In recent years, the need for test subjects in experimental drug trials has exploded as the industry has brought to market an ever-increasing number of new products. In response, drug companies have developed new methods of finding patients for the trials by turning to private-practice doctors who recruit from their lists of patients. But even that influx of participants has not been enough to satisfy the demand.
Filling the gap, according to industry officials and researchers, are chronically ill patients with limited or no health insurance. For these people, experiments have become treatments; clinical investigators are their specialists.Medical experts recognize the shortcomings of this system. On the one hand, the doctors are white knights, providing a critical service that such patients cannot obtain any other way. Patients "are better off getting experimental therapy than no therapy at all," said Paul Menzel, a philosophy professor at Pacific Lutheran University, in Tacoma, Wash.
But the benefit can be fleeting or nonexistent. Chronically ill patients with no other options could be treated with an experimental medication that does not work or that even worsens their condition. Or they could end up with a placebo rather than the medication itself. And once the study ends, usually after weeks, they are left to their own devices. They can be barred by the rules of one clinical trial from participating in another study for months.
"Studies are becoming like a stopgap" with the private doctors, said Dr. Richard A. Friedman, director of the psychopharmacology clinic at New York Hospital-Cornell Medical Center in New York City. "And that's pretty bad, taking from them what they need and then tossing them back."
That description underscores a hard fact of medical research: The subjects of drug trials are not, technically speaking, being treated for a disease. Rather, they are participating in an experiment.
"One will often hear from physicians and economists that there is always a way for them to get medical care, so this must be one of the ways," said Norman Daniels, a professor of philosophy at Tufts University who specializes in ethics and health policy. "In my view, it does not count as medical care."
Nobody keeps track of how many uninsured people seek health care from clinical studies; but researchers agree that they number in the thousands and that their ranks are growing.