DRUG RESEARCH ON KIDS ATTACKED AS RACIST, RISKY

Fenfluramine, the fen in the off the market 'fen-phen,' was being tested on
black and Hispanic boys in two studies.

New York-A government-funded study in which poor black and Hispanic boys
were given a now-recalled diet drug to test for violent tendencies is being
criticized as risky and racist. The federal government has launched an
investigation.

Scientists at an institute affiliated with Columbia University were testing
the brain chemistry of 34 boys using fenfluramine, which has since been
taken off the market because of suspected links to heart-valve damage in
adults. It is the fen in the diet-drug combination "fen-phen."

Critics say the experiments, conducted in 1994 and 1995, offered no medical
benefits and put the children at risk.

"These racist and morally offensive studies put minority children at risk
of harm in order to prove they are generally predisposed to be violent in
the future," said Vera Hassner Sharav, director of Citizens for Responsible
Care in Psychiatry and Research.

The researchers defended their efforts as a legitimate attempt to
understand the roots of violence.

The children were given a single fenfluramine pill and were kept in a
hospital bed for at least five hours with a catheter in their arm while
blood samples were taken. They were without food for at least 17 hours.

The boys all had older brothers who were juvenile delinquents, and the
scientists wanted to know whether levels of serotonin in the brain could
signal aggression. Fenfluramine induces the brain to release serotonin.

The boys' parents sighed consent forms for the research at the New York
State Psychiatric Institute.

Similar research, conducted by Queens College and Mount Sinai School of
Medicine, is also under fire. That project used fenfluramine on 66 boys of
various ethnicities who had been treated for attention-deficit disorder.

The institute, which reached no firm conclusions in a study published in
September, issued a statement Thursday saying its research tried to
identify factors that could trigger aggression "in a population at risk for
the development of antisocial behavior."

Fenfluramine and a chemically similar diet drug, Redux, were pulled from
the market because they were linked to potentially deadly heart valve
damage. Earlier this month, however, a large study found no sign that brief
use of Redux causes dangerous heart valve problems.

Queens College, which is part of the City University of New York, said its
study "posed no danger to children. ... No child was harmed in any way."
Mount Sinai said the research complied with federal regulations. Its
subjects were one-third black, one-third Hispanic and one-third white.

Two nonprofit legal groups filed complaints about both experiments with the
federal Office of Protection from Research Risks in Rockville, Md.

Members of the state's congressional delegation, the New York City Council
and activist minister Al Sharpton are among those demanding investigations.

The institute's experiment, which was partially federally funded, was
conducted on boys ages 6 to 10. They were chosen through Family Court
records, and came from mostly low-income, troubled families in Manhattan
and the Bronx.

"The question is, what were the parents told, and what did they understand
when they signed the consent form?" Sharav said. "These were just kids with
no history of misbehavior, whose brothers were in trouble."

The research on attention-deficit disorder was conducted at Mount Sinai's
medical school over three years, ending in 1996. Those children, ages 7 to
11, were given fenfluramine after treatment for the disorder.

Because all 100 boys received only small, one-time doses of fenfluramine,
"it's highly unlikely it would cause any problems," said Dr. Emil Coccaro,
a psychiatrist at the Medical College of Pennsylvania who pioneered the use
of fenfluramine for adult brain studies.