Science in the Triangle

A Senate committee report blasts GlaxoSmithKline for being more concerned about the sales of Avandia than about possible serious cardiovascular risks associated with the blockbuster diabetes pill. Also, two Research Triangle area companies developing new drugs sign deals.

Intimidation, a leak and a private meeting

A two-year investigation by a Senate committee didn’t solve the question whether GlaxoSmithKline’s diabetes pill Avandia does or doesn’t increase the risk of heart attack. But the report issued by the committee’s Democratic chairman and ranking Republican member claims GSK, which has its U.S. headquarters in Research Triangle Park, deliberately kept the evidence inconclusive to avoid having to withdraw the drug from market.

Warning signs about possible cardiovascular side effects arose as early as 1999, but GSK forced Dr. John Buse, a diabetes expert at the University of North Carolina at Chapel Hill, to stop talking and writing about his concerns. According to the report, GSK threatened to sue Buse and complained about him to his superiors.

The Senate committee investigators, who reviewed more than 250,000 documents, determined that GSK was aware Avandia possibly increased cardiovascular risks as early as 2004 but failed to disclose this to patients and physicians.

In May 2007, the New England Journal of Medicine published an analysis of 42 studies by Dr. Steven Nissen, an outspoken cardiologist at the Cleveland Clinic. Nissen’s analysis suggested that Avandia was associated with a 43 percent increased risk of heart attack, a finding with which GSK executives strongly disagreed and that another researcher couldn’t repeat.

The Senate committee report found that a GSK consultant and peer reviewer for the medical journal leaked Nissen’s paper to GSK before publication. A week before the New England Journal of Medicine published the paper online, the New York Times reported, GSK asked Nissen during a private meeting to reconsider publication.

In a statement, GSK rejected the conclusions of the Senate committee report as unfair and unbalanced and accused the investigators of mischaracterizing GSK’s research efforts.

Doctors have long abandoned the drug regardless of whether they believe it poses increased cardiovascular risks or not. As a result, Avandia’s sales have dropped from about $3 billion in 2006 to $1.2 billion last year.

In other business news:

• Biolex raised $10 million in investments and debt. The Pittsboro biotech company will use the money to continue testing a hepatitis drug in patients.
• Viamet Pharmaceuticals of Morrisville signed a drug research partnership with a venture capital arm of Swiss pharmaceutical giant Novartis. The deal could be worth more than $200 million.