What the FDA Doesn't
Want You to Know

By Robert M. Goldberg
Copyright 1998 Dow Jones & Co., Inc.
Wall Street Journal (May 4, 1998)

What does a woman's voice have to do with male impotence? Well, the Food and Drug Administration claims that having a woman instead of a man talk about the risks of using an impotence treatment doesn't fully convey the dangers associated with the therapy. I am not making this up. As a result, the FDA has pulled a television commercial for an injection called Muse until Vivus, the manufacturer, replaces the woman's voice reading risk information with a man's.

According to Nancy Ostrove, an assistant commissioner for drug marketing at the FDA, having a women talk about possible risks is a way of softening the blow. "Notice how women's voices are so much more reassuring then men's. They always--well not always, but in many cases--have women's voices reading the bad stuff. It's very interesting."

This foray into the production values of TV commercials is part of the FDA's sustained effort to ignore a law Congress passed last year requiring the agency to loosen its control over the flow of medical information. The law was passed because doctors and patients were hearing about the risks but not the benefits of new treatments. So Congress told the FDA that drug companies could say more about the uses of their products, as long as the information came from medical journals.

The agency has gone out of its way not only to flout congressional intent but to expand its power in ways that interfere with the freedom of doctors to use medical products as they see fit. As a result, the agency has begun to meddle with medicine in ways that will hurt people. For instance, the FDA wants effectively to ban any health-care organization from providing doctors or patients with information about specific drugs without first getting the agency's approval. This gag rule would apply to HMOs and other organizations that manage health benefits or treat diseases, even if the information in question did not come from the manufacturer. It would even apply to information drawn from leading medical journals or the National Institutes of Health--even if the information is essential to the success of programs designed to improve health.

For instance, with the recent findings about the effectiveness of both tamoxifen and raloxifene in preventing breast cancer, it is imperative that information on the best and safest use of both products be spread to doctors and patients as quickly as possible. But if Salick Health Centers--one of the leading breast cancer treatment programs in the country (owned by Zeneca, the developer of tamoxifen)--wanted to give patients information about the drugs, they couldn't under the FDA gag rule.

In several low-income neighborhoods around the country, drug companies such as Schering-Plough are teaming up with community health groups to implement new approaches to reduce the unconscionably high rate of asthma-related death and suffering in urban areas. These programs are succeeding. But the asthma initiative involves giving doctors and patients information about the relative costs and benefits of specific steroids and anti-inflammatory drugs. Such worthy efforts would also be prohibited by the FDA's regulation. Similarly, recent efforts by HMOs to improve the treatment of depression rely in part on research showing that newer antidepressants like Prozac can help people who do not respond to older medications. Such information is part of a growing clinical literature about the optimal treatment of depression. It too could be banned under the proposed FDA stricture.

The power grab does not end there. For the FDA is eager to stop the "unauthorized" use of medical information, even if it means meddling in the doctor-patient relationship. A chilling example of the ends to which the agency will go in this matter comes from the medical device business.

A group of the nation's leading eye surgeons, led by William Ellis, a pioneer in the use of laser surgery to treat eye diseases, purchased new high-tech lasers made by a company called Summit Technology. The lasers, made at FDA-approved assembly plants in the U.S., had been used in Europe for years. Tired of waiting for Washington's approval, Dr. Ellis and others began using the lasers in their practices. They notified the FDA of their purchases.

Soon thereafter, the FDA told the surgeons it would confiscate the lasers, even though there was nothing illegal about their use or purchase. The agency claimed the surgeons were not using the lasers in the approved manner. Why? Because the lasers used overseas lacked an FDA-approved credit card reader, installed by Summit, that locks out users until they pay a $250 royalty each time the device is used.

At a time when access to medical information is more important than ever to health care quality, the FDA's gag rule does more than expand the agency's control over all forms of medical information. It ignores the will of Congress and the Hippocratic promise to do no harm. With television commercials, people can just change the channel. But with the FDA's recent power grab, people will be left with fewer choices and less medical freedom than ever before.

Mr. Goldberg is a fellow at the Ethics and Public Policy Center in Washington.

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