It will be a busy week for the Food and Drug Administration as the agency prepares to meet to discuss the fate of Avandia, the controversial Diabetes drug that has been linked to an increase in the risk of heart attack. Last week the FDA posted an extensive 700-page review of Avandia and also panned a study published by GlaxoKlineSmith meant to defend the once-popular drug in preparation for its meeting this week. The FDA is in a difficult position as it sits down to decide if Avandia will stay on the market even though the drug was approved ten years ago, but nevertheless has potentially deadly side effects.
The FDA reviewed dozens of studies of Avandia, including the GlaxoSmithKline study, and discovered troubling results. Prior to more recent studies, Avandia, like many other drugs during the 1990s, was approved based on relatively small studies in several thousand patients. While those studies were large enough to detect if the drug was effective in helping control blood sugar levels, they were not large enough to detect all of the drug’s potential side effects. In more recent years, the FDA has required longer, larger studies of diabetes drugs like Avandia that also include more high-risk patients. As a result, the most recent study published last month analyzed 225,000 Avandia users and found that the drug is more likely to cause strokes and heart-related deaths as compared to other Diabetes drugs, such as rival drug Actos.
The FDA will hold its meeting starting on Tuesday to help decide what course of action to take. A panel of outside physicians will consider a range of recommendations including adding more warning labels, limiting which doctors can prescribe Avandia, or pulling the drug from the market. While the FDA is not required to follow the advice of the outside panel, it most often does. Furthermore, politicians on Capitol Hill are touting the Avandia scenario as a litmus test to see how courageous and competent the FDA will be when confronted with deadly drugs that are already approved and on the market. However, former FDA officials argue that political prodding, such as what’s occurring on Capitol Hill now, only serves to harm the agency’s mission. Specifically, Senate Finance Committee ranking Republican Charles Grassley first initiated the review of Avandia with another investigation of GlaxoKlineSmith that concluded that the company purposefully tried to keep the risks associated with Avandia a secret. Last week Grassley demanded that Avandia be pulled from the market. But former FDA are especially concerned about politicians demanding that the FDA take certain actions, particularly since politicians are not scientists. For example, Mary Pendergast, former FDA deputy commissioner, recently stated:
“Public policy decisions don’t get made in a vacuum, and that’s a reality of FDA decision making that everyone has to recognize. But when members of Congress who are not scientists tell the FDA what to decide, I think that’s hard for the FDA.”