Wednesday, January 19, 2011

Afssaps Boots Marimbert, a Victim of His Own Success

Jean Marimbert’s resignation from his post as the Director General of the French medicines agency, Afssaps, carries the whiff of scapegoating and smacks of a blunt sense of irony. His departure, however, prompted by revelations concerning Servier’s diabetes drug, Mediator, which is rumored to have caused upwards of 2,000 deaths, may cause France’s regulatory establishment more problems than it might solve.

Marimbert wasn't a born regulator, but since being appointed as head of Afssaps for a three-year term in 2004, he has become known in European regulatory circles as a solid and determined leader. He was re-appointed in 2007 and once again in 2010. This alone is testament to his ability and the respect accorded him by the health ministry.

His tenure hasn't been without challenges. Since 2004 the number of marketing authorization applications seen by Afssaps has risen by over 30%. At the same time, the agency has had to contend with a plethora of new laws from Brussels, including the Orphan Drug, Paediatric Medicines and Advanced Therapy Medicinal Products Regulations. Over the same period, the number of staff at the agency has risen by barely 6%.

The Vioxx withdrawal prompted Marimbert to focus on specific measures to promote drug safety. Spurred on by politicians who claimed that Afssaps was not doing enough in this area, Marimbert had all of the minutes of the agency’s regular committee meetings published online, starting with those for pharmacovigilance. This was a first for Europe.

Moreover, he tightened the pharmacovigilance system itself, and placed more emphasis on risk management plans within this framework. The irony is that it is transparency and pharmacovigilance, linked with Mediator, that have prompted his downfall.

The Mediator scandal has grown in size since breaking last November, and links between Servier, government ministers and even President Sarkozy have been called into question. Health Minister Xavier Bertrand has in the first instance pointed the finger of blame at Servier, but he also referred to severe failures in the functioning of the regulatory system, a veiled reference to Afssaps and Marimbert. The government’s main aim, it would appear, is to put an end to the Mediator scandal well in advance of the presidential elections in 2012. Marimbert’s departure serves well to deflect attention.

Bertrand is now looking at whether pharmacovigilance should be carved out of the medicines agency and set up a separate entity to carry out this task. This is unequivocally the height of folly. What’s more, it comes at a time when European competent authorities have identified and begun to consolidate the link between risk-benefit assessment and the regular monitoring of marketed drugs.

For example, the Heads of Medicines Agencies, the network of the Heads of the EU National Competent Authorities says that an effective medicines regulatory system must be able to estimate the risk-benefit of medicines, communicate that information effectively and take regulatory action when necessary to protect health. All of this must be ongoing in unison during the life cycle of the product.

This approach benefits not only patients, but also manufacturers. Thus, if an adverse incident is flagged up through effective pharmacovigilance, instead of simply withdrawing the product, a re-assessment of the risk-benefit of the product in light of the new information can be made. Marimbert made this point clear in his resignation letter, published in the French daily Liberation, last week.

What direction he will take is as yet uncertain. However, there is a job going at the European Medicines Agency, following the departure of its Executive Director, Thomas Lönngren on Dec. 31, 2010. However, whilst Marimbert hovers in limbo, Lönngren has been snapped up by independent regulatory and market access consultancy NDA and has been asked to play a strategic advisory role.

The problem for Marimbert is that he may have to wait a while before the taint of scandal fades. On the other hand, he should be safe in the knowledge that the government owes him one. -- Faraz Kermani

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