15 July 2010

Counting the Votes on Avandia

Today’s Boston Globe reported on its front page:

A Food and Drug Administration advisory panel recommended yesterday that the diabetes drug Avandia be allowed to remain on the market despite a variety of studies that show it poses elevated risks of heart attack.
Today’s New York Times reported on its front page:
A federal medical advisory panel recommended Wednesday that Avandia, a controversial diabetes drug, should either be withdrawn from the market or have sales severely restricted because it increases the risks of heart attacks.
What gives? The two papers, both part of the same corporation, headlined opposing interpretations of the FDA advisory panel’s complex vote. The panel considered several options with the following vote totals:
  • Take Avandia off the market: 12.
  • Restrict Avandia sales and beef up its warning labels: 10.
  • Beef up the warning labels: 7.
  • Make no changes: 3.
  • Weaken the warning labels: 0.
  • Abstain: 1.
Depending on how you group the options, either two-thirds of the panel voted to withdraw or restrict Avandia, or slightly less than two-thirds voted to keep it on the market in some way.

I don’t have diabetes or a close friend or relative who does, so I have no personal experience or feeling about the drug. But the recent revelations about how GlaxoSmithKline manipulated and concealed studies revealing its dangerous side effects make me feel a little sick.

The Times notes that the FDA has left a risky drug on the market with restrictions only if it provides unique benefits, but studies (including some that Glaxo suppressed) show Avandia’s competitors are just as good without the side effects.

If Avandia does remain on the market, perhaps Glaxo can lose its patent for scientific misconduct.

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