[Fwd: childhood experiments]

Graeme Bacque (gbacque@arcos.org)
Wed, 15 Apr 1998 17:20:01 -0400


---------forwarded message---------
 Experiments on Children Are Reviewed -- NY Times article

 April 15, 1998


         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 Yor k 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 thre e 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 Service s.

         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 biologica l 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 defi cit 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."

             Copyright 1998 The New York Times Company