Intended for healthcare professionals

News

French health minister announces reform of drug regulation

BMJ 2011; 342 doi: https://doi.org/10.1136/bmj.d360 (Published 20 January 2011) Cite this as: BMJ 2011;342:d360
  1. Paul Benkimoun
  1. 1Paris

The 88 year old founder of France’s second largest drug company, Laboratoires Servier, has been subpoenaed by lawyers acting for six patients who experienced serious cardiovascular side effects after being treated with the diabetes drug benfluorex (Mediator).

The drug, which was mainly prescribed as an appetite suppressant in patients with type 2 diabetes, has been linked to around 500 deaths (BMJ 2010;341:c6882; doi: 10.1136/bmj.c6882). The delay in banning the drug in France is set to be one of the biggest medical scandals of recent years.

French health minister Xavier Bertrand has announced that he will radically reform the way that drugs are regulated in France.

He said he favoured granting a marketing authorisation only to drugs which showed they are “at least equivalent to reference drugs on the market.”

Mr Bertrand also strongly advocated greater transparency to expose conflict of interests, including compulsory declarations of interests by cabinet members and ministers.

He made his announcement after an inquiry into the licensing of the drug by the Inspection Générale des Affaires Sociales (Igas). The inquiry, which was authorised by the Ministry of Health and published on 15 January, focused on the management of the case by the French administration and especially the French medicines agency Afssaps (Agence française de sécurité sanitaire des produits de santé).

The report says that health authorities have been misled over the past 35 years by Servier who concealed the true pharmacological nature of the drug. They state that in spite of studies led by Servier research teams establishing its appetite suppressant effects in the 1960s, the company’s “doctrine” was to try to sell it as an antidiabetic drug, while concealing its true appetite suppressant nature.

The report points at incomprehensible decisions made by the French medicines agency, which missed several opportunities to take benfluorex off the market. In 1997, all other compounds of the fenfluramine group were withdrawn apart from benfluorex.

Two years later, when all appetite suppressants were banned, benfluorex still remained on the market despite a first notification of a valvulopathy in a patient treated with this drug.

The French medicines agency is criticised as a “heavy, slow and poorly reactive structure” with a process that benefits companies rather than patients and public health.

Jacques Servier, alongside four other high ranking executives of Laboratoires Servier and its division Biopharma, as well as the two companies themselves are accused of deliberately disguising the true nature and qualities of the drug. This charge, if proved, could lead to a four year prison sentence.

The lawyers accuse the defendants of purposely misleading patients taking benfluorex, which was finally withdrawn from the French market in 2009.

Jacques Servier and the other defendants are due to stand trial in Nanterre on 11 February 2011. If the case is proved, social security could claim back from the accused companies the costs of prescribing benfluorex. From 1999 to 2009 reimbursements to patients for benfluorex amounted to €423m (£356m; $569m).

The case is based on the fact that benfluorex is closely related to fenfluramine and dexfenfluramine, as all three are quickly metabolised into norfenfluramine, with similar plasma levels when taken at therapeutic doses.

Two parliamentary committees, one in the National Assembly and the other in Senate, are also set to investigate the affair which looks set to rival the tainted blood scandal discovered in the 1990s.

Servier said it was investigating the allegations made in the report. However, the group insisted that the report had been prepared without any evidence taken from Servier itself. “There was no right of response,” the company said. In a statement on 15 January, the group said it was “stunned” by the findings which it said “do not appear to conform to reality.”

Notes

Cite this as: BMJ 2011;342:d360

Log in

Log in through your institution

Subscribe

* For online subscription