Franklin Miller

: 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.

On June 16, 1966, the New England Journal of Medicine published “Ethics and Clinical Research” by Henry K. Beecher. Beecher’s account of 22 examples of unethical contemporary clinical research shook up the medical profession and helped pave the way for U.S. federal regulation of research involving human subjects. Five decades later, in this issue of Perspectives in Biology and Medicine, we pay tribute to the lasting significance of this whistle-blowing article and to the remarkable contributions of Henry Beecher. Beecher was a pioneer in anesthesiology as an academic discipline and in research on pain and the placebo effect. He was an early and influential champion of randomized placebo-controlled...

Surgical clinical trials have seldom used a "sham" or placebo surgical procedure as a control, owing to ethical concerns. Recently, several ethical commentators have argued that sham surgery is either inherently or presumptively unethical. In this article I contend that these arguments are mistaken and that there are no sound ethical reasons for an absolute prohibition of sham surgery in clinical trials. Reflecting on three cases of sham surgery, especially on the recently reported results of a sham-controlled trial of arthroscopic surgery for arthritis of the knee, I present an ethical analysis that focuses on the methodological rationale for use of sham surgery, risk-benefit assessment, and informed consent.

Doctor–patient communication is a crucial component in any therapeutic encounter. Physicians use words to formulate diagnoses and prognoses, to disclose the risks and benefits of medical interventions, and to explain why, how, and when a therapy will be administered to a patient. Likewise, patients communicate to describe their symptoms, to make sense of their conditions, to report side effects, to explore other therapeutic options, and to share their feelings. Throughout the history of medicine, the ethics of the doctor–patient communication has been traditionally grounded on considerations of paternalistic beneficence and nonmaleficence. In this respect, it was no different from the ethics regulating..

The term therapeutic misconception was coined by Paul Appelbaum and his colleagues to describe the tendency of patients enrolled in clinical trials to confuse research participation with the personal clinical attention characteristic of medical care. It has not been recognized that an analogous therapeutic misconception pervades ethical thinking about clinical research with patient-subjects. Investigators and bioethicists often judge the ethics of clinical research based on ethical standards appropriate to the physician-patient relationship in therapeutic medicine. This ethical approach to clinical research constitutes a misconception because it fails to appreciate the ethically significant differences between clinical research and clinical care.In this article I argue that the assumption that the ethical principles governing the practice of therapeutic medicine should also apply to clinical research with patient- subjects produces incoherence in research ethics and erroneous guidance concerning certain controversial research designs.

Some ethical issues facing contemporary medicine cannot be fully understood without addressing medicine's internal morality. Medicine as a profession is characterized by certain moral goals and morally acceptable means for achieving those goals. The list of appropriate goals and means allows some medical actions to be classified as clear violations of the internal morality, and others as borderline or controversial cases. Replies are available for common objections, including the superfluity of internal morality for ethical analysis, the argument that internal morality is merely an apology for medicine's traditional power and authority, and the claim that there is no single, "core" internal morality. The value of addressing the internal morality of medicine may be illustrated by a detailed investigation of ethical issues posed by managed care. Managed care poses some fundamental challenges for medicine's internal morality, but also calls for thoughtful reflection and reconsideration of some traditionally held moral views on patient fidelity in particular.