Open Medicine EU

Archives for Medicines

I’m back after a (very) long summer break. There were two significant events in July. One was a US fine of $3 billion for Glaxo Smith Kline for mis-selling various medicines and other bad practices. The other was the publication by the European Commission of a proposal to revise the directive governing clinical trials. The… » 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

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.… » read more

Posted by Jim Murray

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… » read more

Posted by Jim Murray