Personal Injury Law

Harvard Psychiatrist Promised Clinical Trial Results To Drugmakers

By Jane Akre

No wonder he wants the court documents sealed away from the public eye.

Dr. Joseph Biederman, a well-known Harvard psychiatrist became the poster-child for conflicting interests when Sen. Charles Grassley uncovered that he underreported to the university most of the $1.6 million he was paid by drug companies, while promoting their antipsychotics to children.

Now as a key witness in litigation by state attorneys general seeking Medicaid reimbursements from those drugmakers - documents show Biederman went so far as to make promises about the outcome of clinical trials to the drug companies before he conducted them.

That information comes from his deposition The New York Times has received and published portions.  

• Court documents show Dr. Biederman outlined plans to Johnson & Johnson company executives about a proposed trial of the antipsychotic drug risperidone (Risperdal).  The trial "will support the safety and effectiveness of risperidone in this age group," he promised before even conducting the drug trial.
  
• In "Key Projects for 2004" (a set of slides the doctor presented to company executives) included a proposed trial comparing risperidone to its nearest competitor in managing pediatric bipolar disease. Dr. Biederman promises the trial "Will clarify the competitive advantages of risperidone vs. other neuroleptics."

In 2005, a study authored by Dr. Biederman compared Risperdal (Johnson & Johnson) and Zyprexa concluding the former improved depressive symptoms. Zyprexa did not.

• Among the "Key Projects for 2005" a slide shows another proposed study of adolescents making Concerta, a Johnson & Johnson stimulant.  Again Dr. Biederman promises a "positive findings with Concerta in A.D.H.D" in unusual cases of hyperactivity.

Dr. Biederman was the director of the Johnson & Johnson Center for Pediatric Psychopathology Research at Massachusetts General Hospital in Boston.

He is a national leader in diagnosing bipolar disorder and well-known advocate for treating children with the disorder with antipsychotics.

The New York Times reports, "Dr. Biederman's work helped to fuel a 40-fold increase from 1994 to 2003 in the diagnosis of pediatric bipolar disorder and a rapid rise in the use of powerful, risky and expensive antipsychotic medicines in children."

Dr. Biederman is under investigation by the National Institutes of Health and Harvard for violation of university and federal rules.  He has lost his and he has suspended his work with the drug industry while the investigation is underway.  He says the revelations have publicly embarrassed him. 

In the February 26 deposition, Dr. Biederman was asked his rank or title at Harvard.

"Full professor" he says.  What comes after that, a lawyer asks.

"God" says Dr. Biederman.    #

Full post as published by InjuryBoard on March 20, 2009 (boomark / email).