Summary
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.
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References
Anon. Europe delays BST decision. Nature 340: 415, 1989
Barash CI, Lasagna L. The Bendectin saga: ‘voluntary’ discontinuation. Journal of Clinical Research and Drug Development 1: 277–292, 1987
Fagius A, Ostermann PO, Siden A, Wilholm BE. Guillain-Barré syndrome following zimelidine treatment. Journal of Neurology, Neurosurgery and Psychiatry 48: 65–69, 1985
Health and Welfare Canada. Health Risk Study, phase II national survey, Health and Welfare Canada, Ottawa, 1984
Inman WHW. Post-marketing surveillance. In Burley D, Inman WHW (Eds) Therapeutic risk, pp. 27–33, John Wiley, Chichester, 1988
Krewski D. Risk and risk management: issues and approaches. In McColl RS (Ed.) Environmental health risks: assessment and management, pp. 29–51, University of Waterloo Press, 1986
Krewski D, Somers E, Birkwood PL. Risk perception in a decision making context. Journal of Environmental Science and Health, Environmental Carcinogenesis Reviews C5 (2): 175–209, 1987
Lowrance WW. A broad framework for confronting health risks. In Horisberger B, Dinkel R (Eds) The perception and management of drug safety risks, pp. 9–18, Springer-Verlag, Berlin, 1989
Mishell DR. Use of oral contraceptives in women of older reproductive age. American Journal of Obstetrics and Gynaecology 158: 1652–1657, 1988
Slovic P. Perception of risk. Science 236: 280–285, 1987
Slovic P, Kraus NN, Lappe H, Letzel H, Malmfors T. Risk perception of prescription drugs: report on a survey in Sweden. In Horisberger B, Dinkel R (Eds) The perception and management of drug safety risks, pp. 90–111, Springer-Verlag, Berlin, 1989
Somers E. Issues in risk communication. In Risk Communication Symposium, University of Waterloo Press, 1989
Starr C. Social benefit versus technological risk. Science 221: 1026–1028, 1969
Torrance G, Markham B, Feeny D, Rosenbloom D, Gafni A. Risk-benefit and quality-of-life analyses of prescription drugs, McMaster University, p. 66, 1988
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Somers, E. Risk Assessment of Drugs. Drug-Safety 5 (Suppl 1), 149–154 (1990). https://doi.org/10.2165/00002018-199000051-00023
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DOI: https://doi.org/10.2165/00002018-199000051-00023