Vioxx creates trouble for FDA

ASSOCIATED PRESS

The public is "virtually defenseless" if another medication such as Vioxx proves unsafe after it has won Food and Drug Administration approval, a government drug-safety expert said yesterday.

"I would argue that the FDA as currently configured is incapable of protecting America against another Vioxx," said Dr. David Graham, who warned that the arthritis-relief drug had been linked to an increased risk of heart attack and stroke.

He told the Senate Finance Committee of at least five other drugs on the market that warrant scrutiny: the acne-reducing drug Accutane, the weight-loss drug Meridia, the cholesterol-lowering drug Crestor, pain-reliever Bextra and the asthma-relief drug Serevent.

Astra-Zeneca Pharmaceuticals, maker of Crestor, said it was confident that the drug was safe.

"To date, the FDA has not given us any indication of a major concern regarding Crestor," spokeswoman Emily Denney said.

Tim Lindberg, a spokesman for Abbott Laboratories, said, "Science continues to support the safe use of Meridia to treat obesity, the leading health epidemic in the U.S."

Carolyn Glynn, spokeswoman for Roche Holdings AG, a manufacturer of Accutane, noted the drug is intended for serious cases and does carry risks.

"This drug is extremely beneficial as long as it's used safely and appropriately," she said.

GlaxoSmithKline, which makes Serevent, said the medication is safe and effective "when used appropriately and in accordance with labeling and treatment guidelines."

Representatives of Pfizer, the manufacturer of Bextra, were not available yesterday.

A second FDA official, Dr. Sandra Kweder of the Office of New Drugs, did not agree with Dr. Graham's assessment of the risk posed by the five drugs.

She said, "There is no magic formula" to determine which drugs most raise the most serious safety concerns.

Vioxx's maker, Merck & Co., pulled the drug from the market on Sept. 30 after a study indicated the popular painkiller doubled the risk of heart attacks and stroke when taken for longer than 18 months.

Raymond V. Gilmartin, the company president, said in prepared testimony that Merck acted within four days of learning about the risk.

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

Mr. Gilmartin said the company was surprised by the cardiovascular risk because it differed from the results of past clinical trials.

"My wife was a user of Vioxx until the day we withdrew it from the marketplace," he said.

The FDA has defended its actions regarding Vioxx. In a statement late Wednesday, the agency cited its "well-documented and long-standing commitment to openness and transparency in its review of marketed drugs."

But the committee chairman, Sen. Charles E. Grassley, Iowa Republican, said an independent board of drug safety might be needed to ensure the safety of medications after they are approved for the market.

"Consumers should not have to second-guess the safety of what's in their medicine cabinet," Mr. Grassley said.

Dr. Graham told the committee that research indicated that Vioxx caused up to 160,000 heart attacks and strokes. He said his research helped persuade the FDA to withdraw a number of drugs, including Fen-phen, a weight-loss drug.

Yet he also questioned the agency's commitment to removing unsafe drugs from the market because doing so would call into question their approval.

Dr. Lester Crawford, FDA acting commissioner, said the agency initiated and paid for reviews of Vioxx and antidepressants after those drugs had reached the marketplace.

"That is evidence the system is working," he said.

Critics contend that the agency ignored risks in both instances, then intimidated its own reviewers when they pointed to safety concerns.