High-stakes meeting on Avandia exposes internal rifts among FDA scientists

By Matthew Perrone, AP
Tuesday, July 13, 2010

Diabetes pill controversy shows rift in FDA ranks

WASHINGTON — The diabetes pill Avandia has been used by millions of patients and racked up billions in sales in more than a decade on the market. This week the Food and Drug Administration is trying to answer a seemingly simple question: Does it cause heart attacks?

It’s the type of crucial safety question that the agency was established to answer. But as the FDA began a two-day meeting Tuesday to determine Avandia’s fate, it became clear that the agency’s own scientists are divided.

On Wednesday the FDA will ask a panel of advisers to untangle the mess of data that has stumped its own scientists for over three years.

The group will vote on recommendations, including possible withdrawal of the drug. The FDA will make a final decision in coming months.

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