Mediator: who's to blame?

摘要

Asher Milliard's World Report summarising the story of Mediator (benfluorex; March 12, p 890) shows that there are important lessons to be learned about dealing with old drugs. We do not wish to defend the drug, the manufacturer, or the French regulatory system, but to focus on the scapegoating to which Mullard alludes. The regulatory body AFSSAPS has removed Anne Castot and Carmen Kreft-Jais, its most senior pharmaco-vigilance personnel. It is clearly wrong to blame them personally for wider system failings: such people have to work within legal and bureaucratic frameworks and resource limits set by others-ie, politicians and senior executives. It is very easy with hindsight to say that the drug should have been withdrawn in 1999 on the basis of just two cases, but the major problem then was a lack of capacity to undertake rapid pharmacoepidemio-logical research in France to confirm and measure the risk. Also, desire to protect data privacy worked agai nst the availability of suitable data resources.