Open Medicine EU

Archives for BioTech

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

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

In an unusual move the European Medicines Agency has criticised the Roche pharmaceutical company for not analysing and reporting on over 100 000 suspected adverse drug reactions in the US and elsewhere. About 80 000 reports from a company sponsored “patient support programme” were not evaluated. These included 15,161 reports of deaths, but it is… » 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

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