April 26, 1998

The New York Post

POLS TO SEEK TIGHTER KID DRUG-TEST REGS

By DOUGLAS MONTERO

Pg. 028

Two city congressmen are calling for tighter controls over controversial drug experiments on kids conducted at several New York institutions – and around the country.

The Post has learned that Cornell University Medical College is one of the research facilities that gave fenfluramine to children to study its effect on their behavior.

The drug – one half of the popular fen-phen diet pill – was yanked from the market last fall because it can lead to heart damage.

Cornell is one of four New York City facilities whose controversial research has come to light in a Post investigation.

But they are part of a nationwide practice in which hundreds of other children were given fenfluramine.

One federally funded study at Ohio State University involved giving 30 mentally retarded children up to three doses of fenfluramine, federal documents show.

Fenfluramine experiments were also conducted on more than 100 children at University of Southern Mississippi, Western Psychiatric Institute in Pittsburgh and at the National Institute of Mental Health.

The Cornell experiment used children with psychiatric disorders – such as autism – federal documents show.

Critics argue the experiments are unethical.

“If this experiment used autistic children – who cannot understand the risks involved – merely to explore the brain chemistry with no possible therapeutic benefit to them, it is unethical,” said Vera Hassner Sharav, director of Citizens for Responsible Care in Psychiatry and Research.

The Cornell study – which ended in 1994 – was federally funded and was in full compliance with federal regulations, said spokeswoman Kathleen Robinson. She was unable to provide additional details.

Reps. Charles Schumer (D-Brooklyn) and Jose Serrano (D-Bronx) say they will propose legislation to better regulate such experiments.

“There is definitely a need for legislation,” Schumer said. “The question is, how are we going to approach this most effectively to make sure this sort of thing never happens again.

Researchers and the Food and Drug Administration say the one to two doses of fenfluramine administered in the local experiments are harmless.

Serrano said he also wants to know if the parents were fully aware of the risks, even though they signed a consent form.

In addition to the Cornell experiments, tests were conducted on at least 100 children at the New York State Psychiatric Institute, at Queens College and at the Mt. Sinai School of Medicine.

The NYSPI tests – which were allowed to continue even after fen-phen was banned – included 64 children not diagnosed with any mental or emotional problems, documents show.

All three institutions say none of the children were hurt.

The Legal Aid Society is calling for an investigation into the release of juvenile records by Peter Reinharz, the city Law Department’s chief for Family Court.

Mayor Giuliani has blamed the blunder on the previous administration.

But Jane Spinak of Legal Aid said, “As long as Reinharz continues to hold high office in the administration, we certainly would like the mayor to take responsibility and investigate.”