Drug Trials

L.A. County‘s Department of Mental Health is considering a proposal to allow testing of experimental psychotropic drugs on more than 2,000 gravely disabled patients under its care. The plan has alarmed patient advocates and others in the mental-health field concerned about possible conflicts of interest and potential ethical and human-rights violations.

If the proposal is approved, it will end a five-year moratorium on such testing, imposed in the wake of complaints from mental-heath advocates and the suicide of a patient who had been participating in a clinical trial at Camarillo State Hospital.

”The whole idea is ludicrous and hypocritical,“ says Sally Zinman, executive director of the Sacramento-based California Network of Mental Health Clients. ”If they’re capable of participating in an experiment, then why are they under the county‘s care?“

The new plan involves the close cooperation of two agencies that have recently come under strong criticism for substandard performance: Metropolitan State Hospital in Norwalk, where the testing would likely be conducted, and the county’s Public Guardian, the office responsible for the patients who would be used in the drug trials.

The proposal highlights an ongoing debate within the mental-health community, a debate that pits those who fear that drug trials violate the rights of the mentally ill against researchers who say that without the trials, new treatments will not be found to help those most in need.

”Ultimately, this debate must consider whether the potential benefits from this research are commensurate with the dangers it entails,“ says Roderick Shaner, medical director for the Mental Health Department. ”If we can find some way to protect people while having this research, it may be something we should do.“

Known as conservatees, patients under legal guardianship are the most disabled and least functional of the mentally ill. Most of L.A. County‘s conservatees are adults living below the poverty line and suffering from severe schizophrenia. Symptoms include delusions, paranoia, hallucinations and disordered perceptions. As conservatees they may lose their right to vote and to drive, and can be forced -- by the courts, at the bidding of the Public Guardian -- to take medication against their will.

Opponents of the proposal argue that county conservatees are the most vulnerable of the mentally ill, in part because they do not have family or friends to look after them, and instead are at the mercy of an impersonal bureaucracy. Such patients, critics contend, cannot be expected to offer informed consent on taking experimental psychoactive drugs.

The problem is exacerbated in L.A. County, they argue, because the Office of the Public Guardian is not an auton-omous agency; instead, it operates under the auspices of the Mental Health Department. ”The job of the Public Guardian is to look out for the interests of the conservatee, and the job of the Mental Health Department tilts more toward advancing science,“ says Edward Opton, a clinical psychologist who serves on the state’s Committee for the Protection of Human Subjects, which must approve all drug testing to be conducted at Metropolitan. ”What‘s good for science may not be good for the guinea pig.“

Shaner counters that each of the county’s clients would have the right to decide whether to participate in the trials, but patient advocates argue that state law prohibits drug testing on prisoners and children, and that the severely mentally ill need at least as much protection. ”The problem is, once something like this gets approved, how do you make sure the standards are being followed,“ says Pamila Lew, an attorney for Protection and Advocacy, Inc., a statewide nonprofit charged with safeguarding the rights of the mentally ill. ”There is ample room for abuse.“

Recent reviews of both Metropolitan and of the Office of the Public Guardian have raised just such concerns.

In August 1998, the County Board of Supervisors directed the Department of Mental Health to address a number of complaints about the handling of its conservatees. The board action was prompted in large part by Harold Shabo, who has been the Mental Health Department‘s supervising judge in L.A. Superior Court for nine years.

The decision on whether a person will become a county conservatee is made during a public hearing in Shabo’s courthouse. He found that the Public Guardian conducted only ”superficial“ investigations to decide whether mentally ill clients should become conservatees, and was routinely late in transferring case information to the public defender, causing multiple postponements during which the clients were shuffled off to wait in mental hospitals -- for weeks or months.

Shabo was further dismayed by the lack of contact between the Public Guardian and its conservatees, with meetings occurring, on average, just twice a year. In the past year, the Mental Health Department has hired six new staff members and made other improvements. But in an interview this week, Shabo said the changes ”are not adequate to meet the burden that the Public Guardian is required by law to carry out.“

At Metropolitan, a highly critical survey conducted in 1998 by the L.A. County Department of Health Services alleged many incidents of physical and psychological abuse by staff. ”The facility,“ according to the report, ”failed to demonstrate that patients have the right to be free from abuse.“ The hospital‘s executive director, William Silva, responded with a plan of correction, and the hospital was re-certified.

Under the proposal now being considered by the county, the estimated 310 conservatees housed at Metropolitan would be the most likely candidates for testing clinical drugs because of the severity of their illnesses and because they live in a controlled environment where researchers can monitor their direct response to medication. The county’s 1995 moratorium brought such testing to a halt, says Steven Potkin, senior research scientist at Metropolitan.

The county, Potkin says, has a responsibility to make testing available to its clients. ”I told the county that I thought their taking four or five years to reevaluate their policy was unconscionable,“ says Potkin, who is also director of psychiatric research at UCI Medical Center. Before the moratorium, Potkin oversaw an important drug trial at Metropolitan that included many county conservatees. The drug clozapine, which was tested in the trial, was found to be highly effective in treating many schizophrenics who had not responded to other medication. ”I‘ve seen so many people transformed by clozapine,“ Potkin says. ”It’s a tragedy to deny people a chance to get better when they‘ve been ill for so long.“

Drug companies have their own reasons to seek avenues for testing new products. U.S. sales of anti-psychotic drugs, which are the biggest moneymakers in the pharmaceutical industry, grew from an estimated $1 billion in 1995 to a projected $4 billion this year. Researchers and hospitals stand to benefit from this windfall, Opton says, in the form of generous grants, free trips and ample payments of overhead costs. ”The financial stakes are high,“ Opton says.

The Department of Mental Health’s seven-member Human Subject Research Committee has been reviewing the drug-testing proposal for the past several months. For committee member Ron Schraiber, director of the department‘s consumer-affairs office, the issue is personal and complex. Schraiber has been diagnosed at various times with paranoid schizophrenia and manic depression, and has been involuntarily committed 20 times at Camarillo and Metropolitan. He once narrowly avoided being made a county conservatee himself.

”The basic dilemma is that people with mental illness should be given as much right to choice as possible,“ he says. ”At the same time, you’re looking at a group of people who are very vulnerable. They are a captive audience in a dependent living situation where they are under tremendous implicit pressure to go along with what the doctor wants. They want to be pleasing, especially if they feel it might help them get out.“

The research committee expects to make a recommendation soon to the Mental Health Department‘s executive committee, which will then conduct its own review, says executive committee member Shaner. Two attorneys in the County Counsel’s Office have already given the proposal verbal approval. There is no automatic hearing before the Board of Supervisors, Shaner says, but a board member could request one at any time.

Both San Diego and Orange counties prohibit experimental drug testing on county conservatees, and San Diego has gone one step further, barring pharmaceutical companies from posting drug-trial ads at any of its mental-health clinics. ”The ‘90s have been the decade of the brain,“ says Piedad Garcia, San Diego County’s clinical director for mental-health services. ”There has been this push to do more research, which is great, but we have an obligation to protect the patient as well.“

Research assistance provided by Christine Pelisek and Cathy Pascual.


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