{"id":11635,"date":"2011-08-06T02:46:06","date_gmt":"2011-08-06T06:46:06","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=11635"},"modified":"2011-08-06T07:53:32","modified_gmt":"2011-08-06T11:53:32","slug":"no-leg-to-stand-on","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2011\/08\/06\/no-leg-to-stand-on\/","title":{"rendered":"no leg to stand on&#8230;"},"content":{"rendered":"<div align=\"justify\">So I get home from a three week trip to Hawaii and fire up my real computer. There are two Google Alerts from today blinking at the top of my email list:        <\/div>\n<blockquote>\n<div align=\"center\"><u><strong><a target=\"_blank\" href=\"http:\/\/blogs.plos.org\/speakingofmedicine\/2011\/08\/05\/ghostwriting-%e2%80%93-how-does-academic-medicine-justify-it\/\"><font color=\"#200020\">Ghostwriting &ndash; how does academic medicine justify it?<\/font><\/a><\/strong><\/u><br \/>               <strong><font color=\"#200020\">Speaking of Medicine [PLOS Blog] <\/font><\/strong><br \/>                by Jocalyn Clark<br \/>               August 5th, 2011<\/div>\n<p align=\"justify\"><sup>We&rsquo;re always interested at <em>PLoS Medicine<\/em> in different perspectives on the ghostwriting problem. Following <u><strong><a href=\"http:\/\/www.google.com\/search?aq=f&#038;hl=en&#038;gl=us&#038;tbm=nws&#038;btnmeta_news_search=1&#038;q=plos+medicine+ghostwriting\" target=\"_blank\">considerable news coverage<\/a><\/strong><\/u> of our recent Stern and Lemmens paper on<u> <strong><a href=\"http:\/\/blogs.plos.org\/speakingofmedicine\/2011\/08\/05\/2011\/08\/02\/doctor-ghostwriting-fraud\/\" target=\"_blank\">legal liability for ghostwriting<\/a><\/strong><\/u>, another article, this one by Jonathan Leo and colleagues (who have previously written for us on the <u><strong><a href=\"http:\/\/www.plosmedicine.org\/article\/info:doi%2F10.1371%2Fjournal.pmed.1000230\" target=\"_blank\">lack of ghostwriting policies in major US medical schools<\/a><\/strong>)<\/u>, has appeared in <em>Society<\/em>. In it they offer some explanations for why <u><strong><a href=\"http:\/\/www.springerlink.com\/content\/9lm84u2110821211\/fulltext.pdf\" target=\"_blank\">ghostwriting is &ldquo;allowed&rdquo; in academic medicine<\/a><\/strong><\/u>.<\/sup><\/p>\n<p align=\"justify\"><sup>The parts I found most intriguing were their examples of how academic  medicine is complicit. We all know that in the &ldquo;publish or perish&rdquo;  environment of medical academia publications are <em>currency<\/em>, which must help explain why many academic guest authors receive no monetary payment at all for their <u><strong><a href=\"http:\/\/thestar.blogs.com\/ethics\/2009\/08\/ghostwriting-why-they-do-it.html\" target=\"_blank\">unethical and dishonest collusion with pharma<\/a><\/strong><\/u> that allows them to take (academic) credit for papers they didn&rsquo;t write. But don&rsquo;t institutions expect their faculty and members to publish ethically and in the best interest of patients?<\/sup><\/p>\n<p align=\"justify\"><sup>Apparently not. One particular example cited by Leo and colleagues,  involving the widely-prescribed Paxil (paroxetine; an SSRI  antidepressant), jumped out at me: they describe allegations that an  American Psychiatric Press (APP) textbook called &ldquo;Recognition and  Treatment of Psychiatric Disorders,&rdquo; ostensibly authored by leading  psychiatrists Charles Nemeroff and Alan Schatzberg, was actually  ghostwritten by writers employed by the manufacturer of Paxil,  GlaxoSmithKline, who paid the writing firm US$120,000. &nbsp;An earlier draft  of the text written by the paid medical writers is on the website of  the US-based<strong> <u><a href=\"http:\/\/pogoblog.typepad.com\/pogo\/gw-attachment-d.html\" target=\"_blank\">Project on Government Oversight<\/a><\/u><\/strong>.<\/sup><\/p>\n<p align=\"justify\"><sup>What&rsquo;s astonishing is not that the institutions and publishers deny  the involvement of GSK-paid ghostwriters (they don&rsquo;t), but that <em>they accept and justify the ghostwriting<\/em>  because the authors &ldquo;signed off on the final copy.&rdquo; Leo and colleagues  quote James Scully, Medical Director for the American Psychiatric  Association: &ldquo;The book was reviewed for any potential bias (among other  things) by eight independent reviewers, and there was no undue influence  on the content from industry or any other outside source.&rdquo; The  psychiatrist Daniel Carlat, in his <u><strong><a href=\"http:\/\/carlatpsychiatry.blogspot.com\/2010\/12\/nemeroff-and-schatzbergs-textbook.html\" target=\"_blank\">New York Times blog<\/a><\/strong><\/u> last year, on the other hand, called the textbook &ldquo;<em>an advertisement for Paxil<\/em>.&rdquo;<\/sup><\/p>\n<div align=\"justify\"><sup>That medical academia finds these types of arrangements acceptable  is, I think, at the heart of the problem of ghostwriting. But for anyone  who has been a student or trainee in medical academia\u00e2\u201d\u20acsubject to strict  codes of conduct prohibiting plagiarism etc. \u00e2\u201d\u20ac this apparent  double-standard will strike as more than a little ironic. Clearly we  need to address this hypocrisy. I love the analogy Leo and colleagues  draw, so I quote from their article directly:<\/sup><\/div>\n<ul>\n<div align=\"justify\"><sup><em>A college professor determines one of his graduate  students handed in a paper largely written by someone else. After being  confronted, the student acknowledges that indeed someone else wrote the  paper. The student then says, &ldquo;I approved the final copy, and had eight  classmates look over the paper and they all vouch for its unbiased  conclusions.&rdquo;<\/em><\/sup>              <\/div>\n<\/ul>\n<\/blockquote>\n<blockquote>\n<div align=\"center\"><a href=\"http:\/\/pogoblog.typepad.com\/pogo\/2011\/08\/nihs-plan-for-public-disclosure-is-getting-help-from-senator-grassley.html\" target=\"_blank\"><u><strong><font color=\"#200020\">NIH&#8217;s Plan for Public Disclosure Is Getting Help from Senator Grassley<\/font><\/strong><\/u><\/a><br \/>           <strong><font color=\"#200020\">PROJECT ON GOVERNMENT OVERSIGHT [Blog]<\/font><\/strong><br \/>           By NED FEDER<br \/>           August 5th, 2011 <\/div>\n<p>          <\/p>\n<div align=\"justify\"><sup>One  of the best of our government agencies, the National Institutes  of  Health (NIH), is getting some well-deserved help from Senator Chuck  Grassley (R-IA). In  recent years, Senator Grassley exposed several academic  physicians for  taking large amounts of money from companies with a  direct financial  interest in their research, some of it funded by the  NIH. The list  reads like a who&rsquo;s who in academic research:<\/sup><\/div>\n<ul>\n<li>\n<div align=\"justify\"><sup>Dr. Charlie Nemeroff, former Chair of the Psychiatry Department at Emory University, who <u><strong><a target=\"_blank\" href=\"http:\/\/www.nytimes.com\/2008\/10\/04\/health\/policy\/04drug.html?fta=y&#038;pagewanted=all\">failed to report hundreds of thousands of dollars in payments<\/a><\/strong><\/u>  from GlaxoSmithKline while researching that same company&rsquo;s drugs with   an NIH grant. &nbsp;Dr. Nemeroff was bounced from Emory and has now taken   over the Chair of Psychiatry at the University of Miami.<\/sup><\/div>\n<\/li>\n<li>\n<div align=\"justify\"><sup>Dr. Alan Schatzberg, former Chair of the Psychiatry Department at Stanford University <strong><u><a target=\"_blank\" href=\"http:\/\/www.pharmalot.com\/2008\/06\/senate-targets-stanford-psychiatrist-over-conflicts\/\">received an NIH grant to study a drug<\/a><\/u>  <\/strong>while partially owning a company that was seeking FDA approval of said   drug. An NIH oversight group recommended that Stanford&rsquo;s clinical trial   on mifepristone be &ldquo;<u><a target=\"_blank\" href=\"http:\/\/pogoblog.typepad.com\/pogo\/2011\/01\/the-ugly-underbelly-of-medical-research.html\"><strong>terminated immediately and permanently<\/strong><\/a><\/u>.&rdquo; &nbsp;The recommendation was made because of concerns over conflicts of interest, patient safety and other issues.<\/sup><\/div>\n<\/li>\n<li>\n<div align=\"justify\"><sup>Dr. Joseph Biederman and two other researchers at Harvard University <u><strong><a target=\"_blank\" href=\"http:\/\/www.nytimes.com\/2008\/06\/08\/us\/08conflict.html\">failed to report<\/a><\/strong><\/u> almost a million dollars each in outside income while heading up several NIH grants. Harvard later <u><strong><a target=\"_blank\" href=\"http:\/\/www.pharmalot.com\/2011\/07\/harvard-docs-disciplined-for-conflicts-of-interest\/\">disciplined the three physicians<\/a><\/strong><\/u>.<\/sup><\/div>\n<\/li>\n<\/ul>\n<div align=\"justify\"><sup>A government requirement for public disclosure would obviously make  these  secret payments more difficult &ndash; and that&rsquo;s just what the NIH is  trying  to do. A new regulation proposed by the Department of Health and  Human  Services would deal with investigators&rsquo; financial arrangements  by  requiring these arrangements to be disclosed on a publicly  accessible  website&nbsp;if those arrangements created a conflict of  interest. Good step by the NIH! But, as reported by <u><a target=\"_blank\" href=\"http:\/\/www.nature.com\/news\/2011\/110801\/full\/476017a.html\">M<strong>eredith Wadman of the journal Nature<\/strong><\/a><\/u>,   the NIH&rsquo;s new regulation is being blocked by the Office of Management   and Budget (OMB), discrediting the Obama administration&rsquo;s boast about a   new era of transparency in the federal government. Senator Grassley <u><strong><a target=\"_blank\" href=\"http:\/\/grassley.senate.gov\/about\/upload\/2011-08-04-CEG-to-OMB.pdf\">wrote<\/a><\/strong><\/u> yesterday to Jacob Lew, the OMB director, that he was concerned by this story:<\/sup><\/div>\n<ul>\n<div align=\"justify\"><sup>I am troubled that taxpayers cannot learn about the outside  income of the  researchers whom the taxpayers are funding, and this  flies in the face  of President Obama&rsquo;s call for more transparency in  the government. The  public&rsquo;s business should be public&#8230;. I urge OMB  to follow through and  approve a rule that includes a publicly available  website.<\/sup><\/div>\n<\/ul>\n<div align=\"justify\"><sup>In  his letter, Senator Grassley requested all records related to the  OMB&rsquo;s  weakening of the proposed conflict-of-interest rule. He also  asked to  see all calendar meetings for Administrator Cass Sunstein, OMB  Office of  Information and Regulatory Affairs, from May 1, 2010, to the  present.<\/sup><sup> &ldquo;Transparency  is a backstop against research that&#8217;s compromised by  doctors&#8217;  self-interest, to the detriment of consumers,&rdquo; Grassley <u><strong><a target=\"_blank\" href=\"http:\/\/grassley.senate.gov\/news\/Article.cfm?customel_dataPageID_1502=36314\">said in a statement<\/a><\/strong><\/u>.<strong> <u><a target=\"_blank\" href=\"http:\/\/www.pogo.org\/pogo-files\/letters\/public-health\/ph-iis-20110711-1.html\">In a letter three weeks ago<\/a><\/u><\/strong>,   POGO pressed OMB Director Lew to drop his agency&rsquo;s resistance to the   proposed new requirement for public disclosure. POGO is meeting in a few   days with some of those in OMB who are working on this rule. We&rsquo;ll be sure to inform readers of this blog post what happens.<\/sup><\/div>\n<\/blockquote>\n<div align=\"justify\">Tomorrow, I have three things on my agenda: Pick up my dogs from the Kennel; Pick up my new Jeep [to replace my truck that was stolen the night before we left on the trip]; and then read every link in each of these articles from <strong>PLoS<\/strong> and <strong>POGO<\/strong>. While I was gone, I read and reread Dr. Marcia Angell&#8217;s two articles in the New York Review of books, and the letters in response:<\/div>\n<ul>\n<li>\n<div align=\"justify\"><a href=\"http:\/\/www.nybooks.com\/articles\/archives\/2011\/jun\/23\/epidemic-mental-illness-why\/\" target=\"_blank\"><u><strong><font color=\"#200020\">The Epidemic of Mental Illness: Why?<\/font><\/strong><\/u><\/a><\/div>\n<\/li>\n<li>\n<div align=\"justify\"><a href=\"http:\/\/www.nybooks.com\/articles\/archives\/2011\/jul\/14\/illusions-of-psychiatry\/\" target=\"_blank\"><u><strong><font color=\"#200020\">The Illusions of Psychiatry<\/font><\/strong><\/u><\/a><\/div>\n<\/li>\n<li>\n<div align=\"justify\"><u><strong><a href=\"http:\/\/www.nybooks.com\/articles\/archives\/2011\/aug\/18\/illusions-psychiatry-exchange\/\" target=\"_blank\"><font color=\"200020\">&lsquo;The Illusions of Psychiatry&rsquo;: An Exchange<\/font><\/a><\/strong><\/u><\/div>\n<\/li>\n<\/ul>\n<div align=\"justify\">Dr. Angell writes a stinging indictment of Psychiatry and the modern turn to psychopharmacology. She sees psychiatry as way off base right now. In <font><strong><a href=\"http:\/\/www.nybooks.com\/articles\/archives\/2011\/aug\/18\/illusions-psychiatry-exchange\/\" target=\"_blank\"><font color=\"200020\">&lsquo;The Illusions of Psychiatry&rsquo;: An Exchange<\/font><\/a><\/strong><\/font>, several prominent Psychiatrists acknowledge the problems, but go on to defend the specialty and its current directions. I think that&#8217;s a mistake. While I agree that some of the anti-medication current in many recent writings may go too far, in my opinion, it&#8217;s not the place of psychiatrists to defend anything right now. That&#8217;s for later, if and when we&#8217;ve restored some credibility to our scientific processes and literature, when our evidence is based on genuine science. Right now, right-thinking psychiatrists need to focus on clearing out the forces among us that have made our specialty a target of mockery. Dr. Angello ends her second installment with:<\/div>\n<ul>\n<div align=\"justify\"><sup>The books by Irving Kirsch, Robert Whitaker, and  Daniel Carlat are powerful indictments of the way psychiatry is now  practiced. They document the &ldquo;frenzy&rdquo; of diagnosis, the overuse of drugs  with sometimes devastating side effects, and widespread conflicts of  interest. Critics of these books might argue, as Nancy Andreasen implied  in her paper on the loss of brain tissue with long-term antipsychotic  treatment, that the side effects are the price that must be paid to  relieve the suffering caused by mental illness. If we knew that the  benefits of psychoactive drugs outweighed their harms, that would be a  strong argument, since there is no doubt that many people suffer  grievously from mental illness. But as Kirsch, Whitaker, and Carlat  argue convincingly, that expectation may be wrong.<\/sup><\/div>\n<p align=\"justify\"><sup>At the very  least, we need to stop thinking of psychoactive drugs as the best, and  often the only, treatment for mental illness or emotional distress. Both  psychotherapy and exercise have been shown to be as effective as drugs  for depression, and their effects are longer-lasting, but unfortunately,  there is no industry to push these alternatives and Americans have come  to believe that pills must be more potent. More research is needed to  study alternatives to psychoactive drugs, and the results should be  included in medical education.<\/sup><\/p>\n<div align=\"justify\"><sup>In particular, we need to rethink  the care of troubled children. Here the problem is often troubled  families in troubled circumstances. Treatment directed at these  environmental conditions&mdash;such as one-on-one tutoring to help parents  cope or after-school centers for the children&mdash;should be studied and  compared with drug treatment. In the long run, such alternatives would  probably be less expensive. Our reliance on psychoactive drugs,  seemingly for all of life&rsquo;s discontents, tends to close off other  options. In view of the risks and questionable long-term effectiveness  of drugs, we need to do better. Above all, we should remember the  time-honored medical dictum: first, do no harm (<em>primum non nocere<\/em>). <br \/> <\/sup><\/div>\n<\/ul>\n<div align=\"justify\">Who wants to argue with that? Not me. I&#8217;d rather join forces with the efforts in those first two pieces [<strong>PLoS<\/strong> and <strong>POGO<\/strong>]&nbsp; to end ghostwriting and insist on transparency in our scientific literature. With the likes of Nemeroff, Schatzberg, Biederman, and many others prominently in our midst, we haven&#8217;t got a leg to stand on in defense of anything&#8230;<\/div>\n<div align=\"center\"><img decoding=\"async\" border=\"1\" width=\"150\" vspace=\"5\" src=\"http:\/\/blogs.cornell.edu\/theessentials\/files\/2008\/06\/faunagreatblueheron2-1.jpg\" \/>&nbsp;<\/div>\n","protected":false},"excerpt":{"rendered":"<p>So I get home from a three week trip to Hawaii and fire up my real computer. There are two Google Alerts from today blinking at the top of my email list: Ghostwriting &ndash; how does academic medicine justify it? Speaking of Medicine [PLOS Blog] by Jocalyn Clark August 5th, 2011 We&rsquo;re always interested at [&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-11635","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/11635","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=11635"}],"version-history":[{"count":18,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/11635\/revisions"}],"predecessor-version":[{"id":11653,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/11635\/revisions\/11653"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=11635"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=11635"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=11635"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}