Johnson & Johnson gave hundreds of thousands of dollars to a research center run by an influential child psychiatrist explicitly to generate data to help expand sales of the company's antipsychotic drug Risperdal in children, according to court documents.
The documents shed new light on Johnson & Johnson's close relationship with Joseph Biederman, a Harvard University psychiatrist at the center of a controversy involving the dramatic increase in antipsychotic drugs, including Risperdal, prescribed for children, often for unapproved uses.
Johnson & Johnson spent at least $700,000 to fund the Johnson & Johnson Center for Pediatric Psychopathology at Massachusetts General Hospital. The purpose of the center, according to an internal company e-mail contained in the court documents, was to "generate and disseminate data supporting the use" of Risperdal in children and adolescents.
Risperdal is used to treat bipolar disorder and schizophrenia.
The e-mails were from 2001 and 2002, long before the U.S. Food and Drug Administration approved Risperdal for use in children in 2006. Physicians are allowed to prescribe drugs for unapproved uses or patients, but drugmakers are barred from marketing drugs for such off-label uses and can face civil charges and steep fines.
Officials at Ortho-McNeil-Janssen Pharmaceuticals Inc., the Johnson & Johnson subsidiary in Titusville, N.J., that makes Risperdal, said they funded the center "to conduct rigorous clinical trials to clarify appropriate use and dosing of Risperdal in children."
The company said it promoted its products "only for their FDA-approved indications."
Biederman did not return a phone call.
The documents were provided by plaintiff lawyers pursuing a class-action suit against Johnson & Johnson, contending that such a powerful drug should not have been widely recommended for children.
The court papers show Johnson & Johnson:
Budgeted $6.4 million to hold "educational summits" and sponsor advisory panels in part to counter negative media reports on the research, diagnosis and treatment of children with mental illness;
Was actively involved in drafting research that Biederman was to present at a medical conference and asked him how to deal with unfavorable research results suggesting that a placebo worked as well as Risperdal;
Discussed clinical trials for drugs as "growth opportunities" and tied trial proposals to sales potential.
Biederman is a Harvard researcher and psychiatrist whose work has fueled a rapid rise in diagnoses of bipolar disorder in children. His studies, often on small numbers of children and funded by drug companies, have expanded the use of what are known as atypical antipsychotics in children.
Children are believed to be much more vulnerable to the side effects of these drugs, which include weight gain, breast milk production in both sexes, facial tics and muscle tremors.
Last Tuesday, a panel of federal drug experts said antipsychotic medicines were overused in children and urged the Food and Drug Administration to do more to warn doctors of their risks.
Besides Risperdal, atypical antipsychotics include Zyprexa, made by Eli Lilly & Co.; Seroquel, made by AstraZeneca P.L.C. and others.
The documents, which resulted from discovery efforts in the lawsuits, portray Biederman as using his influence to get money out of Johnson & Johnson.
In an e-mail from November 1999, for example, Johnson & Johnson marketing executive John Bruins warned his bosses to quickly issue a $3,000 check to Biederman to pay for a lecture.
"Dr. Biederman is not someone to jerk around," Bruins wrote. "He is a very proud national figure in child psych and has a very short fuse."
Bruins also suggested that Biederman had taken business away from Johnson & Johnson after the company turned down the doctor's request for a $280,000 research grant. "I have never seen someone so angry," Bruins wrote. "Since that time, our business became non-existant (sic) within his area of control."
In the court documents, e-mails from Johnson & Johnson executives said Biederman had asked the company to fund a pediatric research institute at Massachusetts General Hospital, resulting in a donation of at least $700,000 in 2002. Biederman is listed as the chief of the Johnson & Johnson Center for Pediatric Psychopathology.
Biederman is the subject of investigations by Harvard and by Sen. Charles Grassley (R., Iowa) for failing to disclose to Harvard at least $1.4 million in funds from Johnson & Johnson and other companies. Laws require researchers to disclose such relationships to their employers, to protect the integrity of medical research.
Massachusetts General said yesterday in a statement that it planned to investigate the allegations raised in the court documents.
Harvard said it was not connected to Massachusetts General Hospital or to the pediatric institute there. A university spokesman said he could not comment on Harvard's review.
Biederman first told Grassley he had received $3,500 from Johnson & Johnson, but the company told the senator's office the figure was $58,169 in 2001.