ABC Resumes Posting Comments RE: Tots Drug Experiments

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[sSRI-Research] 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, Brian 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: Brian Ross <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 <veracare

 

 

 

 

 

Drug-Free School Zone? Just Say NO to Prozac for Children.