Brussels, 26/07/2011 (Agence Europe) - OLAF, the European Anti-Fraud Office, announced on Monday 25 July that it had opened an investigation into possible conflicts of interest in the European Medicines Agency (EMA) in the Mediator issue. Mediator is a medicine for overweight diabetics, also prescribed as an appetite suppressant, which was withdrawn from the Spanish, Italian and French markets after serious side-effects were noted which caused the deaths of hundreds of patients.
In an email to MEP Michèle Rivasi (Greens/EFA, France), OLAF announced that it had opened an internal investigation at the EMA on 22 July in order to look into allegations of conflicts of interest following information provided by Rivasi on possible irregularities at the EMA. In a press release, Rivasi and Eva Joly, also a French Green MEP, said they had asked OLAF to investigate possible conflicts of interest at the European Medicines Agency which failed to demand the withdrawal of Mediator from the market as early as 1999 when an Italian study clearly flagged up the risks associated with this product. The two MEPs suspected the EMA, which has a number of representatives of the French health product safety agency (Afssaps) and the French state, of connivance with the Servier laboratory, which marketed Mediator (see EUROPE 10317). Five months later, OLAF has acceded to their request. In the meantime, the European Parliament has made clear its unease: in May, MEPs refused to discharge the EMA budget, giving the Agency six months to reform. “OLAF has clearly seen that there was a conflict of interest … This is a first victory which will mean we can dig deeper into the workings of the EMA”, said Rivasi, noting that the investigation will be carried out in tandem with French judicial authorities. “I want us to have a European medicines agency in which we can have confidence on monitoring of medicines and side-effects. If the power lies with the pharmaceutical laboratories, then there is no point in having a European agency”, she added.
Mediator was marketed in a number of European countries, including France, for over 30 years. Since 1998, several studies have drawn attention to serious side-effects directly linked to taking this product. Mediator was withdrawn from the Spanish market in 2003 and the Italian market in 2004, and as early as 1997 from the Swiss market. France was one of the last countries to ban it, in November 2009. According to Rivasi and Joly, the EMA should have looked into Mediator in 1999, in view of the alarming findings of the Italian study. The EMA has defended itself, pointing out that it had no authority to comment of national authorisation procedures for Mediator, and emphasising that it had amended its internal rules on conflicts of interest. Following investigation, it may be decided to take no further action, recover monies, refer the EMA to disciplinary authorities or return the issue to national judicial authorities, OLAF says in its notification. (I.L./transl.rt)