E-DRUG: Prescrire on medicines policy after the benfluorex (Mediator°) scandal
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[The diabetes drug benfluorex, is alleged to have caused an estimated 500 to 2,000 deaths from valvular heart disease in France, triggering a major overhaul of the country's drug and health safety system.. Moderator]
In the wake of France's Mediator° scandal, the country's medicines policy has been broadly called into question. Several institutions have joined in a debate aimed at proposing improvements to this policy.
France's health ministry has incorporated a large proportion of the proposals from the national "Assises du médicament" conference convened for the occasion, as well as recommendations by the other delegations, and this is laudable. However, several essential points are missing from the proposed measures.
However, several essential points are missing from the proposed measures:
- development of robust, publicly funded clinical research. Firstly, it does not make sense to allow pharmaceutical companies to provide most of the essential clinical evaluation data on their own drugs: this places them in a position of major conflict of interest. Secondly, financing by pharmaceutical companies reinforces numerous ties between companies and experts. This evaluation must eventually be entrusted mainly to public authorities;
- public access to clinical evaluation and pharmacovigilance data, indispensable for the transparency of decision-making and to allow for a plurality of assessments outside those of the official agencies;
- strengthening of the public pharmacovigilance system;
- a change in the way community pharmacists work and the way they are compensated, allowing them to wholly fulfil their role as healthcare professionals, well placed in the healthcare delivery system to avoid numerous adverse drug effects.
Several points need to be spelled out:
- registers of conflicts of interest ("the French Sunshine Act") must be searchable by the healthcare professional's name and not just by company name;
- development of monitoring programmes and education for healthcare professionals must include patient safety (safe practices to prevent healthcare-related errors), and not just adverse effects of drugs and other healthcare products;
- transparency is non-negotiable: video recordings of the various proceedings must be made available in whole, and not just limited to "critical health issues": medicines are by definition a "critical health issue".
Full press release at:
english.prescrire.org/en/81/168/47025/0/NewsDetails.aspx
Christophe Kopp
email: ckopp@prescrire.org
website: english.prescrire.org