Fw: [abmd] Children 4-6 years old with bipolar - opinion piece plus info from ClinicalTrials.gov

May 21, 2006

Under the heading " Believe it or Not "

[abmd] Children 4-6 years old with bipolar - opinion piece plus info

from ClinicalTrials.gov

Outrage! Preschoolers used as guinea pigs in psychotropic drug tests

Posted Thursday, May 18, 2006 by Mike

Print this article Permalink: http://www.NewsTarget.com/019389.html

Key concepts: psychiatry, preschoolers and psychiatrists.

--------------------------------------------------------------------------

As ClinicalTrials.gov reveals, in 2005, Massachusetts General Hospital

conducted an 8-week trial study that recruited children as young as four years

old to be drugged and monitored, including having their blood drawn, to see if

their tiny four-year-old bodies would tolerate a powerful psychotropic drug

(Seroquel).

Here's more from ClinicalTrials.gov:

This is an 8-week open-label study aimed at assessing the effectiveness

and tolerability of Quetiapine, in the treatment of preschool children aged 4 to

6 years with bipolar and bipolar spectrum disorder. This is an exploratory,

pilot study, seeking to determine whether Quetiapine is efficacious and well

tolerated in the treatment of preschoolers with pediatric bipolar and bipolar

spectrum disorder in this age group.

Ages Eligible for Study:4 Years - 6 Years, Genders Eligible for Study:

Both

Subject must be able to participate in mandatory blood draws.

Massachusetts General Hospital, Cambridge, Massachusetts, 02138, United

States; Recruiting

ph Biederman, MD, Principal Investigator

Chemical child abuse

In my view, this exploitation of young children for drug testing amounts

to nothing less than chemical child abuse. What possible medical justification

could these doctors, hospital staff and drug pushers have for prescribing

mind-altering drugs to four-year-olds? Even the " disease " being treated here is

entirely fictional. So-called " bi-polar disorder " was wholly invented by

psychiatrists with strong financial ties to drug companies. The purpose of this

disease is not to help children, but to sell drugs to anyone and everyone,

including toddlers.

I often wonder when the rest of the country will wake up and notice that

the mass-drugging of our nation's children has gone too far. Why isn't the

mainstream media giving this front-page coverage? Why aren't lawmakers demanding

an end to the chemical abuse of our children? Why isn't the FDA halting these

trials on toddlers out of plain decency?

ou already know the answer: Because they're all making money from

this chemical assault on our nation's children. The doctors, hospitals, drug

companies, psychiatrists and mainstream media all profit handsomely from the

sales of mind-altering drugs to children. Ethics will never get in the way of

old-fashioned greed, even when we're talking about the health and lives of

four-year-olds.

Modern psychiatry, with all its false authority, drugging of

children and rampant disease mongering, is an affront to all people who believe

in honest medical science and basic human decency. Armed with the DSM-IV,

on-the-take psychiatrists invent diseases out of thin air (like " bi-polar

disorder " ), then vote official treatment protocols into the reference books. Yet

a recent review of such decision panels reveals that one hundred percent of the

psychiatrists and doctors involved in such decisions have financial ties to the

drug companies that coincidentally happen to manufacture the recommended drugs.

This is a life-threatening scandal of such proportion that it

deserves a Dept. of Justice investigation, complete with criminal charges being

brought against many of these so-called " doctors. " To characterize this as a

crime against humanity is not an exaggeration.

Blatant quackery

Let's face it: Modern psychiatry and its incessant disease mongering

amounts to quackery at its worst. This group both invents the diseases, then

hawks the snake oil that " treats " those diseases. And underneath it all, there's

absolutely no physiological evidence of any such diseases at all. They can be

diagnosed in children on a whim, based on a mere sixty seconds of casual

observation combined with the biased opinion of a drug-pushing psychiatrist

being bribed by Big Pharma.

education, psychiatry

This is not medicine, folks. And it's certainly not science. It's

just plain medical fraud. Yet the whole of conventional medicine goes along with

it, pretending that nothing is amiss. Doctors, hospitals, FDA bureaucrats,

teachers and even many parents just pretend that all these mysterious brain

chemistry diseases have spontaneously appeared in the world over the last ten

years, suddenly afflicting tens of millions of children. And thank goodness the

drug companies just happened to have invented all these treatment drugs at the

exact same moment in history when these psychiatric diseases became so

widespread! Imagine the odds...

Where are the skeptics on this issue? Where are the quack busters on

the drugging of our children? The silence is deafening. They have nothing to say

about the lack of science behind psychiatric disease mongering. They aren't

skeptical at all. Clear thinking, it seems, isn't allowed when the conclusions

might question the institutions of modern medicine. And thus, the skeptics

reveal themselves as little more than purveyors of medical dogma; protectors of

a drug-the-children medical cult that demands unquestioning obedience to its

profit-minded beliefs.

Good science has long since left psychiatry. And if you want to know

the true, horrifying history of the mental health industry, visit the Citizen's

Commission on Human Rights. Prepare to be shocked.

Born psychotic

Psychiatry believes there is no child too young to diagnose as

having psychiatric disorders. It won't be long before psychiatrists will be

hanging out in delivery rooms, declaring children to be mentally diseased at

birth (because they keep crying, obviously) and immediately injected with

powerful mind-altering drugs. To psychiatry, human life has no value other than

the possibility of creating a new paying customer, and every new birth is seen

as another opportunity for dispensing profitable drugs.

on natural medicine

There's no end to the evil that psychiatry might do in the years

ahead. As long as society continues to give psychiatrists carte blanche to

invent fictitious diseases, there is no human behavior, emotion or condition

that's safe from being labeled a pathology. So-called " adult ADHD screening

tests " label a whopping 80 percent of participants with the disease. Behavioral

disorders screenings for children demonstrate similar numbers. And the things

that can get you labeled as " diseased " are all too mundane: Feeling overwhelmed,

feeling distracted by modern life, handling too many projects as once, being

afraid of public speaking, feeling shy in social situations... gee, is there

anyone who doesn't experience these sooner or later?

But it wasn't enough to attempt to drug up all the adults, you see.

Modern psychiatry had to expand its markets, and that meant reaching younger and

younger " customers. " A couple of decades ago, they started drugging teens with

antidepressant drugs. Then they attacked younger schoolchildren with Ritalin.

Now they're targeting preschoolers, and the trend is clear: Children will soon

be " born psychotic " if psychiatry has anything to do with it.

Years ago, the giant soda companies handed out baby bottles emblazed

with the logos of their flagship soft drink products. The idea was to get

mothers to feed their infants soda instead of infant formula, thereby altering

the taste of the infant for life, creating a lifelong consumer of soft drinks.

When I first uncovered this disturbing report, I thought it was perhaps the most

evil thing a corporation could do to the health of infants. But now, psychiatry

takes the prize.

Using four-year-olds as guinea pigs to test psychotropic drugs is

more than merely unethical; it's predatory. It's Nazi-esque in its use of human

beings for medical experiments, and yet it remains strangely acceptable across

society. Child Protective Services does nothing. Hospitals gladly run the trials

(they get paid, of course). Psychiatrists and doctors happily drug these

children, observe them, then draw their blood, all in the name of corporate

profits. And thus, they all join the long and sordid history of human medical

experimentation that demonstrates ethics, or human lives, or plain decency will

never get in the way of the forward march of medicine.

true history of modern medicine and psychiatry (1833-1965)

The complicity of conventional medicine is astounding. The American

Medical Association, to my knowledge, says nothing skeptical about disease

mongering by psychiatry. Few doctors see any problem at all, and fewer still

have the courage to speak out. The FDA, which is supposed to protect people,

gladly approves one psychotropic drug after another, even for use on toddlers.

Lawmakers take campaign finance contributions from drug companies and look the

other way, and the mainstream media continues publicizing fictitious diseases,

lending them false credibility and creating customer demand for dangerous drugs.

Only a handful of doctors, authors, organizations and celebrities

dare tell the truth on this issue, and they are singled out for incessant

ridicule. Take Tom Cruise, for example. Although he speaks the truth about the

drugging of children, he is endlessly dragged through the mud of public opinion

simply because he expresses authentic passion for ending this chemical child

abuse. Cruise should be applauded for his efforts, not ridiculed.

Let's hospitalize the psychiatrists

When it comes to mental health, there is one group of people in this

country that truly needs to be drugged: The psychiatrists. Because to practice

psychiatry today, and to support the mass drugging of toddlers and

schoolchildren, is to demonstrate a deep-rooted madness that may justify

chemical restraint. To drug toddlers, or to use them for medical experiments,

should be rightly regarded as a crime. And there's no question whatsoever that

the children of our nation would be safer, healthier and happier if the practice

of modern psychiatry simply disappeared.

Besides, the real cause of depression, mood swings, emotional

disorders or other so-called " diseases " mostly comes down to diet and lifestyle.

Remove the food additives and refined sugars from a child's diet, and he returns

to normal in about two weeks. Feed children healthy oils, live foods, whole

grains and superfoods, and you automatically create energetic, curious,

fast-learning children who need no drugs. Give children some sunshine, play time

and some time with nature, and you get balanced, healthy children. It's no

secret, it's just common sense.

epidemic

But psychiatry has no common sense, and no one in the industry dares

mention that most so-called mental disorders are really just caused by

nutritional imbalances. Because to admit to the truth about the mental health of

children would be to render their careers irrelevant. And no psychiatrist is

going to commit career suicide by admitting that bi-polar disorder was just made

up, or that toddlers need good food, not expensive drugs. Just like conventional

doctors, psychiatrists have to protect their egos and revenue streams, and that

means convincing parents that little ny has a brain chemistry imbalance and

he'll have to take psychotropic drugs for life. The parents, as gullible as

ever, naively go along with the scam, usually after being frightened into

compliance by a psychiatrist who warns them what might happy to little ny of

they don't drug him. " He might commit suicide, " they're sternly warned.

Will the scams of modern medicine never cease? Is there no child too

young to be targeted for medical experiments? Will the sinister desire for Big

Pharma profits ever be balanced against basic human decency?

Probably not. The world has, indeed, gone half mad. And psychiatry

is standing by, ready to drug everyone, regardless of their age or mental health

status.

Link back to this article: http://www.NewsTarget.com/019389.html

**************************

http://www.clinicaltrials.gov/ct/show/NCT00181883?order=1

Home Search Listings Resources Help What's New About

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

Disorder

This study is currently recruiting patients.

Verified by Massachusetts General Hospital March 2006

Sponsored by: Massachusetts General Hospital

Information provided by: Massachusetts General Hospital

ClinicalTrials.gov Identifier: NCT00181883

Purpose

This is an 8-week open-label study aimed at assessing the effectiveness and

tolerability of Quetiapine, in the treatment of preschool children aged 4 to 6

years with bipolar and bipolar spectrum disorder. This is an exploratory, pilot

study, seeking to determine whether Quetiapine is efficacious and well tolerated

in the treatment of preschoolers with pediatric bipolar and bipolar spectrum

disorder in this age group. The study results will be used to generate

hypotheses for a larger randomized controlled clinical trial with explicit

hypotheses and sufficient statistical power.

Condition Intervention Phase

Bipolar Disorder

Mania

Drug: quetiapine (Seroquel)

Phase IV

MedlinePlus related topics: Bipolar Disorder

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group

Assignment, Safety/Efficacy Study

Official Title: Open-Label Study of Quetiapine for Mania In Preschool Children 4

to 6 Years of Age With Bipolar and Bipolar Spectrum Disorder

Further study details as provided by Massachusetts General Hospital:

Primary Outcomes: reductions in symptoms measured by; Young-Mania Rating Scale

(Y-MRS); Mania Symptom Checklist

Expected Total Enrollment: 20

Study start: February 2005

S elroquil is a psychotropic agent that affects multiple neuro transmitter

receptors in the brain: serotonin 5HT1A and 5HT2, dopamine D1 and D2, histamine

H1 (IC50=30nM), and adrenergic receptors.

This is an 8-week open-label study aimed at assessing the effectiveness and

tolerability of Quetiapine, in the treatment of preschool children aged 4 to 6

years with bipolar and bipolar spectrum disorder. This is an exploratory, pilot

study, seeking to determine whether Quetiapine is efficacious and well tolerated

in the treatment of preschoolers with pediatric bipolar and bipolar spectrum

disorder in this age group. The study results will be used to generate

hypotheses for a larger randomized controlled clinical trial with explicit

hypotheses and sufficient statistical power.

Eligibility

Ages Eligible for Study: 4 Years - 6 Years, Genders Eligible for Study:

Both

Criteria

Inclusion Criteria:

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

b.. 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).

c.. Subjects and their legal representative must have a level of understanding

sufficient to communicate intelligently with the investigator and study

coordinator, and to cooperate with all tests and examinations required by the

protocol.

d.. Subjects and their legal representative must be considered reliable.

e.. Each subject and his/her authorized legal representative must understand

the nature of the study. The subject's authorized legal representative must sign

an informed consent document.

f.. Subjects must have an initial score on the Y-MRS total score of at least

20.

g.. Subject must be able to participate in mandatory blood draws.

h.. Subjects with comorbid ADHD, ODD, CD, anxiety and depressive disorders

will be allowed to participate in the study provided they do not meet for any of

the exclusionary criteria.

i.. For concomitant stimulant therapy used to treat ADHD, subjects must have

been on a stable dose of the medication for 1 month prior to study enrollment.

The dose of the stimulant therapy will not change throughout the duration of the

study.

Exclusion Criteria:

a.. Investigator and his/her immediate family; defined as the investigator's

spouse, parent, child, grandparent, or grandchild.

b.. Serious, unstable illness including hepatic, renal, gastroenterological,

respiratory, cardiovascular (including ischemic heart disease), endocrinologic,

neurologic, immunologic, or hematologic disease.

c.. Uncorrected hypothyroidism or hyperthyroidism.

d.. History of severe allergies or multiple adverse drug reactions.

e.. Non-febrile seizures without a clear and resolved etiology.

f.. Leukopenia or history of leukopenia without a clear and resolved etiology.

g.. Judged clinically to be at serious suicidal risk.

h.. Any other concomitant medication with primarily central nervous system

activity other than specified in Concomitant Medication portion of the protocol.

i.. A non-responder or a history of intolerance to an adequate trial of

Quetiapine(2 months or more at an adequate dose) as determined by the clinician.

j.. Current diagnosis of schizophrenia.

k.. Non English speaking subjects will not be allowed into the study for the

following reasons: a) the assessment instruments are not available and have not

been adequately standardized in other languages; our clinical trials facility

is located in Cambridge and not in the MGH main campus without the availability

of translators; c) psychiatric questionnaires and evaluations are taxing and

adding the complexity of a translator has the potential to make the patient

experience even more exhausting.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier NCT00181883

Meghan Dougherty, BS 617 503-1051 mdougherty2@...

Massachusetts

Massachusetts General Hospital, Cambridge, Massachusetts, 02138, United

States; Recruiting

Meghan Dougherty, BS 617-503-1051 mdougherty2@...

Aleardi, BA 617 503-1405 maleardi@...

ph Biederman, MD, Principal Investigator

Study chairs or principal investigators

ph Biederman, MD, Principal Investigator, Massachusetts General Hospital

More Information

Study ID Numbers: 2004-P-001509

Last Updated: March 10, 2006

Record first received: September 13, 2005

ClinicalTrials.gov Identifier: NCT00181883

Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on 2006-05-19

U.S. National Library of Medicine, Contact NLM Customer Service

National Institutes of Health, Department of Health & Human Services

Copyright, Privacy, Accessibility, Freedom of Information Act

* * * *

Vaccinate'em 'til they break, then sell pharms for the symptoms. Bill for all

procedures.

* * * *

The material in this post is distributed without

profit to those who have expressed a prior interest

in receiving the included information for research

and educational purposes. For more information go to:

http://www4.law.cornell.edu/uscode/17/107.html

http://oregon.uoregon.edu/~csundt/documents.htm

If you wish to use copyrighted material from this email

for purposes that go beyond 'fair use', you must obtain

permission from the copyright owner.

Sign In

Fw: [abmd] Children 4-6 years old with bipolar - opinion piece plus info from ClinicalTrials.gov

Recommended Posts

Guest guest

Join the conversation

Activity