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J&J gave money in return for positive drug studies

Johnson & Johnson gave hundreds of thousands of dollars to a research center run by an influential child psychiatrist specifically to generate data to help expand sales of the company's antipsychotic drug Risperdal in children, according to court documents.

Johnson & Johnson gave hundreds of thousands of dollars to a research center run by an influential child psychiatrist specifically 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.

Officials at Johnson & Johnson said today that they were preparing a response.

Calls left for Biederman and officials at Massachusetts General Hospital were not immediately returned today.

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's Titusville, N.J.-based subsidiary Janssen Pharmaceutica:

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 are overused in children and urged the U.S. Food and Drug Administration to do more to warn doctors of their risks.

In addition to Risperdal, atypical antipsychotics but now include Zyprexa, made by Eli Lilly & Co.; Seroquel, made by AstraZeneca P.L.C.; Geodon, made by Pfizer Inc.; and Abilify, made by Bristol-Myers Squibb & Co. Users of the drugs have filed thousands of injury lawsuits against those companies, and lawyers have requested documents as part of the discovery process.

The documents detailing the close relationship between Biederman and Johnson & Johnson resulted from those discovery efforts. They 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 in payment for a lecture he gave.

"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 that 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), who disclosed that Biederman had failed 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.

Biederman first told Grassley that he had received $3,500 from Johnson & Johnson, but the company told the senator's office that the figure was $58,169 in 2001.