Tuesday, July 13, 2010

The fate of Avandia

So the FDA has a great opportunity in front of it.  As some of you might have read, the safety of the drug Avandia has been brought into question.  It is now well established that, while the drug does provide some benefits to diabetics, it comes with cardiovascular risks.  Recent studies highlight these findings and also show that the drug is no more effective than its competitors.  While this alone should be sufficient to pull the drug from the shelf, the controversy goes much deeper.  Glasko Smith Klein, the maker of Avandia, had evidence as early at 1999 that there was significant cardiovascular risks for patients on the drug, but decided to hide that evidence from the public and the FDA.  They continued to hide increasing amounts of internal data for years in order to keep the money coming in (an internal memo from the company estimated that releasing the negative data could result in hundreds of millions of dollars lost), before the courts finally forced their hand. 

To me, and maybe to many of you, it seems logical that the drug be pulled from the shelf and huge penalties be thrown at GSK, however, I'm not to confident that will happen.  When a member of the review committee for Avandia suggested the drug not go to market over concerns about cardiovascular risks she was kindly asked to leave.  Hopefully the increased public awareness and mounting evidence will sway the upper echelon of the FDA towards the correct, ethical decision.

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