Medical ethics changed dramatically in the past 30 years because physicians and humanists actively engaged each other in discussions that sometimes led to confrontation and controversy, but usually have improved the quality of medical decision-making. Before then medical ethics had been isolated for almost two centuries from the larger philosophical, social, and religious controversies of the time. There was, however, an earlier period where leaders in medicine and in the humanities worked closely together and both fields were richer for it. (...) This volume begins with the 18th century Scottish Enlightenment when professors of medicine such as John Gregory, Edward Percival, and the American, Benjamin Rush, were close friends of philosophers like David Hume, Adam Smith, and Thomas Reid. They continually exchanged views on matters of ethics with each other in print, at meetings of elite intellectual groups, and at the dinner table. Then something happened, physicians and humanists quit talking with each other. In searching for the causes of the collapse, this book identifies shifts in the social class of physicians, developments in medical science, and changes in the patterns of medical education. Only in the past three decades has the dialogue resumed as physicians turned to humanists for help just when humanists wanted their work to be relevant to real-life social problems. Again, the book asks why, finding answers in the shift from acute to chronic disease as the dominant pattern of illness, the social rights revolution of the 1960's, and the increasing dissonance between physician ethics and ethics outside medicine. The book tells the critical story of how the breakdown in communication between physicians and humanists occurred and how it was repaired when new developments in medicine together with a social revolution forced the leaders of these two fields to resume their dialogue. (shrink)

: Recent controversial decisions to terminate several large clinical trials have called attention to the need for developing a sound ethical framework to determine when trials should be stopped in light of emerging efficacy data. Currently, the fundamental rationale for stopping trials early is based on the principle that equipoise has been disturbed. We present an analysis of the ethical and practical problems with the "equipoise disturbed" position and describe an alternative ethical framework based on the principle of nonexploitation. This (...) framework acknowledges the need for balancing the dual ethical obligations of clinical research, the protection of human subjects and the generation of new medical knowledge. Based on this framework, we put forward a proposal to make early stopping guidelines more stringent under specified conditions. The temporary withholding of apparent benefits in certain circumstances is justified by achieving a fair contract with the research participants, one that protects them from undue harm and exploitation while reducing the many uncertainties surrounding new investigational treatments that arise when trials are stopped prematurely. (shrink)

This paper critically examines a particular strategy for resolving the central ethical dilemma associated with randomized clinical trials — the “community equipoise” strategy . The dilemma is that RCTs appear to violate a physician's duty to choose that therapy which there is most reason to believe is in the patient's best interest, randomizing patients even once evidence begins to favor one treatment. The community equipoise strategy involves the suggestion that our judgment that neither treatment is to be preferred is to (...) be assessed according to a community rather than an individual standard. Thus, though a physician may personally believe that there is some reason to prefer one treatment, patients can legitimately be randomized if there remains disagreement in the community of medical professionals. Rationales in favor of this conception include the following: medical knowledge is best understood as residing in the community, the judgments of others count as evidence, and so should change one's own opinion, subjects would not be better off outside the trial, and the point of any trial is the resolution of dispute in the medical community. I critically examine these rationales and argue that they are insufficient. Amongst the problems are tensions between various of these underlying rationales, and important ambiguities in just what the CE criterion is to amount to. Finally, I argue that even if use of CE was justified, it would not justify carrying out RCTs anywhere near long enough to discharge our duty to gain reliable knowledge on which to base safe and effective medical practice. Hence, we need some different justification for carrying out RCTs. (shrink)

This paper critically examines a particular strategy for resolving the central ethical dilemma associated with randomized clinical trials (RCTs) — the “community equipoise” strategy (CE). The dilemma is that RCTs appear to violate a physician's duty to choose that therapy which there is most reason to believe is in the patient's best interest, randomizing patients even once evidence begins to favor one treatment. The community equipoise strategy involves the suggestion that our judgment that neither treatment is to be preferred (that (...) there obtains a state of “equipoise”) is to be assessed according to a community rather than an individual standard. Thus, though a physician may personally believe that there is some reason to prefer one treatment, patients can legitimately be randomized if there remains disagreement in the community of medical professionals. Rationales in favor of this conception include the following: (i) medical knowledge is best understood as residing in the community, (ii) the judgments of others count as evidence, and so should change one's own opinion, (iii) subjects would not be better off outside the trial, and (iv) the point of any trial is the resolution of dispute in the medical community. I critically examine these rationales and argue that they are insufficient. Amongst the problems are tensions between various of these underlying rationales, and important ambiguities in just what the CE criterion is to amount to. Finally, I argue that even if use of CE was justified, it would not justify carrying out RCTs anywhere near long enough to discharge our duty to gain reliable knowledge on which to base safe and effective medical practice. Hence, we need some different justification for carrying out RCTs. (shrink)