CABF Pepsi Project Fundraiser: Advisor Janet Wozniak trialed Seroquel on 4 year olds

CABF bpkids Scientific Advisory board member Janet Wozniak trialed the antipsychotic Seroquel (not approved for use in children under age 10) on 4 year olds

Janet Wozniak, who once partnered with Joseph Biederman trialing the antipsychotic Risperdal in children has completed a study trialing the antipsychotic SEROQUEL, made by Astra Zeneca in children 4-6 years of age at Massachusetts General Hospital.

Biederman has been investigated by Senator Charles Grassley for a protocol breach in the/a Risperdal trial, as well as being investigated for non-disclosure of over $1 million dollars of pharmaceutical industry income into his personal bank account.
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I wrote about Wozniak and Biederman here, in August 2007 in my series: "1999- 2007: OCD: ADHD: Childhood Bipolar Disorder: The Evolution of a Diagnosis" ; part 20

From that page:

Journal of the American Academy of Child & Adolescent Psychiatry. 38(8):960-965, August 1999.

FRAZIER, JEAN A. M.D.; MEYER, MICHELE C. M.D.; BIEDERMAN, JOSEPH M.D.; WOZNIAK, JANET M.D.; WILENS, TIMOTHY E. M.D.; SPENCER, THOMAS J. M.D.; KIM, GRACE S. M.A.R.; SHAPIRO, STEPHANIE B.A. -1999

Conclusions

Although limited by its retrospective nature, this study suggests that risperidone may be effective in the treatment of manic young people and indicates the need for controlled clinical trials of risperidone and other atypical neuroleptics in juvenile mania.

J. Am.Acad. Child Adolesc. Psychiatry, 1999, 38(8):960-965. Copyright 1999 (C) American Academy of Child and Adolescent Psychiatry"
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Janet Wozniak sits on the bpkids CABF Scientific Advisory board along with Joseph Biederman.

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I find several things troubling to say the least about the recent Seroquel trial in 4-6 year olds.

Quetiapine for Mania In Preschool Children 4 to 6 Years of Age With Bipolar Disorder:


STUDY INCLUSION CRITERIA

•Male or female subjects, 4-6 years of age.

•Subjects must have a DSM-IV diagnosis of bipolar I, bipolar II disorder or bipolar spectrum disorder and currently displaying manic, hypomanic, or mixed symptoms (with or without psychotic features) according to the DSM-IV based on clinical assessment and confirmed by structured diagnostic interview (Kidd Schedule of Affective Disorders and Schizophrenia Epidemiological Version). Bipolar spectrum disorder (or sub-threshold bipolar disorder) is operationalized as having severe mood disturbance, which meets DSM-IV Criteria A for bipolar disorder but meet fewer elements in criteria B (only require 2 items for elation category and 3 for irritability).

Responsible Party: Massachusetts General Hospital ( Janet Wozniak, MD )
ClinicalTrials.gov Identifier: NCT00181883 History of Changes
Other Study ID Numbers: 2004-P-001509
Study First Received: September 13, 2005
Last Updated: June 18, 2010
Health Authority: United States: Institutional Review Board


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There is no criteria for diagnosing pediatric bipolar disorder other than adult criteria currently listed in the DSM-IV. Who decided the 4-6 years olds were bipolar?

REBECCA RILEY

DIED at age 4 after being diagnosed bipolar and placed on Seroquel, Depakote and other psychiatric medications.

Both of her parents were eventually charged with murder, they are in prison and Rebecca's doctor's medical license was restored. Rebecca Riley's doctor testified under immunity.

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I feel it is with reckless disregard for children's health that Mass General would allow such a study to take place, with a drug, Seroquel in known litigation for diabetes and weight gain lawsuits, a drug that is a powerful antipsychotic and not approved for use in children.

Rebecca Riley's death should have been a wake up call for America.

Apparently, it was not a wake up call for C.A.B.F. Child Adolescent Bipolar Foundation, Wozniak, Biederman, Mass General or our government agency that should be watching over the safety of children with psychiatric neuroleptics: THE FDA.

When will the pharmaceutical industry assault on our children stop?
Who will fight for the kids? do parents know Seroquel is not an antidepressant, it is an antipsychotic? do parents know that AstraZeneca buried data that showed they knew it could cause diabetes yet they marketed the drug anyway?

If you are a parent considering these childhood "mental illness" disorders being given to your toddlers and preschoolers, you need a wake up call, you need to research these drugs and pay attention. These drugs can cause permanent body and brain damage, they are not approved for use in little kids and there is no medical model for a diagnoses for childhood bipolar, and certainly no proof that the drugs prescribed are safe for long term use in kids.
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Further reading:

This "Connect-the-dots" round up of KOL's and how they are all connected in "Oh what a tangled web we weave, when first we practice to deceive” – Big Pharma and the evil minions that market their Magic Poison Pills to Children" on the mental health awareness(without sugarcoating) blog, Is Something Not Quite Right with Stan