one of France's biggest medical scandals of recent years


what's Mediator
Mediator was marketed to overweight diabetics but often prescribed to healthy woman as an appetite suppressant when they wanted to lose a few pounds.

what Happened

By now, the drug has killed at least 1800 people (diabetics and healthy people) from heart valve damage. On top of that, 4200 people have cardiovascular complications (kidney failure and strokes) that limited their daily lives.

The drug was sold to 5.000.000 people between 1976 and 2009

who's responsible
Mediator was produced by Servier Labaratories, France's second biggest pharmaceutical company.. Jacques Servier, head and founder of Servier, faces charges of 'aggravated deception', and manslaughter.

How could this deadly drug be on the market for 33 years without someone taking action? Who are to blame and who are involved?

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We first take a look at how the affair unfolds from the creation of the drug to the most recent events in Servier's trial.


UK The drug was never authorised in these countries.


Irene Franchon
publishes book about Mediator

Servier withdraws Benfluorex by not re-applying for marketing authorisation   France
November 2009, AFSSAPS suspends marketing of Benfluorex in France, citing both efficacy and safety issues. Servier withdraws the drug worldwide
IGAS publishes report about the "Mediator scandal"
Italian regulators raise concern because of the pharmacovigilance investigation of Benfluorex   Two cases of cardiovascular complications. This is the year in which benfluorex should have been withdrawn.   Irene Frachon (physician) discovers dangers of Mediator in own research

Servier creates three types of drugs:

Benfluorex (Mediator)

All three drugs are pharmacologically linked. Yet, Servier classifies them separately, for different types of diseases.

20 years later, this has serious consequences when the AFFSSAPS takes down the fenfluramines but not Benfluorex, because of the classification.

healthcare organisation IGAS
notifications from the 2011 report

countries selling Mediator
(no data from Asia and Afrika)

medicines Agency AFSSAPS
French drug regulators

Trail against Servier

Under a European Directive, benfluorex (and all other drugs approved before 1976) is re-assessed, and approval in the diabetes setting is not upheld. A revised marketing approval is not issued
The use of Fenfluoramine is restricted because of cardiovascular safety concerns.
is withdrawn, but benfluorex remains on the market. French drug regulator AFSSAPS revokes approval of benfluorex for diabetes in April, only to rescind the action 2 months later.
placed under "official" pharmacovigilance investigation in France, due to its "potential danger".
taken off the market
AFSSAPS is aware of the expired but fails to take action
AFSSAPS begins another review of benfluorex safety. Approval for hyperlipidaemia, but not diabetes, is revoked.
AFSSAPS publishes study
based on data from
Januari 2011
French association of drug manufacturers (LEEM) suspends Servier in an attempt to distance themselvesfrom the affair.
Februari 2011
First trail, Servier offers victems 20 million.
116 charges so far.
May 2014
Servier charged with:
- aggravated deception
- medical injury
- manslaughter
- (corruption, related trail)
personal connections and money
pressure and influence
monitoring and research

pharmaceutical industry, Servier

donations   lobbying  


French drug authorities and
medical community.

Jacques Servier
receives highest award in knightly order of French President Nicolas Sarkozy. Sarkozy used to be the lawyer of Servier.
Cardiologist Chiche contact the authorities because of his concerns regarding Mediator. Later he was called by a local politician who sentenced him that there was no link between the drug and the side effects.

French government

It's clear that despite the obvious signs it still took 33 years before the drug was fully banned. The answer lies within these four key culprits:

- Distinct classifications of Benfluorex by Servier
- Overly complex bureaucracy and fear of litigation within AFSSAPS
- Aggressive marketing tactics by Servier
- Unhealthy ties between industry and regulators

AFSSAPS recently published a list of 77 drugs that it has placed "under reinforced surveillance" because of undesirable side-eff ects. But some still wonder how effectively the agency would be able to take action on these.

These culprits seem to be the base of a bigger problem that involves the entire health care system. With the lobbying power of the pharmaceutical companies and the inefficiency of organizations like AFSSAPS it's just waiting for a new disaster.

It's clear that change is needed, IGAS sets out two recommendations:

- separate pharmaceutical lobbyists from drug regulators

- safeguards against political influence over regulatory decisions

AFSSAPS is working on a second report outlining a set of recommendations for regulatory reform. It hopes to propose a system that is "entirely focused on the interests of patients and of public health". And everybody agrees that change is needed.

Mediator: sterfte op recept. Joop Bouma - Februari 9, 2011
World Report Vol 377 - March 12, 2011
Slachtoffers Mediator blij met oprichting Frans fonds. - April 7, 2011
Mediator scandal engulfs French compensation body. The Lancet, Volume 381, Issue 9880 - May 25, 2013