Two Centuries of Assessing Drug Risks

N Engl J Med 2012;  Jerry Avorn, M.D.July 19, 2012
The history of medicine is largely the story of medicines — a continuing tale of unfolding risks and benefits. Yet the medical world into which the Journal was born in 1812 did not systematically assess the side effects of treatments in relation to the good they did. Often, there was no understanding of the causal linkage between adverse events and the therapies that led to them. The mixed bag that was the era’s pharmacopoeia is illustrated in the first article of the Journal‘s first issue, “Remarks on Angina Pectoris,” in which John Warren describes a patient with acute cardiac ischemia who “was ordered to take opium and aether, or the fetid gums; to bathe the feet in warm water; and under the direction of a physician, to lose a little blood. . . . The nitrate of silver was prescribed in solution.” Tobacco rounded out the regimen (1812; see Historical Journal Articles Cited). There was no systematic approach for determining which treatments could be effective with an acceptable level of risk and which were merely toxic. Read More