Transcript Slide 1

Drug-Induced Mental Health
Crisis
Vera Hassner Sharav
Allen Jones
Alliance for Human Research Protection
(AHRP)
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.
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
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
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
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 druginduced harms suffered by children
treated for ADHD.
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.
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
“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.
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
“Brandon & the Bipolar Bear”
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
“Medicating Aliah,” Mother Jones, 2005
+ Cogentin—for drug-induced
Parkinson’s
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
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?
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.
AHRP Urges Actions to Minimize
Risks for Children
• Mandatory restrictions on access to these drugs—
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- 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.
Does Mommy Know the Drug’s
Adverse Effects?
Joe Camel: Kids Drug Consumers