The Center for Science in the Public Interest reports:
The Food and Drug Administration last week gave three scientists, including two with financial ties to Merck, permission to serve on an advisory committee and to vote on the fate of the company’s new Cox-2 inhibitor pain pill. The Arthritis Drugs Advisory Committee will consider Arcoxia (etoricoxib) when it meets later this month. Preliminary clinical trial data released by the company last year indicated Arcoxia raises blood pressure in some patients, but does not result in the same heart attack risk as Vioxx, the Cox-2 inhibitor Merck removed from the market in late 2004.According to agency documents that were released last week, the committee will include Robert Levine, a gastroenterologist at the State University of New York, who owns between $25,000 and $50,000 in Merck stock. The FDA identified four gastroenterologists willing to take the slot, but two had more extensive conflicts than Levine. The FDA also granted a waiver to Kenneth Saag, a rheumatologist at the University of Alabama at Birmingham, who receives somewhere between $10,000 and $50,000 a year from Merck. Saag, the FDA said, is expert in analyzing large databases (Merck has tested the drug in over 35,000 patients) and the agency “was unable to find anyone as qualified.� However, the agency admitted that it only scrutinized its current roster of advisers and employees of the National Institutes of Health to identify candidates. Committee chair Dennis Turk, an anesthesiology professor at the University of Washington, also received a waiver for the $10,000 a year or less he earns from a company that competes with Merck on unrelated issues.
The Wall Street Journal reports:
Merck tested Arcoxia in a massive study, called Medal, that included 34,701 patients enrolled in three trials. The study showed a similar cardiovascular risk for Arcoxia and an older drug, diclofenac. But FDA committee members may question the use of diclofenac as the comparator, because while diclofenac is not categorized as a Cox-2 drug, experts including the American Heart Association view it as closer to the Cox-2s than other painkillers in its class. "What they did is say, our Cox-2 is similar to another Cox-2," says Bruce Psaty, a professor at the University of Washington who wrote about the issue in a recent New England Journal of Medicine commentary. "That's not terribly reassuring."Steven Nissen, immediate past president of the American College of Cardiology, also pointed out that more patients on certain Arcoxia doses dropped out of the study due to high blood pressure. "I do not believe that [Arcoxia] should be approved," he said.
Wanna bet on the outcome?
Posted by schwitz at April 5, 2007 08:19 AM | TrackBackHow do they decide who is qualified to serve on these committees? Are they supposed to be experts on the particular drugs or classes of drugs? If so, they're not going to be able to avoid conflicts of interests. If, however, they turn to experts in evaluating evidence, as the NIH Consensus Development Program does, who may or may not also be cardiologists, they're much more likely to be able to find the qualified people they need.
Posted by: Emily DeVoto at April 5, 2007 09:16 AMThe people on these committees with conflicts of interest come from a range of specialties, but the FDA insists that those with ties to industry are the "most qualified." By their logic, all business reporters should buy stock in the companies they cover, and all medical reporters should take pens, mugs and free trips from the companies whose products and tests they're writing about.
Posted by: Merrill Goozner at April 6, 2007 09:46 AM