33 years ago, French pharmaceutical company Servier won approval for its diabetes drug, Mediator (benfluorex). Although Mediator was approved for diabetes, and then granted an additional drug license for hyperlipidaemia, Mediator was prescribed off-label for weight loss.
The ANSM is investigating complaints from hundreds of patients who claim to have suffered serious adverse events from Mediator, and from hundreds of families who claim that their family members died from Mediator. Mediator is said to have caused heart valve damage, causing death in between at least 500 to 2000 patients. French regulators ignored studies that linked Mediator to heart-valve issues.
France called an investigation into its national regulatory agency, previously named AFSSAPS, to assess the conflicts of interest (COI) present between Servier and the regulator. AFSSAPS failed for years to remove Mediator from the market, when other national regulatory agencies had already pulled the drug off of their respective markets after recognizing health concerns and numerous deaths. France regulators permitted Mediator to remain on the French market until 2009, although the United States and other countries had withdrawn Mediator 10 years prior.
Many countries, including the United States, typically protect their federal agencies from criminal prosecutions, but the Mediator scandal has raised important questions about the potential for COI between drug makers, consulted experts, and regulatory agencies that are supposed to oversee drug safety. In light of the Mediator scandal, France has taken action and, after investigation, Louis Servier, founder of Servier, is facing manslaughter charges. Louis Servier, along with six of his companies, were charged in the case. Louis Servier, and other Servier executives, face jail time from these charges. Additional charges regarding whether the company misrepresented the drug, as well as misled authorities and consumers about Mediator are pending.
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