{"id":67923,"date":"2016-09-14T22:35:43","date_gmt":"2016-09-15T02:35:43","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=67923"},"modified":"2016-09-17T09:04:34","modified_gmt":"2016-09-17T13:04:34","slug":"say-amen","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2016\/09\/14\/say-amen\/","title":{"rendered":"say amen…"},"content":{"rendered":"\n

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I first heard the term ghost-writing<\/font><\/em> used in the scientific literature at the end of 2010 [see roaches…<\/a>]. I must’ve known what was coming because I added added the roach to the ad image [from something our exterminator said, "For every roach you see, there are a hundred behind the walls<\/em>"]. Sure enough, six months later I got hold of The Rothman Report<\/font><\/em> [see detestable…<\/a>] that described a medical writing firm ghost-writing Risperidone®<\/font><\/em> articles faster than they could find guest authors<\/font><\/em> to front them. I guess one can only take in so much at a time. I exhumed that old STI ad to show the top line, the significance of which eluded me at the time – publication planning, advocacy development<\/font><\/em>.<\/p>\n

If you read the content of that STI ad, it talks about a lot more than just medical writing, but I was slow to catch on – apparently a lot of us were. By the time I saw the ad in 2010, Scientific Therapeutics Information Inc <\/font>had been at it for a very long time [for example, managing the Paxil Launch<\/a> <\/font>in 1993]. Since then, it has gradually dawned on us that most all of the industry funded clinical trial articles in psychiatry are ghost-written. And these days, it’s right there in the Acknowledgments<\/font><\/em> under editorial-assistance-provided-by<\/font><\/em>. So exposing professional ghost-writing hasn’t made much of a difference [see rebranding…<\/a>]. Industry and journal editors just adapted.<\/p>\n

But I don’t think I personally got the full extent of industry’s modus operandi until recently, first from reading Lisa Cosgrove et al<\/font>‘s article and the idea of ghost management<\/font><\/strong>…<\/div>\n
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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 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<\/font><\/strong>" 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… <\/div>\n<\/blockquote>\n

… and then reading one of Karen Dineen Wagner<\/font>‘s depositions [see author·ity…<\/a>] –<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
DEPOSITION OF KAREN DINEEN WAGNER, M.D., Ph.D.<\/a>
by Michael Baum, Esq., of Baum, Hedlund, Aristei & Goldman
on Tuesday, July 16, 2013, page 28 [pdf page 8]<\/font><\/strong><\/sup> <\/p>\n
<\/td>\n<\/tr>\n
QUESTION<\/font><\/strong> Okay. So do you recall whether you had access to patient level data when you were working on this publication?<\/font><\/strong><\/em><\/sup><\/td>\n<\/tr>\n
 <\/sup><\/td>\nANSWER<\/font><\/strong> No. We have access — well, as an individual investigator, you have access to your patients. But the individual patient data from other sites, usually when the data is presented, it’s put together. So I don’t — I just don’t recall if I saw individual — individual data.<\/font><\/strong><\/em><\/sup><\/td>\n<\/tr>\n
QUESTION<\/font><\/strong> When you say "put together," does that refer to the pharmaceutical company compiling information and providing it to you?<\/font><\/strong><\/em><\/sup><\/td>\n<\/tr>\n
 <\/sup><\/td>\nANSWER<\/font><\/strong> The data is the property of the pharmaceutical company.<\/font><\/strong><\/em><\/sup><\/td>\n<\/tr>\n
QUESTION<\/font><\/strong> And so they collect it and provide some form of summary of it to you?<\/sup><\/td>\n<\/tr>\n
 <\/sup><\/td>\nANSWER<\/font><\/strong> Correct.<\/sup><\/td>\n<\/tr>\n
QUESTION<\/font><\/strong> And except for the patient level data that you had from your own particular site, you relied upon the information conveyed to you by the pharmaceutical company regarding the other sites. Is that correct?<\/sup><\/td>\n<\/tr>\n
 <\/sup><\/td>\nANSWER<\/font><\/strong> In multicenter studies, each individual investigator has their own data and then it depends who sponsors the study. This was a Forest-initiated and Forest-sponsored study, so all of the data from the sites go to Forest.<\/sup><\/td>\n<\/tr>\n
QUESTION<\/font><\/strong> Then they compiled it and then did statistical evaluations of it?<\/sup><\/td>\n<\/tr>\n
 <\/sup><\/td>\nANSWER<\/font><\/strong> Yes.<\/sup><\/td>\n<\/tr>\n
QUESTION<\/font><\/strong> Did you do any of the statistical evaluations yourself?<\/sup><\/td>\n<\/tr>\n
 <\/sup><\/td>\nANSWER<\/font><\/strong> No.<\/sup><\/td>\n<\/tr>\n
QUESTION<\/font><\/strong> It was essentially provided to you by Forest statisticians?<\/sup><\/td>\n<\/tr>\n
 <\/sup><\/td>\nANSWER<\/font><\/strong> Correct. I’m not a statistician.<\/sup><\/td>\n<\/tr>\n<\/table>\n

– that she hadn’t actually seen the data or participated in the analysis, even as a Principle Investigator for the study<\/font><\/em>. And it wasn’t just that fact itself. It’s that she said it in such a matter-of-fact way, like what she was saying was some kind of explanation that we should understand. It reminded me of a piece from several years back that addressed what happened when a recruited author insisted on actually seeing the study data. See selling seroquel VII: indication sprawl…<\/a> for a telling example in which Nassir Ghaemi did exactly that, and was summarily unrecruited<\/font><\/em>.<\/p>\n

I synopsized my own dawning awareness here because without having gone through that process, I doubt I could’ve read Alastair Matheson’s papers and really understood them. I might have seen his waving us off of focusing so much on ghostwriting [Ghostwriting: the importance of definition and its place in contemporary drug marketing<\/a>] as a bias from his years working in industry. But that’s not how I see his writings now. He brings a fresh point of view to the discussion of this pharmaceutical invasion of the medical literature, having spent close to twenty years doing many of the things we write about [see rebranding…<\/a> and directly as he proposes…<\/a>]. He’s an "insider"<\/font><\/em>:<\/p>\n

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"I worked on over one hundred drugs, most of which were, in my estimation, mediocre products that could be better pitched if a more persuasive scientific angle could be found for them. I visited corporate headquarters and congresses; analyzed markets, products, and competitors; groomed key opinion leaders; ghostwrote manuscripts; developed publications plans; and devised marketing strategies."<\/div>\n<\/blockquote>\n
He’s cataloged his writings on a website:<\/div>\n