Open Medicine EU

A Paris court has ruled in favour of Prescrire in the case taken by Astellas Pharma. The company had claimed that the independent drugs bulletin had wrongly criticised the use of Protopic (tacrolimus) for long term maintenance/prevention in certain cases of eczema. Congratulations to Prescrire and a sigh of relief. The result was not unexpected but the consequences of a different outcome would have been horrific.

Robust discussion and freedom of expression are essential to good science.

Although lawsuits like this can have bad effects in any case, it is interesting that the defence of cases like this, and the consequences of losing such a case, are nowhere near as ruinously expensive in France as in the UK. British government, please take note.

The Prescrire statement in English is set out below, their statement in French can be read here

Astellas’ lawsuit against Prescrire: French court rules that Prescrire did not “denigrate” Protopic° (tacrolimus)
A Paris court handed down its ruling on Wednesday 2 March, rejecting a suit brought by pharmaceutical company Astellas against the French journal Prescrire. At a time when French society is reeling in the wake of the scandal caused by weight-loss drug Mediator° (benfluorex), the 2 March ruling comes as very good news for healthcare professionals and for patients.

In its September 2009 French edition, Prescrire analysed a new indication for topical tacrolimus (Protopic°, from Astellas) in the prevention of outbreaks of atopic eczema. Prescrire concluded its 2009 article, which is a continuation of an in-depth review published in 2003, by saying that tacrolimus should be avoided in atopic eczema, in view of its unfavourable risk-benefit balance.
The drug company Astellas Pharma filed suit against Prescrire on the grounds of “denigration”, protesting against the “erroneous, or even deceitful, nature of certain critiques contained in the disputed article”.
The Tribunal de Grande Instance de Paris delivered its ruling on Wednesday 2 March, rejecting the suit brought by drug company Astellas. The judges indeed found that Prescrire “did not exceed the legitimate objective that it had set for itself, nor the expectation on the part of its subscribers to have access to a documented critical analysis on a subject which falls into the domain of public interest and healthcare safety”.
What is at stake in a decision of this kind, as Prescrire’s lawyers Jean Martin and Guillaume Prigent pointed out, is recognition of the right to information and the right to criticise, unimpeded by the official position of health authorities, by the kind of censorship that Astellas was attempting to impose. This right must nonetheless be supported by rigorous and fully documented analysis, which the court recognised was indeed the case with Prescrire’s article.
At a time when French society is reeling in the wake at the Mediator° scandal and the failings of its drug regulatory authorities, the 2 March ruling comes as very good news for healthcare professionals and for patients.

©Prescrire 2 March 2011

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