GlaxoSmithKline reportedly threatened diabetes expert over Avandia warnings

GSKby David Gutierrez

(NewsTarget) A diabetes expert has claimed that pharmaceutical company GlaxoSmithKline threatened him with legal action after he raised concerns about the safety of the company's anti-diabetes drug rosiglitazone, marketed as Avandia.

In a written testimony to a congressional subcommittee, John Buse of the University of North Carolina said that he received phone calls from company executives in 1999, just after Avandia's release, warning him that his comments about the drug "were scurrilous enough to attempt to hold me liable for a loss in market capitalization." Buse later signed a statement, drafted by GlaxoSmithKline, attempting to alleviate the concerns that his comments had raised with stockholders.

GlaxoSmithKline's CEO J.P. Garnier has denied that the company made any threats, saying instead that Buse made a "correction" to his prior comments.

In March 2000, Buse -- who is expected to become the next president of the American Diabetes Association -- warned the FDA that Avandia might increase users' risk of heart attacks. He also publicly criticized the company's "blatant selective manipulation of data," which he said functioned to make the drug appear more effective and less dangerous.

Buse's recent comments were directed to the House Committee on Oversight and Government Reform, which is investigating the FDA's role in approving Avandia. The committee convened a hearing on the issue after the New England Journal of Medicine announced that it would be publishing a study linking Avandia use to increased cardiovascular problems. The study, published on June 14, found that the drug led to a 43 percent higher risk of heart attack and a 64 percent higher risk of heart death.

As a result, Congress is investigating why the early warnings given by Buse and the World Health Organization were not heeded in the FDA approval process.

The FDA's process for approving new drugs has come under increasing fire recently, spurred on by scandals such as the discovery that Merck's popular anti-inflammatory Vioxx led to increased risk of heart attack and stroke.