Health Law

[Note: this Blog was originally written for and appeared as Guest Blog in PLoS' Blog "Speaking Of Medicine" (May 30, 2014) Reproduced here with permission]

Things were looking good recently in Europe for data transparency, a necessary, albeit not sufficient, tool to promote integrity of pharmaceutical data. The European Court’s Vice-President overturned in November 2013 two lower court interim suspensions of EMA’s data access decision in relation to Abbvie’s drug Humira and Intermune’s Esbriet, which had stalled EMA’s data release approach. Shortly after, Abbvie withdrew the Humira lawsuit. Then in April 2014, the European Parliament approved the new Clinical Trials Regulation that introduced a requirement to register all clinical trials and make all clinical study reports in relation to EMA approved drugs publicly available. These developments put EMA again in the driver’s seat for the further implementation of its promised prospective data release policy.

In an earlier blog of October 15, 2013, I reported on the controversy surrounding the death of Dan Markingson, a patient who participated in a controversial clinical trial of anti-psychotic medication, in a University of Minnesota hospital. (To get a sense of the wider concerns the case raises about clinical trial practices and human research protection, see the earlier blog, various links there, and recent blogs by Bill Gardner, Dale Hammerschmidt and Kirstin Borgerson). I was happy to report in a follow-up blog in December that a request for an independent inquiry, supported by more than 170 scholars in health law, research ethics, medicine and other relevant disciplines, and directed at the University of Minnesota Senate, appeared at first sight successful.