When a Congressional committee holds a hearing next Wednesday, the subject will be the safety of the diabetes drug Avandia and whether federal drug regulators have paid close enough attention to its potential risks.
But for one witness who is scheduled to appear, Dr. John B. Buse, a nationally noted diabetes specialist, the hearing will take a different turn, focusing on whether he was the target of an effort by the drug’s maker, GlaxoSmithKline, to silence his criticism of the drug.
In a statement last night, Dr. Buse said his full story would be told at the hearing, including the account of how he was intimidated by Glaxo. But he said the company apologized and he later reported his concerns about the drug to the Food and Drug Administration.
“It was upsetting, but it was not life-altering,” Dr. Buse’s statement said. “I hold no ill will toward Glaxo or any of its employees.”
Congressional investigators have been looking into what they have called “very serious” claims that Avandia’s maker “silenced one or more medical professionals who attempted to speak out about the potential for cardiovascular problems with Avandia,” according to a letter to Glaxo last week from the Senate Finance Committee.
Glaxo denied yesterday that it made any effort to stifle a scientific discussion of its drug, used for Type 2 diabetes. Avandia is the company’s second-largest product with more than $3 billion in sales last year.
Dr. Buse has declined to discuss any details of his story, saying he wanted them to come out during sworn testimony. But one of his friends, a University of Michigan diabetes expert, Dr. Charles F. Burant, said that Dr. Buse had been troubled by the pressure he had received from Glaxo.
Dr. Burant said he was not familiar with specifics, but that the pressure had included Glaxo’s contacting the University of North Carolina medical school, where Dr. Buse was then on the faculty and is now the head of endocrinology.
Although Glaxo is based in London, it has major operations in Research Triangle Park, N.C., and the company’s foundation has donated millions of dollars to the University of North Carolina.
Dr. Buse, who is about to become the president of the American Diabetes Association, was an early and frequent critic of Avandia after it reached the market in 1999. In a March 2000 letter to the F.D.A., he said Avandia might raise patients’ risk of heart attacks, and he criticized the company’s marketing, saying it employed “blatant selective manipulation of data” to overstate the drug’s benefits and understate its risks.
The following year, after demanding that Glaxo strengthen the language on Avandia’s label describing its potential heart risks, the F.D.A. sent Glaxo a letter reprimanding the company for playing down those risks in discussions between sales representatives and undercover investigators at a medical conference.
Dr. Buse, meanwhile, had also raised his concerns about Avandia in speeches to other doctors. Avandia, an oral medication, is used for a patient population already at increased risk for heart disease.
More recent questions about Avandia’s potential risks, as outlined in a New England Journal of Medicine article last week, have prompted the Congressional hearing. The author of that article, Dr. Steven E. Nissen, a heart specialist at the Cleveland Clinic, has also been called to testify.
In an interview this week, Glaxo’s president of United States operations, Chris Viehbacher, acknowledged that the company was looking for any records that would shed light on the accusations that it tried to suppress Dr. Buse’s criticisms. Mr. Viehbacher said that the events occurred years ago and that the employee who was thought to have been involved had left the company.
In that interview, Mr. Viehbacher repeated Glaxo’s ’s contention that Avandia’s risks were in line with those of other diabetes medications.
Yesterday, in a written statement issued by a spokeswoman, Mary Anne Rhyne, the company said: “Discussions occurred with Dr. John Buse in 1999 and 2000 regarding his views on Avandia, and we had a scientific disagreement that was later resolved. We regret if, at any time, Dr. Buse felt the conduct of any GSK employee was contrary to the spirit of open, scientific debate regarding his views on Avandia.” The statement also said that the company “does not condone any efforts by GSK’s staff to limit an individual’s ability to discuss or publish adverse events related to Avandia.”
Dr. Buse’s friend, Dr. Burant, said in a telephone interview, “I never wrote a prescription for Avandia because of the heavy-handed way Glaxo treated John Buse.”
When Glaxo sales representatives have asked him why he was not prescribing Avandia, “I was very straight with them,” Dr. Burant recalled.
“When they were giving John a hard time, I just told them that if this is the way you’re going to treat people who are doing their usual scientific review of the product, it’s not the kind of company I’m going to support,” Dr. Burant said. “I just told them flat-out.”
When Dr. Buse addressed his concerns about Avandia to the F.D.A. in early 2000, he was one of several physicians who had been outspoken supporters of Rezulin, a diabetes drug that was taken off the market that year after being linked to liver disease. After viewing early data on Avandia, he said, he concluded that it might be just as hazardous as Rezulin, if for different reasons.
