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July 30, 2007
Avandia's Latest Round
I have to say, I think the FDA vote on Avandia (rosiglitazone) was well done. As those following the story know, David Graham at the agency had been pushing to have the drug removed from the market, but a panel just voted 22 to 1 to keep it, albeit with warning labels and stricter standards for use.
That's as it should be. As mentioned here before, we really don't have hard enough data on the compound's risks yet and whether or not they outweight its benefits. I think that this decision is a grown-up one: to say that yes, rosiglitazone appears as if it may have some cardiovascular risks, but since we're not sure about that, for now it appears that they're risks worth taking. It'll be up to patients and their physicians to make the call.
Would that it always worked this way! Drugs have side effects, how ever much we might wish that they didn't. Some are bad enough to wipe out any benefit, and some aren't. It's a judgement call every time, and I'm glad that the panel exercised some instead of going reflexively with the "no risk to anyone for any reason, ever" mindset.
Avandia may well be taken off the market when more data come in. And if that happens, then we'll know that it was the right decision. But we don't know that yet. How, I wonder, will this vote affect the lawsuits that are already being prepared? Can you sue for being (allegedly) harmed by a drug the FDA just re-reviewed and decided to keep?
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