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Avandia Reports Raise More Concerns

Feb 21, 2010 | Parker Waichman LLP

An Avandia report from the Senate Finance Committee  says GlaxoSmithKline knew for years about the drug’s heart attack risks years before they became public, but took steps to keep them quiet.  Meanwhile, it seems that some Food & Drug Administration (FDA) reviewers have called for Avandia to be removed from the market.

The Senate report is the result of a 2-year investigation of Avandia. According to CNN, 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.

According to the report, 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:

“GSK executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk and sought ways to downplay findings that a competing drug might reduce cardiovascular risk,” the report says.

The Senate committee report doesn’t address whether sales of Avandia should end, but some at the FDA think that's what should happen.  According to a report published in The New York 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.

According to The New York Times, Graham and Gelperin also argued in two separate internal reports that a new GlaxoSmithKline study, called TIDE, is “unethical and exploitative” because patients given Avandia face far greater risks than those given Actos, with no promise of any additional benefit. The FDA ordered the study in 2007 to give a definitive picture of Avandia’s safety. The trial, which will involve 16,000 participants, is still enrolling patients.

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. According to the Times, the advisory panel meeting is expected to take place this summer.

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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