Transcript Link - thejabberwock

America’s Children Need a
Rescue Operation
by
Vera Sharav
President
Alliance for Human Research
Protection
ICSPP
OCTOBER 13th - 14th, 2007
Washington DC
What is FDA’s Safety Standard?
1998-2005 FDA drug death Reports:
932 Vioxx deaths  Vioxx withdrawn
3,277 Clozaril death reports
1,093 Risperdal death reports
1,005 Zyprexa death reports
Moore, Arch Internal Medicine, 2007
These antipsychotics
continue to kill
How does a lethal drug gain FDA approval?
How does it become a blockbuster seller?
Why have children become primary
consumers of hazardous drugs?
Why do harm producing drugs remain on the
market—even after the lethal risks are
known?
What is FDA’s responsibility?
What must be done?
Without the willing collaboration of
psychiatry, its leadership, academic
institutions, and government, in particular,
the FDA, industry could not have a
stranglehold on medicine.
And children would be protected from braindamaging drugs.
Science transformed into Marketing
Industry funds 80% of clinical trials
spending $14 billion annually on
transforming science into a controlled
marketing tool.
Companies engage in corrupt practices
skewing trial results, concealing failed
efficacy and lethal drug effects.
Companies control the data & results
Analysis of every published trial
comparing 5 new antipsychotics:
9 in 10 favored sponsor’s drug.
"it appears that whichever company
sponsors the trial produces the better
antipsychotic drug."
John Davis MD, American Journal of Psychiatry 2006
Academic “Authors”
Academics have betrayed the public trust and
undermined the integrity of science.
Prominent academics signed off on ghostwritten
promotional copy masquerading as science in
medical journals declaring:
‘Atypical’ antipsychotics “safe & effective,” “well
tolerated,” “with a more favorable side-effect profile.”
They helped conceal failed trials and lethal effects.
Industry’s Willing Collaborators
A Glaxo PR firm found
three psychiatrists
willing to ‘author’ a
ghosted letter for
publication “minimizing
Paxil withdrawal
symptoms.”
Dr. Bruce Pollack
(U. Pitt) signed it.
The Journal of Clinical Psychiatry published it.
Absentee Guardian
FDA fails to ensure that: “the public gets
accurate, science-based information.”
Physicians are misinformed by marketing
propaganda masquerading as science.
Physician ignorance about hazardous
effects of drugs they prescribe poses a
serious public health hazard.
FDA Derailed
Rx Drug User Fee Act, 1992
FDA financially dependent on industry
FDA Modernization Act, 1997
Fast-track approval overrides safety
Financial incentives to test drugs on kids
Daniel Troy, FDA Chief Counsel (2001-2004)
argued: deceptive marketing is protected
under 1st amendment.
FDA Focus Shifted dramatically
1999 –2001: FDA issued 250 "Warning" letters
2002 – 2004: only 70 letters—60% reduction
FDA focus shifted from regulating drug
marketing to protect the health and safety of
consumers
--toward shielding companies’ secrets
about the hazards their drugs pose.
Industry spends $18.5 billion influencing
doctors’ prescribing
“Doctors are bombarded with deceptive
messages in all areas of their professional life,
when reading journals, attending conferences,
meeting with sales representatives…”
Abigail Caplovitz, NJ PIRG, 2006
FDA fails to use its authority to provide
countervailing accurate information.
Worst Drugs are the most advertised
Painkillers: Oxycontin, Neurontin
COX-2 pain: Celebrex, Bextra
Statins: Crestor, Lipitor, Zocor, Mevacor
Sleeping pills: Ambien, Sonata, Lunesta
Antidepressants: Prozac-Cymbalta, Paxil,
Zoloft, Lexapro, Celexa, Effexor
Antipsychotics: Zyprexa, Risperdal,
Geodon, Seroquel
Doctors Rx these drugs widely off-label
6 Million U.S. Children Rx Psych Drugs
Are American Children So Different?
2004:
http://research.imshelath.com/research/mentalhealth_europesummary.htm
A Survey of young child psychiatrists (2002)
9 of 10 (91%) children referred to a
professional are Rx psychoactive drug –
only 9% received psychotherapy.
Stubbe, J Amer Acad Child Adoles Psyc, 2002
One of every 10 teenage boys who visits a
doctor leaves with a Rx for a psych drug.
25% of teens Rx psych drugs "did not have an
associated mental health diagnosis.“
Parks, Trends in Use of Psych Meds Adolesc, 1994 – 2001,
Psychiatric Services, Jan. 2006
Commercially Driven Spiraling Rx
Pattern
"The bottom line is that the use of psychiatric
medications far exceeds the evidence of
safety and effectiveness. What people need
to do is what's in the best interest of children
instead of what's in the best interest of
people's pocketbooks.”
But children don't vote.
Dr. Ronald Brown, APA Psych Meds Evidence, 2006
Are These Drugs Helping or
Harming?
“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 ADHD Review 2006
ADHD drugs: “helping” kids “graduate” from difficulty
staying on task to psychopathology and
psychopharmacology
Rescue the Children
Rex at 6: ADHD, Rx stimulant
hallucinated about worms & bugs
at 8: Rx Risperdal for “probable” OCD
at 9: Dose increased, severe tremors
Parents wean off drugs—TD USA Today, 2006
Zach: ADHD, anxiety, depression.
Rx Ritalin, then Prozac, then Paxil manic.
Prozac + Zyprexa—gained 40 lbs in 5 months.
His psychiatrist Rx Seroquel…still “aggressive”
considers switching to Geodon…
Sacramento Bee, 2002
ADHD Gateway to Antipsychotics
"to me the most striking
thing was that nearly
one in five psychiatric visits
for young people included
a prescription for
antipsychotics."
Mark Olfson, MD Arch. Gen Psych, 2006
2.5 Million US Children Rx
Antipsychotics
Most children Rx antipsychotics are not psychotic.
Mostly Rx for unapproved “conditions” –
ADHD, Autism, Oppositional Defiance, Conduct Disorder
Vanderbilt University, Associated Press, 2006
Black Box Warnings:
“Increased mortality” in elderly
Other Serious Hazards:
acute weight gain (>100 lbs),
insulin resistance in children, type II diabetes,
hyperglycemia, liver function abnormalities,
neuroleptic malignant syndrome, heart disease,
stroke...
New neuroleptics: Worse than Old
CATIE study confirms:
No evidence drugs help patients recover.
"the side effect outcomes are staggering in
their magnitude and extent and demonstrate
the significant medication burden for
persons with schizophrenia… Sky-high drug
discontinuation rates were seen, suggesting
rampant drug dissatisfaction and inefficacy."
Dr. Carol Tamminga, Editorial, AJP, 2006
Life-span shortened: possibly 25-years
Colton & Manderscheid Mortality Rates, CMHS, CDC, 2006
Antipsychotics: Pathway to
Metabolic Syndrome
“Children and adolescents are at higher risk than
adults for antipsychotic induced weight gain,
metabolic abnormalities and elevated serum
prolactin.”
“Weight gain is a leading pathway to the
metabolic syndrome and diabetes mellitus.”
Correll and Carlson, J Amer Acad Child /Adolesc Psych 2006
Evolution of Metabolic Syndrome—
a.k.a. Zyprexa Syndrome
The Economist Newspaper Limited (2003), Cover illustration. The Economist; Dec. 13
Children Risk Insulin Resistance
Johns Hopkins: All six children on moderate or high
doses of antipsychotics, and 3 of 5 children on
low doses -- evidence of insulin resistance.
"The insulin resistance seen in these children was
greater than what would be expected from weight
gain alone, suggesting there is a factor distinct
from excess weight that directly induces insulin
resistance."
Mark Riddle, M.D., director, Johns Hopkins U Child and Adolescent
psychiatry, 2004
Children  Diabetes
1997–2003: Children hospitalized with diabetes+200%
New York University School of Medicine
2001 to 2006 children, 10 to 19:
Antipsychotic use: girls ………+117%
boys……… + 71%
Diabetes medications: girls…. + 59%
boys…….... + 14%
Diabetes type 2 medication
girls……… +167%
boys….….. + 33%
MEDCO Health Solutions, 2007
TMAP = Rx blockbuster sales
TMAP (Texas Medication Algorithm Project)
concocted in 1995 under Gov Bush
Collusion: pharmaceutical companies,
U of Texas psychiatrists, state mental health &
corrections officials.
Exposed by Allen Jones
TMAP mandates use of the most expensive
psych drugs as first line treatment—without
regard for drug hazards.
Antipsychotics, U.S. Sales:
TMAP expands a small market
TMAP guidelines Rx for disaster
Texas: Psychotropic drugs = 76% of all meds Rx
for foster children.
1996-2000: Antipsychotic Rx children + 494%
“Of youth receiving antipsychotics, 42.9% had
no history of or current psychosis.”
Behavioral Health Services & Research, 2004
Tennessee Medicaid: 1996-2001
Antipsychotics Rx children nearly doubled
– from 23 to 45 per 10,000 children
Rx for ages 6 to 12 + 93%;
Rx for 13 to 18 +116%
Rx for preschoolers + 61%
Medicaid Pays the Bill
Since 2000 MH costs increased > 50%
Public funds 63% of MH spending
> $300 billion per year
A Third Way Approach to Fix America’s Mental Health, 2005
“Nationwide, Medicaid programs
purchase an estimated 60% to 75% of
antipsychotic drugs.”
San Francisco Chronicle, October 23, 2005
Antipsychotics - Total U.S. Sales $ in Thousands
Rank Drug 2005
2004
2003
2002
2001
Class Total $10,471,598 $9,560,117 $8,406,791 $6,619,177 $5,374,591
Seroquel
$2,596,076 $2,077,150 $1,572,050 $1,090,417
$703,666
Zyprexa $2,543,375 $3,016,650 $3,302,748 $2,972,044 $2,514,8093
Risperdal $2,310,229 $2,195,661 $2,117,131 $1,854,064 $1,622,8614
Abilify
$1,540,020 $1,041,943 $365,656
$22,072
*****
Geodon
$648,514 $514,304 $547,708
$253,124 $141,285
Source: IMS Health, IMS National Sales PerspectivesTM, 2/2006
1995-2000 Sales: $900 million  $4.8 billion
2001-2005 Sales: $5.4 billion  $10.5 billion.
Medco Health Solutions, 2007
Despite antipsychotics’ demonstrably poor
clinical performance, despite their
“staggering” adverse effects which
are even worse in children and
adolescents, off-label prescriptions for US
children / adolescents surged by 82%
from 2001 to 2006.
gynecomastia (male breast enlargement)
is not much discussed in journals—
Lawyers files provide
the documentation.
At 9 ½ Sean Rx Risperdal,
developed breasts
requiring surgical removal at 13
The scope, magnitude and nature of physiological
harm produced by antipsychotics has been denied or
trivialized by psychiatry, industry, and the FDA.
Rampant Drugging of Foster Children
Abusive use of psychotropic drugs—as “chemical
restraints” across the U.S.
At greatest risk: disadvantaged, poor children treated
within state mental health systems
– clinics, hospitals, foster care & juvenile justice
55%—60% foster children
– multi-drug “cocktails”
– Even toddlers <3 are heavily drugged
“Medicating Aliah,” Mother Jones, 2005
4 SSRI Antidepressants
Anti-anxiety drug
2 ‘Atypical’ Neuroleptics
Old Neuroleptic
2 Anticonvulsants:
Anti-Parkinson's drug
At discharge from a State
mental hospital Aliah was
on 5 psych drugs.
Risperdal was added to
her “cocktail”
13 year old Aliah Gleason
New Jersey Medicaid 2006:
> 39,000 children Rx psych drugs.
647 Rx for children aged 4 or less.
Florida 2006: 18,305 children Rx Antipsychotics
+250% from 1999.
Michigan Medicaid 2005:
13,000 children <17 Rx antipsychotics
3,064 children aged 4 or less, Rx psych drug.
933 children < 5 were Rx anticonvulsants
972 children < 5 were Rx Antidyskinetics
One child is currently Rx 17 psych drugs
Ben Hansen, Northern Express, 2007
The Diagnosis Maze
Paul Williams, 13, has had as many
psychiatric diagnoses as birthdays:
“Compulsive tendencies”
“Oppositional defiant disorder”
“pervasive developmental disorder” or some
combination.
Each diagnosis---a different regimen of drugs.
At age 11 “bipolar disorder” —
a whole new set of Rx.
New York Times 11/ 2006
DSM-IV: Pathology Grab Bag
“Bipolar Child”
Historically rare, now “highly prevalent”
"Five years ago, pinning down bipolar disorder in
children was like nailing Jello to the wall.
Today, we've seen significant advances—we
are now nailing cheesecake to the wall."
“so far [genetic] research has not consistently
shown increased occurrence of the disorder in
children who are supposed to be at high risk.”
Gabrielle Carlson, M.D. Psych News, 12-2-2005
Bipolar has Become a Catchall
40-fold increase in children
diagnosed “Bipolar”
“Psychiatrists made almost 90%
of the diagnoses, and two-thirds
of the young patients were boys”
Olfson, Arch Gen Psych, 2007
DSM-IV Broadened Criteria
“One factor that may have contributed to this
increase is a revision in the diagnostic criteria
of bipolar disorder in the Diagnostic and
Statistical Manual (DSM. 1994).” Mark Olfson, 2007
“we simply don’t know how accurately we can
diagnose bipolar disorder…The label may or
may not reflect reality.”
John March, NYT, 2007
“The number of children & adolescents being
diagnosed with bipolar disorder… resulted in a
significant rate of polypharmacy.”
2005
Jon McClellan, MD, Psychiatrist, Psych Times,
Rebecca Riley “diagnosed” Bipolar
age 2½.
Psychiatrist Rx lethal drug
Cocktail: antipsychotic,
Seroquel; mood stabilizer,
Depakote; blood pressure
drug, Clonidine.
Rebecca Riley, aged 4 Dead of
multi-drug toxicity, 2007
Jos. Woolston, MD, Yale
"probably tens of thousands of kids" are on
random combinations of psychoactive
medications.
“We’re using them as guinea pigs,
and not even keeping track of them."
“Use of multiple psychiatric drugs in children has
become ‘extremely common.’ The vast majority
of kids are on at least two different medications
and many are on three or four or five
different medications.”
Bloomberg News, 2006
MassHealth Children’s Records
MassHealth Reviews 82,900 records children
< 5 to identify other preschoolers like
Rebecca Riley.
955 children < 7 Rx Clonidine
536 children < 7 Rx Antipsychotic.
Boston Globe, Oct. 7, 2007
MassHealth only seeking children < 5
Rx “at least three psych drugs” or an
antipsychotic
?
Dennis Maltez, dead at age 12,
Florida, May 2007
Dennis acquired multiple "diagnoses,"
including: autism, depression,
schizophrenia, and
mild retardation.
Rx multiple psych drugs:
Two antipsychotics—
Seroquel and Zyprexa +
anti-seizure drug Depakote.
1.6 Million U.S. Children on Multiple
Psychotropic drugs
Lee, aged 9, was Rx a combination drug cocktail:
2 antidepressants + 2 antipsychotics. She descended
into suicidal violence.
Tampa Tribune, 2003
Stephen, 15, takes 2 antidepressants; anticonvulsant
to stabilize his moods; a psychostimulant to improve
concentration.
Jacob, 14, takes a psychostimulant for concentration;
an anticonvulsant; an antipsychotic; and an
antihypertensive to induce sleep.
Over three years, each boy Rx 28 psychotropic drugs.
New York Times, 2006
Erratic Inpatient Diagnosing
Biological Psychiatry, 2007
National Hospital Discharge Survey
1996: Bipolar Disorder = least frequent diagnosis
Children =
Adolescents =
Adults =
10%
10.2%
9.9%
2004 BPD = most common diagnosis among
Children =
Adolescents =
Adults =
40%
25.8%
14.9%
Children
+ 439%
Adolescents + 296%
“The increase was
especially steep from
2002 through 2004
for black
youngsters.”
Psychiatry News, American Psychiatric Assoc, 2007
"We are using these medications and don't
know how they work, if they work, or at what
cost. It amounts to a huge experiment with
the lives of American kids, and what it tells us
is that we've got to do something other than
we're doing now.”
John March MD, Prof. child /Adolescent Psychiatry, Duke
“We have to realize that we are risking treating
children who could turn into obese diabetics
with involuntary movements.”
Neuroscientist Steven Hyman MD, Former Director, NIMH 2007
FDA denies drug-related casualties
FDA MedWatch: +1,328 reports of serious
antipsychotic side effects in children
At least 45 deaths linked to antipsychotics
41 cases of Neuroleptic Malignant Syndrome—
risk of death within 24 hours.
MEDCO-USA Today, May, 2006
FDA: "we haven't been alerted to any particular
or unusual concern…The effects (in kids) are
similar to what we're seeing in adults.“
Thomas Laughren, Director, FDA Psych Products, 2006
What is FDA’s Safety Standard?
“We have not systematically looked at the data
for children.“
2007: FDA approved Risperdal for Autistic
children, Zyprexa for teens—even as evidence
demonstrates these drugs’ life-threatening
metabolic hazards are even more severe in
children.
Thomas Laughren, director, FDA psychiatry products, 2006
Currently Recruiting 3-7 year olds
“We are seeing an increasing number of very young
children, ages 3-7 years, with… frank symptoms of
BP disorder. Many of these young BPD patients have
been treated with stimulants or antidepressants”
FDA-approved: Protocol NCT00221403:
“Valproate and Risperidone
in 60 Young Children ages 3-7
with Bipolar Disorders”
PI: Robert A Kowatch, MD
U Cincinnati
Stanley Foundation
“Even before their first birthday,
babies can suffer from clinical
depression, traumatic stress
disorder, and a variety of other mental health
problems.” Florida Strategic Plan for Infant Mental Health, 2001
Surreal Rx for Disaster
“Psychopharmacology is on the horizon as
preventive therapy for children with genetic
susceptibility to mental health problems.”
David Willis, M.D., Medical Director, Pediatric News, January, 2004
Science or Science Fiction?
“One in ten children aged two to five had
obvious signs / symptoms of psychiatric
illnesses such as ADHD, anxiety or depression…
It suggests that such conditions begin
very early in life, perhaps even in the womb”
“Screening and treating these disorders in
babies and infants is the way forward –
waiting until childhood or adulthood is too late.”
Dr. Adrian Angold, Duke BBC, Newsweek, 11-2005
Actions to Protect Children
AHRP Recommends:
• Mandatory restrictions on access to Rx
psychoactive drugs.
• Mandatory registry for doctors.
• Limit product promotion: prohibit all
advertising of drugs linked to mania, violent
or psychotic behavior.
• Require physicians to provide parents with
copy of FDA-approved label + MedGuide.
• Require signed parental informed consent.