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Is the FDA Bipolar or Just Complicit in Legalizing Illegal Drug Pushing?

June 8, 2009

A Catalyst for Public Debate: Promoting Openness, Full Disclosure, and Accountability


The FDA’s expanded marketing approval process for antipsychotics, highly toxic drugs, is unaffected by evidence uncovered by the US Justice Department showing that the studies submitted by drug manufacturers were often flawed, if not fraudulent. FDA officials are ignoring the real world tragedies–drug-induced deaths of children. Unfortunately for the children, child psychiatrists in particular are noted for irresponsibly prescribing high doses of the most toxic drugs in pharmacopoeia for young children who do not have a valid medical condition, much less a life-threatening illness that would justify the magnitude and scope of risks posed by these drugs, singly and in untested combinations.

The latest child casualty reported by the press, is four-year-old, Destiny Hager, who was prescribed two highly toxic antipsychotic drugs–quetiapine (Seroquel) and ziprasidone (Geodon)–since age three.

The Topeca Capital Journal reports that an X-ray revealed the child’s colon was blocked – a known side effect of Seroquel and Geodon.

An autopsy confirmed that the child died of fecal impaction and had “antipsychotic drugs present in concentrations considered therapeutic in adults.”  Destiny Hager weighed 38 lbs.

This week, on June 9-10, an FDA advisory panel will be considering applications for expanded approval of highly toxic antipsychotics for use in children aged 10 to 17.  The drugs under consideration are:  Seroquel (AstraZeneca), Zyprexa (Eli Lilly) and Geodon (Pfizer).

Rather than focus on protecting children’s safety,  FDA officials are doing their utmost to legitimize irresponsible, off-label prescribing of exceedingly toxic antipsychotics for children–thereby ensuring that far greater numbers of children will be victimized and die.

FDA has already approved Johnson & Johnson’s antipsychotic Risperdal for use as a chemical restraint to curb aggression in autistic children without a public hearing–and despite the J & J’s withdrawal of its application in the
UK, after the British panel required rigorous medical monitoring of children prescribed risperdone (Risperdal). FDA officials have also approved (aripiprazole) (Abilify), manufactured by  Otsuka Pharmaceutical and Bristol-Myers Squibb (BMS) to treat manic and mixed episodes associated with bipolar I disorder in pediatric patients ages 10-17.

It should be underscored that the diagnoses, schizophrenia and bipolar in children are highly controversial–indeed, pediatric bipolar is not recognized elsewhere in the world and there is evidence uncovered during litigation by the US Attorney strongly suggesting that prominent US academic child psychiatrists promoted both the diagnoses and antipsychotic drugs while receiving considerable cash payments from these drugs’ manufacturers.

[Below, an EXCELLENT Op Ed in NEWS BLAZE cites some of the recently uncovered corrupt practices that should have precluded FDA from even considering expanding market approval for these drugs.]

Most troubling are confirmatory preliminary scientific findings about the rapid onset of severe hazards these drugs pose for children. Alarmed by their findings, researchers reported them at the American Psychiatric Association meeting (below)

Beyond acute weight gain, the researchers reported: “Atypical Antipsychotics Linked to Rapid, Adverse Metabolic Changes in Children.”

In just 12 weeks “the entire group of children exposed to one of the antipsychotic drugs exhibit “striking changes in [metabolic] parameters.”

“These preliminary results suggest that weight gain is associated with a significant decrease in insulin sensitivity.”

Reuters and The Wall Street Journal quote from a May 8 memo to the advisory committee by Dr. Thomas Laughren, the agency’s director of the FDA’s psychiatric product division:   “We generally are in agreement that the sponsors have provided adequate support to suggest effectiveness.”

While acknowledging that the risks posed by these drugs are “of particular concern in pediatric patients because of the life-long nature of these disorders.”

Dr. Laughren couched his directive to the advisory committee in “forked tongue” fashion acknowledging concern for safety issues, but hedging on the lack of proof of efficacy. He retreated from evidence for concern by claiming the risks for children appeared “to be qualitatively similar to those observed” with adults.

If approved, these exceedingly toxic drugs will be widely prescribed for children whose misbehavior will condemn them to the drugs’ irreversible hazards.

Question: What are FDA’s medical, scientific, or moral standards for considering approval of demonstrably toxic drugs for use in otherwise physically healthy children who would be irreparably harmed by these drugs?

A concern not acknowledged by the FDA nor ever considered by psychopharmacologic advisory panels is the fact that there is a cumulative incremental danger posed by  these drugs’ multiple severe, adverse, disabling, life-shortening health hazards–including diabetes, metabolic syndrome, and cardiovascular disease and sudden death.

The negative risk / benefit ratio is acknowledged by Dr.Thomas Insel, Director of the National Institute of Mental Health, who recommends precaution:
“With current antipsychotics you risk either metabolic side effects or neurological side effects. Sometimes these
potentially serious risks are worth the benefit, but in children the balance needs to favor minimizing risks.”

Question: What are FDA’s medical, scientific, or moral standards (if any) for considering approval of demonstrably toxic drugs whose hazards are disabling and life-shortening, for use in otherwise physically healthy
children who would be irreparably harmed ?

Contact: Vera Hassner Sharav
June 5, 2009

FDA Sees Benefits, Risks in Antipsychotics for Children

Child taking pillPowerful antipsychotics currently used to treat adults for
schizophrenia and bipolar disorder appear to be effective in treating
children and teens as well, though there are serious risks associated with
the medicines, according to documents put out by the FDA staff today.

AstraZeneca’s Seroquel, Eli Lilly’s Zyprexa and Pfizer’s Geodon are all
being considered by the FDA for use in children. A panel of outside experts
will meet next week to discuss the risks and benefits of these medicines for
use in children and make a recommendation to the FDA.

Though they work at combating serious symptoms such as delusions and
hallucinations in schizophrenia, or severe mood swings associated with
bipolar disorder, the drugs also appear to induce weight gain and
sleepiness, according to Dow Jones.

“These risks are of particular concern in pediatric patients because of the
life-long nature of these disorders,” wrote Thomas Laughren, director of the
FDA’s psychiatric product division, in a memo.

Recent studies of effectiveness have shown that the antipsychotics aren’t as
good as previously believed. “They reduce some symptoms for some people but
they help too few people recover,” Thomas Insel, director of the National
Institute of Mental Health, wrote in an email to the Health Blog. “We really
need a new generation of compounds that will target the full range of
problems in serious mental illness.”

Insel said using antipsychotics in children is a “tough balance” between the
risk vs. the benefits of the medicines. “With current antipsychotics you
risk either metabolic side effects or neurological side effects,” he wrote.
“Sometimes these potentially serious risks are worth the benefit, but in
children the balance needs to favor minimizing risks.”

Currently only two antipsychotics, J&J’s Risperdal and Bristol-Myers’s
Abilify, are approved for use in children.

Copyright 2008 Dow Jones & Company, Inc. All Rights Reserved

April 16, 2009
Op-Ed Contributor

Is the FDA Bipolar?
By Martha Rosenberg

In February the Justice Department charged Forest Laboratories with
illegally marketing antidepressants Celexa and Lexapro to younger patients
and burying a study that showed suicidal side effects in children. But the
next month the FDA approved Lexapro for depression in adolescents 12 to 17.

In March the Justice Department charged AstraZeneca with knowing and hiding
the diabetes side effects of Seroquel. But this month the FDA considers
expanding the antipsychotic’s approvals to depression and anxiety.

And in January, Eli Lilly pled guilty to promoting its antipsychotic Zyprexa
for unapproved and dangerous uses in a $1.4 billion settlement. But in March
the FDA approved Lilly’s Zyprexa/Prozac combo, Symbyax for treatment
resistant depression (TRD). What do you get when you cross Zyprexa with
Prozac? Someone who gains 100 pounds and feels great about it!

“TRD” is such a new pharma invention it googles as Toyota Racing
Development and Teacher Recruitment Days. But it will soon move ‘script like
GAD (general anxiety disorder), MDD (major depressive disorder) ADD
(attention deficit disorder) RLS (restless legs syndrome) GERD
(gastroesophageal reflux disease) and PMDD (Premenstrual dysphoric
disorder)-and for the same reasons.

Of course FDA drug approvals are only as good as the studies. Which is the

Forest paid Massachusetts General Hospital’s Jeffrey Bostic, MD $750,000 to
chat up Celexa and Lexapro according to US District Court in Boston filings.
AstraZeneca paid University of Minnesota Charles Schulz, MD $112,000 to push
Seroquel according to US District Court in Orlando filings. And a decade of
pain “studies” conducted by Baystate Medical Center’s Scott S. Reuben, MD on
Vioxx, Lyrica, Celebrex and Effexor were completely fabricated-including the
patients say published reports.
And speaking of “made up, Coast IRB, an institutional review board which
oversees some 300 clinical trials and 3,000 researchers agreed last year to
approve a human trial for “Adhesiabloc,” a surgical gel which Congress and
the Government Accountability Office completely made up in a sting
operation. Oops.

And let’s not forget Joseph your-child-is-bipolar Biederman, MD at Harvard
who assured benefactor Johnson & Johnson his studies would have pro
Risperdal results according to the New York Times-in advance of doing them.
(Why leave things up to science?)
And Charles “Paxil” Nemeroff, MD who was forced to step down in December as
psychiatry chairman at Emory University thanks to unreported GlaxoSmithKline
income of up to $800,000.

And the pharma funded studies continue!
Last May a pro Lexapro article, “Escitalopram and Problem-Solving Therapy
for Prevention of Poststroke Depression,” ran in JAMA, the Journal of the
American Medical Association, with no mention of financial ties author
Robert G. Robinson, MD has to Forest.

Why was, “a researcher with a history of being funded by SSRI makers…given
a forum in the national media to tell the general public that anyone who has
had a stroke, whether or not they have been diagnosed with depression,
should start a prophylactic regimen of Lexapro…even though non-medical
approaches perform just as well,” wrote Jonathan Leo, PhD, Associate
Professor of Neuroanatomy at Lincoln Memorial University in the British
Medical Journal in March.
And then there’s AstraZeneca’s “studies.”

Seroquel is linked to high blood sugar, weight gain, diabetes, cholesterol
and triglycerides abnormalities, sudden cardiac death, suicide, Iraq war
veteran deaths and the tardive dyskinesia it is supposed to prevent.

But its “safety” was established by a different kind of chemistry.

Research director for Seroquel, Wayne MacFadden, was having affairs with two
women responsible for Seroquel studies say court documents: a researcher at
the Institute of Psychiatry in London and a ghostwriter at Waltham, MA-based
medical communications firm Parexel.

The studies upon which the FDA approved Seroquel for bipolar disorder-called
“Bolder” I and II-were written by a ghostwriter, possibly accelerated by a
motel room. And seated on the FDA’s Psychopharmacologic Drugs Advisory
Committee at the time was Jorge Armenteros, MD, who has been a paid
AstraZeneca speaker for five years according to the Philadelphia Inquirer.

He now heads the committee as the FDA considers expanding Seroquel approvals
to include depression and anxiety this month-and to children in June.

Hopefully FDA will keep some Seroquel for itself.

Martha Rosenberg is a columnist and cartoonist, who writes about public

Copyright C 2009, NewsBlaze, Daily News

JUNE 5, 2009
FDA: Adult Antipsychotic Drugs Effective In Children
By Jennifer Corbett Dooren

WASHINGTON (Dow Jones)–Food and Drug Administration staff said Friday three
drugs currently approved to treat bipolar disorder and schizophrenia in
adults were effective at treating the disorders in children and adolescents,
but carry “significant risks.”

The agency is considering applications for AstraZeneca PLC’s (AZN) Seroquel
and Eli Lilly and Co.’s (LLY) Zyprexa to treat bipolar disorder and
schizophrenia in children and adolescents, and Pfizer Inc.’s (PFE) Geodon to
treat bipolar disorder in children 10 to 17. An FDA panel of outside medical
experts is scheduled to meet to discuss the drugs next Tuesday and
Wednesday. The panel is being asked to vote on whether each product is safe
and effective for children ages 10 to 17.

The FDA as well as the companies said studies showed the products were
effective at treating the symptoms of bipolar and schizophrenia, but the
drugs all had side effects that included sedation and weight gain. Reviews
of the products were posted on FDA’s Web site Friday.

“These risks are of particular concern in pediatric patients because of the
life-long nature of these disorders” said Thomas Laughren, director of the
FDA’s psychiatric product division, in a memo.

The concern with weight gain seen with most antipsychotic drugs whether it
causes additional problems like diabetes and cardiovascular disease.

The FDA said all three products are already being used in children even
though they aren’t approved. Approved products include Risperdal, by a unit
of Johnson & Johnson (JNJ), and Abilify by Bristol-Myers Squibb Co. (BMY)
and Otsuka Pharmaceutical Co., Ltd, the agency said.

The FDA asked each company to look at which side effects were more commonly
seen in children compared to adults who were studied in clinical trials.

Lilly said clinical studies of Zyprexa showed the product was associated
with greater weight gain and changes in blood lipid parameters than seen in
adults using the product.

The company is seeking FDA approval of Zyprexa as a second-treatment for
children and adolescents, meaning that other products should be tried first.
Zyprexa is Lilly’s top-selling drug with $4.7 billion annual sales in 2008.

AstraZeneca said side effects that occurred more frequently in children
compared to adults on Seroquel included increases in blood pressure and
increased appetite. The company also said incidences of certain movement
side effects such as tremors were higher among patient taking Seroquel
compared to patients in placebo groups, or patients not taking the drug.
Seroquel is AstraZeneca’s second-best selling drug with $4.45 billion in
sales in 2008.

Pfizer said children taking Geodon were more likely than adults to report
feeling sleepy, or sedation. The company said the drug didn’t have a big
impact on weight gain with 7% of people taking Geodon experiencing a 7% or
greater gain in weight compared to 4% in the placebo group. The company also
said the drug didn’t increase metabolic markers such as cholesterol.

Schizophrenia afflicts about 1% of Americans. According to the National
Institute of Mental Health, people with schizophrenia may hear voices other
people don’t hear or they may believe that others are reading their minds,
controlling their thoughts or plotting to harm them. The disorder is also a
cause of suicide and is typically diagnosed in a person’s late teens or 20s.
Bipolar disorder also known as manic-depressive illness, is believed to
affect about 1% to 3% of the population, and is characterized by unusual
shifts in mood, energy and activity levels. There’s evidence that bipolar
disorder in children is more severe than typically seen in adults.

– By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
Medscape Medical News
APA 2009: Atypical Antipsychotics Linked to Rapid, Adverse Metabolic Changes
in Children
Caroline Cassels

June 3, 2009 (San Francisco, California) – Early findings from a study
looking initial exposure to atypical antipsychotics in children show that
concurrent with significant improvement in behavioral symptoms, including
severe aggression, irritability, and disruptive behavior across multiple
childhood-onset psychiatric disorders, these medications are associated with
rapid, adverse metabolic changes.

Presented here at the American Psychiatric Association 162nd Annual Meeting,
preliminary results from the Metabolic Effects of Antipsychotics in Children
(MEAC) study show that 12 weeks of initial antipsychotic treatment was
associated with significant mean increases in overall adiposity and
percentage of body fat, as well as a decrease in whole-body insulin

Further, the investigators found antipsychotic treatment was also linked to
significant increases in body-mass index (BMI) percentile and fasting plasma
triglyceride levels, both clinically available indicators of adverse
metabolic changes associated with increased adiposity.
Dr. Ginger E. Nicol

“The reason we wanted to present these preliminary results is that we saw
such striking changes in these [metabolic] parameters in the entire group of
patients. Weight gain is something that many of us see clinically with these
medications in our pediatric patients, and it is of great concern. However,
these preliminary results suggest that weight gain is associated with a
significant decrease in insulin sensitivity,” study investigator Ginger E.
Nicol, MD, from Washington University School of Medicine, in St. Louis,
Missouri, told Medscape Psychiatry.

A 5-year study funded by the National Institute of Mental Health (NIMH),
under the direction of John Newcomer, MD, from Washington University School
of Medicine, MEAC’s purpose is to quantify antipsychotic treatment-related
changes in adiposity and insulin sensitivity in antipsychotic-naive children
and adolescents with irritability, aggression, and disruptive behaviors,
which are common presenting symptoms for many mental disorders in this

Study subjects included children age 6 to 18 years with Aberrant Behavior
Checklist (ABC) irritability subscale scores of more than 18 who were
randomized to 12 weeks of open-label treatment with olanzapine (Zyprexa,
Lilly), risperidone (Risperdal, Janssen), or aripiprazole (Abilify,
Otsuko/Bristol-Myers Squibb).

“We used 18 as the cutoff score on the ABC irritability subscale because it
is consistent with what has been used in other antipsychotic-treatment
studies of irritability and aggression. Many of these children are very
physically aggressive and as a result have frequently been suspended from
school or are on the verge of hospitalization,” said Dr. Nicol.

The MEAC study seeks to enroll only children in whom other approaches have
failed and who are already under clinical consideration for antipsychotic

Children are screened for a variety of potential diagnoses that have
associated symptoms of aggression and irritability, including depression and
attention-deficit/hyperactivity disorder (ADHD), that may have previously
gone undetected or were inadequately treated. In such cases, patients are
referred back to their primary clinician with recommendations to pursue
appropriate first-line treatments.

“The risk/benefit ratio is very carefully considered for each individual
participant in terms of whether they are likely to derive benefit from being
placed on an antipsychotic,” said Dr. Nichol.

Treatment-Naive Population

Following randomization to 1 of the 3 study medications, subjects received
weekly monitoring and scheduled assessments to detect any metabolic change.
The study’s primary end points include measures of body composition with
dual-energy X-ray absorptiometry (DEXA), abdominal magnetic resonance
imaging (MRI), and insulin sensitivity with stable isotopomer tracing during
hyperinsulinemic-euglycemic clamp conditions.

According to Dr. Nicol, MEAC is 1 of the first studies to look at a
treatment-naive pediatric population and is the only study in children
taking antipsychotics to date that is using gold-standard measures of
adiposity and insulin sensitivity.

The preliminary pooled-groups analysis of the first 57 study completers
revealed that 12 weeks of initial antipsychotic treatment was associated
with significant mean increases from baseline in DEXA total fat (2.74 kg)
and DEXA total percent body fat (2.97%),  with an associated mean decrease
in whole-body insulin sensitivity.

Similarly, change in clinically available indicators of adiposity and
insulin sensitivity were also observed, with significant increases in BMI
percentile of 14.8 percentile points and a mean increase in fasting plasma
triglycerides of 18.1 mg/dL.

In a positive light, the study also showed treatment with antipsychotics was
associated with marked reductions in the ABC irritability score, with a mean
drop of 15.37 points.

Study Sheds New Light on Everyday Problem

Asked by Medscape Psychiatry to comment on the study, Lawrence Maayan, MD,
an expert in the metabolic effects of psychotropic medications and treatment
and evaluation of pediatric psychosis, said these early findings shed new
light on the metabolic effects of these medications in children – a problem
that child psychiatrists “see every day.”

“There have been findings from randomized controlled trials showing these
agents cause weight gain, especially with risperidone and olanzapine, but
this study really looks at this group [of agents] broadly and has a number
of different features that haven’t been looked at in children previously,”
said Dr. Maayan, director of outpatient research at the Nathan S. Kline
Institute for Psychiatric Research at New York University.

Dr. Maayan said he looks forward to the final study findings, which will
demonstrate whether there are differences between the 3 agents in terms of
their adverse metabolic effects.

“Certainly there are good data out there showing that olanzapine is most
likely to cause weight gain in susceptible individuals; risperidone seems to
be somewhere in the middle, although it appears it is more likely to cause
weight gain in kids; and the picture for aripiprazole is not clear. But to
have a study like this that is NIMH-funded that really looks at this
question will be very valuable, whatever way it comes out,” said Dr. Maayan.

A number of studies have tested potential interventions to help offset the
metabolic effects of these medications. These include behavioral
interventions that run the gamut of cognitive behavioral therapy to
nutrition counseling, most of which do appear to have at least a modest
effect on weight gain.

Other studies have shown pharmacological interventions, including the use of
the oral antidiabetic agent metformin, can help slow weight gain. Dr. Maayan
said in his own practice he routinely counsels children taking
antipsychotics about the value of exercise and healthy eating choices.

Dr. Nicol reports no disclosures.

American Psychiatric Association 162nd Annual Meeting: Abstract NR5-030.
Presented May 19, 2009.
Authors and Disclosures

Journalist Caroline Cassels is the news editor for Medscape Psychiatry. A
medical and health journalist for 20 years, Caroline has written extensively
for both physician and consumer audiences. She helped launch and was the
editor of Health Digest, an award-winning Canadian consumer health
publication. She was also national editor of the Heart & Stroke Foundation
of Canada’s Web site before joining Medscape Neurology & Neurosurgery in
2005. She is the recipient of the 2008 American Academy of Neurology
Journalism Fellowship Award. She can be contacted at

Medscape Medical News C 2009 Medscape, LLC
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