-
- 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
-
- BACKGROUND PAPER March 3, 1998
-
- 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.
-
- Bibliography
-
- 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: www.breggin.com
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