FENFLURAMINE STUDY HURT BOY: Single Dose of Controversial Drug Altered Personality, She Says By MICHAEL O. ALLEN

Sunday, April 26, 1998

The Brooklyn woman said she got a letter telling her to bring her 8-year-old son to the state psychiatric institute for a survey on children whose older brothers had been convicted in Family Court of crimes as juveniles.

“They wanted to do a study on my son to find out if he had any behavioral problems,” said the woman, who spoke to the Daily News on condition that no one in her family be identified.

Last week, she was in tears after reading in The News that the study was steeped in controversy, with critics blasting the use of fenfluramine on children and questioning the use of only black and Latino boys. The Food and Drug Administration last year banned fenfluramine, the offending half of the prescription diet drug fen-phen. The researchers, meanwhile, issued statements denying wrongdoing, but refused to discuss their studies.

In all, the parents of 34 boys ages 6 to 10 made the trip to the New York State Psychiatric Institute in Washington Heights in 1994 and 1995. The boys fasted for 12 hours, were given psychiatric and psychological tests, then a single oral 10 mg. dose of fenfluramine. Then, while hooked to a catheter, they had blood drawn each hour for about five hours.

The Brooklyn woman said she and her son were given $ 230, plus a $ 100 Toys “R” Us gift certificate for their participation, then were sent home.

But that is no solace to the Brooklyn woman.

Her son was happy-go-lucky, did well in school and never had a behavioral problem. But she figured she had to cooperate with the letter because an older son was incarcerated on a robbery conviction.

Her son ceased being his happy-go-lucky self soon after the experiment, she said. The boy, now 11, suffers anxiety attacks, has severe headaches, has developed a learning disability and is about to be put in special-education classes.

Claudia Bial, a spokeswoman for the psychiatric institute, expressed surprise at the symptoms the boy’s mother described.

“A single dose of fenfluramine poses no risk,” Bial said. “I’m sorry that the child suffered these things, but I don’t think it has anything to do with that one dose.”

But critics of the studies disagree with Bial. Vera Hassner Sharav, the head of Citizens for Responsible Care in Psychiatry and Research, cited a study published in 1996 in the journal Society of Biological Psychiatry that said a single dose of fenfluramine had been shown to cause headaches, lightheadedness and difficulty concentrating in 90% of adults who took just one dose of the drug.

“Since there is no study to show the drug is safe for children, but there is plenty of evidence to show that it is unsafe for adults and it is unsafe for animals I mean it causes brain damage in animals you would think that little children would never be exposed to it,” she said.

Mount Sinai School of Medicine and the Queens College Psychology Department conducted a study about the same time, experimenting on a group of boys diagnosed with attention deficit hyperactive disorder. That study and the one that tested the Brooklyn woman’s son were trying to determine: Were these boys predisposed to violence or crime?

Some criminologists and psychiatrists increasingly use fenfluramine in studies to stimulate and measure serotonin in the brain. The more serotonin a person has, the less likely he or she is to engage in anti-social behavior, they hypothesize.

Evan Balaban, senior fellow in experimental neurobiology at the Neurosciences Institute in La Jolla, Calif., is a leading critic of the fenfluramine behavioral genetic studies. The studies have become more prevalent in the past 10 years.

“What people were trying to say beforehand which I believe I’ve shown is not true is that they [those prone to violence] are not releasing enough serotonin and that for some reasons, which are not specified very well, this predisposes you to violent behavior,” he said.

Irving Gottesman, a professor of psychology and genetics at the University of Virginia in Charlottesville, defended fenfluramine studies, saying they help researchers understand individual differences in human aggression, He said the studies could lead to interventions that are ethical and based on science.