The Numerical Method in Therapeutic Medicine: 43d James M. Anders Lecture

Abstract

MEDICINE is an important but small component of the total of human activities. For good or bad, medicine must integrate with the social and economic as well as the scientific patterns of its community and its time. When medicine appears to be out of step in its ecology, critics are fast and numerous. The ridiculous sketches of physicians in Moliere's comedies and the savage etchings of Goya, in which physicians appear with donkey heads, cannot be dismissed as mere caricature. They also portray, alas, the inadequacies and pomposities of medicine during their times. In our society criticisms of certain aspects of medicine are not difficult to find. When such criticisms reach public consensus, they are voiced through hearings and legislative acts in the Congress of the United States. It is neither justified nor prudent to condemn these as uninformed politics, to be resisted at all points along the line. Rather, it is preferable to examine objectively the circumstances that lead to such manifestations and to initiate remedial measures in which the interests of the public and of the medical profession are restored to balance. The case in point is the Federal Food, Drug, and Cosmetic Act of 1962, which attempts to correct, and perhaps to over-correct, some of the practices that stemmed from the cornucopia of chemotherapeutic agents that has deluged medicine during the past 25 years. During the therapeutic doldrum of the thirties, useful drugs could be counted on one's fingers. Then came steroid hormones, sulfonamides, antibiotics, antihistamines, tranquilizers-each with dozens of modifications, some of structure and substance, others of packaging and trivial names. Obsolescence of drugs as an economic problem approached that of obsolescence in detergents. Untoward effects required special monographs, with such revealing titles as Diseases of Medical Progress (1). It is not surprising, therefore, that regulations under the Federal Food, Drug, and Cosmetic Act of 1962 require more stringent evidence of safety for new drugs. Included are tests for genetic and teratogenic effects over several generations of animals in order to avoid a recurrence of the thalidomide tragedy. There are requirements of prompt reporting of side effects in patients and of prompt withdrawal of suspected drugs from the market. Usefulness as well as safety is introduced as a criterion of acceptability of new agents. There are also, unfortunately, provisions regarding labeling that Dr. Shimkin, who is chief of cancer biology, Fels Research Institute, and professor of medicine, Temple University School of Medicine, delivered the 43d James M. Anders Lecture of the College of Physicians of Philadelphia on December 4, 1963. The lecture is reprinted from the January 1964 issue of Transactions and Studies of the College of Physicians of Philadelphia.