The Government Gets Aggressive with Diabetes Drug-Avandia

Three years ago, Dr. Steven E. Nissen, a cardiologist at the Cleveland Clinic, conducted a landmark study that suggested that the best-selling diabetes drug Avandia raised the risk of heart attacks. The study led to a Congressional inquiry, stringent safety warnings, a sharp drop in the drug's sales and a plunge in the share price of GlaxoSmithKline, Avandia's maker.

A Congressional investigation released Saturday concluded that GlaxoSmithKline had threatened scientists who tried to point out Avandia's risks, and internal memorandums from the Food and Drug Administration show that some government health officials want Avandia withdrawn. The drug is still being taken by hundreds of thousands of patients, and sales last year were $1.19 billion.

So the battle over Avandia has begun anew, and issues raised in the meeting between the four executives and Dr. Nissen are likely to be raised again. For instance, during the meeting, company executives repeatedly promised to begin a crucial analysis of the safety of Avandia "within days." Nearly three years later, such a study has not been published in a medical journal, although the company has posted results on its Web site.

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