Ties to drug firms continue on FDA review panel
WASHINGTON — Less than a month after proposing a stricter conflict-of-interest policy for outside experts, the Food and Drug Administration has included three doctors with financial ties to the drug industry on a panel that will evaluate the first successor to the pain reliever Vioxx.
A special advisory panel of doctors and scientists will meet today to weigh approval of the new drug, Arcoxia. Intended to relieve arthritis pain, Arcoxia belongs to the same chemical class of drugs as Vioxx -- the widely popular painkiller that was withdrawn from the market in 2004 because of heart risks. Studies indicate that all drugs of this type pose some degree of increased heart risks. Arcoxia is manufactured by Merck, the company that made Vioxx.
The panel considering Arcoxia is not bound by the tougher conflict-of-interest rules because they have not been officially adopted yet, but critics said they should have been followed anyway.
The meeting about Arcoxia "is an ideal opportunity for the FDA to demonstrate its seriousness about the proposed rules and simply prevent these people from voting," said Peter Lurie, author of a study on the frequency of financial conflicts among medical experts serving on safety advisory panels. He is deputy director of the Health Research Group of Public Citizen, a consumer advocacy organization.
"This is one of the most controversial calls in medicine to come along in a long time," said Merrill Goozner of the Center for Science in Public Interest, another consumer group. "You want two things on this committee: completely objective people and a sufficient number of people skilled in sifting through the data to evaluate the risk."
Under the FDA's proposed policy, the three experts would have been barred from voting on Arcoxia.
The handling of the issue shows "insincerity" and casts doubt on the FDA's promises, said Rep. Maurice D. Hinchey (D-N.Y.), who has sought stricter rules on financial interests. "They know they should be eliminating these conflicts, but nevertheless they continue to have people with conflicts on the panels."
"That's not going to encourage consumer confidence in these decisions, or, ultimately, in the product itself," he said.
FDA spokeswoman Kimberly Rawlings said the agency is following its existing conflict-of-interest rules because the proposed ones are still being refined. An open-comment period on the new policy is in effect until May 21.
