ABC Resumes Posting Comments RE: Tots Drug Experiments

[Guest guest]

ABC Resumes Posting Comments RE: " Tots Drug Experiments "

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and

Accountability

http://www.ahrp.org/cms/

FYI

ABC News has reposted its report about the drug

experiments conducted on

young children at Harvard University affiliate,

Massachusetts General

Children's Hospital.

ABC investigative reporter, Ross explains:

" We're putting this story

back on line because of the many fascinating

reactions.

My question: Is this an organized campaign or

true grass roots reaction? "

Posted by: Ross

<mailto:brian.ross@...> | May 17, 2006

10:34:02 PM

You can post your comments at:

http://blogs.abcnews.com/theblotter/2006/05/tots_used_as_hu.html

Below are two abstracts from published journal

reports of two (out of

numerous) psychotropic drug experiments conducted

on children as young as 2.

In one experiment toddlers were exposed to the

high risks of two of the most

toxic drugs in psychiatry--Zyprexa (olanzapine)

and Risperdal (risperidone).

The other, a " high-risk pilot study " is " fishing

for " " behavioral

disinhibition " in toddlers, speculating it is a

predisposition to conduct

disorder. The researchers speculate:

" " Behavioral disinhibition " represents an extreme

tendency to seek out

novelty, approach unfamiliar stimuli, and display

disinhibition of speech

and action in unfamiliar

settings. "

There are no laboratory tests for diagnosing any

of the " disorders " the

children were presumed to be " at risk " of, the

experiment is entirely

speculative in nature.

The findings: " the rate of behavioral inhibition

did not differ between the

offspring of parents with and without bipolar

disorder (consensus behavioral

inhibition: 11 of 34 [32%] versus 76 of 244

[31%], respectively, odds

ratio=0.99 [95% CI=0.44-2.24]). The lack of

difference between groups was

observed regardless of the definition of

behavioral inhibition used. "

These experiments on very young children are a

radical example of disease

mongering.

Is this evidence of a veritable cottage industry

targeting young children

for experiments to expand the use of

antipsychotic drugs in children?

They appear to fall outside the boundaries of

" permissible " medical research

inasmuch as the foreseeable risks are not

outweighed by any demonstrable,

empirical evidence.

The experiments, therefore, fail to meet

universally accepted ethical

research standards--as defined in the Nuremburg

Code and the Declaration of

Helsinki; nor do they conform with the Federal

Code of Regulations.

~~~~~~~~~~~~~~

1. Biological Psychiatry. 2005 Oct

1;58(7):589-94.

Open-label, 8-week trial of olanzapine and

risperidone for the treatment of

bipolar disorder in preschool-age children.

Biederman J Mick E , Hammerness P Harpold T

Aleardi M , Dougherty M ,

Wozniak J

Pediatric Psychopharmacology Research Department,

Massachusetts General

Hospital, Boston, Massachusetts 02114, USA.

jbiederman@...

BACKGROUND: To evaluate short-term safety and

efficacy of atypical

antipsychotics in a single-site, prospective,

open-label, 8-week study of

risperidone and olanzapine monotherapy in

preschoolers with bipolar disorder

(BPD).

METHODS: Risperidone was initiated at an

open-label dose of .25 mg/day,

increased weekly according to response and

tolerability to a maximum does of

2.0 mg/day. Olanzapine was initiated at 1.25

mg/day and increased to no more

than 10 mg/day. RESULTS: Thirty-one CHILDREN AGED

4-6 years were treated

with olanzapine (n = 15, 6.3 +/- 2.3 mg/day) or

risperidone (n = 16, 1.4 +/-

..5 mg/day). At study end point (week 8 or last

observation carried forward),

there was a 18.3 +/- 11.9 point (t = -5.6, p <

..001) reduction in

risperidone-treated subjects and a 12.1 +/- 10.4

point (t = -4.4, p < .001)

reduction in Young Mania Rating Scale (YMRS)

scores in olanzapine-treated

subjects that did not differ between groups (t =

1.4, p = .2). Response

criteria (Clinical Global Impression improvement

of " Much " or " Very Much "

improved or a YMRS change of >or= 30% or more)

indicated no difference in

rate of response with risperidone and olanzapine

(69% vs. 53%, chi(2)((1)) =

..8, p = .4).

CONCLUSIONS: This prospective open study suggests

that treatment with

risperidone or olanzapine may result in a rapid

reduction of symptoms of

mania in preschool children with BPD. Because of

substantial residual

symptomatology and adverse effects, however, a

pressing need exists to

identify additional safe and effective treatments

for the management of BPD

in this high-risk population.

2. American Journal of Psychiatry. 2006

Feb;163(2):265-71.

Laboratory-observed behavioral disinhibition in

the young offspring of

parents with bipolar disorder: a high-risk pilot

study.

Hirshfeld-Becker DR , Biederman J , Henin A

Faraone SV , Cayton GA ,

Rosenbaum JF

Mass. General Hospital Pediatric

Psychopharmacology Program, 185 Alewife

Brook Parkway, Suite 2100, Cambridge, MA 02138,

USA. dhirshfeld@...

OBJECTIVE: This study tested whether behavioral

disinhibition is more

prevalent among offspring of parents with bipolar

disorder than among

offspring of parents without bipolar disorder.

METHOD: The authors conducted a secondary

analysis of data from a

preexisting high-risk study of offspring at risk

for panic disorder and

depression (N=278) that had included some

children with parents who had

bipolar disorder (N=34). CHILDREN (AGES 2-6) had

been classified as

behaviorally inhibited, disinhibited, or neither

in laboratory assessments.

RESULTS: Offspring of bipolar parents had

significantly higher rates of

behavioral disinhibition than offspring of

parents without bipolar disorder.

Behavioral inhibition did not differ between

groups. Differences were not

accounted for by parental panic disorder or major

depression or by parental

history of attention deficit hyperactivity

disorder, conduct disorder,

antisocial personality, or substance use

disorders. CONCLUSIONS: Results

suggest a familial link between bipolar disorder

in parents and behavioral

disinhibition in their offspring. Behavioral

disinhibition may be a

familially transmitted predisposing factor for

dysregulatory distress later

in life.

" From the Pediatric Psychopharmacology Program,

Massachusetts General

Hospital; the Department of Psychiatry,

Massachusetts General Hospital,

Boston; the Department of Psychiatry, Harvard

Medical School, Boston; and

the Department of Epidemiology, Harvard School of

Public Health, Cambridge,

Mass.

Address correspondence and reprint requests to

Dr. Hirshfeld-Becker, MGH

Pediatric Psychopharmacology Program, 185 Alewife

Brook Parkway, Suite 2100,

Cambridge, MA 02138; dhirshfeld@...

(e-mail).

Supported by NIMH grant R01 MH-47077-10.

Contact: Vera Hassner Sharav

212-595-8974

veracare@... <mailto:veracare@...>

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