Researchers to Revise Patient Consent Procedure : Science: Following a reprimand from a federal agency, UCLA psychiatrists will increase their written explanations of schizophrenia test risks.
UCLA researchers studying a schizophrenia drug are revising their procedures for informing patients about potential risks from the studies and are increasing oversight of the research after they were chastised by a National Institutes of Health committee, university officials said Thursday.
A draft of the NIH report also found no evidence that the clinical treatment of the subjects in the experiment was inappropriate and that the study’s design was “scientifically and ethically justifiable,” said UCLA clinical psychologist Keith M. Nuechterlein, co-leader of the study with Dr. Michael Gitlin.
The NIH review was prompted by complaints from the families of Antonio Lamadrid and Greg Aller, who charge that both suffered severe relapses when the drug was withdrawn from them during the study to determine whether patients could maintain improvements without medication--thereby avoiding the drug’s potentially serious side effects. Lamadrid committed suicide (he was no longer enrolled in the program at the time), and Aller threatened to kill his parents and planned to travel to Washington to assassinate then-President George Bush, he said, at the order of space aliens.
C. Kumar Patel, vice chancellor of research at UCLA, said the university has conducted the study responsibly. “We take very seriously our responsibility to people who volunteer to participate in research studies, and have fully cooperated with (NIH) over the past three years in continually reviewing and enhancing the informed-consent process in this study,” said Patel.
But Robert Aller, Greg’s father, angrily denounced the report as a “whitewash. NIH didn’t talk to one single patient or one single family (other than the Allers and the Lamadrids),” he said in an interview. “They talked to us because we complained, but they didn’t get hold of anyone else.”
Lamadrid’s brother Enrique, a Spanish professor at the University of New Mexico in Albuquerque, told The Times he was gratified that the NIH report said that “they should have acted, should have done more” to prevent Antonio’s suicide. “There are things there that prove to me that I was right in making the complaint.”
The Lamadrid family has also filed a wrongful-death suit against UCLA because of the suicide, Enrique Lamadrid said.
NIH officials would not discuss the case or the report Thursday “because it is still under investigation,” according to a spokesman for the National Institute of Mental Health, which funded the research.
The draft, issued by NIH’s Office of Protection From Research Risks, was distributed this week to UCLA and the families involved, and both groups have 30 days to respond before a final report is prepared.
The report does not discuss any potential punishment of the UCLA researchers. “Historically, that office has seen its mission as educational rather than regulatory,” said George Annas, a lawyer and ethicist at Boston University. “They want to teach people how to do things right rather than sanction them for doing things wrong.”
Dr. Gary Tischler, chairman of UCLA’s psychiatry department, said the university would not object to the report’s conclusions. “We’re very comfortable with its recommendations,” he said.
Tischler and Nuechterlein said that the informed-consent papers signed by patients upon enrollment in the study have been revised once and are being revised again to incorporate more information about the study and its potential side effects. Much information that had previously been given to patients orally will now be written, they said.
Tischler also said that the university would add a patient to the 16-member review board that oversees experiments on psychiatrically impaired patients. It will also establish one or more independent review boards to monitor studies where the researchers also provide clinical care for the subjects being studied.
Outside reaction to the report was mixed. Annas, for one, thinks the UCLA study was poorly designed and that treatment of the subjects whose medication was withdrawn should have been resumed before symptoms reached a severe stage. “You could bring them close to relapse, then start treating them again. The arguments about what could be learned (by withdrawing medication) are secondary to the potential for damage to the patients,” he said.
Schizophrenia is a severely disabling illness affecting more than 1.2 million Americans and is characterized by delusions, hallucinations and severe disorders in thought processes.
The concern about virtually all antipsychotic drugs--including Prolixin, which was used in the UCLA study--is that they have severe side effects. Prolixin and other drugs can cause a permanent movement disorder called tardive dyskinesia. Gitlin and Nuechterlein’s hope was that patients could be weaned from the drug to reduce the likelihood of such outcomes.
Nuechterlein and UCLA officials argued forcefully that patients withdrawn from the drug were monitored very carefully for the return of symptoms and that the researchers were prepared to restore treatment when it became necessary. “When it’s needed, medication is given and that overrides any research need,” Tischler said.
But Aller and other parents have argued that they and the subjects were not adequately warned about the severity of the potential relapse. Robert Aller also charges that he and his wife “practically begged” the team to restore treatment to Greg Aller, but that their request was refused until it was too late. (Greg Aller is now under private care and his condition is much better, according to his parents.)
But Nuechterlein said that when the medication was withdrawn, “we . . . tried to make the best decision we could with the information we had.”
He also said that no suicides occurred during the study among patients whose medication was withdrawn. Enrique Lamadrid confirmed that his brother was no longer enrolled in the study when he committed suicide.
