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