FDA Advisers Disagree on Avandia

NEW YORK, July 13 (UPI) — U.S. government scientific advisers disagreed Tuesday on whether the diabetes drug Avandia should be removed from the market, officials said.

At the first day of a two-day meeting of the 22 scientific advisers in Gaithersburg, Md., Thomas A. Marciniak of the U.S. Food and Drug Administration presented a critique of a GlaxoSmithKline sponsored study that provided the best evidence of the drug’s safety, but Marciniak said the drug company excluded data that indicated the drug increased heart risk, The Washington Post reported.


Kate Gelperin, also an FDA scientist, presented an analysis that Avandia increased the risk for heart attacks, heart failure and death.

FDA researcher Ellis F. Unger challenged Marciniak’s interpretation of how the data were selected and agreed with the company’s analysis that the drug was safe. Murray Stewart, of GlaxoSmithKline, said other studies had found no increased cardiac risks, the Post said.

After its FDA approval in 1999, Avandia became the world’s most popular drug to treat type 2 diabetes. In 2007, a Cleveland Clinic study indicated the drug significantly increased the risk for cardiovascular problems.

GlaxoSmithKline, when it was known as SmithKline Beecham, tried to cover up test results on the diabetes drug Avandia, The New York Times reported.

Citing documents including sealed depositions, the newspaper said Tuesday the company spent 11 years trying to keep under wraps the results of a 1999 study comparing Avandia to Actos, a competing drug made by Takeda. The study found Avandia was no more effective than Actos and that, by some indications, Avandia might pose a greater risk of heart problems, the Times reported.

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