{"id":52599,"date":"2014-12-29T08:00:24","date_gmt":"2014-12-29T13:00:24","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=52599"},"modified":"2014-12-29T08:27:50","modified_gmt":"2014-12-29T13:27:50","slug":"the-recommendation","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2014\/12\/29\/the-recommendation\/","title":{"rendered":"the recommendation?&#8230;"},"content":{"rendered":"<div align=\"justify\" class=\"small\">Rarely do you get to see an industry production that has all of these elements rolled into one article, but look no further. This article has all the right moves. It&#8217;s a review article in an industry friendly CME journal, <strong><font color=\"#200020\">Journal of Clinical Psychiatry<\/font><\/strong>. Its got some well known KOLs for guest authors: <font color=\"#200020\">Alan Schatzberg<\/font> former Chairman at Stanford, former <a href=\"http:\/\/www.corcept.com\/\" target=\"_blank\">Corcept<\/a> principle, former APA President, former <a href=\"http:\/\/1boringoldman.com\/wp-admin\/a \u201cquintessential resource\u201d\u2026 \" target=\"_blank\">Sally Laden client<\/a>, formerly included on Senator Grassley&#8217;s <a href=\"http:\/\/blogs.wsj.com\/health\/2008\/06\/25\/grassley-questions-stanford-psychiatrists-industry-ties\/\" target=\"_blank\">PHARMA income non-reporter list<\/a>; <font color=\"#200020\">Rakesh Jain<\/font>, a principle in the CME conglomerate <a href=\"http:\/\/www.psychcongress.com\/psychcongress\" target=\"_blank\">US Psychiatric and Mental Health Congress<\/a>; and <font color=\"#200020\">Michael Thase<\/font>, <em>just-about-everybody&#8217;s<\/em> KOL.<\/div>\n<blockquote>\n<div align=\"center\" class=\"big\"><a target=\"_blank\" href=\"http:\/\/www.psychiatrist.com\/JCP\/article\/Pages\/2014\/v75n12\/v75n1209.aspx\">An <font color=\"#200020\">Overview<\/font> of Vortioxetine<\/a><\/div>\n<div align=\"center\" class=\"small\">by Alan F. Schatzberg,&nbsp;MD;  Pierre Blier,&nbsp;MD,&nbsp;PhD; Larry Culpepper,&nbsp;MD,&nbsp;MPH; Rakesh Jain,&nbsp;MD,&nbsp;MPH;  George I. Papakostas,&nbsp;MD; and Michael E. Thase,&nbsp;MD<\/div>\n<div align=\"center\" class=\"middle\"><strong><font color=\"#200020\">Journal of Clinical Psychiatry<\/font><\/strong> 2014 75[12]:1411&ndash;1418.<\/div>\n<div align=\"center\" class=\"middle\">[<a target=\"_blank\" href=\"http:\/\/www.psychiatrist.com\/JCP\/article\/Pages\/2014\/v75n12\/v75n1209.aspx\">full text on-line<\/a>]<\/div>\n<p>      <\/p>\n<div align=\"justify\">Six clinicians provide an overview of the serotonergic antidepressant vortioxetine, which was recently approved for the treatment of major depressive disorder in adults. They discuss the pharmacologic profile and receptor-mediated effects of vortioxetine in relation to potential outcomes. Additionally, they summarize the clinical trials, which demonstrate vortioxetine&rsquo;s efficacy, and discuss findings related to safety and tolerability that have high relevance to patient compliance.<\/div>\n<\/blockquote>\n<div align=\"justify\" class=\"small\">In former times, this kind of industry-driven review article came from &quot;roundtables&quot; &#8211; KOL meetings that may or may not have occurred. But it&#8217;s different now &#8211; <em>teleconferences<\/em> among the various KOLs.<\/div>\n<ul>\n<div align=\"justify\"><sup>&#8230; highlights from a series of <strong><font color=\"#200020\">teleconferences<\/font><\/strong> held in the spring of  2014. The series was chaired by Alan F. Schatzberg, MD&#8230; The faculty were  Pierre Blier, MD, PhD&#8230;; Michael E. Thase, MD&#8230;;  George I. Papakostas, MD&#8230;; Larry Culpepper, MD, MPH&#8230;; and Rakesh Jain, MD, MPH&#8230;<\/sup><\/div>\n<\/ul>\n<div align=\"justify\" class=\"small\">The article is obviously ghost-written by a professional medical communications company &#8211; apparently paid by the journal.     <\/div>\n<ul>\n<div align=\"justify\"><sup>This <strong><font color=\"#200020\">evidence-based peer-reviewed <\/font><\/strong><span class=\"smallcaps\">Academic Highlights<\/span>  was prepared and independently developed by <a target=\"_blank\" href=\"http:\/\/www.hcgv.com\/\">Healthcare Global Village,  Inc.<\/a>, with support from Physicians Postgraduate Press, Inc&#8230;<\/sup><\/div>\n<\/ul>\n<div align=\"justify\" class=\"small\">All of the guest authors have extensive industry connections. I&#8217;ve just included two from each, the two companies involved with marketing <strong><font color=\"#200020\">Vortioxetine<\/font><\/strong> &#8211; 100% onboard.     <\/div>\n<ul>\n<div align=\"justify\"><sup><u><strong><font color=\"#200020\">Financial disclosure<\/font><\/strong><\/u>: <strong><font color=\"#200020\">Dr Schatzberg<\/font><\/strong>  received grant funding and\/or honoraria for lectures and\/or  participation in advisory boards for &#8230;  <strong><font color=\"#200020\">Lundbeck\/Takeda<\/font><\/strong>&#8230; <strong><font color=\"#200020\">Dr Blier<\/font><\/strong>  received grant funding and\/or honoraria for lectures and\/or  participation in advisory boards for &#8230; <strong><font color=\"#200020\">Lundbeck <\/font><\/strong>&#8230; <strong><font color=\"#200020\">Takeda <\/font><\/strong>&#8230; <strong><font color=\"#200020\">Dr Culpepper<\/font><\/strong>  received grant funding and\/or honoraria for lectures and\/or  participation in advisory boards for &#8230; <strong><font color=\"#200020\"> H. Lundbeck A\/S<\/font><\/strong> &#8230; <strong><font color=\"#200020\">Takeda<\/font><\/strong>. <strong><font color=\"#200020\">Dr Jain<\/font><\/strong>  received grant funding and\/or honoraria for lectures and\/or  participation in advisory boards for &#8230; <strong><font color=\"#200020\">Lundbeck<\/font><\/strong> &#8230; <strong><font color=\"#200020\">Takeda<\/font><\/strong>. <strong><font color=\"#200020\">Dr Papakostas<\/font><\/strong>  received grand funding and\/or honoraria for lectures and\/or  participation in advisory boards for <strong><font color=\"#200020\">Lundbeck <\/font><\/strong>&#8230; <strong><font color=\"#200020\">Takeda<\/font><\/strong>. <strong><font color=\"#200020\">Dr Thase<\/font><\/strong>  received grant funding and\/or honoraria for lectures and\/or  participation in advisory boards for &#8230; <strong><font color=\"#200020\">H. Lundbeck, A\/S <\/font><\/strong>&#8230; <strong><font color=\"#200020\"> Takeda<\/font><\/strong>.<\/sup><\/div>\n<\/ul>\n<div align=\"justify\" class=\"small\">The actual article is odd. For example, it has a discussion of the meanings of NNT and NNH, but neglects to say what Vortioxetine&#8217;s NNT actually is. It discusses the changing drug\/placebo differences in clinical trials of antidepressants with a borrowed graph, but doesn&#8217;t show a graph of any Vortioxetine values. It mentions six positive clinical trials but not the four negative ones. <\/div>\n<p align=\"center\"><img decoding=\"async\" width=\"400\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/brintellix-1.gif\" \/><br \/>     <sup>[from the <a href=\"http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/nda\/2013\/204447Orig1s000MedR.pdf#page=24\" target=\"_blank\">FDA Medical Review<\/a>]<\/sup><\/p>\n<div align=\"justify\" class=\"small\">It even has a discussion of Irving Kirsch&#8217;s negative meta-analysis of antidepressant trials and a blurb about how the Affordable Care Act expands mental health benefits. There&#8217;s a pitch for <a target=\"_blank\" href=\"http:\/\/www.medicaid.gov\/State-Resource-Center\/Medicaid-State-Technical-Assistance\/Health-Homes-Technical-Assistance\/Downloads\/HH-IRC-Collaborative-5-13.pdf\">Collaborative Care<\/a> and encouragement for Primary Care Physicians to prescribe antidepressants. The review ends with:<\/div>\n<ul>\n<div align=\"justify\" class=\"small\"><em><font color=\"#200020\">&quot;Robinson et al<span class=\"htm-cite\"> <\/span>in a 2005 study estimated that primary care providers are the sole  contacts for more than half of patients with mental illness and that <\/font><strong><font color=\"#200020\"> depressive symptoms are present in nearly 70% of patients visiting  primary care providers<\/font><\/strong><font color=\"#200020\">. A patient in a primary care setting,  particularly one who has recently acquired mental health coverage  through the ACA or Mental Health Parity and Addiction Equity Act, may  have one or more coexisting acute or chronic conditions, and to the  extent possible, an antidepressant that will not aggravate and might be  helpful for these conditions is preferable. A favorable tolerability  profile also may improve patient adherence to treatment, leading in turn  to not only a reduction in depressive symptoms but a reduced risk of  behavioral or social actions that could adversely affect the patient&rsquo;s  overall health and well-being.&quot;<\/font><\/em><\/div>\n<\/ul>\n<div align=\"justify\" class=\"small\">So now we have another SSRI on the market called <strong><font color=\"#200020\">Brintellix&reg;<\/font><\/strong> [AKA<strong><font color=\"#200020\"> Vortioxetine<\/font><\/strong>], with a review article in the style of so many professionally-written industry-driven articles that have been the flotsam and jetsam of the psychiatric literature for several decades.<\/div>\n<p align=\"justify\" class=\"small\">At times, when I wear thin with all the anti-psychiatry criticism, the kind that assumes all psychiatrists think the same [stupid] [wrong] things, I&#8217;m tempted to get defensive or argue. Then I read an article like this, in a journal like this, by authors like these, and it helps me hold my tongue and turn the other cheek. There&#8217;s absolutely nothing here to defend. Fortunately, we don&#8217;t see articles like this so much any more, at least in any places that matter. But it&#8217;s bad enough that we ever had them in the first place [or that anybody is still writing them]. <\/p>\n<hr width=\"90%\" size=\"1\" \/>\n<p align=\"justify\" class=\"small\">In the FDA Medical Report on <strong><font color=\"#200020\">Brintellix&reg;<\/font><\/strong>, the reviewer conveniently included a <a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/wp-admin\/www.accessdata.fda.gov\/drugsatfda_docs\/nda\/2013\/204447Orig1s000MedR.pdf#page=13\">list<\/a> of all of the FDA approved treatments for <strong><font color=\"#200020\">Major Depressive Disorder<\/font><\/strong>:<\/p>\n<p align=\"center\"><img decoding=\"async\" width=\"400\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/brintellix-2.gif\" \/><\/p>\n<p align=\"justify\" class=\"small\">It reminded me of my early days in psychiatry. The drugs available then were the ones in the top two boxes [<em>pink<\/em>]. In those days, the phrase <strong><font color=\"#200020\">Major Depressive Disorder <\/font><\/strong>would&#8217;ve referred to a group of severe conditions I think of as the Melancholic Depressions. I thought of them as diseases, nouns, entities [Depression with a capital &quot;D&quot;]. They aren&#8217;t common, but when you see a case, there&#8217;s nothing routine about it. The patients are quantitatively profoundly depressed. But there are qualitative features that are striking. It&#8217;s as if the affect-generator has been turned to a single frequency &#8211; self-hating gloom. Those were the patients we treated with the Tricyclic antidepressants. Sometimes they responded. Sometimes they didn&#8217;t. And sometimes they were treated with ECT. People like me who usually spend their days talking to depressed people [depression with a little &quot;d&quot;] are stopped in their tracks when Melancholic Depression is the problem. It&#8217;s something else.<\/p>\n<div align=\"justify\" class=\"small\">When the DSM-III came along in 1980, the phrase <strong><font color=\"#200020\">Major Depressive Disorder<\/font><\/strong> took on a new meaning. If you saw a case of Depression with a capital &quot;D&quot;, you could say <strong><font color=\"#200020\">Major Depressive Disorder with Melancholic features <\/font><\/strong>or some such as if there were a continuum between Depression [noun] and depression [symptom] [which isn&#8217;t true in my opinion]. Depression had lost its meaning. Any symptomatic depression became known as &quot;MDD&quot; and had graduated &#8211; had become a disease [and the most common DSM-III diagnosis at that]. But that&#8217;s not the end of the story. In the DSM, there are criteria required to make a diagnosis of &quot;MDD.&quot; They&#8217;re soft compared to the Melancholic Depressions, but they are at least criteria. So I had a specific reason for posting about this review article, an article I would usually just let pass. But when I read that last paragraph, I started writing:<\/div>\n<ul>\n<div align=\"justify\" class=\"small\"><em><font color=\"#200020\"> &quot;&#8230; primary care providers are the sole  contacts for more than half of patients with mental illness and that <\/font><strong><font color=\"#200020\"> depressive symptoms are present in nearly 70% of patients visiting  primary care providers<\/font><\/strong><font color=\"#200020\">.  A patient in a primary care setting,  particularly one who has recently  acquired mental health coverage  through the ACA or Mental Health  Parity and Addiction Equity Act, may  have one or more coexisting acute  or chronic conditions, and to the  extent possible, an antidepressant  that will not aggravate and might be  helpful for these conditions is  preferable.<\/font><\/em>&quot;<\/div>\n<\/ul>\n<div align=\"justify\" class=\"small\">According to this article, you don&#8217;t even have to meet the watered-down DSM-III criteria for &quot;MDD&quot; to get put on an antidepressant medication anymore. All you have to do is go to your GP for any reason and have some <strong><em><font color=\"#200020\">depressive symptoms<\/font><\/em><\/strong> [&quot;particularly&quot; if you have recently acquired mental health coverage].  <strong><font color=\"#200020\">Brintellix&reg;<\/font><\/strong>, with&#8230;<strong><font color=\"#200020\"><br \/> <\/font><\/strong><\/div>\n<ul>\n<div align=\"justify\" class=\"small\"><em><font color=\"#200020\">&quot;A favorable tolerability  profile also may  improve patient adherence to treatment, leading in turn  to not only a  reduction in depressive symptoms but a reduced risk of  behavioral or  social actions that could adversely affect the patient&rsquo;s  overall health  and well-being.&quot; <\/font><\/em> <\/div>\n<\/ul>\n<div align=\"justify\" class=\"small\">In an article from the former chairman of psychiatry at Stanford? From a former APA president? That&#8217;s the recommendation? Unbelievable!&#8230;<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Rarely do you get to see an industry production that has all of these elements rolled into one article, but look no further. This article has all the right moves. It&#8217;s a review article in an industry friendly CME journal, Journal of Clinical Psychiatry. Its got some well known KOLs for guest authors: Alan Schatzberg [&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-52599","post","type-post","status-publish","format-standard","hentry","category-opinion"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/52599","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=52599"}],"version-history":[{"count":60,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/52599\/revisions"}],"predecessor-version":[{"id":52659,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/52599\/revisions\/52659"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=52599"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=52599"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=52599"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}