Like a car crash in slow motion, the years that drug companies have spent encouraging the idea that disruptive children ought to be medicated are resulting in ever more lurid revelations in the business press. Yesterday evening came news that a suit against Johnson & Johnson regarding its drug Risperdal was filled with documents describing $6.4 million that J&J spent to popularize the idea that it is acceptable to give atypical antipsychotics to children, off-label. (Risperdal is the fourth most-used off-label drug in the U.S.) The suit was filed by parents claiming that the drugs damaged their children and should never have been prescribed. The FDA recently heard advice that these drugs are overprescribed.
At the center of many of these allegations is Dr. Joseph Biederman of Harvard, who ran a research center funded by J&J into Pediatric Psychopathology Research Center. As the Times notes:
Dr. Biederman's work helped to fuel a fortyfold 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.To give you an idea of how much cash J&J made available to Biederman in pursuit of this goal, here's a summary of the money J&J gave to Biederman, and others, as it promoted antipsychotic drugs for children in the early part of the decade. The dates refer to emails in which the information is contained. (The original documents can be seen here):
- November 1999: $3,000 for a program at UConn, because "Dr. Biederman is not someone to jerk around--he has a very short fuse-- he has enough projects with Lilly to keep his entire group busy for years."
- 2002: J&J sponsored $224,670 worth of various studies.
- March 2002: 1,000 doctors attend a $700 CME course given by Biederman, where Biederman was not "perceived to be aligned with any company in particular."
- July 2, 2002: $369,000 for a Risperdal study.
- July 10, 2002: $55,000 check for Biederman processed.
- Oct. 21, 2002: KOLs paid $2,500 to attend "National Child and Adolescent Advisory Board."
- Nov. 12 , 2002: Biederman receives another $200,000 in funding.
- Dec. 12, 2002: Grant for $181,500 for a Biederman study.
- 2003 business plan: $1.8 million for a "branded pediatric educational institute" and $2.1 million for KOL advisory boards to gain support for adolescent labeling with the FDA.
- 2003: Grant money available rises to $300,000.
- 2003: Biederman demands reimbursement for $100,000 of drugs dispensed to him from a pharmacy.
- 2002/2003: Selling/Marketing and Medical Affairs budget for Mass. General Hospital at $631,000 and $345,000 for 2002 and YTD 2003, respectively.
- 2003: J&J Pediatric Psychopathology Research Center funds rise to $425,000.
- 2004: $500,000 paid to pediatric research center.