The Committee also points out that CEO Jean-Pierre denied having any knowledge about the intimidation of Dr Buse in a July 25, 2007 interview with The Philadelphia Inquirer, when in fact, emails written in June 1999, show GSK executives discussed Dr Buse in a series of emails they titled, "Avandia Renegade," and silenced him by complaining to his superiors and threatening to sue him. One email cited in the report states:
"The sentiment of the SB group was to write him a firm letter that would warn him about doing this again...with the punishment being that we will complain up his academic line and to the CME granting bodies that accredit his activities....The question comes up as to whether you think this is a sensible strategy in the future (we don't really do too much work at UNC to make any threats)."
SB refers to SmithKline Beecham which is now GSK.
The report also cites an email by Dr Tachi Yamada, GSK's head of research at the time, that was copied to Dr Garnier which discussed plans to retaliate against Dr Buse stating:
"I plan to speak to Fred Sparling, his former chairman as soon as possible. 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...."
According to the report, Dr Yamada did in fact call Fred Sparling, the chairman of Dr Buse's department and GSK also demanded that Dr Buse sign a letter claiming that he was no longer worried about cardiovascular risks of Avandia, which GSK officials referred to as a "retraction letter."
Emails also show that on July 2, 1999, several GSK officials discussed sharing the "Buse retraction letter" with financial analysts who were evaluating GSK's products for investors and the report notes that the emails were copied to GSK executives including Dr Garnier.
However, even though Dr Buse appeared to go silent in public after signing the retraction letter, he did voice his concerns in a letter to the FDA Commissioner on March 15, 2000, about the risks associated with Avandia and GSK's misrepresentations regarding the clinical trial data on the drug.
In the letter, Dr Buse noted the drug's "consistent negative impact on lipids documented in the FDA registration data as well as a worrisome trend in cardiovascular deaths and severe adverse events in the subjects exposed to rosiglitazone versus active comparators."
He also urged the FDA to act forcefully to prevent the abuse of clinical trial data by the company. "I have been shown glossy materials claiming that rosiglitazone has been uniquely studied in patients with preexisting cardiac disease including patients with a number of associated conditions (such as unstable angina)," he stated in the letter.
Dr Buse explained that he knew for a fact that these types of patients were excluded in the Avandia trials because he was the Principle Investigator in one. And while acknowledging that there are probably abuses by all companies that market drugs, he said, "there is something pervasive and systematic that I detect in my travels regarding the marketing of rosiglitazone."
Somehow, GSK obtained a copy of the FDA letter, and GSK executives faxed it among themselves with a cover note that read: "We need to address this as a company....Looks like Dr. Buse doesn't buy into our lipid or cardiovascular story."
According to the Senate report, GSK then drafted a letter to Dr Buse from one of its executives, Martin Freed, that stated: "I remain concerned about your ongoing aggressive posture towards rosiglitazone and SmithKline Beecham. In my opinion, you have presented to [FDA] several unfair, unbalanced, and unsubstantiated allegations."
After that, the report notes that Dr Buse appeared to remain silent for about two years, but voiced his concerns again in a private October 23, 2005 email to Dr Nissen, and described his treatment by GSK after his presentations at the meetings of the Endocrine Society and the ADA and suggested that Avandia may carry increased risks.
"Immediately," he wrote, "the company's leadership contact[ed] my chairman and a short and ugly set of interchanges occurred over a period of about a week ending in my having to sign some legal document in which I agreed not to discuss this issue further in public."
"I was certainly intimidated by them but frankly did not have the granularity of data that you had and decided that it was not worth it," Dr Buse told Dr Nissen.
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