On Friday, The New York Times released evidence from confidential FDA reports showing that the blockbuster diabetes drug Avandia, manufactured by GlaxoSmithKline, greatly raises risks of heart attacks.
According to these reports, Avandia causes roughly 500 heart attacks and 300 instances of heart failure per month in diabetes patients—incidents that could likely be avoided completely if these patients took a similar drug called Actos, made by Takeda. In the third quarter of 2009, more than 300 patients taking Avandia died from heart problems caused by the drug.
“Rosiglitazone should be removed from the market,” one report, by Dr. David Graham and Dr. Kate Gelperin of the Food and Drug Administration, concludes. Both authors recommended that Avandia be withdrawn. –New York Times
And yet, hundreds of thousands of people still take Avandia every day; the official FDA position, despite the recent reports and opinions of its own employees, is that Avandia should remain on the market.
But why? According to the conclusions of recent Senate investigation into Avandia and GlaxoSmithKline, the company
“failed to warn patients years earlier that Avandia was potentially deadly…Instead, 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,” concludes the report, which was overseen by Senator Max Baucus, a Montana Democrat, and Senator Charles E. Grassley, an Iowa Republican.
Mr. Baucus said of the report, “Patients trust drug companies with their health and their lives, and GlaxoSmithKline abused that trust.” –The New York Times
So let’s take it off the market, FDA. Why does this agency consistently insist on waiting until thousands of people have needlessly died from drugs known to be deadly before taking definitive action and removing them from circulation? We don’t need another Vioxx on our hands, but this sounds like exactly what Avandia is shaping up to be.