{"id":16987,"date":"2011-12-07T21:41:08","date_gmt":"2011-12-08T02:41:08","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=16987"},"modified":"2011-12-07T21:41:08","modified_gmt":"2011-12-08T02:41:08","slug":"a-clinical-trial","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2011\/12\/07\/a-clinical-trial\/","title":{"rendered":"a clinical trial&#8230;"},"content":{"rendered":"<div>Says <a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2011\/12\/05\/well-deserved-dust\/#comment-217740\"><u><strong><font color=\"#200020\">Jamzo<\/font><\/strong><\/u><\/a>: <\/div>\n<ol>\n<div align=\"justify\">The <u><strong><font color=\"#200020\">APA Nominating Committee<\/font><\/strong><\/u> reports the following slate of candidates for the 2012 Election. Please note that this slate is considered public, but not official, until the Board approves it at their December 2011 meeting:<\/div>\n<div><strong><font color=\"#200020\">President-Elect<\/font><\/strong><\/div>\n<ul>\n<li>\n<div>Renee L. Binder, MD<\/div>\n<\/li>\n<li>\n<div>Mary Helen Davis, MD<\/div>\n<\/li>\n<li>\n<div><strong><font color=\"#200020\">Jeffrey Lieberman, MD<\/font><\/strong><\/div>\n<\/li>\n<\/ul>\n<\/ol>\n<div align=\"justify\">When I read these nominations, I had an immediate reaction. Whenever I see <strong><font color=\"#200020\">Dr. Jeffrey Lieberman<\/font><\/strong>&#8216;s name, my thoughts go immediately to 2006 when I learned of Dr. Nemeroff&#8217;s article in the Journal he edited [Neuropsychopharmacology] praising a product he had a financial stake in without acknowledging that interest. Shortly thereafter, this letter appeared in the Wall Street Journal supporting Nemeroff. I knew most of the signers of that letter from the Emory faculty. But there were others from elsewhere, including Dr. Lieberman [non-Emory signers at the end of the letter below]. Here&#8217;s what the <strong><font color=\"#200020\">AHRP<\/font><\/strong> had to say at the time:          <\/div>\n<blockquote>\n<div align=\"justify\">&#8230; letters in The Wall Street Journal [below] raise serious  questions &mdash;  including the propriety of a letter signed by 45  signatories &mdash; of who  38 are junior level faculty [Assistant Professors] at  Emory where Dr.  Nemeroff is &ldquo;the boss of bosses.&rdquo;&nbsp; They wrote: &ldquo;&ldquo;Dr.  Nemeroff&#8217;s  extremely productive and successful career as a leader in  academic  psychiatry, we have the utmost respect for his science and  ethics.&rdquo; If  38 of Emory&rsquo;s faculty have &ldquo;utmost respect for his  science and  ethics&rdquo; &mdash; which have earned him considerable criticism, one  must wonder  about the scientific and ethical culture at Emory!&nbsp;  Additionally,  questions surely arise about how easy it might be for  subordinates to  refuse to show solidarity with &ldquo;the boss of bosses.&rdquo; The  other seven  signatories hold positions of authority and have almost as  much of a  financial stake in the business of psychiatry as does Dr.  Nemeroff.  [<a target=\"_blank\" href=\"http:\/\/www.ahrp.org\/cms\/content\/view\/345\/27\/\"><u><strong><font color=\"#200020\">Alliance for Human Research Protection<\/font><\/strong><\/u><\/a>]<\/div>\n<\/blockquote>\n<table width=\"396\" cellspacing=\"0\" cellpadding=\"2\" border=\"0\" align=\"center\">\n<tr>\n<td align=\"justify\"><sup>The Wall Street Journal<br \/>                  Letters to the Editor <br \/>                  Needless Furor Harms Outstanding Psychiatrist <br \/>                  19 September 2006 <\/p>\n<p>                  The  furor arising from your article about the absence of a potential  conflict of information statement in a scientific paper on vagal nerve  stimulation therapy for depression [&quot;Medical Journal Editor Nemeroff  Steps Down Over Undisclosed Ties,&quot; Aug. 28] has potentially harmed the  fields of medicine and psychiatry.<\/p>\n<p>                  Dr. Nemeroff was the lead  author of the article in question, and all of the required individual  conflicts were submitted to the journal, of which he was the editor, but  they weren&#8217;t included due to a regrettable oversight at the level of  administrative publication. Thus, the concern about this is much  overdone, as Dr. Nemeroff has reported his collaboration with the maker  of vagal nerve stimulators in numerous other publications, as well as  public and academic presentations. Dr. Nemeroff&#8217;s decision not to pursue  another appointment as editor of Neuropsychopharmacology is highly  unfortunate, as this journal is more focused on the biological  mechanisms of psychiatric diseases and their treatments than any other,  and Dr. Nemeroff is extremely well-qualified to lead it.<\/p>\n<p>                  Due to  Dr. Nemeroff&#8217;s extremely productive and successful career as a leader in  academic psychiatry, he and others like him are asked to be on the  boards of many pharmaceutical firms specializing in central nervous  system agents. Through such collaborations, the development and testing  of novel treatments are greatly enhanced and the safety of research  subjects strengthened. Yes, these companies must make profits, but they  also share with researchers a desire to find scientific truth, which  usually isn&#8217;t as clear-cut as many believe. The overwhelming majority of  academic researchers are proud of their independence and are dedicated  to advancing their fields through quality research. At a time of  diminishing funding, does it not make sense for industry-sponsored  support to provide a viable alternative, especially if available in a  no-strings-attached way with sufficient academic research oversight?<\/p>\n<p>                  We  are academic psychiatrists and researchers who are colleagues of  Charles Nemeroff, and we have the utmost respect for his science and  ethics. Some of us receive research support from pharmaceutical  companies, some from federal agencies, some from both and some from  neither. All of us want the best for the fields of science, medicine and  psychiatry in their endeavors to better humanity.<\/sup> <\/td>\n<\/tr>\n<tr>\n<td>\n<hr size=\"1\" \/><\/td>\n<\/tr>\n<tr>\n<td align=\"justify\"><sup> Robert N. Golden, M.D.&nbsp; Dean, School of Medicine, U. Wisconsin Madison&#8230;&nbsp; <\/p>\n<p>         Ned H. Kalin, M.D.  Chairman, Dept. Psychiatry, University of Wisconsin&#8230;&nbsp; <\/p>\n<p>         Martin B. Keller, M.D.&nbsp;    Chairman, Dept. Psychiatry, Brown University&#8230;<\/p>\n<p>         Jeffrey A. Lieberman, M.D.:  Chairman Department of Psychiatry, Columbia University College of Physicians and Surgeons&#8230;<\/p>\n<p>         Thomas Schlaepfer, MD:  Assistant Professor Dept. of Psychiatry, Johns Hopkins&#8230; <\/p>\n<p>         Michael E. Thase, M.D:  Professor of Psychiatry, University of Pittsburgh Medical  Center and the Western Psychiatric Institute and Clinic, Pittsburgh, PA&#8230;<\/sup><\/td>\n<\/tr>\n<\/table>\n<p align=\"justify\">By 2006, Dr. Nemeroff was completely out of control. I didn&#8217;t know how far out back then, but I knew enough to feel glad that someone had finally called his hand. The list of people signing from Emory made me sad. I knew most of them, and with some exceptions, they were decent people captured in the Nemeroff spell. But those outside people? They weren&#8217;t spellbound. I suspected that they were in the game too [even though back then I had no clue what the game really was, or how corrupt it had become]. Since then, that list has been branded on my mind. <\/p>\n<div align=\"justify\">Is it fair to say that by signing that letter, Dr. Lieberman disqualified himself forever as being President of the American Psychiatric Association? After all, he&#8217;s a Chairman at Columbia and he directed CATIE, a clarifying study of the Atypical Antipsychotics. He wasn&#8217;t on Grassley&#8217;s 2008 list. Maybe he was just one of Nemeroff&#8217;s personal friends, like pals or something like that. Since then, Lieberman&#8217;s articles always say that he accepts no payment for being an advisor to drug companies. So I decided to do a study to decide if he has been a party to the dark side of psychiatry. I would go to <strong><font color=\"#200020\">PubMed<\/font><\/strong> and put this into a search &#8211; <strong><font color=\"#200020\">lieberman j[Author]) AND nemeroff c[Author]<\/font><\/strong>. It would be like a clinical trial &#8211; I&#8217;d declare my outcome parameter before hand. And the envelope please&#8230;<\/div>\n<blockquote>\n<div align=\"center\"><a href=\"http:\/\/www.cnsspectrums.com\/aspx\/articledetail.aspx?articleid=403\" target=\"_blank\"><u><strong><font color=\"#200020\">From clinical research to clinical practice: a 4-year review of ziprasidone<\/font><\/strong><\/u><\/a>.<br \/>     <sup>by Nemeroff CB, Lieberman JA, Weiden PJ, Harvey PD, Newcomer JW, Schatzberg AF, Kilts CD, and Daniel DG<\/sup><br \/>     <strong><font color=\"#0066ff\">CNS Spectrums<\/font><\/strong>. 2005 10(11 Suppl 17):1-20.<br \/>     <strong><font color=\"#200020\">[full text on-line]<\/font><\/strong><\/div>\n<p>    <\/p>\n<div align=\"justify\"><sup>Ziprasidone  is a second-generation antipsychotic that received Food and Drug  Administration approval in February 2001. It has a unique receptor  profile that includes high-affinity antagonist activity at dopamine D2  receptors, inverse agonist activity at serotonin (5-HT)2A receptors,  agonist activity at 5-HTlA receptors, and a relatively high affinity for  the serotonin and norepinephrine transporters. The 5-HTIA affinity,  together with the inhibitory effect on mono-amine reuptake, may underlie  the hypothesized beneficial effects on comorbid affective and cognitive  abnormalities in schizophrenia and schizoaffective disorder. The  short-term efficacy of ziprasidone for core positive symptoms of  schizophrenia appears to be comparable to other conventional and  atypical antipsychotics. The short-term efficacy of ziprasidone in acute  mania has been established based on two 3-week, double-blind,  placebo-controlled trials.Open-label treatment for up to 52 weeks  confirms the sustained efficacy and safety of ziprasidone in bipolar  disorder. Maintenance studies in schizophrenia and schizoaffective  disorder indicate that long-term ziprasidone therapy is effective in  preventing relapse, while maintaining cognitive and psychosocial  benefits. The safety database suggests that the overall cardiovascular  and cerebrovascular risk associated with ziprasidone is lower than with  other atypicals, with notably lower risk of drug-related increases in  weight, glucose, or lipids. The data also suggest a modestly increased  risk of QTc prolongation that is not dose related or linked to torsades  de pointes. Switching to ziprasidone from other atypicals appears to  improve both clinical symptoms and metabolic parameters, though more  studies are needed to fully characterize these benefits. This monograph  summarizes the efficacy, tolerability, and safety of oral ziprasidone in  the treatment of schizophrenia, schizoaffective disorder, and bipolar  mania.<\/sup><\/div>\n<\/blockquote>\n<div align=\"justify\">This, from the article:<\/div>\n<blockquote><p><span class=\"content\"> <\/p>\n<div align=\"justify\"><sup>This Clinical  Information Monograph is based in part on an expert consensus roundtable  entitled &ldquo;From Clinical Research to Clinical Practice: A 4-Year Review  of Ziprasidone,&rdquo; held in New York City on June 27-28, 2004. The meeting  was moderated by Prakash S. Masand, MD, and contributors included David  G. Daniel, MD, Philip D. Harvey, PhD, Clinton D. Kilts, MD, Jeffrey A.  Lieberman, MD, Charles B. Nemeroff, MD, PhD, John W. Newcomer, MD, Alan  F. Schatzberg, MD, and Peter J. Weiden, MD.<\/sup><\/div>\n<hr width=\"100%\" size=\"1\" \/>  <\/span><\/p>\n<div align=\"justify\"><span class=\"content\"><\/p>\n<div><sup><em>This clinical information monograph  is supported by Pfizer, Inc. Support of this monograph does not imply  the commercial supporters&rsquo; agreement with the views expressed herein.  Although every effort has been made to ensure that the information is  presented accurately in this publication, the ultimate responsibility  rests with the prescribing physician. Neither the publisher, the  sponsor, nor the participants can be held responsible for errors or for  any consequences arising from the use of information contained herein.  Readers are strongly urged to consult any relevant primary literature.  No claims or endorsements are made for any drug or compound at present  under clinical investigation.<\/em><\/sup><\/div>\n<p><\/span><\/div>\n<\/blockquote>\n<div align=\"justify\">The article itself is an advertisement for Geodon [Ziprasidone] with lots of slick slides and tables. I would personally bet a reasonable sum that this round-table never occurred. There&#8217;s nothing in the article that suggested it did. If they met at all, it was to hear what Pfizer had put together. Maybe they talked about golf. Who knows? But if you doubt my cynicism, read it yourself and see if I&#8217;m being unreasonable [and anyway, I declared my outcome variable in advance].<\/div>\n<p><\/p>\n<div align=\"justify\">So, in 2004, Dr. Lieberman signed on to an infomercial for Pfizer&#8217;s Geodon with Dr. Charlie Nemeroff and Emory&#8217;s research director [<span class=\"content\">Clinton D. Kilts, MD<\/span>]. Nemeroff pal Alan Schatzberg was in the house. That was before CATIE was published, before Nemeroff&#8217;s fall, before Alan Schatzberg&#8217;s &quot;stepping down&quot; at Stanford. There are plenty of other signs that Dr. Lieberman is in the game, though he is much more careful these days. <strong><font color=\"#200020\">This article itself is enough for me to see a morality that is seriously flawed. This is a time when the APA is going to have to deal with a DSM-5 Revision that is both troubling and troubled. We don&#8217;t need an APA President who was\/is in <em>the game<\/em> and then tried to play it clean after the hammer fell. Signing on to that letter defending Dr. Nemeroff&#8217;s ethics? Signing on as a &quot;guest author&quot; to Pfizer&#8217;s Geodon Infomercial? Pathognomonic symptoms that can&#8217;t be ignored&#8230;<\/font><\/strong><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Says Jamzo: The APA Nominating Committee reports the following slate of candidates for the 2012 Election. Please note that this slate is considered public, but not official, until the Board approves it at their December 2011 meeting: President-Elect Renee L. Binder, MD Mary Helen Davis, MD Jeffrey Lieberman, MD When I read these nominations, I [&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_topic_count_hidden":0,"_bbp_reply_count_hidden":0,"_bbp_forum_subforum_count":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-16987","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/16987","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=16987"}],"version-history":[{"count":16,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/16987\/revisions"}],"predecessor-version":[{"id":17004,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/16987\/revisions\/17004"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=16987"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=16987"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=16987"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}