by Peter R. Breggin, M.D.
April 21, 1998

The FDA has put the interests of drug companies and the psychiatric research establishment ahead of those of America's children. It is time for the public and concerned professionals to take a stand against unethical pharmacological research on children.
We have learned that tomorrow's New York Post will carry a story of utmost importance for the future of America's children: The FDA has given permission to certain facilities to use the banned diet drug fenfluramine for experimental research on children. The object of the research is to identify biochemical markers and potential treatments for violence. This is an aspect of the notorious violence initiative which we opposed and wrote about in The War Against Children. The FDA's decision has been discovered amid mounting controversy over ongoing experiments on children in New York City involving fenfluramine.
The following comments are intended as an elaboration on a prior March 3, 1998 press release and background paper from the Center for the Study of Psychiatry and Psychology concerning fenfluramine studies conducted on children in New York City. Our criticisms have suddenly become even more important in light of the FDA's determination to condone and to legitimize further such research.
The Dangers of Fenfluramine
The children in the ongoing New York City studies were exposed to fenfluramine, a drug used for weight control that was banned by the FDA in 1997 for causing heart valve defects. However, the controversy concerning these adverse effects extended back years in time before the experiments on children. The drug was already known to be dangerous.
In addition to heart valve dangers, fenfluramine is neurotoxic, causing the death of brain cells in animals at therapeutic dose levels. Fenfluramine is a drug closely related to Ritalin (methylphenidate) and to Dexedrine and Adderall (amphetamines). Animal research shows that it overstimulates and then kills serotonergic brain cells. As early as 1989, controversy was generated surrounding fenfluramine's documented severe neurotoxicity (Barnes, DM. Neurotoxicity creates regulatory dilemma. Science 243:29-30, 1989).
Basic Ethical and Scientific Issues
These studies exemplify several dangerous trends in modern psychiatry, including Hi-Tech Child Abuse and Racism.
First, these NIMH-funded studies at Columbia and Queens College exemplify the growing trend to abuse and suppress children in the name of psychiatric research, technology, and treatment. In a nation where millions of children are being behaviorally controlled and subdued by means of psychiatric drugs such as Ritalin, Dexedrine and Adderall, it is inevitable that our most vulnerable groups of children will be subjected to especially abusive drug experiments.
Second, these NIMH-funded studies exemplify psychiatric and medical racism at its worst. These doctors have been willing to use poor black and Hispanic children to conduct medical experiments that they could not have conducted on more affluent white children. These doctors have taken advantage of these vulnerable children and their families in order to further their own research interests and careers.
Third, while no drug company money is known to be involved in these studies, the drug companies, including Novartis (the maker of Ritalin) and Eli Lilly (the maker of Prozac) have been trying to expand their market among children. This marketing decision to push more drugs on children is at the heart of the research community's growing focus on drugs for children. Fenfluramine studies that examine serotonin as a possible factor in violence are especially important to drug companies such as Eli Lilly who making drugs like Prozac which affect serotonin.
Fourth, these studies reflect the growing trend to mislead parents about the dangers of psychiatric drugs. In a nation in which millions of children are being drugged with stimulants and antidepressants without their parents being told about the serious hazards, it is no surprise that the parents of poor children and racial minorities would be misled, hoodwinked, and coerced into accepting even more dangerous drug research on their children.
The Columbia study is particularly offensive in regard to informed consent. The children were obtained through the Department of Probation. They are the younger brothers of boys already involved in the criminal justice system. Finding experimental subjects through the Department of Probation was in itself an invasion of privacy and a misuse of the criminal justice system. Asking the parents to subject their children to research on the face of it was very coercive. To refuse, they had to risk the enmity of legal authorities in control of their children.
Fifth, the study was of no potential benefit to the children. In fact, it was demonstrated by NIMH studies published in 1989 (see below) that fenfluramine, while having serious side effects, had no therapeutic benefit whatsoever. Thus the children were given a dangerous drug of no possible benefit to them. This is unethical under standard guidelines for medical experimentation on children.
Sixth, the research was highly speculative and unlikely to produce any positive result.
A Dangerous New Trend
This research represents a growing trend in the United States to perform outrageous research on children. The Center for the Study of Psychiatry and Psychology first became involved in these issues in 1972 when we discovered that black children as young as age five were having psychosurgery performed on them at the University of Mississippi in Jackson in order to control "hyperactive" and "aggressive" behavior. Their brains were being implanted with electrodes that were heated up to melt areas of the brain that regulate emotion and intellect. When we first opposed these experiments, and eventually stopped them, we did so despite resistance from organized psychiatry and the research community.
Twenty years later in 1992 we discovered the federal violence initiative--the federal government's agency-wide plan to go into America's inner cities to experiment on children in the hope of finding genetic and biological causes for violence. We opposed this program as racist and abusive of children. Our efforts led to the cancellation of this program. It also led the chief sponsor of the program, psychiatrist Frederick Goodwin, to resign from his post as director of NIMH and to leave a career in the government.
The fenfluramine studies at Columbia and Queens College are part of the violence initiative. They were created under its umbrella before it was cancelled. They confirm our fears that while the public aspects of the violence initiative were withdrawn, the actual individual projects continue unabated.
NIMH has a long history of supporting what we call Hi Tech Child Abuse. Between 1989 and 1994, NIMH was funding experiments with fenfluramine. In a comparison study with Ritalin, principal researcher Michael Aman was giving children doses up to 1.6 mg kg of fenfluramine per day. The children, age 5-13, were mentally retarded--another group notoriously vulnerable to medical experimentation.
Yet it was already known by 1989 that fenfluramine has no positive effect on the behavior of children, even by NIMH standards. This was confirmed in a study conducted during the early 1980s and published in 1989 by NIMH's Child Psychiatry Branch (Maureen Donnelly, Judith Rapoport, et al., "Fenfluramine and Dextroamphetamine Treatment of Childhood Hyperactivity," Archives of General Psychiatry, 46:205-212, 1989).
It is time for Americans to demand that psychiatric researchers stop using children as human guinea pigs.

International Center for the Study of Psychiatry and Psychology 4628 Chestnut Street, Bethesda, Maryland 20814 (301) 652-5580 (301) 652-5924 Fax Peter R. Breggin, M.D., International Director Ginger Ross Breggin, Executive Director
Details Revealed About Dangerous NYC Experiments on Children
A March 3 press release from the International Center for the Study of Psychiatry and Psychology (ICSPP) has publicized and criticized federally-funded studies in New York City which have subjected children to painful and potentially harmful experiments involving the administration of the recently banned diet drug, fenfluramine. This background paper provides additional details on these on-going experiments.
Details of the Columbia University Study
The Columbia University study children are the innocent younger brothers of juvenile offenders in the New York City Probation system. The NYC Department of Probation identified the families of the delinquent children at the request of Dr. Wasserman (Breggin and Breggin, 1994; Stone, 1992).
The Columbia University fenfluramine study involved "34 boys, who were all from impoverished families: 44% were African American and 56% were Hispanic" (Pine, 1997). The study diagnosed many of these children with Attention Deficit-Hyperactivity Disorder (ADHD) and Oppositional Defiant Disorder or Conduct Disorder; but many were not diagnosed with any disorder. Eight of the children were subjected to an earlier experiment involving 38 boys. In that prior research project, they were also subjected to psychological testing and psychiatric evaluation, and had their blood drawn.
Massive, Dangerous Doses of Fenfluramine
Each child in the Columbia University study was given a single oral dose of fenfluramine (10 mg/kg). The adverse effects of this massive dose on the children were not reported by the investigators. However, the negative effects can be estimated from a study conducted on adults by other investigators using a single dose of less than 1/10 the size (an average of 0.78 mg/kg) (Muldoon et al., 1996). This much smaller single dose produced side effects in 90% of the adults, including a flu-like syndrome with fatigue, headache, aching muscles, gastrointestinal disturbances, and "mental cloudiness." At this much lower dose than the children received, "more than half had symptoms the following day, and one-third found their symptoms to be so severe as to prevent or disrupt completion of normal activities, including returning to work and driving a car." Some of the adults experienced drug-induced anxiety reactions and one endured a "frank panic attack." The researchers suggested that fenfluramine research doses should be limited to 0.6 mg/kg. This is a tiny fraction (less than 1/16) of the 10.0 mg/kg given to the children in the Columbia University fenfluramine studies.
The research describing the serious adverse effects on adults from one dose of fenfluramine was published in 1996, one year before publication of the Columbia University and the Queens College fenfluramine studies on children. Yet the later publications on children do not mention fenfluramine's adverse effects. Furthermore, the Columbia University report states that future projects might repeat the administration of fenfluramine to these children "at multiple developmental stages" (Pine et al., 1997, p. 844). Now that fenfluramine has been withdrawn from the market, it is not known if the investigators will attempt to obtain a research exception for its future use or if they will continue the studies with other dangerous drugs and intrusive physical interventions.
Details of the Queens College Study
The studies by Halperin and his associates from Queens College and Mt. Sinai School of Medicine were very similar to the one conducted at Columbia University, except the doses given to the 50 boys were much smaller--1 mg/kg. While this is exactly 1/10 the size of the dose used in the Columbia University studies of children, it is almost double the dose of 0.6 mg/kg recommended for adults (Muldoon, 1996). Like the Columbia University study, the children were subjected to psychological testing and psychiatric evaluations, a lengthy fast, and 5 continuous hours of experimental testing and blood sampling through an indwelling intravenous catheter. Sixteen boys were subjected both of Halperin's fenfluramine challenge studies.
Further Hazards of the Experiments
In addition to the inevitable adverse drug effects from fenfluramine, the children in both the Columbia University and the Queens College studies were subjected to a twelve-hour fast starting the night before, followed by another five or more continuous hours with no food or fluid intake while they were implanted with the indwelling intravenous catheter for the withdrawal of blood samples. These conditions would be very stressful for most if not all children age 6-11 years old. In addition, the experiments must have made many of the children feel like "guinea pigs" or "freaks." These children and their families were also subjected to psychological testing and psychiatric evaluation--all without any therapeutic benefit to the children. Issues about the appropriateness of the experiments and about standards for informed consent are being raised by the Disability Law Advocates in Albany and the New York Lawyers for the Public Interest, Inc. (Zucker, 1997) which are not affiliated with ICSPP.
Breggin, P. and Breggin, G. (1994). The War Against Children (New York: St. Martin's Press) A revised and updated edition will be published as The War Against Children of Color (Monroe, Maine: Common Courage Press).
Breggin, P. (1998, March). Talking Back to Ritalin. (Monroe, Maine: Common Courage Press.)
Connolly, H.M., Crary, J.L., McGoon, M.D., Hensrud, D.D., Edward, B.S., Edwards, W.D., and Schaff, H.V. (1997). Valvular heart disease associated with fenfluramine-phentermine. New England Journal of Medicine, 337, 581-588.
Food and Drug Administration. (1997, summer). FDA public health advisory: Reports of valvular heart disease in patients receiving concomitant fenfluramine and phentermine. FDA Medical Bulletin, 27, p. 2.
Halperin, Jeffrey M.; Newcorn, Jeffrey H.; Kopstein, Ilene, McKay, Kathleen E.; Schwartz, Susan T.; Siever, Larry J.; and Sharma, Vanshdeep. (1997a, October). Serotonin, aggression, and parental psychopathology in children with attention-deficit hyperactivity disorder. Journal of the American Academy of Child and Adolescent Psychiatry, 36, 1391-1398.
Halperin, Jeffrey M.; Newcorn, Jeffrey H.; Schwartz, Susan T.; Sharma, Vanshdeep; Siever, Larry J., Koda, Vivian, H.; and Gabriel, Steven. (1997b). Age-related changes in the association between serotonergic function and aggression in boys with ADHD. Biological Psychiatry, 41, 682-689.
McCann, U. D., Seiden, L.S., Rubin, L.J., and Ricaurte, G.A. (1997). Brain serotonin neurotoxicity and primary pulmonary hypertension from fenfluramine and dexfenfluramine: A systematic review of evidence. Journal of the American Medical Association, 278, 666-672. [The changes caused by fenfluramine are described as "long-lasting neurotoxic effects with respect to both the functional and structural integrity of serotonergic neurons in the brain."]
Muldoon, M. F.; Manuck, S. B.; Jansma, C. L.; Moore, A. L.; Perel, J.; and Mann, J. J. (1996). D,L-fenfluramine challenge test: Experience in nonpatient sample. Biological Psychiatry, 39, 761-768.
Pine, Daniel S.; Wasserman, Gail A.; Coplan, Jeremy; Fried, Jane A.; Huang, Yung-Yu; Kassir, Suham; Greenhill, Laurence; Shaffer, David; and Parsons, Bruce. (1996, April). Platelet serotonin 2A (5-HT2A) receptor characteristics and parenting factors for boys at risk for delinquency: A preliminary report. American Journal of Psychiatry, 153, 538-544.
Pine, Daniel S.; Coplan, Jeremy D.; Wasserman, Gail A.; Miller, Laurie, S.; Fried, Janet E.; Davies, Mark; Cooper, Thomas B.; Greenhill, Laurence; Staffer, David, and Parsons, Bruce. (1997, September). Neuroendocrine response to fenfluramine challenge in boys. Archives of General Psychiatry, 54, 839-846
Stone, Robert (Branch Chief), Department of Probation, Interdepartmental Memorandum, to Manhattan Family Intake and Investigation Probation Officers. (1991, August 30). RE: Research Project. 1 page.
Zucker, Cliff (Disability Law Advocates, Albany, New York) and Lowenkron, Ruth (Disability Law Center, New York Lawyers for the Public Interest, Inc.). (1997, December 23). Letter to Clifford C. Scharke, Chief, Assurance Branch, Division of Human Subject Protections, Office of Protection from Research Risks, 6100 Executive Blvd., suite 3-B-01, Rockville, MD 20892-7507.

International Center for the Study of Psychiatry and Psychology 4628 Chestnut Street, Bethesda, Maryland 20814 (301) 652-5580 (301) 652-5924 Fax Peter R. Breggin, M.D., International Director Ginger Ross Breggin, Executive Director
Center and Advocates Expose Dangerous Drug Experiments on Children Age 6-11. Most of the Children Diagnosed "ADHD"
Parents throughout America are being told that the problems their children have adjusting at home and school are biologically based in conditions such as Attention Deficit-Hyperactivity Disorder (ADHD). This has led to the epidemic use of stimulant drugs such as Ritalin, as well as to newly disclosed, on-going abuses in medical experimentation on children.
Painful and dangerous federally funded experiments using the recently banned diet drug, fenfluramine, have been conducted on more than 80 children in an attempt to locate biological markers for aggression and delinquency. Two New York City research teams have carried out separate invasive fenfluramine experiments on healthy boys ages 6-11 years old, most of them labeled with Attention Deficit Hyperactivity Disorder (ADHD).
Peter R. Breggin, M.D., author of Talking Back to Ritalin, and Director of the International Center for the Study of Psychiatry and Psychology, declared: "These experiments are worthless and they constitute hi-tech child abuse! They are an extreme example of what happens when we look for biological solutions to the psychological, social, and educational problems that children are experiencing in America today."
One series of studies is being carried out at the College of Physicians and Surgeons of Columbia University and the New York State Psychiatric Institute (Pine et al., 1996 & 1997). Sixty children have been subjected to intrusive research in two sets of published studies. This research is financed by grants from NIMH and from the Lowenstein Foundation. The subjects in the more intrusive 1997 Columbia University study are thirty-four children, aged 6-10 years old, from economically disadvantaged inner city African-American and Hispanic families in Manhattan and the Bronx (Pine et al., 1997).
Another series of studies is being conducted by Jeffrey M. Halperin, Ph.D. and his colleagues at Queens College in New York and Mt. Sinai School of Medicine (Halperin et al., 1997a&b). The research is funded by the National Institute of Mental Health (NIMH) and the William T. Grant foundation. Fifty boys aged 7-11, all labeled ADHD, are involved according to Halperin's published reports. The race and socioeconomic status of the children and their families have not been revealed.
Both research projects appear to be continuing. The Columbia University and the Queens College studies involve the administration of fenfluramine as an experimental "challenge" to study the brain neurotransmitter, serotonin, in the boys. In addition to potentially toxic levels of fenfluramine, the children were also subjected to psychological and psychiatric testing, lengthy fasting, and five or more continuous hours of indwelling catheters in their veins.
Fenfluramine, best known as part of the diet drug combination (fen-phen), was withdrawn from the market in late 1997 because it very frequently causes potentially fatal heart value impairments (Connolly et al., 1997; Food and Drug Administration, 1997; reviewed in Breggin, 1998). It can also cause brain cell death (McCann et al., 1997; see Breggin, 1998). The doses of fenfluramine used in these experiments on children as young as age six almost certainly caused additional serious, painful and potentially disabling adverse effects. The Columbia study gave the children doses more than ten times larger than doses already known to cause serious and frequently disabling adverse effects in adults (Muldoon et al., 1996).
The children are the innocent younger brothers of juvenile offenders in the New York City Probation system. The NYC Department of Probation identified the families at the request of Dr. Wasserman (Breggin and Breggin, 1994; Stone, 1992).
Dr. Breggin says, "The research in each of the studies tested speculative theories about human behavior and offered no therapeutic benefit whatsoever to the children or their families."
The complete bibliography is included with the attached Background Paper, "Details Revealed About Dangerous NYC Experiments on Children."
For more information, contact: Peter R. Breggin, M.D 301 652-5580 Website:

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