Archive for the 'Health' Category :

New battles in the struggle for transparency

Posted by jim on 16/12/13

According to rumour, we are making progress on transparency in the revision of the Clinical Trials Directive but the industry (and the Commission, apparently) are fighting back on two other fronts – the proposed free trade and investment agreement with the US (TTIP), and a recent proposal from the Commission for a directive on trade [...]

Could it happen here?

Posted by jim on 09/12/13

There have been many serious cases of mis-selling and off-label promotion of medicines in the US. Could the same thing be happening here, or do pharmaceutical companies behave better on this side of the Atlantic? For my BMJ blog I compiled a table of cases taken by the US Department of Justice since 2004 involving [...]

Submission to the European Medicines Agency

Posted by jim on 08/10/13

I made a personal submission to the EMA Consultation on the Publication and Access to Clinical-Trial Data, which you will find here. As I said in the submission, public consultations are more effective when it is possible … to comment on submissions from others. My submission was partly in the form of a comment on [...]

HARD TALK ON SOFT LAW

Posted by jim on 17/09/13

“Are you aware you are working in a health care industry with patients and human beings?” It Is not often you hear a regulator putting this question to a speaker from the pharmaceutical industry but this happened (twice) at a meeting I attended a couple of weeks ago. The speaker was Neal Parker, a lawyer [...]

A bigger Voice on the EMA case

Posted by jim on 10/05/13

The European Voice has just published my opinion piece on the legal actions taken against the European Medicines Agency. It’s behind a paywall but you can read it here.

Pharma vs The European Medicines Agency – the case of InterMune

Posted by jim on 02/05/13

Like AbbVie, described in my last post, a second American company, InterMune, has taken legal action to prevent or restrict the European Medicines Agency from disclosing certain clinical trial data after a medicine is approved for marketing. On 4th March a federal appeals court upheld the conviction of the former chief executive of InterMune, W. [...]

Pharma vs the European Medicines Agency- the case of AbbVie(Abbott)

Posted by jim on 01/05/13

Two American pharmaceutical companies, AbbVie and Intermune, have taken legal action to prevent or restrict the European Medicines Agency from disclosing certain clinical trial data after a medicine is approved for marketing. In my opinion, both companies have been involved in activities that seem to prove the need for more transparency and not less. AbbVie [...]

Clinical Trials in the European Parliament

Posted by jim on 08/04/13

Well, it’s been a long time since my last post but I have not been neglecting the subject of science and medicine. I have been following the progress of the European Commission’s proposed regulation to revise the Clinical Trials Directive, and have just published an article on the subject in Euractiv, which you can find [...]

Good Book Bad Pharma

Posted by jim on 03/12/12

At a recent lunch in the European Parliament I met a hero of mine, Dr Ben Goldacre, author of Bad Pharma, a great book on science and medicine in the pharmaceutical industry. It is a worthy follow-up to his earlier best seller Bad Science, also a favorite of mine. “Bad Pharma” is not anti-industry but [...]

New Rules for Clinical Trials

Posted by jim on 18/10/12

I have been looking at the proposed regulation for the revision of the Clinical Trials Directive. To help my own understanding I prepared a “simplified” summary of most of the provisions of the proposal, which I am happy to share here. I welcome comments, especially from anyone who feels I’ve got it wrong on any [...]

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