News of the WeekDRUG SAFETY

Planned Study of Avandia in Doubt After FDA Review

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Science  23 Jul 2010:
Vol. 329, Issue 5990, pp. 375
DOI: 10.1126/science.329.5990.375

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Summary

Last week, a committee of 33 top diabetes experts reviewing whether the Food and Drug Administration (FDA) should pull the glucose-lowering drug Avandia from the U.S. market for potentially increasing the risk of heart attacks in diabetes patients couldn't render a clear verdict: Twelve voted to withdraw the drug; 10 said that its use should be restricted; and the remainder wanted it to stay on the market, but perhaps with more warnings. That decision left a lingering scientific question: What should happen to a study, called TIDE, that compares Avandia and a competing drug, Actos? The double-blind, randomized study is supposed to provide what earlier, lower-quality studies don't: a clear assessment of Avandia. A large, recent study that found no increased heart-attack risk, called RECORD, was not blinded, and scientists at the FDA hearing impugned both RECORD's quality and integrity. TIDE, which is meant to enroll 16,000 diabetes patients in 39 countries in a 6-year study, was designed to remedy the problem. But now it is running into trouble itself.