Open Medicine EU

Archives for BioTech

I was irritated recently when I went to a presentation here in Brussels of a survey on off-label prescribing by the Irish Patients Association (IPA). I don’t blame the IPA for this – they presented a perfectly valid study, but I felt the meeting overall was serving another purpose or agenda. The survey, and the… » read more

Posted by Jim Murray

In December, I argued for more transparency in relation to clinical trials, and hoped that the Commission would take up this issue in the forthcoming revision of the Clinical Trials Directive. I thought it might be useful to look at particular cases where more or earlier transparency might have saved lives or reduced harm. Take… » read more

Posted by Jim Murray

I’ve been looking at DG Sanco’s plans for medicines for 2012, and I am disappointed. Two years ago, DG Sanco took over the medicines dossier in the European Commission from DG Enterprise. Many people, myself included, had argued for years for such a transfer – to separate responsibility for medicines from responsibility for promoting the… » 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

What’s New?

I mentioned in passing in my last post that new medicines are not necessarily innovative. This can be seen in the 2010 Report of the French National Health Authority, the “Haute Autorité de santé”. The authority’s “Commission de la Transparence (évaluation des médicaments)” evaluates the efficacy of each medicine under two headings – the therapeutic… » 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

It’s Hard to be Good

To get approval for a new medicine it is necessary to provide evidence that the medicine works – which usually means showing that it is better than a placebo. It is not usually necessary to provide comparative data showing how the new medicine measures up against an existing medicine or treatment. Good comparative data helps… » read more

Posted by Jim Murray

The UK is not the only country where opinions on medicines can be challenged in court. In France, Astellas Pharma, a Japanese multinational pharmaceutical company has filed a lawsuit in Paris against the independent French medical journal, Prescrire, for publishing unfavorable comments about their anti-eczema ointment, tacrolimus (brand name – Protopic). The case arises from… » read more

Posted by Jim Murray