FDAnews Drug Daily Bulletin
Nov. 20, 2007 | Vol. 4 No. 228
Senate Report Alleges GSK Intimidation Over Avandia Concerns

Two high-ranking senators placed a report in the Congressional Record detailing how GlaxoSmithKline (GSK) employees allegedly intimidated a scientist who raised concerns over the company’s Type 2 diabetes drug Avandia.

GSK tried to intimidate and silence university professor John Buse after he raised concerns about Avandia’s (rosiglitazone maleate) link to cardiovascular events, Senate Finance Committee Chairman Max Baucus (D-Mont.) and Ranking Member Chuck Grassley (R-Iowa) said. The lawmakers are concerned the incident could be part of a “more troubling pattern of behavior by pharmaceutical executives,” the report says.

Buse spoke about the company’s intimidation at a House Oversight and Government Reform Committee hearing earlier this year. GSK said the accusations were “absolutely false.” After his testimony, Baucus and Grassley sent letters to GSK and the University of North Carolina at Chapel Hill asking for documents, contacts and communications between the organizations related to Avandia.

According to the report, after Buse voiced concerns with Avandia, GSK employees labeled him a renegade, complained to his superiors and threatened a lawsuit, the report says. At one point, Buse said a company employee told his department chair that Buse could be held liable for a $4 billion drop in the company’s stock.

GSK then prepared a letter for Buse to sign that said he was no longer worried about an increased risk of cardiovascular events with Avandia use. The company showed the letter to a consulting firm that was evaluating GSK’s products for investors. Buse also signed a legal document agreeing not to discuss the issue in public.

High-ranking executives, including CEO Jean-Pierre Garnier, were involved in discussions to silence Buse, according to the committee report.

If GSK had taken Buse’s concerns more seriously, some of the thousands of heart attacks caused by Avandia may have been avoided, the report says. “Attacks on medical researchers by the pharmaceutical industry must stop. And stop now,” Grassley said.

The committee report can be seen here

http://www.whale.to/a/zapper_q.html