"So we caught more of them early on rather than later on," Gitlin tells me. "Now, if we really wanted to let schizophrenic patients go bad, they would have all ended up in the hospital. It took very little change in symptoms for us to say, 'Oops, we've gotta intervene.' That's very different than saying, 'Gee, let's let this person be floridly psychotic and severely ill while we watch them and see what it does.' That bears zero resemblance to what we did."
Sometimes, though, things got messy. "We intervened if we saw symptoms in a mild stage, as long as it was clear that the person was getting psychotic," Gitlin explains. "But there were some people we saw on Mondays who were fine and by Wednesday night they were floridly psychotic, and the first phone call I got, we'd intervene at that point. They were clearly symptomatic. That's because they'd go from 0 to 6 like that," he says, snapping his fingers. "But had I spoken to them when they were a 4, I would have intervened at that point."
They say they did everything "by the book." Every year, they got approval from the UCLA Human Subjects Protection Committee. Every patient who was in the study signed the informed consent form. The project itself was approved at least three different times by the NIMH, and that federal agency reviewed the informed consent forms at least once with no objections. "So," Gitlin says, "it's not as if we secretly had this informed consent and didn't tell anybody what was in it and did something in any way deviously or illegally. There's absolutely none of that."
In our conversation, the researchers seem less than persuasive once--when I ask about research suggesting that relapse causes irreversible injury. "The famous Richard Wyatt thing," Gitlin says derisively, referring to a 1991 article by Wyatt, chief of the NIMH Neuropsychiatry Branch. In his review of 22 studies, Wyatt found evidence that stable schizophrenic patients whose neuroleptics are discontinued and suffer relapses may have a difficult time returning to their previous level of function because of scarring to their brains. "What Wyatt is talking about is psychosis left untreated is probably not good for brains," Gitlin tells me. "That bears no resemblance to anything that went on in our project."
When I phone Wyatt to clarify his lengthy paper, he disputes Gitlin's view. He says he meant what he wrote when he cautioned that "greater consideration should be given to the usual clinical practice of taking patients off neuroleptics after they have recovered from an acute psychosis and appear stable." The problem, Wyatt adds, "is there is a risk, and it's a risk people hadn't previously thought about."
What bearing does this have on the UCLA researchers? One scientific paper, appearing late in their decade of research, doesn't amount to evidence that what they had been doing was a mistake. "But they would have to reconsider a bit," Wyatt says. "It puts them in a bind, I suppose."
But even Wyatt, like other clinical researchers, is less worried about the ethical ramifications than the practical ones that might impede progress of conducting research for schizophrenia. "The work is so hard to do," he says. "Anything like this will set us back, whether Nuechterlein and Gitlin were right or wrong. Having this come up--who needs it?"
IN MAY, THE OFFICE FOR PROTECTION FROM RESEARCH RISKS RELEASED its final report on the Nuechterlein-Gitlin study. Two years earlier, when the researchers were still enrolling participants, the federal investigators had recommended that the project's consent form be modified to more clearly disclose risks, treatment options and the fact that the study design, not individual needs, would determine drug dosage for those enrolled in the Aftercare program.
The final report was mostly a formality: UCLA, the government confirmed, had violated federal regulations by failing to adequately protect its subjects in the informed consent process. It now required changes in the university review system and made more suggestions about the study's already modified consent forms.
It also addressed the question of Tony Lamadrid's suicide. According to the OPRR, even though he was no longer part of a protocol at the time of his death, he was still being treated by research staff and his progress was still being charted for study data. UCLA, which was allowed to respond in the report, dug in its heels at the implication of this finding: "No factual or legal connection between the study and (Lamadrid's) suicide . . . has been established."