Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation firstname.lastname@example.org
SPECIAL REPORT #28
Servier Begins a Massive Trial over Mediator.
French pharma Laboratoires Servier begins trial today, in Paris, as the company stands accused of manslaughter and deceit over Mediator, a diabetes weight loss drug supposed to be linked to as many as 2,000 deaths. The drug, Mediator (benfluorex), was removed from the French Market in November 2009 after 33 years of commercialisation, (the drug had been pulled out of Spain and Italy in 2003 and 2004). A year later, the French medicine safety agency announced the drug was suspected of causing multiple deaths, sparking outrage, political outcry, a criminal investigation and triggered a series of reforms to the country’s system of regulating the pharmaceutical industry.
Mediator is an amphetamine-based appetite suppressant and though it was marketed as a way to address excess weight in diabetics, it was reportedly widely prescribed, off label, as a weight loss drug, including to many healthy women. Authorities estimated 5 million people took the drug before it was removed from pharmacies. Mediator has been long suspected to induce arterial pulmonary hypertension and in most severe cases, aortic valvulopathy inducing major fatigue and death. Dr. Isabelle Frachon, a French pneumologist had initiated a thorough pharmacovigilance investigation of patient records and informed health authorities of a strong link between Mediator and serious lung and heart damages, many years back. During the last ten years she has operated as an efficient “whistleblower” on the Mediator case. In January 2011, IGAS (Inspection Générale des Affaires de Santé) the French Health Inspection Agency has issued its official report and concluded that Servier as well as AFSAPPS, the French drug regulator, had major operational, behavioural and ethical dysfunctioning.
Two main studies were performed on the drugs’ negative impact, one finding it caused 500 deaths, another, 2,000 deaths. Servier disputes these figures but acknowledged the deaths and said it was working on compensating victims, already handing out €132 million ($146 million) in payments. But it denied the charges that it misled the public and lied about the drug’s side effects. ANSM, (Agence Nationale de Sécurité du Médicament et des Produits de Santé) the current French drug regulator, which replaced former AFSAPPS, is also on trial, accused of leniency and a failure to act to prevent patient deaths. The agency has said it will cooperate with the trial.
The trial will involve 21 defendants, including 14 people, among them a former Servier vice president, civil servants, a former senator and a professor of pediatrics retained by Servier and is expected to last 7 months involving as many as 2,600 plaintiffs.
“I scratched the earth and I found a mass grave. The trial comes as a crucial step. Compensating patients is not a matter of justice” Frachon told a French media.
September 23, 2019
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