Scientist: FDA Incapable of Protecting Safety

Says Vioxx 'Tragedy' Proves Agency Is Poorly Organized; Cites Five Other Drugs as Potentially Unsafe

By Todd Zwillich
WebMD Medical News Reviewed By Michael Smith, MD
on Thursday, November 18, 2004


Nov. 18, 2004 - An FDA scientist says the FDA, which is charged with protecting America's prescription drug supply, is incapable of doing so. He also warned that the problems with the arthritis drug Vioxx, which was removed from shelves earlier this year, may be just one of several drugs that aren't safe.

David J. Graham says he was pressured by superiors not to warn the public about the cardiovascular risk of Vioxx and urged lawmakers Thursday to create an independent safety office free of influence from regulators who approve new pharmaceuticals.

Graham told senators that the FDA's ability to police the safety of drugs already on the market is being compromised because the agency is "too cozy" with the drug industry.

He also stunned the hearing audience and some committee members when he warned that besides Vioxx, which was pulled from the market by its maker, Merck & Co., on Sept. 30, there are five more available drugs that should be closely reviewed for safety.

Graham specifically cited:


Crestor, for high cholesterol
Bextra, for arthritis
Meridia, for obesity
Accutane, for acne
Serevent, for asthma

5 Drugs Questioned

When asked by Sen. Jeff Bingaman (D-N.M.) to list the five drugs, Graham said the weight loss drug Meridia may not work as well as expected because side effects cause many patients to stop taking it before it can have an effect. The side effects, including elevated blood pressure, may not be worth the limited benefit, he said.

Graham also questioned the use of the acne drug Accutane and the cholesterol-lowering drug Crestor. Accutane is known to cause birth defects if pregnant women use the drug, but Graham said the FDA has not done enough to ensure that women of child-bearing age follow safety measures. Crestor can increase the risk of kidney failure and a muscle disorder called rhabdomyolysis but may offer little advantage over other cholesterol drugs on the market, he said.

Graham also listed Bextra, a drug from the same class as Vioxx, and the asthma drug Serevent, saying that data suggest that it could increase the risk of death from asthma.

Lawmakers then asked Sandra L. Kweder, MD, acting director of the FDA's Office of New Drugs, to respond to Graham's list of potentially dangerous drugs.

"It's important not to get so focused on the risks that one forgets about the benefits," she said.

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http://my.webmd.com/content/article/97/104115.htm?z=3734_00000_1000_ts_02

Just like another U.S. government agency. The FAA.