Re: Science, vol 305, no. 5687, August 20, 2004, p 1088

News of the Week

Human Subjects Research

Pediatric Study of ADHD Drug Draws High-level Public Review.

To the Editor: September 8, 2004 (submission date)

The journal Science should be about science. Everything medical-biological about ADHD and all psychiatric “disorders” is pseudo-science. Your article supporting the administration of dextroamphetamine to normal children as well as ADHD children, who, are just as normal, reads:

· “A trial that would give healthy children an amphetamine is prompting heated debate…”

By “healthy” you must mean normal/disease-free.

· “Early next month, a newly formed FDA advisory panel will meet…to discuss the proposal’s safety and ethics…”

What safety? What ethics? All physicians go to medical school to learn the difference between normal and abnormal/diseased, and how, clinically, to distinguish the two. FDA physicians know that no psychiatric disorder, is an abnormality/disease in a medical-biological sense.

· “The NIH study is designed to answer a long-standing question: Does a type of medication prescribed for hyperactivity affect the brains of children with ADHD differently than it does the brains of children without the condition?”

“Children with ADHD” and “children without the condition” are both physically normal/ disease-free, and, therefore, physically indistinguishable. Both groups are to be given addictive, dangerous, dextroamphetamine. It is presumed, but, never been proven, that an abnormality/disease is present in the “children with ADHD.”

• “Her project (that of Judith Rapoport, NIMH) ‘could tell us a lot about what’s dysfunctional in ADHD,’ says F. Xavier Castellanos…”

Castellanos infers there is something dysfunctional/abnormal/diseased in the brains of individuals with ADHD, knowing full-well that no study, including the PET scan study of Zametkin et al (1990) or the structural MRI study of Castellanos et al (2002) has been replicated, meaning, that there is no evidence that ADHD is a disease having a confirmatory, objective abnormality for which to test, by which to distinguish, “children with ADHD” from “children without the condition.”

• “Rapoport and her colleagues aim to enroll 76 children, ages 9-18, including 24 sets of twins, only one of whom in each pair has the disorder. Subjects will receive a dose of dextroamphetamine and undergo functional magnetic resonance imaging scans.”

In that there is no physical abnormality for which to test, by which to distinguish, twins “with ADHD” from twins “without the condition,” there is no justification for the study to proceed. All biological studies which presume that ADHD is an abnormality/disease when this has never been proved, are destined to prove nothing, and, if carried out, are unethical and immoral.

• “On the one hand, he (D. Diekema bioethicist) says dextroamphetamine has been used for decades for ADHD and is generally considered safe.”

On the contrary, the DEA (1995) holds that all amphetamines have a “very high” potential for abuse and are listed in Schedule II of the Controlled Substances Act.

Moreover, between 1990 and the present, 16 structural-MRI studies have been done, showing brain atrophy in ADHD subjects, claiming this is the proof that ADHD is a brain disease.

However, only one of the 16 studies--that of Castellanos, et al, (2002)-- contained “a substantial number of previously unmedicated children and adolescents with ADHD,” and it was rendered invalid by the use of control subjects more than two years older than the ADHD subjects, and not comparable. In all of the remaining 15 studies, the majority of the ADHD subjects were “treated ” proving, not that ADHD is a disease, but that the amphetamines used to treat them were the cause of the brain atrophy. When it was divulged at the 1998, NIH, ADHD, Consensus Conference that all such studies, to that date, dealt with “treated” ADHD subjects, the Conference Panel was forced to conclude: “ ...we do not have an independent, valid test for ADHD, and there are no data to indicate that ADHD is due to a brain malfunction.” In 1998, with no proof that ADHD was an actual abnormality/disease, the epidemic stood at our million.

Whereas (1) ADHD is not a proven disease, and (2) the Schedule II, psycho-stimulants (amphetamines, Ritalin, etc.) used to “treat” it cause grossly-evident brain atrophy and are highly addictive--no biological-medical research such as this is justifiable. For the same reasons, that is, because the risk vs. benefit analysis is unacceptable, there should be an immediate embargo of these, and all psychoactive drugs for the treatment of children said to have ADHD, which, in fact, is not an abnormality/disease at all.

Bibliography:

F. Xavier Castellanos, MD ; Patti P. Lee, MD; Wendy Sharp, MSW; Neal O. Jeffries, PhD; Deanna K. Greenstein, PhD; Liv S. Clasen, PhD; Jonathan D. Blumenthal, MA; Regina S. James, MD; Christen L. Ebens, BA; James M. Walter, MA; Alex Zijdenbos, PhD; Alan C. Evans, PhD; Jay N. Giedd, MD; Judith L. Rapoport, MD Developmental Trajectories of Brain Volume Abnormalities in Children and Adolescents With Attention- Deficit/Hyperactivity Disorder.
JAMA. 2002;288:1740-1748.

Drug Enforcement Administration of the US Department of Justice. Methylphenidate (A Background Paper) October, 1995. Drug and Chemical Evaluation Section, Office of Diversion Control.

NIH Consensus Development Conference on ADHD (transcript), November 16-18, 1998, National Institutes of Health, Bethesda, MD.

Zametkin AJ, et al. Cerebral Glucose Metabolism in Adults with Hyperactivity of Childhood Onset. N Engl. J. Med. 1990;323:1361-6.