J&J helped plan child research institute: report

CHICAGO (Reuters) - Internal company documents suggest Johnson & Johnson, maker of the antipsychotic drug Risperdal, agreed to fund a child psychiatry research center at Massachusetts General Hospital to generate data to support use of the drug in children, the Wall Street Journal reported on Monday.

The drug, known generically as risperidone, recently came under fire from an advisory panel to the U.S. Food & Drug Administration after documents submitted to the panel revealed children and teenagers make up nearly 25 percent of its sales.

An e-mail from an employee of J&J’s Janssen unit, posted on the Journal’s Web site, describes a series of meetings with Dr. Joseph Biederman of Harvard University and Massachusetts General in which Biederman proposed creation of a joint center for bipolar disorders in children.

“The rationale for this center is to generate and disseminate data supporting use of risperidone in this patient population,” the 2002 e-mail read.

The e-mails, produced in a lawsuit against the company, suggest J&J helped plan and fund the institute, and that company officials even helped to write research done by Dr. Biederman and his colleagues, the Journal reported.

U.S. Sen. Charles Grassley has accused Biederman of failing to fully disclose payments from drug companies.

Janssen spokeswoman Kara Russell said in a statement the company helped fund the institute in 2002 to conduct “rigorous clinical trials to clarify appropriate use and dosing of Risperdal in children.”

These included treatment of schizophrenia in adolescents aged 13 to 17 and irritability associated with autistic disorder in children and adolescents aged 5 to 16, uses of the drug that were later approved by the FDA.

“We promote our products only for their FDA-approved indications,” Russell said in the statement.

Once approved, doctors are free to use a drug as they like, but companies cannot promote drugs for unapproved uses.

According to documents submitted to the FDA panel last week, Risperdal is increasingly being prescribed to children for unapproved uses. These include attention deficit hyperactivity disorder. Its side effects include muscular tics, rapid weight gain and increased risk for diabetes.

A statement from Massachusetts General Hospital e-mailed to Reuters said agreements governing the J&J grant specified the center was for “scientific and educational purposes only and not for purposes of promoting, directly or indirectly, the products of Johnson & Johnson and its affiliates.”

The hospital said news reports have raised questions about the implementation of those agreements. “The MGH takes these allegations very seriously and intends to investigate these issues thoroughly,” the hospital said in its statement.

(Editing by Chris Wilson)


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