Abstract
Medical ghostwriting is the practice in which pharmaceutical companies engage an outside writer to draft a manuscript submitted for publication in the names of “honorary authors,” typically academic key opinion leaders. Using newly-posted documents from paroxetine litigation, we show how the use of ghostwriters and key opinion leaders contributed tothe publication of a medical journal article containing manipulated outcome data to favor the proprietary medication.The article was ghostwritten and managed by SmithKline Beecham, now GlaxoSmithKline (GSK) and Scientific Therapeutics Information, Inc. without acknowledging their contribution in the published article. The named authors with financial ties to GSK had little or no direct involvement in the paroxetine 352 bipolar trial results and most had not reviewed any of the manuscript drafts. The manuscript was originally rejected by peer review; however, its ultimate acceptance to the American Journal of Psychiatrywas facilitated by the journal editor who also had financial ties to GSK. Thus, GSK was able to take an under-powered and non-informative trial with negative results and present it as a positive marketing vehicle for off-label promotion of paroxetine for bipolar depression. In addition to the commercial spin of paroxetine efficacy, important protocol-designated safety data were unreported that may have shown paroxetine to produce potentially harmful adverse events.
Highlights
Since the late 1990s, industry-sponsored ghostwriting for the medical literature has been exposed in a number of articles, plaintiffs’ lawsuits and government investigations
In the current deconstruction article, we examined forty-two publicly-available documents produced by Scientific Therapeutics Information, Inc. from paroxetine litigation
Because ghostwriting is designed to evade detection and is only revealed as a result of litigation or government inquiries, it is imperative to document the cases in which ghostwriting has facilitated misrepresentation of clinical trial results
Summary
Since the late 1990s, industry-sponsored ghostwriting for the medical literature has been exposed in a number of articles, plaintiffs’ lawsuits and government investigations. Upon your approval to proceed, I'll have a submission package prepared for you to submit the manuscripts to the journal This email from Laden to Nemeroff, together with the September 13th email exchange above, indicate to us that Nemeroff and the other academic authors had little or no scientific input into the original or revised 352 data analyses and that virtually all of the revisions were made by Sally Laden and GSK employees i.e., Drs Zaninelli, Pitts, Oakes, and Gergel. Laden recognized that GSK may not want to expend additional time and money on publishing the 352 manuscript in the American Journal of Psychiatry; in which case it will definitely be accepted in Nemeroff’s Depression & Anxiety journal.[34] It appears that Nemeroff was probably successful in gaining Dr Kumar’s approval to have GSK continue working with STI and Gorman. Dr Freedman did not respond, and the scientific record remains uncorrected. (The letter from the current authors is published as a supplemental file to this article)
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