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Healthy Skepticism Library item: 19770

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.


Publication type: Journal Article

Braillon A
Mediator: who's to blame?
The Lancet 2011 Jun 11; 377:(9782):2003 - 2004


Asher Mullard1 focuses his analysis of the French “Mediator scandal” on the drug company Servier and AFSSAPS, the French Medicines Agency, and might have missed several points.
The report of the Inspection Générale des Affaires Sociales (IGAS), requested by the Health Minister, is not exactly an “independent account”. The co-Director General of AFSSAPS is an IGAS member. In 2006, she was the technical adviser for medicinal products in the cabinet of the Health Minister who renewed the reimbursement of Mediator (benfluorex) through the mandatory national health insurance scheme. This minister, who is now again in charge, promoted her to interim Director General of AFSSAPS. Additionally, none of the IGAS inspectors is known for expertise on drugs.
Mullard could also have mentioned that AFSSAPS long ignored the yearly calls from the independent drug bulletin La Revue Prescrire for benfluorex’s withdrawal.2 AFSSAPS also allowed the marketing of two generics of Mediator in 2009, yet, by contrast, issued a national warning to pharmacists and doctors after a mix-up in the labelling of two homoeopathic remedies.3
Among the regulators, Mullard does not mention the Haute Autorité de Santé (the French health-care watchdog) and its “transparency” committee. This committee assesses drugs for reimbursement and pricing. A draft report4 it produced in 2006 on the reassessment of benfluorex included a prominent note that benfluorex was (a) a hidden anorexigen misused for slimming; (b) a derivate of the fenfluramine family, withdrawn for pulmonary hypertension and valvular disease; and © withdrawn in Spain for these same adverse effects. The final version of the report contained no such note.5
Lastly the role of the experts and of many medical colleges was not mentioned by Mullard. This might need a separate piece.
I was sacked by the Department of Health from my position as a senior tenured consultant in public health at Amiens University Hospital.


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