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GlaxoSmithKline Tried to Intimidate, Silence Avandia Critic Report Says

Nov 19, 2007 | Parker Waichman LLP GlaxoSmithKline, the maker of Avandia, made a concerted effort to intimidate a prominent physician into keeping quiet about some of the controversial diabetes drug’s safety issues, a congressional investigation has found.   The shocking allegations against Glaxo only serve to underscore questionable practices many drug companies use to monitor and influence respected doctors whose opinions can affect sales of medications.

Avandia’s cardiovascular problems have been the subject of concern since May, when an analysis of 42 clinical trails published by the Cleveland Clinic showed that patients taking the drug had a 43-percent higher risk of having a heart attack.  Over the summer, GlaxoSmithKline, the maker of Avandia and the Food & Drug Administration (FDA) came under fire for an apparent failure to warn the public about the cardiac risks associated with Avandia. Testimony at a congressional hearing in June revealed that the company and the FDA had known about the heart attack risk as far back as September 2005.  That congressional investigation also uncovered allegations that in 2005, an unnamed FDA scientist who had advocated for a strong black box warning on Avandia about its risk for congestive heart failure had been removed from an Avandia safety review.

Now, a new Senate Finance Committee report has alleged that Glaxo tried to silence Dr. John Buse, a diabetes expert and professor of medicine at the University of North Carolina in Chapel Hill. In 1999, Dr. Buse began expressing concerns about the cardiovascular risks of Avandia.   Earlier this summer, the Senate committee heard testimony from Dr.  Buse, who said he felt pressured by the drug’s maker, SmithKlineBeecham (now part of GlaxoSmithKline) to sign a clarifying statement drafted by the company that downplayed his concerns.  During his testimony, Dr. Buse described name-calling and what he said was the veiled threat of a lawsuit by a high-ranking drug company executive after he had criticized Avandia at a medical meeting.  Dr. Buse also testified that Glaxo complained about him to his supervisors at the University of North Carolina.

Now, the Senate Committee has implicated two high-ranking Glaxo executives in the intimidation campaign against Dr. Buse.  The report alleges that Glaxo Chief Executive Jean-Pierre Garnier and former research chief Tachi Yamada were involved in the intimidation.   Dr. Buse had also named Yamada in testimony to the Senate committee.

For its part, Glaxo told the Wall Street Journal that it denies trying to stifle Dr. Buse.  A spokesperson told the newspaper that it disputes the committee's conclusions.   However, the spokesperson conceded that Glaxo had tried to correct Dr. Buse's "inaccuracies"  "People at the time were very passionate about this new medicine and could perhaps have handled the interactions with Dr. Buse better," the Glaxo spokesperson said. "We did apologize to Dr. Buse for the tone of some of the conversations.”

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