1 Boring Old Man

July 20, 2012

 

Whose Emperor is Naked?

To the Editor:

In 2003 we wrote to you1 with an analysis of a paper by Keller et al (2001)2 reporting a clinical trial (Study 329) comparing the use of paroxetine with placebo in major depression in adolescents. Study 329 has subsequently become notorious in the legal action against GlaxoSmithKine for healthcare fraud, to which GSK has entered a guilty plea and agreed to pay a fine of $3 billion.

In reply to our 2003 analysis, which identified many of the same issues subsequently cited in the legal case, Keller and his colleagues wrote a defence3 of their article. They failed to acknowledge distortions that have now become clear during the legal action and concluded with a paragraph seeking to impugn our integrity and motivations. Their final statement was “their emperor has no clothes”.

GSK has recently entered a guilty plea to allegations that it “engaged in a fraudulent scheme to deceive and defraud physicians, patients, regulator, and federal health care programs to cause prescribing and payment for certain of GSK’s drugs. This conduct includes repeatedly publishing and promoting false and misleading accounts of studies and treatment guidelines to convince physicians to use GSK drugs.”4 In relation to Study 329, it was noted that “GSK promoted Paxil for use in this population, while concealing the fact that Paxil failed to show efficacy on any of the primary endpoints in three controlled trials funded by GSK to study Paxil for this population. To drive these promotional efforts, GSK touted a medical journal article that it paid to have drafted and that exaggerated Paxil’s efficacy while downplaying risks identified during one of the trials.” The article in question is, of course, the very same Keller et al (2001), which is described in the legal document as follows: “the article falsely stated that Paxil met one of the primary endpoints”, and that “GSK and STI [a contract ghost writing company] revised the article to falsely state that only one of the 11 serious adverse events in Paxil patients was considered related to treatment – and failed to mention the fact that others had been listed by the study investigators as possibly related to treatment”.4

Given the clear misrepresentations present in the Keller et al (2001) article, it would be appropriate for the Journal to withdraw it immediately. Decisive action would benefit the psychiatric and general community, given that this paper inappropriately exaggerates the efficacy of paroxetine in young patients. It would also be beneficial to the Journal’s reputation. As a secondary consideration, we would be willing to receive an apology from Keller et al for their unpleasant final paragraph. We now know whose emperor was naked!

To: Jureidini, Jon
Subject: JAACAP-D-12-00325 Decision

Dec 19, 2012

RE: JAACAP-D-12-00325, "Whose emperor is naked?"

Dear Dr. Jureidini,

Thank you for your Letter to the Editor, submitted July 20, 2012, regarding Keller et al., 2001. Following the June 27, 2012 settlement between GlaxoSmithKline and the U.S. Department of Justice, the Journal’s editorial team undertook a thorough evaluation of the article, the legal settlement, and related materials. The authors of the article were contacted and asked to respond to the questions and concerns raised by the settlement. After a comprehensive and extensive review, the Journal editors found no basis for retraction or other editorial action.

Due to the nature of the concerns and serious consideration given to the situation, the evaluation process was quite lengthy, and we appreciate your patience while the editorial team conducted its review. The inquiry is considered complete, and as such, your letter will not be published in the Journal.

Sincerely,
    Andres Martin, M.D., M.P.H.
    Editor-in-Chief
    Journal of the American Academy of Child and Adolescent Psychiatry