Brussels, 16/02/2011 (Agence Europe) - On Wednesday 16 February, two Green/EFA MEPs, Eva Joly and Michèle Rivasi, asked the European Anti-Fraud Office, OLAF to investigate the European Medicines Agency following the Mediator scandal, an appetite depressant made by pharmaceutical company Servier, that is reported to have killed between 500 and 2,000 people in France alone.
In a press release, the two MEPs explain that in December 2009, a month after the French health product safety committee AFSSAPS made its decision, the European Medicines Agency (EMA) recommended that benfluorex-containining medicines be withdrawn from the European Union, although the damaging side-effects of Mediator were the subject of much debate within the EMA from 1998 onwards.
Joly and Rivasi ask what held up the Mediator dossier at the EMA for years (from 1999 to 2003) and why the Italian warning of 1999 only led to a simple email asking a few questions. Why did the human medicines committee take until 2011 to ask Servier for more tangible information about research promised back in 1999 and why did no member state request arbitration?
The IGAS report published in France in January 2011 (Inspection Générale des Affaires Sociales) reveals that several key positions on medicines monitoring and human medicines assessment at the EMA are held by French individuals representing AFSSAPS and the French state. Joly and Rivasi ask in a press release whether AFSSAPS representatives at the EMA have abused their influence to avoid problems for pharmaceutical company Servier and whether this amounts to complacency, corruption or illegal abuse of interest.
The medicine in question was withdrawn from sale in pharmacies by Spain in 2003, Italy in 2004, France in 2009 and Portugal in 2009. The EMA recommended the withdrawal of national permits for the sale of benfluorex on 18 December 2009, confirmed by the European Commission on 14 May 2010. (L.C./transl.fl)