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The Food and Drug Administration voted overwhelmingly to keep the diabetes drug Avandia on the market, despite its known deadly effects. Two FDA committees met yesterday in Gaithersburg, Maryland, to consider whether the drug -- which has led to the deaths of 80,000 people -- should be pulled from the marketplace.
The FDA does not deny that the drug is dangerous. Members of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted 20-3 to acknowledge the finding that the drug raises the risk of heart attacks, and called for stronger warning labels.
Dr. Clifford J. Rosen, from St. Joseph Hospital in Bangor, Maine, said after the meeting that "there was enough concern on the advisory committee that virtually everybody felt there was risk" of heart attacks from taking Avandia.
Nonetheless, committee members voted 22-1 to keep the drug on the market, knowing full well that the drug would kill some percentage of those patients who take it.
Avandia death toll: 80,000 people and counting?The dangers of Avandia are well documented and are not news to the FDA. In May, the New England Journal of Medicine published a study that found Avandia increases the risk of heart attacks. But FDA officials already knew that; indeed the drug's maker, GlaxoSmithKline LLC, based in London, told the agency of the risk two years ago. However, the FDA failed to pass along the warning to the one million Americans who already take the drug.
Even within the FDA, scientists have presented the risks of Avandia to colleagues and fellow committee members. Dr. David Graham, a drug safety officer with the FDA's Office of Surveillance and Epidemiology, estimates that Avandia has caused as many as 205,000 heart attacks and strokes, some of them fatal, between 1999 and 2006. Graham's analysis indicates that since Avandia was approved, some 80,000 patients have died from the drug's side effects. For every month that Avandia is sold, he said, 1,600 to 2,200 patients will suffer more of these events.
The FDA's continued approval of this drug, therefore, is a kind of death sentence for American consumers, racking up a body count so large that it already exceeds the total number of Americans killed in the entire Vietnam War!
Gerald Del Pan, director of the Office of Surveillance and Epidemiology, expressed concern about keeping Avandia on the market. "Cardiovascular disease being the leading cause of death of people with diabetes, having a treatment that causes that is something that doesn't make sense to me," he said.
Glaxo inundates the FDA with confusing dataYet the majority at the FDA sided with the drug company Glaxo. "Let's not throw out the baby with the bathwater," Philip L. Hooper, a physician at the University of Colorado Health Sciences Center, stated, claiming that doctors need as many pharmaceutical resources as possible, apparently regardless of whether they are actually safe for patients.
Others within the FDA were quick to point out how difficult their jobs can be. Karen Mahoney, an FDA medical officer, said that reviewing all the relevant data was "extraordinarily complex." The data sets were so complicated, she said, that FDA computers had to be upgraded to handle the load. Glaxo presented hundreds of documents including its own studies which claim that Avandia has no risk of increased heart attacks.
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Wednesday, August 01, 2007
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