Open Medicine EU

Archives for EU Priorities

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

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

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

More experts are questioning the practice of screening in particular cases – the testing of apparently healthy populations for underlying risk factors or undiagnosed conditions, such as some cancers, with a view to prevention or early treatment. Supporters of screening sometimes respond to their critics with more heat than light, but I don’t know who… » read more

Posted by Jim Murray

As I said in my last post, decisions of medicines regulators can affect the share price of a pharmaceutical company. A few recent examples – all from the past week: The shares of Shires PLC sank 10% on Monday when the FDA approved a generic version of a competing drug. The shares of Protalix BioTherapeutics… » read more

Posted by Jim Murray

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