It's worth a look inside the Senate Finance Committee's 342-page report on GlaxoSmithKline (GSK)'s Avandia diabetes medicine if only for the allegations of cloak-and-dagger intimidation the company aimed at scientists who had bad things to report about the drug. In there you will meet Dr. Tachi Yamada (pictured), GSK's fixer on Avandia, who with just a few phone calls to your superiors can derail your drug research.FDA reviewers believe Avandia caused 500 extra heart attacks per month, and Senators Charles Grassley and Max Baucus are asking the agency to remove the drug from the market. GSK has mounted a feisty defense, saying that the Senate report "cherry picks" information and that "the scientific evidence simply does not establish that Avandia increases cardiovascular ischemic risk or causes myocardial ischemic events." Seven trials have not shown a statistical link between Avandia and heart attacks, GSK insists.
GSK's combative stance is paralleled in the report. That document suggests that if you were an independent scientist doing a study of Avandia's side effects, then Yamada, GSK's top R&D man, would make some calls and your study would either be spiked, leaked pre-publication, or rubbished in the press by GSK's pr machine. Said one University of Pennsylvania scientist, whose case study of a single patient with liver failure ended up not being published:
I have never encountered anything like this in my career. I don't even know how [GSK] knew that we were publishing. It's the kind of thing you imagine happening on TV.Here's a sample from Yamada's email, in which former GSK president David Stout asks Yamada to "place another call to your contacts" about some research that is "not [in] anyone's best interest":
The report gives the best details regarding Dr. John Buse, a professor of medicine at the University of North Carolina. Buse appeared at conferences and had written to the FDA to say that he suspected heart problems in Avandia in 1999:
According to GSK emails made available to the Committee, GSK executives labeled Dr. Buse a "renegade" and silenced his concerns about Avandia by complaining to his superiors at UNC and threatening a lawsuit. The call to Dr. Buse's superiors was made by Dr. Tachi Yamada, then GSK's head of research.Yamada denied he was making calls to intimidate Buse:
Instead, Dr. Yamada argued that he had made the call to determine if Dr. Buse was making legitimate statements or if he was possibly on the payroll of a GSK rival.Another UPenn physician said the calls had a chilling effect:
"It was really ridiculous. It was a case report and I had no intention of bringing down GSK. I just wanted people to know." The physician added, "It left a really bad taste in my mouth. After that happened, I said that I would never work for a drug company."The report also gives more background detail on the famous battle GSK had with Dr. Steven Nissen of the Cleveland Clinic. It was Nissen's analysis of Avandia data that first raised public concerns about Avandia and heart attacks. The report says the study was leaked to GSK ahead of publication, and that:
... allowed GSK to launch a public relations plan to protect Avandia.