{"id":58508,"date":"2015-07-23T10:33:46","date_gmt":"2015-07-23T14:33:46","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=58508"},"modified":"2015-07-23T14:39:38","modified_gmt":"2015-07-23T18:39:38","slug":"out-of-my-league","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2015\/07\/23\/out-of-my-league\/","title":{"rendered":"out of my league&#8230;"},"content":{"rendered":"<br \/>\n<blockquote>\n<div align=\"center\" class=\"big\"> <a href=\"http:\/\/blogs.wsj.com\/pharmalot\/2015\/07\/22\/funds-join-campaign-to-pressure-pharma-to-disclose-trial-data\/\" target=\"_self\">Funds Join Campaign to Pressure Pharma to Disclose Trial Data<\/a><\/div>\n<div align=\"center\" class=\"big\"><strong><font color=\"#004400\">Pharmalot<\/font><\/strong><\/div>\n<div align=\"center\" class=\"middle\">By Ed Silverman<\/div>\n<div align=\"center\" class=\"small\">07\/22\/2015<\/div>\n<p align=\"justify\"><img decoding=\"async\" vspace=\"4\" border=\"1\" hspace=\"4\" height=\"140\" align=\"right\" src=\"http:\/\/1boringoldman.com\/images\/ben-3.jpg\" \/>The investors, which collectively manage about $3.8 trillion, plan to  meet with drug makers in which they invest to ensure that trials are  registered and results are reported, according to Sile Lane, campaign  director at Sense About Science, a non-profit that launched the <a href=\"http:\/\/www.alltrials.net\/\" target=\"_blank\">AllTrials campaign<\/a>. In an unprecedented move, a group of 85 asset managers and pension  funds is teaming with a U.K. non-profit campaign to pressure drug makers  to disclose clinical trial data. The effort is likely to escalate a  closely watched battle that has increasingly placed the pharmaceutical  industry on the defensive as researchers and regulators call for  increased disclosure in the U.K. to agitate for greater trial data disclosure.<\/p>\n<p align=\"justify\"><img loading=\"lazy\" decoding=\"async\" width=\"162\" border=\"0\" hspace=\"4\" height=\"120\" align=\"left\" src=\"http:\/\/1boringoldman.com\/images\/all-trials.gif\" \/>Drug makers will be asked to retrospectively register past and  ongoing clinical trials, and register all future trials before they  begin;<strong>&nbsp;<\/strong>publish methods and full results of all trials,  include information on adverse events; post objective summary results  within one year of completing a trial, and support efforts to provide  independent researchers access to anonymized individual patient data,  according to a <a href=\"http:\/\/www.alltrials.net\/news\/pharma-company-investors-call-for-clinical-trials-transparency\/\" target=\"_blank\">statement<\/a>. &ldquo;We believe this is going to be game changing,&rdquo;&nbsp;Lane tells us. To  facilitate the process, the AllTrials campaign is conducting an audit of  disclosure policies for the 50 largest drug makers and will<strong>&nbsp;<\/strong>score  each one. The results are expected to be published in September. &ldquo;This  will become a tool readily available to investors,&rdquo; she says.<\/p>\n<p align=\"justify\">The move comes amid growing clamor from academics and consumer groups  to press drug and device makers to release trial data. At issue is the  ability for researchers to independently verify study results and,  consequently, improve patient treatments that can lead to better health  and lower costs. Concerns have been heightened following various safety scandals that  revealed trial data for some products was never fully published or  disclosed. In recent months, regulators in the U.S. and Europe have  responded by releasing new rules designed to widen access. And several  drug makers, in varying degrees, have taken steps to release trial data.<\/p>\n<p align=\"justify\">For instance, GlaxoSmithKline created a <a href=\"https:\/\/www.clinicalstudydatarequest.com\/Study-Sponsors-Info.aspx\" target=\"_blank\">website<\/a>&nbsp;where  data requests are made to 10 different drug makers, Johnson &amp;  Johnson is working with Yale University to provide access to data, and  Bristol-Myers Squibb will grant access to academics as part of a  collaboration with Duke University. AstraZeneca f<a target=\"_blank\" href=\"http:\/\/blogs.wsj.com\/pharmalot\/2015\/03\/24\/astrazeneca-to-disclose-trial-data-but-how-independent-is-its-review-panel\/\">ormed a pane<\/a>l to review requests for data, although questions were raised about its independence. But critics say such efforts are few and far between. Helena Vines  Fiestas, who heads sustainability research at BNP Paribas, says there is  increasing concern that a lack of transparency about medicines &ndash; past  and present &ndash; is having a negative impact on stock valuations. BNP got  involved as an outgrowth of a broader effort to rate and benchmark  companies in different industry sectors.<\/p>\n<p align=\"justify\">For instance, she says fines paid by 21 drug makers for marketing  malfeasance between 2007 and mid-2015 was $40 billion, and 43% was  directly related to minimizing side effects that were identified during  clinical trials but not properly reported. Her team also queried  analysts and discovered that an average of about 30% of drug company  stock valuations directly relate to results of Phase III clinical  trials.<\/p>\n<div align=\"justify\">&ldquo;The lack of complete and unbiased information can mislead decisions  made not only regulators and doctors, but also investors,&rdquo; Fiestas tells  us. &ldquo;We think if the companies become more transparent and take the  issue around auditing and reports more seriously that the decisions made  by analysts can be more closely aligned with reality&rdquo;&#8230;<\/div>\n<\/blockquote>\n<div align=\"justify\" class=\"small\">So if appeals to common sense and common decency move too slowly, where else to turn but to big money. It makes an odd kind of sense, but who&#8217;d have thought it? I suppose the next question is obvious, &quot;<em><font color=\"#200020\">But will the backing of the representatives of investors&#8217; money bring the same corrupting influence that caused the problem in the first place?<\/font><\/em>&quot; Answering that is way out of my league, that&#8217;s one thing I&#8217;m sure of&#8230; <\/div>\n","protected":false},"excerpt":{"rendered":"<p>Funds Join Campaign to Pressure Pharma to Disclose Trial Data Pharmalot By Ed Silverman 07\/22\/2015 The investors, which collectively manage about $3.8 trillion, plan to meet with drug makers in which they invest to ensure that trials are registered and results are reported, according to Sile Lane, campaign director at Sense About Science, a non-profit [&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-58508","post","type-post","status-publish","format-standard","hentry","category-opinion"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/58508","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=58508"}],"version-history":[{"count":25,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/58508\/revisions"}],"predecessor-version":[{"id":58533,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/58508\/revisions\/58533"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=58508"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=58508"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=58508"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}