Risk assessment of drugs.

The value of risk-benefit analysis for drugs is outlined with emphasis on its special qualities compared with decisions on environmental agents, occupational risks and other societal risks. Consideration is given to the issue of risk perception and examples given of risk assessment in practice in Canada for Bendectin, isotretinoin, bovine somatropin (somatotrophin) and oral contraceptives. The changes in regulatory approaches for AIDS drugs are noted. It is suggested that an understanding of the risk-benefit balance should be incorporated into the drug evaluation process, perhaps eventually by the use of quality-of-life measures.