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FDA Failed Public on Vioxx -- Scientist
29 minutes ago Health - Reuters
By Lisa Richwine
WASHINGTON (Reuters) - The U.S. Food and Drug Administration (news - web sites) failed to protect the public from Merck & Co. Inc.'s (NYSE:MRK - news) now-withdrawn painkiller Vioxx and is incapable of guarding America from dangerous drugs, a veteran FDA (news - web sites) researcher told Congress on Thursday.
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Slideshow: Merck Pulls Arthritis Drug Vioxx From Market
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Dr. David Graham, a 20-year FDA scientist who had warned about heart risks with the Vioxx arthritis pill, called the agency's oversight of the drug "a profound regulatory failure."
Concerns about a link between the medication and heart problems were building during more than four years on the market. The FDA required a warning about possible heart risks but felt the drug's benefits, few ulcers and less stomach bleeding, made it worth keeping on the market.
Merck Chief Executive Raymond Gilmartin said the company had believed wholeheartedly in Vioxx and had followed a rigorous scientific procedure every step of the way.
"In fact, my wife was taking Vioxx ... up until the day we withdrew it from the market," Gilmartin told the Senate Finance Committee.
Millions of Americans had used Vioxx before Merck withdrew the drug on Sept. 30 after a study showed the medicine doubled heart attack and stroke risk.
"I would argue the FDA as currently configured is incapable of protecting America against another Vioxx. We are virtually defenseless," said Graham, associate director for science in the FDA's Office of Drug Safety.
Graham estimated Vioxx had caused between 88,000 and 139,000 excess cases of heart attack and stroke.
Gilmartin and FDA official Dr. Sandra Kweder said those numbers were projections and there was no way of knowing the actual number.
Committee Chairman Charles Grassley, an Iowa Republican, said he worried the FDA was "far too cozy" with drug companies and an independent drug safety office might be needed.
Kweder, deputy director of the FDA's Office of New Drugs, said the agency "worked actively and vigorously with Merck to inform public health professionals of what was known regarding (cardiovascular risk) with Vioxx and to pursue further definitive investigations."
Kweder also declined to fault Merck: "I believe that Merck acted responsibly once the problem was recognized."
Graham said he felt pressured by supervisors to water down his findings, from a study of patient insurance records, that Vioxx users had a 50 percent greater chance of heart attack and sudden cardiac death than people who took Pfizer Inc.'s (NYSE:PFE - news) rival Celebrex.
Graham named five medicines currently on the market that he believes need closer scrutiny for safety: Abbott Laboratories Inc.'s (NYSE:ABT - news) weight-loss drug Meridia, AstraZeneca Plc's (AZN.L) cholesterol-lowering drug Crestor, Pfizer Inc.'s (PFE.N) painkiller Bextra, Roche's (ROG.VX) acne drug Accutane, and GlaxoSmithKline Plc's (GSK.L) asthma drug Serevent.
Kweder disagreed. "I do not have reason to believe that set of five drugs is specifically more concerning," she said.
Graham said during his career he had recommended 12 drugs be withdrawn from the market, and 10 of them were pulled.
In a statement on Wednesday, acting FDA Commissioner Lester Crawford said Graham had violated procedures when he submitted his Vioxx research to a medical journal without FDA clearance.
Grassley said Crawford's statement appeared intended to intimidate a witness.
Vioxx was the second example this year of the FDA not respecting its own scientists, Grassley said. Another FDA reviewer, Dr. Andrew Mosholder, had warned antidepressants were linked to suicidal behavior in youth, but supervisors initially kept him from making those views public.
Grassley also faulted Merck for aggressively marketing Vioxx in the nearly two years between submitting results of a trial to the FDA in June 2000 showing a higher incidence of cardiac problems with Vioxx, and the FDA approving a new label detailing those risks in April 2002.
Merck's Gilmartin insisted the firm had acted properly with Vioxx. "Over the past six years, we have promptly disclosed results of numerous Merck-sponsored studies to the FDA, physicians, the scientific community and the media," he said.
