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FDA Critic Sees More Drug Drama

Updated from 1:47 p.m. EST

A veteran researcher for the Food and Drug Administration told legislators Thursday that the recent withdrawal of Vioxx by Merck (MRK) represents "a profound regulatory failure" that could easily be repeated with other drugs."

The scientist, David J. Graham, who was the lead author in a study criticizing Vioxx, said he was pressured by senior management to alter his conclusions that Vioxx represented a greater cardiovascular risk than Celebrex, a similar arthritis treatment and pain reliever made by Pfizer (PFE).

Graham was the first witness in a hearing held by the Senate Finance Committee, which is investigating the Vioxx case as well as the FDA's drug approval and drug safety review efforts. The last witness of the day was Raymond V. Gilmartin, chairman and CEO of Merck, who said the company acted quickly and responsibly once carefully designed medical research showed that Vioxx presented a greater risk of heart attack and strokes among people who used the drug for more than 18 months. If the trial had ended at 18 months, he noted, there would have been no statistically significant difference in risk between patients who took Vioxx and patients who received a placebo.

Graham said the FDA is "incapable of protecting America against another Vioxx" because of bureaucratic torpor and calcified policies. Graham noted that during his FDA career, he has recommended that 12 drugs be pulled from the market, adding that only two remain on the market.

Calling Vioxx "a national disaster" and arguing that the drug should have been removed from the market as far back as four years ago, Graham directed most of his anger at the FDA. He said the agency creates a bureaucratic culture in which "post-marketing safety is an afterthought." (For a history of Vioxx, click here.)

Graham illustrated what he said is the FDA's inability or unwillingness to act quickly on safety alerts by using the analogy of a weather report. If a weather forecaster tells you there's an 80% chance of rain, he told the senators, you will bring an umbrella to work. But if you use the FDA's philosophy, he said, you won't bring an umbrella unless you're 95% certain it will rain.

Graham also said several other drugs now on the market have sufficient safety issues that their manufacturers or the FDA should consider additional clinical tests, greater scrutiny or greater restrictions on their use. He cited the obesity drug Meridia, made by Abbott Laboratories (ABT); the cholesterol drug Crestor, made by AstraZeneca (AZN); the arthritis drug Bextra, made by Pfizer (PFE); Accutane, a treatment for acne, made by Roche; and Serevent, an asthma treatment from GlaxoSmithKline (GSK).

Sandra L. Kweder, the FDA's deputy director in the Office of New Drugs, said there was "no reason to believe" that these five drugs pose more concern than other drugs. "That's Dr. Graham's opinion," she told the committee. "All drugs pose some safety risk. There is no magic formula."

"Unless a new drug's demonstrated benefit outweighs its known risk for an intended population, FDA will not approve the drug," Kweder said. "However, we cannot anticipate all possible effects of a drug during the clinical trials that precede approval."

Merck's Message

"The Food and Drug Administration approved Vioxx only after Merck had extensively studied the medicine and found it to be safe and effective," said Gilmartin, repeating comments that he has made in news conferences and analysts' meetings since Merck pulled Vioxx from the market on Sept. 30. "Merck continued to extensively study Vioxx after it was approved for marketing to gain more clinical information about the medicine."

For the past six years, he added, " we have promptly disclosed the results of numerous Merck-sponsored studies to the FDA, physicians, the scientific community and the media and participated in a balanced, scientific discussion of its risks and benefits," he added.

Gilmartin's comments were presented to the Senate Finance Committee, whose chairman, Sen. Charles E. Grassley (R., Iowa), has criticized the actions of the company as well as the Food and Drug Administration.

"Mr. Chairman, Merck believed wholeheartedly in Vioxx," Gilmartin said. "I believed wholeheartedly in Vioxx. In fact, my wife was a user of Vioxx until the day we withdrew it from the marketplace."

Grassley's committee is examining Merck's handling of Vioxx amid accusations by some prominent cardiologists and medical journals that Merck should have withdrawn the drug as early as four years ago because there was enough evidence for the company to act. Merck has been the subject of blistering editorials recently in The New England Journal of Medicine and the British medical journal The Lancet.

The committee also is investigating the FDA's relationship with Merck, in light of complaints by some scientists and legislators that the FDA was too slow to act and too cozy with the company. "Consumers should not have to second-guess" the safety of a drug, Grassley said Thursday. "There is more to learn about this drug disaster."

The Justice Department and the Securities and Exchange Commission are investigating Merck's actions.

The withdrawal of Vioxx has provoked a flood of lawsuits: Merck said it knows of 375 as of Oct. 31. Three credit rating companies -- Moody's Investors Service, Fitch Ratings and Standard & Poor's -- have recently cut the company's rating by several notches primarily due to the loss of Vioxx $2.5 billion annual revenue -- and the uncertainty over the legal costs. The company's stock has lost about 40% of its value. Shares were down 13 cents, or 0.5%, to $27.21 on Thursday.

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