FDA Official Defends Agency's Safety Role

WASHINGTON – An official of the Food and Drug Administration (search) said Friday "we categorically reject" accusations the agency has done a poor job of protecting the public against dangerous drugs.

"All the drugs that are on the market have risks," asserted Dr. Steven Galson (search), acting director of the FDA's Center for Drug Evaluation (search).

Appearing on morning television a day after an FDA critic renewed allegations the regulatory agency mishandled the arthritis drug Vioxx (search), Galson also said that a review is under way of five other medications whose safety were questioned.

In testimony to the Senate Finance Committee Thursday, FDA reviewer David Graham had cited Meridia, Crestor, Accutane, Bextra and Serevent as having problems. The manufacturers of these drugs immediately defended the use and safety of their products.

Graham argued that the country is "virtually defenseless" against a repeat of the Vioxx debacle. Galson immediately rejected that, saying it had "no basis in fact."

"What we're concerned about is the sort of hysterical charges that come out, that aren't based on reality," Galson said Friday on NBC's "Today" show.

"I think the drug industry would be astounded at the charges we're too cozy with them," he said. "I spend a lot of time dealing with complaints from the drug industry."

Dr. Sidney Wolfe, health research director for Ralph Nader's watchdog group Public Citizen, said Friday he believes many more physicians and others at FDA should have the opportunity to air their concerns about drugs on the market.

"I think Dr. Graham is speaking, in a way, for many people in the FDA who know there are problems, but their superiors, supervisors, don't want them to talk," Wolfe told ABC's "Good Morning America."

"My faith in the FDA rests in the midlevel employees," Wolfe said, "the physicians, the epidemiologists, who know about problems and are frequently frustrated."

Wolfe said Public Citizen already had asked the FDA to take Crestor and Meridia off the market. He also said he believes Bextra should be removed.

Merck & Co. pulled Vioxx 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.

The committee chairman, Sen. Charles Grassley, told the hearing he believes an independent board of drug safety may be necessary to ensure the safety of medications after FDA approval.

An "awful lot of red flags" were raised before Vioxx was withdrawn, said Grassley, R-Iowa., and the agency disdained, rather than listened to, its own reviewers.

Graham contended that FDA has an inherent conflict of interest that triggers "denial, rejection and heat" when safety questions emerge about products it has approved.

In his view, the five most worrisome drugs that demand speedy action:

_Meridia, a weight-loss drug. He said the agency should consider whether its benefits outweigh the risks of higher blood pressure and stroke among people taking it.

_Crestor, an anti-cholesterol drug. He said the government should evaluate the occurrence of renal failure and other serious side effects among people taking Crestor.

_Accutane, an acne drug linked to birth defects. Graham said the drug represents a 20-year "regulatory failure" by the FDA and sales should be restricted immediately.

_Bextra, a painkiller. Graham said the drug poses the same heart attack and stroke risk as Vioxx. He recommended designing studies to look at the drug's cardiovascular risks.

_Serevent, an asthma treatment. He said the drug was shown, with 90 percent certainty in a long-term trial in England, to cause deaths due to asthma.

In his testimony, Graham said the FDA's Office of New Drugs unrealistically maintains a drug is safe unless reviewers establish with 95 percent certainty that it is not. That rule does not protect consumers, Graham told the Senate committee. "What it does is it protects the drug," he said.