Servier Begins a Massive Trial over Mediator.
Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation jcm9144@gmail.com
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
This document has been prepared by btobioinnovation and is provided to you for information purposes only. The information contained in this document has been obtained from sources that btobioinnovation believes are reliable but btobioinnovation does not warrant that it is accurate or complete. The views presented in this document are those of btobioinnovation’s editor at the time of writing and are subject to change. btobioinnovation has no obligation to update its opinions or the information in this document.
Last News
- Note de réflexion de fin d’année
- EMA re-examines its opinion and approves Leqembi for the treatment of Alzheimer’s disease
- Le déclassement de la France
Events
News archives
- December 2024
- November 2024
- October 2024
- September 2024
- August 2024
- July 2024
- June 2024
- March 2024
- February 2024
- January 2024
- November 2023
- September 2023
- July 2023
- April 2023
- March 2023
- January 2023
- December 2022
- November 2022
- October 2022
- August 2022
- June 2022
- May 2022
- April 2022
- March 2022
- January 2022
- December 2021
- November 2021
- October 2021
- September 2021
- August 2021
- July 2021
- June 2021
- May 2021
- April 2021
- March 2021
- February 2021
- January 2021
- December 2020
- November 2020
- October 2020
- September 2020
- July 2020
- June 2020
- May 2020
- April 2020
- March 2020
- February 2020
- January 2020
- December 2019
- November 2019
- October 2019
- September 2019
- June 2019
- May 2019
- April 2019
- March 2019
- February 2019
- January 2019
- December 2018
- October 2018
- June 2018
- May 2018
- March 2018
- February 2018
- January 2018
- December 2017
- November 2017
- October 2017
- September 2017
- August 2017
- July 2017
- June 2017
- May 2017
- April 2017
- March 2017
- February 2017
- January 2017
- December 2016
- November 2016
- September 2016
- July 2016
- June 2016
- May 2016
- April 2016
- March 2016
- February 2016
- January 2016
- December 2015
- November 2015
- October 2015
- September 2015
- August 2015
- July 2015
- June 2015
- May 2015
- April 2015
- March 2015
- February 2015
- January 2015
- December 2014
- November 2014
- October 2014
- September 2014
- June 2014
- May 2014
- April 2014
- March 2014
- January 2014
- November 2013
- September 2013
- July 2013
- May 2013
- April 2013
- March 2013
- January 2013
- December 2012
- November 2012
- October 2012
- March 2012