{"id":19313,"date":"2012-02-07T14:55:56","date_gmt":"2012-02-07T19:55:56","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=19313"},"modified":"2012-02-07T15:05:19","modified_gmt":"2012-02-07T20:05:19","slug":"unacceptable-had-become-routine","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2012\/02\/07\/unacceptable-had-become-routine\/","title":{"rendered":"unacceptable had become routine&#8230;"},"content":{"rendered":"\n<p align=\"justify\">You might be tired of hearing about Martin Keller&#8217;s Study 329, but I&#8217;m not. So I was glad to see Ed Silverman&#8217;s post on <a href=\"http:\/\/www.pharmalot.com\/2012\/02\/brown-university-a-paxil-study-and-retractions\/\" target=\"_blank\"><u><strong><font color=\"#006600\">Pharmalot<\/font><\/strong><\/u><\/a> yesterday with the primary documents for the latest round between <strong><font color=\"#290b00\">Brown University<\/font><\/strong> and the people at <strong><font color=\"#200020\">Healthy Skepticism<\/font><\/strong>. How&#8217;s this for a non-response?               <\/p>\n<p align=\"center\"><a target=\"_blank\" href=\"http:\/\/freepdfhosting.com\/c40dadc79d.pdf\"><img loading=\"lazy\" decoding=\"async\" width=\"400\" height=\"470\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/brown-1.gif\" \/><\/a><br \/>                <sup>[click for original]<\/sup><\/p>\n<p align=\"justify\">He also had a letter from the <strong><font color=\"#200020\">HHS Office of Research Integrity<\/font><\/strong>. I was a little surprised at my reaction. I thought it wasn&#8217;t half bad in that it at least acknowledged the reality of the complaint, and even though they didn&#8217;t take on the task, their procedural explanation at least made sense in the legal context under which they operate [Note to self: The next time a study 329 comes along, report it to HHS early on to see if they&#8217;re really willing to take on a case that fits their mandate].               <\/p>\n<p align=\"center\"><a target=\"_blank\" href=\"http:\/\/freepdfhosting.com\/33af4ef04b.pdf\"><img loading=\"lazy\" decoding=\"async\" width=\"400\" height=\"550\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/brown-2.gif\" \/><\/a><br \/>                <sup>[truncated for simplicity]<br \/>                [click for the original]<\/sup><\/p>\n<div align=\"justify\">But the reason I&#8217;m writing about it was my reaction to something in the small print in the footnote. In discussing their requirements for research misconduct, the <strong><font color=\"#200020\">Office of Research Integrity<\/font><\/strong> lists three criteria:<\/div>\n<ul>\n<div align=\"justify\"><strong><font color=\"#290b00\">[a]&#8230;There be a significant departure from accepted practices of the relevant research community; and<\/font><\/strong>              <\/div>\n<div align=\"justify\"><strong><font color=\"#290B00\">[b]&#8230;The misconduct be committed intentionally, knowingly, or recklessly; and<\/font><\/strong>              <\/div>\n<div align=\"justify\"><strong><font color=\"#290B00\">[c]&#8230;The allegation be proven by a preponderance of the evidence.<\/font><\/strong>              <\/div>\n<\/ul>\n<div align=\"justify\"><strong><font color=\"#290B00\">[b] <\/font><\/strong>and <strong><font color=\"#290B00\">[c] <\/font><\/strong>are shoe ins &#8211; well demonstrated by a library of publicly available documents and dramatically illustrated in Alison Bass&#8217;s book, <a href=\"http:\/\/www.amazon.com\/Side-Effects-Whistleblower-Bestselling-Antidepressant\/dp\/1565125533\" target=\"_blank\"><u><strong><font color=\"#200020\">Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial<\/font><\/strong><\/u><\/a>. But my thought was that in the final analysis, <strong><font color=\"#290b00\">[a] <\/font><\/strong>is the real problem [<strong><font color=\"#290b00\">There be a significant departure from accepted practices of the relevant research community<\/font><\/strong>]. Unfortunately, the in 2001 when Study 329 was published, it was hardly a singular occurrence for a ghost-written, industry funded, research article with fudged numbers and unsupported conclusions to get published in our psychiatric literature. <\/div>\n<p>       <\/p>\n<div align=\"justify\">Looking at the output of author, Sally Laden, during that period, Paul Thacker [then with POGO] found&nbsp; plenty of other similar examples of her work [<a target=\"_blank\" href=\"http:\/\/www.pogo.org\/pogo-files\/letters\/public-health\/ph-iis-20101129.html\"><strong><u><font color=\"#200020\">POGO Letter to NIH on Ghostwriting Academics<\/font><\/u><\/strong><\/a>]. This time last year, I was looking at the studies that got Seroquel approved a few years before Keller&#8217;s Study 329, and found this kind of note in the Acknowledgements of all the papers [<u><strong><a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2011\/02\/10\/seroquel-iii-their-best-shot%e2%80%a6\/\"><font color=\"#200020\">seroquel III: their best shot&hellip;<\/font><\/a><\/strong><\/u>]:<\/div>\n<ul>\n<div align=\"justify\"><sup>Accepted for publication November 6, 1996. This study was supported by a  grant from Zeneca Pharmaceuticals, Macclesfield, England, and  Wilmington, Del. We thank <font color=\"#990000\"><strong>Suzanne Bristow-Marcalus<\/strong> <strong>for medical writing support<\/strong><\/font>&#8230; <\/sup><\/div>\n<\/ul>\n<div align=\"justify\">At the same time, Janssen Pharmaceuticals and their contracted medical writing firm, <strong><font color=\"#990000\">Excerptia Medica<\/font><\/strong>, were churning out articles about Risperdal so fast that they got behind in finding academics to sign on as guest authors [<u><strong><a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2011\/06\/29\/harvard-for-sale\/\"><font color=\"#200020\">bipolar kids: harvard for sale&hellip;<\/font><\/a><\/strong><\/u>, <u><strong><a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2011\/06\/16\/gpp\/\"><font color=\"#200020\">gpp?&hellip;<\/font><\/a><\/strong><\/u>]. And this from the Forest Laboratories CEO in his 2004 business plan for Lexapro [<u><strong><a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/wp-admin\/..\/index.php\/2011\/04\/30\/or-ghostwritten-for\/\"><font color=\"#200020\">or ghostwritten for&hellip;<\/font><\/a><\/strong><\/u>]:<\/div>\n<div align=\"center\"><img decoding=\"async\" width=\"450\" vspace=\"5\" border=\"1\" src=\"http:\/\/pogoblog.typepad.com\/.a\/6a00d8341c68bf53ef01538df45b62970b-800wi\" \/><\/div>\n<div align=\"justify\">And who could forget Jon Kilner, ubiquitous writer for Dr. John Rush and the STAR*D team [<u><strong><a href=\"http:\/\/1boringoldman.com\/index.php\/2011\/04\/13\/a-study-in-pollen\/\" target=\"_blank\"><font color=\"#200020\">a study in pollen&hellip;<\/font><\/a><\/strong><\/u>]?    <\/div>\n<p align=\"justify\">These are just a few examples of a widespread practice found by an old guy in the Appalachians with nothing but a good Internet connection and some free time, but I can easily extrapolate that given the right tools and access, a full compendium of ghost-written, industry funded, inaccurate scientific articles from the era would fill volumes. So though I doubt that Martin Keller and his twenty-one other co-guest-authors would mount an argument that &quot;everyone does it!&quot; in any public forum, I expect that fact is well-known to decision makers behind closed doors, and a major force in Brown University and Dr. Wing refusing to deal definitively with Martin Keller&#8217;s clear [and dangerous] infraction. The unacceptable had become routine.<\/p>\n<div align=\"justify\">And that&#8217;s why I&#8217;m not tired of hearing about Study 329. I hope Healthy Skepticism doesn&#8217;t tire either [see <a target=\"_blank\" href=\"http:\/\/www.tandfonline.com\/doi\/full\/10.1080\/08989621.2011.542683\"><u><strong><font color=\"#200020\">Conflicted Medical Journals and the Failure of Trust<\/font><\/strong><\/u><\/a>]&#8230;         <\/div>\n","protected":false},"excerpt":{"rendered":"<p>You might be tired of hearing about Martin Keller&#8217;s Study 329, but I&#8217;m not. So I was glad to see Ed Silverman&#8217;s post on Pharmalot yesterday with the primary documents for the latest round between Brown University and the people at Healthy Skepticism. How&#8217;s this for a non-response? [click for original] He also had a [&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":[2],"tags":[],"class_list":["post-19313","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/19313","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=19313"}],"version-history":[{"count":27,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/19313\/revisions"}],"predecessor-version":[{"id":19340,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/19313\/revisions\/19340"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=19313"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=19313"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=19313"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}