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MARCIA ANGELL

What ails the FDA? Payola

LET'S FACE it. The FDA is doing a poor job of ensuring that prescription drugs are safe and effective. It approves drugs that offer only minimal benefit, and then sometimes leaves them on the market long after they've been shown to be dangerous.

Take Vioxx, the hugely popular arthritis drug that was taken off the market in September and now might return if an FDA advisory panel has its way. This is one of a class of drugs called COX-2 inhibitors (Celebrex and Bextra are the others) that are supposedly easier on the stomach than over-the-counter remedies like Advil or Aleve. It was rushed to market in 1999 even though it was never shown to be any better for relieving pain than the older drugs.

The FDA then let it stay on the market for four years after a clinical trial showed it was probably more likely to cause heart attacks or strokes than to prevent stomach ulcers. It could have insisted that the manufacturer, Merck, immediately conduct a large-scale study to better define the risks and that the company add a warning in its direct-to-consumer ads that made Vioxx sound like a miracle drug (think Dorothy Hamill skating effortlessly to ''It's a Beautiful Morning"). The FDA is now implying it doesn't have that authority, but it does.

Why is the nation's most important regulatory agency appeasing the pharmaceutical industry instead of protecting the public? One answer is that it is on the industry's payroll. Literally.

Since 1992, by an act of Congress, drug companies pay the FDA ''user fees," which are earmarked almost entirely for speeding up drug approvals. Consequently, the agency now behaves as though that were its main job, not ensuring safety and effectiveness.

Even worse, the 18 standing advisory committees of outside experts who help the agency decide whether drugs should be approved include paid consultants to drug companies. They are supposed to recuse themselves from decisions that directly affect the companies they work for, but that rule is regularly waived on the dubious grounds that their expertise is uniquely valuable. (Imagine judges not recusing themselves from cases in which they have a financial stake on the grounds that their expertise is invaluable!) The advisory committee that originally recommended approval of Vioxx, for example, consisted of six people, four of whom had received waivers because of their ''potential for a conflict of interest."

Last month a special advisory panel (two of the standing committees combined) held public hearings on the safety of COX-2 inhibitors and decided that the benefits outweighed the risks. What was not publicly disclosed was that at least 10 of the 32 panel members (we don't yet know the exact number) were paid consultants for the companies that make the drugs. If their votes had been discounted, the panel would have recommended that Vioxx and Bextra be removed from the market. No wonder drug companies hire members of FDA advisory committees.

Drug companies and the FDA sometimes respond to critics by reminding them that nearly all prescription drugs have side effects. Even so, one of the FDA's most important jobs is to make sure the risks don't outweigh the benefits. When potential benefits are great, as with many cancer treatments, it is acceptable to run substantial risks. But when there are few benefits over drugs already sold, as in the case of the COX-2 inhibitors, it is not.

Vioxx is estimated to have caused tens of thousands of heart attacks or strokes. It is hard to see how the panel could have concluded that the benefits were worth those risks, especially given the fact that taking over-the-counter Prilosec in addition to an older pain reliever would probably have provided as much protection from stomach ulcers. The fact is, this was a public health disaster.

To prevent such disasters in the future, the FDA must be made independent of the industry it regulates. First, the legislation that authorized user fees should be repealed and the money replaced and augmented by appropriations that restore a better balance between drug approval and safety monitoring. The public is the primary ''user" of the FDA, not the industry, and funding should reflect that. Second, FDA advisory panels should not include paid consultants for drug companies. Their conflict of interest is real, not ''potential." The excuse that they are indispensable is not only self-serving but insulting to the experts who don't consult for industry.

The FDA is vital to our public health. We need to strengthen it as an independent watchdog, not an industry lapdog.

Dr. Marcia Angell is a senior lecturer in social medicine at Harvard Medical School and author of ''The Truth About the Drug Companies: How They Deceive Us and What to Do About It."


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