DRUG and medicines watchdog ANSM has been indicted for “manslaughter and involuntary wounding” over its negligence on the drug Mediator, which has been blamed for between 500 and 2,000 deaths.
It is thought to be the first time a government agency has faced criminal charges and the ANSM is accused of failing to highlight and act on problems with the drug, which was long linked to heart-valve problems and deaths.
Mediator was never authorised in the UK or US but was originally used to treat diabetes and then prescribed massively as a slimming aid. It was taken by up to five million patients between 1997 and 2009, when it was taken off the market in France, years after being banned in Spain and Italy.
It was made by the laboratory Servier – whose owner Jacques Servier has himself been charged with manslaughter – and the scandal exposed the overwhelming strength of the drugs lobby in France. Servier’s former lawyer, former president Nicolas Sarkozy, awarded him the Legion d’Honneur less than a year before Mediator was withdrawn.
The lawyer representing several hundred Mediator victims, Jean-Christophe Courbis, told 20 Minutes: “Since the start we have highlighted the failures of this agency, and with it [health safety agency] Afssaps, which allowed laboratories such as those of Mr Servier to prosper.”
He added that ANSM had been complicit in allowing Servier to continue making and selling the drug.