{"id":65658,"date":"2016-05-19T14:48:07","date_gmt":"2016-05-19T18:48:07","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=65658"},"modified":"2016-05-19T14:52:10","modified_gmt":"2016-05-19T18:52:10","slug":"publication-bias-i-encounters-of-the-second-kind","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2016\/05\/19\/publication-bias-i-encounters-of-the-second-kind\/","title":{"rendered":"publication bias I – close encounters of the second kind…"},"content":{"rendered":"
Publication bias is the term for what occurs whenever the research that appears in the published literature is systematically unrepresentative of the population of completed studies. Simply put, when the research that is readily available differs in its results from the results of all the research that has been done in an area, readers and reviewers of that research are in danger of drawing the wrong conclusion about what that body of research shows…<\/font><\/em><\/sup><\/div>\n
in<\/font> Publication Bias in Meta-Analysis – Prevention, Assessment and Adjustments<\/font><\/a>, 2005<\/font><\/sup><\/div>\n

<\/p>\n

The usual version of publication bias is the practice of simply not publishing negative clinical trials. The result is obvious. The positive trials "average out" to a falsely inflated result and the drug looks better than it actually is. We’ve pretty much caught on to that ploy by requiring all trials be registered in advance [clinicaltrials.gov<\/a>], developingtools to detect missing trials [funnel plots<\/font>], and doing meta-analyses that include unpublished trials [the Tamiflu saga]. A variant would be publishing Paxil Study 329<\/font> which was claimed to be positive, but not publishing two negative trials of the same drug [Paxil Study 377 <\/font>and Paxil Study 701<\/font>] until after the patent had run out [see paxil in adolescents: “five easy pieces”…<\/a> and study 329 x – “it wasn’t sin – it was spin”…<\/a>]. This post isn’t about that kind of publication bias. It’s about a getting published<\/font><\/em> version of publication bias. <\/div>\n

[Note: This particular post is kind of redundant, not too different from the last one. But it’s here because I finally figured out what I wanted to say].<\/font><\/em><\/sup><\/p>\n

I was on the RIAT<\/a> team that reanalyzed Paxil Study 329 <\/font>[Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence<\/a>]<\/font>. It was the end product of over a decade of effort by armies of people from many professions all over the world working to make it happen. It was in a high impact journal [British Medical Journal<\/font><\/strong>] and was extremely well received<\/a>. In spite of all that preparatory work and a receptive editorial staff, writing it and getting it published was a grueling experience, roughly outlined at Restoring Study 329<\/font><\/a> [in Background<\/font>], and there will be more to follow. But in spite of its success, you have to ask yourself "Why did it take such a herculean effort by an army and fourteen years to get it in print?<\/em><\/font>" And for that matter, "Why was I an author – a retired adult psychiatrist who writes a blog at the edge of the galaxy?<\/font><\/em>" It should’ve been authored by a chairman of child psychiatry at a prestigious medical school or the president of the American Academy of Child an Adolescent Psychiatry<\/font>. Actually, Study 329<\/font> should never have been published in the first place as it is written [Efficacy of Paroxetine in the Treatment of Adolescent Major Depression: A Randomized, Controlled Trial<\/a>], or should have been subsequently retracted. <\/p>\n

And now we have another article about an antidepressant clinical trial in kids, The citalopram CIT-MD-18 pediatric depression trial: Deconstruction of medical ghostwriting, data mischaracterisation and academic malfeasance<\/a>. It’s authored by a heavily credentialed multidiscipliary team. In this paper, the data comes from the sponsor’s own internal documents and focuses in on the processes involved in creating the original publication [A Randomized, Placebo-Controlled Trial of Citalopram for the Treatment of Major Depression in Children and Adolescents<\/a>]. While they show the same things we documented [deviations from the a priori protocol, add-on parameters, questionable analyses, etc], they go further. Using verbatim quotes from the sponsor, they show that all of this jury-rigging of data, analysis, and presentation was done by the sponsor’s employees with the specific intent of deceiving the reader by making this negative trial look positive. And yet they had a hell of a time getting it published [see background notes<\/a>]. It wasn’t turned down because it was wrong, or badly written, or poorly documented, or didn’t have proven authors. "Why did they have such a hard time getting it published?<\/font><\/em>" It’s in the International Journal of Risk and Safety in Medicine<\/font><\/strong>, a perfectly legitimate peer reviewed medical journal, but hardly in the upper echelon. Since it was unfunded research, the journal graciously made it Open Access by waiving the fee. But thus far, it hasn’t been covered in the main stream media. "Why not?<\/font><\/em>" It is  at least as important as our article, if not more-so, as it documents active fraudulent behavior<\/font><\/em> on the part of the sponsor.<\/p>\n

To my mind, this is publication bias of a second kind<\/font><\/em> [see a mighty hard row…<\/a>], a problem getting a contrarian take on a clinical trial published and into the discourse where it belongs. It fits the opening definition to a tee. This is a form of publication bias exerted by the publishers themselves, and may not necessarily be the result of direct or even indirect involvement of the original clinical trial’s sponsor. I’m not going to speculate further about all the motivations involved here. There’s more than enough speculation flying around about this topic already. But I do want to talk about it’s impact, and illustrate it with a contemporary example… <\/div>\n","protected":false},"excerpt":{"rendered":"

Publication bias is the term for what occurs whenever the research that appears in the published literature is systematically unrepresentative of the population of completed studies. Simply put, when the research that is readily available differs in its results from the results of all the research that has been done in an area, readers and […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_bbp_topic_count":0,"_bbp_reply_count":0,"_bbp_total_topic_count":0,"_bbp_total_reply_count":0,"_bbp_voice_count":0,"_bbp_anonymous_reply_count":0,"_bbp_forum_subforum_count":0,"footnotes":""},"categories":[5],"tags":[],"class_list":["post-65658","post","type-post","status-publish","format-standard","hentry","category-opinion"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/65658","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/comments?post=65658"}],"version-history":[{"count":25,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/65658\/revisions"}],"predecessor-version":[{"id":65683,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/65658\/revisions\/65683"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=65658"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=65658"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=65658"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}