The way medical researcher John Buse recalled it yesterday, the lead researcher at pharma giant SmithKlineBeecham (now GlaxoSmithKline) called him a "liar" and said he was a "scoundrel" for questioning the risks of a diabetes drug, Avandia, the company was pushing.
The researcher who maligned and threatened him eight years ago was Dr. Tadataka Yamada, now the director (since 2006) of global health for the Bill & Melinda Gates Foundation in Seattle.
Buse was testifying at a House hearing in D.C. where lawmakers are probing how Avandia and other drugs get onto the market without proper warnings of their hazards.
Buse suggested that Avandia was approved in part because Yamada bullied him into backing off, therein allowing the drug to reap billions for GlaxoSmith even though it was unsafe.
The FDA yesterday announced the drug must carry a restrictive "black box" warning on its label. There is evidence that the drug Yamada campaigned to get on the market can potentially cause heart attacks or other cardiovascular problems, just as Buse claimed in 1999.
In his prepared statement yesterday, Buse, a member of the medical staff at the University of North Carolina, recalled he had discovered "a trend toward increases in serious cardiovascular events and cardiovascular deaths with Avandia as compared to active comparators...
I recognized that this was potentially an explosive issue and went to rather extreme ends to make sure that I was not making an error including sharing the results and the slides I was going to present with research scientists from SmithKline Beecham (SKB), the manufacturer of Avandia. Those discussions were cordial and helpful.
Couched with many caveats, I presented the issues outlined at least twice in June of 1999. In the week that ensued, there were a number of phone calls in this regard from SKB. During these calls, it was mentioned on two occasions that there were some in the company who felt that my actions were scurrilous enough to attempt to hold me liable for a loss in market capitalization...
After Yamada told UNC officials that Buse was a liar and scoundrel, Buse wrote Yamada, saying "Please call off the dogs...I cannot remain civilized much longer under this kind of heat."
The Gates Foundation did not respond to our request for comment today.Buse's testimony is here. A New York Times story is here.