La revue médicale Prescrire, dansune publication du 1er janvier 2018, met en garde contre des critères d’évaluation pas assez sévères concernant l’autorisation de mise sur le marché des médicaments au point que 22 d’entre-eux pourraient être inefficaces et plus toxiques que prévu.

Les critères de validation d’autorisation de mise sur le marché pour les médicaments sont-ils insuffisants ? C’est en tout cas, ce que pointe du doigt le revue medicale Prescrire . Dans une publication du 1er janvier, les auteurs du site spécialisé rapportent que « de nombreuses autorisations de mise sur le marché (AMM) sont fondées sur des essais cliniques dans lesquels les effets du médicament sont évalués sur des critères intermédiaires ». Selon eux, les vrais résultats qui comptent pour les patients ou les essais exploratoires ne seraient pas assez pris en compte, exposant à des médicaments avec des risques d’effets secondaires importants.

Des médicaments actuellement en vente plus toxiques que prévus

Prescrire illustre son propos avec une étude américaine ayant démontré que sur 36 médicaments validés sur des critères intermédiaires comme « le délai avant progression d’une tumeur » seul 5 d’entre-eux ont réellement apporté de l’efficacité sur un critère qui comptent plus pour le patients comme l’allongement de la durée de vie. Dans un autre cas, une étude de l’Agence américaine du médicament aurait démontré que 22 traitements actuellement en vente ont été validés par la phase II, dîte « exploratoire », basée sur les fameux critères intermédiaires, ont été jugés inefficaces voire plus toxiques que prévu après des résultats plus poussés.

La revue Prescrire appelle donc les professionnels reconnaître l’importance de valider les médicaments sur des critères « plus solides » et les mettre en place car il en va de la santé des patients.


Source: medisite




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