Congress Told FDA Failed Public on Vioxx

Thursday November 18, 4:09 PM EST

By Lisa Richwine

WASHINGTON (Reuters) - The U.S. Food and Drug Administration failed the public in its oversight of Merck & Co Inc.'s (MRK) withdrawn painkiller Vioxx and is "incapable of protecting America" from another dangerous drug, an agency researcher told Congress on Thursday.

David Graham, an FDA scientist who had warned about the heart risks of Vioxx, called the FDA's actions "a profound regulatory failure."

Concerns about a possible link between Vioxx and heart problems were building during the drug's more than four years on the market. The FDA required a warning about heart risks but felt the drug's benefits 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, using Vioxx, up until the day we withdrew it from the market," Gilmartin told the Senate Finance Committee.

Merck withdrew Vioxx, which was taken by millions of Americans, on Sept. 30 after a study showed the drug 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.

Committee Chairman Charles Grassley, an Iowa Republican, said he was concerned the FDA had a "far too cozy" relationship with drug companies and suggested an independent office of drug safety might be needed.

Dr. Sandra 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 told the committee 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 (PFE) rival medicine Celebrex.

Graham named five medicines currently on the market that he believes need closer scrutiny for safety: Abbott Laboratories Inc.'s (ABT) weight-loss drug Meridia, AstraZeneca Plc's (AZN) cholesterol-lowering drug Crestor, Pfizer Inc.'s (PFE) painkiller Bextra, Roche's (ROG) acne drug Accutane, and GlaxoSmithKline Plc's (GSK) asthma drug Serevent.

Kweder disagreed. "I do not have reason to believe that set of five drugs is specifically more concerning," she said.

In a statement on Wednesday, acting FDA Commissioner Lester Crawford said Graham had violated long-standing procedures for publishing scientific findings when he submitted his research to a medical journal without FDA clearance.

Grassley said Crawford's statement appeared intended to intimidate a witness on the eve of a hearing.

Sen. Orrin Hatch, a Utah Republican, urged fellow senators to keep an open mind, saying, "Today some are trying to punish one drug company for acting appropriately within the framework of our regulatory system."

But Grassley said Vioxx was the second example this year of the FDA not respecting its own scientists. Another FDA reviewer, Dr. Andrew Mosholder, had warned that antidepressants were linked to suicidal behavior in pediatric patients, but supervisors initially kept him from making those views public.

"Now we have scientists in this particular (Vioxx) case who are being harassed within the agency because of sticking to their own science," Grassley said.

He also faulted Merck for aggressively marketing Vioxx for nearly two years between submitting results of a trial to the FDA in June of 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 company 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.

©2004 Reuters Limited.

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