FDA official, panelists dispute Avandia letter

After July's FDA panel review of Avandia, regulators ordered GlaxoSmithKline (NYSE: GSK) to notify doctors involved in a clinical trial comparing the diabetes drug to Actos about the panelists' worries--including their fears that the trial itself might be unethical, given indications that Avandia carries more cardiovascular safety risks than its rival.

But now, as the New York Times reports, some panelists and an FDA official say that the letter GSK dispatched is misleading and incomplete. "This summary is biased, misleading and not truthful," the FDA's David Graham--who has called for the trial to be stopped--tells the NYT. "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."

"This letter is really deceptive," agreed panel member Dr. Clifford Rosen. Another panelist called the letter "very Avandia friendly."

GSK spokeswoman Mary Anne Rhyne defended the letter, saying GSK and the Tide trial leader agreed that it "reflected the science and data discussed " at the committee meeting. And another panelist, Dr. Sanjay Kaul, said he thought the letter "faithfully" represented the advisory panel's discussions.

The argument comes as the FDA continues to deliberate over what to do about Avandia; the panelists ended up voting mostly for new warnings and/or restrictions for the drug, though three voted to leave the labeling as-is and 12 voted for withdrawal. The mixed vote puts the ball squarely in FDA's court. A decision is expected by mid-September.

- read the NYT piece