"The purpose of this study is to take people like me off medication in a way that will give the most information about the medication, its effects on me, on others and on the way the brain works," the form read, in part. It detailed trivial risks, like the possible pain of a needle prick from drawing blood, and devoted less space to central issues, like how severe a relapse might be. It in no way indicated what the researchers had written in the protocol, that they expected "most" of the subjects to backslide. "New symptoms may occur," it allowed, and "my condition may improve, worsen or remain unchanged." And it put a positive spin on going off "meds": "I may benefit from this study by being taken off medication in a careful way while under close medical supervision."
By the time Tony Lamadrid joined the second protocol in 1987, however, Nuechterlein and Gitlin's risk hypothesis was being backed up by their preliminary data. Most of their patient-subjects were relapsing. According to a document obtained through the Freedom of Information Act, on Feb. 10, 1986, a government peer review team, conducting a site visit of the project, expressed concern over the ethical implications of these preliminary results. In its summary report, the team noted that "a comment was made about the risk/benefit ratio for the withdrawal protocol, since, to date, 11 of 14 patients have relapsed during the 18 months of neuroleptic (drug) withdrawal."
Nuechterlein responded with a list of benefits, saying, "that most study patients are eager to discontinue neuroleptics, that many clinicians would consider drug discontinuation to be clinically indicated by this time, and that the study will yield clinically important information about predictors of early relapse." Ultimately, the NIMH reviewers were satisfied: "In light of project staff's ability to reinstate neuroleptics very rapidly if clinical decompensation begins, the site visitors judged that subjects are adequately protected."
But were they? The informed consent document was reassuring but once again vague. "If I do show a significant return of symptoms," it read, "I understand that the clinic staff will use active medication again to improve my condition"--never defining "significant return of symptoms."
The 1986 grant application omitted specific references to exactly how relapsing patient-subjects like Tony Lamadrid would be handled. In a 1988 application, the methodology was more specific: Participants would be removed from the study (and presumably remedicated) when their symptoms were rated at specific levels. But rating symptoms is something of a judgment call, the doctors would later admit, and the protocol description also said that the participants' clinical interests would be deferred, at least temporarily, until the researchers could conduct their tests and make their measurements: "Information-processing, psychological, and blood testing will be done, and the patient will then be treated. . . ."
As troubling is a 1988 article Nuechterlein and one of his graduate students published in the Journal of Abnormal Psychology. They analyzed relapses in the UCLA study that reached the "severe or extremely severe level," noting that the research had not been restricted "by the necessity to increase medication to avoid a possible relapse." However rapidly decompensation was treated during the protocols, this sub-analysis found 17 instances of severe psychotic symptoms in 23 patient-subjects. Later, Nuechterlein would say that the choice of words in the article had been bad, and that it didn't accurately reflect the criteria for relapse and remedication in the main study.
Some families I spoke to said their relatives were put back on medication as soon as they noticed minor symptoms, like acting bizarrely or not sleeping or pacing. One parent, whom the researchers asked to speak to me and who requested anonymity, told me how much she respected Gitlin, explaining he would "break the blind" (intervene during the double-blind phase) at any time. The problem was she lacked authority over her adult son, who was relapsing on the placebo but "fooling everyone"--hearing voices yet denying it because he wanted to stay off the medication. She began crying. "I'll tell you the truth," she said of the study during which her son was hospitalized. "I don't resent the fact that my son went through it. But I wish he hadn't. It caused him a lot of pain. And a lot of months of recuperation." At one point during the recuperation, she said, he tried to jump out of his car on the freeway.
