{"id":68472,"date":"2016-10-09T14:12:01","date_gmt":"2016-10-09T18:12:01","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=68472"},"modified":"2016-10-10T14:58:37","modified_gmt":"2016-10-10T18:58:37","slug":"devolution-i","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2016\/10\/09\/devolution-i\/","title":{"rendered":"devolution I&#8230;"},"content":{"rendered":"<div class=\"small\" align=\"justify\">In his recent <strong><font color=\"#0066ff\">BMJ<\/font><\/strong> article [<em><strong><font color=\"#200020\">30 August 2016<\/font><\/strong><\/em> &#8211; <a href=\"http:\/\/www.bmj.com\/content\/354\/bmj.i4578\" target=\"_blank\">Ghostwriting: the importance of definition and its place in contemporary drug marketing<\/a>], <font color=\"#200020\">Alastair Matheson<\/font> describes how <strong><font color=\"#200020\">industry is trying to claim that a hired medical writer isn&#8217;t a &quot;<em>ghostwriter<\/em>&quot; if they&#8217;re named in the small print of the Acknowledgements section of an article<\/font><\/strong>  [see <a href=\"http:\/\/1boringoldman.com\/index.php\/2016\/09\/02\/rebranding\/\" target=\"_blank\">rebranding&hellip;<\/a>]. He received several responses from Medical Writer&#8217;s Groups. I&#8217;ve tried to pull out the essential pieces of their month&#8217;s long dialogue:      <\/div>\n<blockquote>\n<div align=\"justify\"><a href=\"http:\/\/www.bmj.com\/content\/354\/bmj.i4578\/rr\" target=\"_blank\"><em>12 September 2016<\/em><\/a>: from Al Weigel &#8211; President and CEO, International Society for Medical Publication Professionals [ISMPP]<\/div>\n<p align=\"justify\">&#8230; ISMPP&rsquo;s long-standing position is that &ldquo;ghostwriting&rdquo; &#8211; defined by Laine and Mulrow in 2005 as &ldquo;individuals who wrote the paper but are not acknowledged&rdquo; &#8211; is an unacceptable practice. ISMPP fully supports the role of professional medical writers and the complete and transparent disclosure of their involvement in medical publications and the source of their funding. In fact, the contributions and expertise of medical writers working with authors is associated with more complete reporting of the results of clinical trials and higher quality content.<\/p>\n<div align=\"justify\">Over more than a decade, disclosure of the role of medical writers [and their funding] in contributing to medical publications has progressed to become standard practice today. The involvement of medical writers, statisticians, and others are made fully transparent to journal editors and peer reviewers, and ultimately to the readers of the published literature, along with the authors&rsquo; disclosures and potential conflicts of interest. Through their interactions with authors, medical writers are important contributors to the timely and complete dissemination of clinical data in the medical literature&#8230;<\/div>\n<\/blockquote>\n<blockquote>\n<div align=\"justify\">\n<div class=\"response-date\">         <a href=\"http:\/\/www.bmj.com\/content\/354\/bmj.i4578\/rr-0\" target=\"_blank\"><em>15 September 2016<\/em><\/a>: from Serina Stretton, Cindy Hamilton, Jackie Marchington, Art Gertel, Julia Donnelly &#8211; Global Alliance of Publication Professionals [GAPP]<\/div>\n<p>    <\/div>\n<div align=\"justify\">&#8230; At the core of Matheson&rsquo;s article are claims that there is no  distinction between ghostwriters and professional medical writers, and  that the pharmaceutical industry uses medical writers to insert  commercial messages into the peer-reviewed literature.  We completely  agree with and support the International Society for Medical Publication  Professionals [ISMPP] response to Matheson&rsquo;s claims  that there has been no &ldquo;rebranding of ghostwriting&rdquo; by industry and  that rather, &ldquo;there has been a positive evolution of transparency and  completeness in medical publications reporting industry research.&rdquo;  As  GAPP has stated consistently, professional medical writers are NOT  ghostwriters because they ARE transparent about their involvement, are  strictly prohibited from ghostwriting, and work within ethical  publication guidelines that require authors to contribute to and control  the content at every step of the publication process&#8230; <\/div>\n<\/blockquote>\n<div class=\"small\" align=\"justify\">Parenthetically, it&#8217;s a little hard to imagine that they actually believe what they&#8217;ve said here, since they usually work from a package prepared by the sponsor&#8217;s statisticians and marketeers to prepare an initial draft for the &quot;authors&quot; to see [for the very first time]. <font color=\"#200020\">Matheson<\/font> responded politely, but he was hardly convinced by their arguments, responding&#8230; <\/div>\n<blockquote>\n<div align=\"justify\"><em><a href=\"http:\/\/www.bmj.com\/content\/354\/bmj.i4578\/rr-3\" target=\"_blank\">21 September 2016<\/a><\/em> from Alastair Matheson<\/div>\n<div align=\"justify\"><em><a href=\"http:\/\/www.bmj.com\/content\/354\/bmj.i4578\/rr-4\" target=\"_blank\">21 September 2016<\/a><\/em> from Alastair Matheson   <\/div>\n<p align=\"justify\">Weigel and Stretton both object to my article by emphasizing their trade&rsquo;s commitment to &ldquo;transparency&rdquo;. My analysis shows, however, that modest transparency and small print disclosure, while better than nothing, paradoxically provides an apparatus for subtle misattribution, concealment and spin. My article discusses this as a cultural problem within medicine for which many stakeholders are responsible. It is important not to lay the blame at industry&rsquo;s door alone. As Stretton rightly points out, it is journals that make authorship rules, and decide how disclosures should be presented to their readers&#8230;<\/p>\n<div align=\"justify\">Numerous articles are produced for journal publication every year, scientific platforms and publications plans are developed, academics are recruited to participate as authors, trade writers draft manuscripts, and substantial payments pass from corporations to agencies, but little of this activity is in the public domain. Indeed, the process has been characterized as &lsquo;ghost management&rsquo;. Commercial secrecy has no place in an open scholarly discourse. Since this literature has been placed within the public academic forum with the goal of informing treatment decisions, readers and their patients have a right to know exactly what commercial considerations were at work in its development, and who was paid by whom to create the material&#8230;<\/div>\n<\/blockquote>\n<div class=\"small\" align=\"justify\">&#8230; and then <font color=\"#200020\">Matheson<\/font> lists a number of ways they could prove their transparency claims [&quot;<em><font color=\"#200020\">Will your companies place in the public domain full lists of every journal article they have produced since 2000?<\/font><\/em>&quot; &quot;<em><font color=\"#200020\">Will your companies place in the public domain all the publications  plans relating to these articles, including supporting documentation on  product positioning, scientific platforms, &#8216;educational objectives&#8217;,  communication points and messages?<\/font><\/em>&quot;<em><font color=\"#200020\"> etc<\/font><\/em>]. Their response ignored his challenges&#8230;<\/div>\n<blockquote>\n<div align=\"justify\"><a href=\"http:\/\/www.bmj.com\/content\/354\/bmj.i4578\/rr-6\" target=\"_blank\"><em>30 September 2016<\/em><\/a> from Alison M Rapley, President, European Medical Writers Association<\/div>\n<p align=\"justify\">The International Society for Medical Publication Professionals (ISMPP) and Global Alliance of Publication Professionals [GAPP] have already provided detailed responses to the issues raised in the article by Alastair Matheson. The American and European Medical Writers Associations [AMWA and EMWA] fully support these responses which were prepared by medical communications leaders who have been on the forefront of assessing and establishing ethical and robust professional standards. These standards included input from editors of first-tier peer-reviewed medical and scientific journals. There was no pharmaceutical industry review or input into these rapid responses. Clearly Dr Matheson&rsquo;s interpretation of what constitutes ethical transparency differs from that of these major medical communications organizations representing thousands of professionals working around the globe, as well as differing from that of the International Committee of Medical Journal Editors [ICMJE] who represent more than 500 medical journals.<\/p>\n<div align=\"justify\">The undersigned organizations have been working towards transparency and disclosure for more than 15 years and invite all interested parties with a stake in the future of effective and ethical medical publications to tender constructive suggestions directly to them.<\/div>\n<ul>\n<div align=\"justify\">Alison Rapley &ndash; President, European Medical Writers Association<br \/>  Brian Bass &ndash; Past President, American Medical Writers Association<br \/>  Al Weigel &ndash; President and CEO, International Society for Medical Publication Professionals<br \/>  Serina Stretton &ndash; Global Alliance of Publication Professionals<\/div>\n<\/ul>\n<\/blockquote>\n<div class=\"small\" align=\"justify\"><font color=\"#200020\">Matheson<\/font>&#8216;s summary followed: <\/div>\n<blockquote>\n<div class=\"big\" align=\"center\"><a href=\"http:\/\/www.bmj.com\/content\/354\/bmj.i4578\/rr-10\" target=\"_blank\">Trade associations&#8217; joint statement on transparency in the commerical publications trade<\/a><\/div>\n<div class=\"big\" align=\"center\"><strong><font color=\"#0066ff\">British Medical Journal &#8211; Rapid Response<\/font><\/strong> <\/div>\n<div class=\"middle\" align=\"center\">by Alastair Matheson<\/div>\n<div class=\"middle\" align=\"center\"><strong><font color=\"#200020\">October 7, 2016<\/font><\/strong> <\/div>\n<p align=\"justify\">The debate following my article has culminated in a very  rare, and unaccommodating, <a href=\"http:\/\/www.bmj.com\/content\/354\/bmj.i4578\/rr-6\" target=\"_blank\">joint public statement on transparency<\/a> by  the three foremost trade associations of the commercial publications  industry &ndash; the International Society for Medical Publication  Professionals [ISMPP] and the European and American Medical Writers  Associations [AMWA and EMWA].They have been joined in this statement by  the Global Alliance of Public Professionals [GAPP], the most active  advocacy group for the trade. In this statement, these groups have given their official response to  <a href=\"http:\/\/www.bmj.com\/content\/354\/bmj.i4578\/rr-4\" target=\"_blank\">a series of specific transparency requests<\/a> which I made in order to  clarify where the trade stood on secrecy and transparency in its  development of medical journal articles. The trade chose to meet none of  these requests, indicating its commitment to continued secrecy on these  aspects of the medical publications business.         <\/p>\n<p align=\"justify\">In particular, the trade did not agree to reveal any details of the  commercial publications plans, scientific platforms, product positioning  and key messages underpinning its past, and future, journal articles;  nor did it agree to release details about its recruitment and use of  &ldquo;key opinion leaders&rdquo;; nor details of intellectual property rights; nor  any indication of how much money its companies receive from industry  clients to plan and develop these articles. All this information is to  be remain withheld  from the readers of this literature and their  patients. Most remarkably, the trade did not agree even to disclose exactly  what it has published. It did not agree to provide simple lists of its  published output; it did not agree to disclose any secret ghostwriting  it may be aware of in the published journal literature; and it did not  agree to encourage writers to disclose such articles, or to waive their  confidentiality agreements if they do so.          <\/p>\n<div align=\"justify\">This affirmation of continued commercial secrecy on these aspects of  medical journal literature &ndash; made directly to the medical community  itself, in a leading medical journal &ndash; will be of broad ethical and  policy concern. <em><strong><font color=\"#660033\">The joint statement ends by claiming the trade has been  &ldquo;working towards&rdquo; transparency and disclosure for 15 years. There is  clearly a long road yet to travel<\/font><\/strong><\/em>&#8230; <\/div>\n<\/blockquote>\n<div class=\"small\" align=\"justify\">I followed this dialogue in the <strong><font color=\"#0066ff\">BMJ Rapid Responses<\/font><\/strong> for a month, keeping my mouth shut, not because I didn&#8217;t have something to say. I was waiting for the back and forth to reach some kind od natural ending. I guess I had the same feeling Matheson expresses when he says, &quot;<em><strong><font color=\"#660033\">This affirmation of continued commercial secrecy on these aspects of   medical journal literature &ndash; made directly to the medical community   itself, in a leading medical journal &ndash; will be of broad ethical and   policy concern.<\/font><\/strong><\/em>&quot; This is enough to digest for the moment. I&#8217;ll put my reactions to all of this in&nbsp; the next post &#8211; <a href=\"http:\/\/1boringoldman.com\/index.php\/2016\/10\/10\/devolution-ii\/\">devolution II&hellip;<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>In his recent BMJ article [30 August 2016 &#8211; Ghostwriting: the importance of definition and its place in contemporary drug marketing], Alastair Matheson describes how industry is trying to claim that a hired medical writer isn&#8217;t a &quot;ghostwriter&quot; if they&#8217;re named in the small print of the Acknowledgements section of an article [see rebranding&hellip;]. He [&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":[5],"tags":[],"class_list":["post-68472","post","type-post","status-publish","format-standard","hentry","category-opinion"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/68472","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=68472"}],"version-history":[{"count":21,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/68472\/revisions"}],"predecessor-version":[{"id":68512,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/68472\/revisions\/68512"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=68472"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=68472"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=68472"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}