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FDA under fire

Testimony stirs concerns agency OK'd drugs too fast, lagged on checking safety

First, Vioxx was pulled from the market. Now attention turns to five other drugs, which deserve scrutiny, a Food and Drug Administration scientist warned Congress this week.

Consumer advocates say Dr. David Graham's comments Thursday during a Senate committee hearing highlight their concerns that for the past decade, the FDA has been too quick to approve drugs with serious health risks and with benefits no greater than existing treatments. Critics say the agency bows to pressure from the drug industry to approve their products more rapidly and that it does not effectively monitor the safety of drugs once they are on the market.

"Since the mid-'90s, the FDA has seemed more concerned about meeting the needs of the average drug company than meeting the needs of the average patient," said Dr. Jerry Avorn, an associate professor at Harvard Medical School and author of "Powerful Medicines: The Benefits, Risks and Costs of Prescription Drugs."

But after Graham's testimony, FDA officials said they did not agree with his contention that the five medicines -- Crestor, a cholesterol-lowering statin; Accutane, an acne drug; Serevent, an asthma drug; Meridia, a weight-loss drug; and Bextra, an arthritis and pain drug -- had serious safety issues.

Kathleen Quinn, an FDA spokeswoman, said yesterday that the drugs' safety would continue to be monitored, as it is for all drugs, but that no new evaluations were planned as a result of Graham's testimony. All have risks that have been documented, but they are currently deemed by the FDA to be safe and effective for use, she said. The manufacturers of all five drugs said they were safe.

Public Citizen, a nonprofit consumer advocacy group, has been battling all five drugs for years. The organization has urged limited distribution of Accutane, which can cause birth defects, and put the rest on a "do not use" list for consumers. In addition, Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, has petitioned the FDA to withdraw Meridia and Crestor. The weight-loss drug, which increases blood pressure in some patients, was linked to a death in a clinical trial, and patients taking the cholesterol drug are 75 times more likely to suffer kidney failure or damage than patients taking other statins, according to Public Citizen's analysis.

The FDA placed its most serious "black box" warning on Serevent in 2003, after a safety study found that it was linked to a higher rate of asthma-related deaths, particularly in African-Americans. Bextra has been linked in two studies to an increased risk of heart attack in bypass surgery patients when taken orally and intravenously, and will soon carry a black-box warning about the risk of a rare, but sometimes fatal, skin disease, according to its manufacturer, Pfizer.

Patients on these drugs should not stop taking them, doctors said, but should consult their physician if they are concerned. "There's a lot of sensationalism, and I'm not really sure where the reality really is" on all five drugs, said Dr. Stephen Lazarus of the University of California, San Francisco, who did some of the initial studies of Serevent in the mid-1990s and found that it was unsafe when prescribed alone. He said that he would continue to prescribe Serevent in combination with a steroid and "absolutely" disagreed that the drug should be pulled from the market.

Consumer advocates, however, say that Thursday's testimony should remind patients and doctors to be wary of newer drugs, because unusual but serious side effects may not become evident until after a drug has been used widely for several years.

"There's the five- to seven-year rule when new things come onto the market," said Arthur Levin, director of the Center for Medical Consumers in New York. Crestor was first marketed in 2003, Bextra in 2001, and Meridia in 1998.

Avorn said Serevent, which entered the market in 1994, Bextra, and Crestor pose unknown safety risks, while alternative drugs that have been around longer, with better-known drawbacks, exist for treating asthma, arthritis, and high cholesterol.

"Because of the current relationship between industry and the FDA, we're seeing drugs being approved now that we wouldn't have seen approved 20 years ago," said Larry Sasich, pharmacist and research analyst at Public Citizen.

Avorn, the Harvard Medical School professor, said the FDA yields to pressure from pharmaceutical companies to get drugs on the market, even though there may be unresolved safety issues. Although the Office of Drug Safety is independent of the Office of New Drugs, which evaluates and approves applications, critics think it is problematic that the same agency that approves drugs for use must also monitor their use afterward because they may be less critical of the drugs.

Jeff Trewhitt, a spokesman for the Pharmaceutical Research and Manufacturers of America, argued that the five drugs were not symptomatic of a larger problem within the agency. "We're talking about a handful of products. There are about 10,000 drugs on the market at the moment, and the vast majority are doing what they are meant to do, and that is treat patients," he said.

The agency recently asked the Institute of Medicine to evaluate the FDA's approach to drug safety and surveillance of the drugs.

Early next year, the FDA plans to examine the safety of Bextra and other Cox-2 inhibitors. This drug class includes Vioxx, which was pulled from the market by Merck & Co. after it was found to increase the risk of heart attacks.

Carolyn Johnson can be reached at Alice Dembner can be reached at

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