Open Medicine EU

Archives for EU Institutions

Thanks to friends in HAI for telling me about a bizarre case before the European Ombudsman. It is a complaint from an employee of the European Medicines Agency, alleging that the agency is guilty of maladministration in forcing her to sell her shares in a pharmaceutical company. This is the summary of the complaint on… » read more

Posted by Jim Murray

The issue of open access to clinical trial data is getting more attention among EU decision makers – as shown by a lunch discussion in the European Parliament on 6th June. About fifty people attended, with many turned away for lack of room. In a sometimes technical paper, Dr Wolf-Dieter Ludwig from the Drug Commission… » read more

Posted by Jim Murray

The issue of open access to data from clinical trials is moving to the fore. Four regulators, from the British, Dutch, French and European medicines agencies, have responded to an earlier paper arguing for open access in PLoS Medicine. This is high level stuff. The authors reject the notion that clinical trial results could be… » read more

Posted by Jim Murray

Nobody has a greater interest in access to clinical trial data than patients. Patients are exposed to the possibility of some risk, small it is hoped, when they enroll in a clinical trial and yet the sponsoring company owns the trial data and decides when, how, whether and to what extent the results are published.… » read more

Posted by Jim Murray

I covered previously the written question from Nessa Childers MEP arising from the extensive bribery of surgeons in Greece some years ago – see my earlier post here. The Commission has now given an answer, and it is bizarre. While the bribery was going on, certain orthopedic devices were twice as expensive in Greece compared… » read more

Posted by Jim Murray

I’ve just read four papers on access to clinical trial data published in open access (no paywall) in “Circulation: Cardiovascular Quality and Outcomes”, a journal of the American Heart Association. One is a paper by Peter Gotsche, essentially a written version of his address to a seminar in the European Parliament which I covered in… » read more

Posted by Jim Murray

In my post on the Innovative Medicines Initiative I mentioned the danger that industry subsidies might sometimes be “little more than corporate social welfare, subsidising an already rich industry or, worse, paying for something that industry would otherwise have done for itself”. That was meant as a general point and not as a specific comment… » read more

Posted by Jim Murray

I spent an interesting morning last week in the European Parliament at a presentation of the Innovative Medicines Initiative. IMI is a joint undertaking between the European pharmaceutical association EFPIA and the EU to carry out projects, mostly in pre-competitive research, to help develop new and innovative medicines. (New medicines are not necessarily innovative –… » read more

Posted by Jim Murray

The recent conference in Cork on conflict of interest was extremely interesting and will provide the basis for a few posts on this blog – the speakers’ presentation can be seen here. In a well received intervention, Noel Wathion of the European Medicines Agency announced that the agency would now publish an electronic declaration of… » read more

Posted by Jim Murray