{"id":12072,"date":"2012-04-17T17:50:21","date_gmt":"2012-04-17T21:50:21","guid":{"rendered":"http:\/\/pmedicine.org\/epatients\/?p=12072"},"modified":"2024-12-27T07:32:45","modified_gmt":"2024-12-27T12:32:45","slug":"the-cancer-at-the-core-of-evidence-based-medicine-ben-goldacre-on-the-missing-data","status":"publish","type":"post","link":"https:\/\/participatorymedicine.org\/epatients\/2012\/04\/the-cancer-at-the-core-of-evidence-based-medicine-ben-goldacre-on-the-missing-data.html","title":{"rendered":"&#8220;The cancer at the core of evidence-based medicine&#8221;: Ben Goldacre on the missing data"},"content":{"rendered":"<p><em>Updates: The text below the video was added later on 4\/17, and the graphic was added 4\/18.<\/em><\/p>\n<p>For me the evidence highlight of TEDMED last week was a talk by Ben Goldacre MD (@BenGoldacre), a charming and articulate doctor who&#8217;s dug deeply into what seems to be scurrilous business: suppression of evidence that doesn&#8217;t favor the drug being studied. So he&#8217;s undertaken a project to dig up <em>all <\/em>the clinical trials that were registered with the FDA, and find the ones that never got published.<\/p>\n<p>Think this is nit-picking? Watch this 6 minute hallway chat I had with him, late the last night of the conference. He calls it &#8220;The cancer at the core of evidence-based medicine.&#8221;<\/p>\n<p>The video is hand-held-iPad shaky &#8211; forgive me, ignore it, just listen to the audio.<\/p>\n<p><span class=\"embed-youtube\" style=\"text-align:center; display: block;\"><iframe loading=\"lazy\" class=\"youtube-player\" width=\"1080\" height=\"608\" src=\"https:\/\/www.youtube.com\/embed\/OkfmAMDy0pg?version=3&#038;rel=1&#038;showsearch=0&#038;showinfo=1&#038;iv_load_policy=1&#038;fs=1&#038;hl=en-US&#038;autohide=2&#038;wmode=transparent\" allowfullscreen=\"true\" style=\"border:0;\" sandbox=\"allow-scripts allow-same-origin allow-popups allow-presentation allow-popups-to-escape-sandbox\"><\/iframe><\/span><\/p>\n<p>&nbsp;<\/p>\n<p>Example: in a survey of all 74 trials ever submitted to the FDA for anti-depressants, about half had positive outcomes &#8211; but <strong>only 40 papers were published,<\/strong>\u00a0of which <strong>37 were positive<\/strong>. Of the 36 negative outcomes, only 3 were published.<\/p>\n<p>So here&#8217;s how that boils down: <em>(Graphic added 4\/18)<\/em><\/p>\n<p><!--more--><a href=\"https:\/\/participatorymedicine.org\/epatients\/wp-content\/uploads\/sites\/3\/2012\/04\/Fat-Tony-and-Goldacre.png\" data-rel=\"lightbox-image-0\" data-rl_title=\"\" data-rl_caption=\"\"><img loading=\"lazy\" decoding=\"async\" class=\"size-medium wp-image-12083 alignright\" title=\"\" src=\"https:\/\/participatorymedicine.org\/epatients\/wp-content\/uploads\/sites\/3\/2012\/04\/Fat-Tony-and-Goldacre-300x236.png\" alt=\"\" width=\"300\" height=\"236\" srcset=\"https:\/\/participatorymedicine.org\/epatients\/wp-content\/uploads\/sites\/3\/2012\/04\/Fat-Tony-and-Goldacre-300x236.png 300w, https:\/\/participatorymedicine.org\/epatients\/wp-content\/uploads\/sites\/3\/2012\/04\/Fat-Tony-and-Goldacre-600x473.png 600w, https:\/\/participatorymedicine.org\/epatients\/wp-content\/uploads\/sites\/3\/2012\/04\/Fat-Tony-and-Goldacre.png 743w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/a><strong>Reality:<\/strong> 51% positive<br \/>\n<strong>Published:<\/strong> 92% positive (37\/40)<br \/>\n<strong>Withheld \/ unpublished:<\/strong> 97% negative (33\/34)<\/p>\n<p><em>[Added 4\/18]\u00a0<\/em>At right is a calculation from GraphPad.com of the probability that this is random: p &lt; .0001 (1 in 10,000), &#8220;extremely statistically significant.\u201d (See discussion of realist &#8220;Fat Tony&#8221; in <a href=\"https:\/\/participatorymedicine.org\/epatients\/archives\/2012\/04\/the-cancer-at-the-core-of-evidence-based-medicine-ben-goldacre-on-the-missing-data.html\/comment-page-1#comment-100673\" target=\"_blank\" rel=\"noopener\">this comment<\/a>.)<\/p>\n<p>That much skewing is an extreme example, but Goldacre says only about half the trials that are conducted are ever published, and (p=.0392) positive outcomes are twice as likely to be published as unfavorable ones.\u00a0<em>[End 4\/18 addition]\u00a0<\/em><\/p>\n<p>Impact:<\/p>\n<ul>\n<li>Inhibits patients from getting good information<\/li>\n<li>Inhibits doctors from having good information, too, with which to treat their patients<\/li>\n<li>Makes an absolutely mockery of evidence-based medicine<\/li>\n<li>As Goldacre points out, it&#8217;s a severe disservice to the patients who put themselves at risk by being in a clinical trial to help improve the body of scientific knowledge.<\/li>\n<\/ul>\n<p>I&#8217;d welcome thoughts from all, especially clinicians, on how to spread awareness of this. Goldacre says he&#8217;s going to start AllTrials.org and will plumb the database of all trials ever registered, to find and publish their outcomes.<\/p>\n<p>There&#8217;s more in his TEDMED talk than in this 6 minute video but for now this is a start.<\/p>\n<p>&#8212;&#8212;&#8212;-<\/p>\n<p>Related posts on this blog:<\/p>\n<ul>\n<li>Feb 2009:\u00a0<strong><a href=\"https:\/\/participatorymedicine.org\/epatients\/archives\/2009\/02\/medpage-negative-data-on-seroquel-suppressed-by-drugs-maker.html\" target=\"_blank\" rel=\"noopener\">MedPage: Negative Data on Seroquel Suppressed by Drug\u2019s Maker<\/a><\/strong><\/li>\n<\/ul>\n<blockquote><p>ORLANDO, Feb. 27 \u2014 Newly unsealed court documents suggest that AstraZeneca tried to minimize the risk of diabetes and weight gain associated with its antipsychotic drug quetiapine (Seroquel), in part by\u00a0<strong>\u201ccherry-picking\u201d data for publication.<\/strong>\u00a0\u2026 lawsuits by some 9,000 people who claim to have developed diabetes while taking the drug. \u2026 a 1999 e-mail indicating that the company had\u00a0<strong>\u201cburied\u201d three clinical trials<\/strong>\u00a0and was considering doing so with a fourth. \u2026 Another \u2026 discussed ways to \u201cminimize\u201d and\u00a0<strong>\u201cput a positive spin\u201d<\/strong>\u00a0on safety data from\u00a0<strong>a \u201ccursed\u201d study<\/strong>\u2014 one of those later described as \u201cburied.\u201d<\/p><\/blockquote>\n<ul>\n<li>January 2011:\u00a0<strong><a title=\"Permanent Link to The Decline Effect: Is there something wrong with the scientific method? (New Yorker)\" href=\"https:\/\/participatorymedicine.org\/epatients\/archives\/2011\/01\/the-decline-effect.html\" rel=\"bookmark\">The Decline Effect: Is there something wrong with the scientific method?\u00a0<\/a><\/strong><\/li>\n<\/ul>\n<blockquote><p>A recurring theme on this blog is the need for empowered, engaged patients to understand what they read about science. It\u2019s true when researching treatments for one\u2019s condition, it\u2019s true when considering government policy proposals, it\u2019s true when reading advice based on statistics. If you take any journal article at face value, you may get severely misled; you need to think critically.<\/p>\n<p>Sometimes there\u2019s corruption (e.g. the fraudulent vaccine\/autism data reported this month, or \u201c<a href=\"https:\/\/participatorymedicine.org\/epatients\/archives\/2009\/03\/dr-reuben-deeply-regrets-that-this-happened.html\">Dr. Reuben regrets this happened<\/a>\u201c), sometimes articles are retracted due to errors (see the new\u00a0<a href=\"https:\/\/participatorymedicine.org\/epatients\/archives\/2011\/01\/retractionwatch.wordpress.com\" target=\"_blank\" rel=\"noopener\">Retraction Watch<\/a>\u00a0blog), sometimes scientists simply can\u2019t reproduce a result that looked good in the early trials.<\/p><\/blockquote>\n<ul>\n<li>Last month: <strong><a href=\"https:\/\/participatorymedicine.org\/epatients\/archives\/2012\/03\/former-nejm-editors-on-the-corruption-of-american-medicine-ny-times.html\" target=\"_blank\" rel=\"noopener\">Former NEJM editors on the corruption of American medicine<\/a><\/strong><\/li>\n<\/ul>\n<blockquote><p>[A rule at NEJM prohibiting articles about a drug, written by people with financial ties <em>to<\/em> the drug] was reversed in 2002, after the journal\u2019s current editor in chief, Dr. Jeffrey M. Drazen, took the job. Dr. Drazen and his colleagues reported that\u00a0<strong>for some subjects, so few experts\u00a0<em>without\u00a0<\/em>financial ties could be found<\/strong>\u00a0that the journal\u2019s scope was becoming artificially curtailed.<em>(Emphasis added)<\/em><\/p><\/blockquote>\n<p>Reading <em>The Decline Effect,\u00a0<\/em>I thought we were experiencing a <em>weakness<\/em> of the scientific method. Despite the Seroquel item and the NEJM piece (and others like it), it never dawned on me that we might be experiencing wholesale <em>distortion<\/em> of scientific research: actively suppressing half the data. Goldacre&#8217;s data suggests that perhaps we are.<\/p>\n<p>To paraphrase him: If he tossed a coin 100 times and only reported half of the outcomes, he could convince you &#8211; and doctors, and insurance companies, and Medicare, and everyone &#8211; that the coin was different than it is. And that wouldn&#8217;t be good science.<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Updates: The text below the video was added later on 4\/17, and the graphic was added 4\/18. For me the evidence highlight of TEDMED last week was a talk by [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":12083,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"give_campaign_id":0,"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","_price":"","_stock":"","_tribe_ticket_header":"","_tribe_default_ticket_provider":"","_tribe_ticket_capacity":"0","_ticket_start_date":"","_ticket_end_date":"","_tribe_ticket_show_description":"","_tribe_ticket_show_not_going":false,"_tribe_ticket_use_global_stock":"","_tribe_ticket_global_stock_level":"","_global_stock_mode":"","_global_stock_cap":"","_tribe_rsvp_for_event":"","_tribe_ticket_going_count":"","_tribe_ticket_not_going_count":"","_tribe_tickets_list":"[]","_tribe_ticket_has_attendee_info_fields":false,"jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[21,62],"tags":[],"coauthors":[8070],"class_list":["post-12072","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-e-ptsresources","category-reforming-healthcare"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>&quot;The cancer at the core of evidence-based medicine&quot;: Ben Goldacre on the missing data - SPM Blog<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/participatorymedicine.org\/epatients\/2012\/04\/the-cancer-at-the-core-of-evidence-based-medicine-ben-goldacre-on-the-missing-data.html\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"&quot;The cancer at the core of evidence-based medicine&quot;: Ben Goldacre on the missing data - SPM Blog\" \/>\n<meta property=\"og:description\" content=\"Updates: The text below the video was added later on 4\/17, and the graphic was added 4\/18. 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