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Avandia Faces More Scrutiny

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Could Avandia’s days on the market be numbered? According to a New York Times report, some officials at the Food & Drug Administration (FDA) think the controversial diabetes drug should be pulled from the market because of its link to heart attacks. Meanwhile, a Senate Finance Committee report released over the weekend claims GlaxoSmithKline knew for years about Avandia’s heart attack risks, but took steps to keep the public in the dark.

According to The New York Times, Dr. Janet Woodcock, director of the FDA’s drug center, ordered that another FDA panel be convened to reconsider whether Avandia should stay on the market, after writing in a December 2009 memo that “there are multiple conflicting opinions” about Avandia within the agency. The advisory panel meeting is expected to take place this summer.

According to the Senate report detailed by the Times, in July 2007 the FDA’s own scientists estimated that Avandia was responsible for more than 80,000 heart attacks. The report maintains that some of those could have been avoided if Glaxo had considered Avandia’s cardiovascular risks in 1999 when they were first raised. Instead, the report maintains that Glaxo tried to undermine criticism of the drug.

The Senate report is the result of a 2-year investigation of Avandia. It draws from more than 250,000 pages of documents provided by Glaxo, the FDA and several research institutes, as well as interviews with officials from both the company and agency, as well as well as anonymous whistleblowers. The report was signed by U.S. Senator Max Baucus, a Democrat and committee chairman, as well as Sen. Chuck Grassley, the top-ranking Republican on the committee.

The Senate committee report doesn’t address whether Avandia should be taken off the market. But internal reports from the FDA do recommend such action. According to the Times, an October 2008 internal FDA memo authored by Dr. David Graham and Dr. Kate Gelperin recommends that Avandia be removed from the market. Graham had argued to an advisory panel in 2007 that Avandia sales should be stopped, but the panel voted 22-1 to recommend it remain on the market.

According to the memo, 500 heart attacks and 300 cases of heart failure could be avoided each month if diabetics taking Avandia took Actos instead. Avandia was linked to 304 deaths during the third quarter of 2009.

Avandia’s cardiovascular problems have been the subject of concern since May 2007, when an analysis of 42 clinical trails published by the Cleveland Clinic showed that patients taking the drug had a 43-percent higher risk of having a heart attack. In November 2007, a black box warning – the FDA’s strongest safety warning – detailing Avandia’s association with myocardial ischemia was added to the drug’s labeling. Since the May 2007 study highlighting Avandia’s heart risks was released, thousands of people injured by the drug have filed lawsuits against Glaxo.

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