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Expert Warns Against
5 FDA-Approved Drugs

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. Drug makers defended the use and safety of their products.

Graham contended the country is "virtually defenseless" against a repeat of the Vioxx debacle. Dr. Steven Galson of the FDA rejected that comment as having "no basis in fact."

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 An "awful lot of red flags" were raised before Vioxx was withdrawn, said Grassley, R-Iowa., and the agency disdained, rather than listened to, its own reviewers.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. "I don't think Meridia passes that test," Graham said.

_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. Two of three other statin competitors prevent heart attack and stroke and do not cause renal failure, he said.

_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. GlaxoSmithKline, told by the FDA to do a large, clinical trial, begged off. "We've got case reports of people dying, clutching their Serevent inhaler," Graham said. "But Serevent is still on the market."

Galson, acting director of the FDA's Center for Drug Evaluation and Research, said the agency already has taken steps to alert consumers to those drugs' safety concerns. That includes heightened warnings for Serevent; a tougher risk-management plan to ensure pregnant women don't use Accutane; and an upcoming advisory committee hearing regarding Bextra.

"Each of these do have special safety issues, but they're under evaluation and we're watching them carefully," Galson said.

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 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.

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," he said.

Reference Source 89
November 19, 2004



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