ABC Resumes Posting Comments RE: “Tots Drug Experiments”

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 <mailto:brian.ross@abcnews.com>  | May 17, 2006 10:34:02 PM

Further evidence of the alarming increase in the misuse of antipsychotic drugs in the U.S., FDC Reports:  Antipsychotic growth rate fastest in children  The number of children under age 20 using antipsychotic drugs is increasing (73% from 2001-2005) at a faster rate than other age groups, a Medco analysis finds. The trend in atypical antipsychotics, which are not approved for use in children, differs from the steady or declining use of other behavioral drugs, including ADHD treatments, Medco said. The PBM’s analysis found that children receive atypical antipsychotics, rather than older treatments, 97% of the time….    [See: FDC Reports May 15, 2006 Volume 68  |  Number  020]

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 at Mass General Children’s Hospital.

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.

Contact: Vera Hassner Sharav
veracare@ahrp.org <mailto:veracare@ahrp.org>
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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@partners.org

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@partners.org

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@partners.org (e-mail).  Supported by NIMH grant R01 MH-47077-10.