{"id":32047,"date":"2014-07-28T14:10:51","date_gmt":"2014-07-28T13:10:51","guid":{"rendered":"https:\/\/blogs.bmj.com\/bmj\/?p=32047"},"modified":"2014-07-28T14:10:57","modified_gmt":"2014-07-28T13:10:57","slug":"the-bmj-today-dabigatran-the-impact-of-the-bmjs-investigation","status":"publish","type":"post","link":"https:\/\/blogs.bmj.com\/bmj\/2014\/07\/28\/the-bmj-today-dabigatran-the-impact-of-the-bmjs-investigation\/","title":{"rendered":"The BMJ Today: Dabigatran\u2014the impact of The BMJ\u2019s investigation"},"content":{"rendered":"<p><a href=\"https:\/\/blogs.bmj.com\/bmj\/files\/2014\/03\/TJackson_09.jpg\"><img loading=\"lazy\" decoding=\"async\" class=\"alignleft size-thumbnail wp-image-31202\" src=\"https:\/\/blogs.bmj.com\/bmj\/files\/2014\/03\/TJackson_09-150x110.jpg\" alt=\"TJackson_09\" width=\"150\" height=\"110\" \/><\/a>\u201cThe results of this investigation are somewhat shocking to me, but, reviewing the information, not entirely surprising.\u201d That was the verdict of David Haines, section head of the Heart Rhythm Center at Beaumont Health System in the United States, on <a href=\"http:\/\/www.bmj.com\/content\/349\/bmj.g4793\"><em>The BMJ<\/em>\u2019s investigation into dabigatran<\/a>, the first of the new oral anticoagulants licensed to prevent stroke in patients with non-valvular atrial fibrillation. One of the main findings of <em>The BMJ<\/em>\u2019s investigation\u2014by investigations editor Deborah Cohen\u2014was that Boehringer Ingelheim, the manufacturer of dabigatran, withheld important analyses from the regulators, which showed that monitoring blood levels and dose adjustment could improve the drug\u2019s safety.<!--more--><\/p>\n<p>Dr Haines, <a href=\"http:\/\/www.medpagetoday.com\/Cardiology\/Arrhythmias\/46901\">speaking on a video created by <em>MedPage Today<\/em><\/a> in the wake of our investigation, said, \u201cThe approval process for dabigatran was rushed.\u201d He questioned the US Food and Drug Administration\u2019s reliance on a \u201csingle, albeit large\u201d randomised trial (the RE-LY trial) as part of its approval process, saying this was \u201cnot standard.\u201d<\/p>\n<p>On the same video from <em>MedPage Today<\/em> (which is a US based CE and CME accredited medical news service providing daily coverage of developments that impact clinical practice), vascular neurologist Cathy Sila, director of the Comprehensive Stroke Center at University Hospitals Case Medical Center, said that not being able to monitor the drug \u201cwas really a disadvantage from our perspective.\u201d Boehringer Ingelheim had marketed dabigatran as not needing any monitoring, unlike warfarin. In fact, no need for monitoring was the drug\u2019s unique selling point.<\/p>\n<p>Dr Haines said that he would not be surprised if, in the wake of <em>The BMJ<\/em>\u2019s investigation, a test became available for monitoring drug plasma concentrations. \u201cI think when that test becomes available, it will be fairly routine to check trough\u00a0levels of drug after new initiation of this drug in patients, and then down adjust the dose if necessary.\u201d<\/p>\n<p>In response to our investigation, Boehringer Ingelheim issued <a href=\"https:\/\/www.youtube.com\/watch?v=Tm0NWWmDMwU\">a video statement<\/a> on YouTube by Charles de Wet, the company\u2019s medical director in the UK, in which he said he wanted to \u201cset the record straight\u201d about Pradaxa, the proprietary name for dabigatran. He said that all of the allegations about BI\u2019s behaviour in relation to dabigatran were \u201cabsolutely false.\u201d \u201cEthical behaviour and patient safety are at the core of everything we do,\u201d he said.<\/p>\n<p>http:\/\/youtu.be\/Tm0NWWmDMwU<\/p>\n<p><em><strong>Trevor Jackson<\/strong>\u00a0is a deputy editor, The BMJ.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u201cThe results of this investigation are somewhat shocking to me, but, reviewing the information, not entirely surprising.\u201d That was the verdict of David Haines, section head of the Heart Rhythm [&#8230;]<\/p>\n<p><a class=\"btn btn-secondary understrap-read-more-link\" href=\"https:\/\/blogs.bmj.com\/bmj\/2014\/07\/28\/the-bmj-today-dabigatran-the-impact-of-the-bmjs-investigation\/\">More&#8230;<\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5750,1357],"tags":[],"class_list":["post-32047","post","type-post","status-publish","format-standard","hentry","category-the-bmj-today","category-us-health-care"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - 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