{"id":10317,"date":"2011-06-16T12:11:28","date_gmt":"2011-06-16T16:11:28","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=10317"},"modified":"2011-06-16T13:51:31","modified_gmt":"2011-06-16T17:51:31","slug":"gpp","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2011\/06\/16\/gpp\/","title":{"rendered":"gpp?&#8230;"},"content":{"rendered":"<div align=\"justify\">These days, we&#8217;re so inured to stories of payments to &#8216;KOLs&#8217; and ghostwritten articles in psychiatry that new instances have become almost routine. There were, however, some variations on the theme in that Report in my last post that I found jarring. <strong><font color=\"#990000\">Dr. Allen Frances<\/font><\/strong> was Chairman of Psychiatry at Duke [1992-1998] and lead the DSM-IV task force [1994]. The Duke <a href=\"http:\/\/education.psychiatry.duke.edu\/about-us\/history-and-vision\" target=\"_blank\"><u><strong><font color=\"#200020\">web-site<\/font><\/strong><\/u><\/a> says he was &quot;&#8230;perhaps best known for his work in constructing the DSM-IV and a number of <strong><font color=\"#600060\">groundbreaking practice guidelines in psychiatry<\/font><\/strong>.&quot; <strong><font color=\"#990000\">Dr. John Docherty<\/font><\/strong> was Vice-Chairman at Cornell at the time. His <a href=\"http:\/\/www.brainresource.com\/about_us\/index.php?30&#038;id=183\" target=\"_blank\"><u><strong><font color=\"#200020\">bio<\/font><\/strong><\/u><\/a>:<\/div>\n<ul>\n<div align=\"justify\"><strong><sup>Trained as a clinical research fellow in neuropsychopharmacology at  NIMH, he later returned as Chief of the Psychosocial Treatments Research  Branch, responsible for all federally supported psychosocial treatment  research in mental health nationwide. He oversaw the landmark National  Collaborative Study in the Treatment of Depression and served as a  member and Chairman for over 10 years on the NIMH and then NIDA  Treatment Research IRGs. &nbsp;Dr. Docherty has wide experience in  successfully implementing innovation in both clinical and managed health  care. He founded Northeast Psychiatric Associates in 1985. As National  Medical Director for National Medical Enterprises, he oversaw medical  control and quality improvement in 74 hospitals in 34 states. He was the  Executive Vice-President and Chief Medical Officer for Merit Behavioral  Care, which then covered 30 million people. In 1998, he founded  Comprehensive NeuroScience (CNS). <\/sup><sup><font color=\"#600060\">Its Care Management Technologies are  currently implemented in 17 state Medicaid plans<\/font><\/sup><\/strong><strong><sup>. Dr Docherty has  received numerous honors and awards and has authored over 100 scientific  publications.<\/sup><\/strong><\/div>\n<\/ul>\n<div align=\"justify\">And <strong><font color=\"#990000\">Dr. David A. Kahn<\/font><\/strong> is on the <u><a href=\"http:\/\/asp.cumc.columbia.edu\/facdb\/profile_list.asp?uni=dak1&#038;DepAffil=Psychiatry\" target=\"_blank\"><strong><font color=\"#200020\">faculty of Columbia<\/font><\/strong><\/a><\/u>:<\/div>\n<ul>\n<div align=\"justify\"><strong><sup>After his research fellowship, Dr. Kahn pursued a clinical  administrative career, initiating a number of core programs including  two new inpatient units and new outpatient psychopharmacology and  psychotherapy teaching clinics.  He currently oversees faculty practice  outpatient programs including the Columbia Day Program at East 60th  Street, the inpatient teaching service at New York Presbyterian  Hospital\/Columbia, and the inpatient and outpatient research and  clinical programs at the Psychiatric Institute. He has served on  numerous advisory committees related to mental health services and  quality management.  He has published over 40 articles and book chapters  related to psychopharmacology focusing on bipolar disorder, issues in  combining medication with psychotherapy,<\/sup><font color=\"#600060\"><sup> and the quantification of  expert consensus in the development of practice guidelines<\/sup><\/font><\/strong><strong><sup>.<\/sup><\/strong><\/div>\n<\/ul>\n<div align=\"justify\">Notice that all three list their guideline work as accomplishments. And the Report lists some other big names. <strong><font color=\"#990000\">Dr. A.J. Rush<\/font><\/strong> was in charge of <strong>TMAP<\/strong> and went on to be the Principle Investigator on the largest Clinical Trial in depression every done [<strong>STAR*D<\/strong>]. The Report was particularly critical of <strong><font color=\"#990000\">Dr. Joseph Biederman<\/font><\/strong> at Harvard who essentially created a J&amp;J funded research center to include children in the Risperdal target population. But equally jarring were the reports of the Texas psychiatrists <strong><font color=\"#990000\">Dr. Lynn Crismon<\/font><\/strong>, <strong><font color=\"#990000\">Dr. Alexander Miller<\/font><\/strong>, <strong><font color=\"#990000\">Dr. John Chiles<\/font><\/strong>, and particularly <strong><font color=\"#990000\">Dr. Steven Shon<\/font><\/strong> who essentially functioned like they were Johnson &amp; Johnson employees selling Risperdal, even though they held jobs working for the Texas State Mental Health system.<\/div>\n<p>        <\/p>\n<div align=\"justify\">On my first time through the Rothman Report, I couldn&#8217;t stay with the ghostwriting examples. I kept getting sidetracked &#8211; googling <strong><font color=\"#990000\">Excerpta Medica<\/font><\/strong>, anything to divert my attention from what I was reading. Usually, when we&#8217;re talking about ghost-writing, we define it by who wrote the first draft. With J&amp;J, the early drafts [or whole articles] were often written before the author was picked:<\/div>\n<div align=\"center\"><img loading=\"lazy\" decoding=\"async\" height=\"282\" border=\"0\" width=\"400\" vspace=\"5\" src=\"http:\/\/1boringoldman.com\/images\/em-1.gif\" \/><\/div>\n<div align=\"justify\">Rothman included these two reports to show how many articles were written prior to the authors even being chosen [TBD], but there&#8217;s something else. &quot;Of the 80 articles listed in the July 2003 schedule &#8230;&quot; &quot;Of the 65 articles that EM was developing in December 2003 &#8230;&quot; The number of articles being written [ghost-written] is in itself staggering. When we say the literature was being flooded, we aren&#8217;t kidding. So it looks like <u><strong><a href=\"http:\/\/www.janssen.com\/index.html\" target=\"_blank\"><font color=\"#990000\">Janssen<\/font><\/a><\/strong><\/u> and <a href=\"http:\/\/www.excerptamedica.com\/\" target=\"_blank\"><u><strong><font color=\"#990000\">Excerptia Medica<\/font><\/strong><\/u><\/a> have a <em>close working relationship<\/em>:<\/div>\n<div align=\"center\"><img loading=\"lazy\" decoding=\"async\" height=\"376\" border=\"0\" width=\"403\" vspace=\"5\" src=\"http:\/\/1boringoldman.com\/images\/omj-em.gif\" \/><\/div>\n<div align=\"justify\">That whole decade [1995-2005] must have been the apogee of some kind of curve &#8211; the flagrant disregard for even the appearance of scientific integrity [not that the curve has fallen even yet].    <\/div>\n<p align=\"justify\">The<strong><font color=\"#400040\"> <\/font><\/strong><a href=\"http:\/\/www.psychguides.com\/home\" target=\"_blank\"><u><strong><font color=\"#400040\">EKS<\/font><\/strong><\/u><\/a> Guideline company [<a href=\"http:\/\/web.archive.org\/web\/20010721161536\/http:\/\/psychguides.com\/\" target=\"_blank\"><u><strong><font color=\"#400040\">archives<\/font><\/strong><\/u><\/a>] founded by Frances, Docherty, and Kahn is still in existence [hat tip to EP &amp; jamzo]. <a href=\"http:\/\/www.excerptamedica.com\/\" target=\"_blank\"><u><strong><font color=\"#990000\">Excerptia Medica<\/font><\/strong><\/u><\/a> is still just down the road from Janssen in New Jersey. The Risperdal profits are banked and\/or spent. And the TMAP suit still awaits trial. Looking back over that Report, I have a difficult time reading it without taking a break, even after multiple readings. I think it&#8217;s still hard for me to imagine the climate of those few years ago when the events in that Report were taking place. The Doctors involved in writing the Guidelines and proselytizing TMAP must&#8217;ve thought at some level that what they were doing was okay. The people at EM must&#8217;ve felt like ghost-writing those articles was also okay. The Drug Company executives who masterminded this whole story must&#8217;ve seen this as good business &#8211; making profits for their shareholders. That&#8217;s what psychiatrists call <strong><em>denial<\/em><\/strong>. I doubt that any of them visited a Texas mental health center where the schizophrenic patients whose lives they were playing with congregate, or went to a nursing home where the elderly were being dosed per their instructions.       <\/p>\n<div align=\"justify\">There&#8217;s a <a target=\"_blank\" href=\"http:\/\/www.excerptamedica.com\/?page=newsroom&#038;item=343\"><u><strong><font color=\"#200020\">blurb<\/font><\/strong><\/u><\/a> on the Excerptia Medica web-site about GPP [Good Publication Practice] that I also had some trouble reading without wincing. It sure wasn&#8217;t in place in their &quot;Risperdal Years&quot;&#8230;  <\/div>\n<div align=\"justify\">\n<blockquote>\n<div align=\"center\"><a target=\"_blank\" href=\"http:\/\/www.excerptamedica.com\/?page=newsroom&#038;item=343\"><u><strong><font color=\"#200020\">Excerpta Medica has been recognized as a Good Publication Practice (GPP) thought leader by <em>Pharmaceutical Marketing Europe<\/em><\/font><\/strong><\/u><\/a><br \/>    03\/24\/2011<\/div>\n<p><strong><sup><em>Flying the Industry Standard<\/em>, which is available both online and in a special publication planning edition of <em>Pharmaceutical Marketing Europe<\/em>, brings Excerpta Medica&rsquo;s wealth of knowledge in this field to a wider audience.<\/sup><\/strong><\/p>\n<p><strong><sup>Program Director and author of <em>Flying the Industry Standard<\/em>  Hester van Lier believes that &ldquo;The publication of GPP standards  reinforces the industry-wide commitment to ethical and transparent  practices. Now is the time to take the next step and demonstrate actual  adherence to these standards. This will benefit the medical  communications agency, authors, publishers, and industry alike. By  operating together with transparency towards high-quality and accurate  reporting of medical research, we can have a positive impact on the  evidence base that healthcare providers use to make decisions and,  ultimately, on patient care.&rdquo;<\/sup><\/strong><\/p>\n<div><strong><sup>The publication offers a six-step guide to assist agencies partnering  with pharma and biotech, authors, and publishers, in creating robust  processes from staff education to innovation and documentation, to  ensure that all steps in publication development are in line with GPP.<\/sup><\/strong><\/div>\n<\/blockquote><\/div>\n","protected":false},"excerpt":{"rendered":"<p>These days, we&#8217;re so inured to stories of payments to &#8216;KOLs&#8217; and ghostwritten articles in psychiatry that new instances have become almost routine. There were, however, some variations on the theme in that Report in my last post that I found jarring. Dr. Allen Frances was Chairman of Psychiatry at Duke [1992-1998] and lead the [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","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":[2],"tags":[],"class_list":["post-10317","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/10317","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=10317"}],"version-history":[{"count":62,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/10317\/revisions"}],"predecessor-version":[{"id":13302,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/10317\/revisions\/13302"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=10317"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=10317"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=10317"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}