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Pressure mounts on Servier over Mediator controversy

Published on 03/02/11 at 01:45pm
Mediator patient representative
Patient representatives are seeking to sue Servier for alleged damage caused by Mediator

Dr Jacques Servier has stepped down from his role as head of a French pharma industry association as controversy grows around the Mediator affair.

Dr Servier is the president and founder of the pharmaceutical company Servier, which has been caught up in a major safety scandal concerning its diabetes treatment Mediator (benfluorex).

The drug was developed as a diabetes treatment but millions of people used it to help them lose weight, and it was withdrawn from the French market in November 2009 because of safety concerns. 

New research suggests it is linked to at least 500 deaths in France between 1976 and November 2009.

The controversy has badly damaged the reputation of France’s medicines regulator AFSSAPS, as well as Servier, one of the country’s biggest pharma companies.

The 88-year-old Dr Servier has now stepped down from his role as president of the G5 industry group, which represent Ipsen, Pierre Fabre, Sanofi-Aventis, Servier and LFB.

The G5 group said Dr Servier was stepping down in order to concentrate on rebuilding his company’s reputation.

Dr Servier is due to appear in court on 11 February in a case brought by alleged victims and their relatives, claiming that his company did not “behave in a transparent way” and made ‘misleading claims’ about its diabetes drug Mediator.

On the 15 January the French health minister Xavier Bertrand said he would undertake a radical reform of the French medical regulatory system, after an official report showed that Servier’s diabetes drug had caused up to 2,000 deaths from heart disease. Bertrand has also stated that the blame lay squarely with Servier, but also pointed to failings at AFSSAPS.

The health minister has vowed to end the current system of financing the drug regulator, which currently obtains 80% of its funding from charges to pharma companies.

A report written by the Social Affairs Inspectorate, said the drug should have been banned 10 years earlier and added that it was ‘incomprehensible’ that the authorities had failed to act sooner.

The affair has become politicised as Dr Servier is reported to have had high-level political connections.

Marc de Garidel, the president of Ipsen, will become the new president of the G5, and Olivier Bohuon, the managing director of Pierre Fabre, has become its new spokesman.

In light of these reforms, the G5 has said it would revisit its fundamental commitments to ensure that another case such as Mediator could not arise.

This includes their commitment to better serve the patient through innovation and ensuring better monitoring of all their medications.

The G5 says it supports the proposals for reform and the aim of achieving greater transparency from pharma companies.

In particular, it fully supports one of the key ideas of the reform agenda which involves publishing a list of links between experts and laboratories, and the amount of money paid for services rendered.

Ben Adams

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