he 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.

he 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).

ather than focus on protecting children’s safety, FDA officials are doing their utmost to legitimize irresponsible, off-label prescribing of exceedingly toxic anti-psychotics 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.

ost 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.” See article

euters 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 thelack 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’ irreversiblehazards.

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. 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 ?

[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.]

Is the FDA Bipolar?

By Martha Rosenberg

n 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 problem.

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 proRisperdal 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 AdvisoryCommittee 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 health.