Drug Trials

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.