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JUDY NORSIGIAN AND DIANA ZUCKERMAN

Adding bite to FDA screening

SENATOR EDWARD M. KENNEDY is leading efforts in Congress to pass legislation to overhaul the Food and Drug Administration. Such reform is needed, because the FDA has repeatedly failed to protect the public from drugs and medical devices that prove dangerous to patients. Unfortunately, the proposed legislation is so weak that it is unlikely to save any lives.

We hoped for more. Last year, Mike Enzi, a conservative Republican from Wyoming, was in charge of health legislation in the Senate, and Kennedy was in the minority party. The two senators introduced a drug safety bill that pleased the pharmaceutical industry considerably more than consumer advocates. This, supposedly, was the best these advocates could get from a Republican Congress.

The bill was delayed, luckily, and much has happened since then. Kennedy is now in charge of health legislation in the Senate. Nevertheless, he and Enzi introduced the same bill this year.

When drugs are allowed into the market before their side effects are fully evident, the potentially deadly results are all too familiar: think of drugs like Vioxx, Trasylol, and Ketek, and devices such as drug-eluting stents and defibrillators.

Preventing unnecessary deaths will take more congressional muscle. For example, when new drugs are widely advertised to consumers before the risks are known, thousands of those who take them may be harmed. Most could have been treated by older, safer, cheaper drugs. That's why the American Medical Association, most physicians, and the Institute of Medicine -- a respected nonprofit that offers advice on biomedical issues -- recommend a two-year moratorium on direct-to-consumer advertising of all new drugs.

That sounds like a great idea, but the Senate bill rejects it. Instead, it would allow (but not require) the FDA commissioner to impose a moratorium only when there is clear evidence that advertising to consumers would harm patients. This is hard to prove because new drugs lack data on widespread use. Even worse, Kennedy's bill doesn't even require the FDA to review new drug ads for accuracy.

The Institute of Medicine also calls for reducing conflicts of interest among FDA advisory panel members. A few weeks ago, the FDA adopted some of those suggestions. It proposed to exclude from advisory panels all doctors and scientists with financial ties of more than $50,000 in the previous 12 months to the products under review; those with a lesser financial interest could still serve on the committees, but only as nonvoting members.

Having any advisers with a financial interest is like having referees who bet on their own games -- an obvious conflict of interest. Yet the Senate bill allows paid consultants, scientists with stock in the companies, and other financially conflicted experts to vote on FDA advisory committees -- as long as their financial ties are made public and the FDA grants a waiver. And, the bill would also create a new foundation, also funded by drug companies, to do the kind of drug safety research that the FDA should be doing.

This month, Kennedy is expected to attach provisions of his drug safety bill to another measure that, among other provisions, expands the user fees that are charged to pharmaceutical companies to pay for drug reviews. Meantime, the FDA itself proposed several changes that Congress should build on -- but hasn't. For example, the FDA proposed that $29 million of the almost $400 million dollars in user fees paid by drug companies should be spent to "ensure the safety of medications after they are on the market." But the Institute of Medicine has said $100 million is needed for this purpose.

Much more -- almost $370 million in user fees -- would be spent to speed up the review process, so companies can get their drugs to market more quickly. Although new medications can potentially save lives, most "new drugs" approved by the FDA in recent years are merely newer, more expensive versions of equally effective drugs. Speeding up their approval translates to millions of dollars for pharmaceutical companies, but usually no lives saved.

It's a sad day when the public good is completely overshadowed by pharmaceutical companies' lobbying. A strong reform bill would protect the health of all Americans. We hope Senator Kennedy will fix this bill before it's too late.

Judy Norsigian is executive director of Our Bodies Ourselves, a women's health advocacy organization. Diana Zuckerman is president of the National Research Center for Women & Families.

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