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When did the FDA learn about Avandia?

The way that the US Food and Drug Administration (FDA) dropped the ball on Type 2 diabetes drug Avandia has fueled calls from both in and outside of government for FDA reform. We should all be afraid, very afraid, that a government body charged with protecting the public good on such a basic level is toothless. And that's putting it kindly.

The public radio show Marketplace just ran a two part feature on this issue. Its reporter asks the question: when did the FDA first learn about the health risks posed by Avandia (namely, increased risk for heart attack)? Also, what did the FDA know before the story broke in the media? Shockingly, Avandia manufacturer GlaxoSmithKline (GSK) informed the FDA back in 2005 that the drug raised the risk of heart attack. GSK even supplied the FDA with a copy of its internal analysis on the subject in 2006, which the FDA then confirmed with its own analysis. The FDA's explanation for its silence was that it was trying to assemble a comprehensive picture of the situation before acting. Sure. But how much longer would the FDA have sat on the Avandia issue if the story hadn't broken following the criticisms of cardiologist Steven Nissen?

Because the FDA is supposed to be our public health watchdog, these questions will ultimately prove far more significant than questions about what GSK knew and when. Big Pharma - like all business enterprises, large and small - is focused on the bottom line. It's up to the FDA to look out for the rest of us. Yet many in our government believe in letting market forces prevail; that in a healthy economy, little government oversight is necessary. Fact is, this just doesn't work. Are you scared yet?

Happy July 4th!

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