April 22

FDA Boss to Answer to Congress for Drug Tests on Kids — NY Post

April 22, 1998

The New York Post



Pg. 012

The head of the Food and Drug Administration will be grilled by congressional probers today on why his agency allowed a psychiatric institute to experiment on city kids with a controversial drug.

The FDA is under fire because it allowed the New York State Psychiatric Institute to continue giving fenfluramine – which was pulled off the market because it causes heart damage – to depressed children.

“This is unethical behavior on the part of the FDA,” said Dr. Peter Breggin, an author and director for the advocacy group the Center for the Study of Psychiatry in Bethesda, Md.

“This is a drug with no known therapeutic value and no anticipated value on children – and therefore it should not be tested on children.”

The experiments outraged Rep. Dan Burton (R-Ind.), who plans to grill acting FDA Commissioner Michael A. Friedman during a hearing before his Committee on Government Reform and Oversight today in Washington.

“I am shocked and appalled that scientific experiments are being conducted on disadvantaged children in New York City,” said committee chairman Burton.

“We need to ensure that all Americans, especially children, are protected from abuse in the name of science.”

NYSPI admitted conducting fenfluramine experiments on depressed and suicidal children after the drug was pulled off the market in September 1997, but would not provide details.

NYSPI-conducted experiments on 34 children aged 6 and 11 – before September 1997 – led to a federal investigation because advocacy groups complained the study was non-therapeutic, which violates the law.

None of the children were injured, NYSPI has said.

Murry Lumpkin, deputy director of the FDA’s drug evaluation and research department, said all research institutes conducting fenfluramine experiments were sent notices when the drug was pulled off the market.

It urged the institutes to conduct echocardiograms on patients before and after the drug was administered – but allowed the tests to proceed.

“Just because a drug is pulled off the market … it still may have a legitimate use for research,” Lumpkin said.

“The benefit of the product will outweigh the risk.”

Lumpkin and Dr. Robert Temple, the director of the FDA’s office of drug evaluation, admitted they had “very little data” showing the impact – good or bad – one or two doses of fenfluramine will have on children.

“If there were those kinds of data or concern available, then the procedure experiments would’ve not been allowed to go on,” Temple said, referring to negative impact on children.

Vera Hassner Sharav, a co-founder of the advocacy group Citizens for Responsible Care in Psychiatric Research, said there’s no scientific study examining the long-term effects of fenfluramine on children.

She said studies have shown a single dose of fenfluramine caused an “undesirable and even severe side effects” on 90 percent of the adults given the drug.

“The FDA’s own files contain 70 reports of death, and 545 cases of severe heart-valve problems” among long-term users, she said.


GRAPHIC: “I am shocked and appalled that scientific experiments are being conducted on disadvantaged children in New York City.” REP. DAN BURTON

LOAD-DATE: April 22, 1998

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