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Avandia Heart Risks Buried by Drug Company: Report
Date:7/13/2010

By Amanda Gardner
HealthDay Reporter

TUESDAY, July 13 (HealthDay News) -- The pharmacy company that makes Avandia knew more than a decade ago that the blockbuster diabetes drug caused an increased risk of heart problems but covered up the information, according to a report published Tuesday in The New York Times.

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 message the Times obtained, Dr. Martin I. Freed, a company executive, wrote about the study results: "This was done for the U.S. business, way under the radar. Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK." GlaxoSmith Kline is the corporate successor to SmithKline.

The safety of Avandia (rosiglitazone) comes under U.S. government scrutiny starting Tuesday, as an advisory panel of experts begins two days of hearings.

The new information released by the Times comes after new doubts surfaced last week on a key trial that helped keep Avandia on the market.

Last Friday, a medical reviewer for the U.S. Food and Drug Administration posted remarks on the agency's Web site suggesting that GlaxoSmithKline's "mishandling" of trial results may have masked some cardiovascular effects of Avandia.

The official's posting was part of a safety reassessment package prepared for the FDA's advisory panel meeting.

At issue in the review posting were the results of the landmark RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes) trial, which was done by Glaxo at the FDA's r
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