November 16, 2004
FDA To Reconsider Furberg Role on Safety Panel
They're backtracking at the Food and Drug Administration.
Dr. Curt Furberg was notified Tuesday that the agency is still considering appointing him to the advisory committee that will evaluate the safety of all Cox-2 pain relievers. Furberg's tentative appointment had been summarily withdrawn last week after he told news reporters that his analysis of clinical trials showed Pfizer's Bextra may have the same heart problems as Merck's Vioxx, which was withdrawn from the market in late September.
Sandra Kweder, acting director of the FDA's Center for Drug Evaluation and Research, told the press in the wake of Furberg's dismissal that his remarks showed he was biased.
According to Furberg, the FDA official in charge of advisory committees, Igor Cerny, called him Tuesday to apologize for the agency's actions. "He told me someone took action without following proper procedure," he said. "He said this was a mistake."
Furberg is one of the nation's leading drug safety experts and a frequent industry critic. He is also a permanent member of the FDA's drug safety advisory committee. He and another drug safety expert had been invited to take part in the arthritis drugs advisory committee meeting in February that will evaluate the safety of Cox-2s.
At the last meeting of the arthritis committee, which took place in June, 7 of 12 outside experts reported financial conflicts of interest that had to be waived before they could sit in on the meeting. Financial conflicts of interest are cause for dismissal from a federal advisory committee unless the agency issues a waiver based on needing the scientist's expertise.
The FDA's bumbling on Furberg's appointment couldn't have come at a worse time for the agency. The Senate Finance Committee on Thursday will begin its investigation into the FDA's handling of Vioxx.
Besides testimony from Merck chairman Raymond Gilmartin, the hearing will focus on efforts by FDA higher-ups to delay publication of an internal study by David Graham that showed an excess of heart attacks among people taking Vioxx. Graham's study will be published in this week's Lancet, a leading British medical journal.
The change of heart on Furberg may also have been helped along by inquiries from the Office of Government Ethics (OGE), which oversees federal agencies' compliance with conflict of interest laws. An OGE official on Tuesday called the FDA to get the internal handbook that contains guidelines for handling potential conflicts of interest and bias on advisory committees.
Those guidelines list the steps agency officials can take to manage bias such as not allowing a biased member to dominate the discussion. None of the steps include dismissal since the law requires that bias be balanced, not eliminated. "Sometimes people use the broad phrase conflict of interest to cover a multitude of things, but it doesn't cover intellectual bias," said an OGE official.