Reviewer - Five drugs may find fates similar to Vioxx

The list includes Meridia, Crestor, Accutane, Bextra and Serevent

By Diedtra Henderson ~ The Associated Press

WASHINGTON -- At least five medications now sold to consumers pose such risks that their sale should be limited or stopped, said a government drug reviewer who raised safety questions earlier about the arthritis drug Vioxx.

In testimony Thursday before the Senate Finance Committee, Food and Drug Administration reviewer David Graham cited Meridia, Crestor, Accutane, Bextra and Serevent.

The nation is "virtually defenseless" against a repeat of the Vioxx debacle, he said.

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, suggested an independent board of drug safety may be needed 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 An "awful lot of red flags" were raised before Vioxx was withdrawn, said Grassley, R-Iowa., and the agency ignored its own reviewers.

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

But an FDA colleague, when asked about Graham's short list, said, "That is clearly Dr. Graham's opinion." Dr. Sandra Kweder, deputy director of the FDA's Office of New Drugs, said there is no "magic formula" to determine which marketed drugs are most worrisome.

Drug makers defended the use and safety of their products.

Tim Lindberg, a spokesman for Abbott Laboratories, said "science continues to support the safe use of Meridia to treat obesity."

AstraZeneca PLC, maker of Crestor, has confidence in the drug, spokeswoman Emily Denney said. "To date, the FDA has not given us any indication of a major concern regarding Crestor," she said.

Carolyn Glynn, spokeswoman for Roche Holdings AG, a maker of Accutane, acknowledged that the drug carries risk and said it is reserved for serious cases. "This drug is extremely beneficial as long as it's used safely and appropriately," she said.

Susan Bro, a Pfizer spokeswoman, said Bextra did not increase the risk of serious cardiovascular events in a recent analysis of nearly 8,000 arthritis patients who took the drug from six weeks to 52 weeks. She said Bextra has been found to be safe and effective when used as indicated.

GlaxoSmithKline, maker of Serevent, issued a similar statement about its product.

In his testimony, Graham said Kweder's office at the FDA 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.

Grassley accused the FDA of attempting to intimidate Graham. Sen. Jeff Bingaman, D-N.M., urged President Bush to name a new leader at the FDA, where Lester Crawford is the acting commissioner.

Graham said he fears continued intimidation.

"I was frightened before," he told reporters after the hearing. "Senior management at the FDA did everything in their power to intimidate me prior to my testimony."

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