Ethics study focuses on mentally ill

0 Comments | Insight on the News, March 27, 1995 | by Leslie Alan Horvitz

Admissions of clandestine experimentation on unwitting human subjects by both the government and academia have raised a hue and cry for increased oversight.

When scientists and mental-health professionals gathered in Baltimore Jan. 7-9 to talk about the ethics of human research, they quickly turned the program into a free-for-all debate about the rights of the mentally ill. Much of the discussion focused on a controversial study conducted at the University of California at Los Angeles in the early nineties. In one part of the study, doctors deliberately withdrew medication from schizophrenics under their treatment to determine whether the subjects could function without psychotropic drugs. Such "relapse studies" are common: At least 2,500 schizophrenics have been involved in 41 such trials during the last 30 years.

Of the 50 subjects exploited in the UCLA study, 23 suffered induced relapses. Subsequently, the families of several of the subjects contacted the Office of Protection from Research Risk, or OPRR, a division of the National Institutes of Health, raising serious questions about the treatment of their relatives. The OPRR is charged with ensuring that all federally funded human-research studies meet strict guidelines set by the Department of Health and Human Services. According to reports received by the OPRR, some of the patients experienced severe relapses: One committed suicide, another broke his back attempting suicide and three others suffered potentially permanent psychological damage. (The suicide victim hadn't been an active participant in the research phase of the study for a year before he took his life; how ever, he was still being seen in a follow-up program on a regular basis.) The families further contended that their pleas to restore the medication were ignored by researchers.

"These experiments aren't scientifically necessary," says Adel Shamoo, head of the Center for Biological Ethics at the University of Maryland at Baltimore, who organized the Baltimore conference. "If somebody decompensates [suffers symptoms of a relapse], even if there's no evidence of brain damage, it'll take them longer to recover." Others criticized the UCLA study for failing to anticipate the reactions of patients once they were removed from medication. "We have to assume that since the subjects were all adults, they were capable of giving informed consent at the time they gave it," says John Miller, deputy director of the OPRR. When some subjects refused to go back on medication after participating in the study, there was nothing researchers could do, notwithstanding protests from the subjects' families.

Frederick J. Frese III, an Ohio psychologist, describes the dilemma starkly in an article for the Journal of the California Alliance for the Mentally Ill: "Too frequently I have seen a patient who was refusing medication while in a floridly psychotic state. After a long period of time, when we have been able to obtain legal authorization to medicate and the patient has improved, he or she will often ask why we allowed them to remain in psychosis without treatment for such a long period of time. Clearly, as professionals, we labor in a system of rules that prevent persons in need from receiving available benefits." Even so, Frese acknowledges that some patients experiencing psychosis may have perfectly legitimate reasons for remaining off medication, such as an aversion to its side effects, which include drooling and problems with muscular coordination.

While it found no demonstrable evidence of clinical mistreatment or unethical research, the OPRR criticized researchers for failing to adequately describe the risks of long-term withdrawal to the subjects who agreed to participate in the study. The OPRR also faulted researchers for not explaining alternative treatments. Nevertheless, the OPRR's ruling in the case -- UCLA was instructed to modify its consent forms and revise its record-keeping -- failed to satisfy many of the families who since have sought redress in the courts. Several mental-health experts were outraged by the affair as well.

While the most notorious experiments on human beings were conducted in the Nazi death camps, American researchers and physicians also have been found guilty of deliberately violating both the Hippocratic oath and Nuremberg code. Many of them, in fact, have shown a breathtaking callousness toward human subjects. As far back as the 1920s, doctors forced women considered mentally retarded to undergo sterilization. In 1977, Adm. Stansfield Turner, former director of the CIA, disclosed that the agency had conducted surreptitious brainwashing experiments on prisoners and patients who were mentally ill or suffering from cancer; he admitted that agents had slipped LSD and other psychotropic drugs to patrons at bars in New York City and San Francisco -- at a cost to taxpayers of $25 million.

In still more diabolical experiments, a doctor in Long Island, N.Y, injected his patients with live cancer cells, and surgeons at Veterans Administration hospitals performed brain surgery on prisoners and patients ostensibly for the purpose of altering violent behavior -- unauthorized procedures that sometimes succeeded in their objective, but also reduced the subjects to a "semivegetative state of mind," according to Samuel Chavkin, author of The Mind Stealers. The Department of Energy has revealed that its predecessor, the Atomic Energy Commission, conducted radiation experiments on approximately 9,000 Americans, including children and newborns, often without their consent. This number does not include soldiers and others who were forced to participate in potentially lethal radiation studies under the auspices of the Pentagon.