{"id":33475,"date":"2013-02-19T05:40:38","date_gmt":"2013-02-19T10:40:38","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=33475"},"modified":"2013-02-19T05:40:38","modified_gmt":"2013-02-19T10:40:38","slug":"zoloft-beyond-the-approval-i","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2013\/02\/19\/zoloft-beyond-the-approval-i\/","title":{"rendered":"zoloft: beyond the approval I…"},"content":{"rendered":"
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Well here we are at the part of the story we now know all too well. Maybe we don’t know the Pfizer\/Zoloft version so well as some of the others, but the involvement of the professional ghost writing firms was apparently an industry-wide story of a literature filled with ghost-written studies with "guest authors." And no, the ghosts aren’t there to make up for the grammatical and stylistic deficits of a bunch of scientists who spent too much time in the chemistry lab and never learned how to put pen to paper. They’re there to play with  the numbers and statistics that are supposed to tell us what happened when the volunteers took some unknown medicines, and make them tell us something they weren’t meant to say – something a drug company wants them to say. I had no clue at the time. I doubt that many of us did. And Zoloft was an early drug, so it came before we got rigorous about funding sources, authorship, and conflicts of interest. So these articles looked for all the world like they were legitimate to the journal’s readers unless they were read suspiciously. But they weren’t <\/strong><\/sup>legitimate – not even close…<\/strong>
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Now back to the complaint [Laura A. Plumlee et. al. v. Pfizer<\/a>]: <\/div>\n
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Pfizer’s Ghostwriting Operation<\/a><\/div>\n

Pfizer understood that the best way to ensure the success of Zoloft was to convince the scientific and medical community that Zoloft was safe and effective by cultivating a body of "peer-reviewed research" to enhance Zoloft’s credibility. To that end, Pfizer created a large-scale ghostwriting program. Pfizer would author, or have a medical communications company author, a study specifically designed to promote a marketing message, i.e., Zoloft’s efficacy. Then, Pfizer would pay "key opinion leaders" ["KOL’ s"] to put their name on the article and get the article published in specifically targeted medical journals. When the article appeared in the journal, there would be no indication of Pfizer’s involvement.<\/strong><\/sup><\/p>\n

Pfizer had an entire team devoted to the publication of positive medical journal articles about Zoloft. In addition, Pfizer worked with outside medical ghostwriting vendors to create a steady stream of Zoloft-positive medical journal articles. Dr. David Healy, a psychopharmacologist and professor at the University of Wales College of Medicine, and a colleague conducted an analysis of Zoloft articles that were "coordinated" by a medical communications company called Current Medical Direction <\/em>["CMD"]. Pfizer had hired CMD to promote Zoloft in the 1990’s. David Healy & Dinah Cattell, Interface Between Authorship, Industry and Science in the Domain of Therapeutics<\/font><\/em> [see below<\/em>]. According to the study, CMD coordinated over 85 medical journal articles about Zoloft during a three-year period. By early 2001, 55 of these articles had been published in journals such as the New England Journal of Medicine, Journal of the American Medical Association [JAMA], Archives of General Psychiatry and the American Journal of Psychiatry.<\/strong><\/sup><\/p>\n

Interestingly, all of the clinical trial results were favorable to Zoloft. The analysis found that "the CMD-linked articles reported universally positive results" and that there were "significant discrepancies between published data and the raw data from the actual clinical trials." Most of the 85 articles appeared to have been authored by CMD and, in a number of instances, the authors were listed in Pfizer internal memos as "TBD" [i.e., "to be determined"]. The study concluded that:<\/strong><\/sup><\/div>\n