Monday, November 21, 2011

Paxil Study 329 contd. - 1 Boring Old Man » a walk on the wrong side side of the street?…

President Ruth J. Simmons
Office of the President
Brown University

Dear President Simmons,

We write to you about our ongoing concerns regarding a journal article that originated at the Department of Psychiatry and Human Behavior, under the leadership of Dr. Martin Keller.

Between 1993 and 1998, SmithKline Beecham [subsequently GlaxoSmithKline] provided $800,000 to Brown University for its participation in the above study. The results were published in 2001 by Keller et al. in a journal article, ‘Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial’, in the Journal of the American Academy of Child & Adolescent Psychiatry. The article was ghostwritten by agents of the manufacturer, and seriously misrepresented both the effectiveness and the safety of paroxetine in treating adolescent depression.

While problems with study 329 and the Keller et al paper have been thoroughly exposed in legal actions, the bioethical and medical literature, a book, and a BBC Panorama documentary, the paper continues to be cited uncritically in the medical literature as evidence of the efficacy of paroxetine for treatment of adolescent depression. Our main concern is that adolescents are being harmed because well-intentioned physicians have been misled.

Moreover, the misrepresentation has been compounded by the following:
[1] The Journal was asked by two of the undersigned, Drs. Jureidini and McHenry, to retract the article, but has refused to do so.
[2] In a letter of May 13, 2008, from Pamela D. Ring to Dr. David Egilman, Brown University refused to release information about its internal investigation into Dr. Keller’s conflicts of interest and scientific misconduct.

Study 329 reveals the pervasive influence of GlaxoSmithKline’s marketing objectives on the preparation and publication of a ‘scientific’ manuscript and peer-reviewed journal article. GlaxoSmithKline’s own internal documents disclosed in litigation show that company staff were aware that the study 329 did not support a claim of efficacy but decided that it would be "unacceptable commercially" to reveal that.

The data were therefore selectively reported in Keller et al.’s article, in order to "effectively manage the dissemination of these data in order to minimise any potential negative commercial impact". As it turns out, the Keller et al. article was used by GlaxoSmithKline’s to ward off potential damage to the profile of paroxetine and it was used to promote off-label prescriptions of Paxil® and Seroxat® to children and adolescents, some of whom became suicidal and self-harmed as a result.

The unretracted article is a stain on Brown University’s reputation for academic excellence. The University cannot claim to be a leader in scientific research and moral integrity while failing to act to redress this article that negligently misrepresents scientific findings. In its accreditation document for the New England Association of Schools and Colleges (NEASC), Brown University claims in relation to ‘Standard Eleven: Integrity’ that ‘The institution manages its academic, research and service programs, administrative operations, responsibilities for students and interactions with prospective students with honesty and integrity’, that it ‘expects that members of its community, including the board, administration, faculty, staff, and students, will act responsibly and with integrity’, and that ‘Truthfulness, clarity, and fairness characterize the institution’s relations with all internal and external constituencies’. The University’s inaction in relation to study 329 casts doubt on the validity of these claims.

We ask that you write to the editor, Dr. Andrés Martin, Journal of the American Academy of Child & Adolescent Psychiatry supporting our request for retraction of the journal article. We are making this letter available to interested parties and it will be posted on the Healthy Skepticism website [].

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