{"id":56419,"date":"2015-04-29T14:17:52","date_gmt":"2015-04-29T18:17:52","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=56419"},"modified":"2015-04-29T21:18:32","modified_gmt":"2015-04-30T01:18:32","slug":"machiavellian-medicine-lives","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2015\/04\/29\/machiavellian-medicine-lives\/","title":{"rendered":"machiavellian medicine lives&#8230;"},"content":{"rendered":"<div align=\"justify\" class=\"small\">I missed something. In <a href=\"http:\/\/1boringoldman.com\/index.php\/2015\/04\/22\/the-spice-must-flow-2\/\" target=\"_blank\">the spice must flow&#8230;<\/a>, I was looking at the two papers recently published about Brexpiprazole, a new Atypical Antipsychotic and found the the only academic authors were from the same faculty and research institute:<\/div>\n<blockquote>\n<div align=\"center\" class=\"middle\"><a target=\"_self\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/25882325\"><font color=\"#990000\">Efficacy  and Safety of Brexpiprazole for the Treatment of Acute Schizophrenia: A  6-Week Randomized, Double-Blind, Placebo-Controlled Trial<\/font><\/a><\/div>\n<div align=\"center\" class=\"small\">by <strong><font color=\"#990000\">Correll CU<\/font><\/strong>,<strong><font color=\"#0033ff\"> Skuban A<\/font><\/strong>,<strong><font color=\"#0033ff\"> Ouyang J<\/font><\/strong>,<strong><font color=\"#0033ff\"> Hobart M<\/font><\/strong>,<strong><font color=\"#0033ff\"> Pfister S<\/font><\/strong>,<strong><font color=\"#0033ff\"> McQuade RD<\/font><\/strong>,<strong><font color=\"#0033ff\"> Nyilas M<\/font><\/strong>,<strong><font color=\"#0033ff\"> Carson WH<\/font><\/strong>,<strong><font color=\"#0033ff\"> Sanchez R<\/font><\/strong>,<strong><font color=\"#0033ff\"> and Eriksson H.<\/font><\/strong><\/div>\n<div align=\"center\" class=\"middle\"><strong><font color=\"#004400\">American Journal of Psychiatry.<\/font><\/strong> 2015 Apr 16 [Epub ahead of print]<\/div>\n<div align=\"center\" class=\"middle\">[<a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT01396421\" target=\"_blank\">NCT01396421<\/a>]   <\/div>\n<\/blockquote>\n<blockquote>\n<div align=\"center\" class=\"middle\"><a target=\"_self\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/25682550\"><font color=\"#008800\">A  multicenter, randomized, double-blind, controlled phase 3 trial of  fixed-dose brexpiprazole for the treatment of adults with acute  schizophrenia.<\/font><\/a><\/div>\n<div align=\"center\" class=\"small\">by <strong><font color=\"#008800\">Kane JM<\/font><\/strong>, <strong><font color=\"#0066ff\">Skuban<\/font><\/strong>, <strong><font color=\"#0066ff\">Ouyang<\/font><\/strong>, <strong><font color=\"#0066ff\">Hobart, Pfister<\/font><\/strong>, <strong><font color=\"#0066ff\">McQuade<\/font><\/strong>, <strong><font color=\"#0066ff\">Nyilas<\/font><\/strong>, <strong><font color=\"#0066ff\">Carson<\/font><\/strong>, <strong><font color=\"#0066ff\">Sanchez<\/font><\/strong>, <strong><font color=\"#0066ff\">and Eriksson<\/font><\/strong>.<\/div>\n<div align=\"center\" class=\"middle\"><strong><font color=\"#200020\">Schizophrenia Research.<\/font><\/strong> 2015 Feb 12. [Epub ahead of print]<\/div>\n<div align=\"center\" class=\"middle\">[<a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT01393613\" target=\"_blank\">NCT01393613<\/a>]   <\/div>\n<\/blockquote>\n<div align=\"justify\" class=\"small\">Towards the end of writing that post, I looked up the chemical structures and realized what a clone Brexpiprazole was of Aripiprazole [<font color=\"#200020\">Abilify&reg;<\/font>] [the number one overall seller in the US] that&#8217;s about to go off patent:<\/div>\n<div align=\"center\" class=\"small\"><img loading=\"lazy\" decoding=\"async\" width=\"265\" height=\"177\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/abilify-15.gif\" \/><\/div>\n<div align=\"justify\" class=\"small\">But something was nagging at me, and it just occurred to me what it was. A month and a half ago, I wrote a post about a CME for Aripiprazole [Long Acting Injectable] which is <font color=\"#200020\">Abilify&reg;Maintena<\/font> [see <a href=\"http:\/\/1boringoldman.com\/index.php\/2015\/03\/08\/a-crying-shame\/\" target=\"_blank\">a crying shame&hellip;<\/a>] &#8211; which I saw as a patent-extender move now that <font color=\"#200020\">Abilify&reg;<\/font> is going generic [analogous the same ploy with <font color=\"#200020\">Seroquel&reg;XR<\/font> or <font color=\"#200020\">Paxil&reg;CR<\/font>]. What I didn&#8217;t notice was the authorship on the <font color=\"#200020\">Abilify&reg;Maintena<\/font> paper or the presenters of the CME.<\/div>\n<blockquote>\n<div align=\"center\" class=\"middle\"><a href=\"http:\/\/bjp.rcpsych.org\/content\/bjprcpsych\/205\/2\/135.full.pdf\" target=\"_blank\">Aripiprazole once-monthly for treatment of schizophrenia: double-blind, randomised, non-inferiority study<\/a><\/div>\n<div align=\"center\" class=\"small\">by W. Wolfgang Fleischhacker,<strong><font color=\"#0033ff\"> Raymond Sanchez<\/font><\/strong>,<strong><font color=\"#0033ff\"> Pamela P. Perry<\/font><\/strong>,<strong><font color=\"#0033ff\"> Na Jin<\/font><\/strong>, <strong><font color=\"#0033ff\">Timothy Peters-Strickland<\/font><\/strong>,<strong><font color=\"#0033ff\"> Brian R. Johnson<\/font><\/strong>,<strong><font color=\"#0033ff\"> Ross A. Baker<\/font><\/strong>,<strong><font color=\"#0033ff\"> Anna Eramo<\/font><\/strong>,<strong><font color=\"#0033ff\"> Robert D. McQuade<\/font><\/strong>,<strong><font color=\"#0033ff\"> William H. Carson<\/font><\/strong>, David Walling and <strong><font color=\"#009999\">John M. Kane<\/font><\/strong><\/div>\n<div align=\"center\" class=\"middle\"><strong><font color=\"#0066ff\">The British Journal of Psychiatry<\/font><\/strong>. 2014 205:135&ndash;144.<\/div>\n<div align=\"center\" class=\"middle\">[<a href=\"http:\/\/bjp.rcpsych.org\/content\/bjprcpsych\/205\/2\/135.full.pdf\" target=\"_blank\">full text on-line<\/a>] <\/div>\n<div align=\"center\" class=\"middle\">[<a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/study\/NCT00706654\" target=\"_blank\">NCT00706654<\/a><\/div>\n<div align=\"center\"><em><strong><font color=\"#200020\">Funding<\/font><\/strong><\/em><\/div>\n<div align=\"justify\">This study was supported by Otsuka Pharmaceutical Commercialization, Inc. [Tokyo, Japan]. Editorial support for the preparation of this manuscript was provided by Suzanne Patel at Ogilvy Healthworld Medical Education and Amy Roth Shaberman, PhD, and Brett D. Mahon, PhD, at C4 MedSolutions, LLC, a CHC Group company; funding was provided by Otsuka Pharmaceutical Commercialization, Inc. and H. Lundbeck A\/S.<\/div>\n<div align=\"center\"><em><strong><font color=\"#200020\">Acknowledgements<\/font><\/strong><\/em><\/div>\n<div align=\"justify\">The authors would like to thank Svetlana Ivanova, PhD, Otsuka Pharmaceutical Development &amp; Commercialization, Inc., Rockville, MD, USA, for her contribution to the analysis and interpretation of data.                 <\/div>\n<\/blockquote>\n<div align=\"justify\" class=\"small\">and [from <a href=\"http:\/\/1boringoldman.com\/index.php\/2015\/03\/08\/a-crying-shame\/\" target=\"_blank\">a crying shame&hellip;<\/a>]&#8230;<\/div>\n<blockquote>\n<div align=\"justify\">So we wonder who is on the faculty of this <em><font color=\"#200020\">Free CME<\/font><\/em>?&nbsp; I clicked on the link to <a target=\"_blank\" href=\"http:\/\/globalacademycme.realcme.com\/cms\/node\/549226\">Adherence, Recovery, and the Role of LAIs in Schizophrenia<\/a>:<\/div>\n<div align=\"center\"><strong><font color=\"#200020\">Faculty<\/font><\/strong><\/div>\n<ul>\n<li>\n<div align=\"justify\"><strong><font color=\"#990000\">Christoph U. Correll, MD<\/font><\/strong><br \/>                        <em>Professor of Psychiatry and Molecular Medicine<\/em><br \/>                        Hofstra North Shore &ndash; LIJ School of Medicine<\/div>\n<div><em>Medical Director of<\/em>&nbsp;<em>Recognition and Prevention (RAP) Program<\/em><br \/>                        The Zucker Hillside Hospital<br \/>                        Glen Oaks, NY<\/div>\n<\/li>\n<li>\n<div align=\"justify\"><strong><font color=\"#0099cc\">John M. Kane, MD<\/font><\/strong><br \/>                      <em>Professor of Psychiatry<\/em><br \/>                      Hofstra North Shore &ndash; LIJ Health System School of Medicine<br \/>                        <em>Vice President<\/em><br \/>                        Behavioral Health Services of the<em>&nbsp;<\/em>North Shore &ndash; LIJ Health System<br \/>                        <em>Chairman of Department of Psychiatry and Chief of Staff<\/em><br \/>                        The Zucker Hillside Hospital<br \/>                        Glen Oaks, New York<\/div>\n<\/li>\n<li>\n<div align=\"justify\"><strong><font color=\"#200020\">John Lauriello, MD <\/font><\/strong><br \/>                      <em>Chancellor&rsquo;s Chair of Excellence in Psychiatry<\/em><br \/>                      <em>Executive&nbsp;Medical Director of the Missouri Psychiatric Center<\/em><br \/>                      School of Medicine, University of Missouri Health System<br \/>                        Columbia, MO<\/div>\n<\/li>\n<\/ul>\n<div align=\"justify\">Take a look at the <strong><font color=\"#200020\">Learning Objective<\/font><\/strong> and guess what you&rsquo;re going to learn &ndash; for free. Oh by the way, <strong><font color=\"#200020\">John Lauriello, MD <\/font><\/strong> is the senior author of a glowing <a href=\"http:\/\/www.clinicalschizophrenia.net\/pdfs\/Featured_Paper-July2013-Gopalakrishna.pdf\" target=\"_blank\">handout review<\/a> of <font color=\"#200020\">Abilify&reg;Maintena<\/font>.<\/div>\n<\/blockquote>\n<div align=\"justify\" class=\"small\">Familiar? All the authors in <font color=\"#200020\"><strong><font color=\"#0033ff\">blue<\/font><\/strong><\/font> are Lundbeck or Otsuka employees. The three academic authors are all on Bureaus or Boards for both Lundbeck or Otsuka. John Kane, listed as senior author <strike>wrote<\/strike> was a listed author on one of the <font color=\"#200020\">Brexpiprazole<\/font> papers and is on Bureaus or Boards for both Lundbeck or Otsuka. And the <font color=\"#200020\">Abilify&reg;Maintena<\/font> CME has both of the Academic Authors from the <font color=\"#200020\">Brexpiprazole<\/font> papers on the faculty.   <\/div>\n<p align=\"justify\" class=\"small\">In<em> <\/em><a href=\"http:\/\/1boringoldman.com\/index.php\/2015\/04\/22\/the-spice-must-flow-2\/\"><em>the spice must flow&hellip;<\/em><\/a>, I joked &quot;[it was <em><font color=\"#200020\">one&middot;stop shopping<\/font><\/em> for both <em><font color=\"#200020\">ghost&middot;writers<\/font><\/em> and <em><font color=\"#200020\">KOLs<\/font><\/em>],&quot; but it was bigger than I knew. The Hofstra faculty provided not only authors for both <font color=\"#200020\">Brexpiprazole<\/font>&nbsp; papers, but also the <font color=\"#200020\">Abilify&reg;Maintena<\/font> paper&nbsp; and the <font color=\"#200020\">Abilify&reg;Maintena<\/font> CME &#8211; all of which were aimed at holding onto the market as <font color=\"#200020\">Abilify&reg;<\/font> becomes generic. This was <em><font color=\"#200020\">one&middot;stop shopping-maximus<\/font><\/em> [though <font color=\"#200020\">Abilify&reg;Maintena<\/font> did get different ghost-writers]. The <font color=\"#200020\">Abilify&reg;Maintena<\/font> study had 98 sites!<\/p>\n<div align=\"justify\" class=\"small\">Lest&nbsp; you&#8217;re getting excited about all the reforms, this is<em><strong> <font color=\"#200020\">Academic&middot;Industrial&middot;Complex<\/font><\/strong><\/em> all the way &#8211; complete with KOLs, ghost-writers, CRO-style Trial with many sites and foreign sites, industry stats, ignoring the results database, COI everywhere you turn, commercial rather than scientific motives [replacing <font color=\"#200020\">Abilify&reg;<\/font> as a cash cow], no primary data posted, etc.:<\/div>\n<ul><span class=\"small\">          <\/p>\n<li>\n<div align=\"justify\"><em><strong><img decoding=\"async\" width=\"90\" hspace=\"4\" border=\"0\" align=\"right\" src=\"http:\/\/1boringoldman.com\/images\/md-ticket.gif\" \/><font color=\"#200020\">Guest Authors:<\/font><\/strong><\/em> In this case, the articles are no longer crammed with academics like a decade ago. I guess it only takes one to be the ticket into an academic journal. In this case, the main authors came from <a href=\"http:\/\/medicine.hofstra.edu\/department\/psychiatry\/psychiatry_chair_kane.html\" target=\"_self\">Hostra<\/a> [The <a href=\"http:\/\/www.feinsteininstitute.org\/\" target=\"_blank\">Feinstein Institute<\/a>] for the articles and C.M.E. Their C.V.s and C.O.I. are heavily weighted with Clinical Trials of drugs.         <\/div>\n<\/li>\n<li>\n<div align=\"justify\"><em><strong><font color=\"#200020\">Ghost-Writers:<\/font><\/strong><\/em> All articles had the characteristic writing\/editorial support usually indicating the paper being ghost-written [and some ghost-statisticians].         <\/div>\n<\/li>\n<li>\n<div align=\"justify\"><em><strong><font color=\"#200020\">Multiple International sites<\/font><\/strong><\/em> [60+57+98=215] and <em><strong>large subject cohorts<\/strong><\/em> [636+674+662=1972; 1972&divide;215=~9 subjects\/site] [&quot;fast&quot; &quot;sensitive&quot; trials].<\/div>\n<\/li>\n<li>\n<div align=\"justify\"><em><strong><font color=\"#200020\">Selective Presentation:<\/font><\/strong><\/em> eg effect sizes reported in Correll et al [high] but not Kane et al [low].        <\/div>\n<\/li>\n<li>\n<div align=\"justify\"><em><strong><font color=\"#200020\">Results Database on ClinicalTrials.gov:<\/font><\/strong><\/em> Missing in Correll et al and Kane et al.<span class=\"small\"> <\/span><\/div>\n<\/li>\n<li>\n<div align=\"justify\"><em><strong><font color=\"#200020\">And:<\/font><\/strong><\/em> a bunch of stuff I can&#8217;t see through the haze&#8230;<\/div>\n<\/li>\n<p>  <\/span><\/ul>\n<div align=\"justify\" class=\"small\">Machiavellian Medicine at its finest&#8230;<\/div>\n","protected":false},"excerpt":{"rendered":"<p>I missed something. In the spice must flow&#8230;, I was looking at the two papers recently published about Brexpiprazole, a new Atypical Antipsychotic and found the the only academic authors were from the same faculty and research institute: Efficacy and Safety of Brexpiprazole for the Treatment of Acute Schizophrenia: A 6-Week Randomized, Double-Blind, Placebo-Controlled Trial [&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_topic_count_hidden":0,"_bbp_reply_count_hidden":0,"_bbp_forum_subforum_count":0,"footnotes":""},"categories":[5],"tags":[],"class_list":["post-56419","post","type-post","status-publish","format-standard","hentry","category-opinion"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/56419","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=56419"}],"version-history":[{"count":32,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/56419\/revisions"}],"predecessor-version":[{"id":56479,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/56419\/revisions\/56479"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=56419"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=56419"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=56419"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}