Open Medicine EU

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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

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

Two American pharmaceutical companies, AbbVie and Intermune, have taken legal action to prevent or restrict the European Medicines Agency from disclosing certain clinical trial data after a medicine is approved for marketing. In my opinion, both companies have been involved in activities that seem to prove the need for more transparency and not less. AbbVie… » read more

Posted by Jim Murray

Well, it’s been a long time since my last post but I have not been neglecting the subject of science and medicine. I have been following the progress of the European Commission’s proposed regulation to revise the Clinical Trials Directive, and have just published an article on the subject in Euractiv, which you can find… » read more

Posted by Jim Murray

Good Book Bad Pharma

At a recent lunch in the European Parliament I met a hero of mine, Dr Ben Goldacre, author of Bad Pharma, a great book on science and medicine in the pharmaceutical industry. It is a worthy follow-up to his earlier best seller Bad Science, also a favorite of mine. “Bad Pharma” is not anti-industry but… » read more

Posted by Jim Murray

I have been looking at the proposed regulation for the revision of the Clinical Trials Directive. To help my own understanding I prepared a “simplified” summary of most of the provisions of the proposal, which I am happy to share here. I welcome comments, especially from anyone who feels I’ve got it wrong on any… » read more

Posted by Jim Murray

I’m back after a (very) long summer break. There were two significant events in July. One was a US fine of $3 billion for Glaxo Smith Kline for mis-selling various medicines and other bad practices. The other was the publication by the European Commission of a proposal to revise the directive governing clinical trials. The… » read more

Posted by Jim Murray

Glenis Wilmott, MEP, leader of the UK Labour Group in the European Parliament has posted a blog here on the GlaxoSmithKline fraud case. I will look at this case myself more closely in a future blog (I’m on holidays in Ireland at present). It has implications for the regulation and reporting of clinical trials, as… » read more

Posted by Jim Murray