{"id":65862,"date":"2016-05-25T17:24:00","date_gmt":"2016-05-25T21:24:00","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=65862"},"modified":"2016-05-25T17:24:00","modified_gmt":"2016-05-25T21:24:00","slug":"thatll-preach","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2016\/05\/25\/thatll-preach\/","title":{"rendered":"&#8220;that&#8217;ll preach&#8221;&#8230;"},"content":{"rendered":"\n<div align=\"justify\"><sup><strong><em><font color=\"#200020\">My good friend Andy died a couple of years back. By education, he was a minister, but he did other things instead, mostly good. Maybe he&#8217;d left the pulpit, but his way of saying things betrayed his history, so when he ran across something that really mattered or was unusually right, he&#8217;d smile and say &quot;That&#8217;ll preach!&quot; Reading this editorial, I heard his voice&#8230;<\/font><\/em><\/strong><\/sup><\/div>\n<blockquote>\n<div align=\"center\" class=\"big\"><a target=\"_blank\" href=\"http:\/\/www.bmj.com\/content\/353\/bmj.i2770\">Money back guarantees for non-reproducible results?<\/a><\/div>\n<div align=\"center\" class=\"middle\"><strong><font color=\"#200020\">There are better solutions to the &ldquo;reproducibility crisis&rdquo; in research<\/font><\/strong><\/div>\n<div align=\"center\" class=\"middle\">by Eric J. Topol <\/div>\n<div align=\"center\" class=\"middle\"><strong><font color=\"#0033ff\">British Medical Journal<\/font><\/strong>. 2016 353:i2770.<\/div>\n<div align=\"center\" class=\"middle\">[<a target=\"_blank\" href=\"http:\/\/www.bmj.com\/content\/353\/bmj.i2770\">full text on-line<\/a>] <\/div>\n<p align=\"justify\">Money back guarantees are generally unheard of  in biomedicine and healthcare. Recently, the US provider Geisenger  Health System, in Pennsylvania, started a programme to give patients  their money back if they were dissatisfied.  That came as quite a surprise. Soon thereafter, the chief medical  officer at Merck launched an even bigger one, proposing an  &ldquo;incentive-based approach&rdquo; to non-reproducible results &mdash; what he termed a  &ldquo;reproducibility crisis&rdquo; that &ldquo;threatens the entire biomedical research  enterprise.&rdquo;<\/p>\n<p align=\"justify\">The problem of irreproducibility in biomedical research is real and has been emphasised in multiple reports.&nbsp; In the same vein, the retraction of academic papers has been rising,  attributable, in nearly equal parts, to irreproducible results or data  that have been falsified. But  this problem is not confined to basic science or animal model work from  academic laboratories. Clinical trials, the final common pathway for  the validation and approval of new drugs, have been plagued with serious  drawbacks.<\/p>\n<div align=\"justify\">The bad science in clinical trials has been well documented and includes selective publication of positive results, data dredging, P hacking, HARKing, and changing the outcomes that were prespecified at the beginning of the study [below]. Indeed, the high prevalence of switching outcomes in drug industry funded trials led Ben Goldacre and colleagues at the University of Oxford to organise Compare, an initiative to track this considerable problem. Furthermore, the disparity between what appears in peer reviewed journals and what has been filed with regulatory agencies is long standing and unacceptable.<\/div>\n<ul>\n<div align=\"center\"><u><strong><font color=\"#200020\">Bad science<\/font><\/strong><\/u><\/div>\n<li>\n<div align=\"justify\"><strong><font color=\"#200020\"><em>Data dredging<\/em><\/font><\/strong> &mdash; Mining a dataset with innumerable unplanned analyses<\/div>\n<\/li>\n<li>\n<div align=\"justify\"><em><strong><font color=\"#200020\">P hacking<\/font><\/strong> <\/em>&mdash; Repetitively analysing data in ways not prespecified to find a significant P value<\/div>\n<\/li>\n<li>\n<div align=\"justify\"><strong><font color=\"#200020\"><em>HARKing (hypothesising after the results are known<\/em>)<\/font><\/strong> &mdash; Retrofitting  the hypothesis after the results are known to portray an exploratory,  retrospective analysis as if it was prospectively declared<\/div>\n<\/li>\n<\/ul>\n<div align=\"center\"><img decoding=\"async\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/snip.gif\" \/><\/div>\n<\/blockquote>\n<div align=\"justify\" class=\"small\">In case you don&#8217;t recognize the name, <a href=\"https:\/\/en.wikipedia.org\/wiki\/Eric_Topol\" target=\"_blank\">Eric Topol<\/a> is the Cardiologist who started the ball rolling that exposed the dangers of Vioxx&reg;. He later left the Cleveland Clinic in a conflict over corporate influences and now directs the Scripps Institute [among other things].        <\/div>\n<blockquote>\n<div align=\"center\" class=\"big\"><strong><font color=\"#200020\">Transparency is key<\/font><\/strong><\/div>\n<p align=\"justify\">What is missing is the deep commitment&mdash;across  academia and the life science industry&mdash;for open science and open data.  Everyone asks for accountability of research findings, which can be  vastly promoted by making them fully transparent. But compliance is  poor. Even the mandatory requirement for publishing results on  Clinicaltrials.gov within two years was evaded for 87% of 4347 clinical  trials in academic centres.<\/p>\n<p align=\"justify\"><strong><font color=\"#660033\">When we start to see all the protocol, prespecified  hypotheses, and raw data available for review, along with full  disclosure of methods and analyses and what, if anything, changed along  the course of experiments, be it at the bench or in clinical trials,  we&rsquo;ll have made substantive progress.<\/font><\/strong> A promising, low cost digital  solution exists to capture all of the data and promote trust and  reproducibility in biomedical research. <font color=\"#2f1401\">Use of blockchain<\/font> technology has recently <font color=\"#6d543d\">been shown to provide<\/font> <font color=\"#8c7461\">an  immutable ledger of<\/font> <font color=\"#a99485\">every step in a clinical <\/font> <font color=\"#c6b4a9\">research protocol, and this<\/font> <font color=\"#d3d4cd\">could easily be adapted to&hellip;<\/font><\/p>\n<div align=\"justify\">Until we develop the right system, we don&rsquo;t need or  want money back guarantees on research reproducibility. But I&rsquo;d be  interested to pick up on that refund offer for my medications or any  medical care that doesn&rsquo;t work.<\/div>\n<\/blockquote>\n<div align=\"justify\"><sup><em><strong><font color=\"#200020\">Maybe I should just say &quot;Amen, brother!&quot;That&#8217;s all Andy would&#8217;ve said&#8230;<\/font><\/strong><\/em><\/sup><\/div>\n","protected":false},"excerpt":{"rendered":"<p>My good friend Andy died a couple of years back. By education, he was a minister, but he did other things instead, mostly good. Maybe he&#8217;d left the pulpit, but his way of saying things betrayed his history, so when he ran across something that really mattered or was unusually right, he&#8217;d smile and say [&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-65862","post","type-post","status-publish","format-standard","hentry","category-opinion"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/65862","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=65862"}],"version-history":[{"count":17,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/65862\/revisions"}],"predecessor-version":[{"id":65879,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/65862\/revisions\/65879"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=65862"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=65862"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=65862"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}