Drug-Induced Mental Health Crisis

1. Drug-Induced Mental Health Crisis Vera Hassner SharavAllen Jones Alliance for Human Research Protection (AHRP)

2. ADHD: Hazardous Treatments • FDA finally confirms that approved ADHD drugs cause psychosis, aggression & violence in children. • As with antidepressants, pain killers, & sleeping pills, FDA approval is synonymous with dangerous—not “safe & effective.” • Violent behavior induced by these drugs is a danger to self and others—including school mates.

3. ADHD: Dubious Diagnosis • “the working dogma that ADHD is a disease or neurobehavioral condition does not hold up to evidence.” Lydia Furman, MD, J Child Neurology 2005 • “there is no diagnostically definitive test for ADHD” McNeil Concerta briefing document FDA 2006 • "There are no physical or laboratory findings; there is no psychological testing that can make the diagnosis for certain.“ Andrew Mosholder, MD, FDA Officer, 2006

4. Treatment Efficacy Unproven Meta-Analysis of ALL (2,287) ADHD studies worldwide found: • No evidence demonstrating clinical efficacy No evidence that drugs improve academic performance, risky behaviors, social achievements or other measures. • No evidence on long-term safety of drugs; Oregon Drug Effectiveness Review Project, 2005

5. Are drugs “helping” kids “graduate” from difficulty staying on task to psychopathology? • “The most important finding of this review is that signs and symptoms of psychosisormania, particularly hallucinations, can occur in some patients with no identifiable risk factors at usual doses of any of the drugs currently used to treat ADHD.” FDA AERS Review 2006

6. Drug-Induced Epidemic • FDA’s review does not include ALL drugs Rx for ADHD—the most toxic being the Atypical antipsychotics. • Therefore, this panel does not have adequate information to appreciate the full scope and magnitude of severe drug-induced harms suffered by children treated for ADHD.

7. ADHD Drugs: Gateway to Antipsychotics • 2.5 Million U.S. Children Rx Antipsychotics -- More than half were Rx for ADHD and other unapproved conditions. Vanderbilt University, Associated Press March 16, 2006 • Antipsychotics now carry Black Box Warnings Hazards include: acute weight gain (>100 lbs), insulin resistance in children, Type II diabetes, heart disease, cholesterol spike, & early death.

8. ADHD Drugs: Gateway to Bipolar • “antipsychotics are widely used…mostly for aggression…driven by the number of children being diagnosed with bipolar disorder.” Jon McClellan, MD, Psychiatrist, Psych Times, 2005 • Historically rare in children, now bipolar is “highly prevalent” only in the U.S. “We are seeing an increasing number of very young children,ages 3-7 years, with…frank symptoms of BP disorder.” ClinicalTrials.gov NCT00221403

9. “Bipolar Child”—a Public Health Crisis • “ Many of these young BPD patients have been treated with stimulants or antidepressants” ClinicalTrials.gov NCT00221403 The observed link between spiraling ADHD drug use—& epidemic of Bipolar among U.S. children is alarming. • No other country in the world allows the health of its children to be sacrificed to increase wealth of an industry.

10. Science or Science Fiction? • “One in 10 children aged 2 to 5 …had obvious signs and symptoms of psychiatric illnesses such as ADHD, anxiety or depression…It suggests, such conditions begin very early in life, perhaps even in the womb.” Dr. Adrian Angold, Duke University Medical Center Dr. Angold “believes that screening for and treating these disorders in babies and infants is the way forward.” BBC, Nov 28, 2005

11. “Brandon & the Bipolar Bear”

12. Aliah Gleason, 13, “disruptive behavior” "oppositional disorder” Rx Drug Cocktail 12 drugs 4- SSRI Antidepressants Zoloft, Celexa, Lexapro, Desyrel Anti-anxiety--Ativan 3- Atypical antipsychotics Geodon, Abilify, Risperdal + Haldol 2- Anticonvulsants Trileptal, Depakote + Cogentin—for drug-induced Parkinson’s “Medicating Aliah,” Mother Jones, 2005

13. Psych Drug Cocktails=Multiple Toxicities • “If you or I were on that regimen we would have a lot of trouble attending to work or school. We don't have any idea what that combination of medications does to a developing child. It may have a number of long-term side effects.” Joseph Woolston, MD, Psychiatrist, Yale University, MJ 2005

14. There ought to be a law… “...both children were medicated with Zyprexa, Trileptal and Adderall XR by a nurse practitioner…Nick went from a slim 52 lbs. to 146 lbs. Nathan went from 45 lbs. to 118 lbs.” “Sadly, my story is not unique. It involves my family, although it could be any family in the United States.” Leslie Darr, mother of two healthy boys harmed Rx drugs for ADHD How many children suffered irreparable harm?

15. What’s to be done? • Action is needed to protect the life safety of children from indiscriminate, mostly off-label, Rx of psychoactive drugs, for ill-defined behavioral symptoms designated psychiatric disease. • Action needed to protect the safety of their school mates who are also at risk of drug-induced violence. • This committee has a moral duty to recommend a Risk Minimization Action Plan for ALL classes of drugs that trigger psychosis / violence. Black Box warnings are NOT enough.

16. AHRP Urges Actions to Minimize Risks for Children • Mandatory restrictions on access to these drugs— - mandatory registry for doctors who Rx; • Contra-indication for psychoactive drug cocktails— --at least warning that polypharmacy has not been tested for safety, is therefore, experimental; • Limit promotion: no advertising of drugs linked to violent or psychotic behavior; • Require physicians to provide parents with a copy of FDA-approved label & MedGuide; • Require signed parental informed consent.

17. Does Mommy Know the Drug’s Adverse Effects?

18. Joe Camel: Kids Drug Consumers