Don't overreact to meta-analysis, FDA says

Mention the word "meta-analysis" and some drug executives would brace themselves. After all, a series of meta-analyses have raised safety questions about some high-profile drugs. The most obvious example is GlaxoSmithKline's Avandia, which was tagged with increased cardiovascular risks after a much-publicized meta-analysis by Cleveland Clinic cardiologist Dr. Steve Nissen.

Forbes points out a couple more: Novartis' bowel drug Zelnorm, which got yanked off the market after a meta-analysis, for one. Then there's Spiriva, a lung drug from Boehringer Ingelheim and Pfizer. A meta-analysis raised questions about its safety, but the FDA has decided not to force the drug off the market.

So it should be a comfort to drugmakers that the agency explained its Spiriva decision by shaking its head over the proliferation of meta-analyses. In the current New England Journal of Medicine, three FDA officials advise "measured restraint" when evaluating such studies. Publication of meta-analyses that identify potential safety problems "commonly leads to urgent calls to take immediate regulatory action without acknowledgment of potential pitfalls in the interpretation of data," the officials write.

The upshot? New info should be evaluated carefully, the FDA researchers say, so that drugs aren't unduly restricted.

- read the Forbes piece

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