On the day before the report was made public (a few copies had been leaked earlier to news organizations), I went to Yale to visit Jay Katz, a psychoanalyst and professor emeritus of law, medicine and psychiatry at Yale Law School. Katz has been an outspoken critic of the UCLA study. When I suggested to him that the researchers believed their experiment reflected what any good doctor would offer a recently diagnosed schizophrenic, he scoffed: "With all due respect, they must be crazy if they say that. Because they put down 1-2-3-4-5-6-7--delusions, suicidality, etc. If they didn't mean to do that, what the hell is it doing in the protocol?" A good doctor's first priority, he pointed out, would be to prevent exacerbation and relapse.

An expert on ethics and medical experiments, Katz was a member of an advisory committee in 1973 that helped to first promulgate federal regulations to protect human subjects in the wake of revelations about the Tuskegee study. Now, he is a member of a presidential commission considering recent disclosures about Cold War-driven radiation experiments conducted without consent. He is always skeptical of physician authority and the ways in which doctor-researchers rationalize their behavior. In his mind, Tuskegee and UCLA are on the same continuum--in both instances, in his estimation, patients were deliberately left unmedicated; in both instances, consent was manipulated. The UCLA study, he will concede, is a subtler example, but the problem remains the same.

"There is persistent confusion between research and (clinical) practice and the obfuscation of the two," he told me as he tugged on a cigarette and sipped sherry at lunch. "This is what happened at Tuskeegee. (The researchers) had the best of intentions of combining the two, but in the process they confused themselves and their patient-subjects, because the objectives of treatment and the objectives of research aren't the same."

I asked Katz whether Nuechterlein and Gitlin had been guilty of nothing more than setting up a design that adhered to most schizophrenics' wishes to stop taking medication. "C'mon, c'mon," he said impatiently. "They want to find out, and that is laudable, when, if ever, and under what circumstances can you take patients off medications. But in getting laudable results, which I heartily endorse, they were running roughshod over human beings' autonomy. And that's the issue. You cannot use people--or you should not use people--as means for other's ends and for ends that might ultimately even be good."

Informed consent is Katz's area of expertise, and it is the bottom-line ethical consideration in human subject experimentation, though he views it as it is currently practiced as little more than an "empty ritual."

"In my mind," he said of the UCLA study, "it was immoral from the perspective of informed consent, because (they) were deceiving subjects." In a 1993 law review article, he tore into the new form that UCLA created in response to the government's requirements, still finding it misleading, vague and inadequate. "The (revised) consent form did not state with sufficient clarity that the primary objective of the study was to conduct research for the sake of future patients . . . that it was not therapy for the subject's individual present needs." And, Katz says, there's a whole other consent question that the UCLA controversy sidestepped: Are schizophrenics competent enough to give informed consent? Katz would like to see the mentally ill included in the same "vulnerable" class as children, prisoners and fetuses, and extended the same heightened protections--experimentation involving them must have a therapeutic benefit and be of minimal risk.

Katz also agrees with the OPRR report that the trouble at UCLA was as much the fault of the institutional review board as it was the research itself. Part of the problem is that the federal regulations cannot be applied rigidly to make determinations of whether a proposed research activity is ethically right or wrong. The process is a flexible one. As such, the IRBs are in a position of unbridled power.

Despite the presence of non-scientists on these boards, one of the central problems in the ethics of research is that review boards are chiefly made up of colleagues of the researchers. When the Nuechterlein-Gitlin study was approved, UCLA's IRB for medical research consisted of 12 faculty members, two nurses, two pharmacists and two public members representing the community at large. "It's a very clubby situation," explains UCLA psychology professor Irving Maltzman, who has been on the faculty for 45 years. "You don't blow the whistle on (your colleagues) because they might be on your committee the next time you're up for promotion."

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