GSK letter to TIDE investigators provokes Avandia critics Reply

letter describing the July FDA advisory panel on Avandia that was sent by GlaxoSmithKline to TIDE investigators has sparked criticism from some FDA officials and panel members, according to an article by Gardiner Harris in the New York Times.

Following the July panel meeting, the FDA put the controversial Avandia safety trial TIDE on “partial clinical hold” and instructed the company to “update investigators, institutional review boards (IRBs) and ethics committees involved in the TIDE trial” with information about the 2-day panel meeting.

The cardiovascular safety trial had been initiated following the earlier 2007 FDA Avandia panel in an agreement that allowed the drug to remain on the market. The ethical status of TIDE has been questioned by leading Avandia critics, including Steven Nissen and the FDA’s David Graham.

“This summary is biased, misleading and not truthful,” Graham told the Times. “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.” The Times story also includes highly critical comments from panel members Clifford Rosen and Curt Furberg.

However, another panel member, Sanjay Kaul, told the Times that the letter “faithfully reflects the deliberations of the Avandia advisory meeting. ”An FDA spokeperson told the Times that the FDA “did not preclear or approve the content,”  and a GSK spokesperson said that the leader of TIDE had agreed that the letter “reflected the science and data discussed at the advisory committee meeting.”

Harris points out in his article that the “dispute is part of a continuing battle over what the 33-member committee actually decided in July.”

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