News

France to prosecute its drug regulator and Servier in scandal over diabetes drug

BMJ 2017; 358 doi: https://doi.org/10.1136/bmj.j4231 (Published 11 September 2017) Cite this as: BMJ 2017;358:j4231

Benfluorex / mediator® scandal, or scandals?

Dyer titled in the news section “France to prosecute its drug regulator and Servier in scandal over diabetes drug” (i.e. benfluorex / mediator®).(1)

In fact, there are several regulators and one may question why the High Authority for Health (Haute Autorité de Santé, the French health-care watchdog) was not prosecuted. Its Transparency (sic) Committee assesses drugs for reimbursement and pricing to advise the ministry of health. The draft report produced in 2006 for the reassessment of benfluorex by the Committee highlighted on its cover page that benfluorex was (a) a hidden anorexigen misused for slimming; (b) a derivate of the fenfluramine family, withdrawn for pulmonary hypertension and valvular disease; and (c) withdrawn in Spain for these same adverse effects. No warning on the final version of the report approved by the Committee, which recommended reimbursement by the mandatory healthcare.(2) The ministry of health, who had two members of its administration in the committee, renewed the reimbursement.

1 Dyer O. France to prosecute its drug regulator and Servier in scandal over diabetes drug. BMJ 2017;358:j4231.
2 Braillon A. Mediator: who's to blame? Lancet 2011;377:2003-4.

Competing interests: AB was sacked in 2003 from a tenure position as chief of the Transparency unit. In 2007, his non-tenured position as a regional advisor for quality of care was not renewed by the Haute Autorité de Santé after a year in contrast to a hundred of others. According to an e-mail obtained in 2011 after a lengthy proceedings before the Administrative Court of Montreuil he was evaluated as “uncontrollable”. AB was also sacked in 2009 from a tenure position (senior consultant at the university hospital of Amiens) but the Administrative Court of Paris ruled in 2012 the decision of the ministry of health was illegal. (Addiction 2012;107:1714-5). Available at https://www.healthwatch-uk.org/images/Newsletters/Number_86.pdf

23 September 2017
alain braillon
senior consultant
university hospital. 80000 Amiens. France