He wants the advisory committee to address two issues: (1) the validity of ADD/ADHD as diseases; and (2) effective alternative behavioral treatments that reduce reliance on drugs.
Dr Stein's behavioral/cognitive treatment methods have won awards from the American Psychological Association (One of top ten research projects at the 1998), the International Center for Psychiatry and Psychology (2005), and the Ritalin Litigation Conference (2001).
"It is my hope," he says, "that the committee will consider that within the decision tree, the physician's choice to use drugs can be lowered in favor of, at the very least, recommending properly designed behavioral parent training."
According to court certified expert and author of many books on ADHD, Dr Peter Breggin, all stimulants commonly cause "a continuum of stimulation, including agitation and irritability, anger, hostility, disinhibition, hypomania and mania."
The stimulant or activation syndrome, he advises, was originally observed decades ago with stimulant drugs such as amphetamines, Adderall, and Dexedrine, and methylphenidates such as Ritalin and Concerta.
It also occurs, he notes, with dexmethylphenidate such as Focalin, and selegilines like Sparlon and Provigil, as well as the atomoxetine, Strattera.
In a review of the summary data for the FDA Spontaneous Reporting System through March 1997, Dr Breggin counted the following: Psychosis, 43; hallucinations, 44; and psychotic depression, 11. His review also counted more than 50 reports in the combined category of overdose, overdose intentional, and suicide attempt.
"In regard to both amphetamines and methylphenidate," he explains, "there are a surprising number of animal and human studies showing persistent biochemical changes and atrophy after several weeks or more exposure."
"While the changes in children are sometimes mistakenly attributed to ADHD or OCD, they are a known effect of stimulants on the animal brain," he advises. "A known toxic drug effect is a far more likely culprit than a highly speculative "biochemical imbalance" in these children," he adds.
Dr Breggin will also testify at the advisory committee hearing on behalf of the International Center for Psychiatry and Psychology, and will recommend that labels for stimulant drugs include the following neuropsychiatric warnings:
(1) A warning concerning depressive/OCD ADRs that includes depression, apathy, lethargy, listlessness, tiredness, sadness, crying, withdrawal, and social isolation as well as worrying, ruminating, over-focusing, and other obsessive-compulsive behaviors.
(2) A warning concerning stimulation or activation ADRs that includes insomnia, anxiety, agitation, panic attacks, irritability, hostility, aggressiveness, violence, impulsivity, disinhibition, hypomania, and mania.
(3) Strengthened warning concerning psychosis, paranoid ideation and hallucinations.
(4) Strengthened warning about rebound, dependence and abuse, especially for methylphenidate products (all current methylphenidate labels especially inadequate).
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