Risperdal Promotion Questioned in LawsuitNov 25, 2008 | Parker Waichman LLP
A prominent Harvard psychiatrist may have promised that his work at a psychiatric research institute would promote the off-label pediatric use of Risperdal in a bid to convince Johnson & Johnson to fund the facility, The Boston Globe reported today. The revelations come from emails and other documents released in a lawsuit involving Risperdal and other atypical antipsychotics.
Risperdal wasn't approved for use in children until 2007. However, it is known that doctors prescribed the drug off-label for thousands of children years before that. While off-label prescribing is legal, drug companies are legally barred from marketing off-label uses. But according to The Boston Globe, the companies often skirt that prohibition by paying respected "opinion leaders" - usually top experts in their field - to discuss their off-label prescribing experiences at "educational" talks or meetings.
According to the Boston Globe, Harvard psychiatrist Dr. Joseph Biederman -one of the country's top experts on bipolar disorder in children - is one of those "opinion leaders". As we've reported previously, Biederman has long advocated the use of atypical antipsychotics, like Risperdal, to treat children diagnosed with bipolar disorder.
Biederman's dealings with drug companies have been questioned before. According to The Wall Street Journal, an investigation by Sen. Charles Grassley (R-Iowa) found that from 2000 through 2007, Biederman received $1.6 million from Johnson & Johnson. However, only a fraction of that was reported to Harvard.
According to the Journal, Biederman and colleagues published many favorable Risperdal studies while he was on the Johnson & Johnson payroll. A 2005 study, for instance, concluded that "risperidone (Risperdal) treatment was associated with a significant short-term improvement of symptoms of pediatric bipolar disorder."
Now, documents released as part of a huge, multi-state lawsuit have raised questions about Biederman's role in convincing Johnson & Johnson's to fund a center on pediatric bipolar disorder at Massachusetts General. According to the Boston Globe, the lawsuit was brought on behalf of more than 2,000 patients, including children, who claim to have been injured by atypical antipsychotics, including Risperdal. Though Biederman is not a defendant in the suit, the Globe reports that plaintiffs lawyers are using his relationship with Johnson & Johnson to illustrate how researchers and drug companies conspired to boost off-label prescriptions of atypical antipsychotics.
According to the Globe article, emails written between executives at Johnson & Johnson subsidiary Janssen Pharmaceuticals indicate Biederman had repeatedly proposed that the company help fund the center. One of the emails, written in 2002, stated that "the rationale of this center is to generate and disseminate data supporting the use of risperidone (Risperdal) in this patient population." Another email mentions at least $700,000 in Johnson & Johnson payments to the center, the Globe said.
The Boston Globe also reports that the research institute's 2002 annual report states that one of the center's "essential features" is its ability to conduct research that "will move forward the commercial goals of J&J (Johnson & Johnson)"
Hopefully, Biederman himself will be able to shed more light on his dealings with Johnson & Johnson. According to the Globe, lawyers representing plaintiffs in the atypical antipsychotic lawsuit recently won their bid to compel an interview with Biederman. The Globe said he is expected to be interviewed under oath by January.