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Nov. 18, 2004, 4:18 p.m. EST

FDA: We can't prevent another Vioxx

Official says agency is 'virtually defenseless' at hearing

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By Laura Gilcrest, CBS MarketWatch

WASHINGTON (CBS.MW) -- A Food and Drug Administration official told lawmakers Thursday that the agency, in its current form, is unable to protect the public from another Vioxx-type incident.

A clinical study showed increased cardiac risk linked to long-term use of the Merck arthritis drug and painkiller Vioxx.

David Graham, associate director for science and medicine in the FDA's Office of Drug Safety and the drug reviewer who first warned of a Vioxx danger, told members of the Senate Finance Committee that the agency as currently configured "is incapable of protecting Americans against another Vioxx."

"We are virtually defenseless," Graham said.

Graham, other public health officials and Merck Chief Executive Raymond Gilmartin are testifying before the Senate panel, which is investigating whether the Merck /zigman2/quotes/209956077/composite MRK +1.95% drug should have been pulled from the market more quickly when an increased cardiac risk became apparent.

Graham told lawmakers that much of the blame for the Vioxx incident lies with the FDA's Center for Drug Evaluation and Research, or CDER.

"When a serious safety issue arises post-marketing, their immediate reaction is almost always one of denial, rejection and heat," he said.

The prevailing atmosphere at CDER is that "they approved the drug, so there can't possibly be anything wrong with it." Graham added that the same group responsible for approving a drug at the FDA is later charged with taking regulatory action against it if need be. He labeled the situation an "inherent conflict of interest."

"FDA has let the American public down," he told the committee.

Naming names

Graham also warned of potential risks to users of a number of other drugs that are currently being prescribed. For example, Graham said, the agency should take a serious look at the recently approved lipid-lowering drug Crestor, made by AstraZeneca /zigman2/quotes/200304487/composite AZN +0.63% , which he said appears to have a risk of renal failure.

That caused the company's shares to drop 9 percent to $40.15 in late trading.

He pointed out that there are already a number of other drugs in Crestor's class -- so-called statins -- on the market that do not pose such a risk. Another example is the Pfizer /zigman2/quotes/202877789/composite PFE -0.09% arthritis drug Bextra, which, according to Graham, "needs good studies of cardiac risk." Pfizer was down 11 cents to $27.88.

In the case of GlaxoSmithKline's /zigman2/quotes/209463850/composite GSK +0.69% asthma treatment Serevent, Graham said the FDA approved the drug even though a study in the United Kingdom pointed to a possible increased risk of respiratory failure.

He explained that the FDA had asked Glaxo for a bigger study to more clearly understand that potential danger, but he said that the firm canceled that study and the drug remains on the market. Glaxo shares lost 3.4 percent to $43.50.

Sandra Kweder, deputy director of FDA's Office of New Drugs, disagreed with Graham's warnings.

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