that long.
Science by committee Like the flourishing American affinity for alternative medicine, an antifat movement evolved independently of science in the 1960s. It was fed by distrust of the establishment--in this case, both the medical establishment and the food industry--and by counterculture attacks on excessive consumption, whether manifested in gas-guzzling cars or the classic American cuisine of bacon and eggs and marbled steaks. And while the data on fat and health remained ambiguous and the scientific community polarized, the deadlock was broken not by any new science, but by politicians. It was Senator George McGovern's bipartisan, nonlegislative Select Committee on Nutrition and Human Needs--and, to be precise, a handful of McGovern's staff members--that almost single-handedly changed nutritional policy in this country and initiated the process of turning the dietary fat hypothesis into dogma.
McGovern's committee was founded in 1968 with a mandate to eradicate malnutrition in America, and it instituted a series of landmark federal food assistance programs. As the malnutrition work began to peter out in the mid-1970s, however, the committee didn't disband. Rather, its general counsel, Marshall Matz, and staff director, Alan Stone, both young lawyers, decided that the committee would address "overnutrition," the dietary excesses of Americans. It was a "casual endeavor," says Matz. "We really were totally naïve, a bunch of kids, who just thought, 'Hell, we should say something on this subject before we go out of business.' " McGovern and his fellow senators--all middle-aged men worried about their girth and their health--signed on; McGovern and his wife had both gone through diet-guru Nathan Pritikin's very low fat diet and exercise program. McGovern quit the program early, but Pritikin remained a major influence on his thinking.
McGovern's committee listened to 2 days of testimony on diet and disease in July 1976. Then resident wordsmith Nick Mottern, a former labor reporter for The Providence Journal, was assigned the task of researching and writing the first "Dietary Goals for the United States." Mottern, who had no scientific background and no experience writing about science, nutrition, or health, believed his Dietary Goals would launch a "revolution in diet and agriculture in this country." He avoided the scientific and medical controversy by relying almost exclusively on Harvard School of Public Health nutritionist Mark Hegsted for input on dietary fat. Hegsted had studied fat and cholesterol metabolism in the early 1960s, and he believed unconditionally in the benefits of restricting fat intake, although he says he was aware that his was an extreme opinion. With Hegsted as his muse, Mottern saw dietary fat as the nutritional equivalent of cigarettes, and the food industry as akin to the tobacco industry in its willingness to suppress scientific truth in the interests of profits. To Mottern, those scientists who spoke out against fat were those willing to take on the industry. "It took a certain amount of guts," he says, "to speak about this because of the financial interests involved."
Mottern's report suggested that Americans cut their total fat intake to 30% of the calories they consume and saturated fat intake to 10%, in accord with AHA recommendations for men at high risk of heart disease. The report acknowledged the existence of controversy but insisted Americans had nothing to lose by following its advice. "The question to be asked is not why should we change our diet but why not?" wrote Hegsted in the introduction. "There are [no risks] that can be identified and important benefits can be expected." This was an optimistic but still debatable position, and when Dietary Goals was released in January 1977, "all hell broke loose," recalls Hegsted. "Practically nobody was in favor of the McGovern recommendations. Damn few people."
McGovern responded with three follow-up hearings, which aptly foreshadowed the next 7 years of controversy. Among those testifying, for instance, was NHLBI director Robert Levy, who explained that no one knew if eating less fat or lowering blood cholesterol levels would prevent heart attacks, which was why NHLBI was spending $300 million to study the question. Levy's position was awkward, he recalls, because "the good senators came out with the guidelines and then called us in to get advice." He was joined by prominent scientists, including Ahrens, who testified that advising Americans to eat less fat on the strength of such marginal evidence was equivalent to conducting a nutritional experiment with the American public as subjects. Even the American Medical Association protested, suggesting that the diet proposed by the guidelines raised the "potential for harmful effects." But as these scientists testified, so did representatives from the dairy, egg, and cattle industries, who also vigorously opposed the guidelines for obvious reasons.
This juxtaposition served to taint the scientific criticisms: Any scientists arguing against the committee's guidelines appeared to be either hopelessly behind the paradigm, which was Hegsted's view, or industry apologists, which was Mottern's, if not both.
Although the committee published a revised edition of the Dietary Goals later in the year, the thrust of the recommendations remained unchanged. It did give in to industry pressure by softening the suggestion that Americans eat less meat. Mottern says he considered even that a "disservice to the public," refused to do the revisions, and quit the committee. (Mottern became a vegetarian while writing the Dietary Goals and now runs a food co-op in Peekskill, New York.)
The guidelines might have then died a quiet death when McGovern's committee came to an end in late 1977 if two federal agencies had not felt it imperative to respond. Although they took contradictory points of view, one message--with media assistance--won out.
The first was the USDA, where consumer-activist Carol Tucker Foreman had recently been appointed an assistant secretary. Foreman believed it was incumbent on USDA to turn McGovern's recommendations into official policy, and, like Mottern, she was not deterred by the existence of scientific controversy. "Tell us what you know and tell us it's not the final answer," she would tell scientists. "I have to eat and feed my children three times a day, and I want you to tell me what your best sense of the data is right now."
Of course, given the controversy, the "best sense of the data" would depend on which scientists were asked. The Food and Nutrition Board of the National Academy of Sciences (NAS), which decides the Recommended Dietary Allowances, would have been a natural choice, but NAS president Philip Handler, an expert on metabolism, had told Foreman that Mottern's Dietary Goals were "nonsense." Foreman then turned to McGovern's staffers for advice and they recommended she hire Hegsted, which she did. Hegsted, in turn, relied on a state-of-the-science report published by an expert but very divergent committee of the American Society for Clinical Nutrition. "They were nowhere near unanimous on anything," says Hegsted, "but the majority supported something like the McGovern committee report."
The resulting document became the first edition of "Using the Dietary Guidelines for Americans." Although it acknowledged the existence of controversy and suggested that a single dietary recommendation might not suit an entire diverse population, the advice to avoid fat and saturated fat was, indeed, virtually identical to McGovern's Dietary Goals.
Three months later, the NAS Food and Nutrition Board released its own guidelines: "Toward Healthful Diets." The board, consisting of a dozen nutrition experts, concluded that the only reliable advice for healthy Americans was to watch their weight; everything else, dietary fat included, would take care of itself. The advice was not taken kindly, however, at least not by the media. The first reports--"rather incredulously," said Handler at the time--criticized the NAS advice for conflicting with the USDA's and McGovern's and thus somehow being irresponsible. Follow-up reports suggested that the board members, in the words of Jane Brody, who covered the story for The New York Times, were "all in the pocket of the industries being hurt." To be precise, the board chair and one of its members consulted for food industries, and funding for the board itself came from industry donations. These industry connections were leaked to the press from the USDA.
Hegsted now defends the NAS board, although he didn't at the time, and calls this kind of conflict of interest "a hell of an issue." "Everybody used to complain that industry didn't do anything on nutrition," he told Science, "yet anybody who got involved was blackballed because their positions were presumably influenced by the industry." (In 1981, Hegsted returned to Harvard, where his research was funded by Frito-Lay.) The press had mixed feelings, claiming that the connections "soiled" the academy's reputation "for tendering careful scientific advice" (The Washington Post), demonstrated that the board's "objectivity and aptitude are in doubt" (The New York Times), or represented in the board's guidelines a "blow against the food faddists who hold the public in thrall" (Science). In any case, the NAS board had been publicly discredited. Hegsted's Dietary Guidelines for Americans became the official U.S. policy on dietary fat: Eat less fat. Live longer.
Once politicians, the press, and the public had decided dietary fat policy, the science was left to catch up. In the early 1970s, when NIH opted to forgo a $1 billion trial that might be definitive and instead fund a half-dozen studies at one-third the cost, everyone hoped these smaller trials would be sufficiently persuasive to conclude that low-fat diets prolong lives. The results were published between 1980 and 1984. Four of these trials --comparing heart disease rates and diet within Honolulu, Puerto Rico, Chicago, and Framingham--showed no evidence that men who ate less fat lived longer or had fewer heart attacks. A fifth trial, the Multiple Risk Factor Intervention Trial (MRFIT), cost $115 million and tried to amplify the subtle influences of diet on health by persuading subjects to avoid fat while simultaneously quitting smoking and taking medication for high blood pressure. That trial suggested, if anything, that eating less fat might shorten life. In each study, however, the investigators concluded that methodological flaws had led to the negative results. They did not, at least publicly, consider their results reason to lessen their belief in the evils of fat.
The sixth study was the $140 million Lipid Research Clinics (LRC) Coronary Primary Prevention Trial, led by NHLBI administrator Basil Rifkind and biochemist Daniel Steinberg of the University of California, San Diego. The LRC trial was a drug trial, not a diet trial, but the NHLBI heralded its outcome as the end of the dietary fat debate. In January 1984, LRC investigators reported that a medication called cholestyramine reduced cholesterol levels in men with abnormally high cholesterol levels and modestly reduced heart disease rates in the process. (The probability of suffering a heart attack during the seven-plus years of the study was reduced from 8.6% in the placebo group to 7.0%; the probability of dying from a heart attack dropped from 2.0% to 1.6%.) The investigators then concluded, without benefit of dietary data, that cholestyramine's benefits could be extended to diet as well. And although the trial tested only middle-aged men with cholesterol levels higher than those of 95% of the population, they concluded that those benefits "could and should be extended to other age groups and women and ... other more modest elevations of cholesterol levels."
Why go so far? Rifkind says their logic was simple: For 20 years, he and his colleagues had argued that lowering cholesterol levels prevented heart attacks. They had spent enormous sums trying to prove it. They felt they could never actually demonstrate that low-fat diets prolonged lives--that would be too expensive, and MRFIT had failed--but now they had established a fundamental link in the causal chain, from lower cholesterol levels to cardiovascular health. With that, they could take the leap of faith from cholesterol-lowering drugs and health to cholesterol-lowering diet and health. And after all their effort, they were eager--not to mention urged by Congress--to render helpful advice. "There comes a point when, if you don't make a decision, the consequences can be great as well," says Rifkind. "If you just allow Americans to keep on consuming 40% of calories from fat, there's an outcome to that as well."
With the LRC results in press, the NHLBI launched what Levy called "a massive public health campaign." The media obligingly went along. Time, for instance, reported the LRC findings under the headline "Sorry, It's True. Cholesterol really is a killer." The article about a drug trial began: "No whole milk. No butter. No fatty meats ..." Time followed up 3 months later with a cover story: "And Cholesterol and Now the Bad News. ..." The cover photo was a frowning face: a breakfast plate with two fried eggs as the eyes and a bacon strip for the mouth. Rifkind was quoted saying that their results "strongly indicate that the more you lower cholesterol and fat in your diet, the more you reduce your risk of heart disease," a statement that still lacked direct scientific support.
The following December, NIH effectively ended the debate with a "Consensus Conference." The idea of such a conference is that an expert panel, ideally unbiased, listens to 2 days of testimony and arrives at a conclusion with which everyone agrees. In this case, Rifkind chaired the planning committee, which chose his LRC co-investigator Steinberg to lead the expert panel. The 20 speakers did include a handful of skeptics --including Ahrens, for instance, and cardiologist Michael Oliver of Imperial College in London--who argued that it was unscientific to equate the effects of a drug with the effects of a diet. Steinberg's panel members, however, as Oliver later complained in The Lancet, "were selected to include only experts who would, predictably, say that all levels of blood cholesterol in the United States are too high and should be lowered.
And, of course, this is exactly what was said." Indeed, the conference report, written by Steinberg and his panel, revealed no evidence of discord. There was "no doubt," it concluded, that low-fat diets "will afford significant protection against coronary heart disease" to every American over 2 years old. The Consensus Conference officially gave the appearance of unanimity where none existed. After all, if there had been a true consensus, as Steinberg himself told Science, "you wouldn't have had to have a consensus conference."
The test of time To the outside observer, the challenge in making sense of any such long-running scientific controversy is to establish whether the skeptics are simply on the wrong side of the new paradigm, or whether their skepticism is well founded. In other words, is the science at issue based on sound scientific thinking and unambiguous data, or is it what Sir Francis Bacon, for instance, would have called "wishful science," based on fancies, opinions, and the exclusion of contrary evidence? Bacon offered one viable suggestion for differentiating the two: the test of time. Good science is rooted in reality, so it grows and develops and the evidence gets increasingly more compelling, whereas wishful science flourishes most under its first authors before "going downhill."
Such is the case, for instance, with the proposition that dietary fat causes cancer, which was an integral part of dietary fat anxiety in the late 1970s. By 1982, the evidence supporting this idea was thought to be so undeniable that a landmark NAS report on nutrition and cancer equated those researchers who remained skeptical with "certain interested parties [who] formerly argued that the association between lung cancer and smoking was not causational." Fifteen years and hundreds of millions of research dollars later, a similarly massive expert report by the World Cancer Research Fund and the American Institute for Cancer Research could find neither "convincing" nor even "probable" reason to believe that dietary fat caused cancer.
The hypothesis that low-fat diets are the requisite route to weight loss has taken a similar downward path. This was the ultimate fallback position in all low-fat recommendations: Fat has nine calories per gram compared to four calories for carbohydrates and protein, and so cutting fat from the diet surely would cut pounds. "This is held almost to be a religious truth," says Harvard's Willett. Considerable data, however, now suggest otherwise. The results of well-controlled clinical trials are consistent: People on low-fat diets initially lose a couple of kilograms, as they would on any diet, and then the weight tends to return. After 1 to 2 years, little has been achieved. Consider, for instance, the 50,000 women enrolled in the ongoing $100 million Women's Health Initiative (WHI). Half of these women have been extensively counseled to consume only 20% of their calories from fat. After 3 years on this near-draconian regime, say WHI sources, the women had lost, on average, a kilogram each.
The link between dietary fat and heart disease is more complicated, because the hypothesis has diverged into two distinct propositions: first, that lowering cholesterol prevents heart disease; second, that eating less fat not only lowers cholesterol and prevents heart disease but prolongs life. Since 1984, the evidence that cholesterol-lowering drugs are beneficial--proposition number one--has indeed blossomed, at least for those at high risk of heart attack. These drugs reduce serum cholesterol levels dramatically, and they prevent heart attacks, perhaps by other means as well. Their market has now reached $4 billion a year in the United States alone, and every new trial seems to confirm their benefits.
The evidence supporting the second proposition, that eating less fat makes for a healthier and longer life, however, has remained stubbornly ambiguous. If anything, it has only become less compelling over time. Indeed, since Ancel Keys started advocating low-fat diets almost 50 years ago, the science of fat and cholesterol has evolved from a simple story into a very complicated one. The catch has been that few involved in this business were prepared to deal with a complicated story. Researchers initially preferred to believe it was simple--that a single unwholesome nutrient, in effect, could be isolated from the diverse richness of human diets; public health administrators required a simple story to give to Congress and the public; and the press needed a simple story--at least on any particular day--to give to editors and readers in 30 column inches. But as contrarian data continued to accumulate, the complications became increasingly more difficult to ignore or exclude, and the press began waffling or adding caveats. The scientists then got the blame for not sticking to the original simple story, which had, regrettably, never existed.
More fats, fewer answers The original simple story in the 1950s was that high cholesterol levels increase heart disease risk. The seminal Framingham Heart Study, for instance, which revealed the association between cholesterol and heart disease, originally measured only total serum cholesterol. But cholesterol shuttles through the blood in an array of packages. Low-density lipoprotein particles (LDL, the "bad" cholesterol) deliver fat and cholesterol from the liver to tissues that need it, including the arterial cells, where it can lead to atherosclerotic plaques. High-density lipoproteins (HDLs, the "good" cholesterol) return cholesterol to the liver. The higher the HDL, the lower the heart disease risk. Then there are triglycerides, which contain fatty acids, and very low density lipoproteins (VLDLs), which transport triglycerides.
All of these particles have some effect on heart disease risk, while the fats, carbohydrates, and protein in the diet have varying effects on all these particles. The 1950s story was that saturated fats increase total cholesterol, polyunsaturated fats decrease it, and monounsaturated fats are neutral. By the late 1970s--when researchers accepted the benefits of HDL--they realized that monounsaturated fats are not neutral. Rather, they raise HDL, at least compared to carbohydrates, and lower LDL. This makes them an ideal nutrient as far as cholesterol goes. Furthermore, saturated fats cannot be quite so evil because, while they elevate LDL, which is bad, they also elevate HDL, which is good. And some saturated fats--stearic acid, in particular, the fat in chocolate--are at worst neutral. Stearic acid raises HDL levels but does little or nothing to LDL. And then there are trans fatty acids, which raise LDL, just like saturated fat, but also lower HDL. Today, none of this is controversial, although it has yet to be reflected in any Food Guide Pyramid.
To understand where this complexity can lead in a simple example, consider a steak--to be precise, a porterhouse, select cut, with a half-centimeter layer of fat, the nutritional constituents of which can be found in the Nutrient Database for Standard Reference at the USDA Web site. After broiling, this porterhouse reduces to a serving of almost equal parts fat and protein. Fifty-one percent of the fat is monounsaturated, of which virtually all (90%) is oleic acid, the same healthy fat that's in olive oil. Saturated fat constitutes 45% of the total fat, but a third of that is stearic acid, which is, at the very least, harmless. The remaining 4% of the fat is polyunsaturated, which also improves cholesterol levels. In sum, well over half--and perhaps as much as 70%--of the fat content of a porterhouse will improve cholesterol levels compared to what they would be if bread, potatoes, or pasta were consumed instead. The remaining 30% will raise LDL but will also raise HDL. All of this suggests that eating a porterhouse steak rather than carbohydrates might actually improve heart disease risk, although no nutritional authority who hasn't written a high-fat diet book will say this publicly.
As for the scientific studies, in the years since the 1984 consensus conference, the one thing they have not done is pile up evidence in support of the low-fat-for-all approach to the public good. If anything, they have added weight to Ahrens's fears that there may be a downside to populationwide low-fat recommendations. In 1986, for instance, just 1 year after NIH launched the National Cholesterol Education Program, also advising low-fat diets for everyone over 2 years old, epidemiologist David Jacobs of the University of Minnesota, Twin Cities, visited Japan. There he learned that Japanese physicians were advising patients to raise their cholesterol levels, because low cholesterol levels were linked to hemorrhagic stroke. At the time, Japanese men were dying from stroke almost as frequently as American men were succumbing to heart disease. Back in Minnesota, Jacobs looked for this low-cholesterol-stroke relationship in the MRFIT data and found it there, too. And the relationship transcended stroke: Men with very low cholesterol levels seemed prone to premature death; below 160 milligrams per deciliter (mg/dl), the lower the cholesterol level, the shorter the life.
Jacobs reported his results to NHLBI, which in 1990 hosted a conference to discuss the issue, bringing together researchers from 19 studies around the world. The data were consistent: When investigators tracked all deaths, instead of just heart disease deaths, the cholesterol curves were U-shaped for men and flat for women. In other words, men with cholesterol levels above 240 mg/dl tended to die prematurely from heart disease. But below 160 mg/dl, the men tended to die prematurely from cancer, respiratory and digestive diseases, and trauma. As for women, if anything, the higher their cholesterol, the longer they lived (see graph on p. 2540).
These mortality data can be interpreted in two ways. One, preferred by low-fat advocates, is that they cannot be meaningful. Rifkind, for instance, told Science that the excess deaths at low cholesterol levels must be due to preexisting conditions. In other words, chronic illness leads to low cholesterol levels, not vice versa. He pointed to the 1990 conference report as the definitive document on the issue and as support for his argument, although the report states unequivocally that this interpretation is not supported by the data.
The other interpretation is that what a low-fat diet does to serum cholesterol levels, and what that in turn does to arteries, may be only one component of the diet's effect on health. In other words, while low-fat diets might help prevent heart disease, they might also raise susceptibility to other conditions. This is what always worried Ahrens. It's also one reason why the American College of Physicians, for instance, now suggests that cholesterol reduction is certainly worthwhile for those at high, short-term risk of dying of coronary heart disease but of "much smaller or ... uncertain" benefit for everyone else.
This interpretation--that the connection between diet and health far transcends cholesterol--is also supported by the single most dramatic diet-heart trial ever conducted: the Lyon Diet Heart Study, led by Michel de Lorgeril of the French National Institute of Health and Medical Research (INSERM) and published in Circulation in February 1999. The investigators randomized 605 heart attack survivors, all on cholesterol-lowering drugs, into two groups. They counseled one to eat an AHA "prudent diet," very similar to that recommended for all Americans. They counseled the other to eat a Mediterranean-type diet, with more bread, cereals, legumes, beans, vegetables, fruits, and fish and less meat. Total fat and types of fat differed markedly in the two diets, but the HDL, LDL, and total cholesterol levels in the two groups remained virtually identical. Nonetheless, over 4 years of follow-up, the Mediterranean-diet group had only 14 cardiac deaths and nonfatal heart attacks compared to 44 for the "Western-type" diet group. The likely explanation, wrote de Lorgeril and his colleagues, is that the "protective effects [of the Mediterranean diet] were not related to serum concentrations of total, LDL or HDL cholesterol."
Many researchers find the Lyon data so perplexing that they're left questioning the methodology of the trial. Nonetheless, says NIH's Harlan, the data "are very provocative. They do bring up the issue of whether if we look only at cholesterol levels we aren't going to miss something very important." De Lorgeril believes the diet's protective effect comes primarily from omega-3 fatty acids, found in seed oils, meat, cereals, green leafy vegetables, and fish, and from antioxidant compounds, including vitamins, trace elements, and flavonoids. He told Science that most researchers and journalists in the field are prisoners of the "cholesterol paradigm." Although dietary fat and serum cholesterol "are obviously connected," he says, "the connection is not a robust one" when it comes to heart disease.
Dietary trade-offs One inescapable reality is that death is a trade-off, and so is diet. "You have to eat something," says epidemiologist Hugh Tunstall Pedoe of the University of Dundee, U.K., spokesperson for the 21-nation Monitoring Cardiovascular Disease Project run by the World Health Organization. "If you eat more of one thing, you eat a lot less of something else. So for every theory saying this disease is caused by an excess in x, you can produce an alternative theory saying it's a deficiency in y." It would be simple if, say, saturated fats could be cut from the diet and the calories with it, but that's not the case. Despite all expectations to the contrary, people tend to consume the same number of calories despite whatever diet they try. If they eat less total fat, for instance, they will eat more carbohydrates and probably less protein, because most protein comes in foods like meat that also have considerable amounts of fat.
This plus-minus problem suggests a different interpretation for virtually every diet study ever done, including, for instance, the kind of metabolic-ward studies that originally demonstrated the ability of saturated fats to raise cholesterol. If researchers reduce the amount of saturated fat in the test diet, they have to make up the calories elsewhere. Do they add polyunsaturated fats, for instance, or add carbohydrates? A single carbohydrate or mixed carbohydrates? Do they add green leafy vegetables, or do they add pasta? And so it goes. "The sky's the limit," says nutritionist Alice Lichtenstein of Tufts University in Boston. "There are a million perturbations."
These trade-offs also confound the kind of epidemiological studies that demonized saturated fat from the 1950s onward. In particular, individuals who eat copious amounts of meat and dairy products, and plenty of saturated fats in the process, tend not to eat copious amounts of vegetables and fruits. The same holds for entire populations. The eastern Finns, for instance, whose lofty heart disease rates convinced Ancel Keys and a generation of researchers of the evils of fat, live within 500 kilometers of the Arctic Circle and rarely see fresh produce or a green vegetable. The Scots, infamous for eating perhaps the least wholesome diet in the developed world, are in a similar fix. Basil Rifkind recalls being laughed at once on this point when he lectured to Scottish physicians on healthy diets: "One said, 'You talk about increasing fruits and vegetable consumption, but in the area I work in there's not a single grocery store.' " In both cases, researchers joke that the only green leafy vegetable these populations consume regularly is tobacco. As for the purported benefits of the widely hailed Mediterranean diet, is it the fish, the olive oil, or the fresh vegetables? After all, says Harvard epidemiologist Dimitrios Trichopoulos, a native of Greece, the olive oil is used either to cook vegetables or as dressing over salads. "The quantity of vegetables consumed is almost a pound [half a kilogram] a day," he says, "and you cannot eat it without olive oil. And we eat a lot of legumes, and we cannot eat legumes without olive oil."
Indeed, recent data on heart disease trends in Europe suggest that a likely explanation for the differences between countries and over time is the availability of fresh produce year-round rather than differences in fat intake. While the press often plays up the French paradox--the French have little heart disease despite seemingly high saturated fat consumption--the real paradox is throughout Southern Europe, where heart disease death rates have steadily dropped while animal fat consumption has steadily risen, says University of Cambridge epidemiologist John Powles, who studies national disease trends. The same trend appears in Japan. "We have this idea that it's the Arcadian past, the life in the village, the utopia that we've lost," Powles says; "that the really protective Mediterranean diet is what people ate in the 1950s." But that notion isn't supported by the data: As these Mediterranean nations became more affluent, says Powles, they began to eat proportionally more meat and with it more animal fat. Their heart disease rates, however, continued to improve compared to populations that consumed as much animal fat but had less access to fresh vegetables throughout the year. To Powles, the antifat movement was founded on the Puritan notion that "something bad had to have an evil cause, and you got a heart attack because you did something wrong, which was eating too much of a bad thing, rather than not having enough of a good thing."
The other salient trade-off in the plus-minus problem of human diets is carbohydrates. When the federal government began pushing low-fat diets, the scientists and administrators, and virtually everyone else involved, hoped that Americans would replace fat calories with fruits and vegetables and legumes, but it didn't happen. If nothing else, economics worked against it. The food industry has little incentive to advertise nonproprietary items: broccoli, for instance. Instead, says NYU's Nestle, the great bulk of the $30-billion-plus spent yearly on food advertising goes to selling carbohydrates in the guise of fast food, sodas, snacks, and candy bars. And carbohydrates are all too often what Americans eat.
Carbohydrates are what Harvard's Willett calls the flip side of the calorie trade-off problem. Because it is exceedingly difficult to add pure protein to a diet in any quantity, a low-fat diet is, by definition, a high-carbohydrate diet--just as a low-fat cookie or low-fat yogurt are, by definition, high in carbohydrates. Numerous studies now suggest that high-carbohydrate diets can raise triglyceride levels, create small, dense LDL particles, and reduce HDL--a combination, along with a condition known as "insulin resistance," that Stanford endocrinologist Gerald Reaven has labeled "syndrome X." Thirty percent of adult males and 10% to 15% of postmenopausal women have this particular syndrome X profile, which is associated with a several-fold increase in heart disease risk, says Reaven, even among those patients whose LDL levels appear otherwise normal. Reaven and Ron Krauss, who studies fats and lipids at Lawrence Berkeley National Laboratory in California, have shown that when men eat high-carbohydrate diets their cholesterol profiles may shift from normal to syndrome X. In other words, the more carbohydrates replace saturated fats, the more likely the end result will be syndrome X and an increased heart disease risk. "The problem is so clear right now it's almost a joke," says Reaven. How this balances out is the unknown. "It's a bitch of a question," says Marc Hellerstein, a nutritional biochemist at the University of California, Berkeley, "maybe the great public health nutrition question of our era."
The other worrisome aspect of the carbohydrate trade-off is the possibility that, for some individuals, at least, it might actually be easier to gain weight on low-fat/high-carbohydrate regimens than on higher fat diets. One of the many factors that influence hunger is the glycemic index, which measures how fast carbohydrates are broken down into simple sugars and moved into the bloodstream. Foods with the highest glycemic index are simple sugars and processed grain products like pasta and white rice, which cause a rapid rise in blood sugar after a meal. Fruits, vegetables, legumes, and even unprocessed starches--pasta al dente, for instance--cause a much slower rise in blood sugar. Researchers have hypothesized that eating high-glycemic index foods increases hunger later because insulin overreacts to the spike in blood sugar. "The high insulin levels cause the nutrients from the meal to get absorbed and very avidly stored away, and once they are, the body can't access them," says David Ludwig, director of the obesity clinic at Children's Hospital Boston. "The body appears to run out of fuel." A few hours after eating, hunger returns.
If the theory is correct, calories from the kind of processed carbohydrates that have become the staple of the American diet are not the same as calories from fat, protein, or complex carbohydrates when it comes to controlling weight. "They may cause a hormonal change that stimulates hunger and leads to overeating," says Ludwig, "especially in environments where food is abundant. ..."
In 1979, 2 years after McGovern's committee released its Dietary Goals, Ahrens wrote to The Lancet describing what he had learned over 30 years of studying fat and cholesterol metabolism: "It is absolutely certain that no one can reliably predict whether a change in dietary regimens will have any effect whatsoever on the incidence of new events of [coronary heart disease], nor in whom." Today, many nutrition researchers, acknowledging the complexity of the situation, find themselves siding with Ahrens. Krauss, for instance, who chairs the AHA Dietary Guidelines Committee, now calls it "scientifically naïve" to expect that a single dietary regime can be beneficial for everybody: "The 'goodness' or 'badness' of anything as complex as dietary fat and its subtypes will ultimately depend on the context of the individual."
Given the proven success and low cost of cholesterol-lowering drugs, most physicians now prescribe drug treatment for patients at high risk of heart disease. The drugs reduce LDL cholesterol levels by as much as 30%. Diet rarely drops LDL by more than 10%, which is effectively trivial for healthy individuals, although it may be worth the effort for those at high risk of heart disease whose cholesterol levels respond well to it.
The logic underlying populationwide recommendations such as the latest USDA Dietary Guidelines is that limiting saturated fat intake--even if it does little or nothing to extend the lives of healthy individuals and even if not all saturated fats are equally bad--might still delay tens of thousands of deaths each year throughout the entire country. Limiting total fat consumption is considered reasonable advice because it's simple and easy to understand, and it may limit calorie intake. Whether it's scientifically justifiable may simply not be relevant. "When you don't have any real good answers in this business," says Krauss, "you have to accept a few not so good ones as the next best thing."
Natural Health Newsletter
Randall Neustaedter OMD
Here they go again
Those bad boys at the drug companies are at it again. First they lower the normal cholesterol recommendations from 220 to 200 and then 180. Wow have the sales for Lipitor and other statin-type cholesterol- lowering drugs been soaring. That amounts to a lot of bucks $$$$ for the drug industry, despite all those pesky lawsuits for the deaths caused by Baycol, which was taken off the market. Watch out for those side effects, including liver damage. They can get you faster than cholesterol-related heart disease.
Now a new decree has lowered the numbers for blood pressure as well. Brace yourselves for a barrage of advertisements for blood pressure medications because all of you who thought you had normal blood pressures of 120/80 are now classified with a disease called pre-hypertension as of the announcement on May 15, 2003. You thought 140/90 was the upper limit of normal didn't you? Not anymore. The current recommendation (this week) is to treat anyone with prehypertension and other complicating diseases such as diabetes or kidney problems with drugs. The rest of us can expect to get lectures about losing weight, exercise, and low fat diets.
Doctors Appeal to free Innocent Incarcerated "Munchausen" Mom
Roanoke, VA 24014 May 20, 2003
More than five years after her wrongful prosecution for death and injury to her children in 1981-82 a mother remains behind bars in West Virginia for reasons known only to those maintaining injustice under color of law.
Signed by doctors who have examined specimens (some still emerging years post-trial), who know their science and support failure to prosecute initially because both children shared a metabolic disorder, a second appeal for clemency letter from Citizens to Free Marybeth Davis was sent May 15 (2003) to Gov. Wise.
The first letter was mailed Feb. 1, 2002.
"Tegan was not murdered and there was no attempt to murder Seth. The confirmed diagnosis for Tegan is Reyes Syndrome, a condition to which it is now thought she was predisposed by a genetic metabolic (birth) defect. The confirmed diagnosis for Seth is Human Growth Hormone Deficiency (HGHD), formally included under the general name of Leighs Syndrome, a genetic metabolic (birth) defect that causes, amongst other things, reoccurring episodes of hypoglycemia," the correspondence appeal reminds the state's top executive.
Adding a major fact that took years of frustrating effort to find in medical files withheld from defense, the letter reveals "It has also been discovered that Seth suffered brain damage due to lack of oxygen when his endotracheal tube became displaced on the helicopter flight to Pennsylvania.
"However, the courts do not acknowledge the existence of these diagnoses of natural causes made and confirmed by licensed physicians, and they continue year after year with their legal procedures, pretending to be oblivious to the fact that no crimes were committed and that the September 1997 trial was totally in error."
The latest appeal letter and other evidence and court documentation can be found at Click here: Free Marybeth Davis (http://www.freemarybethdavis.homestead.com)
Stating a reasonable conclusion remaining in the aftermath of the stunning 1997 trial result--life without mercy for Marybeth--the letter's next paragraph notes: "Dr. Joseph Aldrich, the attending physician for both Tegan and Seth and an eyewitness, told former Greenbrier County prosecutor, Mark Burnette, prior to the trial, that he and other doctors in 1981-82 had determined that the health problems of the children were due to natural causes and that no murder or attempted murder had been committed.
"From all indications, the former prosecutor simply chose to ignore this information and went to trial knowing that there was no proof that the suspected crimes had been committed. That was either gross stupidity or deliberate wrong doing."
To fast-forward to current events, during his second and ultimately successful bid for election to the West Virginia Senate, former prosecutor Burnette mentioned his success in convicting Marybeth Davis in his electioneering.
Ten months before his belated trial of the stunned mother the prosecutor regaled media which treated the public to emotive speculation about supposed "new evidence." Although the innocent mother was never evaluated for or diagnosed with the still scientifically baseless motivation theory--coined name "Munchausen Syndrome by Proxy"-- it had been accepted by careless courts fairly soon after publication of Dr. Roy Meadow's "Hinterlands" article in August 1977, years prior to the illness and death of the Davis children.
Careful reading of the MSP theory shows Dr. Meadow admitting to saltloading a frequently ill baby in the United Kingdom. The infant always was admitted with high salt levels shown by lab findings. By the doctor's own words his actions were not a standard treatment, not an accident, and not approved or consented research. That is how MSP motivation theory began. It could end in West Virginia if Gov. Wise reads more carefully, than did local prosecutors and the Greenbrier County Court, Sir Roy Meadow's nearly 26-year-old bold confession at: http://web.tiscali.it/humanrights/articles/meadow77.html
Putting in the fewest possible words the prosecution's route to wrongful conviction, the letter continues: "The former prosecutor then convinced an uneducated jury that, contrary to common sense and medical findings, Marybeth had committed murder/attempted murder because she fit the profile for a parent with Munchausen Syndrome By Proxy, a hypothetical and highly controversial psychiatric condition that is not recognized as legitimate by the American Medical Association or the American Psychiatric Association.
"In the final analysis, Marybeth was convicted of committing an imaginary murder (with the amount of caffeine in a cup of coffee as the supposed murder weapon) because she was suspected of having an imaginary psychiatric disorder. The absurdity of this tragedy boggles the mind, and illustrates, once again, that modern medicine and common sense are not a match for ignorance." With the story behind the story still unfolding--just why it appears vital for those with official and personal interests to leave an innocent mother in prison--the letter alludes to the former Illinois governor's freeing wrongly convicted innocents and urges similar action by Gov. Wise.
"More than five years after the trial for crimes that did not happen, the West Virginia Courts refuse to acknowledge that they put an innocent woman in prison whose children suffered from metabolic birth defects. We suspect that the authorities involved are now trying to cover up their mistake by delaying Marybeth's release from prison for as long as possible." "Citizens to Free Marybeth Davis is once again asking that you do that which is morally right, acknowledge the absence of crimes and the existence of the medical diagnoses of natural causes for the alleged victims, and order Marybeth released from prison.
"She is not guilty of poisoning her children because her children were not poisoned. If the Governor of Illinois can order the release of falsely convicted people from prison in his state, you should be able to do the same for a person who was convicted without crimes in West Virginia," the letter concludes. After the tragic death of their daughter and the truly "new evidence" of injury to and more recently the death of their son, Marybeth and her husband adopted a lovely daughter and had a son, today healthy teens. Her attorney--now pressing her case into a third exhausting decade--is Paul Detch of Lewisburg, W. Va.
For more on MSP see also http://www.expertclick.com/NewsReleaseWire/default.cfm?Action=ReleaseDetail&ID=4128
and another mother's story at http://www.expertclick.com/NewsReleaseWire/default.cfm?Action=ReleaseDetail&ID=4172
Barbara Bryan (BHBryan@aol.com)
National Child Abuse Defense & Resource Center
P.O. Box 8323
Roanoke, VA 24014
Phone : 540-345-1952
Fax : 540-345-1899
Suit Says Drugs Made From Tainted Blood
Tue Jun 3, 2:56 PM ET Add Top Stories - AP to My Yahoo!
By KIM CURTIS, Associated Press Writer
SAN FRANCISCO - Several hemophiliacs filed a lawsuit against Bayer Corp. and other companies, claiming they exposed patients to HIV (news - web sites) and hepatitis C by selling medicine made with blood from sick, high-risk donors. The lawsuit alleges the companies continued distributing the blood-clotting product in Asia and Latin America in 1984 and 1985, even after they stopped selling it in the United States because of the known risk of HIV and hepatitis transmission.
The lawsuit filed Monday in federal court seeks class-action status on behalf of thousands of foreign hemophiliacs who received the product, said attorney Robert Nelson. It accuses the companies of negligence and fraudulent concealment. "This is a worldwide tragedy," Nelson said. "Thousands of hemophiliacs have unnecessarily died from AIDS (news - web sites) and many thousands more are infected with HIV or hepatitis C."
Bayer rejected the claims, saying in a statement from its headquarters in Leverkusen, Germany Tuesday that it would examine the lawsuit and prepare its defense. "Bayer at all times complied with all regulations in force in the relevant countries based on the amount of scientific evidence available at the time," the company said, adding that decisions made 20 years ago should not be judged by today's scientific knowledge.
Nelson said the lawsuit was filed in California because defendant Cutter Biological, now a division of Bayer, was formerly based in Berkeley. Several plasma donation sites also were located in the San Francisco Bay area, he said. The lawsuit was filed less than two weeks after an investigation by The New York Times accused the company of selling old stock of the medicine abroad, while marketing a newer, safer product in the United States.
Bayer told Times it sold the old medicine because some customers doubted the effectiveness of a new version of the product, and because some countries were slow to approve its sale. While the company said it acted responsibly and in line with the best medical knowledge at the time, Bayer and three other companies that made the concentrate settled 15 years of U.S. lawsuits from people who took the drug, paying about $600 million.
The medicine, called Factor VIII concentrate, can stop or prevent potentially fatal bleeding in people with hemophilia. Early in the AIDS epidemic, the medicine was commonly made using mingled plasma from 10,000 or more donors. Because there was not yet a screening test for HIV, the virus that causes AIDS, thousands of hemophiliacs were infected.
But the lawsuit alleges Bayer and the others refused to take precautions that could have made the product safer. As of 1992, the contaminated blood products had infected at least 5,000 hemophiliacs in Europe with HIV. More than 2,000 had already developed AIDS and 1,250 had died from the disease, the lawsuit said. By the mid-1990s in Japan, hemophiliacs accounted for the majority of the country's 4,000 reported cases of HIV infection and virtually all infections of Japan's hemophiliacs have been linked to contaminated blood products imported from the United States, the lawsuit said. In Latin America, at least 700 HIV cases are linked to use of contaminated blood products by hemophiliacs, the lawsuit said.
Patients used as drug 'guinea pigs'
Firms pay out millions to doctors to test medicines
Antony Barnett, public affairs editor
Sunday February 9, 2003
When Italia Sudano went for a check-up with her GP, Dr Robert Adams, she was in good health. Her husband had died a few months earlier and her blood pressure was a little high. Yet nothing could have prepared Sudano, 72, for the nightmare that was to follow and the discovery of a trail of greed and fraud that went right to the heart of the medical profession.
She was astonished to discover that her trusted GP had been using her as a guinea pig by giving her tablets which had not been medically approved. Worse still, he was being paid to do so by a pharmaceutical company. An investigation by The Observer has revealed that many doctors are risking their patients' health by subjecting them to medical trials without their knowledge.
Sudano's ordeal began when Adams took a blood test and asked her to return the next week. She had been living at Letchworth in Hertfordshire since arriving from Italy 50 years earlier and she trusted British doctors.
Over the next few weeks Adams asked Sudano to return for more blood tests. By the end of the second month her arms were black and blue. Her son, Joe, said they looked as though they had been slammed in a door. She said: 'At one point I asked if he was selling my blood.' Little did Sudano know how close to the truth her comment was. On her last visit, Adams took a bottle of pills from the top drawer of his desk and suggested Sudano take one a day. While she thought it strange she wasn't being given a prescription, she trusted her doctor.
But within hours of swallowing the pill, she could hardly walk because she was so dazed. Her face had swollen up badly and she was in considerable pain. She stopped taking the tablets and complained to Hertfordshire Health Authority. This sparked an investigation that led to one of the largest cases of medical research fraud ever uncovered in Britain.
It emerged that over the previous five years Adams had earned more than £100,000 from drug companies, including the European giants AstraZeneca, GlaxoSmithKline and Bayer. They were all paying him to test their new drugs on his patients. Like Sudano, many of his patients had never given their consent and had no knowledge they were being used as human guinea pigs in a medical trial. Patients with no symptoms were given drugs and others who needed proper medication were given placebos. Adams was receiving almost £1,000 for each patient.
Last month Adams was found guilty by the General Medical Council (GMC) of serious professional misconduct and suspended for 12 months. The GMC's lawyer described it as 'assault' and Sudano is now looking to sue Adams.
GlaxoSmithKline was using Adams to study its anti-depressant Paroxetine, but had to cancel the trial at a cost of hundreds of thousands of pounds.
The drugs industry talks of bad apples and the odd errant doctor milking the system but insists that trials using GPs are essential for medical advances and that payment to doctors for the extra work involved is ethically correct.
But an investigation by The Observer suggests the problem of GPs using patients as guinea pigs without their consent is more widespread. Some 3,000 doctors each year are paid by drug firms to sign up their patients to tests and on average 15 patients are needed for each trial. With doctors picking up £1,000 per patients drug companies are spending £45m on getting doctors onside. There is no suggestion the companies are implicated in moves to carry out the tests by doctors on patients secretly.
Medical fraud experts estimate that one per cent of all drug trials involve fraud, including failure to get proper consent from patients. This means hundreds of patients a year are being given unapproved and potentially dangerous drugs without their knowledge.
The Observer has discovered that in the last five years the GMC has taken action in a dozen cases involving GPs undertaking fraudulent research. Examples include:
· Dr Vasu Agrawal from Chigwell, Essex, removed samples of womb from menopausal women as part of a trial into a new hormone replacement drug called Divina Nova. Agrawal failed to tell the women they were testing a drug that could have serious side-effects. Agrawal, who forged signatures on consent forms, received almost £6,000 from Orion Pharma International.
· Dr Paul Chima from Edinburgh is estimated to have received more than £200,000 from a range of pharmaceutical companies for testing their new drugs for angina, asthma, high blood pressure and depression. He failed to warn patients of possible side-effects and offered one a £2,000 bribe not to give evidence against him.
· Dr James Boschler from south London was given £22,500 from Bayer and Solvay Healthcare. He claimed to have signed up 36 patients, but 25 of the consent forms were discovered to be forgeries.
The country's foremost investigator of medical research fraud is Peter Jay, the former Metropolitan Police detective chief inspector who arrested serial killer Dennis Nilsen. Since 1996 Jay has run MedicoLegal Investigations, an independent body, and has taken 12 doctors to the GMC.
Jay is investigating six further cases, including one involving a GP in Manchester. Dr Mark Northfield is alleged not to have obtained consent from patients for entering them into trials to test drugs manufactured by Bayer and Roche to treat high blood pressure and heart problems. Northfield is contesting the allegations before the GMC professional conduct committee.
Jay said: 'While the industry has become more alert to the problems over the last decade there is still clearly a worrying and persistent problem in research fraud involving doctors. This is not just an issue of patient safety, but a problem that might lead to bad drugs being approved or good drugs failing to be approved.'
The Observer's revelations of the continuing problem of research fraud have sparked calls for industry guidelines to be toughened up. David Hinchcliffe, the Labour chair of the House of Commons Health Select Committee, described the situation as bordering on 'scandalous' and said his committee would look into the issue.
He said: 'The relationship between the drug firms and the medical profession is one that needs to be thoroughly investigated. It is extremely worrying that patients' trust is being abused by doctors who are more interested in making money from the pharmaceutical industry.'
Dr Evan Harris, health spokesman for the Liberal Democrats, suggested that doctors involved in trials should be subject to on-the-spot inspections and that a patient's consent to take part in a drug trial should be given outside the GP's surgery, for example to a research officer acting for the firm.
Additional research by Charlotte Coulon
16 die in hospital 'by mistake': report
SIXTEEN people reportedly died in Victorian hospitals due to medical mistakes last financial year, including a child who was given the wrong medication. Almost a dozen other people suffered injury due to medical staff treating the wrong patient or body part, instruments being left behind after surgery and neurological damage according to documents The Age has reportedly
Five more patients reportedly committed suicide in hospital. The deaths and injuries reported to the State Government in 2002-03 - the second year details of such mistakes have been supplied - are regarded as only a small number of those that actually take place. "It's still a relatively low proportion of the major incidents and deaths that are occurring," said Michael Walsh, chief executive of Bayside Health - which covers hospitals including the Alfred - and deputy chair of the Australian Council for Safety and Quality in Health Care, a body set up in 2000 by federal and state health ministers. "The reality is that hospitals have an appreciable element of risk about them, particularly for folk with complex care needs, who are quite old, and come through the emergency department," he said. Documents detailing the events, obtained under freedom of information laws, did not disclose which hospitals were involved or information that might identify patients, the paper said. This report appears on news.com.au.
Immunity's Memories, Lost and Found
Discovery of peripheral effector T cells dismantles the lymphoid tissue
paradigm | By Josh P. Roberts
Courtesy of Mark Jenkins
SLICED MICE: Single-cell-thick sections of adult mice expressing CD45.1 stained with nuclear dye (blue) and a monoclonal antibody specific for CD45.2 (red). The left panel shows a background level of CD45.2 staining. The center panel shows a mouse that received several million Salmonella peptide-specific CD4 T cells from a transgenic mouse expressing CD45.2. Transferred naïve T cells were found only in secondary lymphoid organs. At right, when also injected with Salmonella peptide three days prior to staining, CD4 T cells proliferated and migrated into nonlymphoid organs.
Scientists have long believed that immunological memory--the record of infections past--is maintained by highly differentiated T cells and B cells that were generally thought to reside in the spleen and lymph nodes, the secondary lymphoid organs. Thus, the lymph nodes and blood (considered a surrogate for the spleen) are typically used to probe the long-term effects of immunological challenge. But as it turns out, these memory seekers may have been looking in all the wrong places. In this issue's Hot Papers, two research teams, using different but complementary techniques, discovered that nonlymphoid tissues such as the lungs and fat pads also harbor memory T cells. These cells seem to respond to antigenic rechallenge differently than their counterparts in the spleen and lymph nodes.
Data derived from the Science Watch/Hot Papers database and the Web of Science (ISI, Philadelphia) show that Hot Papers are cited 50 to 100 times more often than the average paper of the same type and age.
D. Masopust et al., "Preferential localization of effector memory cells in nonlymphoid tissue," Science, 291:2413-7, 2001. (Cited in 195 papers)
R.L. Reinhardt et al., "Visualizing the generation of memory CD4 T cells in the whole body," Nature, 410:101-5, 2001. (Cited in 175 papers)
"The magnitude of the populations of memory cells that you could find in these nonlymphoid tissues hadn't been appreciated," says Leo Lefrançois, of the University of Connecticut Health Center in Farmington and a principle investigator on one paper.1 "Our data showed that probably an equal number, if not a greater number, of memory cells were found in the nonlymphoid tissues at any time during the response to infection as there were in the lymphoid tissue." What Lefrançois' team found for CD8+ (cytotoxic) T cells, Marc Jenkins' University of Minnesota-Twin Cities team found for CD4+ (helper) T lymphocytes.2 The findings, says Jenkins, "really forced people to consider nonlymphoid tissue as a reservoir of memory cells." And that, says Susan Swain, director of the Trudeau Institute in Saranac Lake, NY, is one of the reasons that so many of her fellow immunologists have paid attention to the papers. "They didn't really think of [T] cells going to bizarre places like fat pads and other nonlymphoid sites," she says. It had been known for some time that activated cells, those that had recently encountered antigen, can migrate throughout the body. But these papers piqued the immunology community's interest for two reasons: First, not all the peripheral T cells Lefrançois and Jenkins looked at expressed the phenotypic markings of activation. Second, many had the characteristics of effector cells, which provide help to cytotoxic or phagocytic cells, or are themselves cytotoxic, much more so than even those seen in lymphoid tissues. VISUALLY STUNNING RESULTS In the years leading up to these publications, many labs had seen that the clonal expansion of T cells responding to an immunization peaked at about five to seven days. This was followed by a dramatic loss of antigen-specific cells from the lymphoid tissue, and finally stabilization in cell numbers. "We were wondering whether that loss phase could be explained partly, simply by exodus of cells from the lymphoid tissue into nonlymphoid tissue," Jenkins recalls. "We decided that to make the accounting exercise complete, we needed to sample the nonlymphoid body." There were, essentially, two ways to accomplish this goal. One was to "take out and grind up all the nonlymphoid organs, try to get the cells out, and see if we could find the antigen-specific cells there," Jenkins explains. The other was to "use a method that could sample everything at once," which is what his lab ended up doing. They refined a technique called whole-body thin sectioning to resolve single antigen-specific T cells. "[First author] Lee [Reinhardt] worked out a catalytic amplification system that gave him an intense signal from the primary antibody he was staining with," says Jenkins. By analyzing multiple sections through different animals, at different time points, he showed that "many of these cells appear in nonlymphoid tissue, even though none were there before immunization." The method is incredibly labor-intensive. Even after he had determined the ideal conditions for staining, Reinhardt still needed to take about 750 digital images for eachsection, and "jigsaw all those together in a precise way that created the total picture," Jenkins, his mentor, explains. "It took him four years to do that paper, basically." The results were "visually stunning," says Graham Le Gros, director of research for New Zealand's Malaghan Institute. Lefrançois' group took the other route to their findings, grinding samples from different tissues. They isolated lymphocytes from both lymphoid and nonlymphoid tissues of mice that had been previously infected with virus or bacteria, and used flow cytometry, staining for antigen-specific T-cell receptors and other markers, to determine the percentages of memory cells in different organs. Even 296 days after infection, virus-specific CD8+ T cells were seen in nonlymphoid tissues in significant numbers. Says Lefrançois: "We performed a major cataloging of the immune response to infection throughout the entire body, which hadn't been done before." CENTRAL AND EFFECTOR MEMORY To the surprise of Lefrançois and his fellow immunologists, the cells found in the periphery "had immediate effector function," he says. This helped to prove a hypothesis put forward a year and a half earlier by Antonio Lanzavecchia and his colleagues at the Basel Institute for Immunology in Switzerland. The hypothesis states that there are at least two functional phenotypes of memory cells.3 In a recent review, Lefrançois explains: "Central memory T cells are located in the secondary lymphoid tissues, have little cytolytic activity, and are proposed to have limited migratory potential. Effector memory T cells reside in nonlymphoid tissues, are cytolytic, and have promiscuous circulatory potential."4 Meanwhile, Jenkins says he was surprised to find that peripheral CD4+ cells made interferon-gamma (IFN-*),indicating that they, too, were effector cells. His group had spent considerable time analyzing lymphoid tissue, but previously could not find many IFN-*-producing cells. These cells should be plentiful, given that the mice were making IgG2a antibodies, an indication of IFN-* production. "Both papers inform us very clearly that we must look at the behavior of lymphocytes in their true, most relevant, context: peripheral tissues," says Le Gros. All the paradigms have been built up based on lymph node T cells, but behavior and properties of lymphocytes in peripheral tissues cannot be ignored. They are "very disease-relevant, and very relevant to the design of vaccines," Le Gros adds. When physicians or vaccine designers such as the National Institutes of Health's Robert Sedar want an indication of the human response to immunization, they typically look for effector cytokines such as IFN-* or interleukin-4 (IL-4), but only in the circulating lymphocytes. "So we're massively underestimating, probably, the effector response by limiting ourselves in humans just to blood," Sedar says. Lefrançois' and Jenkins' work "opened our eyes." Le Gros says that in his studies of asthma, much drug discovery is aimed at controlling the activation and proliferation of T cells in a lymph-node context, but this may be wrong. He and his colleagues have recently reported that activated T cells in the lymph nodes can migrate to the lung and airway. Once there, while able to produce considerable amounts of the asthmatic cytokine IL-4 upon antigenic challenge, they are completely unable to divide or migrate back to the lymph nodes.5 Swain's group has found that "there is continuum of effector heterogeneity, and only the most differentiated effectors can migrate into an inflammatory" or other nonlymphoid site.6 They suggest that these "heterogeneous effector populations may give rise to corresponding memory populations."7 The raison d'etre for extralymphatic effector lymphocytes is easy to guess. It just makes sense for antigen-specific effector cells to be where an infection is likely to recur. Many researchers now are teasing out additional differences between these and the cells in the lymphatic organs.
Josh P. Roberts (email@example.com) is a freelance writer in Minneapolis Minn.
(Note: Marc Jenkins was a member of Roberts' PhD committee at the University of Minnesota.)
1. D. Masopust et al., "Preferential localization of effector memory cells in nonlymphoid tissue," Science, 291:2413-7, 2001. (Cited in 195 papers)
2. R.L. Reinhardt et al., "Visualizing the generation of memory CD4 T cells in the whole body," Nature, 410:101-5, 2001. (Cited in 175 papers)
3. F. Sallusto et al., "Two subsets of memory T lymphocytes with distinct homing potentials and effector functions," Nature, 401:708-12, 1999.
4. K.S. Schluns, L. Lefrançois, "Cytokine control of memory T-cell development and survival," Nat Rev, 3:269-79, April 2003.
5. N.L. Harris et al., "Differential T cell function and fate in lymph node and nonlymphoid tissues," J Exp Med, 195:317-26, 2002.
6. S.L. Swain et al., "Regulation of memory CD4 T cells: Generation,localization and persistence," Adv Exp Med Biol, 512:113-20, 2002.
7. E. Roman et al., "CD4 effector T cell subsets in the response to influenza: heterogeneity, migration, and function," J Exp Med, 196:957-68, 2002
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
Contact: Vera Hassner Sharav
To err is human, but Johns Hopkins researchers have shown a tendency to cut corners on safety and ride roughshod with experimental subjects--human and animal.
This time the victims are 10 monkeys and baboons who died as a result of being injected with d-amphetamine in an experiment that was testing the toxicity of Ecstasy. Failure by anyone at the laboratory to examine and properly label the vials containing d-amphetamine and Ecstasy, resulted in their death. The New York Times reports that Dr. Richard Ricaurte, the principle investigator said his laboratory made "a simple human error." "We're scientists, not politicians."
Don't we expect scientists to be meticulous about following proper scientific methods in the laboratory to protect the safety of the living subjects, not to mention to ensure the integrity of their findings?
The culture that dominates academia is reflected in the scientist's response to the reporter's question: why were the vials not checked first? Dr. Ricaurte's replied: "We're not chemists. We get hundreds of chemicals here. It's not customary to check them." Is the proper labeling of controlled, Schedule II psychoactive substances a requirement of FDA regulations?
PHARMOPHILIA: Why Do Doctors Love Drugs So Much?
"Modern medicine" may well be defined as "the experimental study of what happens when poisonous chemicals are placed into malnourished human bodies." Politically powerful medical quackery is nothing new. Drug-and-cut doctors have been ignoring nature's laws for a long time, with disastrous results. "General Washington was taken in the night (in December, 1799) with a sore throat. The 'bleeder' being sent for, he took from him 14 ounces of blood. The following morning, the family physician arrived, and proceeded to bleed him copiously, twice within a few hours, and again the same evening, giving him thereafter a dose of calomel (mercury). Next morning he was given another dose. The next day another physician was called in consultation, and the result was that they took an additional 32 ounces of blood from General Washington. There was no alleviation of the disease. Ten grains more of calomel were given, followed by a tartar emetic in large doses. To his extremities blisters were applied, and to his throat poultices."
"General Washington died."
(from the Pittsburgh Health Club Newsletter, July 31, 1931)
Former First President George Washington, the father of our country, died from a sore throat? No sir: he died from the treatment. Washington had the best scientific medical attention of his day. And? They bled him no fewer than five times in three days. Let's do the grisly arithmetic. The first bleeding removed 14 ounces; there were then three bleedings of unspecified quantity, collectively described as "copious"; and then a final full quart was removed. Assuming that the three "copious" bleedings were also 14 ounces each, that is another 42 ounces lost. Adding up, we have:
14 x 3 = 42
Some 88 ounces of blood was taken from George Washington. The human body contains about 10 units, that is to say 10 pints (5 quarts) of blood. 88 ounces is pretty close to 3 quarts, or nearly 6 units; that's well over half the blood in a person. Some estimates place Washington's total bleeding
closer to 8 units. It doesn't take a conspiracy, nor does it require an assassin, to kill a great man. Stupidity will do it just as well.
"The Dark Ages of Medicine are long over," you say? If only that were true. Let's take a short hop over to Britain for some very unsettling news that may well bring avoidable sickness and unnecessary death to millions.
MOST VITAMIN SUPPLEMENTS TO BE BANNED THROUGHOUT EUROPE:
THE EU FOOD SUPPLEMENTS DIRECTIVE
by P.M. Goodwin, United Kingdom
The European Union Food Supplements Directive was passed by the EU Parliament on 13 March 2002, and became law in the 15 EU member states on 1 August 2003.
This legislation, if unchallenged, will have the effect of banning over 300 vitamin and mineral forms and 5000 products from the European market, by 1st August 2005.
By 2007, if not earlier, the Food Supplements Directive will also be applied to other nutrient groups such as fatty acids and amino acids, with similarly devastating results. Other EU legislation currently in the pipeline, such as the Traditional Herbal Medicinal Products Directive and the Pharmaceuticals Directive (which proposes to amend the definition of a medicine) threatens to remove still further categories of natural health products from the European market.
Readers of this newsletter who live outside of the EU and who think that this legislation bears no relevance to them should think again. The Food Supplements Directive bears a strong resemblance to legislation now under discussion at a global level by the Codex Alimentarius committee (a little known commission of the United Nations World Trade Organization). Indeed, many of the architects of the Directive are also members of the Codex committee. If the Food Supplements Directive is not stopped it will strongly influence the deliberations of the Codex committee, who advocate similar tight restrictions on the sale of supplements. The USA would then come under strong international pressure to implement the Codex recommendations because of its' having signed up to the NAFTA and GATT international trade agreements. All decisions emanating from the Codex Alimentarius Commission are directly incorporated by the World Trade Organization (WTO) and will ultimately overrule all current national laws.
Although many US supplement companies have been led to believe that US laws cannot be downgraded ("harmonized") to WTO/Codex, close examination of WTO rules appear to make this almost inevitable; especially so considering the weak statutory wording of the 1997 FDA Modernization Act, which purports to protect American health freedoms from harmonization to restrictive rules elsewhere.
The Alliance for Natural Health (ANH) http://www.alliance-natural-health.org is an international organization of scientists, practitioners, lawyers, public relations and media experts working specifically to amend European legislation in order to maintain the availability of innovative, safe and effective food supplements. While progress has been made in proposing amendments to the Traditional Herbal Medicinal Products Directive and the Pharmaceuticals Directive, the time for lobbying in respect of The Food Supplements Directive is over. The only option remaining now to eliminate the devastating effects of this Directive is a lawsuit. This is a costly process, and funds are very urgently needed. Please consider making a donation to the ANH legal campaign-fund at
Legal papers to challenge the directive have to be filed in London by the end of October, at the very latest, or our window of opportunity will close. The future rights of all people on this planet to buy safe and effective dietary supplements are now at stake, and a choice regarding whether or not we are prepared to defend these rights must now be made by each and every one of us.
The Doctor Shrugged
Thursday, October 30, 2003
By Julia Gorin
I find the show "ER" fascinating. On it, the people in white coats actually rush around as if something is at stake. Their faces show expression, often of concern, as if they're worried whether a patient lives or dies. It isn't like any emergency room or doctor's office I've ever seen.
In real life, one goes to a hospital if he or she is curious to have a near death experience. Medical treatment is the third leading cause of death in the United States, after heart disease and cancer, according to a 2000 Journal of the American Medical Association article by Dr. Barbara Starfield (search) of the Johns Hopkins School of Hygiene and Public Health. Starfield places medically-related deaths at 225,000 a year, while a more conservative estimate by a 1999 Institute of Medicine report placed the number of deaths by medical error at 100,000 a year.
The subsets of statistics behind these numbers are even more alarming. Starfield's JAMA report claimed that 106,000 deaths are caused by correctly prescribed medications, while prescription error accounts for 7,000 annual deaths. (Meanwhile, a 1998 JAMA study claims prescription error seriously injures 2.1 million patients every year.)
Last week, ABC's "Primetime Thursday" attributed 100,000 annual deaths to hospital infections alone--at least 50,000 of them preventable through the practice of basic hygiene by hospitals. The report mentioned that ABC sportscaster Dick Schaap died two years ago from a hospital infection he got after routine hip replacement surgery because the medical staff at New York's prestigious Lenox Hill Hospital couldn't be bothered to wash their hands between patients.
My former college professor, who has a heart condition, caught on early. Whenever hospital staff enter his room, he asks, "What is my name? And what am I here for?" Otherwise, he fears, healthy organs may get removed and the wrong appendages amputated. But even this kind of diligence would not have helped a former colleague of mine, a 115-pound woman who went into the hospital for a colonoscopy and wound up in the intensive care unit after being injected with enough local anesthetic for a 220 pound man.
When I was paying out-of-pocket for an HMO that didn't cover medication, I was given a prescription for medicine to treat a condition opposite of what I had. After the mistake was discovered--and after I had paid for and ingested the pills-- I asked the substitute doctor if I could get reimbursed for the expensive but incorrect prescription his partner prescribed. He condescendingly defended the erring doctor saying, "Doctors are only human. We make mistakes. Haven't you ever made a mistake?" Needless to say, I got a new doctor, an obstetrician with whom I was very happy until one day, after delivering a patient's baby via cesarean section, he decided to carve his initials into the woman's stomach.
Consider that when medical doctors in Israel went on strike (search) in early 2000, the funeral industry tanked. The burial association complained to the government to increase doctors' salaries. The only city that did not see a decline in its death rate was Netanya, where doctors had a no-strike clause in their contracts.
Doc, when your parents sent you to medical school so you could make a killing, they didn't mean literally.
The frightening statistics, coupled with the negative doctor-patient experiences behind them (35 percent of doctors themselves complain about the doctor care they or their families get, according to the IOM report) might explain why there is something called alternative medicine (search). It gives people an alternative to dying.
Don't think I wasn't skeptical when my homeopath told me the pain in my neck was being caused by a troubled gall bladder. But sure enough, after she treated my gall bladder, I could move my neck. That's because holistics know how one body part can "refer" pain to a seemingly unrelated body part. Conventional doctors don't know that one body part has anything to do with another. If they did, they wouldn't operate on the wrist for carpal tunnel syndrome when the pain and tingling in the forearm usually stems from a pinched nerve in the neck or back.
But mention to a physician that you see a holistic practitioner and he may well call such party a "quack." That was the response of my primary care physician after he discovered I'd been seeing a holistic chiropractor for chronic back trouble. Sounding a bit like a spurned lover, he whined, "You didn't have me look at your back."
But why see an MD for a misaligned back? So he can say, "It's not fractured. Do you want a painkiller?" Indeed, to be a doctor in America all you need to know is the word "painkiller." "We're basically pill pushers," one young physician admitted at a party, adding that, much like a diner waitress hoping you'll stick to the menu, doctors are looking for the path of least resistance.
Unless you demonstrate classic symptoms of one of the six or so conditions that fall into a medical doctor's limited repertoire of common, recognizable conditions, he won't really know what's wrong with you until the autopsy. You get more answers from a veterinarian, for crying out loud. (Which would explain the expression "healthy as a horse.") From the physicals to the check-ups to the trial-and-error means of diagnosing, coming into a doctor's office for any reason other than antibiotics is an exercise in futility. It's a running joke that a primary care physician's competence is best measured by how expeditiously his staff fills out referrals.
God bless Western medicine for all the breakthroughs--the vaccinations, the transplants, the emergency life-saving procedures and cutting-edge modern miracles. But these days its practitioners perform best for those on the brink of death, and that's where you'd better be when you come to these people, or they'll bring you there.
I'm not saying doctors have to be flawless. I'm just asking them to appreciate the difference between a patient and a piece of furniture. Because there are errors, but there is also apathetic negligence, not to mention an arrogance that is buttressed by a rigid hierarchy at hospitals, wherein ranking doctors can't be questioned or corrected by nurses or lower doctors. It's not uncommon for nurses to sneak around doctors' orders to keep from killing the patients, as a nurse I knew observed another nurse do when the doctor was overdosing a patient on intravenous medication.
Doctors must stop discouraging patients from seeking alternative care--whose purpose is not to compete with, but to supplement, traditional care. Thankfully, there are the "radicals" of the profession bridging the Western model and the Eastern model, some practicing both, others referring patients to alternative care specialists (which insurance companies are increasingly covering). There is a place for both conventional and alternative medicine, and MDs should know their place.
If any of the symptoms mentioned here hit too close to home for some doctors, they should read this twice and call each other in the morning. And if the truth still hurts, take a painkiller and ignore the problem.
Julia Gorin is the author of the newly released "The Buddy Chronicles," available through Bruiserbooks.com, and a contributing editor to JewishWorldReview.com. She is the featured comedian in Republican Riot, a monthly comedy show in New York.
'Major measles epidemics likely' due to MMR rates
The UK will face serious outbreaks of measles this winter unless parents stop boycotting MMR, latest figures suggest. One of the doctors who first suggested the triple jab may be linked to autism is now warning of 'major measles epidemics'. This comes as the Health Protection Agency says there have already been 360 confirmed cases of measles in the UK this year - compared with 308 for the whole of 2002. And recent Welsh figures reveal 323 mumps cases and 40 cases of measles.
Latest Scottish figures also suggest a rise in childhood diseases over the past 18 months. Suspected cases of measles, mumps and rubella have risen by 18 per cent, 27 per cent and 22 per cent, respectively. The HPA says national uptake for MMR now stands at 78.7 per cent, although in parts of Wales, coverage is as low as 69 per cent, and in parts of London it has dipped to 61 per cent.
In this week's Lancet, Dr Simon Murch of London's Royal Free Hospital, one of the authors of the report that first sparked speculation of a link between the MMR vaccine and autism, says low vaccine uptake means measles is 'certain' to become endemic in the UK again, and the near elimination of congenital rubella syndrome is likely to be reversed. 'Unless vaccine uptake improves rapidly, major measles epidemics are likely in the UK this winter,' he says.
Dr Murch, who worked with Dr Andrew Wakefield on his controversial study, now says there is 'unequivocal evidence' MMR is not linked to autism. RCGP spokesman on immunisation Dr George Kassianos said unless the jab rate was 95 per cent, there would be measles outbreaks. 'It's not whether you could - you will. In some areas, it's so low that it's inevitable.' He added MMR was the saf- est vaccine available for measles, mumps and rubella and single jabs had no place in the UK's immunisation strategy.
Medical defence warning
Defence organisations have advised GPs to tighten up vaccination procedures following accusations doctors have been giving MMR by stealth. The national media has highlighted claims that children getting Haemophilus influenzae b boosters have, at the same time, been given the triple jab without their parent's knowledge.
The accusation comes from Sarah Dean, chief executive officer of Direct Health 2000, which offers single vaccines. She said at least 70 parents had contacted her company with such claims. Medical indemnifiers said they had seen no evidence that GPs had been purposely giving MMR without parental consent and that the threat of legal action would make it unlikely. However, they said mistakes could occur with all jabs and advised GPs to make sure they got the correct authority from parents.
Dr Stephanie Bown, of the Medical Protection Society, said: 'What's important is that all practices have got a policy in place which makes sure that issues of consent are clear.' Hertfordshire GP Dr Mike Ingram said that giving vaccinations by stealth would be in breach of the 'moral code that binds general practice'.
Lancet, 2003, 362, 1498-9
Injuries in Hospitals Pose a Significant Threat to Patients and a Substantial increase in Health Care Costs
Press Release Date: October 7, 2003
Medical injuries during hospitalization resulted in longer hospital stays, higher costs, and a higher number of deaths in 2000, according to a study from the Agency for Healthcare Research and Quality. The study, "Excess Length of Stay, Charges, and Mortality Attributable to Medical Injuries During Hospitalization," is published in the October 8 Journal of the American Medical Association.
Researchers, led by AHRQ's Chunliu Zhan, M.D., Ph.D., found that the impact of medical injuries varies substantially. Postoperative bloodstream infections had the most serious consequences, resulting in hospital stays of almost 11 days longer than normal, added costs of $57,727, and an increased risk of death after surgery of 21.9 percent. Based on this data, researchers estimate that 3,000 Americans die each year from postoperative bloodstream infections. The next most serious event was postoperative re-opening of a surgical incision, with 9.4 excess days, $40,323 in added costs, and a 9.6 percent increase in the risk of death. This equates to an estimated 405 deaths from reopening of surgical incisions annually. Birth and obstetric trauma, in contrast, resulted in little or no excess length of stay, cost, or increase in the risk of death.
"This study gives us the first direct evidence that medical injuries pose a real threat to the American public and increase the costs of health care," said AHRQ Director Carolyn M. Clancy, M.D. "The nation's hospitals can use this information to enhance the efforts they already are taking to reduce medical errors and improve patient safety." The study used AHRQ's Patient Safety Indicators and Healthcare Cost and Utilization Project's National Inpatient Sample data to identify medical injures in
7.45 million hospital discharges from 994 acute care hospitals across 28 states in 2000. The study provides, for the first time, specific estimates for excess length of stay, charges, and the risk of death for each of 18 of the 20 AHRQ Patient Safety Indicators.
"The message here is that medical injuries can have a devastating impact on the health care system," said Dr. Zhan. "We need more research to identify why these injuries occur and find ways to prevent them from happening."
For more information, please contact AHRQ Public Affairs: Ron Rabbu (301)
427-1862 (RRabbu@ahrq.gov); Karen Migdail, (301) 427-1855 (KMigdail@ahrq.gov).
Injuries in Hospitals Pose a Significant Threat to Patients and a Substantial increase in Health Care Costs. Press Release, October 7, 2003. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/news/press/pr2003/injurypr.htm
July 26, 2002 2,610 Infants died of preventable hospital-acquired infections - Chicago Tribune
President Bush would limit health care liability http://www.nytimes.com/2002/07/26/politics/26BUSH.html .
Clearly neither he nor his advisers have considered The Chicago Tribune's investigative series, Unhealthy Hospitals (excerpt below).
This Tribune series should be required reading for members of the various research "protection" advisory committees that are reinterpreting federal regulations to accommodate the needs of the biomedical research industry. Efforts are under way to give medical researchers easier access to children who are being recruited--often against their best interest--for painful research studies that bring them in contact with hospital-acquired infections. These advisory panels have largely ignore the existing lethal hazards that hospitals pose for children. Instead, they lend support for unjustifiable experiments on the theory that healthy children may be "at risk" of possible future illness.
The Tribune’s investigation linked the deaths of 2,610 infants in the year 2000 to preventable hospital-acquired infections--most were caused by Hospital staff--doctors, nurses, and maintenance workers-- who failure to follow simple hygienic procedures unsanitary: “The lack of hand-washing is responsible for most germs spread in pediatric intensive care units, said Dr. William Jarvis, chief of the CDC's hospital infections program.”
The Tribune identified 75, 000 preventable deaths "where hospital-acquired infections played a major role. This analysis, based on the most recent national data, is the most comprehensive of its kind and draws on thousands of hospital and government inspection reports."
INVESTIGATION: UNHEALTHY HOSPITALS
Lax procedures put infants at high risk
Simple actions by hospital workers, such as diligent hand-washing, could cut the number of fatal infections.
Second of three parts.
By Michael J. Berens Tribune staff reporter
July 22, 2002
Tamia Jones arrived two months early, weighing less than 3 pounds. For the first three days, her life was charted from precarious to uncertain to probable. By the fifth, she opened brown eyes and was weaned from feeding tube to mother's milk. On the seventh, she died.
One of the nation's most prolific and lethal germs, pseudomonas aeruginosa, was on the loose in a hospital nursery.
Tamia's parents say no one at Sinai-Grace Hospital in Detroit even mentioned the infection to them. If it was a secret, it became one that was impossible to keep.
In three months in spring 1997, on the same floor, within the same nursery unit, along the same row of bassinets, hospital germs contributed to the deaths of three other babies and slipped undetected into 15 more newborns at Sinai-Grace…..cut… In the majority of cases in pediatric intensive care units, those lives might have been saved by simple acts of washing hands or isolating patients the moment infections were detected, according to inspection and investigative files at the U.S. Department of Health and Human Services.
The records reveal hundreds of examples of unsanitary conditions and unsafe practices:
His nose dripping from a common cold, a doctor in a Los Angeles hospital in 1999 worked the bedsides of newborn patients for half an hour without stopping to wash his hands. Within a week, 12 critically ill children contracted infections from pneumonia-causing staphylococcus germs. Two newborns died. A hospital investigator traced the germ back to the doctor.
Without protection from a mask, gloves or gown, a New York nurse took the blood pressure of a child suffering from staphylococcus, a germ that attacks the respiratory system. She then immediately embarked on bedside checks in another ward of at least six other premature infants, three of whom contracted pneumonia and died in 1998.
Hospital investigators determined the nurse was the only common link among the infected children [cut].
In analyzing the infection problems inside pediatric units, the Tribune examined computerized patient admission and billing records as well as state and federal health-care enforcement records encompassing nearly 4 million U.S. births each year.
Infants are among the most vulnerable patients, but they routinely are treated in ways deemed inappropriate for adults within the nation's 5,810 registered hospitals. Hospital investigations and CDC and Health and Human Services records show:
- Infants riddled with infections often are treated side by side with healthier babies in large intensive care units, allowing germs to spread among patients. At least 1,200 hospitals use large pediatric wards as a cost-effective way to treat the most children. But pneumonia-causing germs, for instance, can become airborne from coughing and sneezing.
Conversely, adult patients are usually segregated into different recovery rooms based on malady, and they are usually cordoned off with curtains or other barriers not typically found in pediatric wards. Adults also are more likely to be isolated in private rooms, the CDC found.
- Harried nurses rapidly shuttling between the beds of infected patients and other areas of the hospital unwittingly transported germs that are believed to have led to deadly infections in at least 500 children in 2000. Carelessness by nurses and aides also causes life-threatening injuries to thousands more each year. Adult patients with infections are more commonly treated by teams of nurses prohibited from contact with other patients.
- An estimated 200 newborns die each year because most hospitals are unwilling to pay about $5 extra per catheter to use germ-resistant, silver alloy catheters, a federal study found. Most ill babies are connected to catheters, which are hollow, flexible tubes inserted into the body to allow passage of fluids. Although the CDC and leading health-care agencies have called for nationwide adoption of the germ-fighting catheters, many hospital officials argue that the expense is not justified compared with the number of infections prevented.
Premature and low-weight newborns are the most vulnerable patients to infection. Their underdeveloped or non-existent immune systems often coincide with serious cardiac and respiratory ailments.
"The germs can sneak up at you at times," said Mary Gould, infection-control supervisor for Children's Hospital in Birmingham, Ala. "You can't be looking at all directions at the same time.... Something could be going on behind you [cut]...
Sanitation is particularly important in pediatric intensive care units, where hospital-acquired infection rates range as high as 20 percent, compared with less than 1 percent among infants born without medical complications, according to the American Association of Critical-Care Nurses.
Infection rates in pediatric ICUs rank higher than any hospital department because nearly all patients are attached to respirators, intravenous pumps or other invasive devices that can become an entry point for germs.
Deadly germs in the nursery
Sinai-Grace Hospital towers over Detroit's northwest side. Each year the 500-bed medical center handles 3,700 births, about 10 new lives every day.
The uncommon death of Tamia Jones on March 21, 1997, gave no pause to the pace.
On the sixth day of Tamia's life, a laboratory test showed she had been infected by a pseudomonas germ. But the infection caused by the germ worked faster than the antibiotic that was dripped into her body through an intravenous line, hospital records obtained by the Tribune show. She died the next day.
It took more deaths of premature babies and nearly two months before the hospital decided to close the nursery, segregate infected patients and scrub down every piece of equipment.
Pseudomonas is a water-based germ that can flourish in sinks, ice machines, damp towels, on the leaves of potted plants, even inside hand-lotion containers. The germ is typically spread by touch and can result in lethal infections, including in the respiratory and urinary systems. Unlike some germs that live on the skin, pseudomonas quickly looks for pathways into the body, such as respirator tubes.
Infectious-disease experts said even one case of pseudomonas in a pediatric intensive care unit should prompt immediate cleaning, isolation and enhanced testing of all current and future patients in the ward.
Dr. Wasif Hafeez, chief of Sinai-Grace's infectious diseases department, who was a lead investigator on the outbreak, defended the hospital's reaction, saying the bacteria moved so quickly the children were infected before the hospital could identify an outbreak.
"I don't think you could find anything that we could have done better," Hafeez said. The hospital reacted quickly once the outbreak was identified, he said.
"I get upset when someone says we should have been able to forecast that four children were going to die," Hafeez said. "I got my degree in medicine. Not astrology or palmistry."
He characterized the deaths as the "price of modern medicine." Fragile newborns lost 15 years ago are being kept alive with sophisticated machines and stronger medicines, which make patients more prone to "unbelievably virulent" germs like pseudomonas, he said.
After parents banded together to file a lawsuit, hospital officials pointed the finger of blame at Tamia's mother, Tracey Jones, who suffered several prenatal complications the officials said could have been caused by a pseudomonas germ. When Jones was brought to the hospital for an emergency Caesarean section, she might have carried the germ into the facility, a pediatric doctor at Sinai-Grace testified in a deposition.
There was one problem with that theory. Doctors had taken swab tests of Jones' nose and mouth in search of proof that pseudomonas lived on her body after Tamia's death; the tests were negative, according to hospital records obtained by the Tribune.
Hafeez confirmed the negative test results.
What the hospital never divulged to parents is that the germ was found on an employee, internal hospital records show.
Hafeez acknowledged for the first time to the Tribune that pseudomonas was found on the hands of a respiratory therapist who had worked in the intensive care unit. The therapist, he said, was ill and had undergone a colostomy; a small tube ran from the therapist's abdomen, emptying body waste into a bag.
The moist areas of tubing or even the bag could have been breeding spots for the germ, he said.
In addition to the strain of pseudomonas found on the therapist's hands, hospital tests identified two other strains in the intensive care unit, but the source of those germs was never determined, Hafeez said.
Rebecca Walsh, an attorney who represented the families of the dead children, said the parents were never warned of the outbreak or that hospital officials had identified the germ on any of their employees.
Parents would later testify in depositions that lapses in health care were all too evident: Many nurses and doctors did not wash hands or wear gloves while moving from crib to crib.
On March 30, nine days after Tamia died, another baby girl was brought into the neonatal unit. Alexis Crooms, weighing 1 pound 12.3 ounces, showed steady improvement. She stopped breathing 19 days later. An autopsy revealed the presence of pseudomonas.
Despite laboratory evidence that Tamia had died from pseudomonas, Alexis was never specifically tested for the germ while she was alive, according to court depositions by doctors.
While Alexis was in the nursery, a premature infant boy arrived and was placed in the same row of bassinets. Within 17 days, Prateep Bazel Jr. was dead. Tests done shortly before his death revealed pseudomonas, hospital records show.
Pseudomonas can cause dozens of different infections, making diagnosis difficult. Tamia developed inflammation of the spinal cord and brain; Alexis was gripped by lung-destroying pneumonia; Prateep was overwhelmed by inflammation of his internal organs.
The fourth baby died on June 26. Once again doctors identified pseudomonas, but they were too late to save Breanna Friday, whose intestines were attacked by an uncontrollable infection.
The lawsuit filed by the parents of the four infants was settled out of court in 1999 for an undisclosed sum. [cut]
Copyright © 2002, Chicago Tribune
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Posted on Sun, Nov. 30, 2003
Hospitals kept quiet on cause of infant deaths
By Toni Heinzl
Star-Telegram Staff Writer
SPECIAL TO THE STAR-TELEGRAM/JUDY LOWREY
Jacque Gibson White looks through photos of her only child, Rachel, whose death was attributed to a treatment for premature babies.
SPECIAL TO THE STAR-TELEGRAM/JESSICA KOURKOUNIS
Alice Hernandez holds a stuffed toy that had belonged to her son, Jose, who lived only four months. The hardest days for her are his birthday and Christmas, when she visits his grave.
Fort Worth attorney Dwain Dent, who has represented 21 families in E-Ferol lawsuits, believes the number of E-Ferol deaths is higher than the Food and Drug Administration has reported.
Joe and Alice Hernandez look over Jose "Little Joe" Hernandez at Harris Methodist Fort Worth in this 1984 photo. The autopsy said he died because of underdeveloped lungs.
Jacque Gibson White holds her daughter, Rachel, who was born in 1984 at Cook Children's Medical Center and lived for 27 days. More than a decade passed before White learned what caused Rachel's death.
Rachel Ann Eskew was born prematurely and was given E-Ferol to help prevent blindness. She was among dozens of babies nationwide to die after being given the intravenous vitamin E treatment.
Jose Hernandez III was born Feb. 18, 1984, and died four months later. His mother, Alice, says she blamed herself for years until learning that her baby had received an unapproved drug.
The Food and Drug Administration has blamed 38 infant deaths on E-Ferol Aqueous Solution, which was recalled in 1984.
FORT WORTH - All Jacque Gibson White has left of her daughter, Rachel, are memories, painful memories of stroking her baby's head and holding her tiny hands every day of the four short weeks she lived at the intensive care nursery at Cook Children's Medical Center.
Rachel Eskew was her only child.
Born prematurely, she had difficulty breathing. But Rachel was a fighter. White noted in her diary a ray of hope: On Feb. 25, 1984, three days after she was born, Rachel's doctors pegged her survival chances at 85 percent.
Then Rachel suddenly took a turn for the worse. She died March 20, 1984. Doctors initially told White that the cause of death was kidney and heart failure for unknown reasons.
Two years later, the hospital learned that Rachel was among dozens of premature babies nationwide who died after being given E-Ferol Aqueous Solution, an intravenous vitamin E preparation intended to help prevent blindness. But the hospital didn't notify White of the finding. In fact, it would be 11 more years before she learned why her daughter died.
Many other hospitals, perhaps fearing costly lawsuits, also kept families in the dark about the potential link between the deaths or disabilities of their babies and the administration of E-Ferol, which had been marketed without the approval of the Food and Drug Administration.
Now, a federal lawsuit is aiming to force hospitals to disclose the link. At issue is whether hospitals must contact former patients or their families after it is discovered that some aspect of their care may have harmed them.
Cook Children's stance is that notification by the hospital violates doctor-patient confidentiality. Other hospitals have adopted policies to notify patients or families if hospital doctors ascertain that medical or pharmaceutical errors led to serious injury or death, policies that White's attorney maintains should be required of all hospitals.
In the E-Ferol cases, the disclosure issue has taken on urgency because time is running out for parents and patients who survived to sue the corporations that manufactured and sold E-Ferol and the hospitals that administered it.
The statute of limitations in state courts expires 20 years after the babies suffered illness or died. The drug was recalled on April 11, 1984, as death reports mounted from hospitals across the country.
The E-Ferol tragedy resulted in criminal prosecutions of corporate executives. Three executives at two companies that manufactured and sold the drug were convicted of fraud, misbranding and selling an unapproved dangerous drug; they were sentenced to six months in federal prison.
Outrage over the deaths prompted congressional hearings that exposed weaknesses in the nation's regulatory system for pharmaceutical drugs.
But it was never fully ascertained how many deaths or injuries to premature babies the drug caused.
FDA reports indicated that the drug was administered to more than 1,000 babies at more than 100 hospitals, including Cook Children's, Harris Methodist Fort Worth and Baylor Medical Center of Dallas. Based on information provided by hospitals, the FDA reported that at least 38 babies died out of about 100 who suffered such adverse reactions as blindness or damage to the kidneys, liver or brain.
There were no autopsies in some deaths because doctors blamed the babies' prematurity and related ailments, such as underdeveloped lungs. That's the position taken by some hospitals that resist disclosing the names of babies who were given E-Ferol. Cook Children's spokeswoman Carolyn Bobo would not comment on any individual case, instead offering a statement:
"In 1984, neonatologists at Cook Children's cared for several infants whose families were later involved in litigation related to use of E-Ferol, a drug used to treat babies born with extreme prematurity. Neonatologists followed standard care guidelines for these infants. The FDA notified physicians and hospitals throughout the United States that E-Ferol should be withdrawn from use. Neonatologists at Cook Children's stopped use of the drug immediately.
"Physician testimony clearly indicates that these infants suffered from extreme prematurity and complications related to extreme prematurity, and that use of E-Ferol was not a significant factor in their care, health or survival at Cook Children's."
Seeking the victims
One of the experts who exposed the dangers of E-Ferol was Dr. Robert Brown, a pediatric pathologist at Cook Children's.
Brown had studied E-Ferol syndrome in 1984 and 1985 with partial funding from the hospital and published his findings about the drug's harmful effects in an April 1986 article in Pediatrics, the journal published by the American Academy of Pediatrics.
After Rachel's death, her doctors asked Brown to perform an autopsy consultation, in which the initial autopsy is scrutinized. In his report, dated Dec. 15, 1986, he concluded that Rachel died of E-Ferol syndrome. Brown wrote to one of Rachel's physicians that he would be willing to meet with Rachel's doctors and her parents "to discuss these new findings."
Brown also notified the hospital's administration. But no one told White. Nor did the hospital notify others whose infants received E-Ferol. That became a central issue in a long-running liability lawsuit in state district court in Tarrant County. The company that manufactured E-Ferol, Carter-Glogau Laboratories of Glendale, Ariz., and the drug's distributor, O'Neal, Jones & Feldman Pharmaceuticals of Maryland Heights, Mo. -- have been willing to offer settlements in cases where it can be proved that infants received large enough doses of E-Ferol to cause health problems or death, said Dallas lawyer David Taylor, who represented the corporations in about 20 E-Ferol cases in North Texas.
The companies, which went out of business after the scandal but still exist in little more than name only to resolve lawsuits in about 20 states, have settled about 130 E-Ferol lawsuits nationwide. The settlements include cases involving the deaths of six infants in Tarrant County.
Not a single case has gone to trial. But the companies do not know which babies received the drugs. They know only which hospitals received E-Ferol, information O'Neal provided to the FDA during the recall. "My client [O'Neal] sold the product to the hospitals -- the FDA did not know which patients got the drug," Taylor said. "Only the hospitals knew. "In some cases, hospitals made extraordinary efforts to reach families; in other cases they didn't. As today, there was a lot of pressure on litigation, and some hospitals are afraid to get sued." Cook Children's reported to the FDA that it had given the drug to seven infants, according to an FDA document dated June 12, 1984. But attorney Dwain Dent of Fort Worth, who has represented the families of 21 infants in product liability lawsuits involving E-Ferol, believes the number of babies who died or suffered health damage because of E-Ferol nationwide and in Tarrant County is much higher than the official figure because the FDA relied on potentially incomplete reports from the hospitals as the tragedy unfolded.
Dent asked the court to force disclosure of the names, and Cook Children's resisted. Bobo, the hospital's spokeswoman, declined repeated requests for interviews with hospital officials or attorneys and declined to answer questions about infants who received E-Ferol. Court papers outline the hospital's key position that revealing the information would violate doctor-patient privilege.
Former hospital President Peggy Troy testified in 1999 that it was a doctor's responsibility to tell a patient if he or she has been injured or harmed or given an illegal drug such as E-Ferol. In one exchange during the deposition, Troy acknowledged that the hospital did not intend to volunteer the information to the patients or their parents. Dent: "I'm asking if you, as the executive officer of the hospital, have visited with any committees about notifying parents of these children that they received this ... drug during 1984 in your hospital?"
Dent: "And is it on any agenda for the future?"
Dent: "And do you intend to ever give them notice?"
In their rulings in favor of disclosure, two state courts rejected the hospital's claim of doctor-patient privilege.
In an Oct. 18, 2002, order, District Judge Tom Lowe said he had to balance the patients' right to privacy with their "right to know that they have been administered an illegal, non-FDA approved and potentially harmful or lethal drug." "Of concern to this court is that some child may be suffering consequences of E-Ferol toxicity and may not know it," Lowe wrote.
After the 2nd Court of Appeals in Fort Worth upheld Lowe's conclusion, the hospital asked the Texas Supreme Court to review the ruling. Dent then dropped the case. He said he feared that it could be years before the Supreme Court took up the case.
"The kids might lose their rights to file a complaint," he said.
Instead, Dent decided to seek class-action status through a lawsuit in federal court in Wichita Falls. The suit was filed May 29 on behalf of two plaintiffs in Texas and Georgia and all others who received E-Ferol as premature infants between December 1983 and April 1984.
It has been scheduled for a four-week trial in November 2004 before Senior U.S. District Judge Jerry Buchmeyer. "We continue to push for disclosure because we think all families [have] got to know if their child got this dangerous drug in 1984," said Dent, who teamed with Fort Worth lawyer Art Brender in the federal lawsuit. "I'm a parent of two. I'd want to know."
The hospital has sued O'Neal and Carter-Glogau in federal court to recoup more than $250,000 in attorneys' fees and expenses it incurred in defending the health-care liability action in state court. In federal court filings, the hospital describes itself as a victim of the manufacturer and distributor. "Cook was nothing more than an innocent seller of the drug-manufacturing defendants' defective product," the hospital said.
Taylor acknowledged the mistakes the two companies made. But he said they are not willing to pay for the hospital's refusal to turn over the patient names. "Cook's was in this lawsuit because the plaintiffs wanted information from Cook's, and Cook's refused to provide the patient records," Taylor said. "Our position is that it is not our problem to defend Cook's for refusing to give out information. We are defending the product."
The fee-dispute case is still pending before U.S. District Judge Terry Means in Fort Worth.
Parents not informed
The death of Alice Hernandez's first child, Jose, overshadows her life to this day. Jose Hernandez III, or "Little Joe" as his parents called him, was born at Harris Methodist Fort Worth on Feb. 18, 1984. He died exactly four months later. Hernandez, 43, of Mesquite, then a pharmacy technician at Harris Methodist H.E.B., went to see Little Joe at the hospital every day, often staying until late at night.
"When he started getting worse, we asked the head of the ICU if they could give us a different doctor or do anything else," Hernandez said. "They said no, there was nothing else they could do. "The autopsy said he died from underdeveloped lungs. He was fine the first week he was born. He weighed 2 pounds, 9 ounces at birth and was 15 1/2 inches. When he died, he was 9 pounds and his entire body was swollen. He went downhill after he got the drug."
Hernandez wishes the hospital had voluntarily told the families about the E-Ferol treatment immediately after it was recalled. She found out that her son had received high doses of the drug only after hearing from another mother whose premature baby girl had died at Harris that spring.
Hernandez reached a confidential settlement with O'Neal and Carter-Glogau in 1997. Though Harris didn't notify parents or patients at the time of the recall, it has taken a different stance from Cook Children's. Harris, also named as a co-defendant in Dent's previous state lawsuit, complied with requests to produce the names and then was released from the lawsuit. Dent still has one new state case pending against Harris. A spokeswoman for Harris, Laura Van Hoosier, declined to comment.
Harris gave Dent the names of 41 of the 80 patients who hospital officials told the FDA had received E-Ferol, saying those were all the names it could retrieve and that some patient records may have been lost, Dent said. That stance is more in line with recommendations from physician associations, pharmacist groups and consumer advocates, who say that health-care providers should promptly inform patients of serious medical errors.
"Once an organization has determined that a patient was given a dangerous substance or an error has occurred, the institution has a duty to notify patients or their families," said pharmacist Casey Thompson, an expert on patient safety issues with the American Society of Health-System Pharmacists. "Ethically, it would be the right thing to do."
That's not only in the patient's best interest. An often-cited 1999 study of a disclosure policy at the Veterans Affairs Medical Center in Lexington, Ky., found that openly acknowledging serious errors and taking swift measures to prevent similar mistakes actually helps reduce the number of malpractice lawsuits and the amount of damages awarded.
For Hernandez and White, the delay in notification added to their grief.
"The mothers carry this guilt for such a long time," Hernandez said. "I blamed myself and God for 10 years, until I found out the truth." The hardest days for Hernandez are Little Joe's birthday and Christmas, when she makes the trip to Fort Worth's Mount Olivet Cemetery to visit his grave. White did not learn about Brown's finding on her daughter's death until November 1997, after her ex-husband, Brinkley Eskew, responded to an advertisement by Dent's law firm seeking witnesses who had babies at Cook Children's during the time E-Ferol was administered.
At Eskew's request, the hospital released his daughter's records -- without any explanation of what the medical files meant and without acknowledging that she was killed by E-Ferol, Dent said. Dent later wrote to White to tell her of Brown's findings. White then sued the two companies in state district court and reached a confidential settlement this year, as had Eskew. Dent dropped White's state liability suit against the hospital before turning to the federal courts.
White, who now lives near Newport News, Va., insists that doctors and hospitals should notify parents when mistakes are made that cause serious health damage or death. "I spent all these years since she died blaming myself, believing that it was completely my fault that I don't have my child," White, 43, said. "I would not have had to live with that guilt so long had I known." During the 27 days of Rachel's life, White wrote in her diary every day. Occasionally, she flips through the pages, taking a journey into a distant, never-ending past.
Tale of trouble with E-Ferol
Here is a timeline of the drug E-Ferol, which was manufactured by Carter-Glogau Laboratories of Glendale, Ariz., and distributed by O'Neal, Jones & Feldman Pharmaceuticals of Maryland Heights, Mo. August 1982: O'Neal executive James Madison writes to Carter-Glogau President Ronald Carter inquiring about the feasibility of a water-soluble vitamin E preparation for IV infusion. Madison suggests using deception to get the product to the marketplace before a competitor.
November 1983: O'Neal introduces E-Ferol, and sales exceed expectations. O'Neal sells 25,800 vials in the first five months. December 1983: A doctor in Hawaii tells Madison that two babies became ill after receiving E-Ferol. January 1984: A doctor in Spokane, Wash., tells Madison that three babies have died and another is gravely ill. Madison replies that E-Ferol has been proved safe and threatens the doctor with a lawsuit if he goes public with his suspicions.
March 1984: The Centers for Disease Control and Prevention receives reports from hospitals in Cincinnati and Knoxville, Tenn., about unusual illness in 13 premature babies with low birth weights. Eight infants who received E-Ferol died. April 1984: The CDC contacts the Food and Drug Administration, and O'Neal and Carter-Glogau agree to recall E-Ferol.
July 1987: A federal grand jury returns a 25-count indictment charging Madison, Carter, O'Neal President Larry Hiland and the corporations with conspiracy to commit mail and wire fraud and with violations of the Federal Food, Drug and Cosmetic Act. 1988: Carter, Hiland and Carter-Glogau are convicted. Madison and O'Neal plead guilty to reduced charges. January 1989: Carter and Hiland are each sentenced to six months in jail and fined $130,000 each. Madison is sentenced to six months in jail and fined $12,000. The two companies are fined a total of $260,000 and ordered to pay $215,000 for the cost of the government investigation.
Toni Heinzl, (817) 390-7684 firstname.lastname@example.org
HOSPITALS: Are we sure they're places where people go to get better?
Hospitals are dangerous places, as new research has confirmed. Well over 30,000 patients die in American hospitals every year from some medical mishap, while 167,000 will suffer a serious injury that will at the very least extend their hospital stay. And the bad news-if that was not bad enough-is that the picture is far worse than the one presented, researchers who produced the study have said.
The most dangerous procedure was vaginal delivery by forceps and other surgical instruments, with over 22 per cent of all procedures resulting in injury. The second highest was caused by vaginal birth without forceps, with nearly 9 per cent of all procedures injuring the patient. But postoperative sepsis-which occurs in 1.12 per cent of all patients-had the biggest impact, resulting in an extended hospital stay of an additional 11 days.
This alarming picture, prepared by researchers from the Johns Hopkins University in Baltimore, is a 'best guesstimate' based on 7.45 million discharge records collected from 994 hospitals across 28 states in the USA during 2000. As the researchers say, nobody knows the true picture, and their own evaluation is a very conservative one compared with previous research studies, including one that estimated that medical mistakes cause 98,000 deaths a year in American hospitals.
The researchers concede that the situation is far worse than the one they have reported-but just how worse is anyone's guess.
(Source: Journal of the American Medical Association, 2003; 290: 1868-74).
BELLEVUE -- A man with no medical license who gave $45 flu shots here is under investigation by the state Department of Health and the Bellevue Police Department, officials said Tuesday. Officials and at least one parent are wondering if the shots actually contained vaccine.
Shahid Sheikh gave flu shots in an office space at 1611 116th Ave. N.E., but on Tuesday the doors were locked and phone disconnected. ``He´s not licensed as a doctor, nurse or medical assistant,´´ state Department of Health spokesman Donn Moyer said. ``This person is a registered counselor and that category of provider has no authority to give injections.´´ Moyer said the department has opened an investigation into Sheikh, a registered counselor since June, and asking questions of Dr. Clarence Niles, a registered doctor and surgeon since 1984 who might be affiliated with Sheikh.
.. and another thing
We may have finally found a drug company representative we can trust.
Earlier this month, a BBC News report quoted Allen Roses (a senior executive of Europe's largest drug maker, GlaxoSmithKline) as saying that more than 90 percent of all drugs are effective for only 30 to 50 percent of those who use them.
I had to read that twice to make sure my eyes weren't deceiving me.
That comment is something you might expect to hear from a dedicated herbalist or some other alternative healthcare practitioner. But you don't expect to hear it from a high-placed honcho for an international drug giant.
Why would Mr. Roses utter such a statement? Apparently because he's a genetics expert with an eye toward the future of pharmaceuticals in which drugs will be tailored for specific genetic types.
It seems, however, that other executives at GSK may not have been delighted by the press coverage of Mr. Roses' comment. The following day, the UK's Daily Mail reported that GSK was "on the warpath" over the way the comment had been portrayed as a "gaffe."
A GSK spokesman told the Daily Mail that Mr. Roses' statement had been misrepresented. The unnamed spokesman said that anyone working in healthcare knows that "most people respond differently to medicines." And, "Although medicines may not work in all patients, they do work in a very large proportion."
So the spokesman basically rephrased Mr. Roses' comment to make it more ambiguous, without actually refuting the truth of it. That's what you call closing the barn door after the cows are out.
But we already knew the truth about those "cows."
To Your Good Health,
Health Sciences Institute
U.S. IMMUNIZATION NEWS
"State Evades Flu Shot Scam"
Atlanta Journal-Constitution (www.accessatlanta.com/ajc) (12/25/03) P. 1A;
Georgia paid $1.65 million to purchase 100,000 doses of the flu vaccine from a Texas company but was later informed by the FBI that the company does not possess the product. After checking out the Texas company's license to sell prescription drugs in the United States, Georgia health officials decided to purchase the vaccines for a significantly higher rate, because the higher priced flu vaccine was still cheaper than purchasing FluMist, the nasal spray flu vaccine. The state is getting a refund of its entire payment in three payments, two of which already arrived. Details of the investigation remain undisclosed; however, similar fraudulent cases are pending concerning the flu vaccine in other states.
=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.
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 OU Health 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.
PROSTATE CANCER: Hair today, and you're gone tomorrow
Finasteride is a drug hailed as the great new hope to combat prostate cancer. And its standing won't have been dented by a major new study that concluded that the drug can, indeed, prevent or at least slow the cancer. The Prostate Cancer Prevention Trial is a heavyweight study that involved
18,882 men aged over 55 years, and so its findings will matter. Of course, there was a price to pay by those men who took the drug. Their sexual libido all but disappeared, but many might feel that it is a trade-off worth making if you live longer.
And there was another thing mentioned in passing. Those who took the drug also ran a far higher risk of getting a more virulent form of the cancer later on. Since the study started, finasteride was also approved as a hair growth drug for men with male-pattern baldness. So let's get this right. Take finasteride and your hair might grow back. But your sex life disappears, and you stand the chance of getting an aggressive form of prostate cancer.
Does anyone need hair that badly?
(Source: New England Journal of Medicine, 2003; 349: 215:24).
Millions at risk from script errors
By Mary Papadakis
AUSTRALIAN doctors are making potentially deadly mistakes in more than 4½ million prescriptions each year. Almost one in 40 prescriptions contain errors, ranging from simple administrative mistakes to dangerously incorrect drug types and doses. Decimal points placed in the wrong spot, illegible handwriting, adult drugs given to children and wrong instructions are some of the mistakes putting lives at risk. Australian Council for Safety and Quality in Health Care chief Bruce Barraclough said more than 500,000 Australians required hospital treatment each year because of prescription errors.
Professor Barraclough said problems stemmed from the wrong medicine or dosage and the under-use, overuse or misuse of drugs. Medical and hospital errors have been estimated to cost about $4 billion and claim up to 18,000 lives each year. Professor Barraclough said most errors were made by GPs and specialists working in the community. "We would say that 2.4 per cent of about 190 million prescriptions made each year have some sort of error," he said. "Some are picked up by the pharmacist or the patient." Professor Barraclough said not all prescription errors had the potential to
harm patients but any mistake was a concern. "Doctors need to be very aware when they are working and ensure they are working safely," he said.
Patients also had to take greater responsibility, be honest about their medical histories and query anything that did not make sense. Australian Medical Association Victorian president Dr Sam Lees said measures were being taken to reduce prescription errors. "A pressured doctor can make mistakes, but since the advent of computer prescribing, that's helping to reduce the risk," he said.
"There is also intense teaching on proper prescribing, particularly for young doctors." Dr Lees said that while an error rate of 2.4 per cent was "not alarming", the AMA was working on it. "We will probably never get to zero per cent but we have to keep working towards it as a golden goal."
Parents' anger over MMR threat to GPs
BY VICKI SHAW
PARENTS today reacted angrily to news that GPs will lose Government cash if they fail to immunise children with the controversial MMR vaccine. Doctors used to receive bonuses for achieving targets on vaccinating children with the triple measles, mumps and rubella jab. But now, a new policy set down by the Commission for Health Improvement (CHI), states that GPs will LOSE money if they fail to convince enough parents to have the inoculation.
Today family support groups said the new ruling was "outrageous" and put the doctors "between a rock and a hard place." Wakefield mum Maria Woodward, who believes her daughter Francine, 12, was left epileptic and with learning difficulties after having the jab, said: "It's just ridiculous. "GPs would happily provide the separate vaccines parents have been calling for, but the Government won't allow them. Why should they be penalised for something that is not their fault. "Instead of punishing people, the Department of Health should concentrate on restoring the public's confidence in MMR by instigating a fully public inquiry. "I am concerned that doctors will begin to put extra pressure on parents when they are already making what is a terribly difficult decision."
Uptake rates for the combined jab have fallen to an all-time low, with only six in ten children in some areas having the vaccine. Parents began shunning the jab following a report by Dr Andrew Wakefield of the Royal Free Hospital in London which linked the vaccine to bowel disorders and autism. His findings have since been refuted by several other major reports and his own colleagues who worked on the study in 1998 have distanced themselves from him. Parents have been calling for the NHS to provide separate vaccines which they believe put less pressure on the immune system.
However, the Department of Health insists the triple jab is safe and refuses to provide single injections for free. The new CHI ruling will see doctors given star ratings for the number of children they immunise. If they are downgraded they could lose essential cash for their local Primary Care Trust. In the past, NHS hospital trusts that fail to achieve the maximum three stars have lost £1m a year each. It is not known how much cash is attached to the GPs' new inoculation targets.
12 January 2004
Public Citizen Press Releases
Providing the latest information about Public Citizen activities
Feb. 26, 2004
Accutane Linked to Birth Defects, Should Be Pulled From Market, Public Citizen Tells FDA
WASHINGTON, D.C. - The acne drug Accutane, which causes birth defects and life-threatening adverse events, should be removed from the market and prescribed only under very limited and controlled conditions, Public Citizen told a government panel today.
At a meeting of a U.S. Food and Drug Administration (FDA) advisory committee, Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, described how the drug causes such birth defects as malformations of the heart and brain, and can cause depression and create pressure in the brain in patients taking it. About 25 percent of the babies born to mothers taking the drug have serious birth defects and 50 percent are mentally disabled. Many women who become pregnant while taking the drug have abortions because of this high birth defect rate.
Accutane is approved only to treat severe cystic acne but is prescribed to many people who have mild acne. In fact, it is prescribed to 26 times more women than it should be, Wolfe estimates.
A program launched in April 2002 by the FDA and Accutane's manufacturer, Roche, was designed to reduce the number of pregnant women taking the drug, but it has not worked, Wolfe said. In the program's first year, 48 of 61 reported pregnancies (79 percent) ended in elective abortions because of concerns about the high rate of birth defects caused by the drug. Applied to the estimated number of total pregnancies in women taking Accutane during that year, an estimated 431 women had abortions because of the drug's high defect rate, 16 infants were born with birth defects and 31 babies were born with mental retardation. From 1982 to 2000, 162 babies were reported born with birth defects attributable to Accutane.
"If the government doesn't act, this administration and advisory committee will continue to put its imprimatur on the reckless use of a drug that each year causes the need for hundreds of abortions and results in many seriously deformed infants with birth defects," Wolfe said. "This is one of the two worst epidemics of preventable serious birth defects ever seen in the United States. It is time to end it."
Officials have known for at least 20 years of the dangers associated with the drug. In 1983, Public Citizen petitioned the FDA to give patients warning information with the drug. In 1988, Public Citizen petitioned for a ban on Accutane, but the agency didn't act. Public Citizen will petition the agency again soon for the drug's withdrawal, Wolfe said. Wolfe told officials today that the drug should be prescribed only if photographic proof exists of severe cystic acne and the patient has not responded to other acne treatments. In addition, for women, a written statement should detail the patient's contraceptive practices and the patient should have a negative pregnancy test.
To see Wolfe's statement, go to http://www.citizen.org/publications/release.cfm?ID=7302
Medical error causes 40,000 deaths a year
Friday, 13 Aug 2004 10:40
New statistical analysis from the Dr Foster Unit has concluded that 40,000 people die a year following medical mistakes. Drawing on data from the National Patient Safety Agency (NPSA) it concluded that there are around 850,000 "adverse incidents" in NHS hospitals each year. It suggests that this may be an under-estimation of the real extent of the problem.
The Dr Foster Unit notes that the rate of reportage of adverse incidents in trusts ranges from 0 per cent to 15 per cent, and says that it believes the zero reportage rate to be "unlikely". It also cites previous studies which suggested that routine data reports less incidences than analysis of case notes and argues that "adverse events may be under-recorded within hospital episode statistics." An adverse even is defined as "an unintended injury caused by medical management rather than a disease process, resulting in death, life threatening illness, disability at the time of discharge, admission to hospital, or prolongation of hospital stay."
Looking at hospital statistics over the past four years, they conclude that 2.2 per cent of all hospital stays mention an adverse event. Mistakes were more likely to occur in the cases of male patients, elderly people and emergency admissions- though for these groups the report notes "the differences may be due in part to the severity of underlying disease in the different groups and the length of time people are in hospital." The researchers conclude that incidences are being recorded, but "hospitals should be encouraged to improve the recording of events on their systems." The Dr Foster Unit is based at Imperial College London and is an independent organisation "created to examine measures of clinical performance."
http://www.vidyya.com/vol6/v6i216_5.htm In national survey, 45% of specialists report a recent medical error Otolaryngologist Dr. David Roberson has first-hand experience with medical errors. He remembers one near-miss in a patient about to receive a cochlear implant – and says it typifies the kinds of mistakes he and his colleagues have turned up in a national survey.
"I looked at the CT scan carefully to determine if the cochlea would accept the implant," recalls Roberson, from the Department of Otolaryngology and Communication Disorders at Children's Hospital Boston. "I asked a colleague to look at it also, and he commented that the auditory nerves looked small. I then ordered an MRI which showed the patient had no auditory nerves on either side. I came close to performing surgery and putting a major device in a child's head when there was no possibility of benefit, since she had no auditory nerve. I didn't look carefully enough at the entire scan."
Roberson and colleagues sent a brief, anonymous survey to 2,500 members of the American Academy of Otolaryngology-Head and Neck Surgery, and received 466 responses (19 percent). Of these, 210 physicians -- 45 percent -- reported that a medical error had occurred in their practice in the past six months. Errors occurred in all phases of patient care; 78 (37 percent) caused major injury or harm, and 9 (4 percent) were fatal. Both adults and children were affected.
Errors were carefully classified. The largest category, accounting for 19 percent, was technical errors during procedures, and 56 percent of these caused major injury or harm. Next were medication errors (14 percent); these included dosage mistakes and giving medications to which the patient was allergic, or that were contraindicated. Testing errors (10 percent) included physician errors (ordering incorrect tests; not reviewing tests; not acting on the results) and lab errors (lost specimens; errors in labeling and interpretation of results). Surgical planning errors (scheduling mistakes; failing to ensure that all preoperative studies were complete; and judgment errors, such as undertaking surgery when it was risky) accounted for another 10 percent.
Younger physicians were more likely than physicians over age 50 to report errors (approximately 60 versus 40 percent).
Other errors included:
Equipment errors – equipment not available or improperly assembled; equipment failure (9.4 percent)
Errors in post-operative care (8.5 percent)
Wrong site surgery – wrong patient, wrong organ, or wrong side (6 percent);
Drug errors during surgery (4 percent)
Communication errors (4 percent) Roberson and colleagues believe that the proportion of physicians encountering an error -- 45 percent –- is an underestimate. They suggest that doctors may not be trained to recognize errors, and may tend to recall errors that have serious consequences but overlook minor ones.
In one of two editorials accompanying the study, Dr. Lucian Leape of the Harvard School of Public Health concurs, "In the absence of a significant adverse event, most clinicians do not recognize (or admit) errors."
Leape adds that the study provides a unique and useful classification scheme for medical errors. "Not only does this scheme make clinical sense, it would seem to have applicability to other surgical specialties," he writes.
The study is the cover article in the August issue of the journal Laryngoscope. "The probability of an otolaryngologist erring on any individual decision is miniscule," the authors note. "However, because we all make millions of medical decisions, we will all make many errors during our careers… Most errors are made by good or outstanding providers."
Doctors lift lid on MMR scandal Aug 8 2004
By Caroline Wheeler, Sunday Mercury
Scores of children in the Midlands may have been given the controversial MMR jab without their parents’ permission, a leading doctor claimed last night. And nurses have been caught trying to administer the MMR jab alongside children’s pre-school diptheria booster - even after being told not to by worried parents.
The news comes just a month after three year-old Michael Whitfield, from Kidsgrove, Staffordshire, was given the triple-jab without his parents’ permission. The toddler had the jab by mistake by a nurse at his GP’s surgery - despite having already received separate injections at a private clinic. Now a doctor, who asked not to be identified but who runs a clinic offering the option of single vaccines, has lifted the lid on yet another MMR scandal. “I have seen scores of parents who claim that nurses tried to give their children the MMR vaccine without permission,” he said.
“It usually happens when the child has gone for their pre-school diphtheria, pertussis and tetanus boosters. “Some of the more alert parents have stopped their child from being given the the triple vaccine. “But for every parent who notices what is going on, I wonder how many miss that their child has been given the MMR injection? “At first I thought it was just done by accident. Now I think it may have to do with Government targets and financial incentives.” GPs get more money if they vaccinate 95 per cent of the children in their area but those who fail to meet the target - by even one child - can lose thousands of pounds a year.
As a result, the doctor claims that bullying tactics have been employed to encourage parents to get their children inocculated with the triple-vaccine. “I have been staggered by the lies told to parents to get them to consent to the MMR vaccine when they express a specific wish for their child to receive single vaccines instead,” he said. “Shortly after a baby is born parents are issued with a ‘red book’ which lists the schedule of immunisations their child is due to receive. “Parents are asked to sign a ‘blanket consent’ for these vaccinations, but this is not a legally binding document because consent needs to be informed. “I have heard stories of health visitors trying to use this to pressurise parents into giving children the MMR vaccine by saying they have already given their consent for the jab.”
The doctor, who is a specialist in paediatrics, believes that the practice of giving the MMR jab without parental permission is an abuse of human rights. “To deliberately give a child a vaccination without their parents’ consent is medically indefensible particularly when the parents have specifically stated that they do not want the vaccine,” he said. “It is a blatant abuse of human rights. More than that, it constitutes actual bodily harm because it involves puncturing a child’s skin to give the jab.”
Now the doctor is urging parents to be more vigilant and question healthcare professionals more about what they are administering to their children. A spokesman for the Department of Health said: “MMR remains the best form of protection against measles, mumps and rubella. “More than 500 million doses have been used around the world since the early 1970s and it is recognised by the World Health Organisation as having an outstanding safety record.”
SECRET trials to test vaccines were carried out on hundreds of vulnerable children in the UK, according to a report. They allegedly involved orphans, mentally handicapped children and kids in care in the 1950s and 1960s. Campaigners say the tests, which in some cases caused brain damage,were often done without parents' consent. And it is claimed many of the records of the experiments have disappeared. Olivia Price, of the Vaccine Victims' Support Group, said the tests involved a whooping cough vaccine which was part of a jab also covering diphtheria and tetanus.
The claims, revealed in a Radio 4 documentary, are backed by Gordon Stewart, professor of public health at Glasgow University. He was part of a government-appointed team which looked at the side-effects of the trials in 1974.
He said: 'The severe reactions included convulsions and mental defects.
'Some of the children would scream for two to three days. Some were comatose and are now, at the age of 40 or 50, brutally defective.'
Alert raised on head injury treatment
James Meikle, health correspondent
Friday October 8, 2004
A routine treatment for patients with head injuries, used for 30 years, may in fact be slightly increasing their risk of dying, an international trial involving more than 10,000 patients has revealed. The results are likely to lead to big changes in the use of corticosteroids delivered by drip - an anti-inflammatory treatment designed to prevent potentially lethal swelling of the brain.
The results of a study involving patients from more than 50 countries were published in the Lancet. Researchers found that 21% of patients treated with corticosteroids died within two weeks, compared with 18% of those on dummy treatments. There was no difference in outcome depending on the severity of injury or how quickly the corticosteroids, delivered via drips, were administered.
The trial was undertaken by the Medical Research Council. Ian Roberts, of the London School of Tropical Medicine, who was its clinical coordinator, said: "Obviously, we would have preferred to find out that corticosteroids improve patients' chances of surviving head injury, but our results are important because they will improve patient care and protect thousands of future patients from increased risk of death from corticosteroids."