Regulating the regulator

Below is an article from our Affirmative Action Media Monitoring Project. These articles represent a wide variety of views. These views do not necessarily represent the views of AAPF but instead are intended to provide you with an overview of the current affirmative action debate.

March 9, 2011

Dr Dermot Walsh, former Inspector of Mental Hospitals, examines the background to a medical scandal that has rocked the French regulatory system.

On July 7 2009, the President of the French Republic conferred the Grand Cross of the Legion d’Honneur on Dr Jacques Servier, founder and President of the pharmaceutical firm bearing his name.

In his citation, Nicolas Sarkozy lauded Dr Servier for creating in France an industry of world-class renown. Addressing Servier familiarly by his Christian name, he declared that everyone should know that he was a “grand Francais whom I am decorating in the name of the French Republic”.

The same Jacques Servier, now aged 88, together with four of his executives, was cited to appear on February 11 before a Magistrate’s court in Nanterre, near Paris, to face condemnation of the Group Servier for tromperie (deceit, fraud).

How can a figure of the French establishment have fallen from grace in such a short time? The answer lies in the word ‘Mediator’. In 1969, Servier was working on the production of Mediator, their name for benfluorex, which the firm knew to be an anorexogene, or appetite suppressant. However, the drug was marketed from 1976 by Servier as an adjuvant drug for diabetes, a condition for which it had no proven efficacy.

Lack of metabolic study
As early as 1974, disquiet began to surface because of the lack of a comprehensive metabolic study by Servier, deemed imperative because of Mediator’s chemical relationship to fenfluramine, a derivative of amphetamine. These assessments did not take place and the drug began to be vigorously marketed.

In 1999, all anorexogenes were forbidden in France save for Mediator. By now, concerns about its safety were arising when persons on Mediator were noticed to have damaged heart valves. Evidence as to its dangerousness was provided by the independent French revue Prescrire. Ultimately the drug was indicted to the tune of between 500 to 2,000 deaths. Withdrawn in Spain and Italy in 2003, it continued to be marketed in France until withdrawal in November 2009.

How could a drug known to be dangerous continue to be promoted in France? In 1993, following the scandal of contaminated blood products, responsibility for control of health products passed from the Department of Health to an independent agency, the Agence Francaise de Securite Sanitaire des Produits de Santé (AFSSAPS).

This agency failed to take affirmative action against Servier Laboratories, despite its responsibility for ‘pharmacovigiliance’ and mounting evidence of the Mediator side-effects. Eventually, the matter was referred to the Inspectorate General of Social Affairs (IGAS), which set up a tribunal of enquiry.

‘Rolled in flour’
The Inspectorate report, published on January 15, did not mince words. Over 35 years the heath authorities were “rolled in flour” (mislead) by Servier Laboratories, according to witnesses appearing before the Inspectorate. The inquiry found that Servier continued to have the drug commercialised as an anti-diabetic and was widely used, without approval, as an appetite suppressant. When questions arose as to its safety, Servier promised to undertake studies; these studies never eventuated.

By now, Servier knew the benefit/risk balance of the drug was unfavourable. The organisation used all possible means to control pharmaceutical and medical agencies and to ‘anaesthetise’ any resistance to its promotion or to dissemination of its possible dangerous side effects. In addition, its use continued to be reimbursed by the Securite Sociale.
As to  AFSSAPS, the Inspectors found it in a cultural and structural situation of fundamental conflict of interest through its composition of experts with strong connections and interests with the pharmaceutical industry. In addition, its structures were “ponderous, slow and unreactive”.

Cover up and denial
Thus this scandal joins that of the Merck-produced anti-arthritic drug Vioxx, withdrawn in 2004 after cover-up and denial by the firm as to its dangers. And in 2009, Pfizer was fined $2.8 million (€2.09 million) in the US for promoting drugs for conditions for which they were not licensed by the Food and Drug Administration.

All of this resonates with the writer who, in good faith half a century ago, regularly prescribed thalidomide as a hypnotic bec-ause the regulatory authorities vouched for its safety.
M Xavier Bertrand, French Minister for Health,in stating his grave concern in the Servier affair, including the serious conflicts of interest involved, has ordained that in future, no professional participating in industry-sponsored research should serve on any governmental advisory body.

He has promised new regulatory and governance structures involving, among others, patient representatives and other public interest bodies so that there can be no repetition of this affair.

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