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France's Mediator° scandal: take the high road

NEWs ANALYSIS The public health fiasco caused in France by Mediator° (benfluorex) has revealed grave deficiencies in the regulation of a drugs market that is under intense pressure from the pharmaceutical industry. This disaster also brings an historic opportunity to improve public health and to refocus priorities in pharmaceutical policy on patients' interests.

Prescrire applauds the report on benfluorex-Mediator° from France's Inspection Générale des Affaires Sociales or IGAS, the public welfare inspectorate. The IGAS report details the unacceptable behaviour of the drug company Servier, as well as the numerous dysfunctions, equally unacceptable, on the part of drug regulatory bodies. These behaviours exposed patients to totally unjustified risks and resulted in a large number of victims.

The IGAS report will receive useful follow-up in the form of parliamentary inquiries, which will have to answer the questions left hanging by IGAS: why, repeatedly, were decisions that were obvious not made? Why was Mediator° so widely prescribed as an appetite suppressant, when the drug company Servier had been so incredibly successful in persuading numerous experts and a large proportion of the health authorities that it was no such thing?

Prescrire will not comment in detail upon every point contained in the IGAS report on Mediator °. The facts have been established, benfluorex is an appetite suppressant of the amphetamine class which carries the dangers of norfenfluramine, as do fenfluramine (ex-Ponderal°) and dexfenfluramine (ex-Isomeride°).

From now on everything possible must be done to keep this type of disaster from occurring ever again. When medicines have been correctly evaluated, manufactured, regulated, prescribed, dispensed and taken, drugs are therapeutic tools that deserve trust.

Prescrire urges first and foremost that the general conclusions reached in the IGAS report be carefully weighed. These conclusions (Prescrire’s translation) confirm Prescrire's experience over 30 years.

- "Overburdened with its workload, bogged down in heavy and complex legal procedures, in particular because of the interface between its work and the European Medicines Agency, reined in by the fear of litigation from drug companies, the [French] Agency appears, in the case under consideration, to be heavy, slow-moving, unresponsive, stuck, despite the good will and the hard work by most of its agents, in a sort of health bureaucracy; (...)

-  “Pharmacovigilance has failed in its purpose, which is to identify and to investigate, within a reasonable period of time, and in order to guide decisions by health authorities, cases of severe adverse effects linked to the use of medicines. The principal reason for this collective failure should be sought in a poor public health culture, and most particularly in a precautionary principle functioning in reverse; (...)

-  “In this case, as in others before it and those unfortunately still to come, it is not the excess of precaution that is at fault but the lack of precautionary measures; (...)

- “The multiplicity of the health authorities in charge of medicines, the fact that departments work in isolation, and the complexity of their functioning make the system slow and unresponsive, and contribute to a watering-down of responsibilities; (...)

- “The drugs chain functions today in such a way that the benefit of the doubt is given not to patients and to public health but to pharmaceutical companies. The same is true for marketing authorisations, which are thought of as some sort of right to which the pharmaceutical industry is entitled, to sell its products, whatever the state of the market and whatever the public health merits of those products. Re-evaluation of the risk-benefit balance is considered to be an exceptional procedure. Taking risks into account requires strong scientific evidence, whereas the existence of a benefit is easily recognised. In these conditions, the withdrawal of a marketing authorisation is perceived as a procedure of last resort and as a sort of retraction by the committee that granted the authorisation; (...)

- “The Agency's functioning is all too often characterised as, to use an expression heard several times, being "desensitised to risk". Such a phenomenon is incompatible with carrying out its mission of protecting public health; (...)

- “The functioning of the marketing authorisation and pharmacovigilance committees is characterised by the search for scientific consensus, which results in lengthening the time necessary for decision-making. Requesting one study after another to fuel this process has serious pernicious effects. This is especially striking in the case of Mediator°, where Servier made numerous requests of this type. To this can be added a legalism which, in the case of an agency that makes 80 000 decisions a year, means getting bogged down in too many cases. (...)

- “There is also, despite the progress made in this area since 1993, the weight of conflicts of interest on the part of experts who contribute to the work of Afssaps (the French Health Products Safety Agency). There are ties of financial interest and other ties that ought to be declared to the Agency, which is not always the case, according to statements by the current chairman of the marketing authorisations committee himself. (...)

- “More globally, Afssaps, which is a public health agency, currently finds itself structurally and culturally in a situation of conflict of interest. Not because of its financing, which is something approaching an unofficial tax, but by a sort of institutionalised cooperation with the pharmaceutical industry that leads to a co-production of expertise and of the decisions that stem from it. In this respect, the continued presence to this day of an institutional representative of the pharmaceutical industry (LEEM) in the committees, and sometimes in the working groups, appears unacceptable."

The parliamentary reports on medicines (the Senate report in 2006 and the 2008 report by the National Assembly) demonstrate that the peoples’ elected reprensentatives are ready for deep and beneficial change.

Prescrire has noted with great interest the initial statements by France's Health Minister, and we urge him to implement rapidly and firmly the changes announced, in particular:

  • manage conflicts of interest: establish and constantly maintain a database of declarations from various agencies and committees, scientific reviews, in France and elsewhere, by individuals as well as by companies, a database which must allow free and easy access; scrupulously exclude conflicts of interest when it comes to meetings, etc; it is essential to put an end to all collusion between drug companies and agencies, and between drug companies and pharmacovigilance authorities;
  • release detailed minutes of the meetings of working groups and committees, including minority opinions, and published within a few weeks, along with the underlying documents being worked upon;
  • take documented alerts into account, within a reasonable period of time, which includes re-evaluating the risk-benefit balance; without clogging the system with too many hastily examined alerts;
  • inform patients and healthcare professionals in a highly visible way when a drug is under close scrutiny as to its adverse effects;
  • facilitate and lend prestige to pharmacovigilance work by healthcare professionals;
  • strongly reinforce the staffing of regional pharmacovigilance centres, using public funds;
  • implement effective training in clinical pharmacology in the initial training of healthcare professionals.

Prescrire also calls for the Minister to affirm his determination by taking forceful action at the European level, by:

  • setting an example as to the above points;
  • actively defending the necessary changes at this decisive level of responsibility; granting marketing authorisations solely in the case of a tangible advantage over the reference treatment; giving the pharmacovigilance committee powers equal to those of the marketing authorisation committee; and financing pharmacovigilance entirely with public funds.

In any case, Prescrire will carry on with its informational and educational activities, always in the name of better healthcare, first and foremost in the interest of patients.

© Prescrire 21 January 2011

Rédaction Prescrire "Affaire Mediator° : en sortir par le haut",
17 January 2011, www.prescrire.org

Morelle A , Bensadon AC, Marie E "Enquête sur le Mediator" Inspection Générale des affaires sociales, Paris, 2011. Site www.igas.gouv.fr/spip.php?article162