A French court has ruled that a critical article published by thePrescrire medical journal did not tarnish the reputation of the Protopic eczema ointment that is sold by Astellas Pharma, which sued the publication for denigrating its medication. The decision by the Paris tribunal was closely watched because the lawsuit raised concerns about the ability of medical journals in France, and perhaps elsewhere, to freely publish critiques that drugmakers may find offensive without fear of being taken to court.
A 2009 article questioned the preventive use of the ointment and maintained the risk-benefit balance was negative. Astellas, which was seeking nearly $14,000 in damages, charged the piece was misleading and suggested the criticism was part of a smear campaign. Prescrire countered that "freedom of expression and exercise of freedom of criticism are at stake.” The journal has actually run several articles about the ointment, which is also known as tacrolimus (see the list).
However, the judges on the Tribunal de Grande Instance de Paris found that "expressing his opinion on the merits of Protopic...but without distortion of the facts by calling the attention of prescribers (to)the adverse effects of such treatment and the reported cases of cancer which could be involved, 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," according to Le Figaro.
"What is at stake in a decision of this kind," Prescrire's lawyers say in a statement, "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."
We have asked Astellas for a comment and will update you accordingly. UPDATE: A spokeswoman sent us this: "Astellas Pharma believe that the information published by Prescrire about Protopic (tacrolimus ointment) is potentially misleading, and is disappointed with the outcome of yesterday’s court ruling. We remain confident in the safety and efficacy profiles of Protopic in patients with atopic dermatitis." EDITOR'S NOTE: This item was posted on Wednesday night, March 2, but we have placed it higher up on the page in the event that some readers would not have noticed it this morning.