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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But the U.S. can't afford to wait for every research institution to react to its own lapses. That's the impetus for a sweeping overhaul of the OHRP, designed by director Greg Koski--with advice from a newly motivated Johns Hopkins--to make the agency more aggressive in protecting human subjects. It's also behind legislation that will soon be moving through both houses of Congress. Representative Diana DeGette of Colorado will introduce a bill this week that is aimed at finally giving humans the same legislative protections that animals receive; the rules will apply to all research on humans, not just federally funded or FDA-regulated research. Her bill gives the OHRP more auditing responsibility and enforcement options, including the ability to punish individual researchers without shutting down an entire institution--something that office has long wanted. And her bill will lay down new rules that address financial conflicts of interest. In the Senate, Edward Kennedy plans to hold a hearing next week at which Mathias, among others, will testify, and will introduce his own bill soon after.

Both DeGette and Kennedy endorse the idea of accrediting IRBs. But they are split on whether accreditation should be mandatory. So far, Kennedy is saying yes. DeGette, who has championed patient protection in part because the University of Colorado was severely sanctioned by OHRP in 1999, thinks a voluntary system would, paradoxically, protect patients better. "The whole point of accreditation," says DeGette, "is to encourage research institutions to reach for a higher bar, to go above and beyond the minimum requirements."

Critics of the current system have all sorts of ideas about how hospitals and research labs could go beyond the minimum. One is the notion of subject advocates--independent consultants whose sole function would be to look out for the best interests of the subjects, not the scientists. Argues George Annas: "You cannot rely on the conscience of the individual investigator, because he has an inherent conflict of interest. He has to enroll subjects in his study."

Many critics also point to the consent forms people sign when they join a clinical trial. Even when the risks are clearly spelled out--and they frequently aren't--patients tend to misunderstand what's actually going on. The truth is that less than 5% of subjects in Phase I trials, which measure the toxicity of a new drug, will receive any health benefit whatsoever. Yet when a 1995 University of Chicago study quizzed patients about why they enrolled in their Phase I cancer trials, fully 85% answered, "Possible therapeutic benefit."

In another study of cancer patients, at Harvard Medical School, nearly 75% of the subjects did not understand that the trial was investigating a treatment that was not standard. Two-thirds said they did not know they might face additional pain or discomfort. Says Annas: "These trials involve a great deal of mutual self-deception. Patients really want to believe it's treatment, and doctors really want to believe they are curing somebody."

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