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Comment of Fred A. Baughman Jr., MD on:

   January 19, 2001
   American Psychiatric Association Professional News
   AMA Calls for Studies of Psychotropic Use in Children
   The AMA acknowledges that more research must be done on the use of
   psychotropic medications in children. However, experts agree that doing so
   is no easy task.
   By Jim Rosack
   Joining APA, the American Academy of Child and Adolescent Psychiatry, and
   the American Academy of Pediatrics, the American Medical Association last
   month adopted a new policy calling on the pharmaceutical industry and
   federal regulators to study the effects of psychotropic drugs in children
   and acknowledged the need for training of additional qualified clinical
   investigators to do so.

[Fred A. Baughman Jr., MD:
What about the morality and ethics of
putting children with psychiatric disorders, but no actual diseases, on
these drugs, all of which are brain-damaging, many of which are
addictive and dangerous, in other ways as well]

   In a resolution passed by the AMA’s House of Delegates at its Interim
   Meeting in Orlando, the AMA also acknowledged that physicians in general
   need more training on the appropriate use of these medications in America’s

[Fred A. Baughman Jr., MD:
Where is the medical justification for putting
children with behavioral problems, who are physically normal, on
psychiatric medications? There is no such justification, only the
fraudulent claims from psychiatry and all physicians who would turn a
profit this way, that such ‘disorders’ are bona fide diseases.]

   Resolution 504, submitted by the AMA’s Medical Student Section, was amended
   and passed by the House of Delegates after considerable testimony.

[Fred A. Baughman Jr., MD:
What business does the Medical Student Section of the AMA have
being involved in such a matter as this. They cannot yet legally
prescribe, the reason being, they are not yet sufficiently trained to
understand all they need to know regarding diseases and their
treatment. This has all the earmarks of a politically-motivated
maneuver—using the medical students. How many were still freshmen? ]

   Leading the debate was David Fassler, M.D., the delegate of the American
   Academy of Child and Adolescent Psychiatry (AACAP) and vice chair of the
   Section Council on Psychiatry.
   "We, both APA and AACAP, welcome the involvement of the AMA on this issue,"
   Fassler told Psychiatric News. "Given the politically and ethically charged
   nature of using these medications in children, it provides a good forum for
   all of us to work collaboratively to push for research into the safe and
   effective use of all medications, including psychotropic medications, in

[Fred A. Baughman Jr., MD:
Fassler, representing the APA and AACAP at the Committee on
Education and the Workforce, hearing entitled "Behavioral Drugs in
Schools: Questions and Concerns," held September 29, 2000 was unable to
rebut my testimony that anyone calling any psychiatric disorder a
disease, does so fraudulantly.]

   The problem stems from the fact that, with few exceptions, the evidence for
   safety and efficacy of all classes of medications when used in children is
   based solely on anecdotal accounts. Formal clinical trials of even the most
   common drugs used in children, those to treat infections and asthma, have
   only recently been considered. And the same is true of psychotropic drugs,
   complicated by the fact that studying "potentially mind-altering" drugs in
   children has been sensationalized in the popular press over the last few

[Fred A. Baughman Jr., MD:
Fassler laments: "Complicated by the fact that studying
"potentially mind-altering" drugs in children has been sensationalized
in the popular press…!" As if giving such brain- and body-altering drugs to
entirely normal children is not of legitimate concern. ]

   The original Resolution 504 made note of the much publicized study that last
   year claimed to have found a 50 percent increase in the number of
   prescriptions of psychotropic medications in children aged 2 to 4. Fassler,
   however, challenged those data during Reference Committee testimony.
   "In reality," Fassler testified, "we don’t yet have accurate and
   comprehensive data on the increase in the use of psychotropic medications in
   children. We do have some selective data from research on specific
   populations, but we need to be very careful before we use such data to make
   assumptions about the country as a whole or as the basis for broad public
   Fassler, a child and adolescent psychiatrist who chairs APA’s Council on
   Children, Adolescents, and Their Families, also told the Reference Committee
   that his real concern was that due to the issue being sensationalized and
   misrepresented in the media, parents may be frightened and therefore not
   seek appropriate and effective treatment for their children.

[Fred A. Baughman Jr., MD:
When no actual disease exists in these children,
and when clinical trials have yet to demonstrate that the drugs in
question are ‘safe’ much less ‘effective’ , why is Dr. Fassler’s main
concern "that the issue is being sensationalized and misrepresented in
the media, and that parents may be frightened and therefore not
seek appropriate and effective treatment for their children."Having no
disease—no medical condition, there can be no ‘appropriate’, much less,
‘effective’ treatment for the children]

   One of the points of the original Resolution 504 called for the AMA to work
   toward guidelines "to establish. . . criteria for use of these medications
   in 2-4 year olds." Fassler called for the deletion of this part of the
   "Medication can be very helpful," (in 2-4 year olds) Fassler told
   the Reference Committee, "and even lifesaving for some children, but medication
   alone is rarely an appropriate treatment for complex child
   psychiatric disorders, which really require comprehensive multimodal

[Fred A. Baughman Jr., MD:
Calling such medication for 2-4 year-olds
‘livesaving’ when no actual disease is diagnosable and when there exists
no proof of safety or efficacy of any such drugs shows the depths to
which the psychiatric establishment will stoop to push their
drugs—their’s and their partner’s, the world-dominant pharmaceutical
industry. It is very clear now, given the about to get underway
Preschool ADHD Treatment Study that they are targeting infants, no
matter how young, no matter how damaging, no matter that they are normal
to begin with. The scary thing is that they and what they do and are
about to do is considered ‘legal.’ They put the Cali cartel to shame. ]

   Fassler expressed concern about asking the AMA to develop guidelines that
   focused only on medication, saying "I don’t really think it makes sense to
   consider the use of medication in isolation, particularly when we are
   dealing with young children."
   Ultimately, Fassler’s  testimony convinced the Reference Committee to delete
   the call for developing guidelines, which resulted in changing the focus of
   the resolution (and therefore the approved AMA policy) to encourage

[Fred A. Baughman Jr., MD:
With who as subjects? With what moral justification?],


[Fred A. Baughman Jr., MD:
That teaches the diagnosis of what, the treatment of
what? We know it will be with drugs]

  , and training

[Fred A. Baughman Jr., MD:
We know it will
be in prescribing drugs, even if all else that makes up the
‘multi-modal’ goes by the board]

   . The mission of Fassler and growing segments of organized medicine to
   increase recognition of psychiatric illness

[Fred A. Baughman Jr., MD:
There are no
diseases, no abnormalities of biology; of nature. This leaves nurture
alone—what we adults do for them by way of rearing, discipline,
education and preparation. Claiming that their problems are all nature;
biology gone wrong—abnormal as biological psychiatry is doing is
disorienting to the children, and cruel and brings down upon them drugs
that sell and benefit the industry while doing nothing but damage to the
patient. What psychiatry does and the AMA has become full partner in
today, is cruel, anti-therapeutic and morally reprehensible.]

   children and ultimately to
   improve the quality of treatment, may finally be getting some help, from
   none other than the U.S. government.

[Fred A. Baughman Jr., MD:
And yes, I left out the
other partner in the psychopharm scheme of things, the government at all
levels, awash on industry money they can no longer count—money made by
drugging the normal youth of America]

   After years of "looking the other way" as many powerful medications,
   including psychotropics, were widely prescribed, but unapproved for use in
   children, the U.S. Food and Drug Administration (FDA) has begun implementing
   new regulations born out of Section 505A of the Food and Drug Administration
   Modernization Act of 1997 (FDAMA).
   FDAMA required the FDA to develop a list of drugs "for which additional
   pediatric information may produce health benefits in the pediatric

[Fred A. Baughman Jr., MD:
And it may, with normal infants, toddlers and
preshoolers as subjects, kill and maim them. Such studies are without
medical or moral justification at the start and should be embargoed.
The PATS should immediately be embargoed. If any participating medical
institution begins drugging normal 2-4 year olds in the PATS, district
attorneys, jurisdiction-by-jurisdiction should initiate criminal charges
for giving controlled substances to normal children.]

   The initial list was published by the FDA in May 1998 and is updated annually.
   The "priority list" created by FDAMA acknowledged that the drugs on the list
   were either being widely used in children or could potentially be of benefit
   to the pediatric population, but no data existed to assess their efficacy or
   safety in children. The FDA took the stance that it was finally time to
   produce the data needed to prove that the drugs were, indeed, safe and
   The original priority list included nearly 450 entries, from nearly all
   classes of medications, including 25 psychotropic medications. The FDA
   issued written requests for pediatric studies on 12 of the 25 drugs, and the
   FDA has received the data on three of the original 25 psychotropics.
   The government, realizing that for the pharmaceutical industry to spend the
   time, money, and effort to conduct clinical trials in pediatric populations,
   an incentive would have to be awarded for completing and submitting safety
   and efficacy data. The concept of "pediatric exclusivity" was the FDA’s

[Fred A. Baughman Jr., MD:
The FDA serves no public protective function today.
They aid and abet the psychiatric victimizing of the US public and it’s
children. The public would be better off without them. Fewer normal
children would be on psychiatric drugs today and in the future.]

   Pediatric exclusivity provides an additional six months of patent protection
   to the product, effectively delaying the debut of generic competition, not
   only to the specific form tested, but to all forms of the medication
   currently approved.
   For the pharmaceutical companies, that spells dollars in some cases,
   potentially hundreds of millions of dollars on a single product. To the FDA
   and the clinical community, it provides at least minimal data establishing
   the safety, efficacy, and dosing of the medication in children. Pediatric
   exclusivity does not necessarily mean, however, that a drug is "approved"
   for use in children; it simply acknowledges a drug company’s efforts in
   submitting the required data. Of the three psychotropics having received
   exclusivity so far, only fluvoxamine has been approved for pediatric
   Problems of Studying Children
   Researchers, clinicians, and regulators agree that conducting clinical
   trials of medications in pediatric populations is no easy task. First of
   all, pharmaceutical companies must find clinical investigators with the
   expertise to conduct pediatric studies. Physicians must convince parents to
   expose their children to unknown risk and subject them to monitoring and
   testing they would normally not need. The potential pool of recruits for
   pediatric studies is also inherently smaller than those on adults, simply
   because the population of children with the disease or disorder being
   studied is small.

[Fred A. Baughman Jr., MD:
Here, in speaking of psychiatry and
psychotropic drugs they use the term ‘disease’ when there are no
‘diseases’, not one. They recruit by paying bribes or allowances so big
as to constitute bribes and virtually all of the informed consent
documents say or imply that the subject has a ‘disease’ or a ‘chemical
imbalance’, a fatal bias, when it comes to doing a valid study—a bias in
favor of the biological or medical treatment among those offered]

   In addition, children may not cooperate freely or completely with the
   strictness of accepted research methods. And rating symptoms of illness,
   especially psychiatric illness in children, is even more subjective than it
   is in adults. Researchers must also worry about redesigning methods of
   evaluation and monitoring. In the words of one researcher who presented
   testimony on the subject to the FDA, "you simply can’t draw a bucket of
   blood from babies."
   And then there are the ethical questions. For years, researchers have
   worried that studying children was unethical. Robert Ward, M.D., a professor
   of pediatrics at the University of Utah and an expert in ethics of pediatric
   studies, said he thinks the ethics concerns are largely coming to a close.
   "Without controlled clinical trials, we are treating children with less than
   optimal information about effectiveness, dosing, and safety," Ward said.
   "You have to ask the question "Which is more unethical? To do that, or to
   treat a child in a controlled clinical trial?"
   But many still have great concerns. Placebo comparison is still the FDA’s
   gold standard in clinical trials; however, it is extremely difficult, said
   Ward, to get parents to sign informed consent when they really understand
   that their child has the potential to receive no active treatment at all.
   To address these and other critical issues, the FDA released last month its
   "Guidance for Industry E11: Clinical Investigation of Medicinal Products in
   the Pediatric Population."
   While stating that "the pediatric population represents a vulnerable
   subgroup," the guidance offers only general suggestions for review-board
   participation and guidelines for recruitment, consent, and minimization of
   risk. The guidance does note that "in order to minimize risk in pediatric
   clinical studies, those conducting the study should be properly trained and
   experienced in studying the pediatric population, including the evaluation
   and management of potential pediatric adverse drug events."
   New Data on Horizon
   But new data are being developed and analyzed, thanks to the FDAMA
   incentives and a new federal regulation that went into effect last December.
   The new rule gives the FDA the power to require pediatric studies for drugs
   that might directly benefit children. In fact, at the FDA’s discretion,
   approval of the use of a drug in an adult may be withheld, pending at least
   initiation of pediatric trials.
   "The interest in developing the type of trials that need to be completed in
   children has been somewhat overwhelming," said Dianne Murphy, associate
   director for pediatrics at the FDA. "The important thing is, you can't
   simply decide to do any study the FDA determines if there is a public health
   So far about 200 studies have been proposed by pharmaceutical companies,
   including drugs for allergies, asthma, and, yes, depression. The proposed
   research, Murphy said, could involve as many as 20,000 children. By
   contrast, only 11 studies were completed in pediatric populations from 1991
   through 1997, Murphy said.
   The AMA resolution, while not likely to influence the FDA’s stance on the
   issue, may play a role in the public’s mind.
   "With this new policy, the AMA is focusing on the need for sound scientific
   evidence to support treatment of children with medications," AACAP’s Fassler
   told Psychiatric News.
   The AMA resolution is posted on the Web at 

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