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David Mittleman
David Mittleman
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Does the FDA Have a Drug Problem? Impacts of the Avandia Decision

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Just weeks after the Food and Drug Administration decided to keep Avandia on the market, the agency is coming under fire from policymakers and scientists who argue that the incident is yet another example of the drug industry’s ability to outmaneuver regulators.

The FDA’s dilemma began days before a 2007 article in the New England Journal of Medicine was released, which showed that the diabetes drug, Avandia, was linked to a 43% increase in heart attacks compared to other medications or placebos. A group of scientists and executives from the drug’s maker, GlaxoSmithKline, gathered in a conference room at the offices of the FDA in White Oak, Md. GSK wanted to convince the FDA to keep their top-selling drug on the market, and to do that, GSK officials focused not on the heart-attack data, but on a broader category of heart problems known as myocardial ischemia. The most recent studies, they argued, did not yield consistent information about a supposed increased risk of myocardial ischemic events. However, what the GSK officials didn’t tell FDA officials during that same meeting was that just two days earlier on May 14, 2007, GSK’s own Global Safety Board had noted strengthened proof in Avandia studies that the drug did increase cardiac risk. In addition, eight days earlier, the company’s head of research sent an email to its chief medical officer saying that Avandia patients did, indeed, show an “increased risk of ischemic event ranging from 30% to 43%”. Nevertheless, GSK’s strategy worked, as the agency ultimately decided to keep the drug on the market—a move that meant billions of dollars to GSK and a potential safety risk to millions of patients.

More recently, Avandia’s safety was called into question once again. However, by mid-July this year the FDA made the decision, once again, to keep Avandia on the market, despite the dozens of studies that the agency reviewed that showed that the drug was more likely to cause strokes and heart-related deaths. The move prompted FDA critics and drug industry monitors to question the drug-approval process—which they argue is too easy for pharmaceutical companies to buy. There does, indeed, seem to be some problems with the process: while the FDA is responsible for protecting the public from harmful drugs, the agency is not responsible for performing safety testing. Instead, it relies on the drug companies, themselves, to perform premarket testing on drugs for safety and efficacy. On the other hand, the American public has an insatiable appetite for new medicines—in fact, 140 million Americans take at least one prescription drug in any given month. The only definitive conclusion is that the drug approval process is a broken system plagued by the drug industry’s drive for profit and politicians’ willingness to oblige to special interests.