NEW YORK (CNN) -- Two public advocacy groups say that more than 100
New York City children were unethically used in a medical study of the
The two groups, Disability Advocates Inc., in Albany and New York
Lawyers for the Public Interest, filed a complaint with the National
Institutes of Health claiming that three New York institutions gave the
children each a single dose of fenfluramine when there was no possible
therapeutic benefit to be gained.
Fenfluramine, a controversial drug used in the diet pill combination
known as fen-phen, was voluntarily pulled from the market by its
manufacturer in September 1997 after the U.S. Food and Drug Administration
reported that it caused heart valve damage.
The clinical studies in New York were conducted before the drug was
The Research Foundation of the City University of New York, Mount Sinai
Medical Center and the New York State Psychiatric Institute are under
"evaluation" by the Office for Protection from Research Risks, an arm of
There are federal guidelines for conducting experiments on children
that institutions must adhere to, said spokesman Gary Ellis. "And if we
have any indication that there may be a violation, we have the authority
to look into the matter."
'Healthy kids put at risk'
The most alarming of the studies, said Ruth Lowenkron of New York
Lawyers for the Public Interest, involved siblings of children considered
to be juvenile offenders.
"These were healthy kids put at risk just to prove a hypothesis," said
But the New York State Psychiatric Institute, which conducted that
study, defends it, saying such research needs to be done for the benefit
of future treatment.
A second study tested the same drug on children who have attention
deficit disorder and could theoretically benefit from the drug.
Concerns about experiments involving children are not new, especially
in New York state where previous complaints have forced the state's
Department of Health to look into adopting new regulations and guidelines.