Working in the emergency room recently, I admitted a patient with chest pain. He blamed it on a drug that he was taking for schizophrenia. The medicine probably had nothing to do with his pain, but he didn't believe me. He had heard a warning from the government that the pills could kill him.

It was not voices he was hearing, but an edict that the Food and Drug Administration issued that week. The FDA made a splash, through a press release, about new labeling to warn patients about an unapproved use of these atypical antipsychotic drugs in the treatment of symptoms of dementia.

The approach echoed the one the FDA took with a recent "public health advisory" about a category of popular painkillers. That warning, which covered drugs such as Aleve and Advil, sent a wave of worry across the country as patients who didn't know better wondered whether they faced an increased risk of heart attacks.

The problem with both warnings is the agency's message went to the media before reaching practicing physicians. My patient's misguided fears are not unique. It is what happens when medical regulation is enforced through the press.

No doubt, this approach is the agency's response to critics, but a press release is no place for a regulatory agency to flex its muscle. FDA is absorbed in an atmosphere that emphasizes managing drug risks over maximizing overall public health benefits. The agency's response to its critics is to move away from carefully tempered scientific statements made mostly on drug labels and through "Dear Doctor" letters and toward the bully pulpit. The agency is also issuing press releases that shine a spotlight on "emerging risks" rather than focusing on scientifically proven drug side effects.

Critics eager to see a tough FDA may be assuaged by hard-talking headlines, but as my patient's experience shows, shotgun warnings fall indiscriminately on both the right and wrong ears.

What patients hear

Research has shown that the way in which drug safety information is communicated to patients has a profound effect on their willingness to take medicine. One study among many found that subtle changes in how data about the risk of birth defects are presented to expectant mothers could profoundly influence their drug decisions.

All drugs have certain risks, so when regulators choose to highlight one in the press, it should be for good reason. Too much information, especially when it is poorly conceived or scientifically shaky, can be as bad as too little. Overstating a product's risk can discourage legitimate use, too.

Because of this, FDA historically has calibrated its safety messages with care, ensuring both that the risks are substantiated by science and that the overall message balances risks with benefits. I witnessed this deliberate approach firsthand as an adviser at FDA.

What is the tradeoff?

In spring 2003, the agency agonized over whether a class of antidepressant medicines could be causing some young users to become agitated and even act out suicidal behavior. The data were mixed, and the agency worried about the tradeoff between the need to warn of a potential risk vs. the fear it could cause.

When the agency finally yielded to public pressure and issued a broad warning, utilization of the drugs among young people dropped as much as 19%. It is fair to assume some of those who dropped prescriptions were people who didn't need the medicines, but others surely did. FDA has since softened its original warning.

Critics may contend FDA is just matching the muscle of the drug firms, who flood the airwaves with advertising. But if the ads we see fall short of the public health benefits Congress and the law intends, that's best dealt with through new rules and regulations that encourage better ads. The FDA should set a framework for such advertising, rather than try to compete with it.

The FDA can benefit from more routine transparency, but when the agency beats its drums, it must be for good reason. A steady stream of dire announcements will eventually fatigue the public for important warnings and devalue the voice through which the agency speaks.

Scott Gottlieb is a resident fellow at AEI and a practicing physician.