Court documents in a New Jersey, USA, law suit indicate that a leading Harvard Medical School child psychiatrist may have "promised" to help health care major Johnson & Johnson's Janssen Pharmaceutica unit market an antipsychotropic drug for off-label pediatric use. The claim, circulated by a report in the Boston Globe, is part of a case being brought against the manufacturer of Risperdal (risperidone) by a Pennsylvania-based lawyer, Steven Sheller.
A Janssen spokesperson told the Marketletter that the company cannot comment on the details of an ongoing court case. However, she confirmed that, in 2002, Janssen helped fund a pediatric psychopharmacology research center at Massachusetts General Hospital, with an objective to conduct rigorous clinical trials to clarify appropriate use and dosing of Risperdal in children. She said: "these indications were extensively studied and some, such as treatment of schizophrenia in adolescents aged 13-17, and irritability associated with autistic disorder in children and adolescents aged 5-16 were approved by the [Food and Drug Administration]. We promote our products only for their FDA-approved indications."
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