I was getting ready to write some things about a few new developments in the saga of the European Medicines Agency’s Data Transparency policy, and it occurred to me that the story has gone on so long and become so convoluted that I ought to do a rough timeline. I’d like to say it was for the reader who hasn’t followed the story closely, but the truth is that I’ve followed it closely and there are so many twists and turns that I needed to clarify the sequence of things for myself. It certainly has been a chess game – moves and counter moves, gambits and sacrifices, and it’s still not over. So here’s a rough intro starting with the opening moves through the announcement of their policy three weeks ago with some brief comments, a few posts, and the key links – just hitting the high points:
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JUL·2012 | The European Medicines Agency announced that they would release their data on approved drugs. It was the first real breakthrough in Data Transparency that I knew about, and it was pretty exciting. Shortly thereafter, GSK finally posted the long overdue data from PAXIL Study 329 [from the NY settlement in 2004]. | |
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FEB·2013 | The centerpiece of this campaign was Tamiflu, a drug stockpiled in case of an epidemic/pandemic. The Cochrane Collaboration questioned its efficacy and wanted to do a meta-analysis on all the trials. The campaign involved Ben Goldacre’s AllTrials, Fiona Godlee and the BMJ, Tom Jefferson and Peter Doshi of the Cochrane group, and many others. Roche finally began releasing the unpublished data. | |
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APR·2013 | Two American companies filed suits contesting the EMA’s plan to release their data, InterMune and AbbVie. The EU court ordered the EMA to temporarily halt its releasing data. It was a decided setback. | |
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JUN·2013 | A leaked joint memo from the EFPIA [European Federation of Pharmaceutical Industries and Associations] and PhRMA [Pharmaceutical Research and Manufacturers of America] describes an extensive campaign to oppose the EMA’s Data Transparency efforts. | |
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SEP·2013 | At a meeting in Brussels organized by the PhRMA/EFPIA to clear the air, the air was hardly cleared. AbbVie’s lawyer, Neal Parker, made the case against Data Transparency to the horror of the regulators in attendance. It’s a bit of must watch video [@19:/00]. | |
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DEC·2013 | The European Court lifted the hold on Data Release and asked the companies for justification for their claims. The EMA’s response is in the post. | |
another patch of blue… | ||
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APR·2014 | After negotiation with the EMA, AbbVie withdrew its suit having extracted some concessions on redaction. The naive among us thought it was now something of a downhill run. The wary were on edge. | |
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MAY·2014 | The sunny days didn’t last very long. The EMA released a draft of their policy that was dramatically restrictive. Redacted and abbreviated data would be released with a screen-only interface. There was a universal outcry and the European Ombudsman initiated an investigation. | |
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JUN·2014 | And as we closed in on the date the policy was to be announced, another U-turn. They dropped the screen-only interface part and reassured us that their commitment to data transparency was unwavering. But the wariness had, by this time, spread throughout the land. | |
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JUL·2014 | Then, at the 11th hour of announcing their definitive policy, they postponed the release until their October 2nd Board Meeting to get the "wording" right. The Defcon Level rose to wariness²… | |
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SEP·2014 | And while we waited, the other shoe dropped. The new EU President, Jean-Claude Juncker, moved the EMA from the directorate general for health and consumers [DG SANCO] to the directorate general for the internal market, industry, and entrepreneurship [DG ENTR] – reversing the decision of his predecessor. The Defcon Level rose above wariness³ [a major setback]… | |
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OCT·2014 | When the EMA policy was finally released, it was an certainly better than what had preceeded it [which was nothing], but it was nowhere close to where they started in July 2012. Even more disappointing, it didn’t fully clarify several points eg what does a CSR actually contain? the access to the IPD was postponed, etc. I suppose it could’ve been worse, but it had promised to be so much more… | |
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