Open Medicine EU

Some MEPs Work Very Hard

I sometimes feel sorry for MEPs, and not just at Christmas. I’m thinking of those who do a good job as rapporteur on important dossiers, such as the revision of the Clinical Trials Directive. They put this on their website and in their press releases but in most cases their constituents have no idea what… » read more

Posted by Jim Murray

According to rumour, we are making progress on transparency in the revision of the Clinical Trials Directive but the industry (and the Commission, apparently) are fighting back on two other fronts – the proposed free trade and investment agreement with the US (TTIP), and a recent proposal from the Commission for a directive on trade… » read more

Posted by Jim Murray

Could it happen here?

There have been many serious cases of mis-selling and off-label promotion of medicines in the US. Could the same thing be happening here, or do pharmaceutical companies behave better on this side of the Atlantic? For my BMJ blog I compiled a table of cases taken by the US Department of Justice since 2004 involving… » read more

Posted by Jim Murray

Blogging at the BMJ

The British Medical Journal have invited me to be a guest blogger. My first effort has just been published, and you can see it here But, don’t worry! I will continue with this blog.

Posted by Jim Murray

I made a personal submission to the EMA Consultation on the Publication and Access to Clinical-Trial Data, which you will find here. As I said in the submission, public consultations are more effective when it is possible … to comment on submissions from others. My submission was partly in the form of a comment on… » read more

Posted by Jim Murray

HARD TALK ON SOFT LAW

“Are you aware you are working in a health care industry with patients and human beings?” It Is not often you hear a regulator putting this question to a speaker from the pharmaceutical industry but this happened (twice) at a meeting I attended a couple of weeks ago. The speaker was Neal Parker, a lawyer… » read more

Posted by Jim Murray

The Report on Clinical Trials agreed yesterday in the ENVI Committee would bring more transparency than before, but less than was originally proposed by the Rapporteur, Glenis Wilmott. She had proposed the publication of a Clinical Study Report within one year of the completion or termination of a trial. The compromise agreed a two stage… » read more

Posted by Jim Murray

The proposal for the revision of the Clinical Trials Directive will be discussed tomorrow (29th May) in the Envi Committee of the European Parliament. On transparency and disclosure of trial results I am not hearing good news. The rapporteur, Glenis Wilmott, made a good proposal in her report – for the publication of a Clinical… » read more

Posted by Jim Murray

Like AbbVie, described in my last post, a second American company, InterMune, has taken legal action to prevent or restrict the European Medicines Agency from disclosing certain clinical trial data after a medicine is approved for marketing. On 4th March a federal appeals court upheld the conviction of the former chief executive of InterMune, W.… » read more

Posted by Jim Murray