Dr. David B. SteinTHE CAREGIVERS SKILLS PROGRAM BY DR. DAVID B. STEIN- A DYNAMIC DRUG-FREE DISCIPLINE PROGRAM
ABUSE IT-LOSE IT DISCIPLINE PROGRAM FOR CHILDREN BY DR. DAVID KEIRSEY
THE INSIGHT CENTER- DRUG FREE TREATMENT CENTER IN CALIFORNIA
IN MEMORY OF THE CHILDREN WHO HAVE DIED FROM PSYCHOTROPIC MEDICATIONS
IMPORTANT RESOURCES FOR CHILDREN AND FAMILIES
DR. DAVID B. STEIN- ALTERNATIVES TO RITALIN AND DEALING WITH DIFFICULT TEENS
ADHD REPORT
DR. BRUCE LEVINE
DR. THOMAS SZASZ
EXAMINING STRATERRA
PSYCHIATRY IN THE SCHOOLS VIDEO
RECENT LECTURES/TRAININGS
The Under Reported Story: ADHD, Stimulants, and the FDA
by Grace E. Jackson, MD
February 18, 2006
Recently, the media minimized a crucial story which deserved to be front page news. Buried among the reports about Danish cartoons, Iraqi bombings, and domestic wiretaps was a recommendation from Food and Drug Administration safety advisors that stimulants, used in the treatment of 3 to 8 million children with ADHD, carry new warnings about the risks of heart disease, stroke, and death.
On February 9th 2006, members of the Drug Safety and Risk Manage- ment Advisory Committee stunned FDA officials with an 8 to 7 vote which called for the placement of Black Box Warnings on the labels of stimulants. For many industry watchdogs, the recommendation was long overdue.
It was only eight months ago that the FDA convened a similar hearing, partly in response to Health Canada's decision to remove Adderall XR from the market in early 2005.
Although foreign authorities later rescinded that decision, concerns about the cardiovascular risks of Adderall and other stimulants remained. Dramatic media announcements preceded last June's deliberations, but the FDA leadership assured the public that no new warnings were warranted.
In their latest interviews with the press, FDA panelists cited a figure of 25 deaths (1999-2003) among American stimulant users, but 51 deaths are listed in an agency staff report. According to California neurologist, Dr. Fred Baughman, his Freedom of Information Act request revealed 186 deaths in the MedWatch database between 1990 and 2000. Given the fact that a mere 1% of all adverse events are believed to be filed with the FDA under the nation's voluntary reporting system, the true scope of stimulant lethality is much larger than the regulatory agency concedes.
Unfortunately for consumers, the cardiovascular risks of stimulants are hardly new. As early as 1977, Drs. Vernon Fischer and Hendrick Barner documented the cell changes associated with heart muscle enlargement in a chronic consumer of Ritalin (methylphenidate). Those findings were based upon a tissue biopsy obtained from the patient during bypass surgery. Intrigued by this discovery, Fischer teamed up Theodore Henderson in 1995 to publish the results of several animal experiments involving Ritalin. Their research confirmed a causal link between normal doses of the stimulant and the appearance of persistent heart cell abnormalities, identical to the changes observed in humans.
The connection between stimulants, cardiovascular disability, and death has long been documented in the medical literature, but physicians and government regulators have refused to acknowledge the hazards associated with prescriptions. In 2000, the FDA asked manufacturers to voluntarily remove the stimulant ingredient, phenylpropanolamine, from cold remedies and over-the-counter products used for weight control. In 2004, the FDA issued a rule to prohibit the sale of dietary supplements containing the stimulant, ephedra (ma huang). On January 13th 2006, the FDA issued a warning about the importation of Brazilian diet pills which contain a stimulant called Fenproporex. Each of these regulatory decisions stands in striking contrast to the agency's ambivalence about stronger warnings on the labels of ADHD drugs.
Many facts about stimulant medications, and the ADHD industry which sustains them, are commonly misreported or undisclosed. One example is the secret identity of atomoxetine (Strattera), a selective norepinephrine reuptake inhibitor approved by the FDA for children and adults in 2002. Widely marketed in the United States as the first "non-stimulant" for ADHD, the fact is that the World Health Organization designates the compound as a centrally acting sympathomimetic (psychostimulant), according to the international drug classification system. As neurologists at Stanford University have noticed, atomoxetine (and in Europe, the chemically similar reboxetine) possesses stimulant properties which make it an effective treatment for the sleep condition of narcolepsy.
While this classification dispute may seem trivial on the surface, it becomes salient in light of a recent report by North Carolina examiners who detected cardiac abnormalities in the autopsies of Strattera patients. If the FDA ever does decide to add Black Box Warnings about the vascular risks of stimulants, without acknowledging the true physiological effects of Strattera, one can expect Lilly's product to emerge as the clear winner of this year's safety lottery.
A word about regulatory authority is also in order. Contrary to the usual media reports, a Black Box Warning - which refers to the appearance of an explicit safety alert on the product label of a medication or medical device - is not the strongest precautionary measure in the Food and Drug Administration arsenal. The agency may require wording which outlines contraindications. These are statements about specific conditions or populations for which a medical product or device must not be used. Beyond the identification of contraindications, however, the FDA may issue advisories, enact rules, or implement enforcement decisions. Ultimately, the agency may initiate actions to remove a product from the market.
Reflective observers are wondering at this point why stimulants have not been removed from the market as a treatment for ADHD. Their concerns include the preliminary findings of Texan investigators, whose 2005 report in the journal Cancer Letters documented the emergence of chromosomal abnormalities in 12 out of 12 juveniles following three months of treatment with Ritalin. The unreported story is what happened after the behind-the-scenes scramble by officials from the FDA and other governmental bodies, who were dispatched to Houston last May in an effort to establish the validity of the methods and data of the Texan team. Subsequently authenticated, the implications of that research (namely, that Ritalin exposure in childhood may induce changes associated with higher risks of cancer) have been serious enough to trigger follow-up studies at other facilities.
FDA leaders continue to affirm that new warnings on stimulants are unnecessary. As Dr. Thomas Laughren and others have recently opined, ADHD is a serious medical condition for which the benefits of stimulant drug therapy outweigh the conceivable risks. Whether by ignorance or design, however, the regulators remain oblivious to the evidence-based limitations of the prescription pad: at least 40% of all children fail to tolerate or respond to stimulant therapy; about twice as many respond at least as well to non-pharmacological interventions; and, as documented in the National Institute of Mental Health's most prestigious study to date (the MTA study), the long term outcomes for medicated children demonstrate diminishing returns over time, persistent suppression of growth (about 1 cm per year), and artificial behavioral improvements which dissipate when treatment is withdrawn.
The FDA and others are disingenuous when they ignore the contentious nature of identifying ADHD as a neurological disorder for which medications are the best solution. A strong body of evidence now challenges both assertions. Clinicians question the ethic of drugging children and adults, in an effort to suppress symptoms which may be interpreted as transient, developmental delays (most children outgrow ADHD in their teens); normal variants of temperament; contextually appropriate reactions; and/or the failure of caregivers, social systems, or culture to assist others in maximizing their capacities for moral agency and self-control.
It is time for consumers, physicians, educators, and policy makers to confront the distorted and missing information which surrounds the phenomenon of ADHD. More members of the medical community should doubt the legitimacy of the condition, since no biological marker or diagnostic test has been found or devised. When interviewed, a majority of physicians state that they would prefer not to prescribe stimulants to children, due to the physical and psychological side effects. Not surprisingly, the world community observes the United States with alarm for the unjustified chemical exploitation of those who are different, but not diseased.
ADHD drugs linked to child psychosis
WASHINGTON— Reports of psychosis or mania in children were associated with all of the popular drugs used to treat attention deficit hyperactivity disorder, federal health officials say.
The assertion is in documents released as an advisory panel prepares to consider stronger warning labels. The scientific panel is to meet today. The reviews show that the adverse events, particularly hallucinations, can occur in some patients at normal doses of any ADHD drug. The reviews included about 90 studies of the drugs as well as reports from doctors, parents and others. The drugs include Ritalin, manufactured by Novartis Pharmaceuticals Corp. and in generic form by other companies; Adderall, made by Shire Pharmaceuticals Inc.; and Strattera, produced by Eli Lilly.
FDA officials say that patients and doctors should be aware that the small number of events could represent side effects of the drugs, although they cannot point to a definitive link. However, they noted a “complete absence” of similar reports in children treated with dummy pills in dozens of clinical trials of the drugs. In many children, the events ceased once they stopped taking the drugs and resumed if they restarted.
“The predominance in young children of hallucinations, both visual and tactile, involving insects, snakes and worms is striking, and deserves further evaluation,” FDA officials said in a March 3 memorandum included in the briefing documents.
The FDA’s pediatric advisory committee will examine whether the labels of the drugs should be revised to further warn not only of potential psychiatric problems but cardiovascular issues — such as heart attack, stroke and hypertension — as well.
McNeil Consumer & Specialty Pharmaceuticals said in the briefing documents that it is customary to weigh the “therapeutic benefits and potential risks” of treatment, and warned of the negative effects of leaving ADHD untreated. The unit of Johnson & Johnson makes Concerta, a long-acting form of methylphenidate, the drug in Ritalin.
Today’s FDA committee will be the second to take up the issue of whether stronger warning labels are merited. The FDA is not required to follow the recommendations of its advisory committees, but usually does. In February, the FDA’s Drug Safety and Risk Management advisory committee voted to recommend adding “black-box” warnings to stimulants used to treat ADHD. A black-box is the most serious type of warning label a prescription drug can carry. It would alert doctors, patients and parents of the uncertainty regarding the risk that most of the drugs may pose to the cardiovascular system. -------------------------------------------------------------------------------- — The Associated Press
