Subsequent to the July adcomm on Avandia, the FDA asked GSK to send a letter to doctors detailing what took place.
The first question is … why didn’t the FDA do this itself? It was, after all, an FDA event. Was a written synopsis, perhaps, too hot to handle for the folks at White Oak?
To nobody’s surprise, a certain agency employee is unhappy with GSK’s letter.
“This summary is biased, misleading and not truthful,” Dr. Graham told the New York 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.”
Some panel members agree with Dr. Graham. Panel member Dr. Curt D. Furberg, described the letter as “very Avandia friendly. Panel member Dr. Sanjay Kaul, disagreed, saying the letter “faithfully reflects the deliberations of the Avandia advisory meeting.”
Erica Jefferson, an F.D.A. spokeswoman, said that after ordering GlaxoSmithKline to send a summary of the hearing to the Tide trial investigators, the agency had relied on the company to provide a balanced account. “F.D.A. did not pre-clear or approve the content,” she said.
Mary Anne Rhyne, a GlaxoSmithKline spokeswoman, said the company had only one week to write the 10-page summary, which was necessarily brief. But the company and the leader of the Tide trial agreed that the letter “reflected the science and data discussed at the advisory committee meeting,” Ms. Rhyne said.
Avandia? Controversy? Who could have guessed?
Why didn’t the FDA write this letter?
"Please give me some good advice in your next letter. I promise not to follow it."
-- Edna St. Vincent Millay
