Families sue on behalf of schizophrenics in UCLA study
LOS ANGELES (AP) _ Gregory Aller was 24 when space aliens told him he would become president of the United States.
Recognizing their son needed help, Gloria and Robert Aller turned to their alma mater, the University of California, Los Angeles, and enrolled Greg in a schizophrenia study.
For more than a year, treatment was so successful he maintained a 3.8 college average.
Then in 1989, he entered a phase of the study in which doctors took him off his medication. In May 1990, he threatened his mother with a butcher knife and set out hitchhiking to Washington to assassinate then-President Bush under imagined orders from aliens. He got no farther than East Los Angeles, with $2 in his pocket, before he called his father to pick him up.
Jury selection begins Monday in a case combining lawsuits filed against UCLA by Greg and his parents and by the three brothers of Antonio Lamadrid, who committed suicide by jumping off a UCLA building in 1991. Lamadrid died just days after he was dropped from the study and before doctors had arranged alternative care.
The families are convinced their loved ones were abused by federally funded research that put scientific objectives ahead of treatment. After their complaints, a federal agency criticized UCLA.
``The first question that this kind of a case brings to mind is whatever happened to the doctor’s foremost ethical pledge: First do no harm?″ said Vera Hassner Sharav, co-founder of Citizens for Responsible Care in Psychiatry and Research, based in New York.
She criticized the study as an experiment in cold-turkey withdrawal from medication. ``It’s not surprising they have a relapse,″ Sharav said. ``It’s expected. That’s unethical.″
UCLA officials declined to comment on the case, but university doctors have previously said they followed accepted clinical standards, monitored their subjects and provided access to medication during relapses.
The doctors complained that confidentiality laws allow the families to talk about the cases at will, while preventing the doctors from revealing facts that might change public perceptions about Aller and Lamadrid.
Schizophrenia is a notoriously tough illness. Sufferers hear voices, feel persecuted, lose touch with reality. Medications have side effects like the jerky muscle movements called tardive dyskinesia.
Because patients often stop their drugs, the researchers sought a controlled setting to study withdrawal from a standard medication called Prolixin.
The Allers say Greg, now 33 and living at home, was allowed into the drug withdrawal phase even though he was experiencing delusions that should have disqualified him. They say psychologist Keith H. Nuechterlein, the lead researcher, altered records, and that once Greg began relapsing he went about six months before being put back on medication.
The Lamadrid family says psychiatrist Michael Gitlin, another study leader, should have excluded 23-year-old Tony because of past drug abuse.
The families filed suits in 1992 against the University of California regents, study doctors, hospital review board and others.
Both suits allege fraud, deceit, lack of informed consent and violation of civil rights; the Lamadrids also allege wrongful death. The suits before Santa Monica Superior Court Judge David D. Perez don’t seek a specific amount of money; any damage awards would be decided by the jury.
The families contend that doctors participating in the study deliberately allowed patients to relapse and risk permanent setbacks, while falsely reassuring them of a safety net.
The patients signed consent forms stating they understood ``my condition may improve, worsen or remain unchanged″ and that ``I may benefit from this study by being taken off medication in a careful way while under close medical supervision.″
But the families contend they were never told more than 70 percent of schizophrenia patients _ and more than 80 percent of the study subjects _ relapse without medication.
In May 1994, after the families complained, the federal Office for Protection from Research Risks, part of the National Institutes of Health, found the study lacked proper procedures for getting informed consent from the patients. It forced UCLA to bolster internal oversight, undergo closer federal scrutiny and overhaul consent forms.
Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, said the UCLA case could bring about new protections for the mentally ill, whose very disorders make it difficult to weigh the risks of research participation.
``I think the UCLA situation will lead to specific regulations to protect the mentally ill,″ he said and suggested those might include clearer guidelines on what truly constitutes informed consent.