{"id":30771,"date":"2012-12-06T18:54:33","date_gmt":"2012-12-06T23:54:33","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=30771"},"modified":"2012-12-06T19:53:03","modified_gmt":"2012-12-07T00:53:03","slug":"paxil-study-352-and-329-where-are-the-grown-ups","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2012\/12\/06\/paxil-study-352-and-329-where-are-the-grown-ups\/","title":{"rendered":"paxil study 352 [and 329]: where are the grown-ups?&#8230;"},"content":{"rendered":"\n<ul><sup> <\/p>\n<li><a href=\"http:\/\/1boringoldman.com\/index.php\/2011\/07\/13\/go-pogo\/\" target=\"_blank\">go             pogo&hellip;<\/a><\/li>\n<li><a href=\"http:\/\/1boringoldman.com\/index.php\/2012\/03\/01\/closer-to-becoming-indelible\/\" target=\"_blank\">closer             to becoming indelible&hellip;<\/a><\/li>\n<li><a href=\"http:\/\/1boringoldman.com\/index.php\/2012\/11\/22\/back-on-the-front-burner\/\" target=\"_blank\">back on the front burner&hellip; <\/a><\/li>\n<li><a href=\"http:\/\/1boringoldman.com\/index.php\/2012\/11\/25\/paxil-study-352-revisited\/\" target=\"_blank\">paxil study 352 revisited&hellip; <\/a><\/li>\n<li><a href=\"http:\/\/1boringoldman.com\/index.php\/2012\/11\/27\/paxil-study-352-whats-ghost-writing\/\" target=\"_blank\">paxil study 352 &ndash; what&rsquo;s ghost-writing? <\/a><\/li>\n<li><font color=\"#200020\"><a href=\"http:\/\/1boringoldman.com\/index.php\/2012\/11\/29\/paxil-study-352-more-about-ghost-writing\/\" target=\"_blank\">paxil study 352 &ndash; more about ghost-writing&hellip;             <\/a><\/font><\/li>\n<li><a href=\"http:\/\/1boringoldman.com\/index.php\/2012\/12\/05\/paxil-study-352-plausible-deniability\/\" target=\"_blank\">paxil study 352: plausible deniability&hellip; <\/a><\/li>\n<li><a href=\"http:\/\/1boringoldman.com\/index.php\/2012\/12\/05\/paxil-study-352-plausible-deniability\/#comment-232662\" target=\"_blank\">comment<\/a><\/li>\n<p> <\/sup><\/ul>\n<p align=\"center\"><sup><strong><font color=\"#200020\">[Click on the graphics below to link to the full text of the letters]<\/font><\/strong><\/sup><\/p>\n<p align=\"center\"><a target=\"_blank\" href=\"http:\/\/freepdfhosting.com\/33af4ef04b.pdf\"><img loading=\"lazy\" decoding=\"async\" width=\"405\" height=\"504\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/ori-1.gif\" \/><\/a><\/p>\n<p align=\"justify\">A year ago, the Office of Research Integrity [ORI] at NIH\/HHS turned down Healthy Skepticism&#8217;s request that they review <strong><font color=\"#200020\">Paxil Study 329<\/font><\/strong>. They gave several reasons &#8211; a six year statute of limitations, a lack of authority to request a retraction, and the concern that the age of the study would mean that they couldn&#8217;t do a fair investigation. While the statute of limitations seems reasonable, the notion of missing data seems ill informed. There are enough documents scattered around the Internet from previous legal discovery to more than prove the allegations.<\/p>\n<p align=\"justify\">Last Summer, Dr. Jay Amsterdam [author of <a href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/23135337\" target=\"_blank\">The paroxetine 352 bipolar trial: A study in medical ghostwriting<\/a>] filed a similar complaint with the ORI about <strong><font color=\"#200020\">Paxil Study 352<\/font><\/strong>.<\/p>\n<p align=\"center\"><a target=\"_blank\" href=\"http:\/\/www.google.com\/url?sa=t&#038;rct=j&#038;q=&#038;esrc=s&#038;source=web&#038;cd=2&#038;ved=0CDwQFjAB&#038;url=http%3A%2F%2Ffreepdfhosting.com%2Faee290a770.pdf&#038;ei=oK_AUJfHD4689gSeoYHwCw&#038;usg=AFQjCNGs1OVp-aps7ircHPqHLZC_0GoVEg&#038;sig2=DR0i-AKeg8JAvWQK9sI-eg&#038;cad=rja\"><img loading=\"lazy\" decoding=\"async\" width=\"405\" height=\"504\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/ori-2.gif\" \/><\/a><\/p>\n<div align=\"justify\">Apparently, the 6 year deadline is from the last significant citing of the work and this Study is still being cited. Further, Paxil Study 352 lists part of its funding from the NIMH:<\/div>\n<blockquote>\n<div align=\"justify\"><sup><strong>Supported by NIMH grant MH-51761 and a grant from GlaxoSmithKline.<\/strong><\/sup><\/div>\n<\/blockquote>\n<div align=\"justify\">In response to this complaint, the University of Pennsylvania initiated its own investigation which reached a bizarre conclusion:<\/div>\n<blockquote>\n<div align=\"center\"><a href=\"http:\/\/chronicle.com\/article\/U-of-Pennsylvania-Absolves\/130977\/?key=S2gmKVdvaXJIbH9jMmpCMGkAOHxvNRokN3RIb3l2bl1WFQ%3D%3D\" target=\"_blank\"><u><strong><font color=\"#200020\">U. of Pennsylvania Absolves Psychiatry Chairman of Ghostwriting Complaint<\/font><\/strong><\/u><\/a><br \/>                              <strong><font color=\"#200020\">Chronicles of Higher Education<\/font><\/strong><br \/>                              by Paul Basken<br \/>                              February 29, 2012<\/div>\n<p>          <\/p>\n<div align=\"justify\"><strong><sup>The University of Pennsylvania has  concluded that the chairman of its psychiatry department and a colleague  let their names be listed among the authors reviewing a medicine in a  journal article that was actually written by the drug&rsquo;s manufacturer.  The university, however, has decided to take no punitive action against  the chairman, Dwight L. Evans, and an associate professor of psychiatry,  Laszlo Gyulai, for the 2001 article in <em>The American Journal of Psychiatry.<\/em> Penn noted&hellip;<\/sup><\/strong><\/div>\n<\/blockquote>\n<blockquote>\n<div align=\"center\"><strong><u><a target=\"_blank\" href=\"http:\/\/www.pharmalot.com\/2012\/03\/upenn-looks-the-other-way-at-ghostwriting\/\"><font color=\"#200020\">UPenn Looks The Other Way At Ghostwriting<\/font><\/a><\/u><\/strong><br \/>                     <strong><font color=\"#004400\">Pharmalot<\/font><\/strong><br \/>                                           By Ed Silverman<br \/>                     March 1st, 2012<\/div>\n<p align=\"justify\"><sup><strong>The  University of Pennsylvania has denied  allegations made by one of its  professors that several other academics  &ndash; including his department chair  &ndash; allowed their names to be added to a  medical journal manuscript, but  gave control of the contents to  GlaxoSmithKline, according to his  attorney. The study, which was funded  by the drugmaker and the National  Institutes of Health, looked at the  impact of the Paxil antidepressant  on patients with bipolar disorder.<\/strong><\/sup><\/p>\n<p align=\"justify\"><sup><strong>At the same time, the university has acknowledged a claim by  the  professor, Jay Amsterdam, that the 2001 study was ghostwritten by   Scientific Therapeutics Information, his attorney tells us. However, he   says the university is not planning on taking any action in connection   with the ghostwriting. The study, which was published by the American   Journal of Psychiatry [<u><strong><font color=\"#200020\"><a target=\"_blank\" href=\"http:\/\/ajp.psychiatryonline.org\/article.aspx?Volume=158&#038;page=906&#038;journalID=13\">see here<\/a><\/font><\/strong><\/u>], did not mention that STI played any role [here is an <u><strong><a target=\"_blank\" href=\"http:\/\/freepdfhosting.com\/8d006887f2.pdf\">email<\/a><\/strong><\/u> in which STI employee Sally Laden discusses that she would work on the paper].<\/strong><\/sup><\/p>\n<div align=\"justify\"><sup><strong>&ldquo;They said his allegations were not meritorius, although  they did  find that the publication at issue was ghostwritten,&rdquo; says  Bijan  Esfandiari, the attorney, citing a letter and other documents he   received from the university. &ldquo;They acknowledged that a marketing firm   was involved in drafting, and everything associated with, the issue.  But  in response to our complaint, they said that, at the time these  events  took place, which was between 1998 and 2001, ghostwriting was  standard  practice and everyone was doing this, so therefore, we&rsquo;re not  going to  punish any individuals&rdquo;&hellip; <\/strong><\/sup><\/div>\n<\/blockquote>\n<div align=\"justify\">More outrage came from&nbsp;<a href=\"http:\/\/pogoblog.typepad.com\/pogo\/2011\/07\/amy-gutmann-do-the-right-thing-by-president-obama-be-a-leaderand-resign.html\" target=\"_blank\">POGO<\/a>, and even right <a href=\"http:\/\/1boringoldman.com\/index.php\/2011\/07\/13\/go-pogo\/\" target=\"_blank\">here<\/a>, but none so detailed as that of Dr. Amsterdam&rsquo;s Attorney in a follow-up 24 page letter to the ORI on <a href=\"http:\/\/blogs.nature.com\/news\/files\/2012\/06\/Jay-Amsterdam-today-filed-a-24-page-complaint-with-the-Office-of-Research-Integrity-at-the-US-National-Institutes-of-Health.pdf\" target=\"_self\">June 25, 2012<\/a>:<\/div>\n<p align=\"center\"><a href=\"http:\/\/blogs.nature.com\/news\/files\/2012\/06\/Jay-Amsterdam-today-filed-a-24-page-complaint-with-the-Office-of-Research-Integrity-at-the-US-National-Institutes-of-Health.pdf\" target=\"_blank\"><img loading=\"lazy\" decoding=\"async\" width=\"405\" height=\"504\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/ori-3.gif\" \/><\/a><\/p>\n<p align=\"justify\">The <a href=\"http:\/\/www.ori.dhhs.gov\/\" target=\"_blank\">Office of Research Integrity<\/a> in the <strong><font color=\"#200020\">National Institute of Health<\/font><\/strong> is the agency responsible for monitoring research conduct. Like any governmental agency, its <a href=\"http:\/\/www.ori.dhhs.gov\/historical-background\" target=\"_blank\">history<\/a> is complicated and over my head. I don&#8217;t know if the fact that Paxil Study 329 was not government funded had something to do with the ORI not initiating a full investigation. Paxil Study 352 did list NIMH funding in the article [along with GSK sponsorship]. The Grant [<a href=\"http:\/\/projectreporter.nih.gov\/project_info_description.cfm?aid=2251142&#038;icde=14631404\" target=\"_blank\">MH-51761<\/a>] lists Dr. Nemeroff as the Principle Investigator.<\/p>\n<p align=\"justify\">The hardest thing for those of us on the outside to understand is how the rampant research misconduct in psychiatry spanning several decades involving highly placed academicians and pharmaceutical companies in alliance can have gone on without someone lowering the boom on it. The civil suits and DOJ investigations have increased recently, but the HHS\/NIH\/NIMH\/ORI haven&#8217;t been a big players. It feels like there&#8217;s something very wrong, at the level of the SEC overlooking the Madoff Ponzi Scheme. My reading of the University of Pennsylvania&#8217;s response is that they acted as if the Paxil Study 352 issue was an authorship squabble and skipped really looking into the scientific misbehavior involved. That&#8217;s one of the reasons I spent so much time going over it. There is a squabble, sure enough, but it sits on top of a great big cesspool of the opposite of <strong><font color=\"#200020\">Research Integrity<\/font><\/strong>.<\/p>\n<div align=\"justify\">And as for authors, my sense is that Paxil Study 352 was so written by GSK [and STI] that it really had no academic authors at all. If the <strong><font color=\"#200020\">Office of Research Integrity<\/font><\/strong> really lives up to its name, this study is a prime candidate for their attention [as was Paxil Study 329 for that matter]. And I still can&#8217;t accept Dr. Dahlberg&#8217;s comment:<\/div>\n<ul>\n<div align=\"justify\"><sup><strong>&quot;&#8230; given the significant lapse of time between the time the study was conducted and concerns raised, the liklihood of being able to conduct a fair and objective review, given the inevitable difficulty in locating records and relying on memories of events well over ten years ago, seems remote.&quot;<\/strong><\/sup><\/div>\n<\/ul>\n<div align=\"justify\">Don&#8217;t they have Google at the <strong><font color=\"#200020\">Office of Research Integrity<\/font><\/strong>? Call Jon Juriedini of Healthy Skepticism in Australia, or Bob Fiddaman in New Zealand, or David Healy in Wales, or Allison Bass in West Virginia, or even me here in Rural Georgia, or any number of others who haven&#8217;t had any trouble at all finding the incriminating documents on either one of these studies, thanks to the raft of suits that have unearthed them. We&#8217;ll send you the links &#8211; annotated if you like. Imagine what an investigation with actual power could find! Both of these and many other industry sponsored Clinical Trials are exactly what the <strong><font color=\"#200020\">Office of Research Integrity <\/font><\/strong>was established to investigate. And in this case, Dr. Nemeroff charged it off on the NIMH nickle &#8211; so it&#8217;s  solidly in ORI&#8217;s domain. Instead of worrying about bad memory, go ahead and investigate. If there&#8217;s not enough information, then say the investigation was not doable. But don&#8217;t say it up front. The amount of uninvestigated research misconduct in the Clinical Trials in psychiatry in the recent decades would fill a significant section of the Library of Congress, and has many of us wondering &quot;<strong><font color=\"#200020\">where are the grown-ups?<\/font><\/strong>&quot; That&#8217;s what the <strong><font color=\"#200020\">Office of Research Integrity <\/font><\/strong>is supposed to be&#8230;<\/div>\n","protected":false},"excerpt":{"rendered":"<p>go pogo&hellip; closer to becoming indelible&hellip; back on the front burner&hellip; paxil study 352 revisited&hellip; paxil study 352 &ndash; what&rsquo;s ghost-writing? paxil study 352 &ndash; more about ghost-writing&hellip; paxil study 352: plausible deniability&hellip; comment [Click on the graphics below to link to the full text of the letters] A year ago, the Office of Research [&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-30771","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/30771","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=30771"}],"version-history":[{"count":31,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/30771\/revisions"}],"predecessor-version":[{"id":30802,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/30771\/revisions\/30802"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=30771"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=30771"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=30771"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}