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FDA Panel Appears Skeptical Over Key Avandia Data
Date:7/13/2010

By Amanda Gardner
HealthDay Reporter

TUESDAY, July 13 (HealthDay News) During hearings Tuesday into the safety of controversial diabetes drug Avandia, members of the government panel that could decide the drugs' fate seemed skeptical of much of the data presented.

A decision on whether to ban Avandia or not is expected Wednesday.

The hearing has coincided with news that the drug's maker, GlaxoSmithKline, may have buried or manipulated data crucial to Avandia's approval and continued sale.

"Can we trust the sponsor?" Dr. Ellis F. Unger, a U.S. Food and Drug Administration official, asked when referring to GlaxoSmithKline (GSK), The New York Times reported. "I think thats something the committee is going to need to think about here," he said.

Dr. Nancy L. Geller, a member of the FDA advisory committee and director of the Office of Biostatistics Research at the National Heart, Lung and Blood Institute, also made her doubts known, the Times reported. "I'm just concerned about data quality overall," she said.

When told that mortality estimates from clinical trials are generally reliable, Geller replied, "Not if you report the wrong follow-up date and not if you withdraw someone from a trial just before their death."

Things have looked increasingly grim for Avandia this week. In a report released early Tuesday, the Times said that GSK knew more than a decade ago that Avandia caused an increased risk of heart problems but covered up the information.

In a 1999 trial pitting Avandia against its competitor, Actos, the drug company, then known as SmithKline Beecham, found that Avandia posed a heart risk, the newspaper reported.

The Times report, based on internal company documents it obtained, said that the company did not post results of its drug trial findings on its Web site or submit them to federal regulators.

According to a March 29, 2001, e-mail
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