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Below is an article from the NY Times. Please share this info with people you know who may be taking Avandia.
Hundreds of people taking Avandia, a controversial diabetes medicine, needlessly suffer heart attacks and heart failure each month, according to confidential government reports that recommend the drug be removed from the market.
The reports, obtained by The New York Times, say that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart. Avandia, intended to treat Type 2 diabetes, is known as rosiglitazone and was linked to 304 deaths during the third quarter of 2009.
Avandia was once one of the biggest-selling drugs in the world. Driven in part by a multimillion-dollar advertising campaign, sales were $3.2 billion in 2006. But a 2007 study by a Cleveland Clinic cardiologist suggesting that the drug harmed the heart prompted the F.D.A. to issue a warning, and sales plunged. A committee of independent experts found in 2007 that Avandia might increase the risk of heart attack but recommended that it remain on the market, and an F.D.A. oversight board voted 8 to 7 to accept that advice.
Hundreds of thousands still take the medicine,criticizes GlaxoSmithKline, saying it failed to warn patients years earlier that Avandia was potentially deadly.[/B]
In the wake of the controversy, agency officials ordered GlaxoSmithKline to undertake a study comparing how many heart attacks, strokes and heart-related deaths occur among patients given either Avandia, Actos or a placebo. Studies suggest that Actos, made by Takeda, lowers blood sugar as well as Avandia but without hurting the heart as much.
The trial is not expected to be completed until 2020, although the company is hoping to report some results to the F.D.A. by 2014.
Mr. Grassley said the internal agency battle showed that the agency needed to be restructured to give more power to safety officials like Dr. Graham and Dr. Gelperin over their counterparts who approve medicines and deal more directly with drug makers.
The Senate investigation - the result of years of digging through more than 250,000 internal company documents - concludes that GlaxoSmithKline and by extension the F.D.A. delayed far too long in this process.Negotiations with agency officials about how and whether to alert the public continued.
Meanwhile, the company continued to market and advertise Avandia aggressively. The Senate inquiry concludes that the company threatened doctors who suggested in public that Avandia might have serious risks.
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