100 000 Suspected Adverse Drugs Reactions
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...
View ArticleIs Screening Good For You?
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,...
View ArticleMEP Speaks out on GSK Case
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...
View ArticleThe 3 Billion Dollar GSK Case (Part 1)
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....
View ArticleNew Rules for Clinical Trials
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...
View ArticleGood Book Bad Pharma
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...
View ArticleClinical Trials in the European Parliament
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...
View ArticlePharma vs the European Medicines Agency- the case of AbbVie(Abbott)
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...
View ArticlePharma vs The European Medicines Agency – the case of InterMune
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...
View ArticleA bigger Voice on the EMA case
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.
View ArticleHARD TALK ON SOFT LAW
“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...
View ArticleSubmission to the European Medicines Agency
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...
View ArticleCould it happen here?
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...
View ArticleNew battles in the struggle for transparency
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 –...
View ArticleSome MEPs Work Very Hard
I sometimes feel sorry for MEPs, and not just at Christmas. I’m thinking of those who do a good job as rapporteur on important dossiers, such as the revision of the Clinical Trials Directive. They put...
View ArticleMedicines, Industry and Trade
For years, BEUC and many other organisations pressed for the transfer of responsibility for medicines from DG Enterprise to DG Sanco. It seemed wrong that one DG should combine responsibility for...
View ArticleComments on the Proposal for a Directive on Trade Secrets
These are my notes for a speech I made today in the European Parliament on the proposal for a directive on trade secrets. 1 I will not say anything here about the proposal itself in terms of its...
View ArticleTwo days – two pieces of good news
Yesterday (2nd April) the Plenary Session of the European Parliament approved the final text of the Regulation revising the Clinical Trials Directive. The announcement from the Parliament can be seen...
View ArticleUh Oh – Did I Speak Too Soon?
Abbvie’s withdrawal of the case against the EMA was not entirely unilateral – it followed an agreement by the agency to accept a redacted version of the document they were going to publish in January...
View ArticleTransparency – Why the Change in EMA Policy?
There has been an apparent volte-face by the European Medicines Agency on its earlier promise of a pro-active transparency policy that was about “establishing trust and confidence and enabling...
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