{"id":51177,"date":"2014-10-25T07:40:57","date_gmt":"2014-10-25T11:40:57","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=51177"},"modified":"2014-10-25T23:50:05","modified_gmt":"2014-10-26T03:50:05","slug":"european-medicines-agency-a-disappointment","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2014\/10\/25\/european-medicines-agency-a-disappointment\/","title":{"rendered":"European Medicines Agency: a disappointment…"},"content":{"rendered":"\n

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It’s impossible to make sense of the timeline in the last post [European Medicines Agency: a timeline…<\/a>] based only on the facts as presented. What started as an open commitment to full Data Transparency for the Clinical Trials submitted for approval to the European Medicines Agency [EMA] ended with restricted access to redacted partial Clinical Trial reports still under the control of the pharmaceutical sponsor. This particular challenge to PHARMA’s proprietary ownership of the data from Clinical Trials was defeated. But unlike the timeless game of chess in the painting, this contest wasn’t decided on the open field of battle. It appears to have been won in secret in the private chambers of court. It was more like the chess game in Bergman’s allegorical Seventh Seal<\/em> where the Knight’s opponent was invisible to onlookers – and the outcome was inevitable:<\/p>\n

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While the losers in such contests often cry "foul play," in this case, it’s already apparent that such a cry is justified. BMJ blogger, Jim Murray [former director of BEUC—the European Consumers Organisation] has been trying unsuccessfully to obtaim the communications between PHARMA and the EMA, but points us to the European Ombudsman’s release of some of those documents from her investigation – confirming that PHARMA had a substantial input in the process: <\/p>\n\n\n\n\n\n
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OCT·2014<\/strong><\/td>\nIn 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
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  • 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<\/table>\n

    Perhaps even more ominous, Fiona Godlee’s letter<\/a> to Jean-Claude Juncker [new President of the European Commission] makes it clear that the change in the European Commission was a big factor in the EMA’s change in direction:<\/p>\n