{"id":46479,"date":"2014-05-23T23:00:10","date_gmt":"2014-05-24T03:00:10","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=46479"},"modified":"2014-05-23T23:10:33","modified_gmt":"2014-05-24T03:10:33","slug":"the-end-game","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2014\/05\/23\/the-end-game\/","title":{"rendered":"the end game…"},"content":{"rendered":"
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No matter how often I’ve thought about the analogy between the board game of chess and the world of politics and business where the moves people behind the scenes make have an enormous impact on the lives of real people, it’s never hit home so poignantly as when it’s something that affects me personally. The release of the DSM-III in 1980 was like that. Within a short period of time, my career was completely changed in a direction I couldn’t have previously imagined. The current situation I’m referring to has to do with the recent decision of the European Medicines Agency<\/font><\/strong> to radically restrict their policy on access to the data in clinical trials.<\/p>\n

For four years, the EMA has said that it will release all clinical trial data to qualified researchers essentially opening the door to the kind of Data Transparency vital to insure the integrity of Clinical Trial reporting. It was a hard won fight involving the Cochrane Collaboration, the BMJ, the AllTrials campaign, those working on the Tamiflu issue, etc. Even some of the drug companies came on board. But then it came to a halt when two drug companies, AbbVie and InterMune, sued the EMA and the court ordered a temporary stay on data release. And then, on April 3rd, we got the news [AbbVie drops legal action in EU drug secrecy case<\/a>]. My post about that was called a sunny day…<\/a>, but I recall feeling wary…<\/p>\n

Now we read this:<\/div>\n
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EMA’s data sharing policy—towards peeping tom based medicine?<\/a><\/div>\n
BMJ Blogs<\/div>\n
by Tom Jefferson, Peter Doshi, and Trudo Lemmens<\/div>\n
May 22, 2014<\/div>\n

… We had been part of EMA’s clinical trials advisory groups responsible for advising EMA on its proactive release policy: how, going forward, EMA is to share clinical trial data from trials of pharmaceuticals that had been through the regulatory process. Everything seemed to proceed smoothly. Then Trudo, on 24 April, and Tom on 8 May, received warning of a “meeting with academics” to discuss the finalization of the EMA policy. The meeting was scheduled for 10 am GMT, a time that was very awkward for the North-Americans who were included. Peter never received an invitation despite serving on two of the EMA advisory groups. Because of the short notice Tom and Trudo could not reschedule to be at the EMA meeting in London. Tom relied on phone attendance, very much second best, to follow what was going on.<\/p>\n

When Tom and Trudo opened the background documents [admittedly two days before the meeting] they got a shock. No clinical study reports would be proactively released. The companies are apparently being put in the driver’s seat: they will prepare special redacted reports for public use and negotiate their content with the EMA. But no one will be allowed to download even these redacted reports. Screen-only viewing will be allowed without screen capture. The Terms of Use document also contains a list of further transparency exceptions. A noticeable exception is that “novel statistical or other analytical methods and exploratory endpoint results about potential new uses of a medicine” could be commercially confidential. Safety and efficacy data about off-label prescribed drugs could thus be kept out of third party view.<\/p>\n

The Terms of Use contract also contains highly contested clauses and strengthens companies’ control over the process. “The User<\/em> acknowledges that the Information<\/em> is protected by copyright and proprietary rights of the Information Owner<\/em> and can be considered commercially valuable when used for commercial and regulatory purposes.” Researchers thus will have to contractually affirm companies’ legal rights in data, even if these rights are still not clearly established in law and are currently still debated in court cases, including in a case in which EMA is involved. “The User<\/em> acknowledges that the Information<\/em> will be made available to the User<\/em> in a “view-on-screen-only” mode, after completing the registration process. The User<\/em> agrees that the User<\/em> is not permitted to download, save, edit, photograph print, distribute or transfer the Information. The User<\/em> agrees not to access the Information<\/em> using a method other than the interface provided by the EMA, or remove, bypass, circumvent, neutralise or modify any technological protection measures which apply to the Information<\/em>.” Most surprisingly, the draft documents indicate that EMA will ask data users [i.e. researchers] to contractually agree that third parties [i.e. pharmaceutical companies] will have direct legal claims under UK law against them for possible violations of the Terms of Use. Infractions to the cumbersome procedural limits could thus not only be punished by withdrawal of access. Should the EMA’s draft policy be adopted as presently proposed, it appears to open up the possibility of spurious lawsuits over “misuse of data” that essentially silence critics…<\/div>\n<\/blockquote>\n
One can only see this as a massive turnaround, and I presume it was a concession to AbbVie to get them to drop their suit. Though I don’t know that to be true, I can think of no other reason for such a radical about face:<\/div>\n