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 Mediator was only withdrawn from the French market in November 2009, despite reports dating back as far as the 1990s linking similar products to valvular heart disease and pulmonary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

The French connection

In France, the safety issues regarding dexfenfluramine have led to a flurry of lawsuits against Servier, who had marketed the drug as Isomeride. In 2000, Anna Paulos, a patient suffering from pulmonary arterial hypertension, claimed that Isomeride was responsible for her condition and won 349000 in damages from Servier.5 The family of another patient, who died in 1995, also fought a long-running court battle with Servier, which concluded in January 2011 when a court of appeal ordered the company to pay 145500 as compensation.5 The success of these lawsuits and the media coverage they generated has led to other cases against Servier, backed by the high profile patient group L'Association des Victimes du Mediator et de l'Isoméride, which campaigns for those who took the drug.

When the recent safety issues regarding Mediator are considered in light of previous safety concerns over fenfluramine and dexfenfluramine, it is no surprise that there has been anger in France, since benfluorex is a fenfluramine derivative. In fact, recognising the link between the two drugs, the patient organisation campaigning for victims of Isomeride is now inviting those who took Mediator to come forward.

In 2003, the first case of valvular heart disease due to benfluorex was reported in a Spanish medical journal, with the authors describing how a 50year old woman who had been taking benfluorex for a year developed cardiovascular symptoms.6 They noted that the patient had been examined two years prior to treatment, at which time her cardiovascular profile had been normal. Post-treatment, microscopic examination of the valves revealed that the damage seen was identical to that described in patients who had taken fenfluramine and dexfenfluramine. The authors suggested that fenfluramine, dexfenfluramine and benfluorex shared a common mechanism in damaging heart valves.

Despite this case report, and a number of other papers strongly suggesting that patients treated with benfluorex incurred a risk of valvular heart disease, it was not until November 2009 that the French authorities took the drug off the market. Recent reports in the French press show that as long ago as 1998, three eminent French physicians wrote to the AFSSAPS advising them to reevaluate the use of Mediator in diabetes and obesity. The French newspaper, Le Figaro, has been at the forefront of covering the scandal and has obtained a copy of this letter and other enquiries sent to the agency concerning the safety of benfluorex-containing medicines.7

In 1998, at the request of the Italian health authority, a Europeanlevel investigation was initiated over the safety implications of the structural similarity between benfluorex and fenfluramine. According to Le Figaro, both Italy and France were rapporteurs for the enquiry, but while the results of the investigation prompted Italy and Spain to take Mediator off their markets, no action was taken in France. Not surprisingly, these media reports have led to accusations that the AFSSAPS and the French government are too close to the pharmaceutical industry.2


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