{"id":13384,"date":"2011-09-17T16:17:58","date_gmt":"2011-09-17T20:17:58","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=13384"},"modified":"2012-02-04T23:09:21","modified_gmt":"2012-02-05T04:09:21","slug":"racketeer-influenced-and-corrupt-organizations","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2011\/09\/17\/racketeer-influenced-and-corrupt-organizations\/","title":{"rendered":"racketeer influenced and corrupt organizations&#8230;"},"content":{"rendered":"\n<p align=\"justify\"><em>In a recent post, I referenced one of Dr. Nemeroff&#8217;s review articles, guessing that it was ghostwritten during Janssen&#8217;s mid-decade literature Blitzkrieg for Risperdal. As it turns out, this was just one boxcar on a very long train.<\/em><\/p>\n<hr width=\"75%\" size=\"1\" \/>\n<h1><strong><font color=\"#660033\">December 2004<\/font><\/strong>:<\/h1>\n<div align=\"justify\"> Charles Nemeroff [Emory], Mark Rapaport [Cedars-Sinai], and six Janssen authors presented this Risperdal augmentation in depression study in a poster session  at the <em>ACNP 2004 Meeting<\/em>, concluding:<\/div>\n<ol>\n<div align=\"justify\"><sup>Risperidone augmentation resulted in symptomatic remission in a substantial number of patients with chronic resistant depression who were nonresponsive to standard antidepressant therapy. Time to relapse in these remitted patients was similar with risperidone vs. placebo augmentation. In the population of fully nonresponsive patients, relapse was significantly delayed with risperidone augmentation.<\/sup><\/div>\n<\/ol>\n<h1><strong><font color=\"#660033\">Fall 2005<\/font><\/strong>:<\/h1>\n<div align=\"justify\">  Dr. Nemeroff&#8217;s review article is published in a Supplement to the <em>Journal of Clinical Psychiatry<\/em>. That review contained a report of the study mentioned above:<\/div>\n<blockquote>\n<div align=\"center\"><a target=\"_blank\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/16336032\"><u><strong><font color=\"#200020\">Use of Atypical Antipsychotics in Refractory Depression and Anxiety<\/font><\/strong><\/u><\/a><font color=\"#200020\"><br \/>                                                             <sup>by <strong><font color=\"#990000\">Charles B. Nemeroff<\/font><\/strong>, M.D., Ph.D.<\/sup><br \/>                                                            <strong><font color=\"#200020\">Journal of Clinical Psychiatry<\/font><\/strong> 2005 66[suppl 8]:13&ndash;21.<br \/>                                                           [<u><strong><a target=\"_blank\" href=\"http:\/\/www.josephmatta.com\/Journal%20Club\/Week%205\/nemeroff%20atypical%20antipsychotics%20refractory%20depression%20%20%20%20%20%20%20anxiety.pdf\"><font color=\"#200020\">full text on-line<\/font><\/a><\/strong><\/u>]<\/font><\/div>\n<p>                                                <\/p>\n<div align=\"justify\"><sup>Treatment options for bipolar depression  and treatment-resistant unipolar depression include augmentation of  antidepressant therapy with a nonantidepressant drug, including atypical  antipsychotics. Risperidone is effective in combination with  fluvoxamine, paroxetine, or citalopram in treatment resistant unipolar  depression, with reported remission rates of 61% to 76%. Olanzapine in  combination with fluoxetine is safe and effective in patients with  bipolar depression and those with fluoxetine-resistant unipolar  depression. Ziprasidone and aripiprazole augmentation of various  selective serotonin reuptake inhibitors has been reported to be  effective in refractory unipolar depression in open-label studies. Data  on use of quetiapine or clozapine as augmentation therapy for depression  or anxiety are not yet available. Further double-blind,  placebo-controlled studies of augmentation of antidepressants with  atypical antipsychotics in refractory depression and anxiety are  justified based on the available literature.<\/sup><\/div>\n<\/blockquote>\n<h1><strong><font color=\"#660033\">June 2006<\/font><\/strong>:<\/h1>\n<div align=\"justify\">The study was published on-line in <em>Neuropsychopharmacology<\/em> by Mark Rapaport [Cedars-Sinai], Martin Keller [Brown], Charles Nemeroff [Emory], and nine Janssen employees. Dr. Nemeroff was the editor of the Journal at the time:                                  <\/div>\n<blockquote>\n<div align=\"center\"><a href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/16760927#\" target=\"_blank\"><u><strong><font color=\"200020\">Effects  of risperidone augmentation in patients with treatment-resistant  depression: Results of open-label treatment followed by double-blind  continuation<\/font><\/strong><\/u>.<\/a> <br \/>                                              <sup>by <strong><font color=\"#009900\">Rapaport MH<\/font><\/strong>, Gharabawi GM, Canuso CM, Mahmoud RA, <strong><font color=\"#009900\">Keller MB<\/font><\/strong>, Bossie CA, Turkoz I, Lasser RA, Loescher A, Bouhours P, Dunbar F, and <strong><font color=\"#990000\">Nemeroff CB<\/font><\/strong><\/sup><br \/>                                              <strong><font color=\"#200020\">Neuropsychopharmacology<\/font><\/strong>. 2006 31(11):2505-13.<br \/>                                           [<a href=\"http:\/\/www.nature.com\/npp\/journal\/v31\/n11\/full\/1301113a.html\" target=\"_blank\"><u><strong><font color=\"200020\">full text on-line<\/font><\/strong><\/u><\/a>]<\/div>\n<p>            <\/p>\n<div><strong><font color=\"200020\">Erratum<\/font><\/strong> in<\/div>\n<ul>\n<li>\n<div>Neuropsychopharmacology. 2007 May;32(5):1208.<\/div>\n<\/li>\n<li>\n<div>Neuropsychopharmacology. 2006 Nov;31(11):2514.<\/div>\n<\/li>\n<\/ul>\n<div><strong><font color=\"#200020\">Abstract<\/font><\/strong><\/div>\n<div align=\"justify\"><sup>Approximately  one-third of persons with depression do not respond to antidepressant  monotherapy. Studies suggest that atypical antipsychotic augmentation  may benefit these patients. We investigated the longer-term efficacy of  risperidone augmentation of serotonin-selective reuptake inhibitor  treatment for resistant depression. In 57 in- and outpatient centers in  three countries, we conducted a three-phase study with 4-6 weeks of  open-label citalopram monotherapy, 4-6 weeks of open-label risperidone  augmentation, and a 24-week double-blind, placebo-controlled  discontinuation phase. A total of 489 patients with major depressive  disorder and 1-3 documented treatment failures entered the citalopram  monotherapy phase (20-60 mg\/day). Patients with &lt;50% reduction in  HAM-D-17 scores entered the risperidone augmentation phase (0.25-2.0  mg\/day). Patients with HAM-D-17&lt; or =7 or CGI-S &lt; or = 2 were  randomized to risperidone or placebo augmentation. The primary outcome  was time to relapse during the double-blind phase. During citalopram  monotherapy, 434 patients had &lt;50% HAM-D-17 reduction; 299 (68.9%)  were fully nonresponsive (&lt;25% reduction) and 135 were partially  nonresponsive (25-49% reduction). Of the 386 nonresponders who entered  the augmentation phase, 243 remitted and 241 entered the double-blind  phase. Median time to relapse was 102 days with risperidone augmentation  and 85 days with placebo (NS); relapse rates were 53.3 and 54.6%,  respectively. In a post hoc analysis of patients fully nonresponsive to  citalopram monotherapy, median time to relapse was 97 days with  risperidone augmentation and 56 with placebo (p = 0.05); relapse rates  were 56.1 and 64.1%, respectively (p &lt; or = 0.05). Open-label  risperidone augmentation substantially enhanced response in  treatment-resistant patients, but the longer-term benefits of  augmentation were not demonstrated in this study.<\/sup><\/div>\n<p>                                            <\/p>\n<div><strong><font color=\"200020\">Comment<\/font><\/strong> in<\/div>\n<ul>\n<li><a href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/18033236\" target=\"_blank\"><strong><font color=\"200020\">Neuropsychopharmacology<\/font><\/strong>. <u>2008 33(10):2546-7<\/u><\/a>; author reply 2548.[<a target=\"_blank\" href=\"http:\/\/www.nature.com\/npp\/journal\/v33\/n10\/full\/1301613a.html\"><u><strong><font color=\"#200020\">full text on-line<\/font><\/strong><\/u><\/a>]                                        <\/li>\n<\/ul>\n<\/blockquote>\n<h1><strong><font color=\"#660033\">August 2006<\/font><\/strong>:<\/h1>\n<div align=\"justify\">At this point, one could insert another timeline and make this post reach all the way to the floor. The short version of this well known story is that in April 2006, Dr. Nemeroff et al had published a review article in <em>Neuropsychopharmacology<\/em> [on-line] about VNS therapy in depression with no acknowledgement that the authors were all Janssen employees or paid consultants, an article likely written by ghost-writer Sally Laden, in the Journal Nemeroff himself edited [<a href=\"http:\/\/www.nature.com\/npp\/journal\/v31\/n7\/full\/1301082a.html\" target=\"_blank\"><u><strong><font color=\"#200020\">VNS Therapy in Treatment-Resistant Depression: Clinical Evidence and Putative Neurobiological Mechanisms<\/font><\/strong><\/u><\/a>]. In the outrage that followed, Dr. Nemeroff resigned his editorship of <em>Neoropsychopharmacology<\/em> in August 2006 and was subsequently widely [but lightly] censured. This scandal takes up a sizable chunk of the Internet [<a target=\"_blank\" href=\"http:\/\/www.ahrp.org\/cms\/content\/view\/345\/55\/\"><u><strong><font color=\"#200020\">an example<\/font><\/strong><\/u><\/a>], and seems to me to be a nodal point in our awakening to how pervasive the corruption within academic psychiatry had become.<\/div>\n<h1><strong><font color=\"#660033\">November 2006<\/font><\/strong>:<\/h1>\n<div align=\"justify\">The paper above [Rapaport et al] did not have conflict of interest statements included in the on-line version. They were added as a <strong>Corrigendum<\/strong> in November 2006 [<strong><font color=\"#200020\">Neuropsychopharmacology<\/font><\/strong> 2006 <strong>31,<\/strong> 2514.] when the journal issue came out in print. All three [non-Janssen] authors had ties to Janssen Pharmaceutica. One can only conclude that this correction was a response to the then recent scandal involving Dr. Nemeroff&#8217;s earlier VNS review article.                        <\/div>\n<h1><strong><font color=\"#660033\">May 2007<\/font><\/strong>: <\/h1>\n<div align=\"justify\">Another <strong>Corrigendum<\/strong> was published [<strong><font color=\"#200020\">Neuropsychopharmacology<\/font><\/strong>. 2007 32(5):1208], apparently in response to reader complaints:<\/div>\n<ol>\n<div align=\"justify\"><sup>Following the publication of this article, the authors noted that in the  abstract and in the next to last paragraph of the results section, a <em>P<\/em>-value for part of one of the <em>post hoc<\/em> analyses was incorrectly reported. A significant <em>P<\/em>-value  was reported for both the difference in time to relapse and for relapse  rates in a subgroup of patients fully non-responsive to citalopram  monotherapy. Although the <em>P<\/em>-value for time to relapse was correctly reported, the correct <em>P<\/em>-value for the comparison of relapse rates is not significant [<em>P<\/em>=0.4;  CMH test]. This change does not alter the major findings of the study  nor any of the conclusions of the report. We appreciate the assistance  of a diligent reader in identifying this error.<\/sup><\/div>\n<\/ol>\n<h1><strong><font color=\"#660033\">November 2007<\/font><\/strong>:<\/h1>\n<div align=\"justify\">In November 2007, <em>Neuropsychopharmacology<\/em> published a letter from Dr. Bernard Carroll about the study above by Rapaport et al and the response by Dr. Mark Rapaport, the first author of that paper:<\/div>\n<ul>\n<li>\n<div><a target=\"_blank\" href=\"http:\/\/www.nature.com\/npp\/journal\/v33\/n10\/full\/1301613a.html\"><strong><font color=\"#200020\"><u>Neuropsychopharmacology<\/u>.<\/font><\/strong> <u>2008 <strong>33,<\/strong> 2546&ndash;2547<\/u><\/a>. [Carroll&#8217;s letter <a href=\"http:\/\/www.nature.com\/npp\/journal\/v33\/n10\/full\/1301613a.html\" target=\"_blank\"><u><strong><font color=\"#200020\">on-line<\/font><\/strong><\/u><\/a>]                      <\/div>\n<\/li>\n<li>\n<div><a target=\"_blank\" href=\"http:\/\/www.nature.com\/npp\/journal\/v33\/n10\/full\/1301614a.html\"><u><strong><font color=\"#200020\">Neuropsychopharmacology<\/font><\/strong><\/u><strong><font color=\"#200020\">.<\/font><\/strong> <u>2008 <strong>33,<\/strong> 2548<\/u><\/a>. [Rapaport&#8217;s response <a href=\"http:\/\/www.nature.com\/npp\/journal\/v33\/n10\/full\/1301614a.html\" target=\"_blank\"><u><strong><font color=\"#200020\">on-line<\/font><\/strong><\/u><\/a>]                      <\/div>\n<\/li>\n<\/ul>\n<div align=\"justify\">This exchange needs to be read in full. Dr. Carrol noted that the <strong>Corrigendum<\/strong> above only partially retracts the paper&#8217;s claims of the efficacy of Rispeidal augmentation and details his objections to what was not retracted. Dr. Rapaport responded essentially saying that the paper makes no claims of efficacy:                     <\/div>\n<ol>\n<div align=\"justify\"><sup>&nbsp;&nbsp;&quot;The paper repeatedly states in Abstract, Methods and in Discussion that  continuation of risperidone augmentation therapy was not more beneficial  than placebo, and hence the working hypothesis was disproven&#8230;.&quot;<\/sup><\/div>\n<div align=\"justify\">&nbsp;<sub>&quot;I would like to thank the reviewers and the editors of <em>Neuropsychopharmacology<\/em> for having the courage to allow us to publish this negative finding&#8230;.&quot;<\/sub><\/div>\n<\/ol>\n<h1><strong><font color=\"#660033\">January 2008<\/font><\/strong>:<\/h1>\n<div align=\"justify\">Dr. Carroll wrote his narrative of this story on the <em>Healthcare Renewal<\/em> blog [<a target=\"_blank\" href=\"http:\/\/hcrenewal.blogspot.com\/2008\/01\/antipsychotic-drugs-for-depression.html\"><u><strong><font color=\"#200020\">ANTIPSYCHOTIC DRUGS FOR DEPRESSION?<\/font><\/strong><\/u><\/a>] on January 16, 2008 &#8211; the main resource used for constructing this timeline. His conclusions couldn&#8217;t be clearer and I link his post <a target=\"_blank\" href=\"http:\/\/hcrenewal.blogspot.com\/2008\/01\/antipsychotic-drugs-for-depression.html\"><u><strong><font color=\"#200020\">here<\/font><\/strong><\/u><\/a>. As usual, he speaks best for himself.                 <\/div>\n<hr width=\"75%\" size=\"1\" \/>\n<p align=\"justify\">If you&#8217;ve made it this far, good for you. I&#8217;m sure I missed some spots along the way and just caught the high points in this tawdry Saga. And I know for many, this is old news, at least pieces of the story. But it&#8217;s time to put some action along with the story other than just the fact that this is obviously conduct unbecoming scientists, physicians, responsible medical industries.<\/p>\n<p align=\"justify\">After the initial review in the 2005 article which says, &quot;<strong><font color=\"#660033\">Risperidone augmentation resulted in symptomatic remission in a  substantial number of patients with chronic resistant depression who  were nonresponsive to standard antidepressant therapy<\/font><\/strong>,&quot; everything else that I&#8217;ve listed here happened in the pages of the <em>Neuropsychopharmacology<\/em>, the Journal of the <a target=\"_blank\" href=\"http:\/\/www.google.com\/search?q=American+College+of+Neuropharmacology&#038;ie=utf-8&#038;oe=utf-8&#038;aq=t&#038;rls=org.mozilla:en-US:official&#038;client=firefox-a\"><u><strong>American College of Neuropharmacology<\/strong><\/u><\/a> for the next two and a half years until Carroll&#8217;s blog post. That journal is very important to the few neuroscientists that read it, but is hardly on the news-stands or even available to most practicing psychiatrists. Likewise, <em>Healthcare Renewal<\/em> isn&#8217;t exactly daily reading for practitioners. Yet the message about augmenting antidepressants with atypical antipsychotics traveled far and wide, quoted extensively. It&#8217;s still traveling. So, although this is a fine example of a few people&#8217;s persistence in finally debunking a negative and misrepresented study, the desired impact was still profound and came at a lucrative time in Risperdal&#8217;s life cycle [when it was still in patent]. In other words, the gambit worked.<\/p>\n<p align=\"justify\">And on the subject of articles being ghostwritten by people under contract to pharmaceutical companies, this study is a prime candidate. The trial itself was conducted by Janssen, not directed by any non-company investigator. Of the three authors, Nemeroff had a long-time association with ghost-writer Sally Laden at <em>Scientific Therapeutics Information<\/em> both through GSK and Cyberonics as had Martin Keller through GSK. Their &quot;guest authorship&quot; is legend. We know from the Rothman Report filed by an investigator with access to primary discovery documents that <em>Excerptia Medica<\/em>, a medical ghost-writing firm around the corner from Janssen, was churning out articles favorable to Risperdal and soliciting authors during this period. We know that Dr, Nemeroff was editor of <em>Neuropsychopharmacology <\/em>and had used it as a conduit for promoting Cyberonics and apparently Janssen, companies with which he was financially involved. There&#8217;s a hell of a lot more evidence of criminal misbehavior on this page than evidence that Risperdal helps depressed people. And yet the gambit worked.<\/p>\n<div><strong><font color=\"#200020\">Racketeering<\/font><\/strong>. It is what it is&#8230; <\/div>\n","protected":false},"excerpt":{"rendered":"<p>In a recent post, I referenced one of Dr. Nemeroff&#8217;s review articles, guessing that it was ghostwritten during Janssen&#8217;s mid-decade literature Blitzkrieg for Risperdal. As it turns out, this was just one boxcar on a very long train. December 2004: Charles Nemeroff [Emory], Mark Rapaport [Cedars-Sinai], and six Janssen authors presented this Risperdal augmentation in [&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-13384","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/13384","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=13384"}],"version-history":[{"count":72,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/13384\/revisions"}],"predecessor-version":[{"id":13455,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/13384\/revisions\/13455"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=13384"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=13384"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=13384"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}