{"id":60048,"date":"2015-09-21T10:00:41","date_gmt":"2015-09-21T14:00:41","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=60048"},"modified":"2015-09-21T14:06:36","modified_gmt":"2015-09-21T18:06:36","slug":"60048","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2015\/09\/21\/60048\/","title":{"rendered":"lost its mojo&#8230;"},"content":{"rendered":"\n<div align=\"justify\" class=\"small\">One might think that with all of the supportive <a target=\"_blank\" href=\"http:\/\/study329.org\/in-the-news\/\">media<\/a> coverage our <a target=\"_blank\" href=\"http:\/\/www.bmj.com\/cgi\/doi\/10.1136\/bmj.h4320\">Study 329 article<\/a> has received, I would be able to shake off the response from lead author, Martin Keller, reproduced from <a target=\"_blank\" href=\"http:\/\/retractionwatch.com\/2015\/09\/16\/re-analysis-of-controversial-paxil-study-shows-drug-ineffective-and-unsafe-for-teens\/\">Retraction Watch<\/a> in the last post [<a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2015\/09\/18\/keller-responds\/\">keller responds&hellip;<\/a>], or his comment in <a href=\"http:\/\/chronicle.com\/article\/Landmark-Analysis-of-an\/233179\/\" target=\"_blank\">The Chronicle of Higher Education<\/a>:<\/div>\n<blockquote>\n<div align=\"justify\"><em>Dr. Keller contacted The Chronicle on Wednesday to insist  that the 2001 results faithfully represented the best effort of the  authors at the time, and that any misrepresentation of his article to  help sell Paxil was the responsibility of Glaxo. &quot;Nothing was ever pinned on any of us,&quot; despite various trials and  investigations, he said. &quot;And when I say that, I&rsquo;m not telling you we&rsquo;re  like the great escape artists, that we&rsquo;re Houdinis and we did something  wrong and we got away with the crime of the century. Don&rsquo;t you think if  there was really something wrong, some university or agency or  something would have pinned something on us?&quot; In what he described as his first effort to speak publicly about the  matter, Dr. Keller said his critics also have financial and professional  motives for amplifying criticisms, including lawyers representing Paxil  plaintiffs and professors seeking their own records of journal  publication&#8230;<\/em><\/div>\n<\/blockquote>\n<div align=\"justify\" class=\"small\">I had a somewhat similar reaction to Dr. Jeffrey Lieberman&#8217;s <a href=\"http:\/\/www.buzzfeed.com\/catferguson\/paxil-problems\" target=\"_blank\">comment<\/a>:<\/div>\n<div align=\"justify\">\n<blockquote>\n<div><em>&ldquo;The group is a self-appointed watchdog,&rdquo; Jeffrey Lieberman, chair of  psychiatry at the Columbia University College of Physicians and  Surgeons, told BuzzFeed News. &ldquo;One wonders what the motivation is, and  how objective they&rsquo;re going to be.&rdquo;<\/em><\/div>\n<\/blockquote><\/div>\n<div align=\"justify\" class=\"small\">So I spent a day or so with a background chorus of refutations playing like a scratchy record in my mind until they played themselves out. Nobody reading this blog needs to hear them again. You could probably reproduce them yourselves, and I&#8217;ve certainly filled up enough pages saying them. After the din in my head subsided, I was left with just one clear note that I wanted to respond to. It is what has been characterized as the fallacy of an <a href=\"http:\/\/www.nizkor.org\/features\/fallacies\/appeal-to-authority.html\" target=\"_blank\">appeal to authority<\/a>: <\/div>\n<blockquote>\n<div align=\"justify\"><em>&ldquo;The study  authors comprised virtually all of the academic researchers  studying the  treatment of child depression in North America at the  time&rdquo;<\/em>&#8230;<\/div>\n<\/blockquote>\n<div align=\"justify\" class=\"small\">In this case, the BY&middot;LINE is indeed full of <em><font color=\"#200020\">experts<\/font><\/em>:<\/div>\n<blockquote>\n<div align=\"justify\"><em>MARTIN B. KELLER, M.D., NEAL D.  RYAN, M.D., MICHAEL STROBER, PH.D.,  RACHEL G. KLEIN, PH.D., STAN P.  KUTCHER, M.D., BORIS BIRMAHER, M.D.,  OWEN R. HAGINO, M.D., HAROLD  KOPLEWICZ, M.D., GABRIELLE A. CARLSON,  M.D., GREGORY N. CLARKE, PH.D.,  GRAHAM J. EMSLIE, M.D., DAVID FEINBERG,  M.D., BARBARA GELLER, M.D.,  VIVEK KUSUMAKAR, M.D., GEORGE  PAPATHEODOROU, M.D., WILLIAM H. SACK,  M.D., MICHAEL SWEENEY, PH.D.,  KAREN DINEEN WAGNER, M.D., PH.D.,  ELIZABETH B. WELLER, M.D., NANCY C.  WINTERS, M.D., ROSEMARY OAKES, M.S.,  AND JAMES P. MCCAFFERTY, B.S.<\/em><\/div>\n<\/blockquote>\n<div align=\"justify\" class=\"small\">But in spite of Dr. Keller&#8217;s claims otherwise, reading the raft of subpoenaed documents and the depositions, the <em><font color=\"#200020\">author<strong>&middot;<\/strong>ity<\/font><\/em> appears to have rested on the shoulders of ghostwriter Sally Laden and perhaps the last two listed authors, both of whom were GSK employees [<a href=\"http:\/\/pogoarchives.org\/m\/ph\/sally-laden-sti-deposition-20070315.pdf#page=29\" target=\"_self\">Deposition of Sally Laden<\/a>, 2007]:<\/div>\n<ul><sup> <\/p>\n<div align=\"left\"><strong><font color=\"#200020\">QUESTION<\/font><\/strong>: The document that I have marked as Exhibit seven is the final clinical report for Study 329 is that correct?<br \/>           &nbsp;&nbsp;&nbsp;<strong><font color=\"#200020\">ANSWER<\/font><\/strong>: Yes<br \/>           <strong><font color=\"#200020\">QUESTION<\/font><\/strong>: Is this a document that you were referring to that you got the data from?<br \/>           &nbsp;&nbsp;&nbsp;<strong><font color=\"#200020\">ANSWER<\/font><\/strong>: I don t recall what specific document I did receive Whether it was this was one. I mean yes this would be what I would have gotten. I don&#8217;t recall getting it.<br \/>           <strong><font color=\"#200020\">QUESTION<\/font><\/strong>: You don t recall ever receiving it but you know you got it right?<br \/>           &nbsp;&nbsp;&nbsp;<strong><font color=\"#200020\">ANSWER<\/font><\/strong>: Yes I got it. Yes I don&#8217;t recall receiving it.<br \/>         <strong><font color=\"#200020\">QUESTION<\/font>:<\/strong> This provided you with information that you then utilized to prepare the first draft of the manuscript for Study 329?<br \/>           &nbsp;&nbsp;&nbsp;<strong><font color=\"#200020\">ANSWER<\/font><\/strong>: Yes  <\/div>\n<div align=\"left\">           <strong><font color=\"#200020\">QUESTION<\/font><\/strong>: Was it your responsibility alone to create the first draft of  Study 329 or did you get help from some of your colleagues?<br \/>           &nbsp;&nbsp;&nbsp;<strong><font color=\"#200020\">ANSWER<\/font><\/strong>: I believe I created it on my own.<br \/>           <strong><font color=\"#200020\">QUESTION<\/font><\/strong>:  Did Martin Keller tell you what to put in the first draft?<br \/>           &nbsp;&nbsp;&nbsp;<strong><font color=\"#200020\">ANSWER<\/font><\/strong>: I don&rsquo;t recall. I don t think I had any conversation with him until we were, you know, afterwards.  <br \/>           <strong><font color=\"#200020\">QUESTION<\/font><\/strong>:  After you prepared the  first manuscript?<br \/>           &nbsp;&nbsp;&nbsp;<strong><font color=\"#200020\">ANSWER<\/font><\/strong>: To the best of my recollection, yes.<\/div>\n<div align=\"left\">            <strong><font color=\"#200020\">QUESTION<\/font><\/strong>:  In here you list eight main  outcome measures, correct? <br \/>           &nbsp;&nbsp;&nbsp;<strong><font color=\"#200020\">ANSWER<\/font><\/strong>: Yes <br \/>           <strong><font color=\"#200020\">QUESTION<\/font><\/strong>:   And you can&rsquo;t tell from reading &ndash; a reader could not distinguish which  are these &ndash; whether any or all of them are primary or secondary? <br \/>           &nbsp;&nbsp;&nbsp;<strong><font color=\"#200020\">ANSWER<\/font><\/strong>: Correct  <br \/>           <strong><font color=\"#200020\">QUESTION<\/font><\/strong>:&nbsp; My question was do you know whose idea it was to not distinguish between primary and secondary efficacy measures? <br \/>           &nbsp;&nbsp;&nbsp;<strong><font color=\"#200020\">ANSWER<\/font><\/strong>:  A reader cannot. This was a first draft, so this came straight from me.  This was, I guess, my interpretation. I&#8217;m remembering this may have  been my  interpretation of the data. <\/div>\n<p><\/sup><\/ul>\n<div align=\"justify\" class=\"small\">This is only one small example of the extent to which the <a href=\"http:\/\/www.nizkor.org\/features\/fallacies\/appeal-to-authority.html\" target=\"_blank\">appeal to authority<\/a> has pervaded our literature. The <em><font color=\"#200020\">experts<\/font><\/em> are listed on the BY&middot;LINE, but the work that matters is produced by the sponsor. In this case, the subjects were recruited and underwent the study at the institutions of the listed authors, but the article was drafted by the sponsor and written by a paid writer. This kind of &quot;guest&quot; authorship is common &#8211; the <em><font color=\"#200020\">experts<\/font><\/em> are involved, but not in the <em><font color=\"#200020\">authorship<\/font><\/em> as we understand the term. There are many other examples where the sponsors had already completed the papers before even recruiting the academic &quot;guest authors&quot; to sign onto the BY&middot;LINE.          <\/div>\n<p align=\"justify\" class=\"small\"><img decoding=\"async\" width=\"245\" border=\"0\" hspace=\"5\" align=\"right\" src=\"http:\/\/1boringoldman.com\/images\/dsm5-workgroups.gif\" \/>Similar <em><font color=\"#200020\">experts<\/font><\/em> with [financial] PHARMA COI are everywhere: CME presentations; Speaker&#8217;s Bureaus; Review Articles; the list gets longer by the year. A recent NEJM series [<a href=\"http:\/\/1boringoldman.com\/index.php\/2015\/05\/21\/wtf-3\/\">wtf?&hellip;<\/a>, <a href=\"http:\/\/1boringoldman.com\/index.php\/2015\/05\/22\/wtf-for-real\/\">wtf? for real&hellip;<\/a>] argued that their longstanding policy of banning authors with these COI from review articles should change [in part because there&#8217;s a paucity of &quot;clean&quot; <em><font color=\"#200020\">experts<\/font><\/em>]. The DSM-5 Revision was done using panels of <em><font color=\"#200020\">experts<\/font><\/em> heavily laden with COI tainted members [<a href=\"http:\/\/1boringoldman.com\/index.php\/2012\/03\/15\/must-be-crazy\/\">must be crazy&hellip;<\/a>]. <em><font color=\"#200020\">Expert <\/font><\/em>&quot;panels&quot; produced the guidelines and algorithms for the infamous TMAP scam in Texas [<a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2011\/06\/12\/1999-2\/\">1999&hellip;<\/a>]. It appears that we have developed a &quot;cult&quot; of <em><font color=\"#200020\">experts<\/font><\/em> [called Key Opinion Leaders by the pharmaceutical marketers].<\/p>\n<div align=\"justify\" class=\"small\">The <a href=\"http:\/\/www.nizkor.org\/features\/fallacies\/appeal-to-authority.html\" target=\"_blank\">Nizkor Project<\/a> [a study of logical fallacies] lists among the instances where an <a href=\"http:\/\/www.nizkor.org\/features\/fallacies\/appeal-to-authority.html\" target=\"_blank\">appeal to authority<\/a> is considered a logical fallacy:<\/div>\n<ul> <span class=\"small\">  <\/p>\n<li>\n<div align=\"justify\"><em><font color=\"#200020\">If there is evidence that a person is biased in some manner that would affect the reliability of her claims, then an Argument from Authority based on that person is likely to be fallacious. Even if the claim is actually true, the fact that the expert is biased weakens the argument. This is because there would be reason to believe that the expert might not be making the claim because he has carefully considered it using his expertise. Rather, there would be reason to believe that the claim is being made because of the expert&#8217;s bias or prejudice.<\/font><\/em><\/div>\n<\/li>\n<li>\n<div align=\"justify\"><em><font color=\"#200020\">If a person makes a claim about some subject outside of his area(s) of expertise, then the person is not an expert in that context. Hence, the claim in question is not backed by the required degree of expertise and is not reliable. It is very important to remember that because of the vast scope of human knowledge and skill it is simply not possible for one person to be an expert on everything. Hence, experts will only be true experts in respect to certain subject areas. In most other areas they will have little or no expertise.<\/font><\/em><\/div>\n<\/li>\n<p>  <\/span><\/ul>\n<div align=\"justify\" class=\"small\">In this case, when we were able to directly access the <font color=\"#200020\">Individual Participant Data <\/font>[<font color=\"#200020\">IPD<\/font>] and the Case Report Forms [CRFs] using the a priori Protocol as our guide for predefined Primary and Secondary Outcomes following their stated Statistical Analysis Plan, we could not confirm their claim of efficacy or of safety. Quite the opposite. The group listed on the BY&middot;LINE may well be <em><font color=\"#200020\">experts <\/font><\/em>of one sort or another, but they are neither <em><font color=\"#200020\">unbiased<\/font><\/em> nor <em><font color=\"#200020\">experts<\/font><\/em> in analyzing Clinical Trial data. The notion that one can introduce a completely new outcome analysis at the end of a Clinical Trial lasting three years, whether before or after breaking the blind, and expect to be taken seriously in perpetuity is ludicrous &#8211; no matter what the explanation for the change. It&#8217;s equally bizarre to query 27 outcome measures [in the CSR] and ignore correcting for multiple variables. Likewise, the idea that Dr. Keller can claim that the article was written or analyzed by the <em><font color=\"#200020\">experts<\/font><\/em> on the BY&middot;LINE when the hired medical writer testifies that she wrote the <a href=\"http:\/\/www.healthyskepticism.org\/files\/docs\/gsk\/paroxetine\/study329\/DraftI.pdf\" target=\"_blank\">first draft<\/a> [and others] from an industry supplied summary is equally absurd. And our paper was actually soft on some of the statistical manipulation along the way, but these comments apply in that arena as well.   <\/div>\n<p align=\"justify\" class=\"small\">I actually sometimes feel sorry for some&nbsp; of the people on that BY&middot;LINE. For some, I expect their error was in assuming that the analysis of the study was properly conducted. But my empathy is short-lived. I think they must&#8217;ve felt like it was a double return for their efforts. By doing the study on their site, they raised money for their departments <u>AND<\/u> they added an article to their respective resumes. What they got was anything but a boost to their status as <em><font color=\"#200020\">experts<\/font><\/em>. They delegated their <em><font color=\"#200020\">author<strong>&middot;<\/strong>ity<\/font><\/em> to other <em><font color=\"#200020\">experts<\/font><\/em> who were operating deep in the domain of fallacy &#8211; then compounded and continue to compound the problem by their silence.  <\/p>\n<div align=\"justify\" class=\"small\">The <a href=\"http:\/\/www.nizkor.org\/features\/fallacies\/appeal-to-authority.html\" target=\"_blank\">appeal to authority<\/a> argument has lost its mojo, not just in this trial, but in Clinical Trials in general. In our <a href=\"http:\/\/www.bmj.com\/cgi\/doi\/10.1136\/bmj.h4320\" target=\"_blank\">article<\/a>, we concluded:<\/div>\n<blockquote>\n<div align=\"justify\"><em>&#8230; As with most scientific papers, Keller and colleagues convey an impression that &ldquo;the data have spoken.&rdquo; This authoritative stance is possible only in the absence of access to the data. When the data become accessible to others, it becomes clear that scientific authorship is provisional rather than authoritative.<\/em><\/div>\n<\/blockquote>\n","protected":false},"excerpt":{"rendered":"<p>One might think that with all of the supportive media coverage our Study 329 article has received, I would be able to shake off the response from lead author, Martin Keller, reproduced from Retraction Watch in the last post [keller responds&hellip;], or his comment in The Chronicle of Higher Education: Dr. Keller contacted The Chronicle [&hellip;]<\/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-60048","post","type-post","status-publish","format-standard","hentry","category-opinion"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/60048","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=60048"}],"version-history":[{"count":47,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/60048\/revisions"}],"predecessor-version":[{"id":60102,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/60048\/revisions\/60102"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=60048"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=60048"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=60048"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}