February 2, 2012 / 8:35 PM / in 7 years

French drug regulator searched in Mediator case

PARIS (Reuters) - Investigators searched the offices of French healthcare regulator Afssaps on Thursday in connection with a case involving the anti-diabetes drug Mediator, which officials blame for at least 500 deaths in France.

Judicial sources said that investigators also searched the homes of several executives of Afssaps, which is under scrutiny for allowing the sale of Mediator long after it had been pulled from the market elsewhere.

Public concern about the agency has been increased by the scandal over breast implants manufactured by the now-bankrupt French company PIP.

“This important operation took place in the presence of the judges in charge of the case, the public prosecutors and 25 investigators,” a judicial source told Reuters of Thursday’s search.

Jacques Servier, the founder of Servier Laboratories which produced Mediator, is being investigated on suspicion of dishonest practices, deception over the drug’s quality, and of falsely obtaining authorization to sell it.

A trial is expected in May.

Mediator - mostly prescribed by doctors as a weight-loss pill - was sold to as many as 5 million people in France between 1976 and November 2009, when it was withdrawn, years after being pulled in Spain and Italy. State health inspectors have said the drug should have been retired in France a decade earlier.

According to the French health ministry, at least 500 people died of heart valve trouble in France because of exposure to Mediator’s active ingredient, benfluorex. Other estimates based on extrapolations put the death toll closer to 2,000.

Servier denies having misled authorities and patients. The company recognizes 38 deaths linked to the drug, but says only four of these were caused by it.

The Mediator scandal - which has already prompted the resignation of the head of Afssaps - is France’s worst in years.

President Nicolas Sarkozy has promised to shake up the healthcare system and make it more transparent in response to a slew of lawsuits filed by groups of victims’ families.

Servier, 89, was awarded France’s national merit medal, the Legion d’Honneur, by Sarkozy - who was once his lawyer - less than a year before the drug was pulled.

Reporting by Gerard Bon; writing by Daniel Flynn

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