{"id":66011,"date":"2016-06-01T18:43:17","date_gmt":"2016-06-01T22:43:17","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=66011"},"modified":"2016-06-01T18:57:19","modified_gmt":"2016-06-01T22:57:19","slug":"key-opinion-leaders-an-example","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2016\/06\/01\/key-opinion-leaders-an-example\/","title":{"rendered":"key opinion leaders:  an example\u2026"},"content":{"rendered":"\n<ul><sup> <\/p>\n<div><em><font color=\"#200020\">you can&#8217;t learn it from books,<br \/>          you can&#8217;t learn it without books.<\/font><\/em><\/div>\n<div><font color=\"#fff4df\">&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;.<\/font><em><font color=\"#200020\">zen saying&#8230;<\/font><\/em><\/div>\n<p><\/sup><\/ul>\n<div align=\"justify\"><sup><em><font color=\"#200020\">I grew up on the Tennessee River near Lake Chickamauga where I swam,  picnicked, camped, boated, fished, skied, etc. Then I left for college and those things stayed with the lake.  As an adult in Atlanta, I discovered Lake Sydney Lanier an hour north of the city renown for its sailing conditions.  After one outing with a friend, I found myself reading every book about sailing I could get my hands on and  haunting boatyards on the weekends. If being a sailor could be measured by a written test, by the time I bought my boat, I&#8217;m pretty sure I would&#8217;ve scored in the expert range. But on the water in my new boat, I was an anxious dunce. It would be several years before sailing became an intuition, and I could call myself a sailor&#8230;<\/font><\/em><\/sup><\/div>\n<p align=\"justify\" class=\"small\">As an internist and later as a psychiatrist, I read about drugs, but I really learned about them from teachers, colleagues, and patients. When I came back to that part of psychiatry after retiring, I encountered something new &#8211; the people I now call KOLs. They were <em><font color=\"#200020\">a class of experts<\/font><\/em>, academics who published drug studies and wrote endlessly about them. I figured out that their recommendations came from the data from clinical trials, not from their experience. I knew enough of them personally to know that they didn&#8217;t see that many patients, certainly not to follow them long term. So it was a new class for me, not one I&#8217;d encountered in my wanderings through medicine and I was wary of their advice. Since I also found the text-books unhelpful and out-of-date the day they came out, I started reading the Clinical Trial reports myself &#8211; and that&#8217;s what got me here today.<\/p>\n<p align=\"justify\" class=\"small\">One of the early papers I read was <strong><a target=\"_blank\" href=\"http:\/\/www.biomedcentral.com\/1472-6947\/9\/6\">Barriers  to implementation of a computerized decision support system  for  depression: an observational report on lessons learned in &quot;real  world&quot;  clinical settings<\/a><\/strong>. The author, a <font color=\"#200020\">Madhukar Trivedi<\/font>, had a computer program with an algorithm for using the antidepressants. He was trying to study his program, but what he found was that if he didn&#8217;t look over the clinicians&#8217; shoulders, they didn&#8217;t use it. <img decoding=\"async\" width=\"180\" hspace=\"4\" border=\"0\" align=\"right\" src=\"http:\/\/1boringoldman.com\/images\/evidence-1.gif\" \/>So the paper was a sort of amateurish speculation about what psychic conflicts they might have that kept them from using his program [and scuttling his study]. Then I got to the end and read his Conflict of Interest declaration, and it was <em><font color=\"#200020\">his psychodynamics<\/font><\/em> I started thinking about! I wouldn&#8217;t have used his computer program either. Here&#8217;s what I had to say back then [<a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2011\/01\/28\/evidence-based-medicine-i\/\">evidence-based medicine I&#8230;<\/a>]. <font color=\"#200020\">Madhukar Trivedi<\/font>, it turns out, is a <em><font color=\"#200020\">KOL extraordinaire<\/font><\/em>.<\/p>\n<div align=\"justify\" class=\"small\">Apparently, <font color=\"#200020\">Marcia Angell<\/font> had the same kind of reaction when she wrote <a href=\"http:\/\/www.smokescam.com\/marciaeditorial.htm\" target=\"_blank\">Is Academic Medicine for Sale?<\/a> in 2000 after reading this paper in the journal she edited:<\/div>\n<blockquote>\n<div align=\"center\" class=\"big\"><a href=\"http:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJM200005183422001#t=article\" target=\"_blank\">A Comparison of Nefazodone, the Cognitive Behavioral-Analysis System of Psychotherapy, and Their Combination for the Treatment of Chronic Depression<\/a><\/div>\n<div align=\"center\" class=\"middle\"><strong><font color=\"#200020\">by Martin B. Keller, James P. McCullough, Daniel N. Klein, Bruce Arnow, David L. Dunner, Alan J. Gelenberg, John C. Markowitz, Charles B. Nemeroff, James M. Russell, Michael E. Thase, Madhukar H. Trivedi, Janice A. Blalock, Frances E. Borian, Darlene N. Jody, Charles DeBattista, Lorrin M. Koran, Alan F. Schatzberg, Jan Fawcett, Robert M.A. Hirschfeld, Gabor Keitner, Ivan Miller, James H. Kocsis, Susan G. Kornstein, Rachel Manber, Philip T. Ninan, Barbara Rothbaum, A. John Rush, Dina Vivian, and John Zajecka.<\/font><\/strong><\/div>\n<div align=\"center\" class=\"middle\"><strong><font color=\"#990000\">New England Journal of Medicine<\/font><\/strong>. 2000 342:1462-1470.<\/div>\n<div align=\"center\" class=\"middle\">[<a href=\"http:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJM200005183422001#t=article\" target=\"_blank\">full text on-line<\/a>]<\/div>\n<p>            <\/p>\n<div align=\"justify\"><em><strong><font color=\"#200020\">Background<\/font><\/strong><\/em>: Patients with chronic forms of major depression are difficult to treat, and the relative efficacy of medications and psychotherapy is uncertain.<\/div>\n<div align=\"justify\"><em><strong><font color=\"#200020\">Methods<\/font><\/strong><\/em>: We randomly assigned 681 adults with a chronic nonpsychotic major depressive disorder to 12 weeks of outpatient treatment with nefazodone [maximal dose, 600 mg per day], the cognitive behavioral-analysis system of psychotherapy [16 to 20 sessions], or both. At base line, all  <font color=\"#2f1401\">patients had scores of at least 20 on the 24-item Hamilton Rating<\/font> Scale for Depression (indicating clinically significant <font color=\"#6d543d\">depression). Remission was defined as a score of 8 or<\/font> <font color=\"#8c7461\">less at weeks 10 and 12. For patients who did not have remission, a satisfactory<\/font> <font color=\"#a99485\">response was defined as a reduction in the score by at least<\/font> <font color=\"#c6b4a9\">50 percent from base line and a score of 15 or less. Raters were<\/font> <font color=\"#d3d4cd\">unaware of the patients&#8217; treatment assignments.&hellip;<\/font><\/div>\n<\/blockquote>\n<div align=\"justify\" class=\"small\">She was struck by the COI declaration [it&#8217;s online and it is definitely impressive]. However, I&#8217;m interested in the By-Line. <font color=\"#200020\">Martin Keller<\/font>  has included even more KOLs than he mustered for his Paxil Study 329  paper. Notably, here are four of the six &quot;thought leaders&quot; mentioned in <a href=\"http:\/\/1boringoldman.com\/index.php\/2016\/05\/30\/65953\/\">key opinion leaders: the new millennium&hellip;<\/a> [<font color=\"#200020\">Charlie Nemeroff<\/font>, <font color=\"#200020\">Martin Keller<\/font>, <font color=\"#200020\">Alan Schatzberg<\/font>, and<font color=\"#200020\"> Robert Hirschfield<\/font>]. There are the two gurus from TMAP and STAR*D [<font color=\"#200020\">John Rush<\/font> and <font color=\"#200020\">Madhukar Trivedi<\/font>]. There&#8217;s the Board of Directors of the Corcept&reg; Corporation [<font color=\"#200020\">Alan Schatzberg<\/font> and <font color=\"#200020\">Charles DeBattista<\/font>]. And then there&#8217;s <font color=\"#200020\">Michael Thase<\/font>.    <\/div>\n<p align=\"justify\" class=\"small\"><img decoding=\"async\" width=\"180\" hspace=\"4\" border=\"0\" align=\"left\" src=\"http:\/\/1boringoldman.com\/images\/nem-thase-2016.gif\" \/>Dr. Thase was on the faculty of the Western Psychiatric Institute in Pittsburgh from 1984 to 2007 when he moved to the Perlman School of Medicine in Philadelphia as Chief of the Division of Mood and Anxiety Disorders Treatment &amp; Research Program. He writes broadly about the diagnosis and treatment of these disorders and so most of us think of him not in any specific role as an expert professional, but rather as a <font color=\"#200020\">Professional Expert &#8211; a KOL<\/font> who is everywhere. He still may not have caught up with Charlie Nemeroff in total publications, but he&#8217;s closing in fast [he got off to a late start].<\/p>\n<div align=\"justify\" class=\"small\">This is from a paper by <font color=\"#200020\">Sergio Sismondo<\/font> who attended a KOL management meeting to see what was up [<em><font color=\"#200020\">Corporate Disguises in Medical Science: Dodging the Interest Repertoire<\/font><\/em>][see <a href=\"http:\/\/brodyhooked.blogspot.com\/2012\/04\/sismondo-on-how-pharma-disguises.html\" target=\"_blank\">Howard Brody<\/a> on <font color=\"#200020\">Sismondo<\/font>&#8216;s paper]:<\/div>\n<blockquote>\n<div align=\"justify\">Invited to a pharmaceutical industry conference on relationships with key opinion leaders was Dr. Michael Thase, a representative KOL. Thase, who was introduced as having authored over 500 publications and being &ldquo;one of the brightest stars in neuroscience,&rdquo; was a smiling and confident speaker, comfortable giving his narrative to this audience of mostly pharmaceutical company managers <\/div>\n<p align=\"justify\">Thase gave his disclosures in a practiced move. As he explained, <strong><font color=\"#200020\">In the past decade, I have been a consultant to the manufacturer of every compound that has been developed for the treatment of depression or the treatment of bipolar disorder, and some number of other compounds that haven&rsquo;t made it through the multi phases stages of development.<\/font><\/strong><\/p>\n<div align=\"justify\">  Normally, he said, he presents this as two slides. He added a list of six pharmaceutical companies that had paid him to give talks in the previous 3 years, and another four that have recently funded research projects. He does not believe, he opined, that academics are very often dishonest, but he does recognize that &ldquo;who you spend time with, where you make money, and so on,&rdquo; can influence what you believe to be true. Dr. Thase is the quintessential KOL, a nationally recognized expert who is personable and a good public speaker. As one insider defines them, KOLs are well-known specialists who &ldquo;can influence other physicians&rdquo;&#8230;<\/div>\n<\/blockquote>\n<div align=\"justify\" class=\"small\">When he took the reins as editor of the <em><font color=\"#200020\">Psychopharmacology Bulletin<\/font><\/em> in 2002 [occasioned by Charlie Nemeroff&#8217;s moving up to edit <em><font color=\"#200020\">Neuropsychopharmacology<\/font><\/em> &#8211; the journal of the <font color=\"#200020\">American College of Neuropsychopharmacology<\/font>], Thase wrote of his relationship with industry:<\/div>\n<blockquote>\n<div align=\"justify\">A particular area of interest of mine is the increasingly acrimonious  [and often sanctimonious] furor about the relationship between academic  medicine and the pharmaceutical industry. Let me be up-front about my  position: I am a libertarian by nature and firm believer in personal  accountability, free markets, and limited regulatory interference.  Unlike the editors of some of medicines more prestigious journals,  however, I do not plan to write editorials broadly condemning a  pseudomonolithic pharmaceutical industry while the publisher&#8217;s business  office collects money for advertisements or academic supplements. Let me  also be clear about this little economic fact: the Bulletin is a  product of the publisher&#8217;s business, and it must at least break even to  stay afloat. This means that it is essential to maintain honest, yet  mutually beneficial relationships with the industry. Moreover, as &quot;Big  Pharma* is responsible for the development and introduction of virtually  all new psychotropic medications, it seems an act of epic foolishness  to try to impose some sort of hands-off relationship between our  editorial board and the pharmaceutical industry&#8230;<\/div>\n<\/blockquote>\n<div align=\"justify\" class=\"small\">I picked Michael Thase as my example because he&#8217;s so omnipresent and so tangled up in this <font color=\"#200020\">Vortioxetine<\/font> story I&#8217;ve been following &#8211; all the way along its history. Parenthetically, looking at those <font color=\"#200020\">Vortioxetine <\/font>papers collectively, the KOL business must be declining, because they&#8217;ve been able to collect quite an assortment of known KOLs to pair-up with their company doctors on the By-lines&#8230;  <\/div>\n<div align=\"right\"><sup><em><font color=\"#200020\">hat tip to <\/font><\/em><strong><em><font color=\"#200020\">even more librarians<\/font><\/em><\/strong><em><font color=\"#200020\">&hellip;<\/font><\/em> &nbsp;&nbsp; <img decoding=\"async\" height=\"35\" border=\"0\" align=\"absmiddle\" src=\"http:\/\/1boringoldman.com\/images\/hat-tip.gif\" \/><\/sup><\/div>\n","protected":false},"excerpt":{"rendered":"<p>you can&#8217;t learn it from books, you can&#8217;t learn it without books. &#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;&#8230;.zen saying&#8230; I grew up on the Tennessee River near Lake Chickamauga where I swam, picnicked, camped, boated, fished, skied, etc. Then I left for college and those things stayed with the lake. As an adult in Atlanta, I discovered Lake Sydney Lanier [&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-66011","post","type-post","status-publish","format-standard","hentry","category-opinion"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/66011","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=66011"}],"version-history":[{"count":45,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/66011\/revisions"}],"predecessor-version":[{"id":66056,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/66011\/revisions\/66056"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=66011"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=66011"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=66011"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}