FDA Called ‘Defenseless’ Against Unsafe Drugs

WASHINGTON — Merck & Co. and the Food and Drug Administration knew before the agency approved the company’s Vioxx painkiller in 1999 that the drug could have serious adverse effects on the heart, witnesses told a powerful Senate panel today.

But the FDA gave its approval without resolving the concerns, and Vioxx was aggressively marketed to point up its pain relief qualities, not its risks.

As a result, as many as 139,000 Americans who took the drug for arthritis, back pain and other ailments may have suffered serious side effects, said David Graham, a doctor with the FDA’s Office of Drug Safety, which monitors drugs already approved for patient use.

He estimated that 26,000 to 55,000 people may have died as a result.

“Vioxx is a terrible tragedy and a profound regulatory failure,” Graham told the Senate Finance Committee in the first congressional hearing since Merck voluntarily withdrew the painkiller from the market.

“I would argue that the FDA, as currently configured, is incapable of protecting America against another Vioxx,” added Graham, who said his superiors tried to squelch his warnings. “We are virtually defenseless.”

Committee Chairman Charles E. Grassley (R-Iowa) said he was concerned that the FDA “has a relationship with drug companies that is too cozy.”

He is considering making the drug safety office, now a part of the Office of New Drugs, independent of it.

Merck Chairman Raymond Gilmartin took strong exception to the charges, saying the early concerns were not backed up by data. It was Merck’s own investigation that uncovered definitive proof that Vioxx could cause heart attacks, Gilmartin said, leading the company to voluntarily pull the drug from the market on Sept. 30.

“Withdrawing Vioxx was consistent with an ethic that has driven Merck actions and decisions for more than 100 years,” he said.

Associated Press contributed to this report.