The scandal over a Servier Laboratories diabetes pill, which has been blamed for at least 500 deaths in France, has now ensnared the French regulatory agency. The ANSM has come under formal investigation for alleged involuntary manslaughter over concerns the agency neglected to respond to numerous reports that the Mediator drug, which was withdrawn four years ago, was causing serious harm.
The move comes three months after Jacques Servier, the 90-year-old who founded Servier Laboratories, was also placed under investigation for involuntary manslaughter for allegedly misleading patients and authorities about the drug. In a statement, the ANSM promised to offer the "truth to which the victims, their families and users are entitled," but also noted that the scandal occurred under its predecessor, AFSSAPS, and its functions were boosted last year as part of a reorganization.
As we have written in previous stories, the probe focuses on suspicion of dishonest practices, deception over drug quality and falsely obtaining authorization to sell Mediator, which was often prescribed as an appetite suppressant for diabetics. Five companies under the Servier corporate umbrella are also under investigation. Servier is France’s second-largest drugmaker.
The pill was linked to heart-valve damage and government investigators contended the risks were deliberately concealed. As many as 5 million people took the pill between 1976 and November 2009, when it was withdrawn in France, but that was several years after it was yanked in Spain and Italy. French health inspectors say Mediator should have been withdrawn a decade earlier.
The French health ministry says at least 500 people died of heart-valve trouble in France, although other estimates have placed the death toll closer to 2,000. Hundreds of people say they suffer heart-valve damage and have filed complaints. The active ingredient, benfluorex, is closely related to fenfluramine, one half of the infamous fen-phen weight-loss cocktail. Fenfluramine was withdrawn from the US market in 1997 after being linked to heart-valve damage.
crime scene pic thx to alan cleaver on flickr