Nobody has a greater interest in access to clinical trial data than patients. Patients are exposed to the possibility of some risk, small it is hoped, when they enroll in a clinical trial and yet the sponsoring company owns the trial data and decides when, how, whether and to what extent the results are published. [...]

I covered previously the written question from Nessa Childers MEP arising from the extensive bribery of surgeons in Greece some years ago – see my earlier post here. The Commission has now given an answer, and it is bizarre. While the bribery was going on, certain orthopedic devices were twice as expensive in Greece compared [...]

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 [...]

I’ve just read four papers on access to clinical trial data published in open access (no paywall) in “Circulation: Cardiovascular Quality and Outcomes”, a journal of the American Heart Association. One is a paper by Peter Gotsche, essentially a written version of his address to a seminar in the European Parliament which I covered in [...]

I wrote a few times, most recently here, about payments for prescribing medical devices in Greece a few years ago. I see now on the website of the European Parliament a Written Question from Nessa Childers MEP on the subject, which reads as follows: “Legal proceedings in the US(1) and in the UK have disclosed [...]

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 [...]

In some previous posts, here and here, I described how (prior to 2006) orthopaedic surgeons in Greece were paid to prescribe particular medical devices such as knee and hip replacements. The bribery was first uncovered under the Foreign Corrupt Practices Act in the US. This was followed by action by the UK Serious Fraud Office [...]

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 [...]

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 [...]

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 [...]

Through misuse, non-compliance, and over-prescribing, as well as natural factors, we are running out of useful antibiotics. Four of the articles chosen as national finalists for the European Health Journalist prize 2011 are about the crisis. The titles of three of the articles give a flavour of the issue: “The end of Antibiotics” (Lithuania), “Losing [...]

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 [...]

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 [...]

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 – [...]

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 [...]