{"id":67424,"date":"2016-08-16T22:46:01","date_gmt":"2016-08-17T02:46:01","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=67424"},"modified":"2016-08-17T15:51:02","modified_gmt":"2016-08-17T19:51:02","slug":"ignorance","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2016\/08\/16\/ignorance\/","title":{"rendered":"ignor&middot;ance&#8230;"},"content":{"rendered":"<div align=\"justify\"><sup><em><a title=\"Wikipedia definition\" target=\"_blank\" href=\"https:\/\/en.wikipedia.org\/wiki\/Ignorance\">Ignorance<\/a><font color=\"#200020\"> is a state of being uninformed [lack of knowledge].<sup> <\/sup>The word ignorant is an adjective describing a person in the state of being unaware and is often used to describe individuals who deliberately <\/font><strong><font color=\"#200020\">ignore<\/font><\/strong><font color=\"#200020\"> or disregard important information or facts.<\/font><\/em><\/sup><\/div>\n<ul><sup><\/p>\n<div><strong><font color=\"#200020\">ig&middot;nore (&iuml;g-n&ocirc;r&prime;)<\/font><\/strong><\/div>\n<div><font color=\"#200020\"><em>verb<\/em><\/font><\/div>\n<div><font color=\"#200020\">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;To  refuse to pay attention to; disregard.<\/font><\/div>\n<p><\/sup><\/ul>\n<p align=\"justify\" class=\"small\">It&#8217;s telling that the words <em><font color=\"#200020\">ignorance<\/font><\/em> and <em><font color=\"#200020\">ignorant<\/font><\/em> come from the verb <em><font color=\"#200020\">ignore<\/font><\/em>, implying a <em><font color=\"#200020\">chosen<\/font><\/em> version of not knowing. It certainly comes up a lot in matters surrounding clinical trials. For example, the rules for&nbsp; preregistration or resuls posting on clinicaltrials.gov or preregistration of outcomes as a prerequisite to being considered for publication have been regularly ignored [see <a href=\"http:\/\/1boringoldman.com\/index.php\/2016\/08\/13\/the-wrong-tree\/\">the wrong tree&hellip;<\/a>]. Long before we conceived of our RIAT reanalysis of Paxil Study 329, I made a formal request to the <font color=\"#200020\">Ethics Coimmittee<\/font> of the <font color=\"#200020\">American Academy of Child and Adolescent Psychiatry<\/font>. The committee [and the president-elect] responded, investigated, and told me that the question would be discussed at their yearly meeting. Nothing happened and it was not discussed. I later learned that the editor, <font color=\"#200020\">Andres Martin<\/font>, found out and insisted they have no more contact with me [<font color=\"#200020\">ignored<\/font>,<font color=\"#200020\"> disregarded<\/font>] and that was the end of that.<\/p>\n<div align=\"justify\" class=\"small\">In general, the major organizations [<font color=\"#200020\">AACAP<\/font>,<font color=\"#200020\"> APA<\/font>] have <font color=\"#200020\">ignored<\/font> distortion of clinical trial reports in medical journals, including their own official journals when it has been pointed out. In spite of our reanalysis, that paper&#8217;s notoriety, and the $3 B settlement, the&nbsp; Study 329 article still sits in our literature &#8211; unretracted. And now, there&#8217;s another obvious candidate &#8211; the <font color=\"#200020\">Citalopram<\/font> trial in children and adolescents called <font color=\"#200020\">CIT-MD-18<\/font>. The recent article about that paper reveals how it was <em><font color=\"#200020\">actively<\/font><\/em> distorted by the sponsor &#8211; <font color=\"#004400\">Forest Laboratories<\/font> [see <a href=\"http:\/\/1boringoldman.com\/index.php\/2016\/05\/14\/this-tawdry-era\/\">this tawdry era&hellip;<\/a>]<em><font color=\"#200020\">:<\/font><\/em> <\/div>\n<blockquote>\n<div align=\"center\" class=\"big\"><a target=\"_blank\" href=\"http:\/\/content.iospress.com\/articles\/international-journal-of-risk-and-safety-in-medicine\/jrs717\">The   citalopram CIT-MD-18 pediatric depression trial: Deconstruction of   medical ghostwriting, data mischaracterisation and academic malfeasance<\/a><\/div>\n<div align=\"center\" class=\"middle\">by  Jureidini, Jon N., Amsterdam, Jay, D, and McHenry, Leemon B.<\/div>\n<div align=\"center\" class=\"middle\"><strong><font color=\"#1b699e\">International Journal of Risk &amp; Safety in Medicine<\/font><\/strong>, 2016 28[1]:33-43.<\/div>\n<div align=\"center\" class=\"middle\">[<a target=\"_blank\" href=\"http:\/\/content.iospress.com\/articles\/international-journal-of-risk-and-safety-in-medicine\/jrs717\">full text on-line<\/a>]<\/div>\n<div align=\"center\" class=\"middle\">[<a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/background-notes\/\">background notes<\/a>]<\/div>\n<p>    <\/p>\n<div align=\"justify\"><em><strong><font color=\"#200020\">OBJECTIVE<\/font><\/strong><\/em>:   Deconstruction of a ghostwritten report of a randomized, double-blind,  placebo-controlled efficacy and safety trial of citalopram in depressed  children and adolescents conducted in the United States. <\/div>\n<div align=\"justify\"><em><strong><font color=\"#200020\">METHODS<\/font><\/strong><\/em>:   Approximately 750 documents from the Celexa and Lexapro Marketing and  Sales Practices Litigation: Master Docket 09-MD-2067-[NMG] were  deconstructed. <\/div>\n<div align=\"justify\"><em><strong><font color=\"#200020\">RESULTS<\/font><\/strong><\/em>:   The published article contained efficacy and safety data inconsistent  with the protocol criteria. Procedural deviations went unreported  imparting statistical significance to the primary outcome, and an  implausible effect size was claimed; positive post hoc measures were  introduced and negative secondary outcomes were not reported; and  adverse events were misleadingly analysed. Manuscript drafts were  prepared by company employees and outside ghostwriters with academic  researchers solicited as &lsquo;authors&rsquo;. <\/div>\n<div align=\"justify\"><em><strong><font color=\"#200020\">CONCLUSION<\/font><\/strong><\/em>:   Deconstruction of court documents revealed that protocol-specified  outcome measures showed no statistically significant difference between  citalopram and placebo. However, the published article concluded that  citalopram was safe and significantly more efficacious than placebo for  children and adolescents, with possible adverse effects on patient  safety. <\/div>\n<\/blockquote>\n<div align=\"justify\" class=\"small\">The authors wrote the <font color=\"#004400\">American Journal of Psychiatry<\/font> where the original article is published requesting a retraction of <em><font color=\"#200020\">Wagner et al&#8217;s<\/font><\/em> <a target=\"_blank\" href=\"http:\/\/ajp.psychiatryonline.org\/doi\/pdf\/10.1176\/appi.ajp.161.6.1079\">A Randomized, Placebo-Controlled Trial of Citalopram  for the Treatment of Major Depression  in Children and Adolescents<\/a>. That letter is in the <a href=\"http:\/\/1boringoldman.com\/index.php\/background-notes\/\" target=\"_blank\">Background Notes<\/a>, and it received only this terse, belated reply:<\/div>\n<blockquote>\n<div> RE: Am J Psychiatry 2004; 161:1079&ndash;1083 We are not retracting this article. Robert Freedman MD<\/div>\n<\/blockquote>\n<div align=\"justify\" class=\"small\">In a rational world, one might think that an editor might be embarrassed a bit, but generally be glad to hear about an article that&#8217;s as far in left field as this one and look into it &#8211; particularly an article he himself had censured in the past for undeclared ghost-writing and omitting a negative european study [see <a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2014\/10\/16\/collusion-with-fiction\/\">collusion with fiction&hellip;<\/a>]. By the way, throw in its centrality in a pricey legal suit [<a target=\"_blank\" href=\"http:\/\/www.fda.gov\/ICECI\/CriminalInvestigations\/ucm226396.htm\">Drug Maker Forest Pleads Guilty: Will Pay More Than $313  Million to Resolve Criminal Charges and False Claims Act Allegations<\/a>]. But Freedman&#8217;s <font color=\"#200020\"><em>disregarding<\/em> imperative<\/font> [<em><font color=\"#200020\">We are not retracting this article<\/font><\/em>] is anything but that kind of response &#8211; more in the range of a <font color=\"#200020\"><em>scowl in text<\/em>.<\/font>   <\/div>\n<p align=\"justify\" class=\"small\">So the authors appealed to a higher power, <font color=\"#200020\">Maria A. Oquendo, M.D., President of the American Psychiatric Association<\/font>. Dr. <font color=\"#200020\"> Oquendo<\/font> appears to be one of the good guys, able to have a distinguished and successful academic career without the taint of <em><font color=\"#200020\">KOL-dom<\/font><\/em> like her predecessor as Chairman at Penn,<font color=\"#200020\"> Dwight Evans <\/font>[on <font color=\"#200020\"><em>Senator Grassley&#8217;s<\/em> <\/font>list of COI violators among other things]. That letter is posted <a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2016\/08\/02\/a-time-for-change\/\">here<\/a> on this blog [<font color=\"#200020\"><a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2016\/08\/02\/a-time-for-change\/\">a time for change&hellip;<\/a><\/font>], and cosigned by a number of impressive people [and others]. It has been two weeks since it was sent, and there&#8217;s been no response yet.<\/p>\n<p align=\"justify\" class=\"small\">Juriedini et al&#8217;s Deconstruction of CIT-MD-18 is substantively different from our <a href=\"http:\/\/www.bmj.com\/content\/351\/bmj.h4320\" target=\"_blank\">Restoring Study 329 article<\/a>, even though they&#8217;re in the same genre. Ours was a reanalysis, and while we were able to access the Raw Data and definitively show it was a negative study, the RIAT format didn&#8217;t allow for the subpoenaed emails that expose internal goings on. The CIT-MD-18 Deconstruction brings the corrupt processes out into the light of day as well as showing that this trial was also negative. This paper is important for two reasons: this study was part of the FDA Approved indication in adolescents AND it doesn&#8217;t have the negative notoriety of Paxil Study 329. In fact, first author <font color=\"#200020\">Karen Dineen Wagner<\/font> used it in her presentation of antidepressant use in kids at the May 2016 APA meeting. So its findings are still very much<em><font color=\"#200020\"> in use<\/font><\/em> [see <a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2016\/07\/24\/whats-it-going-to-take\/\">what&rsquo;s it going to take?&hellip;<\/a>].  <\/p>\n<hr width=\"75%\" size=\"1\" \/>\n<p align=\"justify\" class=\"small\">It&#8217;s time for the upper levels of academic psychiatry and journal editors to <em><strong><font color=\"#200020\">stop ignoring<\/font><\/strong><\/em> these corrupt clinical trial reports that literally haunt our literature, moving forward as if none of what happened ever really did happen. They have tainted the reputation of the specialty and the profession in general. These papers sit in the literature like rotten fruit in a barrel and they&#8217;re not going to go away. This particular study is unusually influential and must be dealt with. As for the authors, &quot;<em><font color=\"#200020\">don&#8217;t do the crime if you can&#8217;t do the time.<\/font><\/em>&quot; I suspect that many of them had no idea what they were signing on to, but that&#8217;s no excuse. In the case of Dr. Wagner, the first author [and principal investigator], by her own testimony she neither looked at the whole data set nor checked the statistical analysis [see <a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2016\/07\/07\/authority\/\">author&middot;ity&hellip;<\/a>].   <\/p>\n<div align=\"justify\" class=\"small\">So the task before Dr. <font color=\"#200020\"> Oquendo<\/font> is a big one. Is she going to stick her head in the sand? <em><font color=\"#200020\">ignore<\/font><\/em> the obvious? or step up to the plate?&#8230;<font color=\"#200020\"><br \/> <\/font><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Ignorance is a state of being uninformed [lack of knowledge]. The word ignorant is an adjective describing a person in the state of being unaware and is often used to describe individuals who deliberately ignore or disregard important information or facts. ig&middot;nore (&iuml;g-n&ocirc;r&prime;) verb &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;To refuse to pay attention to; disregard. It&#8217;s telling that the [&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-67424","post","type-post","status-publish","format-standard","hentry","category-opinion"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/67424","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=67424"}],"version-history":[{"count":31,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/67424\/revisions"}],"predecessor-version":[{"id":67508,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/67424\/revisions\/67508"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=67424"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=67424"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=67424"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}