Archive for the 'Health' Category :

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 [...]

The 3 Billion Dollar GSK Case (Part 1)

Posted by jim on 05/10/12

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 [...]

MEP Speaks out on GSK Case

Posted by jim on 13/07/12

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 [...]

Is Screening Good For You?

Posted by jim on 09/07/12

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 [...]

100 000 Suspected Adverse Drugs Reactions

Posted by jim on 26/06/12

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 [...]

Conflict of Interest in the European Medicines Agency – Part II

Posted by jim on 26/06/12

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 [...]

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