Glaxo’s Summary of a Hearing on Avandia Is Challenged - NYTimes.com

Dr. David Graham, an F.D.A. medical officer, made an impassioned presentation at the advisory hearing arguing that the study should be stopped because thousands of patients in the trial were being exploited. None of these arguments were mentioned in GlaxoSmithKline’s letter.

“This summary is biased, misleading and not truthful,” Dr. Graham said in an interview. “The whole purpose of this letter is so that they can reassess whether this is an ethical trial going forward, but the step-by-step ethical flaws and problems with the Tide trial are not even referenced.”

Several members of the advisory committee complained that the company’s letter was biased.

“This letter is really deceptive,” said Dr. Clifford J. Rosen, a panel member. He added that the letter also did not refer to a presentation at the hearing by members of an Institute of Medicine study panel that said observational studies could be useful.

Dr. Curt D. Furberg, also a panel member, described the letter as a “very Avandia friendly” document that ignored much of the discussion criticizing the validity of GlaxoSmithKline’s studies. Other panel members expressed similar reservations.

via nytimes.com

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