Thalidomide Still Kills


A prescient friend of mine (she also foresaw Mike Dukakis's presidential bid) once predicted that we'd soon see an explosion of treatments for Alzheimer's disease. Baby boomers, she reasoned, would demand help for their aging parents, and the market would supply.

My friend was right about Dukakis and about Alzheimer's. But she forgot about the Food and Drug Administration.

The FDA is in business to stop the flow of drugs to American medicine cabinets. It is a monument to the idea that people don't know what's good for them, that medical decisions are too important to be left up to doctors and patients. It is the most paternalistic organ of our paternalistic government.

And it is killing people. Its victims are mostly anonymous, stories of "it might have been." When the FDA held up beta blockers, to take a single example, it condemned thousands of heart patients to death. But which ones?

Such hypotheticals don't make for great TV. Nobody holds rallies for statistically predicted casualties. Nobody sues for damages caused by not taking a drug.

But two forces are putting faces on the FDA's victims. One is what my friend predicted—the pressure to find some way to alleviate Alzheimer's. The other, of course, is AIDS.

Alzheimer's and AIDS are both fatal, promising death by slow torture of mind and body. Yet the FDA, in its infinite wisdom (and in accordance with laws passed by Congress), forbids patients medication that might relieve their suffering. By increasing costs and delaying revenue, its policies also stifle innovation.

The FDA is protected from criticism by a magic word—thalidomide. In the early '60s, that tranquilizer caused fatal or crippling birth defects in thousands of European infants. An alert FDA physician realized the problem and the agency prohibited sales of the drug.

The thalidomide tragedy created a powerful myth—and a dangerous law. Thalidomide was unsafe, banned under a 1938 law. But Congress responded to the crisis by outlawing distribution of drugs that haven't been proven both safe and effective. Efficacy testing does nothing to prevent another thalidomide tragedy, but it does add years to the approval process.

If thalidomide marked the FDA's greatest triumph, AIDS marks its most disgraceful failure. AIDS has made it unconscionable to defend mandatory efficacy testing, but the FDA is bound and determined to try. "It's a disservice to let even a dying patient use an unproven drug unless qualified physicians believe it has some chance of helping," says FDA medical officer Alexander Fleming in a self-justifying special report from FDA Consumer magazine. "That only raises false expectations and might cause needless suffering or hasten death."

Not just any "qualified physicians," however, can decide that a drug "has some chance of helping." The FDA determines who is qualified and what constitutes an acceptable belief.

Last year, the agency loosened its restrictions on some experimental drugs. For terminal illnesses, such as AIDS, a pharmaceutical company has to show only a "reasonable basis for concluding" that a new drug "may be effective" and won't contribute "significant additional risks."

All that is well and good and much-heralded. But we haven't exactly been inundated with new drugs—and not because companies haven't invented any. Many AIDS drugs (notably ribavirin) languish unapproved, sold only on the black market. And true to its nature, the FDA still smashes new approaches whenever it gets the chance.

Take the case of William Summers, a physician who treated 17 Alzheimer's patients with the drug THA and the food supplement lecithin. According to an article he published in the New England Journal of Medicine, most showed improvement. The number of patients is small—too small to constitute proof of the drug's general effectiveness. There is plenty of room for further research, and a number of specialists are trying to duplicate Summers's results.

None of this, however, satisfies the FDA, which has threatened Summers with legal action for breaking the agency's experimental-drug rules—rules that dictate a host of record-keeping requirements, laboratory inspections, and study procedures. These rules assume the resources of a large company, not an individual physician. Summers has been forced to stop giving THA to his patients.

No one knows whether THA is in fact an effective treatment for Alzheimer's. But Summers's patients and their families want the chance to try it. Not content to remain anonymous victims of the FDA's cruel and paternalistic policies, they have started a foundation to support Summers.

"My father returned to some of his favorite hobbies, such as woodworking, reading, and gardening as a result of THA," Brent Couvillion told the Wall Street Journal. "We know that THA is not a cure, but shouldn't we have a say in the THA controversy?"

The FDA refuses to let doctors and patients make tradeoffs, to choose how much risk to accept or whether to try a treatment that might not work. Instead, it decides for them—in ways most people would not decide for themselves. It kills choice and it kills hope and it kills people.