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 [...]

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 [...]

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 [...]

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 [...]

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 [...]

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 [...]