{"id":47286,"date":"2014-06-14T00:00:01","date_gmt":"2014-06-14T04:00:01","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=47286"},"modified":"2014-06-14T00:44:07","modified_gmt":"2014-06-14T04:44:07","slug":"thoughts-3","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2014\/06\/14\/thoughts-3\/","title":{"rendered":"thoughts?&#8230;"},"content":{"rendered":"\n<p align=\"justify\">Yeah, I&#8217;m still stuck on the things that lead up to the EMA U Turn, a house that PHARMA built like so many others. I tried sitting down this afternoon and pretending I&#8217;m an AbbVie executive, and then detached from that identification and looked at what I was worried about during my moments as a pretend PHARMA mogul. Neal Ryan was very clear about his company&#8217;s <img loading=\"lazy\" decoding=\"async\" width=\"150\" height=\"150\" border=\"0\" align=\"right\" src=\"http:\/\/1boringoldman.com\/images\/brew.gif\" \/>worry [see <a href=\"http:\/\/1boringoldman.com\/index.php\/2013\/09\/06\/a-deal-breaker\/\" target=\"_blank\">a deal-breaker?&hellip;<\/a>] &#8211; that some &quot;Pakistani&quot; would figure out how they make Humira [a monoclonal antibody that attacks Tumor Necrosis Factor] and begin brewing up cheap batches in the Himalayas. The racism in that comment aside, the point is well taken [they&#8217;re pretty stingy with the formula for Coca Cola too]. That is a legitimate concern for a company, the true meaning of trade secrets.<\/p>\n<div align=\"justify\">The obvious other side of that argument is the PHARMA giants like GSK who hide behind that trade secret argument, using it to keep their Clinical Trial data secret because in the light of day, the blockbuster becomes a maybe not-so-safe weak sister or near inert. We have no dog in corporate wars to hold on to trade secrets, but our duty is to know about the clinical effects of medications. I don&#8217;t mind their keeping those manufacturing secrets to themselves, but we all mind their keeping true efficacy and adverse effects under wraps. In fact, in looking at the EMA changes, in their <a target=\"_blank\" href=\"http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/news_and_events\/news\/2014\/06\/news_detail_002124.jsp&#038;mid=WC0b01ac058004d5c1\">Press Release<\/a>, the EMA said:<\/div>\n<ul>\n<div align=\"justify\" class=\"small\"><font color=\"#200020\">In  light of discussions at the Board, the wording of the policy,  including  practical arrangements for <u>academic and non-commercial  research users<\/u>,  will now be finalised with a view to its adoption by  the Board through  written procedure by mid-July 2014, and will be  effective from 1 October  2014. Importantly, the Agency will ensure that  the policy will not  prejudice citizens&rsquo; rights under existing <span class=\"glossary-term\">access to documents<\/span> legislation and the new clinical trials regulation.<\/font><\/div>\n<\/ul>\n<div align=\"justify\">As you recall, it was requests to the EMA from competitors that got AbbVie in such a wad. I don&#8217;t think that this concern justifies their blocking us from checking their Clinical Trial data, but I can understand their point. All we are asking for is the specific data that addresses &quot;<em>does the medication work?<\/em>&quot; if so, &quot;<em>how well?<\/em>&quot; and &quot;<em>does it harm people?<\/em>&quot; That data has nothing to do with the secrets of making anti-tumor-necrosis-factor mono-clonal antibodies. In fact, I don&#8217;t even care about that. I doubt many clinicians do.  <\/div>\n<p align=\"justify\">So the compromise is fairly clear. Give us the protocol, the data we want from the outcome variables, and the CRFs to look at the AEs, and keep the how-to-make-it secrets to yourself. If that could be done and could he trusted, it&#8217;s a compromise I could live with. But keeping everything secret just to preserve trade secrets won&#8217;t do. Too many companies have cheated too regularly and too destructively to even consider continuing to do that. Actually, it looks like the EMA gave them that point &#8211; &quot;<u>academic and non-commercial  research users<\/u>&quot; [<u>not<\/u> <em>competitors<\/em>] &#8211; which is, in fact, the second part of their venerated <a href=\"http:\/\/www.wto.org\/english\/tratop_e\/trips_e\/t_agm3_e.htm\" target=\"_blank\">Article 39 [3]<\/a>: <\/p>\n<ul>\n<div align=\"justify\" class=\"small\"><font color=\"#200020\">3. Members,          when requiring, as a condition of approving the  marketing          of pharmaceutical or of agricultural chemical products          which  utilize new chemical entities, the submission of          undisclosed  test or other data, the origination of which          involves a  considerable effort, shall protect such data against unfair commercial  use. In addition, Members shall         protect such  data against  disclosure, except where         necessary to protect the public, or <u>unless steps are         taken to ensure that the data are protected against         unfair commercial use<\/u>.<\/font><\/div>\n<\/ul>\n<div align=\"justify\"> Give us the right <strong><u><font color=\"#200020\">protect the public<\/font><\/u><\/strong> and we&#8217;ll give you<strong><font color=\"#200020\"> <u>protected against unfair commercial use<\/u><\/font><\/strong> in return, which is a legitimate concern. What we want really has nothing to do with that. Thoughts?&#8230;  <\/div>\n","protected":false},"excerpt":{"rendered":"<p>Yeah, I&#8217;m still stuck on the things that lead up to the EMA U Turn, a house that PHARMA built like so many others. I tried sitting down this afternoon and pretending I&#8217;m an AbbVie executive, and then detached from that identification and looked at what I was worried about during my moments as a [&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-47286","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/47286","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=47286"}],"version-history":[{"count":20,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/47286\/revisions"}],"predecessor-version":[{"id":47306,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/47286\/revisions\/47306"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=47286"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=47286"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=47286"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}