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MDs distrust industry-funded studies

Posted by medconsumers on September 27, 2012

Here’s an interesting turn of events. A new survey shows that physicians will distrust the results of a study, once they see that it was funded by the pharmaceutical industry.  In fact, many physicians were more likely to trust research funded by a government agency like the National Institutes of Health. But here’s the twist: Many industry-funded studies are of very high quality and some taxpayer-funded studies can be of lesser quality.

If physicians’ prescribing decisions are not guided by the quality of the research, then we’re all in trouble.  But then again, maybe we’re all in trouble, anyway, given the fact that most drug studies are funded by industry. We already know that industry-funded trials tend to produce results that favor their products—and the studies that fail to do so never see the light of day. The latter problem has been resolved—somewhat— for new drugs.  Trials initiated after 2007 are mandated to register on a publicly accessible website so that everyone knows of their existence and goals.

But I digress. The surveyed physicians were given only the abstracts (summaries) of hypothetical clinical trials of three different drugs. The trials were of high, medium or low quality.  Each abstract disclosed whether the study had support from a pharmaceutical company, the National Institutes of Health, or made no mention of support. The follow-up questions determined physician understanding of the trials’ quality, their confidence in the results, and their willingness to prescribe the drugs.

“We found that respondents downgraded the credibility of industry- funded trials, as compared with the same trials randomly characterized as having NIH funding or having no source of support listed,” concluded Aaron S. Kesselheim, MD, Harvard Medical School, and colleagues who developed the survey, published recently in The New England Journal of Medicine.  Ironically, 75% of the surveyed physicians reported “accepting at least one type of industry support.”

What to make of all this?  I have to admit that I was somewhat surprised by the survey results. I didn’t think practicing physicians were that jaded, especially physicians who themselves take industry money. This survey is important, but there’s a far larger problem related to pharmaceutical industry funding. It was addressed by one memorable speaker at a conference held last year by the Cochrane Collaboration. “Many of the clinical trials conducted by the pharmaceutical industry are very well-designed, but they do not answer the questions we want answered,” said John Ionnaides, MD. “We want to know whether the new drug is safer and more effective than the older drugs,” he said.  The “we” he was describing are the physicians who prescribe the drugs as well as the people who take them.

Dr. Ionnaides, an internationally respected researcher, went on to explain that no drug company wants to risk a head-to-head comparison trial, which could find an older, cheaper off-patent drug is better than their new expensive drug. Instead, a new drug goes on the market having proven to the FDA’s satisfaction that it is better than nothing (a placebo). And that’s exactly the way the drug makers want it to be (and lobby Congress to make sure things go their way).

This research gap goes far beyond drugs. No head-to-head comparison study, for example, has been done to guide men through the thicket of treatment options for prostate cancer.

Perhaps information gaps like this can be tackled successfully by the comparative effectiveness research efforts that have emerged as a result of the Affordable Care Act. But wouldn’t it be better if taxpayers did not have pay for this important research? Isn’t it about time to take seriously an idea that bubbles up every now and then:  Make the drug and device companies contribute to a large research fund; and then make them step back to let independent researchers conduct the head-to-head comparison trials.

Maryann Napoli, Center for Medical Consumers©

Posted in Conflict of Interest, Doctors, Drugs | Tagged: , , , , , , , , , | 1 Comment »

Weight loss won’t prevent diabetes

Posted by medconsumers on January 15, 2012

Rare is the public announcement that a long-standing medical recommendation has been found to be impossible to follow. That’s what happened—albeit unofficially— at a recent press briefing when Richard Kahn, PhD, announced that weight loss is not the sure-fire preventive measure for avoiding diabetes 2. Studies show that hardly anyone can lose enough weight to meet the universally recommended goal. And even those who get there halfway usually regain the weight within a few years.

That won’t come as a surprise to anyone has ever tried dieting. What made this press briefing noteworthy, however, is the fact that Dr. Kahn was the chief scientific and medical officer of the American Diabetes Association for 25 years. His study raises questions about the centerpiece of the ADA’s standard diabetes prevention message: “Maintain a healthy weight “(along with increased physical activity). This is the advice that is also given to people diagnosed with prediabetes, a newly created “disease” that indicates they almost have diabetes 2 (more on that later).  According to the ADA, which receives funding from the pharmaceutical industry, there are 79 million Americans who have prediabetes. All are likely to be put on long-term drug therapy once the weight-loss attempts fail or never get off the ground.

At the press briefing, Dr. Kahn, now a professor of medicine at the University of North Carolina, Chapel Hill, described his paper in this month’s issue of the public policy journal Health Affairs, which is primarily devoted to diabetes.  He has based his conclusion about weight loss on the very clinical trials that set the standard for diabetes prevention. Perhaps Dr. Kahn is the first to notice that most of the study participants, all of whom were initially either overweight or obese, regained the weight after the trials were over.

“When you look at the published studies, you see that a substantial amount of weight loss is necessary and hardly anyone can meet the intended goal, explained Dr. Kahn.  “People who participate in the standard community weight loss programs lose about 3-4% of their body weight, but they don’t get an appreciable delay in the onset of diabetes until they reach 7.5% weight loss. So you see they are not coming close to delaying or preventing diabetes.”

Based on the best of the diabetes prevention trials, here’s an estimate from Dr. Kahn’s paper for what a 4% weight loss would actually do for people in terms of health and cost-effectiveness: “If overweight or obese people could maintain for life a 4% reduction in weight at minimal financial cost, there would be a modest 1% reduction in heart attacks and strokes after 20 years. Rates of some microvascular complications [e.g., blindness, neuropathy, foot amputations] would also decline, but it would take at least 20 years—during which time weight loss was continuously maintained—for such an intervention to achieve cost-effectiveness.”

Dr. Kahn was the only author at the press briefing whose paper was not favorable to prevention. Several promoted a nationwide diabetes prevention program. “This would be a waste of resources,” said Dr. Kahn. “Instead we need a better understanding of the biological processes that cause so many people to put on weight.  I don’t think we know enough about energy balance, specifically energy intake vs. energy expenditure. Our bodies regulate that very, very closely, and we just don’t know enough about the components of that [process], or why this imbalance occurs in some people and not others. We eat all the time, food is all around us, food is cheap and maybe our bodies can’t adapt to this environment.”

Until obesity researchers come up with answers, drug therapy is the way to go once diabetes develops, according to Dr. Kahn’s paper,  “We can greatly reduce the likelihood of serious complications through early detection and proper medical management.” (Novo Nordisk, the company that makes diabetes drugs, was thanked by the editor of Health Affairs for partially funding this month’s issue.) However, Dr. Kahn expressed reservations about putting people on drug therapy when they are diagnosed with prediabetes,  “The use of metformin or other glucose-lowering medications might help prevent diabetes, but initiating such therapy prior to the onset of diabetes is basically equivalent to diagnosing the disease at a lower glycemic [i.e., blood sugar level] threshold and therefore deserves more discussion.”

Additional  information about prediabetes and exercise

More and more physicians have begun to treat prediabetes with drug therapy, though there is no evidence to show that this is safe or effective.  One can see tacit support for this practice on the ADA website which states, “Before people develop type 2 diabetes, they almost always have prediabetes—blood glucose levels that are higher than normal but not yet high enough to be diagnosed as diabetes.”  Read this about the pharmaceutical industry’s role in expanding the definition of diabetes 2 and why the current threshold for starting drug therapy is dangerously low for people with diabetes 2.  click here   And this about exercise, “You can be fat and fit.” 

Maryann Napoli, Center for Medical Consumers©

Posted in Conflict of Interest, Diabetes 2, Diet & Exercise, Drugs, exercise, Type 2 Diabetes | Tagged: , , , , , , , | 8 Comments »

Treatment guidelines and conflict of interest

Posted by medconsumers on April 13, 2011

More than half of the cardiologists, cardiovascular surgeons and other experts who produce treatment guidelines have financial ties to companies that make heart drugs or surgically implanted devices. A new study takes a hard look at the conflicts of interest among experts who serve on panels that set the treatment standards for prestigious organizations like the American College of Cardiology and the American Heart Association. While many of us would like to think our physicians and surgeons keep up by reading medical journals. In fact, many physicians rely on these guidelines panels to guide their practice decisions.

I used to think that the main task of these influential panels was to distill the best scientific evidence for practicing physicians who do not have the time or skills to do it themselves. But then I learned from an in-depth review presented at a 2004 Cochrane Collaboration conference that treatment guidelines are largely based on opinion rather than scientific evidence. That’s the first problem, and one not confined to cardiovascular medicine. The second problem is that the panels are supposed to be independent, but in fact, the individuals chosen to join them often have major conflicts of interest.

The new study appears to be the first to determine the scope of the second problem by taking a broad look at the experts who served on heart treatment panels from 2002 to 2008. It found that 56% of them have major conflicts of interest, most commonly a paid consultant to a drug or device company or a member of a company advisory board. Even more troubling was the finding that the physicians who chair the panels are most likely to have conflicts of interest (80%).

The study was led by Todd B. Mendelson, MD, University of Pennsylvania’s Center for Bioethics and Cardiovascular Medicine, and published last month in Archives of Internal Medicine.

In stating their conclusion, Mendelson and colleagues went the glass-is-half-full route, pointing out the bright side of their results. “Conflicts of interest are prevalent in cardiology guidelines, but there seems to be a significant number of experienced experts without conflicts of interest [44%].” In other words, the 44% refute the standard argument that almost all knowledgeable heart specialists take industry money and setting stringent rules about conflicts of interest would leave no one to serve on panels.

There has been a fair amount of media attention given to conflicts of interest over the last decade, and the solution always seems to be disclosure. But in a related commentary entitled, “Can we trust cardiovascular practice guidelines?,” Steven E. Nissan, MD, chairman of cardiovascular medicine at the Cleveland Clinic, dismisses disclosure as a solution and called for banning anyone with conflicts of interest from serving on these panels. “While sunlight is a good disinfectant, there is nothing about disclosure that inherently guarantees scientific independence.” (At the end of his commentary, Dr. Nissen writes that he has consulted for a number of pharmaceutical companies without financial compensation. “All honoraria, consulting fees, or any other payments from any for-profit entity are paid directly to charity, so he receives neither income or tax deduction.”)

These panels are extremely influential, writes Nissan, citing their influence on government and insurance company decisions about which procedures and drugs should receive reimbursement. “Hospitals and clinics use [the guidelines] to decide when innovative, but expensive, therapies are sufficiently mature to warrant a major investment.”

Dr. Nissan comes down hard on professional medical association, stating that any proposed reforms must include them because many receive extensive funding from pharmaceutical and device companies for continuing education for physicians and for advocacy. Although they went unnamed, Dr. Nissan was referring to organizations like the American College of Cardiology. For more on this from ProPublica, click here.

What can you trust? I wish I had an answer. Last February, as I stood outside the cardiac care unit waiting for my husband who just had an emergency angioplasty, I was handed a folder about the drug-emitting stents inserted during the procedure. Not until the surgeon was halfway down the hall did I notice that all the information he gave me came from the company that makes the stents. I’m still looking for independent, long-term safety not only about drug-emitting stents but also the multiple drugs my husband will stay on for the rest of his life.

Maryann Napoli, Center for Medical Consumers©

Posted in Drugs, Heart, testing | Tagged: , , , , | Leave a Comment »

WHO & Pharma under fire over swine flu

Posted by medconsumers on April 2, 2010

Before the faux swine flu pandemic fades from memory, consider this: One country—Poland—made the decision not to knuckle under to the pharmaceutical industry and buy H1N1 swine flu vaccines for its citizens. Dr. Ewa Kopacz, who is Poland’s minister of health, decided against a national vaccination campaign for several good reasons. She was not convinced that the vaccines were completely safe. Furthermore, the H1N1 flu appeared to be relatively mild in the countries of the southern hemisphere where the flu season was coming to an end. But it was the “conditions of purchase” that confirmed her decision. She was told by the vaccine companies that only the government could purchase their products—-vaccines would not be sold to clinics or anyone in Poland.

The price of each vaccine would be two to three times the cost of the yearly seasonal vaccine, though Dr. Kopacz knew the H1N1 vaccine is based on exactly the same technology. What’s more, it was not known at the time whether people would need one or two vaccines for full protection. And most outrageous: the Polish government was expected to sign a contract, stating that anyone injured by a vaccine would be the government’s responsibility. (Note: the U.S. government had long ago accepted this one-sided agreement.) Poland had fewer swine flu deaths this season and the virus was less virulent than in other countries. Though only half the vaccines in the U.S. were used, the estimated number of U.S. flu deaths this season was the lowest in years.

For standing up to the vaccine companies’ threats of dire consequences of her decision, Dr. Kopacz was the star of a hearing conducted on Monday by the Council of Europe in Paris, and attended by members of parliament. The gathering aimed its initial ire at the World Health Organization (WHO) for its changing definitions of pandemic and its alarmist warnings that were described as a “monumental mistake.” The result: a huge waste of money, unnecessary fear and anxiety; and a distortion of health services. Several speakers listed other pandemics like SARS, Creutzfeldt-Jakob disease (“mad cow”) and the avian (bird) flu that never lived up to the threat level announced by WHO. “Not a single person died from the avian flu in my country,” said the professor who was the former head of the French Red Cross. It is like the boy who cried ‘wolf,’ warned Paul Flynn, MP from the U.K, “If a truly dangerous virus does emerge some day, few people will take notice of it. The trust in the WHO has been undermined and it must be rebuilt.”

The WHO was the proverbial empty chair at this meeting because it declined the invitation and, the MPs said, had cloaked itself in secrecy at a prior meeting which was the first attempt to get answers to questions like: who decides that something is a ‘phase-6 pandemic’? And based on what evidence? (Another meeting, this time with WHO representatives, is planned for April 15 in Geneva.) Dr. Tom Jefferson of the Cochrane Collaboration spoke of how little reliable scientific evidence there is—not only to support vaccine use but also for understanding influenza itself. “The randomized trials that have been conducted are too small and too short [in duration],” he said, referring to vaccine trials that are usually funded by companies that make the vaccines. “The harms are not even looked for. We can’t answer the question of whether vaccines are safe.” Dr. Jefferson called for a large taxpayer-funded multi-country vaccine trial to fill the serious information gaps about vaccine effectiveness and possible harms.

As the hearing went on, the pharmaceutical industry became the major target. Several speakers called for more scrutiny of the pharmaceutical industry’s influence on health policy. They know that billions of pounds and Euros were spent on vaccines and unproven antiviral drugs like Tamiflu, and now they want to know who profited from WHO decisions. There must be more scrutiny of WHO’s key opinion leaders, especially those who fanned the flames of pandemic fears while taking pharmacuetical industry consulting fees. (Though unmentioned at this hearing, one H1N1 key advisor to WHO has been under investigation for personally profiting from the vaccination. Click here for more.)

Dr. Marek Twardowski, Poland’s undersecretary of state, ministry of health, brought the discussion back to the vaccine companies’ preposterous contract that his country was expected to sign. “Your governments did in fact sign contracts that shifted the responsibility for vaccine-related harm to your governments, and these agreements were made in confidence [i.e., secret],” he told the MPs. “As of March of this year, none of the vaccine companies brought their products into your countries under normal marketing conditions. Can you imagine if car companies like Toyota decided that they will only sell their cars to a government and then when a serious defect shows up like the Toyota’s accelerator problem, the taxpayers are expected to pay for it?” This is an “extremely dangerous precedent,” he said. “And I hope that today’s deliberations result in this never happening again.”

It’s hard to imagine such a conversation taking place in the U.S. Congress, which is bought and paid for by the pharmaceutical industry. And it’s unlikely many Americans know that vaccine companies already made sure the government pays for injuries caused by their products. In the wake of 9/11, Congress passed a federal law that allows vaccine companies to be protected from liability in the event of a vaccine-related injury. Authorities need only declare a public health emergency for the protection to go into effect. And if you think that the vaccine companies need protection from lawsuits to continue making vaccines, see this Bush-era press release from Public Citizen: “Flu Vaccine Shortage: Another Example of How Bush Dis-Torts the Truth About Lawsuits”

Click here to see the Webcast of the March 29 Council of Europe hearing.

Maryann Napoli, Center for Medical Consumers©ISSN 2155-1480

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Posted in Conflict of Interest, influenza, vaccines | Tagged: , , , , , , , , , , | 1 Comment »

Type 2 diabetes drugs: risks w/o benefit

Posted by medconsumers on December 14, 2009

Yet another study, this one conducted in the U.K, has shown that the oral drugs typically prescribed for people with type 2 diabetes are killing some of them; and many more have suffered heart attacks and congestive heart failure while on the drugs. Ironically, these are the very conditions that the drugs are intended to prevent. The British Medical Journal recently published findings from a 15-year database of more than 91,000 people with type 2 diabetes. The drugs they were taking—Avandia, Actos, Glucophage, and Amaryl—will be familiar to Americans. This is the eleventh published study to acknowledge the fact that oral hypoglycemic drugs are associated with an increased risk of serious harms. This one shows that some are riskier than others.

For those of you who are on one of these drugs, I provide access to the new study and leave it to your doctor to explain. I want to move on to the larger issue of why doctors continue to prescribe these dangerous drugs and how they got on the market in the first place. That last point is more easily addressed. Drugs most often receive FDA approval on the basis of what researchers call surrogate endpoints, for example, blood sugar levels are controlled, blood pressure or cholesterol is lowered, etc. The studies are usually too short in duration to prove what matters most to the people taking the drugs—i.e., they cut the chances of heart attack, stroke, etc.

I put the question of why doctors continue to prescribe these drugs in the face of so much proven danger to Nortin M. Hadler, MD, whom I consider the informed-skeptic-in-chief on this topic. Dr. Hadler is a professor of medicine and microbiology/immunology at the University of North Carolina, Chapel Hill. He is the author of two books, each with excellent sections devoted to type 2 diabetes (see below). Of course, the place to start questioning Dr. Hadler is the very definition of type 2 diabetes, which has been expanded over the years to include more and more people.

Dr. Hadler had a ready answer, “I don’t think America realizes how much input industry has on the medical organizations and their thought leaders who are involved in writing these definitions and treatment guidelines. Several of these entities are so heavily underwritten as to be almost wholly owned subsidiaries of the pharmaceutical industry. Professional meetings have much more the tone and the feel of the marketplace than they do of the academy. And all of this happened in the last 20 years.

“There are several pharmaceutical industry-supported medical groups that compete to establish standards of care for type 2 diabetes and related conditions. Some endocrinologists believe that type 2 diabetes, obesity, high blood pressure, and high cholesterol—all cluster together because they are parts of a single metabolic syndrome, which responds poorly to the treatment of its components. Others argue strenuously for the treatment of one or the other components [of metabolic syndrome]. Rather than choosing meaningful effectiveness as their battle cry, they are more interested in turf wars. The cardiologists are averse to this metabolic syndrome notion and want to pull out cholesterol and maybe hypertension as the most important risk factors to treat. The Endocrine Society and the American Diabetes Association finally got together and came out with their definition of type 2 diabetes and guidelines for lowering blood sugar.

“All of this is driven by the belief that if we normalize cholesterol or blood sugar we will improve longevity and decrease the incidence of blindness, kidney failure, stroke, heart attacks and leg ulcers. The thought leaders are so convinced of their belief that they focus on treating the blood sugar and to question whether they are treating the patient seems unnecessary. Their shortsighted efforts are rewarded with renown by the pharmaceutical industry. Almost all the thought leaders are heavily involved in drug trials where they are paid for studying the drugs. And almost all are vying for a place on the committees that set treatment guidelines.

“We now have three randomized controlled trials of oral hypoglycemic drugs in the treatment of type 2 diabetes and based on these three, we doctors cannot offer any meaningful assurance whatsoever that taking these drugs will decrease the likelihood of having a stroke, death before your time, amputation, renal failure, blindness. Anybody who tells you otherwise is exercising firm beliefs in the face of the evidence. They are wont to argue that oral hypoglycemics might have proven effective if we had done a bigger and/or longer trial. Such an argument is on the thinnest of ice. The available trials are impressive for their duration (measured in over a decade for two of the trials) and their size. Little of importance, if anything, has been missed.

“Maybe it’s time to address the other aspect of the metabolic syndrome that is too long and too often ignored. Most people who fall into the metabolic cluster are facing serious socioeconomic challenges in our society for which type 2 diabetes is one surrogate measure and for which pharmaceuticals are irrelevant.”

When I asked Dr. Hadler about metformin, the oldest and some doctors believe the safest diabetes 2 drug, he was unmoved by the British study that showed it to be effective at reducing the risk of heart attack, stroke, etc. “When you look carefully at that study, you will see the finding [of effectiveness] was not statistically significant [which means it could be due to chance].” As someone who has done an in-depth assessment of this landmark study, called the United Kingdom Prospective Diabetes Study, Dr. Hadler states, “…we doctors cannot offer any meaningful assurance whatsoever that taking these drugs will decrease the likelihood of having a stroke, death before your time, amputation, renal failure, blindness.”

Dr. Hadler is the author of The Last Well person. How to stay well despite the health-care system and Worried Sick. A prescription for health in an overtreated America, each has a strong section on type 2 diabetes. He appears frequently on National Public Radio.

For More Information:
Type 2 diabetes is largely due to lack of exercise and poor eating habits. See our 2008 interview with Dr. Steve Blair on the importance doing at least one-half hour of brisk walking five or more times a week. And to learn how to eat well and lower your risk of type 2 diabetes and other chronic conditions, read Michael Pollen’s new book entitled, “Food Rules.”

If you would like to know more about how the pharmaceutical industry brings the thought leaders around to its way of thinking, read Our Daily Meds by former New York Times business reporter Melody Petersen.

Maryann Napoli, Center for Medical Consumers(c)

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Posted in Chronic Conditions, Conflict of Interest, Drugs, Heart | Tagged: , , , , , , , , , , , , , | 2 Comments »

Swine flu hysteria

Posted by medconsumers on December 4, 2009

So far the H1N1 virus, or swine flu, has been extremely contagious but mild to moderate in severity. About 9,820 Americans have died from swine flu since it emerged in April, according to the Centers for Disease Control and Prevention. The CDC and the World Health Organization estimate that the swine flu may have already peaked in the U.S. But some experts point out that the flu season usually starts in December, therefore another peak would be expected in early 2010. By these estimates, I figure that the 2009-2010 flu season is still not likely to become the pandemic it was heralded to be. Think of it this way, even if the second peak doubles the number of deaths, the total would be lower than the CDC-estimated number of deaths (36,000) in any given flu season. As observed in our September 2009 article, the H1N1 virus appears to be just another seasonal flu, see “Why the Swine Flu is Not a Major Threat.”

The media kicked off the season with the usual fear-mongering that focused on the deaths or near-deaths of healthy young people. 60 Minutes provided the prime example of flu reporting at its worst. It focused on one healthy teenager who became desperately ill with the swine flu, which landed him in the intensive care unit. A news show of this caliber would be expected to let us know who is most likely to die (this teenager did not) and how many deaths occur in those hospitalized with swine flu. In other words, provide a context for this one case.

It wasn’t like a context was unavailable. A “window” on what was to come appeared in the October 2009 Online First version of The New England Journal of Medicine. In the early phase of the swine flu “pandemic,” a research team reviewed the medical records of 272 people hospitalized in the U.S. between April and June 2009. All had tested positive for swine flu. Here’s the finding that 60 Minutes might have included in its reporting, 7% of the people in this study died and nearly half were children. Almost three-fourths of all who died had at least one underlying medical condition, primarily asthma; diabetes; heart, lung, and neurologic diseases; and pregnancy. 60 Minutes might have compared these findings to what happens in a normal flu season when 90% of the deaths occur in people over the age of 65, mostly in those with serious underlying medical conditions.

To its credit, 60 Minutes started the story this way: “99% of people with H1N1 virus, it’s just the flu…a few miserable days at home.” Funny, I didn’t remember hearing this until I saw the show over again on the 60 Minutes Web site while writing this article. Unfortunately, the camera focus on a young man struggling for his life with terrified parents at his side totally overwhelmed the fact that this might be the fate of 1% of the people who contract the H1N1 virus and a tiny fraction of 1% of the entire U.S. population. The tragic deaths of healthy young people would be rarer yet. As of December 10, the CDC estimates that there were 1,100 deaths in children under the age of 18, two-thirds of them had an underlying medical condtion, mainly asthma, cerebral palsy and muscular dystrophy.

Sometimes I get the feeling that the media is doing the CDC’s bidding by encouraging panic so we’ll all rush off and line up for the swine flu vaccine. After all, the federal government paid for these vaccines and would not want to see them go to waste, nor would the CDC want the public to lose faith in vaccines. Maybe this was all a trial run in the event of a real pandemic. Many who lined up for the vaccine were elderly people, usually the priority group, now told to get to the proverbial back of the line.

As time went on, we learned that everyone born before 1957 has natural immunity so they don’t need the vaccine. This is a startling public health about-face. Haven’t we always been told that vaccines are equal to or better than natural immunity—that is, getting the flu naturally? “It is a false assumption that the vaccine provides similar immunity to the natural infection. We have evidence that the natural infection provides long-term immunity for more than 50 years. We don’t know how long the vaccine-induced immunity lasts, but estimates are two to three years at best,” explained researcher, Jim Wright, MD, in response to an e-mail inquiry.

Dr. Wright, based at the University of British Columbia, co-authored a recent letter to the editor of the British Medical Journal in which he called attention to the need for a randomized trial to determine whether vaccines are actually effective for both the H1N1 virus and the seasonal flu. Some of us in the U.S. would like to know why the seasonal flu death rate has remained unchanged in the last 20 years, despite the fact that there was a steady increase in the number of people vaccinated during that time. Even the CDC is tacitly admitting the lack of progress with its 36,000 annual flu deaths statistic that hasn’t changed in years.

There are plans to form a panel of experts from outside the government to watch for any rare or unexpected side effects in the millions of Americans who were vaccinated in the last three months. But that’s not all I want verified. I’d like to know whether we were getting an honest assessment of the threat level of the swine flu. And was it worth spending the billion dollars that the U.S. government put into the production of these vaccines, or are there better ways to spend the taxpayers’ health dollars? Most of all, I want to know whether the H1N1 vaccines were effective in preventing death and hospitalization, especially in young people. When I directed these concerns to the CDC, a spokesman told me no decision has been made to study these issues.

For more information
Read this about the World Health Organization and the investigation of the gross conflict of interest of its expert on the H1N1 virus. And this on the home front: “Advisers on vaccines often have conflicts, report says.”

Maryann Napoli, Center for Medical Consumers©

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Advocacy letters

Posted by medconsumers on August 23, 2009

Here are links to several advocacy letters, co-signed by Arthur A. Levin, MPH, on behalf of the Center for Medical Consumers

Physician Payment Sunshine Law
Urges the Senate to keep a provision in the health care reform bill that would require disclosure of all
payments to doctors and hospitals from companies that make drugs and medical devices.

Protection of Privacy of Computerized Medical Records
Protests the proposed federal goverment regulations that would weaken some protections afforded personal computerized medical information and would limit patient notification about a breach of their privacy.

Injuries Related to Medical Devices
In support of an FDA move to speed up reporting of medical device problems.

Union of Concerned Scientists
Proposed health care reform legislation appoints a number of advisory committees to help federal agencies, like U.S. Health & Human Services, oversee certain key aspects of implementing the suggested changes. The Center has joined other advocates in urging that members chosen for these committee’s be free from conflicts of interest and that all their deliberations be fully transparent.

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Conflicts of Interest Among FDA Advisory Committeee Members

Posted by medconsumers on July 1, 2005

Conflicts of Interest Among Physicians and Scientists Who Serve on FDA Advisory Panels

Recently, there have been after-the-fact revelations that some outside experts who serve on FDA advisory committees have financial ties to companies that make the products under their review. For example, early this year two FDA advisory committees jointly decided that Pfizer’s popular arthritis drugs, Celebrex and Bextra, could remain on the market. And Merck might be allowed to return its arthritis drug, Vioxx to the market. A surprising judgment considering that all three belong to the same drug class, known as cox-2 inhibitors, which are associated with an increased number of heart attacks and strokes. [for more on Cox-2’s and FDA hearings click here] What’s more, all three are expensive and no more effective than older arthritis drugs sold over the counter.

After these decisions were made, it was revealed that 10 of 32 experts who sat on the two FDA advisory committees had financial ties to companies that produce these drugs. Had their votes been excluded, two of the three drugs under review would, very likely, not have remained on the market.

The Center for Medical Consumers recently joined other public interest organizations in supporting legislation that would prohibit scientists and physicians with financial ties to industry from serving on FDA advisory committees. In June 2005, the U.S. House of Representative passed an amendment to the FDA/USDA appropriations bill, which would prohibit experts from serving on FDA advisory panels if they have financial ties to companies that make food, drugs or medical devices that would come under their review. The measure was introduced by Congressman Maurice Hinchey (D-NY) and had bipartisan support. We have urged the Senate to pass this legislation, too. [click to read  letter to Senator Durbin]

Arthur A. Levin, MPH, Center for Medical Consumers © July 2005

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