Ties to drug firms continue on FDA review panel
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arthritis pain, Arcoxia belongs to the same chemical class of drugs as Vioxx -- the widely popular painkiller that was withdrawn from the market in 2004 because of heart risks.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.
Under the current rules, the three doctors can serve as voting members of the advisory panel but must disclose their conflicts and receive an FDA waiver.
It’s unclear how the 20-member panel will vote on Arcoxia, but the Vioxx controversy was a turning point for the FDA, which has been under running attack over its drug safety procedures.
Prominent lawmakers and other critics have charged that the agency has grown too cozy with the drug industry and has neglected its duty as a safety watchdog. Two major outside studies found that the FDA’s safety office was an institutional stepchild, often overpowered by the drug review division. The agency responded by pledging reforms.
The FDA’s proposed policy on financial conflicts would bar advisors from participating in a meeting if they have a financial interest of more than $50,000 in the manufacturer of a drug under discussion, or in a competitor. Those with financial interests of $50,000 or less could take part in panel discussions but not vote.
Dr. Robert Levine, a specialist in problems of the digestive system, disclosed that he owned Merck stock worth between $25,001 and $50,000. Panelists disclose their holdings as a range, not a specific amount.
Dr. Kenneth Saag, a specialist in osteoporosis, disclosed speaker and consulting fees from Merck on drug issues not related to Arcoxia, as well as consulting fees from two competitors. The total was less than $50,000 a year, he said.
And Dr. Dennis Turk, a pain specialist and the designated chairman of the meeting, received fees of less than $10,000 a year from a competing firm.
Saag said in an e-mail that he had fully disclosed his potential conflicts and that he intended to abide by all FDA rules. “The pending deliberation by the advisory committee represents a drug approval issue of significant public health importance that requires careful deliberation by a multi-disciplinary group of experts,” said Saag, a professor of medicine at the University of Alabama at Birmingham.
The other two experts could not be immediately reached.
“The average person is going to take a look at someone who has between $25,000 and $50,000 in Merck stock, and wonder what the FDA must be thinking of,” said Goozner, who does research into financial conflicts in science and medicine. “It seems to me that [the FDA] hasn’t tried very hard to find people without conflicts for these committees.”
Lurie’s study found that 28% of FDA advisors disclosed conflicts, but that only 1% recused themselves from voting. In a majority of cases, excluding the advisors with conflicts would have reduced the margin of approval for the drug under consideration, but it would not have changed the final outcome.
Leading advocates for arthritis patients are urging the FDA to approve Arcoxia. The drug is part of a family of compounds that are gentler on the digestive system than some of the other painkillers arthritis patients take. Currently only one drug in the class is available -- Pfizer’s Celebrex.
“It’s very important that people with arthritis have a choice,” said Dr. Patience White, chief public health officer for the Arthritis Foundation. “Many of the side effects we are talking about increase risks by a couple of percentage points, but if you take nothing for your arthritis, there is a 90% chance that you are going to be disabled.”
Arcoxia is already approved in many countries in Europe, Asia and South America. An FDA analysis found that the risk of blood clots that can lead to heart attacks and strokes posed by Arcoxia is similar to that associated with a comparable older drug. But it found a slightly higher risk of blood pressure and kidney problems with Arcoxia.
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ricardo.alonso-zaldivar@latimes.com
