Tuesday, February 15, 2011

At Afssaps, Two Heads Apparently Better Than One

Whilst countries in the Middle East struggle with the concept of the democratic process, the French minister of health, Xavier Bertrand, is seeking to hand pick the next head of the national medicines agency, Afssaps.

His choice — in fact his second, as the appointment of Hubert Allemand, deputy head of the national insurance system, failed for some unsubstantiated reason — is Dominique Maraninchi, president of the National Cancer Institute (INCA). Bertrand hopes that the appointment, arising as a result of the Mediator scandal, will be rubber-stamped by parliament in a matter of days.

Maraninchi is likely to be only one visage of the double-headed eagle that health minister Xavier Betrand wants to place at the pinnacle of Afssaps. Bertrand is looking to divide responsibilities at the agency between a medical person — arise Maraninchi — and an administrator.

Upon his somewhat unwarranted, yet dishonorable, discharge from the post of Director General at Afssaps — he effectively resigned under pressure — Jean Marimbert set down three goals, the fulfillment of which would re-establish public confidence in the medicines agency: improved pharmacovigilance; increased transparency; and the abolition of conflicts of interest. The question is whether Maraninchi has the determination, the ambition and the credibility to pursue these aims.

Aged 61, Maraninchi has been involved in the fight against cancer for over 30 years, having co-authored in excess of 275 articles, founded a pilot unit for bone marrow transplant in the Paoli-Calmette Institute in 1981 and established a pilot unit for research into treatment with cytokines and immunotherapy techniques at the same instate in 1988. He was appointed Director of the institute in 1990, President of the National Centres for the Fight against Cancer from 2002-2004, permanent advisor to the interministerial mission for the fight against cancer in 2003 and President of the National Institute for Cancer in July 2004.

Whilst nobody can argue about Maraninchi’s impressive pedigree in the field of cancer, there is only limited evidence to suggest that he will be able successfully to nurse an ailing Afssaps back to health. Maraninchi has understandably limited experience of pharmacovigilance, having led an institute that predominantly looks for cures and not faults. Pharmacovigilance is unlikely to fall under the auspices of the next administrator, and therefore there appears to be a slight gap in Bertrand’s plans for Afssaps. Presumably he either expects Maraninchi to learn on the job, or to rely on the expertise of his staff.

Maraninchi is well-known for expressing the view that transparency and the effective provision of medical care go hand in hand. At a meeting organized by the Socialist MP, GĂ©rard Bapt, president of the group for the study of environmental health at France’s National Assembly — the lower house of parliament — Maraninchi, at the time president of the national cancer institute, commented on the benefit of opening up the institute’s advisory bodies to include public health interest groups. It is likely, therefore, that he will pass the health ministry’s transparency test.

The issue that is perhaps likely to catch the imagination of the general public, however, is that of conflict of interest. Media reports highlighting potential links between the government and Servier have incensed the public. More recently, at a grilling of the Afssaps hierarchy at the National Assembly, one deputy took particular satisfaction in pointing to connections between Philippe Lechat, director of medicines evaluation at Afssaps, and Servier.

The connection was tentative at best, with Lechat only taking part in the past in administering clinical trials involving a couple of the companies’ products. However, in turbulent times such as these, the public interprets a relationship between doctors and drug manufacturers as being on a par with the pact between Faust and the devil.

What then, will the media make of a similar link between the esteemed — and, to quote the French media, charming — Maraninchi and both GSK and Roche, particularly in the event of a new health scandal? It appears that Bertrand is banking on the fact that Maraninchi’s medical pedigree — in contrast with Marimbert’s background as a civil servant — will inspire enough confidence to quash public concerns.

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