Exposé Mediator

Today, i’m going to talk about : The scandal of

Mediator medicine in France

My problematic is : What should we learn from this case?

Firstly I will define you Mediator, namely its role and its risks and

secondly, I will explain the progress of the case.

I - What is Mediator ?

A) The role of this medecine

Marketed on the French market since 1976 and manufactured by the

Servier laboratories , the Mediator is a drug composed of benfluorex , an

active molecule aimed primarily at reducing the lipids like cholesterol

circulating in the blood. It was then indicated for overweight patients with

type 2 diabetes according to their marketing authorization. Benfluorex

reduce the level of sugar in the blood.

B) The Risks

Benfluorex promotes the malfunctions of heart valves like the pulmonary

valves. These heart attacks may go unnoticed for years. But sometimes,

symptoms are present: heart failure , shortness of breath with effort,

pulmonary edema ... A sick heart valve is fragile and very sensitive to

infections. Cardiac involvement is not the same for all patients and also

depends on the Mediator's set time.

II - The start of the case

A) Where does the scandal come from?

1976: the Mediator (benfluorex) is marketed by the Servier laboratories.

It is intended for overweight diabetics but is also prescribed as an

appetite suppressant.

2007: the French Agency for Health Safety of Health Products

recommends no longer prescribe it as an appetite suppressant.

Irène Frachon, a respirologist at the University Hospital of Brest, warns of

the dangers of the Mediator, after having investigated for 10 years on its

cardiac effects at the Agence du médicament. It will publish two years later

the best-selling book " Mediator 150g, how many deaths? ".

2009: the Mediator and its generics are withdrawn from the sale in France

by ANSM.The truth breaks out in the press and the affair turns to sanitary

scandal. In total, 5 million people used the Mediator ® in France between

1976 and November 2009.

2011: the General Inspectorate of Social Affairs reported to the Ministry

of Health and concluded that the number of deaths is estimated

between 500 to 2,000 people. In August of the same year, an

investigation opened in Paris for "aggravated deception", "illegal taking

of