Big Pharma's Next Big Thing: Antipsychotic Medicines for Preschoolers

(MoneyWatch)  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

Photo of a baby's straitjacket from Flickr user endora57, CC.