In 2009, Prescrire warned its readers about the fact that topical tacrolimus, used to prevent relapse in eczema, carried risks that were too great in relation to the drug’s questionable efficacy.
The drug company Astellas Pharma filed suit against Prescrire, on the grounds that the drug's marketing authorisation was sufficient proof of a favourable risk-benefit balance, and that casting doubt upon this constituted "denigration".
In 2011 France's Tribunal de grande instance de Paris ruled against Astellas Pharma in its suit against Prescrire. The court pointed out that Prescrire is entitled to the freedom to inform and to criticise, including freedom to criticise a marketing authorisation, as long as this criticism is based upon an in-depth analysis of the drug's evaluation data, which was indeed the case.
The court's ruling is good news for patients. The healthcare professionals who provide their care can get the information they need to deliver quality care, to keep them informed and to involve them in choosing the best option at any given time, in full view of the situation in its entirety. Independent information, and not just the information provided by the companies that market the drug, or by the agencies that authorised its sale. So that healthcare professionals can continue to be informed about a drug's unfavourable risk-benefit balance, even if the regulatory agencies have decided to authorise its sale.
Prescrire's editorial team will continue to carry out its thorough analysis, in all independence, first and foremost in the interest of patients.
©Prescrire 1 July 2011
"Freedom to inform" Prescrire Int 2011; 20 (118): 172. (pdf, free)