{"id":32031,"date":"2014-07-24T12:36:07","date_gmt":"2014-07-24T11:36:07","guid":{"rendered":"https:\/\/blogs.bmj.com\/bmj\/?p=32031"},"modified":"2015-08-03T17:13:53","modified_gmt":"2015-08-03T16:13:53","slug":"the-bmj-today-more-on-transparency","status":"publish","type":"post","link":"https:\/\/blogs.bmj.com\/bmj\/2014\/07\/24\/the-bmj-today-more-on-transparency\/","title":{"rendered":"The BMJ Today: More on transparency"},"content":{"rendered":"<p><a href=\"https:\/\/blogs.bmj.com\/bmj\/files\/2014\/04\/Birte.jpg\"><img loading=\"lazy\" decoding=\"async\" class=\"alignleft size-full wp-image-31357\" src=\"https:\/\/blogs.bmj.com\/bmj\/files\/2014\/04\/Birte.jpg\" alt=\"Birte\" width=\"160\" height=\"160\" srcset=\"https:\/\/blogs.bmj.com\/bmj\/files\/2014\/04\/Birte.jpg 160w, https:\/\/blogs.bmj.com\/bmj\/files\/2014\/04\/Birte-150x150.jpg 150w\" sizes=\"auto, (max-width: 160px) 100vw, 160px\" \/><\/a>In recent years,\u00a0<em>The BMJ<\/em> has campaigned on transparency\u2014the focus of our <a href=\"http:\/\/www.bmj.com\/open-data\">Open Data campaign<\/a>, and an issue of vital importance if modern medicine is to retain the trust of doctors and the public, writes Trevor Jackson in <a href=\"http:\/\/www.bmj.com\/content\/349\/bmj.g4793\">this week\u2019s Editor\u2019s Choice<\/a>.<\/p>\n<p>Dabigatran was the first of the new oral anticoagulants licensed to prevent stroke in patients with non-valvular atrial fibrillation. It was approved by the US Food and Drug Administration in 2010 and by the European Medicines Agency for this use a year later. The drug\u2019s unique selling point, said its manufacturer, Boehringer Ingelheim, was that it would need no monitoring, unlike warfarin.<!--more--><\/p>\n<p>But as Deborah Cohen reveals in <a href=\"http:\/\/www.bmj.com\/content\/349\/bmj.g4670\"><em>The BMJ<\/em>\u2019s latest investigation<\/a>, the company withheld important analyses from the regulators showing that monitoring drug plasma concentrations and adjusting the dose could improve safety. Instead, the company\u2019s marketing strategy emphasised the no monitoring message.<\/p>\n<p>Company documents revealed in the course of US litigation over dabigatran show how, with proper monitoring, and changing the dose as needed, major bleeds could be reduced by 30-40% compared with well controlled warfarin. But, as Cohen discovered, neither doctors nor regulators have ever been aware of these calculations. Instead, guidelines (including those <a href=\"http:\/\/www.bmj.com\/content\/348\/bmj.g3655\">recently issued by the UK National Institute for Health and Care Excellence<\/a>) have recommended the new generation of oral anticoagulants such as dabigatran, in part because they don\u2019t require monitoring.<\/p>\n<p>In an <a href=\"http:\/\/www.bmj.com\/content\/349\/bmj.g4517\">accompanying Analysis article<\/a>, Thomas J Moore and colleagues highlight the differences in how US and European regulators managed the safety problems of the new anticoagulant dabigatran, and ask both to think again and mandate plasma monitoring of dabigatran. And <a href=\"http:\/\/www.bmj.com\/content\/349\/bmj.g4681\">editorialists Rita Redberg and Blake Charlton<\/a> point out that one of the problems is that dabigatran benefited from FDA programmes to stimulate innovation, \u201cwhich also contributed to a less robust evaluation of risks and benefits.\u201d<\/p>\n<p>Our <a href=\"http:\/\/www.bmj.com\/investigation\/dabigatran\">dabigatran page pulls together<\/a> all the relevant articles in this investigation, and also provides access to key documents referred to in the investigation, showing modelling that Boehringer Ingelheim carried out.<\/p>\n<p><em><strong>Birte Twisselmann<\/strong>\u00a0is web editor and obituaries editor, The BMJ.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>In recent years,\u00a0The BMJ has campaigned on transparency\u2014the focus of our Open Data campaign, and an issue of vital importance if modern medicine is to retain the trust of doctors [&#8230;]<\/p>\n<p><a class=\"btn btn-secondary understrap-read-more-link\" href=\"https:\/\/blogs.bmj.com\/bmj\/2014\/07\/24\/the-bmj-today-more-on-transparency\/\">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":[14751,447,5750],"tags":[],"class_list":["post-32031","post","type-post","status-publish","format-standard","hentry","category-birte-twisselmann","category-india","category-the-bmj-today"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - 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