Friday, 10 August 2007

Avandia lesson: drug approval should be about more than blood sugar

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The chairman of the FDA advisory panel that reviewed the safety of rosiglitazone (Avandia) last week believes the time has come to abandon "surrogate endpoints" for approval of type 2 diabetes drugs, according to a report at


OK. English. Basically, the FDA currently approves drugs for diabetes that show great promise for controlling blood sugar. And they do it very quickly. But just because a drug controls blood sugar, doesn't mean it won't hurt your heart.

Endocrinologist Clifford J. Rosen, M.D., wrote his version of that in a perspective published online today by the New England Journal of Medicine. You can read medical jargon filled reports on it here or here. According to the reports, Rosen suggests if the FDA fails to make the shift from surrogate to clinical end points (English: make change to the criteria by which drugs are approved) "with regard to diabetes drugs, we are certain to be in the same position five years from now that we are now: we will again find ourselves in possession of a new wonder drug that is designed to treat a devastating chronic disease but that may do more harm than good."

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