J&J to Pay $2.2B to Settle Off-Label Risperdal Marketing Case

Kermit Cole
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Johnson & Johnson and its subsidiaries will pay more than $2.2 billion – one of the largest health-care fraud settlements in history – to settle criminal and civil liabilities arising from marketing of Risperdal and its injectable version, Invega, for uses not approved by the FDA.  J&J admitted to inappropriate promotion of Risperdal to treat elderly, non-schizophrenic patients for symptoms such as anxiety, agitation, depression, hostility and confusion. “The conduct at issue in this case jeopardized the health and safety of patients and damaged the public trust,” said Attorney General Eric Holder.

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Kermit Cole
Kermit Cole, MFT, founding editor of Mad in America, works in Santa Fe, New Mexico as a couples and family therapist. Inspired by Open Dialogue, he works as part of a team and consults with couples and families that have members identified as patients. His work in residential treatment — largely with severely traumatized and/or "psychotic" clients — led to an appreciation of the power and beauty of systemic philosophy and practice, as the alternative to the prevailing focus on individual pathology. A former film-maker, he has undergraduate and master's degrees in psychology from Harvard University, as well as an MFT degree from the Council for Relationships in Philadelphia. He is a doctoral candidate with the Taos Institute and the Free University of Brussels. You can reach him at [email protected]

17 COMMENTS

    • The doctors were “misled” (lied to). See below.

      The settlement won’t resolve suits brought by attorneys general in Arkansas, Louisiana and South Carolina, where the company has appealed or has said it will appeal judgments over Risperdal sales.

      Judges or juries in those states have ordered J&J to pay a total of about $1.8 billion in damages and fines over Risperdal marketing campaigns that were found to have misled doctors and patients about the drug’s health risks and effectiveness.

      See http://www.bloomberg.com/news/2013-11-04/j-j-settlement-over-risperdal-said-to-be-announced-today.html

      This whole Risperdal thing started real dirty,

      An influential Harvard child psychiatrist told the drug giant Johnson & Johnson that planned studies of its medicines in children would yield results benefiting the company, according to court documents dating over several years that the psychiatrist wants sealed.

      Dr. Joseph Biederman

      The psychiatrist, Dr. Joseph Biederman, outlined plans to test Johnson & Johnson’s drugs in presentations to company executives. One slide referred to a proposed trial in preschool children of risperidone, an antipsychotic drug made by the drug company. The trial, the slide stated, “will support the safety and effectiveness of risperidone in this age group.”

      Dr. Biederman was the lead author of a trial published last year concluding that treatment with risperidone improved symptoms of attention deficit and hyperactivity disorder in bipolar children.

      Dr. Biederman — who was director of the Johnson & Johnson Center for Pediatric Psychopathology Research at Massachusetts General Hospital, in Boston — is in the middle of two controversies: one involves the use of antipsychotic drugs in children, and the other relates to conflicts of interest in medicine.

      He is the world’s most prominent advocate of diagnosing bipolar disorder in even the youngest children and of using antipsychotic medicines to treat the disease, but much of his work has been underwritten by drug makers for whom he privately consults. An inquiry by Senator Charles E. Grassley, Republican of Iowa, revealed last year that Dr. Biederman earned at least $1.6 million in consulting fees from drug makers from 2000 to 2007 but failed to report all but about $200,000 of this income to university officials.

      See http://www.nytimes.com/2009/03/20/us/20psych.html?_r=0

      He kept the 1.6 million dollars and wrote this “apology letter” that doesn’t even say sorry ! Read it, Check it out !

      http://web.archive.org/web/20110708110602/http://freepdfhosting.com/ce3f1b1ea1.pdf

      More

      The Money Trail in the J&J Risperdal/Biederman Case

      November 25, 2008, 9:07 AM

      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.

      http://www.cbsnews.com/8301-505123_162-42840230/the-money-trail-in-the-j038j-risperdalbiederman-case/

  1. Look at this,

    http://www.google.com/search?q=“risperdal+lawsuit”+NAMI+national+alliance+on+mental+illness

    Click it , try searching “Risperdal Lawsuit” + NAMI

    The pharma front group posing as advocates as usual are silent.

    Lets try an old one Zyprexa + NAMI ,http://www.google.com/search?q=“Zyprexa+lawsuit”+NAMI+national+alliance+on+mental+illness

    Again NAMI the phony advocates for the mentally ill say NOTHING online anyone can find.

    “health-care fraud” AOK with NAMI the pharma front group.

  2. Copy-cat, I’m currently reading Gary Greenberg’s “The Book of Woe – The DSM & the Unmaking of Psychiatry.” Greenberg refers to Biederman being questioned about his university position. Biederman states that he holds a very influential post, to which he was asked “And what’s higher than that?” and Biederman answers “God.” Greenberg rightly notes that this is a very strange response from a man who has devoted his career to pushing a disease, the symptoms of which include grandiosity.

  3. The National Alliance For The Mentally Ill

    Marketing Risperidone in 1996,

    Risperidone for Adolescent Aggression

    In a case report, control of aggression was achieved with risperidone therapy in six patients, aged eight to 14 years. All displayed aggressive behaviors that ranged from destructiveness to physical violence. Risperidone therapy produced dosage-related side effects in all six patients, but extrapyramidal side effects (resembling Parkinson’s disease) were avoided at dosages below 3mg/day in adolescents and 2mg/day in children.

    –Medical Focus, Winter 1996

    http://web.archive.org/web/19961221104126/http://www.nami.org/

    http://web.archive.org/web/19961221104126/http://www.nami.org/