At Your Own Risk

Some patients join clinical trials out of desperation, others to help medicine advance. Who is to blame if they get sick--or even die?

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The actual number of such deaths may be considerably higher, but nobody really knows. The monitoring of clinical research in the U.S. is so piecemeal, and the reporting of problems so haphazard, that it's almost impossible to find out what is really happening. Thanks to a patchwork regulatory system, perhaps a quarter of all clinical research--including some studies on reconstructive surgery, dietary supplements, stem cells and infertility treatments, for example--gets no federal oversight whatsoever. And even where oversight is mandated, it's often applied loosely, if at all.

And it can only get worse as the number of trials increases. According to CenterWatch, a patient information group that monitors clinical research, 80,000 clinical trials were conducted in the U.S. last year alone. Adil Shamoo, a bioethicist from the University of Maryland School of Medicine who sits on the National Human Research Protection Advisory Committee, estimates that some 20 million people were enrolled as research subjects last year--three times the number a decade ago.

That figure is expected to grow astronomically in the next few years, as drug companies prepare record quantities of new medicines for market and as the budget of the National Institutes of Health--the government's primary research agency--continues to grow. Says Thomas Murray, president of the Hastings Center, a bioethics think tank: "Our human-subject-protection apparatus is simply not equipped to deal with this demand. We're going to potentially face 100 Oklahomas, 100 Hopkinses."

But what to do about it isn't at all clear. Some experts favor tighter enforcement of existing rules and greater resources for the understaffed, overworked review boards that too often let shoddy research proceed. Others think patients need to be told more clearly and forcefully what the dangers and limitations of clinical trials really are. Still others are convinced that financial conflicts of interest--drug companies sponsoring trials and paying doctors--are the root of all evil. Bills are being introduced in both houses of Congress in the next few weeks that are designed to better protect research subjects, and OHRP, the main research regulatory agency, is rewriting its rules. What's clear to nearly everyone, though, is that without uniform, federally mandated regulations, the situation will only get worse.

It's hard to believe, but as recently as 1974 individual scientists and their financial backers could decide for themselves what constituted ethical research. Most of the time their judgment was sound, but there were plenty of appalling exceptions. In the 1950s Army doctors gave LSD to soldiers without telling them what it was. In 1963 researchers injected prisoners and terminally ill patients with live cancer cells to test their immune responses; they were told only that it was a "skin test." In the 1950s mentally retarded children at Willowbrook, a state institution in New York, were deliberately infected with hepatitis so that scientists could work on an experimental vaccine. And in perhaps the most infamous case on record, doctors at Georgia's Tuskegee Institute, starting in the 1930s, deliberately withheld treatment from syphilis-infected African-American men for 40 years to monitor the course of the disease.

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