MENTAL HEALTH: L.A. County Lifts Ban on Drug Testing
In a move that could enable 2,000 mentally ill residents to gain access to experimental treatments for schizophrenia, the Los Angeles County mental health department has "quietly lifted" a four-year ban on drug testing among its severely mentally ill "conservatees." In addition, county officials are designing a screening program for potential experimental drug trials, the Los Angeles Times reports. Following months of debate, the mental health committee, on Nov. 16, voted 4-3 to lift the ban. Under the new rules, researchers would have to clear numerous hurdles before receiving departmental approval. At that point, the researchers must to obtain permission from a judge to move forward with the proposed study. Included in the regulations are provisos that the tests must be beneficial to the patient and that experiments may not use conservatees as their only participants. Moreover, patients must give their consent to participate. Conceding that the proposal is controversial, county officials indicate that their policies will be "extremely restrictive, most likely allowing only small-scale research that would not be done against conservatees' will." Marvin Southard, director of the Department of Mental Health, said, "We want to support our conservatees and our clients' rights to participate in something we believe is in their best interest and at the same time we want to avoid anything that approaches exploitation." Although the mental health department contends that it has the authority to lift the ban on its own, the county's lawyers have been asked to determine if the Board of Supervisors must set the testing guidelines.
Bad Timing?
The Times notes that the county's move comes at a time of "heightened scrutiny over medical research and patient consent," following several cases involving mistreatment of patients at various facilities throughout the state. Some opponents contend that ethics are often sacrificed as pharmaceutical companies look for new medications to increase their profit margin and researchers succumb to the lure of money offered by the companies supporting their research. However, some argue that the blanket ban on drug tests is actually detrimental to conservatees who would benefit from new medications. Dr. Marcus Weise, chair of the county's human subject research committee siad that the ban may be unethical: "For the next [drug], automatically public guardian conservatees would never be allowed to (benefit from) it. They shouldn't be automatically and positively excluded from it." But patient adovactes are skeptical of that argument, noting that new, useful psychotropic drugs are "few and far between." In addition, advocates contend that the ban was necessary to protect people who could not give independent, informed consent. Alexander Capron, a USC professor and member of the national bioethics panel, said, "These are people who cannot choose their own (approved) psychotropic medicine from those that are available from the FDA. This seems to me to be a real exploitation of people's medical status." Moreover, critics charge that the institution in charge of implementing the regulations, the office of the public guardian, is so fraught with internal problems that any expansion of their responsibilities would further strain the overworked staff. But Barbara Kubik, chief of the office's conservatees services, assured that conservatees participating in clinical studies would be carefully supervised. "We'd make darn sure we had sufficient personnel to monitor the people in these programs," she said (Riccardi, 11/29).