[PAA-Discuss] Fwd: [ICSPP_Discussion_Group] From Bnet:Pharma's Next Big Thing:Psychiatric Drugs for Preschoolers

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From: rebelljb <rebelljb at aol.com>
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Subject: [ICSPP_Discussion_Group] From Bnet:Pharma's Next Big 
Thing:Psychiatric Drugs for Preschoolers




http://m.bnet.com/blog/drug-business/big-pharma-8217s-next-big-thing-antipsychotic-medicines-for-preschoolers/5624

Big Pharma’s Next Big Thing: Antipsychotic Medicines for Preschoolers
By Jim Edwards | September 1, 2010
Dr. Joan Luby, the preschool depression researcher at the center of a
New York Times article that failed to mention her past research was
funded by Johnson & Johnson (JNJ), Shire (SHPGY) and AstraZeneca (AZN),
is currently testing the antipsychotic Risperdal on autistic children
aged 30 months to 5 years old, according to the ClinicalTrials.gov
database. Although the study is not funded by Janssen, the unit of J&J
that makes Risperdal, it nonetheless typifies a new field of drug
research: The use of mood-altering pharmaceuticals on the very, very
young.

The NYT piece investigated the development of preschool depression as a
diagnosis. Slate, like me, found it surprising that the author did not
believe Big Pharma’s interest in the field was relevant. Minyanville
thought the same thing. Such research is controversial. In November
2008, the FDA said antipsychotic drugs were over-used in children and
that more should be done to discourage doctors from treating unruly
kids with powerful drugs.

Luby — who also believes that certain antidepressants may be effective
in children, according to this press release — is just one researcher
looking at extending the use of antipsychotics to very young kids.
Here’s a study on Lithium vs. Risperdal in kids aged 7 and up. And
here’s a similar trial on kids aged 6 and up. GlaxoSmithKline (GSK) is
currently testing Paxil on 7-year-olds despite that medicine’s
well-document propensity to trigger suicides in young patients.

The reason the FDA has warned against use of these drugs in kids is
twofold: First, many of these products are not approved for use in
children. Risperdal — the product in the Luby study of 30-month olds —
is only approved for use in autistic children older than 5; and for
schizophrenics older than 13. Eli Lilly (LLY)’s competing antipsychotic
Zyprexa is not indicated for anyone below the age of 13.

Second, drug companies generally do all their tests on the more robust
bodies of adults. Relying on those results to use drugs in children is
therefore a bit of a crapshoot. Here’s an anecdotal history:

•Risperdal can cause boys to grow breasts, the FDA heard in 2008.
•The FDA put a “black box” warning on GSK’s Paxil because the drug
triggers suicides in children. One of GSK’s researchers is a convicted
criminal who faked her results.
•Likewise, Pfizer (PFE) was cited by the FDA for giving kids overdoses
of Geodon in its pediatric drug trials
•And AstraZeneca just paid nearly $200 million to settle 17,500
lawsuits claiming Seroquel (another antipsychotic) is linked to
diabetes.
Luby did not immediately return two messages requesting comment. In her
defense, it’s worth knowing that she’s also studying non-drug
intervention — therapy, basically — for young children with depression.

Related:

•Meet the Queen of “Preschool Depression” — and Her Drug Company Backers
•AGP to Probe Undisclosed Industry Ties of Doc Who Recommends
Antidepressants for 3-Year-Olds
•Doc Who Urged Antipsychotics for 3-Year-Olds Funded by J&J, AZ and
Shire
•Glaxo Is Testing Paxil on 7-Year-Olds Despite Well Known Suicide Risks

•Kid Overdoses in Antipsychotic Trial Caps a History of Screwups at
Pfizer

•FDA: J&J’s Risperdal and Lilly’s Zyprexa Are Over-Used in Kids

•Breast Growth in Boys Taking J&J’s Risperdal Was Known Since at Least
2004



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