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FDA: No Decision on Whether to Pull Diabetes Drug Avandia Off the Market
Date:2/22/2010

racture risk.

Throughout 2009, more studies reiterating the drug's heart risks also came to light, including one published in the BMJ suggesting that Avandia's risk for heart failure seemed to outstrip those of its related rival, Actos.

By that point, "most clinicians [had] stopped using Avandia -- some will use Actos instead or go to another class completely," Dr. Carl J. Lavie, medical director of cardiac rehabilitation at the Ochsner Heart and Vascular Institute in New Orleans, told HealthDay at the time.

The emergence of the leaked documents on Saturday comes at a time when officials within the FDA seem to be at loggerheads over whether to ban Avandia or not, the Times reported. The newspaper said that some officials believe that safer alternatives exist, while others say the evidence on Avandia's safety is conflicted and the drug should remain available as a treatment option.

Trying to sort things out, in December of 2009 Woodcock asked officials at the FDA to convene another advisory committee to determine whether Avandia should remain on the market, with a decision expected this summer.

In the meantime, a bipartisan Senate investigation -- overseen by Sen. Max Baucus (D-Mont.) and Sen. Charles E. Grassley(R-Iowa) -- has pored over 250,00 internal documents from GlaxoSmithKline. The investigation has placed much of the blame for the Avandia debacle on the company, contending that it neglected to warn patients for years of the drug's dangers.

"G.S.K. 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," according to the Senate investigation report, which was slated for release Monday.

Speaking to the newspaper Friday night, agency commissioner Dr. Margaret Hamburg sai
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