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23.09.2019 Europe

Trial begins over Mediator drug, behind hundreds of deaths in France

By RFI
(REUTERS/Charles Platiau)
SEP 23, 2019 EUROPE

A landmark trial over one of France's biggest pharmaceutical scandals opens today in Paris. The Mediator pills, made by Servier laboratories and prescribed to overweight diabetics, may have killed over 2,000 people.

Some 2,600 plaintiffs are suing privately-owned Servier laboratories as well as the French drug regulator, the Agence Nationale de Sécurité du Médicament (ANSM) and 12 other people.

The Mediator drug was prescribed to 5 million people in France over 33 years until 2009, when it was finally recalled from the market.

The pills were developed to treat excess weight in Type 2 diabetes patients but were also widely prescribed as an appetite suppressant. It is believed to have caused between 500 and 2,100 related deaths.

The drug is suspected of causing heart and pulmonary failure. It was never authorised in the United States or the United Kingdom. Several countries such as Spain and Italy banned Mediator in the early 2000s.

But France only withdrew it in 2009. The trial will question why the authorities allowed the pill to stay on the market for so long.

Fraud and profits
Servier, one of France's most powerful laboratories, has been charged with fraud for allegedly concealing the risks of Mediator. The ANSM drug watchdog is accused of negligence in being too slow to act and too close to pharmaceutical companies.

Lawyers claim that Servier deliberately misled patients and has been accused of making at least one billion euros from the drug, while being aware of its dangers.

In the 677-page French indictment, magistrates wrote that Servier, from the 1970s, “knowingly concealed the medication's true characteristics” and hid medical studies unfavourable to the product, establishing a long-term fraud.

Servier has said it did not lie about the effects of the treatment and hopes to demonstrate it did not act against patient interests.

The company has paid out almost 132 million euros to victims and says it will continue to pay compensation. 

The trial is expected to last until 30 April 2020.
Dr Irene Frachon, a pulmonologist in Brittany, first raised the alarm about Mediator in 2007. She was instrumental in bringing the case to light through her campaign and investigation.

A 2016 French movie, called "150 milligrams", was based on her work.

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