Less than one year after a federal investigation exonerated the New York State Psychiatric Institute of any ethical wrongdoing for experiments on black and Latino boys (using a drug now banned by the Federal Drug Administration (FDA), state legislators are pushing for safeguards in future experiments. A little over two years ago, the New York State Psychiatric Institute revealed that it had conducted a series of experiments—from 1992 to 1995—using the drug, fenfluramine, on children from the Bronx and upper Manhattan to test a hypothesis that links brain chemistry and aggressive behavior. The project was part of a larger study on inner city violence.
The subjects were 34 healthy boys between the ages of six and 10. All were identified by the institute through the Department of Probation as the younger brothers of juvenile delinquents. During the experiments, the children were given fenfluramine to measure fluctuations in serotonin. Some scientists believe that low levels of this neurotransmitter in the brain can result in aggressive behavior. The drug was banned by the FDA in 1997 for harmful side effects such as heart valve defects in adults and brain cell damage in animals.
Describing the experiments as “unethical” and “racist,” a coalition of activists, led by Disability Advocates (DA), a mental health group based in Albany, demanded an investigation by federal authorities; they also pressured politicians for a legislative remedy. In March 1999, Democrat Albert Vann introduced a bill in the state assembly to address these concerns, but later withdrew it to make revisions that he hopes will satisfy Republican legislators.
“This is an important issue for us, because there are many examples of this type of abuse,” says Vann, who will reintroduce the bill, signed by 46 Democratic lawmakers, within the next two months. The bill would require researchers to warn families about possible side effects of future experiments and to notify the New York State health commissioner about the justification for research based on ethnicity or sex.
Activists charge that parents were manipulated and kept in the dark about the side effects of the fenfluramine-related experiments. “We have met a couple of parents who said they were threatened,” says Carol Cage, a member of the Coalition Against the Violence Initiative, one of several organizations that opposed the institute’s experiments. “They are still afraid.”
Under pressure from mental health advocates, the federal Office of Protection From Research Risks (OPRR) began a year-and-a-half-long investigation into the matter; in June 1999, it exonerated the institute.
The institute has consistently denied that the experiments posed any major risk to the children, but independent psychiatrists challenge this position. “There are three kinds of dangers to the child,” says Dr. Peter Breggin, director of the International Center for Psychiatry and Psychology in Bethesda, Maryland, and author of a new book, Reclaiming Our Children. “First, exposure to the drug; second, exposure to the trauma of the experimental condition; and third, the stigma associated with having been experimented upon.”
Breggin and his colleagues have fought against inhumane experiments on people of color since 1972, when, he says, they discovered that black children—as young as five—were having “psychosurgery” performed on them at a Southern university to control “hyperactive and aggressive behavior.”
“Their brains were being implanted with electrodes that were heated up to melt areas of the brain that regulate emotion and intellect,” says Breggin.
Some legal experts also objected to the institute experiments. “This is not only unethical, but illegal as well,” says Dr. Leonard Glantz, professor of health law at Boston University. “They [the OPRR] didn’t ask why the Department of Probation was allowed to give the children’s names to strangers.”
Dr. Daniel Pine, the author of the institute study, declined to comment. Instead, a spokesperson responded to the question: Why did the institute choose only minority children as subjects of the experiment? “The OPRR gave us a clean bill of health,” said Claudia Bial. Though admitting that the institute is still doing studies on children, she said, “There are no more studies with fenfluramine.”
When asked how the children benefited from those experiments, she said, “They did get benefits,” but explained, “I’m not a scientist; I’m a public relations person.”
In a press release defending the experiments, John Oldham, the institute’s executive director, says, “With the disasters in Littleton and elsewhere, it has become abundantly clear that studies of aggressive behavior in children are imperative.
“Indeed, the Institute’s findings have already made a significant contribution by demonstrating that environmental experiences, including the way children are brought up, combine with brain chemistry to affect such behavior.”
The OPRR held that despite risks posed to the children, the research would provide valuable “generalizable knowledge about the subjects’ condition.”
“Not only is such an outcome dangerously close to eugenics, but the legislative language and history clearly indicate that the word ‘condition’ is intended to be interpreted in a medical context,” says Brooklyn Democratic congressman Edolphus Towns, in a letter signed by him and nine legislators and sent to U.S. secretary of health Donna Shalala in November.
“In cities like New York where the poor are disproportionately minorities, OPRR’s decision has a discriminatory impact on children of color,” adds lawyer Cliff Zucker, executive director of DA. “These children will be subject to experiments that may not be conducted on middle-class or Caucasian children.”
In response to legislators’ and activists’ concerns, Surgeon General David Satcher announced in March the formation of a National Advisory Council on Human Research Protections to “assist in setting standards and address human subjects’ protection.” Satcher claims the council will be composed of independent experts who were not involved in the OPRR investigations of fenfluramine experiments.
Activists like Zucker are cautiously optimistic about the federal government’s latest action. “We don’t know who is going to be appointed as a member of the advisory council, but we certainly feel very encouraged by the surgeon general’s response,” Zucker says. He adds, however, that “the whole system will prove to be an illusion if there are people on the council who serve the interests of drug companies.”
Meanwhile, it is still too early to tell if Vann’s bill has enough support to pass in the Republican-dominated state senate. “Last year, we tried to negotiate with the Republicans, and I’m hoping this time they will support us,” Vann says, but adds that “it also depends on the medical community, which opposes our move.” Sources monitoring the legislative process in Albany say that one Republican senator, Nancy Hoffman, is expected to support the legislation.
At this critical juncture, health advocates are not letting up pressure. “It is a disaster that the OPRR exonerated the Psychiatric Institute,” says Breggin. “It’s a blank check to do experiments on any inner city child; if you are poor and black, you are at risk,” he says. “Experiments like those should never be carried out again.”