FDA sets up drug safety panel

Critics call it inadequate response, question independence

February 16, 2005|By Susan Baer | Susan Baer,SUN NATIONAL STAFF

WASHINGTON - The Bush administration announced yesterday the creation of an FDA oversight board to monitor drugs once they're on the market and inform the public about emerging health risks. The move comes on the eve of scientific hearings that could lead to restrictions on a whole class of popular arthritis drugs.

Ever since Merck withdrew Vioxx last fall, after data suggested the arthritis drug increased the risk of heart attacks and strokes, the Food and Drug Administration has been criticized for being slow to respond to safety concerns about drugs it has approved, and public trust in the agency has been shaken.

Pre-empting further attacks expected at the FDA advisory committee hearings that begin today, Health and Human Services Secretary Michael O. Leavitt said the independent board of FDA and other government medical experts would help bring "a new culture of openness and enhanced independence" to the embattled agency.

The board, to be appointed by the FDA commissioner, would recommend information to be put on an agency "Drug Watch" Web page, resolve disputes over drug safety issues and oversee drug safety policy. It would consult with outside medical experts and with patient and consumer groups.

Acting Commissioner Lester M. Crawford, nominated Monday by President Bush to assume the post full time, said the FDA "understands that the public expects better and more prompt information."

Yesterday's announcement and the three-day hearings in Gaithersburg occur at a time when the FDA's drug safety operation is under intense scrutiny. Some lawmakers and scientists, including several on today's panel, have called for an independent office to monitor drug safety that is detached from the FDA's Center for Drug Evaluation and Research, which approves new drugs.

Critics said the addition of a new oversight board was an inadequate response, little more than "window dressing," as Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, put it.

Sen. Charles E. Grassley, an Iowa Republican who is investigating the agency, said that a new board might contribute to FDA oversight, but "it also remains necessary that the drug safety office within the FDA be made a truly independent entity from the office of new drugs."

And Consumers Union questioned how a board made up of government officials appointed by the FDA commissioner could be truly independent. The consumer advocacy group is also calling for an office of drug safety separate from FDA's Center for Drug Evaluation and Research as well as new laws requiring drug companies to make their clinical trials public.

At the hearings, two FDA advisory committees will hear from drug makers, doctors and patients to determine whether cardiovascular problems associated with Vioxx are peculiar to that particular drug or are endemic to the whole class of drugs, called Cox-2 inhibitors.

The hearings could lead to restrictions - or even a ban - on a number of pain medications such as Pfizer's popular Celebrex and its lesser-known drug, Bextra, both of which have been widely prescribed to treat arthritis and other acute pain.

Yesterday, The New England Journal of Medicine published on its Web site three studies that added to the weight of evidence suggesting that all Cox-2 inhibitors might pose the cardiovascular risks that Vioxx did.

In an editorial, Dr. Jeffrey M. Drazen, the medical journal's editor in chief, wrote: "Since three different COX-2 inhibitors were all found to be associated with cardiovascular complications, it appears that this is a class effect." Because there are other well-established treatment options, he added, "it is reasonable to ask whether the use of the drugs can now be justified."

Pfizer stands by the safety of its drugs and has submitted studies supporting its position that Celebrex and Bextra are as safe to use for arthritis pain as older painkillers.

Since their approval about six years ago, Cox-2 drugs have been promoted as superior to older anti-inflammatory drugs, such as ibuprofen and naproxen, because they were thought to be easier on the stomach. But they have never been proved to be more effective than earlier painkillers, and, unlike Vioxx, neither Celebrex nor Bextra has been shown to be safer on the stomach.

Still, the Cox-2 drugs had been so aggressively marketed to doctors and patients that sales more than tripled in five years. Vioxx had sales of $2.5 billion in the year before it was pulled from the market.

"This is serious business," says Arthur A. Levin, director of the Center for Medical Consumers and the consumer representative on the FDA's drug safety panel. "We're not talking about a rare disease or something that affects a small population. This is as big as it gets."

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