{"id":59779,"date":"2015-09-07T20:21:58","date_gmt":"2015-09-08T00:21:58","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=59779"},"modified":"2015-09-07T20:27:47","modified_gmt":"2015-09-08T00:27:47","slug":"anything-goes","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2015\/09\/07\/anything-goes\/","title":{"rendered":"anything goes&#8230;"},"content":{"rendered":"<div align=\"justify\"><sup><em><font color=\"#200020\">&quot;There is only one difference between a bad economist and a good one: the bad economist confines himself to the <em>visible<\/em> effect; the good economist takes into account both the effect that can be seen and those effects that must be foreseen&#8230;&quot;<\/font><\/em><\/sup><\/div>\n<div align=\"justify\"><sup>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<em><font color=\"$200020\">French Journalist\/Economist <a href=\"http:\/\/www.econlib.org\/library\/Enc\/bios\/Bastiat.html\">Fr\u00e9d\u00e9ric Bastiat<\/a><\/font><\/em><\/sup><\/div>\n<p align=\"justify\" class=\"small\">The Law of Unintended Consequences is an all too frequent force in the best laid plans of mice and men &#8211; derailing the most well meant reforms. It&#8217;s like an unseen ghost, lurking behind every tree just waiting to pop out when you least expect it. At the risk of a mundane example, the Kudzu on the sides of some of our Southern byways was actively imported by TVA in its early days to control erosion, but lingers in perpetuity choking everything in its path.<\/p>\n<div align=\"justify\" class=\"small\">Back in 2001 when <a target=\"_blank\" href=\"http:\/\/www.justice.gov\/sites\/default\/files\/opa\/legacy\/2012\/07\/02\/complaint-ex2.pdf\">Paxil Study 329<\/a> was first published, it was a genuine shock to discover that it was ghost-written by professional medical writer, Sally Laden, who created the first draft of that article and oversaw the the subsequent revisions [and other paperwork]:<\/div>\n<blockquote>\n<div align=\"justify\">Children&#8217;s Hospital of Philadelphia [Dr. Weller]; North America Medical Affairs, GlaxoSmithKIine, Collegeville, PA [Ms. Oakes, Mr. McCafferty]. This study was supported by a grant from GlaxoSmithKline, Collegeville. PA. Children&#8217;s Hospital of Philadelphia [Dr. Weller]; North America Medical Affairs, ClaxoSmithKIine, Collegeville, PA [Ms. Oakes, Mr. McCafferty]. This study was supported by a grant from GlaxoSmithKline, Collegeville. PA. The authors acknowledge the contributions of the following individuals; Jill M. Abbott, Ellen Basian Ph.D.. Carolyn Boulos, M.D., Elyse Dubo, M.D., Mary A. Fristad. Ph.D., Joan Hebeler. M.D.. Kevin Kelly. Ph.D.. Sharon Reiter. M.D.. and Ronald A. Weller. M.D. <strong><font color=\"#990000\">Editorial assistance was provided by Sally K. Laden. MS<\/font><\/strong>.<\/div>\n<\/blockquote>\n<div align=\"justify\" class=\"small\">By then, the funding source and the authors who were company employees were also being regularly acknowledged, though the COIs of the authors weren&#8217;t mentioned; ClinicalTrials.gov for trial registration was in its infancy; and Propublica\/Sunshine Act declarations were just a dream in the minds of a few:<\/div>\n<ul>\n<div align=\"justify\"><em><font color=\"#200020\"><sup>In olden days, a glimpse of stocking <br \/>         Was looked on as something shocking. <br \/>         Now heaven knows, <br \/>         Anything goes&#8230; <br \/>         Good authors too who once knew better words <br \/>         Now only use four-letter words <br \/>         Writing prose. <br \/>         Anything goes&#8230;<\/sup><\/font><\/em> <\/div>\n<div align=\"justify\"><sup>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<em><font color=\"#200020\">Cole Porter 1934<\/font><\/em><\/sup><\/div>\n<\/ul>\n<div align=\"justify\" class=\"small\">But have the required declarations made a difference? I&#8217;m sure they have made some difference, but like the <em><font color=\"#200020\">statistical differences<\/font><\/em> in many of our Clinical Trials, is it enough of a difference to really matter? Has it had the desired <em><font color=\"#200020\">effect<\/font><\/em>? I&#8217;m actually beginning to think that the old Law of Unintended Consequences is operating here, and that the insistance on declaring conflicts of interest may have had a paradoxical effect and increased our tolerance for Conflicts of Interest and industry involvement in scientific\/academic matters. It&#8217;s a hypothesis I don&#8217;t care much for. For example, the recent Clinical Trials of the late-coming Atypical Antipsychotic, <em><font color=\"#200020\">Brexpiprazole <\/font><\/em>[<a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2015\/04\/22\/the-spice-must-flow-2\/\"><em>the spice must flow&hellip;<\/em><\/a>, <a href=\"http:\/\/1boringoldman.com\/index.php\/2015\/09\/03\/how-many-stars\/\" target=\"_blank\">how many stars?&hellip;<\/a>]:<\/div>\n<blockquote>\n<div align=\"center\" class=\"big\"><a target=\"_self\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/25882325\">Efficacy   and Safety of Brexpiprazole for the Treatment of Acute Schizophrenia: A   6-Week Randomized, Double-Blind, Placebo-Controlled Trial<\/a><\/div>\n<div align=\"center\" class=\"small\">by <strong><font color=\"#990000\">Correll CU<\/font><\/strong>,<strong><font color=\"#0033ff\"> <\/font><font color=\"#0033ff\"><\/font><font color=\"#200020\">Skuban A<\/font><\/strong>,<strong><font color=\"#200020\"> Ouyang J<\/font><\/strong>,<strong><font color=\"#200020\"> Hobart M<\/font><\/strong>,<strong><font color=\"#200020\"> Pfister S<\/font><\/strong>,<strong><font color=\"#200020\"> McQuade RD<\/font><\/strong>,<strong><font color=\"#200020\"> Nyilas M<\/font><\/strong>,<strong><font color=\"#200020\"> Carson WH<\/font><\/strong>,<strong><font color=\"#200020\"> Sanchez R<\/font><\/strong>,<strong><font color=\"#200020\"> and Eriksson H.<\/font><\/strong><\/div>\n<div align=\"center\" class=\"middle\"><strong><font color=\"#004400\">American Journal of Psychiatry.<\/font><\/strong> 2015 172[9]:820-821. <\/div>\n<div align=\"center\" class=\"middle\">[<a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT01396421\" target=\"_blank\">NCT01396421<\/a>]<\/div>\n<div align=\"justify\" class=\"middle\">\n<div class=\"aff\">From the Zucker Hillside Hospital, Glen Oaks,  N.Y.; <strong><font color=\"#200020\">Otsuka<\/font><\/strong> Pharmaceutical Development &amp; Commercialization,  Princeton, N.J.; and H.&nbsp; <strong><font color=\"#200020\">Lundbeck<\/font><\/strong> A\/S, Valby, Copenhagen, Denmark.<\/div>\n<p>Funded  by <strong><font color=\"#200020\">Otsuka<\/font><\/strong> Pharmaceutical Development &amp; Commercialization, Inc., and  H. <strong><font color=\"#200020\">Lundbeck<\/font><\/strong> A\/S.<strong><font color=\"#990000\"> Jennifer Stewart, M.Sc. [QXV Communications,  Macclesfield, U.K.] provided writing support<\/font><\/strong> that was funded by <strong><font color=\"#200020\">Otsuka<\/font><\/strong>  Pharmaceutical Development &amp; Commercialization, Inc., and H.   <strong><font color=\"#200020\">Lundbeck<\/font><\/strong> A\/S.<\/p>\n<div>Dr.  Correll has been a consultant and\/or advisor to or has received  honoraria from Actelion, Alexza, American Academy of Child and  Adolescent Psychiatry, Bristol-Myers Squibb, Cephalon, Eli Lilly,  Genentech, Gerson Lehrman Group, IntraCellular Therapies, <strong><font color=\"#200020\">Lundbeck<\/font><\/strong>,  Medavante, Medscape, Merck, National Institute of Mental Health,  Janssen\/J&amp;J, <strong><font color=\"#200020\">Otsuka<\/font><\/strong>, Pfizer, ProPhase, Roche, Sunovion, Takeda,  Teva, and Vanda; he has received grant support from Bristol-Myers  Squibb, Feinstein Institute for Medical Research, Janssen\/J&amp;J,  National Institute of Mental Health, NARSAD, and <strong><font color=\"#200020\">Otsuka<\/font><\/strong>; and he has been  a Data Safety Monitoring Board member for Cephalon, Eli Lilly, Janssen,  <strong><font color=\"#200020\">Lundbeck<\/font><\/strong>, Pfizer, Takeda, and Teva. Drs. Skuban, Ouyang, Hobart,  McQuade, Nyilas, Carson, and Sanchez and Ms. Pfister are employees of <strong><font color=\"#200020\">Otsuka<\/font><\/strong> Pharmaceutical Development &amp; Commercialization, Inc. Dr.  Eriksson is an employee of, and owns stock in, H.&nbsp; <strong><font color=\"#200020\">Lundbeck<\/font><\/strong> A\/S.<\/div>\n<\/div>\n<\/blockquote>\n<blockquote>\n<div align=\"center\" class=\"big\"><a target=\"_self\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/25682550\">A   multicenter, randomized, double-blind, controlled phase 3 trial of   fixed-dose brexpiprazole for the treatment of adults with acute   schizophrenia.<\/a><\/div>\n<div align=\"center\" class=\"small\">by <strong><font color=\"#990000\">Kane JM<\/font><\/strong>, <strong><font color=\"#200020\">Skuban<\/font><\/strong>, <strong><font color=\"#200020\">Ouyang<\/font><\/strong>, <strong><font color=\"#200020\">Hobart, Pfister<\/font><\/strong>, <strong><font color=\"#200020\">McQuade<\/font><\/strong>, <strong><font color=\"#200020\">Nyilas<\/font><\/strong>, <strong><font color=\"#200020\">Carson<\/font><\/strong>, <strong><font color=\"#200020\">Sanchez<\/font><\/strong>, and <strong><font color=\"#200020\">Eriksson<\/font><\/strong>.<\/div>\n<div align=\"center\" class=\"middle\"><strong><font color=\"#200020\">Schizophrenia Research.<\/font><\/strong> 2015 164[1-3]:127-35.<\/div>\n<div align=\"center\" class=\"middle\">[<a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT01393613\" target=\"_blank\">NCT01393613<\/a>]<\/div>\n<div align=\"justify\">Contributors: Drs  Kane, Skuban, Youakim, Hobart, Pfister, McQuade, Nyilas, Carson and  Sanchez designed the study and wrote the protocol. Drs Kane, Skuban,  McQuade and Eriksson contributed to interpretation of the data, and Dr  Ouyang performed the statistical analysis. All authors contributed to  and have approved the final manuscript. <strong><font color=\"#990000\">Ruth  Steer, PhD, [QXV Communications, Macclesfield, UK] provided writing  support<\/font><\/strong>, which was funded by <strong><font color=\"#200020\">Otsuka<\/font><\/strong> Pharmaceutical Development &amp;  Commercialization, Inc. [Princeton, USA] and H. <strong><font color=\"#200020\">Lundbeck<\/font><\/strong> A\/S [Valby,  Denmark].<\/div>\n<div align=\"justify\">Conflict of interest Dr  Kane has been a consultant for Amgen, Alkermes, Bristol-Meyers Squibb,  Eli Lilly, EnVivo Pharmaceuticals [Forum] Genentech, H. <strong><font color=\"#200020\">Lundbeck<\/font><\/strong>.  Intracellular Therapeutics, Janssen Pharmaceutica, Johnson and Johnson,  Merck, Novartis, <strong><font color=\"#200020\">Otsuka<\/font><\/strong>, Pierre Fabre, Proteus, Reviva, Roche and  Sunovion. Dr Kane has been on  the Speakers Bureaus for Bristol-Meyers Squibb, Eli Lilly, Janssen,  Genentech and <strong><font color=\"#200020\">Otsuka<\/font><\/strong>, and is a shareholder in MedAvante, Inc. Drs  Skuban, Ouyang, Hobart, Pfister, McQuade, Nyilas, Carson and Sanchez  are employees of <strong><font color=\"#200020\">Otsuka<\/font><\/strong> Pharmaceutical Development &amp;  Commercialization, Inc. Dr Eriksson is an employee of H. <strong><font color=\"#200020\">Lundbeck<\/font><\/strong> A\/S.<\/div>\n<\/blockquote>\n<div align=\"justify\" class=\"small\">And, as I mentioned in <a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2015\/04\/22\/the-spice-must-flow-2\/\"><em>the spice must flow&hellip;<\/em><\/a>, there is only one academic author for each article, and both authors are at the <a target=\"_blank\" href=\"http:\/\/www.feinsteininstitute.org\/clinical-research\/clinical-research-studies\/?keyword=brexpiprazole&#038;topics&#038;subtopics&#038;results_per_page=10&#038;cpage=1&#038;submit=Search\">Feinstein Institute for Medical Research<\/a>. Both articles say:<\/div>\n<blockquote>\n<div align=\"justify\">From  the Zucker Hillside Hospital, Glen Oaks,  N.Y.; <strong><font color=\"#200020\">Otsuka<\/font><\/strong>  Pharmaceutical  Development &amp; Commercialization,  Princeton, N.J.; and H. <strong><font color=\"#200020\">Lundbeck<\/font><\/strong>  A\/S, Valby, Copenhagen, Denmark. <\/div>\n<\/blockquote>\n<div align=\"justify\" class=\"small\">So like Cole Porter said: <\/div>\n<ul>\n<div align=\"justify\"><sup><em><font color=\"#200020\">Now heaven knows,<br \/> Anything goes&#8230; <\/font><\/em><\/sup><\/div>\n<\/ul>\n<div align=\"justify\" class=\"small\">I think if we had seen this much openly declared industry imprint back in 2001 [the days of Study 329], there would have been a loud general outcry [rather than just this complaint on my little blog here on the edge of the galaxy]. These articles are openly industry productions with all but two authors employed directly by industry. Both studies used 60 [!] sites [for rapidity] all over the world. They&#8217;re both ghost-written and the sole academic authors are from the same department and themselves heavily loaded with COI. We should be up in arms that two first-line journals published such obviously tainted articles. But unless I missed it, nobody has had much to say. So, as to that Law of Unintended Consequences, I&#8217;m wondering if our insistence in demanding these disclosures hasn&#8217;t sent the message that this kind of publication is fine. And that what was intended to be a check on tainted Clinical Trials has turned into a tolerance &#8211; a permission to publish them in this form. It damn sure hasn&#8217;t put a stop to them&#8230;<\/div>\n","protected":false},"excerpt":{"rendered":"<p>&quot;There is only one difference between a bad economist and a good one: the bad economist confines himself to the visible effect; the good economist takes into account both the effect that can be seen and those effects that must be foreseen&#8230;&quot; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;French Journalist\/Economist Fr\u00e9d\u00e9ric Bastiat The Law of Unintended Consequences is an all too [&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-59779","post","type-post","status-publish","format-standard","hentry","category-opinion"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/59779","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=59779"}],"version-history":[{"count":28,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/59779\/revisions"}],"predecessor-version":[{"id":59807,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/59779\/revisions\/59807"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=59779"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=59779"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=59779"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}