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European Medicines Agency Responds To Criticism 0f Staff Member

The European Medicines Agency has responded to a letter from a French member of parliament criticizing the conduct of an Agency staff member. The letter from Mr Gérard Bapt to EU Commissioner John Dalli claims that Dr Xavier Kurz currently working in the Agency’s pharmacovigilance and risk management sector minimised and contested a safety signal when he drafted a report in 1994 on aortic valve deficiencies in patients taking anorectic agents such as fenfluramines while working for the Belgian Center of Pharmacovigilance.

The letter from the Agency to Mr Bapt clarifies key facts and describes Dr Kurz’ important role in highlighting the risk associated with fenfluramines which is now considered as a key element in the first European review of the benefit/ risk of anorectic agents. A subsequent European Commission Decision of 9 December 1996 on this review can be linked directly to the issues raised in the study co-authored by Dr Kurz.

Dr Kurz has worked at the Agency as a pharmacovigilance expert since 1 September 2005.

Posted: July 2011