{"id":90,"date":"2008-12-08T20:44:30","date_gmt":"2008-12-09T03:44:30","guid":{"rendered":"http:\/\/cchrstl.org\/wordpress\/?p=90"},"modified":"2024-07-14T05:43:51","modified_gmt":"2024-07-14T10:43:51","slug":"harvard-teaching-hospital-reviewing-jj-ties-to-psychiatry-unit","status":"publish","type":"post","link":"https:\/\/www.cchrstl.org\/wordpress\/2008\/12\/08\/harvard-teaching-hospital-reviewing-jj-ties-to-psychiatry-unit\/","title":{"rendered":"Harvard Teaching Hospital Reviewing J&J Ties to Psychiatry Unit"},"content":{"rendered":"

http:\/\/www.bloomberg.com\/apps\/news?pid=20601087&sid=atN6Se0NVbp0&refer=home<\/a><\/p>\n

By Rob Waters and Julie Ziegler<\/p>\n

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.<\/p>\n

The hospital, in a statement yesterday, said its grant specified the purpose of the center was scientific and educational, not to promote J&J\u00c3\u00a2\u00e2\u201a\u00ac\u00e2\u201e\u00a2s products. Yet the center\u00c3\u00a2\u00e2\u201a\u00ac\u00e2\u201e\u00a2s 2002 annual report said it would undertake studies that \u00c3\u00a2\u00e2\u201a\u00ac\u00c5\u201cwill move forward the commercial goals of J&J,\u00c3\u00a2\u00e2\u201a\u00ac\u00c2\u009d according to documents released in connection with a lawsuit against the company.<\/p>\n

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.<\/p>\n

\u00c3\u00a2\u00e2\u201a\u00ac\u00c5\u201cI would question how this conduct — the acceptance of money — advances public health,\u00c3\u00a2\u00e2\u201a\u00ac\u00c2\u009d 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 \u00c3\u00a2\u00e2\u201a\u00ac\u00c5\u201csupposedly interested in public health.\u00c3\u00a2\u00e2\u201a\u00ac\u00c2\u009d<\/p>\n

David Cameron, a spokesman for Boston-based Harvard Medical School, said Harvard isn\u00c3\u00a2\u00e2\u201a\u00ac\u00e2\u201e\u00a2t involved with the J&J Center at Massachusetts General, a Harvard teaching hospital.<\/p>\n

\u00c3\u00a2\u00e2\u201a\u00ac\u00cb\u0153Individually Governed\u00c3\u00a2\u00e2\u201a\u00ac\u00e2\u201e\u00a2<\/p>\n

\u00c3\u00a2\u00e2\u201a\u00ac\u00c5\u201cHarvard Medical School does not \u00c3\u00a2\u00e2\u201a\u00ac\u00cb\u0153own\u00c3\u00a2\u00e2\u201a\u00ac\u00e2\u201e\u00a2 any of its teaching hospitals,\u00c3\u00a2\u00e2\u201a\u00ac\u00c2\u009d Cameron said in an e-mail. \u00c3\u00a2\u00e2\u201a\u00ac\u00c5\u201cWhile we are affiliated with them through academic appointments, all teaching hospitals are individually governed.\u00c3\u00a2\u00e2\u201a\u00ac\u00c2\u009d<\/p>\n

Biederman didn\u00c3\u00a2\u00e2\u201a\u00ac\u00e2\u201e\u00a2t reply to phone messages and e-mails sent to his office.<\/p>\n

Massachusetts General, which pledged in June to investigate drug industry payments to Biederman, \u00c3\u00a2\u00e2\u201a\u00ac\u00c5\u201ctakes these allegations very seriously and intends to investigate these issues thoroughly,\u00c3\u00a2\u00e2\u201a\u00ac\u00c2\u009d said Peggy Slasman, a hospital spokeswoman, in an e-mail yesterday.<\/p>\n

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.<\/p>\n

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.<\/p>\n

Deposition Battle<\/p>\n

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.<\/p>\n

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 \u00c3\u00a2\u00e2\u201a\u00ac\u00c5\u201coff-label\u00c3\u00a2\u00e2\u201a\u00ac\u00c2\u009d 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.
\nJ&J\u00c3\u00a2\u00e2\u201a\u00ac\u00e2\u201e\u00a2s Response<\/p>\n

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 \u00c3\u00a2\u00e2\u201a\u00ac\u00c5\u201cto conduct rigorous clinical trials to clarify appropriate use and dosing of Risperdal in children,\u00c3\u00a2\u00e2\u201a\u00ac\u00c2\u009d she said in an e-mail yesterday.<\/p>\n

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.<\/p>\n

Biederman \u00c3\u00a2\u00e2\u201a\u00ac\u00c5\u201capproached Janssen multiple times to propose the creation of a Janssen-MGH center,\u00c3\u00a2\u00e2\u201a\u00ac\u00c2\u009d according to an e-mail from a J&J executive. The center would \u00c3\u00a2\u00e2\u201a\u00ac\u00c5\u201cgenerate and disseminate data supporting the use\u00c3\u00a2\u00e2\u201a\u00ac\u00c2\u009d of Risperdal in children, the e-mail said. Pediatric use was approved by U.S. regulators in August 2007.<\/p>\n

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.<\/p>\n

Generating the Data<\/p>\n

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 \u00c3\u00a2\u00e2\u201a\u00ac\u00c5\u201cis effective\u00c3\u00a2\u00e2\u201a\u00ac\u00c2\u009d in treating children with bipolar disorder. In the e-mail, Pandina said he \u00c3\u00a2\u00e2\u201a\u00ac\u00c5\u201cwas able to have our statistics department generate the summary data\u00c3\u00a2\u00e2\u201a\u00ac\u00c2\u009d and asked Biederman to review, comment and sign a form \u00c3\u00a2\u00e2\u201a\u00ac\u00c5\u201cas the presenting author.\u00c3\u00a2\u00e2\u201a\u00ac\u00c2\u009d<\/p>\n

The influence Biederman has on other doctors was hinted at in a 2002 e-mail from Pandina, which noted the psychiatrist was \u00c3\u00a2\u00e2\u201a\u00ac\u00c5\u201cvery well received\u00c3\u00a2\u00e2\u201a\u00ac\u00c2\u009d 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 \u00c3\u00a2\u00e2\u201a\u00ac\u00c5\u201chas the potential of reaching and having a significant impact\u00c3\u00a2\u00e2\u201a\u00ac\u00c2\u009d on child psychiatrists.<\/p>\n

To contact the reporter on this story: Rob Waters in San Francisco at rwaters5@bloomberg.net<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"

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 … Continue reading →<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[2,3],"tags":[],"class_list":["post-90","post","type-post","status-publish","format-standard","hentry","category-big-muddy-river-newsletter","category-press-releases"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/p6NMpC-1s","jetpack_likes_enabled":true,"_links":{"self":[{"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/posts\/90","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/comments?post=90"}],"version-history":[{"count":0,"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/posts\/90\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/media?parent=90"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/categories?post=90"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/tags?post=90"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}