French pharma firm denies drug risk cover up
pharmafile | May 10, 2011 | News story | Sales and Marketing | Mediator, Servier, drug safety
France’s second biggest pharma firm Servier has denied allegations it concealed risks associated with its diabetes drug Mediator (benfluorex).
Research by France’s national institute of health research says the drug could be responsible for around 1,000 – 2,000 deaths in France between 1976 and 2009, but in an email Servier insisted the estimates show ‘imprecision in the analysis’.
“To this day, and notwithstanding the figures cited, no pertinent study makes it possible to estimate with precision the number of patients who may have died of heart-valve damage caused by Mediator,” the company said.
The drug was licensed to treat diabetes patients but used extensively off-label in France as a weight loss treatment.
Off-label prescriptions of the drug “cannot be blamed on Servier,” the company added, and said it sent letters out to doctors to remind them of its proper use.
Servier also blamed French regulators for delays in evaluating the safety of Mediator.
In January French health minister Xavier Bertrand launched an investigation into the way in the nation’s drug regulator – the Agence Francaise de Securite Sanitaire des Produits de Sante, (AFSSAPS) –operates.
He said he would also overhaul the rules about the relationships between pharma and all healthcare professionals.
Servier said the way in which this probe was conducted went against the investigative agency’s own internal rules of fairness.
It added that Servier’s representatives were not questioned in the inquiry, and were therefore unable to present the company’s point of view.
The company did say it accepted there had been problems, and “will assume all responsibility” towards patients and their families who used the drug.
Servier removed Mediator from Spain in 2003 and in Italy in 2004, but did not do so in France for a further five years.
In a further twist that has prompted calls of corruption, the company’s 88-year old president Dr Jacques Servier was reported to have had high-level political connections in France, allegedly helping to keep the drug on the market.
Ben Adams
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