Failure in drug safety assessment: a worrying issue far beyond manufacturer’s potential conflicts of interest


This paper is currently submitted.

In a 20-year old communication, I asked whether post-marketing surveillance was “an art or a science”: no doubt, twenty years later, that drug monitoring is just playacting, which may evolve in tragedies. Analysis of the statin story (amongst others) comes to the sad conclusion that regulatory bodies are currently unable to guarantee the protection of public health as far as a fair assessment of drugs benefit/risk ratios.

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