Intended for healthcare professionals

Letters Observational evidence for determining drug safety

Too high a pedestal

BMJ 2008; 336 doi: (Published 03 April 2008) Cite this as: BMJ 2008;336:735
  1. Jeffrey K Aronson, reader in clinical pharmacology
  1. 1Department of Primary Health Care, Oxford OX3 7LF
  1. jeffrey.aronson{at}

Freemantle and Irs are wrong to say that only properly randomised trials can provide truly reliable evidence on adverse events, just as these are the only source of convincing data on drug efficacy.1 Harms due to drugs differ from benefits in several ways: they are multifarious and affect fewer individuals, some of whom may have particular susceptibilities. Harms often cannot …

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