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Glaxo Product Litigation

Associated Press
Avandia Maker Threatened to Sue Critic
By MATTHEW PERRONE 06.06.07, 4:35 PM ET 

 http://www.forbes.com/feeds/ap/2007/06/06/ap3795714.html

The controversy surrounding GlaxoSmithKline's diabetes drug Avandia grew Wednesday as a medical expert told Congress that executives threatened to sue when he first raised questions in 1999 about the treatment's safety.

That testimony, coupled with a recent medical journal analysis highlighting the heart attack risks associated with Avandia, prompted some Democratic lawmakers to rebuke the Food and Drug Administration for failing to protect consumers, and to call for stricter industry regulation.

"Despite additional warnings from outside experts, despite the millions of patients who rely on Avandia to control their blood sugar, and despite the potential risks involved, FDA never required the manufacturer to conduct a thorough post-market study of its heart risks," Rep. Henry Waxman, D-Calif., said.

Waxman, who chairs the House Committee on Oversight and Government Reform, called Wednesday's hearing after an analysis that appeared last month in the New England Journal of Medicine concluded Avandia could raise patients' risk of heart attack by more than 40 percent.

Glaxo argues that Avandia is safe and that its own patient studies are a more reliable measure of the drug's safety, although outside experts say the company's results are inconclusive.

Dr. John Buse told lawmakers that after he drew attention in 1999 to heart problems among some patients using Avandia, SmithKline Beecham, which later combined with GlaxoWellcome, warned him that some executives wanted to hold him accountable for a $4 billion drop in the company's stock.

In a letter to SmithKline distributed at the hearing, Buse wrote: "Please call off the dogs. I cannot remain civilized much longer under this kind of heat."

Buse, who is head of endocrinology at the University of North Carolina and is set to become president of the American Diabetes Association, said he eventually signed a clarifying statement with the company that was used to ease concerns from investors. But one year later, Buse sent a letter to the FDA raising the same concerns.

FDA Commissioner Andrew von Eschenbach told Congress his agency is still reviewing dozens of often contradictory studies and analyses on the drug's effects on diabetics. FDA has scheduled a July 30 meeting to have a group of outside experts look at the data.

Von Eschenbach revealed that FDA is ordering Glaxo and rival Eli Lilly (nyse: LLY - news - people ) to add black box warnings to their diabetes drugs Avandia and Actos, strengthening existing warnings about heart failure, a condition where the heart does not adequately pump blood. The issue is separate from the trend toward heart attacks highlighted in the New England Journal of Medicine.

More than 6 million people worldwide have taken Avandia or a related drug, Avandamet, since it came on the market in 1999. Glaxo reported total U.S. sales of $2.2 billion for the drug last year.

For its part, Glaxo released the most recent results from a large-scale study of Avandia ahead of the hearing, saying the data show the drug is no more dangerous than other leading diabetes drugs.

The Senate recently passed a version of a bill that makes major changes to FDA's drug safety system. Companion legislation has not yet appeared in the House. Waxman and other leading Democrats said they favor legislation that would give FDA more power to require companies to conduct drug safety studies.

Shares of GlaxoSmithKline (nyse: GSK - news - people ) PLC fell 44 cents to $51.46 Wednesday.



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