> ### Experimentation on Conservatees in LA County

> In November, 1993, Abby McIntyre, a mentally ill patient, died in a drug trial conducted on Unit 45 at Camarillo State Hospital and Developmental Center. Though Abby McIntyre, a conservatee, ( the most severely ill), was suffering a severe deterioration of her health, no doctor or nurse saw her for the last 18 days of Abby's life. Her mother had believed Abby was receiving proper care.

> After Abby's death, a state and federal investigation ensued. A number of serious deficiencies (misdemeanors) were issued by the California Department of Health Facilities. The Federal Office for Protection from Research Risks shut down the research funding entity and its human subjects protection committee after findings of improper practices and failure to protect human subjects pursuant to federal regulations.

> In 1995, representatives from Protection & Advocacy and LA County Mental Health inspected Unit 45 at Camarillo. Shortly thereafter, LA County banned human experiments on conservatees of the LA County Public Guardian. The Public Guardian, however, did not determine what happened to other conservatees on Unit 45 at Camarillo or in other clinical trials.

> Now, four years later, under pressure from researchers, the Public Guardian has proposed allowing clinical trials to again take place on County conservatees at Metropolitan State Hospital in Los Angeles County, where approximately 300 "gravely ill" Public Guardian conservatees reside.

> However, two adjacent counties, (San Diego and Orange), out of concern for the safety of conservatees, and perhaps out of concern for legal liabilities, have banned clinical trials, protecting the dignity and civil rights of the Public Guardian conservatees of those counties.

> It is ironic that California law bans clinical trials on inmates in state prisons, while allowing trials on the mentally ill in state hospitals. However, the California Human Experimentation Act requires that experiments on conservatees should maintain or improve the health of conservatees. In its current proposal, the Public Guardian acknowledges that experiments on conservatees should provide a "promise" or "expectation" of benefit, yet the Public Guardian understandably fails to specify how such benefit will be ensured. Promising benefit is not possible in clinical trials. No one can know the outcome. Some conservatees will get worse.

> In its proposal, the Public Guardian inadequately addresses the possible "cognitive impairment" of the conservatee's decision-making capacity. The Public Guardian also inadequately addresses possible "coercion," in obtaining the informed consent in the state hospital. The existing method for obtaining informed consent from conservatees has already proved to be deficient. No independent monitors are provided in the Public Guardian's plan to allow experiments on conservatees.

> Responding to the Public Guardian's proposal for experiments on conservatees, the Roman Catholic paper in Southern California, "The Tidings," interviewed Father John Coleman, Casassa professor in Social Values at Loyola Marymount University:

> "You can never sacrifice an individual for some abstract statistical common good," said Father Coleman of medical research objectives. "The person is never lost in the equation of the common good. Otherwise whatever you have will not really be the common good if it does not benefit the individual." Father Coleman suggested that the state serve an important role in protecting societies most vulnerable even if it means slowing down research or the release of new medical products.'

> It is known that the appearance of possible financial conflicts-of-interest arise in clinical trials. In addition to University faculty and County staff salaries, experimenters are paid through private corporations set up solely to conduct human experiments. The Public Guardian has made no provision for the full financial disclosure that is material to any proper decision-making for conservatees and those concerned about their future well being.

> Concerned clients of the mental health systems, family members and others believe that the civil rights of conservatees must be vigorously protected. Conservatees should not be risked in clinical trials. They deserve the best-approved treatments available. If necessary, in unique cases, newer medications should be obtained on a humanitarian basis and provided on an individualized basis.