{"id":36473,"date":"2013-05-20T07:00:08","date_gmt":"2013-05-20T11:00:08","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=36473"},"modified":"2013-05-20T07:46:55","modified_gmt":"2013-05-20T11:46:55","slug":"beyond_unacceptable","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2013\/05\/20\/beyond_unacceptable\/","title":{"rendered":"beyond unacceptable&#8230;"},"content":{"rendered":"<div align=\"justify\">In March, friend Nancy Wilson ran across an article syndicated in multiple small town papers hawking the antidepressant, Viibryd&reg;, with commentary by Madhukar Trivedi &#8211; not labeled as an advertisement [<a href=\"http:\/\/1boringoldman.com\/index.php\/2013\/03\/27\/the-article\/\" target=\"_blank\">the article&hellip;<\/a>, <a href=\"http:\/\/1boringoldman.com\/index.php\/2013\/03\/28\/viibryd-coming-to-a-hamlet-near-you\/\">Viibryd&reg; &ndash; coming to a hamlet near you&hellip;<\/a>]. Trivedi is at UT Southwestern where he heads their Depression Clinic. She wrote the chairman who responded that she had discussed it with Dr. Trivedi who denied any knowledge of how his name was associated with the article [read skepticism between the lines]. Now we are <a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2013\/05\/18\/for-the-dsm-5\/#comment-244795\">alerted<\/a> to a press release from Lundbeck about a new antidepressant, <a href=\"http:\/\/en.wikipedia.org\/wiki\/Vortioxetine\" target=\"_blank\">Vortioxetine<\/a> [Brintellix&reg; or Rexulti&reg;] submitted for approval [FDA, EMA]. Look who it quotes:<strong><br \/> <\/strong><\/div>\n<blockquote>\n<div align=\"center\"><a href=\"http:\/\/www.globenewswire.com\/news-release\/2013\/05\/18\/548245\/0\/en\/Vortioxetine-clinical-phase-III-data-show-significant-improvement-in-symptoms-of-major-depression.html\" target=\"_blank\">Vortioxetine clinical phase III data show significant improvement in symptoms of major depression<\/a><br \/>  <strong><font color=\"#200020\">NASDAQ <em>OMX<\/em><\/font><\/strong><br \/>  May 18, 2013<\/div>\n<p>    <\/p>\n<div><sup><strong> <\/p>\n<div align=\"justify\">Vortioxetine clinical phase III data show significant improvement in symptoms of major depression<\/div>\n<ul>\n<li>\n<div align=\"justify\">Takeda and Lundbeck present results from pivotal phase III clinical trials with vortioxetine, an investigational compound for major depression<\/div>\n<\/li>\n<li>\n<div align=\"justify\">First presentation of results from four pivotal clinical studies of doses of up to 20 mg\/day<\/div>\n<\/li>\n<li>\n<div align=\"justify\">Clinical studies demonstrate efficacy at doses of 15 mg and 20 mg per day including an improvement of overall functioning<\/div>\n<\/li>\n<li>\n<div align=\"justify\">The safety profile was shown to be consistent with previously completed studies at lower doses<\/div>\n<\/li>\n<\/ul>\n<div align=\"justify\">Valby, Denmark, 18 May 2013 &#8211; H. Lundbeck A\/S [Lundbeck] and partner Takeda Pharmaceutical Company Limited [Takeda] today announced that the companies will be presenting new data on four pivotal studies on vortioxetine, a novel investigational drug under review by the U.S. Food and Drug Administration [FDA] and the European Medicines Agency [EMA] for the treatment of major depression.  The phase III data will be presented at the 2013 Annual Meeting of the American Psychiatric Association [APA] in San Francisco, USA.<\/div>\n<p align=\"justify\">The objective of these four studies was to evaluate the efficacy and safety profile of vortioxetine in doses ranging from 10-20 mg per day, complementing other studies in the New Drug Application [NDA] submission package that included dose ranges of 5-20 mg per day.  Three of the four pivotal studies met the primary efficacy endpoint as measured by the change from baseline of the Montgomery-&Aring;sberg Depression Rating Scale [MADRS] total score at week 8. Statistically significant improvements in overall symptoms of depression were demonstrated, as compared to placebo. A fourth study did not meet the primary endpoint. Results of all four studies provided additional information regarding the safety profile of vortioxetine. <\/p>\n<div align=\"justify\"><em>&quot;<font color=\"#990000\">It  is important that we continue to seek new options in depression  because, even though there are effective treatments available, many  patients remain symptomatic<\/font><\/em>,&quot; said Madhukar Trivedi, M.D., professor of psychiatry, UT Southwestern Medical Center. &quot;<font color=\"#990000\"><em>As  a clinician, I&rsquo;m encouraged by these data. They represent an important  addition to the broader clinical profile for vortioxetine and support  its potential as a new treatment for patients with MDD<\/em><\/font>.&quot;<\/div>\n<div align=\"right\">Dr. Trivedi &#8230; serves as scientific advisor for Lundbeck and Takeda.<\/div>\n<p><\/strong><\/sup><\/div>\n<\/blockquote>\n<div align=\"justify\">A search of <a target=\"_blank\" href=\"http:\/\/www.clinicaltrials.gov\/ct2\/results?term=Lu+AA21004+trivedi&#038;Search=Search\">clinicaltrials.gov<\/a> and <a target=\"_blank\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed?term=%28Vortioxetine[Title]%29%20AND%20Trivedi%20M[Author]\">PubMed<\/a> does not show that Dr. Trivedi was involved with any of the studies registered or published about Vortioxetine [or for that matter Vilazodone (Viibryd&reg;)]. Vortioxetine is a &quot;me too&quot; antidepressant that comes in behind the active comparators in the studies reported, but that&#8217;s not my point. Notice the careful wording, &quot;<em>I&rsquo;m encouraged by these data.<\/em>&quot; This looks for all the world like <em>endorsements for hire<\/em> to me, a new twist on the KOL motif. It also makes his denial to his chairman look even more suspect. Dr. Trivedi has a special valence for me. It was an article of his that first alerted me several years ago to read the disclosures at the end of every article very carefully [<a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2011\/01\/28\/evidence-based-medicine-i\/\">evidence-based medicine I&hellip;<\/a>]. At a time when psychiatry is fighting for credibility, persisting with this kind of behavior is beyond unacceptable&#8230;<\/div>\n","protected":false},"excerpt":{"rendered":"<p>In March, friend Nancy Wilson ran across an article syndicated in multiple small town papers hawking the antidepressant, Viibryd&reg;, with commentary by Madhukar Trivedi &#8211; not labeled as an advertisement [the article&hellip;, Viibryd&reg; &ndash; coming to a hamlet near you&hellip;]. Trivedi is at UT Southwestern where he heads their Depression Clinic. She wrote the chairman [&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":[2],"tags":[],"class_list":["post-36473","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/36473","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=36473"}],"version-history":[{"count":16,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/36473\/revisions"}],"predecessor-version":[{"id":36487,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/36473\/revisions\/36487"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=36473"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=36473"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=36473"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}