Friday, March 9, 2012

AFSSAPS now ANSM as Mediator scandal slowly resolves.

The French equivalent of the FDA was reorganized and renamed in what the French government hopes will be the final chapter of the Mediator scandal.

AFSSAPS, the Agence Française de Securité Sanitaire des Produits de Santé, was found lax in not removing the drug benfluorex (Mediator®) from the market for many years despite strong evidence that it caused harm. The drug likely caused 500 deaths and at least 3500 hospitalizations related to valvular heart disease in France between 1979 and 2007 when it was finally removed from sale.

The French Parliament passed a law in December 2011 that establishes a new agency, the National Agency for Medicines and Health Products Safety (Agence Nationale de Securité du Médicament (ANSM). The new agency is headed by Dominique Maraninchi who was moved to AFSSAPS in the middle of 2011 from the French National Cancer Institute.

The drug is closely related to one that has been used to treat obesity and diabetes (benfuorex is related to fenfluramine, known more widely as one of the Fen-Phen pair).

The "Mediator scandal" occupied the front pages of French newspapers for much of 2011 after the government auditing agency, IGAS released "A devastating 244-page report on the affair … (and) accused the pharmaceutical company Servier, headquartered in the suburbs of Paris, of misleading authorities about the true nature of benfluorex, which was sold under the brand name Mediator."

The first case of valvulopathy due to Médiator in France was reported in 1999, but no action was taken. The first Spanish case of valvulopathy was reported in 2003, prompting the drug to be banned there in 2005. The US FDA removed fenfluramine from the market in the fall of 1997. The manufacturer of two marketed products derived from the compound, Redux and Pondamin, Wyeth, was the target of a class action lawsuit that may lead to them paying up to $5 billion for damages.

1 comment:

  1. Bravo for the summary. It would be worthwhile checking how much this impacts both 1/the interactions between industry-driven research and ANSM, and 2/the medical community involved in clinical trials (pre- / post- approval) in partnership w/ pharma industry. For instance, are there plans to modify the rules/policies at Conseil National de l'Ordre des Médecin level? Thanks for your help. With best regards