Drug Scandal Shocks France - Pharmaceutical Technology

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Drug Scandal Shocks France
Scandals regarding diabetes treatment Mediator frequently dominate French press headlines. Mediator was only withdrawn from the French market in November 2009, despite reports dating back as far as the 1990s linking similar products to valvular heart disease and pulmonary arterial hypertension. The end result is a great dissatisfaction among the French public with the French medicines regulator and the pharmaceutical industry, prompting a thorough reform of the country's pharmacovigilance system.


Pharmaceutical Technology Europe
Volume 23, Issue 3

A growing scandal

Ever since a World Health Organization report in 2000 ranked the French healthcare system as the best in the world, there has been considerable national pride over the service. The country also has one of the highest levels of pharmaceutical consumption, so the scandal surrounding Mediator and the failings of the country's regulatory system have caused great public anger that will shake confidence in the pharmaceutical industry and its products.

Servier's reputation, in particular, has been damaged. Servier has often publicised the fact that it is one of the most successful French pharmaceutical companies, but there has long been speculation in the French press regarding the extensive political connections of its founder, Jacques Servier. In 2009, he was awarded the prestigious Grandcroix de la Légion d'honneur by French president Nicolas Sarkozy, to whose party some claim he has made contributions to.8 So far, Servier has rejected the links between its drug and valvular heart disease, and is fighting legal claims from patients who used the product. There will be considerable public interest in the outcome of these cases, in addition to how the company is treated as a result of the ongoing government action over the scandal.

Recognising the level of public feeling, French Health Minister Xavier Bertrand announced in January 2011 that there would be a thorough reform of the country's pharmacovigilance system, which is due to be completed by the end of the year.9 He also stated that the decisionmaking process would be reassessed so that the burden of proof would lie with companies regarding safety issues. To date, one of the explanations from the AFSSAPS as to why Mediator was allowed to stay on the French market for so long is that the safety issues recorded through pharmacovigilance measures were not enough to prompt market withdrawal. However, there has been no explanation as to why concerns raised elsewhere in Europe did not feed through to the French system. The French Health Minister has proposed that following the withdrawal of a drug, all countries should be systematically informed.

Conclusion

The scandal regarding Mediator continues to grow, generating almost daily coverage in the French media, and illustrates the importance of establishing a robust and transparent pharmacovigilance system that can respond to safety findings elsewhere in the world. If regulators are implicated in safety scandals, they will be called to account, as was the case with the head of AFSSAPS, Jean Marimbert, who was forced to resign. Similarly, unless the public believe that decisions over the licensing of medicines are taken in a scientific and impartial way, the pharma industry will be subject to increasing suspicion regarding its activities. In a major market such as France, the industry can ill afford to lose public confidence.


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