Assessing drug safety

BMJ 2005; 330 doi: https://doi.org/10.1136/bmj.330.7490.539-b (Published 03 March 2005) Cite this as: BMJ 2005;330:539
  1. Nicholas Moore, professor of clinical pharmacology (nicholas.moore@pharmaco.u-bordeaux2.fr)
  1. INSERM U657, Université Victor Segalen, Bordeaux, France

    EDITOR—Eaton reports that more surveillance of drugs is needed to protect the public.1 All drugs are dangerous, some may also be useful. If drug efficacy is easy to show, drug safety (low risk) is essentially unprovable: absence of demonstration of risk is not demonstration of absence. Assessment of risk and benefit is a matter of health politics and opinion: is it better to die of a heart attack or of colon cancer? But the patient's opinion is rarely sought. Most adverse reactions are related to the known …

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