Avandia Causes Heart Damage Government Concludes

The New York Times has obtained a government report that concludes that the drug Avandia [aka Rosiglitazone], prescribed for diabetes, causes heart attacks and heart failure and should be removed from the market. According to the report, if every diabetic currently on Avandia were instead given Actos, an alternative drug, about 500 heart attacks and 300 cases of heart failure would be avoided every month.

Because of a multimillion dollar advertising blitz, Avandia was, at one time, one of the biggest selling drugs in the world. In 2006, sales of the drug totaled over $3 billion dollars. In 2007, however, a study by a Cleveland Clinic cardiologist suggested that the drug actually damaged the heart, and after a warning from the FDA, sales of the drug dropped dramatically. Despite the findings of heart damage, the drug stayed on the market when “an F.D.A. oversight board voted 8-7” too keep it on the market. (It would be interesting to know the politics at work behind that decision.)

“Rosiglitazone should be removed from the market,” concluded Dr. David Graham and Dr. Kate Gelperin of the FDA in the report obtained by the Times. GlaxoSmithKline, the drug’s manufacturer, disagrees (of course). It has stated that Avandia has been thoroughly tested and that “scientific evidence simply does not establish that Avandia increases” the risk of heart attacks.

A bipartisan multiyear Senate investigation, which will release its report on Monday, will apparently harshly criticize GlaxoSmithKline for failing to warn patients years earlier that Avandia was potentially deadly. According to the forthcoming report from the Senate:

“[GlaxoSmithKline] 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.”

Ultimately, this will be a story about the quest for profits at the expense of human lives.

Source: New York Times

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