The New York Times
HEADLINE: Experiments On Children Are Reviewed
By PHILIP J. HILTS
Federal research-ethics officials are investigating several psychiatric experiments in which 100 New York City boys, many of them black or Hispanic, were given the now-banned diet drug fenfluramine.
The three experiments took place at the New York State Psychiatric Institute, which is affiliated with Columbia University, at Queens College and the Mount Sinai School of Medicine over three years, ending in 1996. In the experiment at the New York Psychiatric Institute, 34 children, all of whom were 6- to 10-year-old black or Hispanic boys, were given intravenous doses of fenfluramine to test a theory that violent or criminal behavior may be predicted by levels of certain brain chemicals.
The investigation was prompted by criticism from patient advocacy groups over whether these children may have been used in experiments in which they had no hope of medical benefit, but may have been exposed to substantial risk. Federal regulations prohibit such experiments except under unusual conditions.
The critics have also asked the investigators to examine possible bias in the racial makeup of the experiments. “What value does the President’s apology for Tuskegee have when there are no safeguards to prevent such abuses now?” asked Vera Sharav, the director of the New York patient advocacy group called Citizens for Responsible Care in Psychiatry and Research, referring to the infamous experiment in which black men with syphilis were not treated but were instead observed.
“These racist and morally offensive studies put minority children at risk of harm in order to prove they are generally predisposed to be violent in the future,” she said.
The drug given to the children, fenfluramine, was a component of the diet drugs called Fen-Phen. The drugs were taken off the market after some adults who had taken them in combination for months were found to have heart-valve defects. In all three experiments, the children received only small, one-time doses of fenfluramine, so experts in the use of that drug say it is unlikely their hearts were damaged.
The boys who were given the drug were the younger brothers of delinquents. The researchers found them through court records and by interviewing mothers to find those who had what the scientists described as “adverse rearing practices.” The mothers were then asked to bring the children into the experiment. In return, they were given $125.
Articles on the experiments were published in scientific journals last fall. Later in 1997, Ms. Sharav reported the studies to the National Bioethics Advisory Commission, a panel that counsels the President. The commission is now reviewing the Federal Government’s rules on experiments with “vulnerable subjects,” such as children and mental patients.
Disability Advocates, Inc., a nonprofit group based in Albany that helps people with disabilities in human rights cases, referred the experiments to the Federal Office of Protection from Research Risks of the Department of Health and Human Services.
On Monday, Dr. Gary Ellis, chief of the Federal office, confirmed that a preliminary investigation has begun and estimated that it would take months to complete.
Researchers at Queens College and Mount Sinai did not offer extensive comment on the experiments, but said in a statement yesterday, “Mount Sinai denies that the research conducted at our institution was in any way illegal, unethical or otherwise improper.”
The chief author of the Psychiatric Institute study, Dr. Daniel Pine, declined to comment, but the director of the Psychiatric Institute, Dr. John Oldham, said in interviews two weeks ago that such studies are very important to study the biological basis of behavior.
“Is there or is there not a correlation between certain biological markers and conduct disorders or antisocial behavior?” Dr. Oldham said. “This study was an effort to look at this with a relatively simple method using fenfluramine.”
In the two experiments published jointly by researchers from Queens College and Mount Sinai, the subjects were 66 boys between ages 7 and 11 with attention-deficit hyperactivity disorder. The boys were taken off their medication for attention deficit and intravenously given fenfluramine to measure for a chemical they believe is linked to aggression.
A spokesman for Mount Sinai, Mel Granick, would not disclose what percentage of the boys in the Queens and Mount Sinai studies were black or Hispanic, saying only that the boys reflected the “ethnically diverse population of our catchment area.”
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