DrugInduced 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
  dangerousnot safe effective.
• Violent behavior induced by these drugs is a
  danger to self and othersincluding 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 psychosis or mania,
  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

• FDAs review does not include ALL drugs Rx for
  ADHDthe 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 usedmostly for
  aggressiondriven 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, withfrank
  symptoms of BP disorder.
• ClinicalTrials.gov NCT00221403

9
Bipolar Childa 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 depressionIt
  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
Cogentinfor drug-induced Parkinsons
Medicating Aliah, Mother Jones, 2005
13
Psych Drug CocktailsMultiple 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
  practitionerNick 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
Whats 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 Drugs Adverse Effects?
18
Joe Camel Kids Drug Consumers