Senate Finance Committee Wants Answers From Former GSK Exec

11/27/2007- Two senior members of the Senate are seeking an interview with Tadataka Yamada, the former chairman of R&D for GlaxoSmithKline (GSK), to discuss his role in the alleged intimidation of John Buse, a professor at the University of North Carolina at Chapel Hill who raised concerns in 1999 about cardiovascular risks associated with Avandia.

Sens. Max Baucus (D-Mont.) and Chuck Grassley (R-Iowa), the chairman and ranking member of the Senate Finance Committee, recently entered a report in the Congressional Record they say details how GSK employees allegedly intimidated the scientist. The committee has jurisdiction over the Medicare and Medicaid programs.

In a letter to Yamada, the senators requested that he schedule a meeting with committee staff by the end of the month to “enhance the committee’s understanding of the facts” surrounding the allegations of intimidation. “Based upon documents received by the committee from GSK and others, it appears that, in your position as chairman of research and development at GSK, you played a significant role in developing and implementing GSK’s strategy for dealing with Dr. Buse’s public airing of his concerns about cardiovascular risks associated with Avandia,” they wrote.

Yamada, who currently heads the Bill & Melinda Gates Foundation’s Global Health Program, retired from GSK last year. A representative for Yamada said the former GSK executive did not intimidate the researcher or direct subordinates to do so. He expects to schedule a meeting with committee staff shortly.

The meeting is part of the committee’s ongoing investigation into the Type 2 diabetes treatment Avandia (rosiglitazone maleate). Physician labeling for the drug recently was updated with a revised boxed warning, and GSK has agreed to conduct a clinical trial comparing the safety of Avandia with other oral diabetes medicines.

Takeda Highlights Safety of Diabetes Drug in Ad Campaign

Takeda is showcasing the cardiovascular safety of its Type 2 diabetes drug Actos (pioglitazone HCl) in a new ad campaign.

The ad does not mention by name a competing product, GlaxoSmithKline’s Avandia (rosiglitazone maleate), which a joint FDA advisory committee voted in July to keep on the market despite its association with cardiovascular adverse events.

Avandia now carries an updated boxed warning and will be the subject of a long-term safety study comparing it with other oral diabetes medications, including Actos. In September, separate reports published simultaneously in The Journal of the American Medical Association delivered good news about the cardiovascular safety of Actos and correspondingly bad news for Avandia.

But Avandia is not the target of the Takeda ad, Shay Weisbrich, general manager of diabetes marketing for Takeda Pharmaceuticals North America, said. “Our reason for doing this is that this has been a very confusing summer for diabetes patients” due to a string of alarming news reports about the safety of diabetes drugs, she said.

The ad will run in 82 daily newspapers and four weekly magazines in the next few weeks, including Newsweek, Time, U.S. News & World Report, People, the Chicago Tribune, The New York Times and the Los Angeles Times, Elissa Johnsen, manager of product public relations for Takeda Pharmaceuticals North America, said.