{"id":4191,"date":"2010-06-19T17:54:36","date_gmt":"2010-06-19T21:54:36","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=4191"},"modified":"2010-06-20T09:41:26","modified_gmt":"2010-06-20T13:41:26","slug":"ru-486-and-stuff","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2010\/06\/19\/ru-486-and-stuff\/","title":{"rendered":"10. RU-486 and stuff&#8230;"},"content":{"rendered":"\n<div align=\"justify\">I have obviously been stirred up by the re-emergence of the story of <strong>Dr. Charlie Nemeroff <\/strong>who became Chairman of Psychiatry at Emory several years after I left the Department over 20 years ago:<\/div>\n<ol>\n<li>\n<div align=\"justify\"><strong><a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2010\/06\/13\/the-trivialization-of-america\/\"><font color=\"#200020\">the trivialization of america &hellip; <\/font><\/a><\/strong><\/div>\n<\/li>\n<li>\n<div align=\"justify\"><strong><a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2010\/06\/13\/accentuate-the-positive-eliminate-the-negative\/\"><font color=\"#200020\">accentuate the positive, eliminate the negative&hellip; <\/font><\/a><\/strong><\/div>\n<\/li>\n<li>\n<div align=\"justify\"><strong><a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2010\/06\/14\/do-no-harm\/\"><font color=\"#200020\">do no harm&hellip; <\/font><\/a><\/strong><\/div>\n<\/li>\n<li>\n<div align=\"justify\"><strong><a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2010\/06\/15\/who-is-not-telling-the-truth-yes\/\"><font color=\"#200020\">who is not telling the truth? yes&hellip; <\/font><\/a><\/strong><\/div>\n<\/li>\n<li>\n<div align=\"justify\"><strong><a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2010\/06\/15\/de-barred-not-a-bad-idea\/\"><font color=\"#200020\">de-barred? not a bad idea&hellip; <\/font><\/a><\/strong><\/div>\n<\/li>\n<li>\n<div align=\"justify\"><strong><a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2010\/06\/16\/fickle-science-fads-and-paradigms\/\"><font color=\"#200020\">fickle science, fads, and paradigms&hellip; <\/font><\/a><\/strong><\/div>\n<\/li>\n<li>\n<div align=\"justify\"><strong><a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2010\/06\/16\/again\/\"><font color=\"#200020\">again&hellip; <\/font><\/a><\/strong><\/div>\n<\/li>\n<li>\n<div align=\"justify\"><strong><a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2010\/06\/16\/much-ado\/\"><font color=\"#200020\">much ado&hellip; <\/font><\/a><\/strong><\/div>\n<\/li>\n<li>\n<div align=\"justify\"><strong><a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2010\/06\/18\/research-lite\/\"><font color=\"#200020\">science lite&hellip; <\/font><\/a><\/strong><\/div>\n<\/li>\n<\/ol>\n<div align=\"justify\">I blog for a number of reasons, but one of them is to &quot;get things off my chest,&quot; and it&#8217;s obvious that this had weighed heavily for a long time. Something I&#8217;ve learned in writing these posts should&#8217;ve been apparent way back when, but it wasn&#8217;t. Dr. Nemeroff rode into Emory during a wave of &quot;brain psychology&quot; in Psychiatry that swept away many more &quot;mind psychology&quot; types than just me. What I realize is that the psychoanalysts and psychotherapists of the 50&#8217;s, 1960&#8217;s , and 70&#8217;s had been as imperious as the Nemeroffs that replaced them &#8211; occupying the Chairmanships, dominating the government grants, presiding over the American Psychiatric Association, just as the biologists have done for the last thirty years [&quot;bipartisanship&quot; is as elusive in scientific disciplines as it is in Congress]. The pendulum probably needed to swing when it did. So in part, I was caught up in a big <a href=\"http:\/\/1boringoldman.com\/index.php\/2010\/06\/16\/fickle-science-fads-and-paradigms\/\" target=\"_blank\"><strong>paradigm shift<\/strong><\/a> that I didn&#8217;t recognize at the time. And I didn&#8217;t realize that the &quot;mind&quot; people had historically demeaned the &quot;brain&quot; people, and earned some of the wrath that came their way as the pendulum swung the other way.             <\/div>\n<p align=\"justify\">So what else is there to say more about the controversy surrounding Dr. Nemeroff&#8217;s moving to Miami&#8217;s Department of Psychiatry? There are, actually, several other things. While the issue on the table is Conflict of Interest [COI], the term doesn&#8217;t do justice to what actually happened. It does seem that the case that got Dr. Nemeroff demoted, raking in speaker fees from GlaxoSmithKlein Pharmaceuticals and serving on some of their boards while being a Principle Investigator of a large NIMH grant studying their products, is obviously a COI. But there were cases that more directly spoke to his lack of integrity, though they seems to have escaped as much notoriety.<\/p>\n<p align=\"justify\"><img loading=\"lazy\" decoding=\"async\" width=\"97\" hspace=\"4\" height=\"130\" border=\"1\" align=\"right\" src=\"http:\/\/t3.gstatic.com\/images?q=tbn:3NkzmpZaQqQ6vM:http:\/\/ecx.images-amazon.com\/images\/I\/51btrf19KRL._.jpg\" \/><img decoding=\"async\" hspace=\"4\" height=\"130\" border=\"1\" align=\"right\" src=\"http:\/\/www.mghcme.org\/img\/schatzberg.jpg\" alt=\"Alan Schatzberg\" title=\"Alan Schatzberg\" \/>Dr. Nemeroff is the co-author of a popular textbook, <a href=\"http:\/\/www.amazon.com\/American-Psychiatric-Publishing-Psychopharmacology-Schatzberg\/dp\/1585623091\/ref=sr_1_2?ie=UTF8&#038;s=books&#038;qid=1276965373&#038;sr=1-2\" target=\"_blank\"><strong>The Textbook of Psychopharmacology<\/strong><\/a> [$228.00], with the Chairman of Psychiatry at Stanford, Dr. Alan Schatzberg [the outgoing president of the <strong>American Psychiatric Association<\/strong>]. They were jointly autographing the new edition of their book at the recent APA convention in New Orleans earlier this year. Well it seems that they were more than just two Department Chairman who as friends and colleagues authored a textbook together. They are also business associates in a company called <a target=\"_blank\" href=\"http:\/\/www.corcept.com\/index.htm\"><strong><font color=\"#200020\">Corcept<\/font><\/strong><\/a>, and they are both also targets of a Congressional Investigation by Senator Chuck Grassley into a Conflict of Interest.<\/p>\n<div align=\"justify\">It&#8217;s a complex story that involves the drug <strong>Mifepristone <\/strong>[<strong>RU-486<\/strong>]. If you&#8217;ve heard of it, it&#8217;s because it&#8217;s the &quot;abortion pill,&quot; often in the news as the abortion debate has raged on in America. The drug is an antagonist to Progesterone and Glucocorticoids. <strong><font color=\"#200020\">Corcept<\/font><\/strong> was formed by Dr. Schatzberg and a colleague in 1998 with the idea of using it in Psychotic Depression, based on their hypothesis that Cortisol has something to do with that. This became one of the big Conflict of Interest Cases looked at by Senator Grassley, in that Schatzberg did not reveal his involvement with <strong><font color=\"#200020\">Corcept<\/font><\/strong>, yet was the Primary Investigator in an NIMH funded drug trial. The drug has never been introduced and probably never will be [because it doesn&#8217;t work]. Meanwhile, Dr. Schatzman made plenty of money on the deal. Here&#8217;s the story:<\/div>\n<ul>\n<li>\n<div align=\"justify\"><strong><a target=\"_blank\" href=\"http:\/\/hcrenewal.blogspot.com\/2008\/08\/follow-money.html\"><font color=\"#200020\">FOLLOW the MONEY<\/font><\/a><\/strong><\/div>\n<\/li>\n<li>\n<div align=\"justify\"><strong><a target=\"_blank\" href=\"http:\/\/hcrenewal.blogspot.com\/2008\/08\/follow-money-part-ii.html\"><font color=\"#200020\">FOLLOW the MONEY, Part II<\/font><\/a><\/strong><\/div>\n<\/li>\n<\/ul>\n<div align=\"justify\">How does that relate to Dr Nemeroff [from the second link]?<\/div>\n<blockquote>\n<div align=\"justify\">Dr. Schatzberg is not the only academic to benefit from Corcept. Dr.  Charles Nemeroff, a member of Corcept&rsquo;s scientific advisory board, also  did well. He exercised options to buy 60,000 shares on joining the  board in 1998. Dr. Nemeroff diligently promoted Corcept&rsquo;s drug.  Following the style <strong><a href=\"http:\/\/hcrenewal.blogspot.com\/2008\/08\/commercial-bias-at-stanford-and-corcept.html\" target=\"_blank\">documented<\/a><\/strong>  for Dr. Schatzberg, Dr. Nemeroff emphasized weak positive trends in the  data while suppressing inconvenient negative analyses. <strong><font color=\"#200020\">In the fall of  2002, Dr. Nemeroff referred to the Stanford-NIH trials as &ldquo;impressive  studies indicating that &#8230; [mifepristone]&#8230;is very effective in the  treatment of psychotic depression.&rdquo; The claims &ldquo;impressive&rdquo; and &ldquo;very  effective&rdquo; are indefensible, and may even be fraudulent. Dr. Nemeroff&rsquo;s<\/font><\/strong> <u><a href=\"http:\/\/www.nature.com\/neuro\/journal\/v5\/n11s\/abs\/nn943.html\" target=\"_blank\"><strong><font color=\"#200020\">exaggerated  promotion<\/font><\/strong><\/a><\/u><strong><font color=\"#200020\"> occurred while the company prepared for its IPO, but he  did not disclose his financial stake<\/font><\/strong>. Right after the 6-month  SEC-mandated lockup period expired, Dr. Nemeroff sold 20,000 shares for  $137,500. His cost was $6.60. Help me, what is the right term for this  behavior?<\/div>\n<\/blockquote>\n<div align=\"justify\">And then there was this:<\/div>\n<blockquote>\n<div align=\"center\"><strong><a href=\"http:\/\/hcrenewal.blogspot.com\/2006\/08\/after-revelations-of-undisclosed.html\" target=\"_blank\">After  Revelations of Undisclosed Conflicts of Interest, a Journal Editor  Steps Down<\/a><br \/>      HealthcareRenewal<\/strong><br \/>      by Roy M. Poses, MD<br \/>      August 30, 2006<\/div>\n<p>     <\/p>\n<div>\n<div align=\"justify\">In July, we briefly <strong><a href=\"http:\/\/hcrenewal.blogspot.com\/2006\/07\/wont-get-fooled-again-again-again.html\" target=\"_blank\">posted<\/a><\/strong>  about several cases in which articles published in prominent journals  were discovered to have been written by authors who had relevant, but  undisclosed conflicts of interest.  One of those cases we summarized  thus:<\/div>\n<div>\n<div align=\"justify\">  <\/div>\n<ul>  An <a href=\"http:\/\/www.nature.com\/npp\/journal\/v31\/n7\/full\/1301082a.html\" target=\"_blank\"><strong>article  was published in Neuropyschopharmacology<\/strong><\/a> in July about vagus nerve  stimulation as a treatment for depression [Nemeroff CB, Mayberg HS,  Krahl SE. VNS therapy in treatment-resistant depression: clinical  evidence and neurobiological mechanisms. Neuropsychopharmacology 2006;  31, 1345&ndash;1355.] The <a href=\"http:\/\/online.wsj.com\/article\/SB115322997681109756.html\" target=\"_blank\"><strong>Wall  Street Journal discovered<\/strong><\/a> that eight of the article&#8217;s nine authors  had financial ties to <strong><a href=\"http:\/\/www.cyberonics.com\/\" target=\"_blank\">Cyberonics  Inc<\/a><\/strong>, the manufacturer of the device. The ninth author is an employee  of the company, which was disclosed.&quot; [See previous post on Cyberonics <strong><a href=\"http:\/\/hcrenewal.blogspot.com\/2006\/06\/now-cyberonics-executives-stock.html\" target=\"_blank\">here<\/a><\/strong>.]  <\/ul>\n<div align=\"justify\">In  August, Bernard Carroll <strong><a href=\"http:\/\/hcrenewal.blogspot.com\/2006\/08\/money-and-medical-journals.html\" target=\"_blank\">posted  in more detail<\/a><\/strong>.  He noted that the case involved more than the  failure to disclose possible conflicts of interest, but also that one of  the authors  of the first draft the article was a hired writer, whose  role was not fully disclosed; that &quot;the review carefully followed the  corporation&#8217;s marketing message and branding language&quot;;  and that  Cyberonics produced a press release touting VNS therapy featuring  Nemeroff, but without revealing his financial relationships with the  company.<\/div>\n<p align=\"justify\">Now the Wall Street Journal, and <a href=\"http:\/\/www.the-scientist.com\/news\/home\/24445\/\" target=\"_blank\"><strong>The Scientist  reported<\/strong><\/a> that Nemeroff, who not only wrote the article in question,  but was the Editor of Neuropsychopharmacology, will be stepping down  from that role in December, &quot;in part, based on the recent adverse  publicity to the journal and the ANCP [American College of  Neuropsychopharmacology].&quot;<\/p>\n<div align=\"justify\">The Scientist also noted that &quot;This  isn&#8217;t the first time that Nemeroff has hit the headlines for undisclosed  financial ties. In 2003, a review he coauthored in Nature Neuroscience  neglected to mention significant financial interests in three therapies  that were reviewed favorably [including owning the patent on one of the  treatments], prompting the Nature Publishing Group to widen its  disclosure policies&quot;&#8230;<\/div>\n<\/div>\n<\/div>\n<\/blockquote>\n<div align=\"justify\">So there it is. It&#8217;s more than just Conflict of Interest, it&#8217;s a broad pattern of recommending treatments for disease based on his personal financial interest, without revealing that financial interest, treatments that are either unproven or ineffective, multiple instances even in the face of previous censure. It&#8217;s more than just his lightweight research or political hutzfa that accounts for the outrage, it&#8217;s something much more sinister.<\/div>\n<p>    <\/p>\n<div align=\"justify\">Physicians, Psychiatrists only have two things to bring to the table &#8211; integrity and an old oath [<strong><font color=\"#200020\">Do no harm<\/font><\/strong>]. The first one is sometimes hard, and the second one is impossible to live up to 100% of the time. <strong><font color=\"#200020\">But to consciously recommend a treatment because you own stock in the company and you don&#8217;t yet even know that the treatment is effective, and to do it repeatedly. That seems to me to be a deal-breaker &#8211; certainly a deal-breaker for someone in a position of power in charge of training other physicians. In my mind, that is an absolute truth&#8230;<\/font><\/strong><\/div>\n<hr size=\"1\" \/>\n<div><strong><font color=\"#200020\">Addendum<\/font><\/strong>: I said above, &quot;<em>While the issue on the table is Conflict of Interest [COI], the term  doesn&#8217;t do justice to what actually happened<\/em>.&quot;<\/div>\n<blockquote>\n<div align=\"justify\">A <a target=\"_blank\" href=\"http:\/\/en.wikipedia.org\/wiki\/Conflict_of_interest\"><strong><font color=\"#200020\">conflict of interest [COI]<\/font><\/strong><\/a> occurs when an individual  or organization is involved in multiple interests,  one of which could <em>possibly<\/em> corrupt the motivation for an act in  the other. A conflict of interest can only exist if a person or testimony is  entrusted with some impartiality; a modicum of trust is necessary to  create it. <strong><font color=\"#200020\">The presence of a conflict of interest is independent from  the execution of impropriety<\/font><\/strong>. Therefore, a conflict of interest can be  discovered and voluntarily defused before any corruption occurs. Examples of some occupations where a conflict of interest is most  likely to be encountered or discovered include: <span class=\"mw-redirect\">policeman<\/span>, lawyer, judge, <span class=\"mw-redirect\">insurance adjuster<\/span>, politician,  engineer,  executive, director of a corporation,  <strong>medical research scientist<\/strong>, <strong>physician<\/strong>,  <strong>writer<\/strong>, and <strong>editor<\/strong>.<\/div>\n<\/blockquote>\n<div align=\"justify\">So the next step is <strong><font color=\"#200020\">impropriety<\/font><\/strong>? That term seems a too soft as well. Looking over the <strong>AMA<\/strong> <a target=\"_blank\" href=\"http:\/\/www.ama-assn.org\/ama\/pub\/physician-resources\/medical-ethics\/code-medical-ethics\/principles-medical-ethics.shtml\"><strong>Principles of Medical Ethics<\/strong><\/a>, <strong><font color=\"#200020\">ethical violation<\/font><\/strong> [at best], <strong><font color=\"#200020\">profiteering<\/font><\/strong>, <strong><font color=\"#200020\">fraud<\/font><\/strong> [more like it] are the terms that come to mind&#8230;<\/div>\n","protected":false},"excerpt":{"rendered":"<p>I have obviously been stirred up by the re-emergence of the story of Dr. Charlie Nemeroff who became Chairman of Psychiatry at Emory several years after I left the Department over 20 years ago: the trivialization of america &hellip; accentuate the positive, eliminate the negative&hellip; do no harm&hellip; who is not telling the truth? yes&hellip; [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","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-4191","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/4191","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=4191"}],"version-history":[{"count":0,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/4191\/revisions"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=4191"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=4191"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=4191"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}