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Too many new drugs with a disproportionate risk-benefit balance

In granting marketing authorisations to new drugs with an extremely unfavourable risk-benefit balance, drug regulatory agencies are not serving the interests of the population.

It is inexcusable that three new drugs with an extremely unfavourable risk-benefit balance are now on the market in France: moxifloxacine and micafungine both carry a fatal risk whereas similar drugs are just as effective and less dangerous; meanwhile there is the risk of severe cardiac arrhythmia with ranolazine, which offers patients only marginal benefits.

Of course, each individual healthcare professional can refuse to expose patients to these risks by explaining, with the help of an independent evaluation, the slim benefits that can be expected and the disproportionate, even life-threatening risks involved. But this requires a huge personal effort. What a waste of energy for well-informed healthcare professionals faced with misguided patients and colleagues who have been swayed by the authoritative arguments of opinion leaders, by contradictory information and by misleading advertising claims!

Each one of us can and must take action. The authorities must strengthen the regulations governing the granting of marketing authorisations. Drug regulatory agencies must stop authorising drugs with an unfavourable risk-benefit balance. In France, the national health authority (Haute autorité de santé – HAS) must refuse to reimburse these drugs. The French health insurance system must have the courage to make a stand against the use of public money for this purpose. Patients and healthcare professionals must put pressure on all these bodies to ensure that new drugs represent progress rather than a backward step.

©Prescrire April 2009

Source: "Coûts humains" Rev Prescrire 2009; 29 (305): 161.

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