Chapter  7: Human Experimentation

Case:  fenfluramine

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 drug fenfluramine.

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 pulled.

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 the NIH.

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 Lowenkron.

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.

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Protest letter:


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Copyright Philip A. Pecorino 2002. All Rights reserved.

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