Healthy Skepticism Library item: 14685

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Publication type: news

Armstrong D, Mundy A.
J&J Emails Raise Issues of Risperdal Promotion
The Wall Street Journal 2008 Nov 25
http://online.wsj.com/article/SB122755237429253763.html

Notes:

Documents available through WSJ link
. J&J email describing discussions about the institute
. A breakdown of J&J’s goals and budget to support work on Risperdal for children and adolescents

Full text:

Johnson & Johnson planned funding for a research institute to focus on use of the antipsychotic drug Risperdal by children well before the treatment was approved for patients that young, according to internal emails produced in a lawsuit against the company.

The 2001 and 2002 emails, which circulated in the drug maker’s Janssen unit, raise issues of whether the company helped promote, through the institute, an unapproved use of Risperdal, which wasn’t cleared by the Food and Drug Administration for widespread use in minors until 2007.
Doctors may prescribe FDA-approved drugs as they see fit, but companies aren’t permitted to market them for uses that aren’t approved by the agency.

Risperdal, which had sales of $4.9 billion last year, is the focus of a growing debate over whether antipsychotic drugs are overused in children. At the center of the controversy is a Harvard University psychiatrist, Joseph Biederman, who proposed and ultimately headed the institute that J&J funded — the Johnson & Johnson Center for the Study of Pediatric Psychopathology,
at Boston’s Massachusetts General Hospital.

J&J, in a statement, said it helped to fund the center in 2002 “with an objective to conduct rigorous clinical trials to clarify appropriate use and dosing of Risperdal in children.” It noted that some of those uses were later approved by the FDA, and it said the company only promotes its
products for FDA-approved indications. Dr. Biederman didn’t return phone calls seeking comment.

Dr. Biederman has been a leading advocate for wider childhood and adolescent use of the drug. The emails were provided to a New Jersey court as part of an effort by patient plaintiffs to force the psychiatrist to testify in their suit against J&J over alleged harms caused by Risperdal. The company has said the drug’s side effects are limited, and it has defended Risperdal’s safety in previous statements.

In a statement Monday, Massachusetts General said “the allegations related to the Johnson & Johnson Center that were described in various media reports today have raised significant questions and concerns about the implementation of those agreements. The MGH takes these allegations very seriously, and intends to investigate these issues thoroughly.”

Risperdal was being prescribed to thousands of teens and younger children before it was approved in mid-2007 for use in children and adolescents with bipolar disorder, according to data presented at an FDA panel last week. The doctors’ panel convened by the FDA said that antipsychotics have been
overprescribed to children and adolescents; nearly 390,000 were given Risperdal in 2007, and 200,000 of them were under the age of 12.

The diagnoses included attention-deficit disorder, for which the drug isn’t approved. Risperdal, whose chemical name is risperidone, has been linked to side effects including serious weight gain and diabetes.

The emails in the lawsuit indicate that Dr. Biederman approached Janssen to start the institute. A spokesman for Harvard said the institute isn’t affiliated with the university. “Dr. Biederman is the pioneer in the area of [child and adolescent] bipolar disorders,” said a 2002 internal email from a Janssen researcher to others at the company. “He approached Janssen multiple times to propose the creation of a Janssen-MGH center for C&A bipolar disorders. The rationale of
the center is to generate and disseminate data supporting use of risperidone in this patient population.”

In a 2002 annual report for the institute, one of the criteria listed as an “essential feature of the center” is moving “forward the commercial goals of J&J,” as well as research to “improve the psychiatric care of children.” The documents don’t indicate if Dr. Biederman profited from the work of the center or derived any income from it. In the 2002 annual report, he was listed as director of the center.

Internal J&J records that are part of the plaintiffs’ filing indicate that Janssen paid, or was requested to make payments, of $500,000 to help start up the center in 2002, another $200,000 for operating funds in 2003 and an additional $250,000 for 2004 activities. Janssen declined to comment on those figures.

Dr. Biederman was receiving direct compensation from J&J during those years, according to records obtained by Sen. Charles Grassley, who has been investigating drug-company payments to the Harvard researcher and others at academic medical centers. In 2001, Dr. Biederman was paid $58,169 by J&J
although he reported to Harvard that he was only paid $3,500, according to Sen. Grassley. In all, Dr. Biederman received more than $1.6 million between 2000 and 2007 from drug companies while reporting to Harvard receiving only several hundred thousand, Sen. Grassley’s documents show.

Harvard declined to answer specific questions about Dr. Biederman’s pay, saying there is an ongoing review of his outside compensation.

The center’s research work, according to the annual report, appeared to focus exclusively on Risperdal. Dr. Biederman and colleagues have published many favorable studies on the drug. A 2005 study, for instance, concluded that “risperidone treatment was associated with a significant short-term improvement of symptoms of pediatric bipolar disorder.”

In 2001, Dr. Biederman began a three-year study on the use of Risperdal in 4- to 6-year-olds. That work appears to have violated rules at Harvard and Mass General forbidding researchers from conducting clinical trials of a drug if they receive payments of more than $20,000 a year from a drug maker.

The Janssen emails indicate the company was concerned about maintaining a positive relationship with Dr. Biederman, who is o chief of clinical and research programs in pediatric psychopharmacology at Mass General, which includes the Johnson & Johnson Center. “Dr. Biederman is not someone to jerk around,” a company official wrote in 1999. “He is a very powerful national
figure in child pysch and has a very short fuse.”

The emails also suggest that the company’s marketing staff were involved in creating the institute and that company officials helped to write and vet research work done by Dr. Biederman and his associates. Dr. Biederman has been ordered to undergo a deposition as part of the New Jersey case on Jan 10.