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Anti-Fraud Agency Puts Spotlight on E.U.'s Drug Watchdog
1 August 2011 2:09 pm
PARIS—The scandal over the French diabetes drug Mediator appears to have taken on a European dimension with the launch of an investigation by the European Anti-Fraud Office (OLAF) into alleged conflicts of interest at the European Medicines Agency (EMA) in London. The inquiry could create new headaches for the European Union's drug watchdog, which has also come under criticism from the European Parliament.
The investigation by OLAF was first reported by Le Parisien, a French newspaper, last week. In an e-mail to ScienceInsider, an OLAF spokesperson confirmed that an inquiry has started on 22 July, but declined to comment further. But Michèle Rivasi, a French Member of the European Parliament (MEP) for Europe Ecologie Les Verts, a green party, says the investigation was triggered by her pressure to investigate EMA's role in the Mediator affair. In a letter to Rivasi, which she sent to Science Insider, OLAF said the inquiry's purpose was to "verify allegations of conflict of interest" at EMA.
Mediator, the French brand name for an antidiabetic drug called benfluorex, was withdrawn from the French market in November 2009 and has since caused a massive scandal that has shaken public confidence in France's regulatory system. Produced by French pharmaceutical firm Servier, the drug was widely prescribed as a weight loss drug for nondiabetics during its 33-year run, despite a number of warnings that it caused potentially fatal heart valve problems.
Studies have estimated that the drug has caused between 500 and 2000 deaths, and the company and its founder and CEO, Jacques Servier, may face charges of "aggravated deception" in French court next year. Rivasi and others have charged that French regulatory officials who allowed the drug on the market had ties to the company, and today, the French cabinet adopted a series of proposals to reform the Health Products Safety Agency (AFSSAPS) beef up oversight.
EMA, created in 1995 to harmonize national drug regulation systems within the European Union, says it has done nothing wrong in the case of Mediator. EMA can only recommend banning a drug that is authorized at the national level after referral by at least one of the 27 E.U. member states, a spokesperson says. AFSSAPS requested a decision on Mediator in November 2009, the same month it pulled the drug from the market. A month later, EMA recommended that the drug be withdrawn; the European Commission endorsed that recommendation in June 2010.
But Rivasi says that EMA should have acted when Italy and Spain got worried and pulled benfluorex from the market in 1998. Experts knew about Mediator's off-label use as an appetite suppressant, she says, but the drug was exempted from a Europe-wide ban on this category of drugs in 1999. EMA's lax attitude, Rivasi claims, is part of a broader problem: the lack of proper safeguards that staff and hired experts don't have a conflict of interest.
Those allegation aren't new. A 2008 audit said EMA should implement new rules to ensure that its reviewers are completely independent. EMA issued those rules in October 2010, and they will come into force in the third quarter of this year. But frustration over the slow pace of change led the European Parliament to refuse to sign off on EMA's 2009 budget last May. The move did not have any direct consequences, but if the parliament continues to withhold its approval, "the agency will have to cut spending," Rivasi says.
Rivasi has been a long-time thorn in EMA's side. One problem, she says, is that 80% of the agency's budget comes from the pharmaceutical industry, making truly independent oversight impossible. "EMA is playing an increasingly important role in the European medicines market, but citizens have lost confidence," Rivasi says. "This must be restored."
Coincidentally, EMA rebuked France on 21 July over its ban of another antidiabetic drug, pioglitazone. AFSSAPS had pulled the drug from the market in early June on the suspicion that it causes bladder cancer, but EMA says that despite "a small increased risk," the molecule remains "a valid treatment option for certain patients with type 2 diabetes."