{"id":51252,"date":"2014-10-26T15:24:11","date_gmt":"2014-10-26T19:24:11","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=51252"},"modified":"2014-10-26T15:59:43","modified_gmt":"2014-10-26T19:59:43","slug":"game-on","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2014\/10\/26\/game-on\/","title":{"rendered":"game on…"},"content":{"rendered":"\n

One way to be boring is to become too detailed on a topic, and I’m there right now. The topic is obviously the European Medicines Agency<\/em> Data Transparency policy released in early October. I did a timeline [European Medicines Agency: a timeline…<\/a>], but it keeps on going and growing. Here are a couple of pieces that need to be added: <\/p>\n\n\n\n\n\n\n
OCT·2014<\/strong>
continued<\/em><\/td>\n		In the wake of the release of the final EMA policy, it’s becoming clear that there were significant private communications between PHARMA and the EMA – only some of which have come to light. <\/td>\n<\/tr>\n
\n
  • European Medicines Agency: a disappointment… <\/a><\/li>\n
  • Ben Goldacre: Pharma industry has destroyed its own reputation<\/a><\/li>\n
  • Undermining the European Medicines Agency’s transparency policy<\/a><\/li>\n
  • Documents released by the European Ombudsman<\/a><\/li>\n<\/td>\n<\/tr>\n
    • \n
    <\/td>\n<\/tr>\n
     <\/td>\nThere was a widespread outcry about the decision to move the EMA from the Health and Consumer directorate. The EFPIA denied lobbying for the change. And Jean-Claude Juncker scrapped the move, saying "Responsibility for medicines and pharmaceutical products will stay with the Directorate-General for Health because I agree with you that medicines are not goods like any other<\/em>"<\/td>\n<\/tr>\n
    \n
  • a change of heart!… <\/a><\/li>\n
  • Pharma industry denies it lobbied for medicines to move to DG Enterprise<\/a><\/li>\n
  • Juncked: Plan to move EMA from DG Health to DG Enterprise is abandoned <\/a><\/li>\n
  • Juncker u-turn puts pharma in health Commissioner’s portfolio<\/a><\/li>\n<\/td>\n<\/tr>\n<\/table>\n

    Instead of bludgeoning you with these fragments, I put the timeline on a separate page that you can call up or ignore. I happen to think in "timelines." It’s how I remember patients’ narratives [or for that matter, almost everything else]. So no more fragments. I’ll just put a link to the page when it changes and leave it up to you [TIMELINE<\/a>].<\/p>\n

    <\/p>\n

    Another way I think is in pictures, and it’s obvious from my graphics that this process has felt like a game of chess to me. My point in this post is that as monotonous as it may seem, I don’t think the game is yet over. That TIMELINE<\/a> shows moves and counter-moves, small victories and concessions, gambits and sacrifices, advantages gained only to be out-maneuvered. And the moves still keep on coming. When I first did the timeline [European Medicines Agency: a timeline…<\/a>], I wrote it like it was over [European Medicines Agency: a disappointment…<\/a>]. But I was just plain wrong about that. It feels still very much like game on<\/em>.<\/p>\n

    One of my favorite books [that I didn’t quite understand] was Gödel, Escher, Bach: An Eternal Golden Braid<\/a>, a 1979 book by Douglas Hofstadter. One of the central themes of the book was things that are self-referential and recursive – where the same principle is repeated at multiple levels. This is one of those things. The content of the controversy is Data Transparency<\/font><\/strong> – insisting that reports on clinical trials are accompanied by access to the raw data rather than having it cloistered behind industry’s claim that they own the data. But if you think about it, this fight over the EMA’s policy is different from past versions, because it’s playing out in real-time<\/u>, on a closely watched public<\/u> stage, and it’s playing out Transparently<\/font><\/strong>. The fight over the Transparency<\/font><\/strong> of Clinical Trial data is being fought with the proxy being the Transparency<\/font><\/strong> of the EMA’s process in setting their policy about Data Transparency<\/font><\/strong>.<\/p>\n

    When the Cochrane group went after the hidden Tamiflu data, they did it by going public, joined by the BMJ, later AllTrials, and many others. It went to UK Parliametary Committees, and Parliament itself. When AbbVie and InterMune sued the EMA, one could read of little else. David Healy put up a petition and the blogs whirred. When the EMA quietly released a draft of a policy that was much more restrictive than previously promised, many fronts immediately turned it into a noisy cause c\u00e9lèbre<\/font>. <\/em>The EMA backed down somewhat, eliminating the periscope screen-only clause and some of the restrictive application process. Moving the EMA from health to business was announced with no fanfare, but the BMJ, editor Godlee, and supportive MPs were on top of that change like hyenas on fresh kill. President Junckers came around. Now, it’s becoming clear that PHARMA likely had secret meetings or input with the EMA along the way, and the noise is escalating. I anticipate we’ll be hearing about those communications real soon.<\/p>\n

    Ben Goldacre’s line was famously, "Sunlight is the best disinfectant<\/font>" [something of value…<\/a>]. That’s true of the way to clear up this terrible mess of ghostwritten, jury-rigged, journal articles and the associated Conflict of Interest problems. But whining about that wasn’t getting us anywhere. Moving it up a level and applying it to the EMA process of setting their Data Transparency policy is not only an equally valid application of the principle, it’s moving things along in the right direction. PHARMA has gotten away with living in the shadows for far too long, and is having a hard time playing in the light of day. And it’s the principle of the "Sunshine Act" as well – flushing the KOLs out into the public eye. I guess there’s something powerful about the simple adage, "We’re only as sick as our secrets<\/font>." <\/div>\n","protected":false},"excerpt":{"rendered":"

    One way to be boring is to become too detailed on a topic, and I’m there right now. The topic is obviously the European Medicines Agency Data Transparency policy released in early October. I did a timeline [European Medicines Agency: a timeline…], but it keeps on going and growing. Here are a couple of pieces […]<\/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-51252","post","type-post","status-publish","format-standard","hentry","category-opinion"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/51252","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=51252"}],"version-history":[{"count":33,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/51252\/revisions"}],"predecessor-version":[{"id":51285,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/51252\/revisions\/51285"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=51252"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=51252"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=51252"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}