Brian Edwards, CBE
University of Sheffield, UK
HOPE (European Hospital and Healthcare Federation)
The Mediator saga continues as the European Anti-Fraud Office (OLAF) has told two French members of the European Parliament (MEP) that it has opened an investigation into possible conflicts of interest in the European Medicines Agency (EMA).
Michele Rivasi and Eva Joly had asked OLAF to investigate why EMA had failed to withdraw Mediator from the market when concerns were first raised. How independent had their evaluation experts been? How involved was EMA, or was Mediator a matter solely for the French regulators?
Mediator was developed by the French pharmaceutical company, Servier, as a treatment for overweight diabetics, but was eventually prescribed extensively as an appetite suppressant. It was banned in 2009 following reports of 500–2000 deaths.
Lawyers representing victims of the drug have issued a legal complaint against Jacques Servier, the owner and founder of the company. When the damage claims are eventually settled the bill could be enormous.
This issue is now deeply intertwined in French politics because President Nicholas Sarkozy was Jacques Servier’s lawyer before he became President. Why, many ask, did it take so long for the French regulatory agencies to respond to the warnings about Mediator? Isomeride, which was based on the same molecule, benfluorex, was banned in the USA in 2007.
In France, Mediator was big business and became one of the 50 most prescribed drugs, with 65% of the cost being reimbursed by the national health insurance fund.
Servier has not denied that Mediator might have been a real risk for some patients but does not accept the higher estimates of likely deaths. Jacques Servier came under a huge amount of media criticism when he talked about only three deaths. Xavier Bertrand, the French health minister, said he was stupefied at such a response and vowed to overhaul the French health care system to make it more transparent and independent from the pharmaceutical lobby.
Some have accused Servier of using a network of influence to avoid unwelcome enquiries into its money-spinning drug. This could be why OLAF wants to see what happened at the EMA.
Did people at EMA work inappropriately with the Servier laboratory? Others argue that the French market has been flooded with drugs that have no value at all for patients and the Mediator case is just the tip of the iceberg.
President Sarkozy has also called for transparency, but the lobbying business is largely hidden in much of western society. It is not just the health sector, of course; any industry where government is a major client will have its lobbyists.
Regulators need to insulate themselves from such pressure and operate more in public, to ensure that when pressure is exercised it is visible. Distinguishing between undue pressure and legitimate technical advice will never be easy.
Perhaps all EMA meetings should be held in public! Arguments about commercial secrecy have been weakened by the Mediator controversy.
The European Parliament will no doubt return to this issue once the OLAF report becomes available. The Mediator saga will rumble on. l