County Lifts Ban on Testing Drugs on Mentally Ill

Los Angeles County’s mental health department has quietly lifted its four-year ban on the testing of psychotropic drugs on severely disabled people in its care.

At the same time, officials are drawing up procedures to screen anticipated proposals for research on the drugs, which are used to treat mental disorders.

The more than 2,000 patients affected are mostly impoverished people afflicted with severe schizophrenia whom a court has ruled unable to care for themselves and placed under the county’s control as “conservatees.” Scattered in nursing homes, board and care facilities and convalescent or state hospitals, conservatees can be forced to take certain drugs and lose their right to vote.

While the mental health department believes it has the power to lift the ban on its own, it has asked the county’s lawyers for an opinion on whether the Board of Supervisors is required to set the guidelines for permissible drug trials. That opinion is forthcoming.

County officials acknowledge that permitting medical tests on conservatees is highly controversial, especially given the heightened national debate over testing. They say their policy will be extremely restrictive, most likely allowing only small-scale research that would not be done against conservatees’ will.

The blanket ban on tests on county conservatees--established after the death of a private conservatee involved in a clinical trial at Camarillo State Hospital--may actually prevent them from receiving benefits of psychotropic drugs that are not yet on the market, said Marvin Southard, the director of the Department of Mental Health.

“We want to support our conservatees and our clients’ rights to participate in something we believe is in their best interest,” he said, “and at the same time we want to avoid anything that approaches exploitation.”

But the county’s move has sparked an outcry among some mental health professionals and activists who point out that state law bans such tests on children or prisoners because they cannot give truly independent, informed consent to procedures that can carry grave medical risks.

“These are people who cannot choose their own [approved] psychotropic medicine from those that are available from the FDA,” said Alexander Capron, a USC professor who sits on a national bioethics panel. “This seems to me to be a real exploitation of people’s medical status.”

Because of those concerns, Orange and San Diego counties do not permit drug testing on conservatees, although apparently no agency tracks which California counties do allow it. Ron Schraiber, the Los Angeles County mental health department’s consumer advocate, has spent time in mental institutions himself and also opposes lifting the ban.

“There’s an inherent pressure of being in a total institution when an individual is dependent on institutional staff for all their needs and freedom,” said Schraiber. “That essentially precludes voluntary consent.”

And although mental health officials say their agency will be up to the task, opponents also argue that the mental health department’s unit that is charged with taking care of conservatees, the office of the public guardian, is too internally troubled to have its responsibilities expanded.

“The public guardian doesn’t carry out its responsibility toward the people it’s protecting,” said Harold Shabo, supervising judge of the mental health court which hears conservatee cases. “Experimentation just adds another level of risk.” Shabo has complained about delays in the office transferring paperwork to the public defender, which represents conservatees in court. The result is that patients can be trapped in mental institutions for weeks.

In an indication of the divisiveness of the issue, the mental health committee that lifted the ban did so in a 4-3 vote Nov. 16 after months of debate. Even opponents of the action on the committee praised the majority for issuing a policy loaded with safeguards that would have to be met before any testing is approved.

“A clear line of ‘no’ is the best protection for clients in my view,” said Mary Mahon Fordes, a member of the human subject research committee who voted against the plan. But, she added, “If it’s going to be done, I think there’s a lot of very good stuff built into the proposal. It’s going to be very hard to get anything through there.”

Southard said the vote voids the ban and his agency is researching whether it can adopt the recommendations of its own human subject research committee as the requirements that must be met before research can proceed on any conservatee or whether the Board of Supervisors would have to approve such policies.

Southard stressed that, under the proposed regulations, research would have to clear several hurdles before it was approved by the department. Then the researcher would have to go to court and persuade a judge to allow the procedure. The patient would have to consent to the process--and Southard said he believes some conservatees are capable of giving consent, even if their functions are impaired in other areas.

Among the regulations are provisos that no experiment can use solely county conservatees as subjects and that the test must be judged to be beneficial for the patient. “We’re not going to take a cohort of 20 Metropolitan [State Hospital] clients and have that be the focus of research for a new drug,” Southard said. “I wouldn’t do that.”

Still, the county’s mental health commission, which advises the Board of Supervisors, has asked to review the mental health department’s proposed regulations. And an aide to county Supervisor Mike Antonovich, who is active in mental health matters, said she expects the issue to come before the board.

The county’s move comes at a time of heightened scrutiny over medical research and patient consent. Scandals have occurred recently involving tests done on minors by Stanford University scientists, research on uninformed patients at the Veterans Administration hospital in West Los Angeles and a report from the National Bioethics Commission that cautions against exploiting vulnerable subjects.

Part of the reason, critics say, is that pharmaceutical companies are raking in increasingly higher profits from new medications and need new test subjects, and scientists may be motivated by money those companies pay for their research.

Other tensions are also at work, said Leonard Glantz, a lawyer and ethics specialist at Boston University’s School of Public Health. “There’s been an increasing sense of mental illness as biological. . . . Advocates are feeling very strongly that more people should be protected. Scientists are thinking that if we do more research we could find better treatments.”

Conservatees are a desirable population for researchers because they are usually in the same place and can easily be monitored, experts say. Conservatees can be placed under the control of private parties, such as friends or families. The county’s conservatees generally have no such people able to care for them and are entrusted to the government.

In 1993, a private conservatee who was participating in a drug trial at Camarillo State Hospital died as a result of a self-administered aspirin dose. Although its conservatees were not involved in the research, Los Angeles County’s public guardian investigated the incident and, alarmed at procedural problems at the hospital, placed a ban on county conservatees participating in drug tests.

But the office of the public guardian has asked the human subject research committee to examine whether the ban should be lifted. “We felt that, because it’s been such a heated topic, we should look at it,” said Barbara Kubik, chief of conservatee services. “There’s nothing on the back burner or in the hopper” in terms of drug trials that spurred the request, she added.

Dr. Marcus Weise, the chairman of the county’s human subject research committee, said a blanket ban on research may be unethical. He cited the drug clozapine, which in tests before the ban greatly improved the conditions of some schizophrenic county conservatees.

“For the next clozapine, automatically public guardian conservatees would never be allowed to [benefit from] it,” Weise said. “They shouldn’t be automatically and positively excluded from it.”

But opponents are skeptical of that rationale, noting that such medicines are few and far between. Out of hundreds of psychotropic drugs tested, experts say, only a handful show promise.

“Beware of people who say ‘I’m only doing this for your own good,’ ” said Edward Opton, an attorney and psychologist who sits on the state’s Committee for the Protection of Human Subjects. “Any drug might benefit anyone. But when you’re looking for new psychotropic drugs you’re looking for a needle in a haystack.”

Many arguments against the county’s move center around one institution where research could begin, Metropolitan State Hospital in Norwalk, where more than 200 county conservatees are housed. The hospital has repeatedly been the subject of complaints by advocates and medical examiners of improper use of restraints on patients.

But Weise said Metropolitan and other state hospitals may not be able to meet the criteria of the proposed testing policy, which requires the level of care in the conservatee’s institution to be equal to that under the proposed tests. That, Weise said, is to ensure that a conservatee does not feel pressured to join a test merely to get better treatment.

But another oft-criticized institution remains inextricably joined to the proposal--the office of the public guardian.

The unit has been expanding its ranks this year, and officials said services are improving. Until recently, its overworked staff was able to see conservatees only twice a year, said Kubik, the chief of conservatee services. Now the agency seeks to visit its conservatees four times a year. Even with new hires, caseloads are still double the level Kubik said is ideal, and the tight labor market is making it tougher to find qualified workers.

Still, Kubik said that any conservatees who would be research subjects would be carefully watched. “We’d make darn sure we had sufficient personnel to monitor the people in these programs,” said Kubik, adding that she expects the number of conservatees affected would be small.

Advocates are skeptical. Opton, for example, cites complaints last year about a two-month backlog in the public guardian’s accounting of its conservatees’ finances. A county audit found the problems were caused by problems in communications from the public defender’s office.

“If they can’t even keep track of the money incoming,” Opton asked, “can they do a good job, or even an adequate job, of making these decisions for these patients?”

Pamila Lew, an attorney at Protection and Advocacy, said she is troubled by the fact that the public guardian is part of the mental health department and may not be able to look out for the conservatees. “There isn’t anybody advocating for the best interest of the patient,” she said, adding that overworked public defenders who are unfamiliar with medical procedures may not be able to adequately represent possible research subjects in court.

Weise, the head of the human subjects research committee, said his group grappled with these issues for months and heard testimony from experts on both sides of the issue.

“God has not spoken to us in the night,” he said, “but we have really struggled with this issue to come up with something besides no research.”