{"id":47225,"date":"2014-06-13T08:05:56","date_gmt":"2014-06-13T12:05:56","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=47225"},"modified":"2014-06-12T23:23:36","modified_gmt":"2014-06-13T03:23:36","slug":"in-the-shadows-2","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2014\/06\/13\/in-the-shadows-2\/","title":{"rendered":"in the shadows&#8230;"},"content":{"rendered":"\n<p align=\"justify\">Back in July of last year, we were treated to a leaked memo from P<em>h<\/em>RMA and EFPIA outlining a broad strategy to fight the EMA Data Transparency initiatives [<a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2013\/07\/28\/a-closing-argument\/\">a closing argument&hellip;<\/a>]. It was reported in the Guardian [<a href=\"http:\/\/www.guardian.co.uk\/business\/2013\/jul\/21\/big-pharma-secret-drugs-trials\" target=\"_blank\">Big pharma mobilising patients in battle over drugs trials data<\/a>] and is shown here as a reminder [read the details]:   <\/p>\n<table width=\"99%\" cellspacing=\"0\" cellpadding=\"0\" border=\"0\" align=\"center\">\n<tr>\n<td>\n<div align=\"justify\" class=\"small\">Dear members and colleagues,<\/div>\n<\/p>\n<p align=\"justify\" class=\"small\">please find below a message from  Richard Bergstroem, EFPIA DG with respect to the various elements of the  Clinical Data sharing debate, the assignment of responsibilities  (including work with US PhRMA colleagues) and next steps<\/p>\n<div align=\"justify\" class=\"small\"><strong><font color=\"#200020\">A. Forthcoming industry commitment, incl advocacy:<\/font><\/strong><\/div>\n<ul>\n<div align=\"justify\" class=\"small\">The EFPIA Board has approved the  draft position paper developed jointly by PhRMA and EFPIA. The final  version is attached, and is now subject to confirmation by the PhRMA  Board two weeks from now. PhRMA and EFPIA plan concomitant press  releases in the week of July 22. The advocacy plan, previously approved  by the two Boards is underway, and follows four strands:<\/div>\n<ol>\n<li>\n<div align=\"justify\" class=\"small\">Mobilising patient groups to express concern about the risk to public health by non-scientific re-use of data.<\/div>\n<\/li>\n<li>\n<div align=\"justify\" class=\"small\">Engaging with scientific associations  to shape the industry commitment for data sharing, and to discuss  concerns about re-use of data. <\/div>\n<\/li>\n<li>\n<div align=\"justify\" class=\"small\">Work with other business sectors that are also concerned about release of trade secrets and commercially confidential data. <\/div>\n<\/li>\n<li>\n<div align=\"justify\" class=\"small\">For the long-term, build a network of  academics across Europe that has the capacity to counteract mis-use of  data (that is deemed to be happen in any case). <\/div>\n<\/li>\n<\/ol>\n<div align=\"justify\" class=\"small\">There will be a series of meetings in  Brussels, organised jointly by PhRMA and EFPIA, in the week of August  26 to advance these strands. This work (commitment and advocacy) is  coordinated by [Redacted], in close cooperation with PhRMA ([Redacted]  and [Redacted]), with oversight by Richard Bergstroem and [Redacted],  PhRMA.<\/div>\n<\/ul>\n<div align=\"justify\" class=\"small\"><strong><font color=\"#200020\">B. EMA consultation on draft :<\/font><\/strong><\/div>\n<ul>\n<div align=\"justify\" class=\"small\">On June 24th , the EMA published its  revised policy on the publication and access to clinical trial data for  consultation. Comments are invited and should be provided to the EMA by  30 September 2013. Whereas the press release was quite balanced, the  detailed proposal raises concerns:<\/div>\n<ol>\n<li>\n<div align=\"justify\" class=\"small\">No process outlined to discuss CCI in CSRs prior to release. <\/div>\n<\/li>\n<li>\n<div align=\"justify\" class=\"small\">Raw data: unenforceable controls to ensure robust and scientifically credible secondary analyses. <\/div>\n<\/li>\n<li>\n<div align=\"justify\" class=\"small\">Requirement for anonymised raw data to be supplied at submission negates EMA&rsquo;s responsibility for release of PP information. <\/div>\n<\/li>\n<li>\n<div align=\"justify\" class=\"small\">Publication of CSRs from withdrawn or unsuccessful submissions could undermine future commercial viability of product. <\/div>\n<\/li>\n<li>\n<div align=\"justify\" class=\"small\">Identification of study personnel. <\/div>\n<\/li>\n<\/ol>\n<div align=\"justify\" class=\"small\">The EMA document takes into  consideration the outcome of the process run by the 5 CT advisory groups  earlier in the year to which EFPIA contributed through the input  prepared by the 5 Temporary Working groups (TWG) set up under the SRM PC  auspices.<\/div>\n<\/p>\n<div align=\"justify\" class=\"small\">A detailed response will be  prepared by a joint EFPIA-PhRMA team. The work will be led by  [Redacted], Lilly, [Redacted]. From the EFPIA side the  EFPIA TWG chairs  (Rules of engagement, Patient confidentiality, good analysis practice,  CT data format, legal aspects) will be part of the drafting group:  [Names of four individuals within the drafting group redacted] PhRMA  will assign a small group of people from the bigger EMA data disclosure  WG. The drafting group will tentatively have a TC July 9. The final  draft will be shared for consultation with the broader membership later  this month.<\/div>\n<\/ul>\n<div align=\"justify\" class=\"small\"><strong><font color=\"#200020\">C: EFPIA-PhRMA intervention in the AbbVie case: <\/font><\/strong><\/div>\n<ul>\n<div align=\"justify\" class=\"small\">[Name], Pfizer, leads this work, in close cooperation with PhRMA and external legal counsel.<\/div>\n<\/ul>\n<div align=\"justify\" class=\"small\"><strong><font color=\"#200020\">D: Clinical Trial Regulation:<\/font><\/strong><\/div>\n<ol>\n<div align=\"justify\" class=\"small\">Advocacy directed at Council (and EC and EP) will focus on:<\/div>\n<ul>\n<li>\n<div align=\"justify\" class=\"small\">avoiding definitions of CCI in the CTR itself, <\/div>\n<\/li>\n<li>\n<div align=\"justify\" class=\"small\">seek to delete preamble text that  CSRs do not &quot;in general&quot; include CCI (even if current text is acceptable  as fall-back position). <\/div>\n<\/li>\n<\/ul>\n<div align=\"justify\" class=\"small\">The EFPIA PACT(Public Affairs on  Clinical Trials) is responsible and will work closely with national  associations and Brussels staff.<\/div>\n<\/ol>\n<div align=\"justify\" class=\"small\">Regards, <\/div>\n<div align=\"justify\" class=\"small\">[Redacted]<\/div>\n<\/td>\n<\/tr>\n<\/table>\n<p align=\"justify\"><img decoding=\"async\" vspace=\"4\" hspace=\"4\" height=\"126\" border=\"1\" align=\"right\" title=\"Neal Parker\" alt=\"Neal Parker\" src=\"http:\/\/1boringoldman.com\/images\/james-parker.jpg\" \/>Notice that they mention <em>&quot;&#8230; a series of meetings in  Brussels, organised jointly by PhRMA and EFPIA, in the week of August  26 to advance these strands.&quot;<\/em> That was that incendiary presentation by AbbVie&#8217;s lawyer, Neal Parker [see <a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2013\/09\/06\/a-deal-breaker\/\">a deal-breaker?&hellip;<\/a>]. You remember, that one where there was smoke coming out of the regulator&#8217;s ears [see <a href=\"http:\/\/davidhealy.org\/wp-content\/uploads\/2013\/09\/AbbVie-v-EMA-2-bmj.f5390.full_.pdf\" target=\"_blank\">Industry and drug regulators disagree on which data should remain confidential<\/a>].<\/p>\n<p align=\"justify\">Well, it looks like they got the job done anyway from the way the EMA took its U Turn. Lets hope the resultant outcry really does reverse some of the damage done. But my point is that all of this was to be behind the scenes. It was only fortuitous that we got to hear about them in action at all. And from what we know now, there was still a hell of a lot that went on in the shadows that we still don&#8217;t know about.  <\/p>\n<div align=\"justify\">It&#8217;s the stuff in the shadows that does the damage&#8230;  <\/div>\n","protected":false},"excerpt":{"rendered":"<p>Back in July of last year, we were treated to a leaked memo from PhRMA and EFPIA outlining a broad strategy to fight the EMA Data Transparency initiatives [a closing argument&hellip;]. It was reported in the Guardian [Big pharma mobilising patients in battle over drugs trials data] and is shown here as a reminder [read [&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-47225","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/47225","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=47225"}],"version-history":[{"count":18,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/47225\/revisions"}],"predecessor-version":[{"id":47228,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/47225\/revisions\/47228"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=47225"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=47225"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=47225"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}