{"id":47381,"date":"2014-06-16T21:53:59","date_gmt":"2014-06-17T01:53:59","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=47381"},"modified":"2014-06-16T22:04:25","modified_gmt":"2014-06-17T02:04:25","slug":"about-all","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2014\/06\/16\/about-all\/","title":{"rendered":"about &#8220;All&#8221;&#8230;"},"content":{"rendered":"<div align=\"justify\">As many of you are aware, the back and forth between David Healy, Ben Goldacre of AllTrials, and Tracey Brown of Sense about Science continues [<a target=\"_blank\" href=\"http:\/\/davidhealy.org\/sense-about-science-follow-the-rhetoric\/\">Sense about Science: Follow the Rhetoric<\/a>, <a target=\"_blank\" href=\"http:\/\/davidhealy.org\/sense-about-science-first-admit-no-harm\/\">Sense about Science: First Admit no Harm<\/a>, <a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/wp-admin\/Sense about Science: Follow the Lawsuit\">Sense about Science: Follow the Lawsuit<\/a>, and their respective comments]. There are many issues in contention, not the least of which is the place of GSK&#8217;s signing up to AllTrials [Healy: a Trojan Horse vs. AllTrials: a valuable ally &#8211; a 180&deg; polarity]. In the spaces, of his last post, there&#8217;s a link to a transcript of the House of Commons Science and Technology Committee from May 2013 where Tracey Brown testified. A piece of it is posted as a <a target=\"_blank\" href=\"http:\/\/davidhealy.org\/wp-content\/uploads\/2014\/06\/Tracey-Brown-AllTrials.docx\">Word Document<\/a> and the <a target=\"_blank\" href=\"http:\/\/www.publications.parliament.uk\/pa\/cm201314\/cmselect\/cmsctech\/104\/130515.htm\">whole transcript<\/a> is on-line. <em>Just for temporal context, the GSK $3 B suit settled in July 2012; AllTrials was launched&nbsp; in January 2013; and GSK signed on to AllTrials in February 2013<\/em>:<\/div>\n<ul><span class=\"small\"><font color=\"#200020\"> <\/p>\n<div align=\"justify\"> <u><strong><font color=\"#660000\">Chair<\/font><\/strong><\/u>:&nbsp;So you are arguing in favour of full release of information.&nbsp;What impact do you think that would have on the pharmaceutical industry?<\/div>\n<p align=\"justify\"><u><strong><font color=\"#660033\">Tracey Brown<\/font><\/strong><\/u>: When you say full release of information, I should just clarify that. It is helpful to think of this at four levels. One is the registration of trials; that is level 1.&nbsp;That has been a problem, certainly historically, although there have been some improvements since the 2007 FDA regulations and other interventions. We do not even have the contents list, if you like, of what has been done, never mind being able to track down some of the results. That is something that reviewers who are looking across a whole range of studies really struggle with; they spend a lot of time just trying to find out what has actually been done but been left in a cupboard somewhere. Registration is about knowing what the trial is for and registering the protocols.<\/p>\n<p align=\"justify\"> The second level of information, which is what&nbsp;AllTrials&nbsp;is calling for, is the basic summary of the clinical study report.&nbsp;That says what was actually found, what the primary outcomes were and what the protocols were. We would like to see as much information there as possible, but that certainly gives you some indication of what research has been done and how it has been undertaken.<\/p>\n<p align=\"justify\"> The area for quite a lot of discussion at the moment is what I would call&nbsp;level 3, which is the full clinical study report.&nbsp;That contains in many cases quite a lot. It is a very large report-quite often, it even runs to thousands of pages-and it may contain quite a lot of individual patient data, things that might be tracked to individual patients or other things that constitute reasons why people might be concerned. There is a discussion about the release of those. I just note that we are seeing their release by the European Medicines Agency already for those drugs that they have them for.<\/p>\n<p align=\"justify\"> Then there is&nbsp;the fourth level, which is individual patient data.&nbsp;A lot of very productive discussion is going on about how to establish good protocols for sharing that among the research community-for example, setting out the same requirements for secondary research as you would for primary research, looking at the same data&#8230;<\/p>\n<div align=\"justify\"><u><strong><font color=\"#660000\">Pamela Nash<\/font><\/strong><\/u>: Ms Brown, just to be clear, is the aim of the&nbsp;AllTrials&nbsp;campaign to have all four levels published?<\/div>\n<p align=\"justify\"><u><strong><font color=\"#660033\">Tracey Brown<\/font><\/strong><\/u>: No, the aim of the&nbsp;AllTrials&nbsp;campaign is to ensure that levels 1 and 2 are published.&nbsp;Levels 1 and 2 do not have a huge amount of practical implication. It&rsquo;s just a shocker that they are not published already. Levels 3 and 4-level 4 particularly has a certain practical implication, depending on the organisation. The requirements of level 3 &#8211; what would be an equivalent to a clinical study report; there are such things, but for an academic, for example-just need to be ironed out and worked on. It is not a huge barrier to publishing that information. There is quite important information at level 3 about serious adverse events, for example, that may need to be shared, but that just takes a little more work and thinking about.<\/p>\n<div align=\"justify\"> We are really pleased that, in signing up to&nbsp;AllTrials,&nbsp;GlaxoSmithKline, for example, committed to publishing a lot of their level 3 data. Obviously, we are going to look at what they encounter in doing that. That is an ongoing discussion with them. A lot of the people who have signed up to&nbsp;AllTrials&nbsp;are committed to that, too, but what we want to do is just to get past the idea that secrecy is okay. That is really the ultimate aim ofAllTrials. It is just to find out what people have done and what they have found, at a very basic level, and then we can go on to look at some of the implications of sharing that&#8230;<\/div>\n<p>  <\/font><\/span><\/ul>\n<div align=\"justify\">Having made this division of four levels, the Committee members repeatedly try to clarify exactly what AllTrials is asking for, and each exchange is confusing, at least to me. I can see why Healy flagged this transcript because it goes from not-much-at-all to some to another not-much to confusing. I&#8217;d recommend reading the <a target=\"_blank\" href=\"http:\/\/www.publications.parliament.uk\/pa\/cm201314\/cmselect\/cmsctech\/104\/130515.htm\">whole transcript<\/a> to see if you can make sense of it. The other worrisome thing is that &quot;<em><strong><font color=\"#200020\">GlaxoSmithKline, for example,  committed to publishing a lot of their level 3 data. Obviously, we are  going to look at what they encounter in doing that. That is an ongoing  discussion with them.<\/font><\/strong><\/em>&quot; What is it about the word &quot;All&quot; [in &quot;AllTrials&quot;] that says anything about negotiations or ongoing discussions? This is just another version of selective publication &#8211; which is the very thing AllTrials is setting out to abolish. At least that&#8217;s what&nbsp;<strike> we all&nbsp;<\/strike> I thought. Admittedly, this testimony is from last year, and this scene has been repeatedly rewritten, but I&#8217;ve had some version of the same worries myself. It&#8217;s the reason I went all obsessive about the abbreviations [<a href=\"http:\/\/1boringoldman.com\/index.php\/2014\/06\/06\/in-the-details-2\/\" target=\"_blank\">in the details&hellip;<\/a>, <a href=\"http:\/\/1boringoldman.com\/index.php\/2014\/06\/08\/achilles-heel-2\/\" target=\"_blank\">achilles&rsquo; heel&hellip;<\/a>, <a href=\"http:\/\/1boringoldman.com\/index.php\/2014\/06\/09\/the-wrong-compromise\/\">the wrong compromise&hellip;<\/a>].    <\/div>\n<p align=\"justify\">I don&#8217;t trust PHARMA, period. Besides the string of regular misbehavior with Clinical Trial Data reaching back over the last two decades, there&#8217;s been an aggressive campaign to undermine Data Transparency in the recent past:<\/p>\n<ul> <span class=\"small\">   <\/p>\n<li> the leaked memo [<a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2014\/06\/13\/in-the-shadows-2\/\">in the shadows&hellip;<\/a>] <\/li>\n<li>their Trade Commission letter [see <a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2014\/06\/13\/an-ill-gotten-fortune\/\">an ill-gotten fortune&hellip;<\/a>] <\/li>\n<li>the AbbVie\/InterMune suit <\/li>\n<li>the PhRMA\/EFPIA conference in Brussels [see <a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2013\/09\/06\/a-deal-breaker\/\">a deal-breaker?&hellip;<\/a>] <\/li>\n<li>the article [<a href=\"http:\/\/www.phrma.org\/innovation\/intellectual-property\" target=\"_blank\">Intellectual Property Protections Are Vital to Continuing Innovation in the Biopharmaceutical Industry<\/a>]   <\/li>\n<li>the EMA U Turn [see <a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2014\/05\/31\/a-crushing-setback\/\">a crushing setback&hellip;<\/a> and <a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2014\/06\/12\/some-further-information\/\">some further information&hellip;<\/a>] <\/li>\n<p>   <\/span><\/ul>\n<div align=\"justify\"> In the 11th hour, we learned that the settlement with AbbVie made extensive changes in the EMA policy [the U Turn], and now in this piece we read that GSK didn&#8217;t sign on to the AllTrials that I originally knew, but negotiated their way on by specifying what they would and would not reveal. That&#8217;s why I don&#8217;t trust PHARMA. There&#8217;s <u>always<\/u> another part of the story that we may or may not find out about. There is <u>no<\/u> incentive for PHARMA to do the right thing and <u>every<\/u> incentive for them not to. Which is why I say repeatedly, they have <u>no<\/u> place at the table when it comes to Data Transparency. I would warn once again that the &quot;devil is in the details.&quot; In evaluating any proposal, make no assumptions about the meaning of any term like CSR [Clinical Study Report] or even Full Clinical Study Report. These are not rigidly defined terms and there&#8217;s a lot of variability possible. To try your patience, once again, the things needed for a full analysis are:<\/div>\n<ul><span class=\"small\"> <\/p>\n<li> the a priori protocol with all legitimate ammendments; <\/li>\n<li>the raw data tables abstracted before the blind is broken [with the unblinding key];<\/li>\n<li> access to the original CRFs to check the AEs;<\/li>\n<p><\/span> <\/ul>\n<div align=\"justify\">which is what the sponsor\/author receives when the blind is broken. The later narratives and summaries in the CSRs are vulnerable to H.A.R.K. [hypothesis after results known] AKA &quot;spin&quot;&#8230;<\/div>\n","protected":false},"excerpt":{"rendered":"<p>As many of you are aware, the back and forth between David Healy, Ben Goldacre of AllTrials, and Tracey Brown of Sense about Science continues [Sense about Science: Follow the Rhetoric, Sense about Science: First Admit no Harm, Sense about Science: Follow the Lawsuit, and their respective comments]. There are many issues in contention, not [&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":[2],"tags":[],"class_list":["post-47381","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/47381","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=47381"}],"version-history":[{"count":15,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/47381\/revisions"}],"predecessor-version":[{"id":47396,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/47381\/revisions\/47396"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=47381"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=47381"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=47381"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}