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Risperdal Researcher Promised Drug Maker Positive Results from Clinical Trials

Mar 20, 2009 | Parker Waichman LLP A prominent Harvard psychiatrist promised positive results to Johnson & Johnson before the start of some clinical trials for Risperdal.  According to The Wall Street Journal, the revelations regarding Dr. Joseph Biederman came to light in court documents that are part of  a lawsuit involving Risperdal and other atypical antipsychotic drugs.  While he is not a defendant in the case, Biederman was called as a witness to illustrate the questionable financial ties between drug makers and the research community.

Some of the 2,000  plaintiffs involved in the multi-state lawsuit are children.  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.

As we reported last November, Biederman was one of those opinion leaders.  Biederman has long advocated the use of atypical antipsychotics, like Risperdal, to treat children diagnosed with bipolar disorder.  The lawsuit has raised questions about Biederman’s role in convincing Johnson & Johnson’s to fund a center on pediatric bipolar disorder at Harvard's Massachusetts General Hospital.

According to a Boston Globe article published at the time, 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.

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. Earlier this year, Biederman agreed to step down from a number of industry-funded clinical trials until Massachusetts General Hospital investigates that lack of disclosure.

Now The Wall Street Journal is reporting that a Powerpoint presentation given by Biederman to Johnson & Johnson executives included a slide that said a future clinical trial  aimed at evaluating the use of Risperdal in preschool children “will support the safety and effectiveness of risperidone (Risperdal) in this age group."

Another slide that addressed a Risperdal trial meant to compare the drug to others in treating pediatric bipolar disorder promised the study would "clarify the competitive advantages of risperidone vs. other neuroleptics," the Journal said.

Meanwhile, the Boston Globe reported today that Biederman is trying to have his own testimony in the antipsychotic lawsuit  sealed.  According report, Biederman's lawyers have argued that making his testimony public “could be immensely damaging to him, both personally and professionally."

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