Les Laboratoires Servier, France’s second-biggest drugmaker, denied allegations by government investigators that the company concealed the risks of a drug now suspected of having caused the deaths of as many as 2,000 people.
Servier also never pressed regulators to keep the drug on the market regardless of the risks, the closely held company, based in Neuilly-sur-Seine, said in a document sent via e-mail made public today. The drug, benfluorex hydrochloride, was sold in France for 33 years until it was pulled from the market in November 2009.
A government investigative agency, the Inspection Generale des Affaires Sociales, said in a Jan. 15 report that Servier depicted benfluorex as a diabetes treatment, when in reality it was a “potent” appetite suppressant closely related to fenfluramine, a component of the diet-drug combination fen-phen. Fenfluramine was withdrawn from the U.S. market in 1997 after it was linked to heart-valve damage.
The report is mistaken and biased, Servier said. The agency didn’t ask the company to provide clinical data that could have led to more accurate conclusions, Servier said.
“Benfluorex is not a fenfluramine in disguise,” the company said in the document. The treatment, sold in France under the brand name Mediator, has a chemical structure similar to that of fenfluramine, but the two compounds work differently once inside the body, according to Servier.
“We always were transparent with regulators,” the drugmaker said in the e-mailed document. “We acted responsibly throughout the entire life of this medicine.”
Estimate of Deaths
Benfluorex was sold in 34 countries. Between 500 and 2,000 people in France may have died following the use of Mediator, Claire Dufour, a spokeswoman for the Caisse Nationale de l’Assurance Maladie, the French health-insurance agency, said in a Jan. 17 interview. The estimate was obtained by France’s drug regulator based on a study conducted by the insurer, she said.
The estimate shows “imprecision in the analysis,” Servier said.
“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 often prescribed by doctors in France as a treatment to lose weight, an indication for which it didn’t have approval, according to the investigative agency.
So-called off-label prescriptions of benfluorex “cannot be blamed on Servier,” the company said in the e-mailed document. Servier said it wrote letters to doctors to remind them of what the medicine was approved for.
Servier also blamed French regulators for delays in evaluating the safety of benfluorex.
French Health Minister Xavier Bertrand said in January he plans to change the way in which the nation’s drug regulator, the Agence Francaise de Securite Sanitaire des Produits de Sante, or Afssaps, operates and is governed. He said he also will overhaul the rules about the relationships between drugmakers, doctors and health-care experts.
The way in which the probe was conducted goes against the investigative agency’s own internal rules of fairness, Servier said. Servier representatives weren’t questioned in the inquiry and were therefore unable to present the company’s point of view, the drugmaker said.
Servier “will assume all responsibility” towards Mediator patients and their families, the company said.
Sanofi SA is France’s largest drug company.
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