Servier accused of covering up potentially fatal side-effects of the Mediator diabetes drug
29 March 2021 | Kim Willsher | Guardian (original link)
A French court has fined one of the country’s biggest pharmaceutical firms €2.7m (£2.3m) after finding it guilty of deception and manslaughter over a pill linked to the deaths of up to 2,000 people.
In one of the biggest medical scandals in France, the privately owned laboratory Servier was accused of covering up the potentially fatal side-effects of the widely prescribed drug Mediator.
The former executive Jean-Philippe Seta was sentenced to a suspended jail sentence of four years. The French medicines agency, accused of failing to act quickly enough on warnings about the drug, was fined €303,000.
The amphetamine derivative was licensed as a diabetes treatment, but was widely prescribed as an appetite suppressant to help people lose weight. Its active chemical substance is known as Benfluorex.
As many as 5 million people took the drug between 1976 and November 2009 when it was withdrawn in France, long after it was banned in Spain and Italy. It was never authorised in the UK or US.
The French health minister estimated it had caused heart-valve damage killing at least 500 people, but other studies suggest the death toll may be nearer to 2,000. Thousands more have been left with debilitating cardiovascular problems. Servier has paid out millions in compensation.
“Despite knowing of the risks incurred for many years, … they [Servier] never took the necessary measures and thus were guilty of deceit,” said the president of the criminal court, Sylvie Daunis.
The pharmaceutical group was acquitted of charges of fraud.
The scandal, which forced the resignation of the head of France’s public health agency, sparked a furore about drugs regulation and the lobbying power of French pharmaceutical companies.
The trial, which opened in 2019, aimed to establish how the medication was allowed to remain on the market for so long in France. The alarm was raised in 2007 by Irène Frachon, a lung specialist from a Brittany hospital, two years before Mediator was withdrawn. Frachon assessed patients’ records and warned of a link between the drug and serious heart and pulmonary damage.
In the 677-page French indictment, magistrates accused Servier of having “knowingly concealed the medication’s true characteristics” from the 1970s and hidden medical studies unfavourable to the product, perpetrating a long-term fraud.
The court case involved 21 defendants and more than 6,500 plaintiffs.
Lawyers for Servier argued that the company was unaware of the risks associated with Mediator before 2009, and said it had never pretended it was a diet pill.