GlaxoSmithKline threatened a respected scientist with a US$4 billion ($5.3 billion) lawsuit to try to silence his criticisms of the company's controversial diabetes drug Avandia, a congressional hearing in Washington DC was told yesterday.
John Buse testified that he was so intimidated by company employees that he senta desperate letter to a board member asking him to "call off the dogs".
The alleged threats and an alleged smear campaign against Buse were made in 1999 when the diabetes expert was publicly warning that there may be heart risks associated with Avandia, then a brand new drug.
Eight years later, and with a million Americans taking Avandia on a regular basis, a study last month concluded that the pill significantly raises the risk of heart attacks and fatal heart problems.
GSK was summoned to a hearing on Capitol Hill to defend Avandia's safety and rebut criticisms that it played down potential side-effects and deliberately failed to launch the right studies to check the risks. It says the drug is as safe as other diabetes pills.
Buse, a respected diabetes researcher who is about to take over as president of the American Diabetes Association, testified that he believed salesmen at SmithKline Beecham (as pre-merger GSK was then called) were over-egging the benefits of Avandia and that there should have been a proper study into the heart risks of the drug.
SmithKline officials dismissed him as a "liar" and impugned his integrity by saying he was "for sale", he said, adding that matters came to a head when he was threatened with a lawsuit.
"The market capitalisation of the company had declined by US$4 billion and there were people in the company who felt I might be liable for that," he said.
After that, Buse sent a three-and-a-half-page letter to Tachi Yamada, then SmithKline's head of research and development, saying: "Please call off the dogs, I cannot remain civilised much longer under this type of heat."
He later signed a statement, drafted by the company, which "clarified" his views on Avandia and agreed to work with SmithKline to study the drug further.
A GSK statement said: "We regret if, at any time, Buse felt the conduct of any GSK employee was contrary to the spirit of open, scientific debate regarding his views on Avandia."
The Food & Drug Administration is now requesting that Avandia and similar alternative drugs carry enhanced warnings on the risk of heart problems.
