As public trust in drug regulation crumbles in France over alleged misdeeds in the marketing of Servier's diabetes pill Mediator, politicians and health officials are scrambling to restore faith in a system that many say didn't act on evidence of the drug's deadly side effects until it was too late.
The backlash against France's health regulator AFSSAPS over the Mediator scandal prompted French senators to adopt a slate of reforms in October, The New York Times reported. Lawmakers aim to nix the kind of conflicts of interest that have been implicated in the failure to quickly address risks of Mediator, which has been linked to an estimated 2,000 deaths and thousands of cases of heart valve damage. The drug was quietly pulled from shelves in France in 2009, 33 years after it hit the market. The drug was prescribed to millions of patients for diabetes and as a diet drug.
France's prescription drug regulators have long been viewed as having a much more, well, laissez-faire attitude than their counterparts at agencies such as the FDA. There are now revelations about alleged shifty marketing practices of Mediator and regulators' apathy surfacing through investigations. People with voting power on decisions about medical products in France have served as consultants to drug companies, the Times reported, and regulators in the country failed to act on early warning signs about the risks of taking Mediator.
Now it appears that French lawmakers want to make its AFSSAPS more FDA-like. U.S. regulators face criminal penalties for failing to disclose business ties to the drug companies they police, for example, according to the Times article. Critics have called the FDA overly cautious about the side effects of drugs, suggesting that the regulator has let even the smallest risks outweigh the benefits of medicines. Perhaps on the other end of the spectrum are France's regulators, and now people in France who believe that their health suffered due to Mediator use are asking tough questions about whether to trust their country's health system.
"There is no public knowledge or acknowledgment of what medicines really are, their limits," Lucy Vincent, a spokeswoman for Servier, told the Times. "They want to believe in the miracle."
- check out The New York Times article