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France pledges reform as controversy escalates over alleged drug deaths

A scathing report released on 15 January by the Inspection Générale des Affaires Sociales (IGAS), the inter-ministerial ‘police’ of the French healthcare system, has stoked further a huge medical controversy in France. The report digs into the details of how Mediator, an appetite-reducing weight-loss drug with lipid-reducing properties, stayed on the French market for decades despite evidence of lethal side-effects. Affsaps, the French state body that makes drug marketing approvals, banned the drug in 2009.

In response, Xavier Bertrand, the health minister, yesterday pledged a reform of the French regulatory system, and said that Afssaps would investigate some 76 other suspect products. He added that he would work to improve the transparency of regulatory systems, including tougher conflict of interest rules for experts.

The controversy broke in November 2010, when an official report estimated that the drug, produced by the French drug company Servier, might have been involved in some 500 or more deaths. The IGAS report says that France should have pulled Mediator from the market in the 1990’s when two closely related weight-loss drugs were found to cause thickening of heart valves, and high blood pressure in the artery from the heart to the lungs. It notes that Mediator, or benfluorex, a modified amphetamine, is a precursor drug, and that its active principle following metabolism, norfenfluramine, is the same as that of the two drugs withdrawn earlier.

The report alleges what it describes as an active strategy by Servier over decades to bill the drug as a lipid reducer/diabetic drug, not as a weight-loss drug, which it said resulted in authorities ignoring the similarity of Mediator’s pharmaceutical mode of action with those of the banned weight-loss drugs. Millions of people, however, took Mediator as a weight-loss drug.

The newspaper, Le Monde cited Servier as responding to the IGAS report as being “astonished” by the allegations it made concerning the company, which it said “did not appear to conform to reality”. It also complained that IGAS had not yet heard Servier’s side of the story.

Although concerns were repeatedly raised as to Mediator’s toxicity, with the drug also being withdrawn in the early 2000’s from several countries, French regulators failed to take action, the report says, arguing that multiple opportunities to have pulled the drug sooner were missed. The report describes Affsaps as being a “poorly-reactive, slow and unwieldy structure,” which despite the hard work of its staff was stuck as a “health bureaucracy.” It complains of what it describes as the “incomprehensible tolerance of the agency [Affsaps] with respect to Mediator.”

Although the controversy has focused on France and Affsaps, the London-based European Medicines Agency, which is responsible for the scientific evaluation of drugs in the European Union only recommended withdrawal of Mediator from across the European Union in December 2009.

The BBC and Reuters have coverage, here and here. But if you read French, Le Monde, Liberation and other French newspapers have more extensive coverage. Prescrire magazine, a fiercely independent publication covering treatments and healthcare, and which was one of the first to call the alert on Mediator, has published its take on the IGAS report here.


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    Uncle Al said:

    “might have been involved in some 500 or more deaths.” “Millions of people, however, took Mediator as a weight-loss drug.”

    That’s a mortality rate of 0.077/10,000 over 65 million French. France’s 2010 crude death rate was 86.5/10,000. 16.6% of poisoning deaths in Scotland involved paracetamol (acetaminophen). England and Wales have a paracetamol death rate 0f 0.1/10,000 Br. J. Clin. Pharmacol. 54(4) 430 (2002). US NSAID mortality rate for arthritis users alone is 0.53/10,000 averaged over all 311 million people.

    One fails to see the problem.

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