{"id":65636,"date":"2016-05-20T14:33:53","date_gmt":"2016-05-20T18:33:53","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=65636"},"modified":"2016-05-20T18:57:57","modified_gmt":"2016-05-20T22:57:57","slug":"publication-bias-iii-close-encounters-of-the-second-kind","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2016\/05\/20\/publication-bias-iii-close-encounters-of-the-second-kind\/","title":{"rendered":"publication bias III \u2013 close encounters of the second kind\u2026"},"content":{"rendered":"
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Under the Influence: the Interplay among Industry, Publishing, and Drug Regulation<\/a>.<\/div>\n
by Lisa Cosgrove, Steven Vannoy, Barbara Mintzes, and Allen Shaughnessy<\/div>\n
Accountability in Research.<\/font><\/strong> 2016 23[5]:257-279.<\/div>\n
[full text on-line<\/a> ?]<\/div>\n

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The relationships among academe, publishing, and industry can facilitate commercial bias in how drug<\/span> efficacy and safety data are obtained, interpreted, and presented to regulatory bodies and prescribers. Through a critique of published and unpublished trials submitted to the Food and Drug Administration [FDA] and the European Medicines Agency [EMA] for approval of a new antidepressant, vortioxetine, we present a case study of the "ghost management" of the information delivery process. We argue that currently accepted practices undermine regulatory safeguards aimed at protecting the public from unsafe or ineffective medicines. The economies of influence that may intentionally and unintentionally produce evidence-biased-rather than evidence-based-medicine are identified. This is not a simple story of author financial conflicts of interest, but rather a complex tale of ghost management<\/font><\/strong> of the entire process of bringing a drug to market. This case study shows how weak regulatory policies allow for design choices and reporting strategies that can make marginal products look novel, more effective, and safer than they are, and how the selective and imbalanced reporting of clinical trial data in medical journals results in the marketing of expensive "me-too" drugs with questionable risk\/benefit profiles. We offer solutions for neutralizing these economies of influence. <\/div>\n<\/blockquote>\n

This article differs from the others in this series in that it is primarily a perspective\/opinion piece about the intersection of industry, the medical literature, and the regulatory processes that uses the recent FDA approval of Vortioxetine <\/font>[Brintellix®<\/font>] as an exemplare. It’s a well-framed discussion of a complex issue, offering suggestions for reform. While some may not agree with their emphases or solutions, it’s an excellent "big picture" article – a thoughtful contribution. But specific to the Vortioxetine<\/font> theme from the last post [publication bias II – close encounters of the second kind…<\/a>]<\/font>, their research into the Vortioxetine<\/font> RCTs is definitely value-added to the other reports. And it’s another example of a contrarian article<\/font><\/em> that they had a really hard time getting published. <\/p>\n

Cosgrove et al looked at all the Vortioxetine<\/font> trials, published and unpublished, and introduced a term I hadn’t run across before – Ghost Management<\/font><\/em><\/strong>. Just saying an article is ghost-written<\/font> doesn’t tell the whole story, because the ghost-writer<\/font> is employed by the RCT’s sponsor. Ghost Management<\/font><\/em><\/strong> is much more accurate in that it conveys the extent of the sponsor’s control over the entire RCT process. I found some of their findings jarring, even after my years of reading these reports. For example, the extent of industry COI:<\/div>\n
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Vortioxetine is typical of virtually all new drugs in that the pre-market RCTs were all sponsored by the manufacturer. However, congruent with commercialized publication planning, every author in all of the published short term RCTs, as well as one longer term randomized drug withdrawal study, had significant commercial ties to the manufacturer, well beyond research funding<\/font><\/strong><\/em> [e.g., they were employees, participated on advisory boards, and\/or had received consulting monies or honoraria]…<\/div>\n

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Below is a summary of the industry-publishing relationships of the eight published studies submitted to the FDA and one additional study submitted to the EMA that was published:<\/div>\n