French regulatory reform promised over diabetes drug scandal

The controversy surrounding Servier's withdrawn diabetes drug Mediator and its possible link to up to 2,000 deaths, a story which has engulfed France in the past few months, is blazing on.

The furore began in November when the French health agency CNAM (Caisse Nationale d'Assurance Maladie) said that Mediator (benfluorex), which was withdrawn in France a year earlier, had caused 500 deaths in the 30-odd years it had been on the market. Now a government agency report has said the drug, which was linked to heart valve damage, was the cause of up to 2,000 deaths and should have been pulled from the market ten years earlier, when several European countries and the USA had withdrawn the treatment.

The BBC has reported that French health minister Xavier Bertrand has now promised a complete revamp of the country's medical regulatory system following the scandal surrounding Mediator which was also prescribed as an appetite suppressant. It quotes the minister as saying that it was now his duty to rebuild the regulatory system to protect the public, after the report concluded it was incomprehensible that the authorities had not acted sooner.

The AFP news agency says that Mr Bertrand claimed that Servier "had primary and direct responsibility" about the case, and "they should respond to their actions". The privately-owned group acknowledged last week that Mediator was associated with a "true risk".

However the BBC notes that Servier disputes the figures which have been mentioned, saying that there are only three documented cases where death can be clearly attributed to Mediator. A judicial investigation has been launched to establish any criminal responsibility while last week saw a number of lawsuits being filed in French courts.

The scandal has already led to the resignation of Jean Marimbert, head of Afssaps, the French public health agency. 

via pharmatimes.com

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