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The former chairman of research and development at GlaxoSmithKline, Tadataka Yamada, has been asked by a US Senate committee to explain his role in what it describes as the “intimidation” of John Buse, a professor of medicine at the University of North Carolina.
In 1999 Dr Buse raised questions about the cardiovascular safety of the diabetes drug rosiglitazone, which is marketed as Avandia (BMJ 2007;334:1237 doi: 10.1136/bmj.39244.394456.DB). He was speaking at a symposium organised by the American Diabetes Association.
A report by the Senate Finance Committee staff has shown that a company official emailed Dr Yamada proposing that a “firm letter” be written to Dr Buse containing a warning that “the punishment will be that we will complain up his academic line and to the CME [continuing medical education] granting bodies that accredit his activities.”
In response Dr Yamada wrote: “I think there are two courses of action. One is to sue him for knowingly defaming our product even after we have set him straight as to the facts—the other is to launch a well planned offensive on behalf of Avandia.” The report also says that Dr Yamada telephoned the chairman of Dr Buse's department, Fred Sparling.
Three days after the call Dr Buse wrote to Dr Yamada mentioning the number of phone calls he had received from company officials and that Dr Sparling had informed him of “implied threats of lawsuits.”
In June 1999 Dr Buse signed a letter drafted by SmithKlineBeecham (SKB), as the company was then known, stating that his original comments “had been taken out of context” and that “only years of use, greater patient exposure and comparative clinical trials” would provide the data needed to allow any drug, “including the thiazolidinediones, into proper perspective.” The letter, which was headed “To whom it may concern,” was then used to persuade financial analysts to modify their assessment of the company's product.
In a later email to a colleague, Dr Buse said, “I was certainly intimidated by them . . . It makes me embarrassed to have caved in several years ago.”
The committee raised the issue of the retaliation against Dr Buse with SKB in May 2007, but the company dismissed the suggestion as “absolutely false.” The committee's report states that SKB, instead of acknowledging its mistake, had “launched a public relations campaign of denial.”
In a media statement issued after the release of the report the company defended its actions but conceded that “perhaps we could have handled interactions with Dr Buse better.”
Tabling the report, the Republican senator Charles Grassley, of Iowa, expressed concern that the case may indicate a wider problem and invited any medical researchers who had been threatened by a drug company to contact his office. In an email to the BMJ Dr Buse explained, “Not even I was aware of the scope of the attention that I had garnered at SKB. I am concerned that Senator Grassley may be correct.” Dr Yamada was unavailable for comment.
The US Food and Drug Administration has upgraded the “black box” warning for rosiglitazone and related combination drugs by mentioning that 42 clinical studies indicated an increased risk of side effects such as angina and heart attack (BMJ 2007;335:586, 22 Sep doi: 10.1136/bmj.335.7620.586-b; BMJ 2007;335:1064, 24 Nov doi: 10.1136/bmj.39405.459074.4E).
The committee's report is at http://finance.senate.gov/press/Bpress/2007press/prb111507a.pdf.