AMA, ALL OF ORGANIZED MEDICINE FAVOR PSYCH DRUGS FOR CHILDREN
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 AMAs 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 Americas children.
[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 AMAs 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
maneuverusing 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 children."
[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 years.
[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 dont 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 policy." Fassler, a child and adolescent psychiatrist who chairs APAs 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. Fasslers 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
diseaseno 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 resolution. "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 intervention."
[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
drugstheirs and their partners, 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 dont really think it makes sense to consider the use of medication in isolation, particularly when we are dealing with young children." Ultimately, Fasslers 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 research
[Fred A. Baughman Jr., MD:
With who as subjects? With what moral justification?],
education
[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
alonewhat we adults do for them by way of rearing, discipline,
education and preparation. Claiming that their problems are all nature;
biology gone wrongabnormal 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 countmoney 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 population."
[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 effective. 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 FDAs answer.
[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 its
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 companys efforts in submitting the required data. Of the three psychotropics having received exclusivity so far, only fluvoxamine has been approved for pediatric labeling. 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 studya 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 cant 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 FDAs 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 FDAâs 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 benefit." 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 FDAs stance on the issue, may play a role in the publics mind. "With this new policy, the AMA is focusing on the need for sound scientific evidence to support treatment of children with medications," AACAPs Fassler told Psychiatric News. The AMA resolution is posted on the Web at