Open Medicine EU

Archives for Science & Research

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

At an award ceremony a few days ago, the overall winners of the 2011 EU Health Prize for Journalists were Ben Hirschler and Kate Kelland from the UK, with an article on antimicrobial resistance “When the drugs don’t work”. The second prize went to Rita Makarész from Hungary for her article “The cheapest antidepressant”. The… » 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

I heard a powerful case recently for access to all clinical trial results. The case was made by Professor Peter C. Gøtzsche, leader of the Nordic Cochrane Collaboration in Copenhagen and one of those whose complaint to the European Ombudsman has led to major improvements in transparency in the European Medicines Agency. The occasion was… » 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

I’ve been looking more closely at the bribery of doctors and health care officials in Greece. My sources are mainly UK court documents, and documents released by UK Serious Fraud Office and the Securities and Exchange Commission and the Department of Justice in the US. The bribery lasted for about eight years from 1998 onwards.… » 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