New drug panel has challenges before it

February 19, 2005|By Julie Bell | Julie Bell,SUN STAFF

This week, as an expert federal advisory panel with access to reams of data struggled to decide if the benefits of certain anti-inflammatory drugs outweigh their risks, osteoarthritis patient Brenda Slater reflected on her attempts to do the same.

But Slater, 60, of Atlanta, makes her drug decisions - such as what to take in place of the no longer marketed anti-inflammatory Vioxx - with far less information than an expert panel. Like many patients, she depends on her doctor's advice, a few Web searches, her experience and those little fact sheets dispensed with prescriptions.

"They list every side effect that can possibly happen to a human being, and 99 percent of people do not have a problem," she said.

Consumers have a difficult time weighing the emerging risks and benefits of drugs on the market, and the Food and Drug Administration said this week that it is moving to help. But the agency's fix - a proposed Drug Safety Oversight Board and a Web page to quickly provide new information to physicians and consumers - is unlikely to make the decisions much easier for people such as Slater, drug-safety experts and consumer advocates say.

That's because, even for experts, telling whether a medicine's risks outweigh its benefits can be complicated. Even if it will be well-funded and independent, the new oversight board won't necessarily have an easier time coming to conclusions than the FDA's scientists or its committees of outside experts, say drug-safety scientists and public advocates.

"I think most people assume drugs are just `safe,' and that's really not the criteria being used," said Sheila Weiss Smith, a drug-safety expert and an associate professor in the University of Maryland School of Pharmacy. "It's a real hard balancing act."

Whether for hormone-replacement therapy, acne treatments or anti-inflammatories, such as Vioxx, Celebrex or Bextra, the FDA has a three-phase process for studying the effectiveness and safety of medicines in groups of up to thousands of patients before drugs hit the market. But the studies, which generally last weeks or months, are short and small compared with the vast numbers who take blockbuster drugs such as Celebrex and Bextra for long periods after they are approved.

Taking a newly marketed drug is akin to participating in the fourth phase of a clinical trial - a large, relatively unsupervised one, advocates and experts say.

"We don't know what the side effects profile will look like six months or two years down the line," said Michael A. Susko, a social worker who is president of the nonprofit Citizens for Responsible Care and Research.

While testing drugs for longer periods in larger groups would add more certainty, the FDA hasn't required it, and consumer groups largely haven't advocated it. That's because it would keep medicines that might save or improve lives from the market longer and potentially make them more expensive.

Rather than prolong the process, the Drug Safety Oversight Board would be expected to monitor drugs on the market and quickly pass on signs of problems to consumers.

While the FDA has an Office of Drug Safety assigned to the task, critics have denounced it as too slow to disclose problems - hampered by being part of an agency considered too cozy with industry and somewhat at the mercy of a largely voluntary system for reporting side effects. The office is part of the FDA's Center for Drug Evaluation and Research, where the agency estimates that about 18 percent of scientific time is spent studying post-market safety.

What's more, drug manufacturers haven't always disclosed the results of negative clinical trials - even to the FDA.

Despite the challenges inherent in the balancing act, drug-safety experts and patient advocates said they welcome the FDA's attempts to provide more meaningful information. The drug-safety board could be an important first step, some said.

Key details lacking

The FDA has yet to offer key details about how the board would operate, and more changes might be coming. The FDA announced in November that it had asked the Institute of Medicine, an independent advisory agency, to study the effectiveness of the U.S. drug-safety system.

But experts and consumer advocates say the board must be independent of the FDA, well-funded and staffed and have clear authority to order actions that could improve medication safety - including by telling pharmaceutical companies to pay for additional tests of marketed drugs when warranted.

An independent model mentioned is the National Transportation Safety Board, which Congress created to be independent of the Department of Transportation and its agencies, including the Federal Aviation Administration.

Consumer groups say the new Drug Safety Oversight Board won't be independent as proposed because the FDA commissioner would appoint medical experts from the FDA and other government agencies to the board.

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