Harvard Teaching Hospital Reviewing J&J Ties to Psychiatry Unit

http://www.bloomberg.com/apps/news?pid=20601087&sid=atN6Se0NVbp0&refer=home

By Rob Waters and Julie Ziegler

Nov. 25 (Bloomberg) — Massachusetts General Hospital will investigate conflicts of interest at a child psychiatry research center it established with funding from Johnson & Johnson, maker of the antipsychotic drug Risperdal.

The hospital, in a statement yesterday, said its grant specified the purpose of the center was scientific and educational, not to promote J&J’s products. Yet the center’s 2002 annual report said it would undertake studies that “will move forward the commercial goals of J&J,” according to documents released in connection with a lawsuit against the company.

The Johnson & Johnson Center for the Study of Pediatric Psychopathology was run by Joseph Biederman, a Harvard University child psychiatrist whose research helped fuel an explosion in the number of children diagnosed with bipolar disorder and treated with antipsychotics. His ties to J&J and other drugmakers were criticized in June by Senator Charles Grassley, an Iowa Republican, who said Biederman failed to disclose most of the $1.6 million he received from the industry from 2000 to 2007.

“I would question how this conduct — the acceptance of money — advances public health,” said Steven Sheller, a Philadelphia attorney who represents the families of children suing J&J in connection with side effects from Risperdal. The hospital is “supposedly interested in public health.”

David Cameron, a spokesman for Boston-based Harvard Medical School, said Harvard isn’t involved with the J&J Center at Massachusetts General, a Harvard teaching hospital.

‘Individually Governed’

“Harvard Medical School does not ‘own’ any of its teaching hospitals,” Cameron said in an e-mail. “While we are affiliated with them through academic appointments, all teaching hospitals are individually governed.”

Biederman didn’t reply to phone messages and e-mails sent to his office.

Massachusetts General, which pledged in June to investigate drug industry payments to Biederman, “takes these allegations very seriously and intends to investigate these issues thoroughly,” said Peggy Slasman, a hospital spokeswoman, in an e-mail yesterday.

The documents were released at a time of fierce debate over the increasing use by children of powerful antipsychotic drugs that can cause weight gain, diabetes and hormonal and neurological effects. Biederman is a leading proponent of the idea that bipolar disorder, once viewed as an adult disease, can begin early in childhood and be treated with drugs. People with bipolar disorder alternate between bouts of depression and mania.

The number of children diagnosed as bipolar increased 40- fold between 1994 and 2003, according to a 2007 study. Sales of drugs used to treat the condition doubled from 2003 to 2006, according to data provided to Bloomberg in 2007 by Wolters Kluwer NV, a prescription-tracking company.

Deposition Battle

Attorneys in a New Jersey state court action against J&J have been battling to depose Biederman to explore the way the company promoted the use of Risperdal. The documents about the doctor and his child psychiatry center at Massachusetts General were released as part of the legal case.

Some plaintiffs allege that J&J promoted Risperdal to patients, including children, for whom it was not approved by U.S. regulators, a practice known as “off-label” prescribing. While doctors are free to prescribe any approved drug to any patient, companies are not allowed to promote drugs for unapproved uses. Drugmakers such as Eli Lilly & Co., the maker of Zyprexa, AstraZeneca Plc, the maker of Seroquel, and J&J are being sued by states and individuals alleging off-label marketing of their antipsychotic treatments.
J&J’s Response

Kara Russell, a spokeswoman for Janssen, the J&J unit that makes Risperdal, said the company promotes the drug and other products only for their approved uses. The company supported the Massachusetts General program “to conduct rigorous clinical trials to clarify appropriate use and dosing of Risperdal in children,” she said in an e-mail yesterday.

The e-mails and internal memos released in the New Jersey lawsuit show Biederman pressed the company for money to establish the center and J&J used the data from center studies to promote Risperdal in children. J&J funded the center from 2002 to 2006.

Biederman “approached Janssen multiple times to propose the creation of a Janssen-MGH center,” according to an e-mail from a J&J executive. The center would “generate and disseminate data supporting the use” of Risperdal in children, the e-mail said. Pediatric use was approved by U.S. regulators in August 2007.

The e-mails released in the lawsuit also show that J&J was closely involved in Risperdal studies undertaken by Biederman and his colleagues at the center.

Generating the Data

In one e-mail, Gahan Pandina, a J&J clinical development executive, sent Biederman a research summary to be presented at a medical conference. The summary listed Biederman as the lead author and concluded that Risperdal “is effective” in treating children with bipolar disorder. In the e-mail, Pandina said he “was able to have our statistics department generate the summary data” and asked Biederman to review, comment and sign a form “as the presenting author.”

The influence Biederman has on other doctors was hinted at in a 2002 e-mail from Pandina, which noted the psychiatrist was “very well received” by a group of 1,000 doctors who paid $700 each for a three-day course on medications for pediatric bipolar disorder. Forming a partnership with Biederman and his program “has the potential of reaching and having a significant impact” on child psychiatrists.

To contact the reporter on this story: Rob Waters in San Francisco at rwaters5@bloomberg.net.