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News (Media Awareness Project) - US: Feds Probe Drug Experiments
Title:US: Feds Probe Drug Experiments
Published On:1998-04-15
Source:New York Times (NY)
Fetched On:2008-09-07 12:03:02
FEDS PROBE DRUG EXPERIMENTS

NEW YORK (AP) -- More than 100 children were the subjects of an experiment
involving a controversial diet drug that was pulled from the market last
year, the New York Post reported today.

Advocacy groups have filed complaints alleging two hospitals and a college
in New York City violated federal research regulations because the
experiments provided no medical benefits to the children.

Boys ages 6 to 11 were given fenfluramine, half of the now-banned drug
combination known as fen-phen, as part of a study of brain activity and
aggression. The studies were conducted by the New York State Psychiatric
Institute, the Psychology Department of Queens College and the Mount Sinai
School of Medicine.

Officials said the experiments were done before fen-phen was pulled from
the market.

The boys were each given a single dose of up to 10 milligrams of the drug
to see if it raised serotonin levels in the brain. Increased serotonin is
believed to reduce aggression.

Researchers told the Post that some of the boys were chosen because they
had older siblings who were juvenile delinquents.

The researchers said the boys' parents were informed of the risks and
maintained the dosages were not health-threatening.

The federal government has begun an investigation, said Dr. Susan Krandall
of the Office of Protection from Research Risk in Rockville, Md.

The federal Food and Drug Administration has estimated that one-third of
the adults who took the diet pills regularly could have suffered
significant heart valve damage as a result.

The manufacturer recalled fenfluramine and the related drug Redux last
summer at the FDA's request.
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