Franklin Miller

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.

This book challenges fundamental doctrines of established medical ethics. It is argued that the routine practice of stopping life support technology causes the death of patients and that donors of vital organs (hearts, liver, lungs, and both kidneys) are not really dead at the time that their organs are removed for life-saving transplantation. Although these practices are ethically legitimate, they are not compatible with traditional medical ethics: they conflict with the norms that doctors must not intentionally cause the death of their patients and that vital organs can be obtained only from dead donors. The aim of this book is to undertake an ethical examination that aims to honestly face the reality of medical practices at the end of life. This involves exposing the misconception that stopping life support merely allows patients to die from their medical conditions, that there is an ethical bright line separating withdrawal of life support from active euthanasia, and that determination of death of hospitalized patients prior to vital organ donation is consistent with the established biological conception of death. A novel ethical justification is required for procuring vital organs from still-living donors. It is contended that in the context of plans to withdraw life support, donors of vital organs are not harmed or wronged by organ procurement prior to death, provided that valid consent is obtained for stopping treatment and organ donation. In view of serious practical difficulties in facing the truth regarding organ donation, an alternative pragmatic account is developed for justifying current practices that relies on the concept of transparent legal fictions. In sum, it is the thesis of this book that to preserve the legitimacy of end-of-life practices, we need to reconstruct medical ethics.

Observational research involving access to personally identifiable data in medical records has often been conducted without informed consent, owing to practical barriers to soliciting consent and concerns about selection bias. Nevertheless, medical records research without informed consent appears to conflict with basic ethical norms relating to clinical research and personal privacy. This article analyzes the scope of these norms and provides an ethical justification for research using personally identifiable medical information without consent

Controversies about the diagnosis and meaning of brain death have existed as long as the concept itself. Here we review the historical development of brain death, and then evaluate the various attempts to justify the claim that patients who are diagnosed as brain dead can be considered dead for all legal and social purposes, and especially with regard to procuring their vital organs for transplantation. While we agree with most commentators that death should be defined as the loss of integration of the functioning of the organism as a whole, we conclude that patients diagnosed as brain dead have not, in fact, lost this integrated functioning. We close with reflections on the implications of this conclusion generally and particularly with regard to organ transplantation, and briefly make reference to alternative approaches to justifying the procurement of transplantable organs that do not depend upon a flawed approach to the diagnosis of death

We argued last year in this journal that extensive integration of research and care is a worthy goal of health system design, and we second the call from Ruth Faden and colleagues to move toward learning health care systems. As they recognize, learning health care systems demand the coordination of research and medical ethics—two sets of normative commitments that have long been considered distinct. In offering a novel ethics framework for such systems, Faden et al. advance the scholarly debate about how best to do this and challenge us to think more deeply about its practical implications. However, we believe that at least three issues they raise require additional attention. First, the research‐care distinction has more normative bite than they are willing to concede. Second, the role for independent oversight requires clarification. Finally, they neglect the concept of stewardship as a guiding obligation of learning health care systems.

It has been presumed within bioethics that the benefits and risks of treatments can be assessed independently of information disclosure to patients as part of the informed consent process. Research on placebo and nocebo effects indicates that this is not true for symptomatic treatments. The benefits and risks that patients experience from symptomatic treatments can be shaped powerfully by information about these treatments provided by clinicians. In this paper we discuss the implications of placebo and nocebo research for risk–benefit assessment and informed consent

In lieu of an abstract, here is a brief excerpt of the content:The Incoherence of Determining Death by Neurological Criteria: A Commentary on Controversies in the Determination of Death, A White Paper by the President’s Council on Bioethics*Franklin G. Miller** (bio) and Robert D. Truog (bio)Traditionally the cessation of breathing and heart beat has marked the passage from life to death. Shortly after death was determined, the body became a cold corpse, suitable for burial or cremation. Two technological changes in the second half of the twentieth century prompted calls for a new, or at least expanded, definition of death: the development of intensive care medicine, especially the use of mechanical ventilators, and the advent of successful transplantation of vital organs. Patients with profound neurological damage, leaving them incapable of breathing on their own and in an irreversible coma, could be maintained for some period of time with the aid of mechanical ventilation. The situation of these patients posed two ethical questions. Is it appropriate to stop life-sustaining treatment? If so, is it acceptable to retrieve vital organs for transplantation to save the lives of others before stopping treatment?In 1968, the Ad Hoc Committee of the Harvard Medical School to Examine the Definition of Brain Death proposed that death could be determined on the basis of neurological criteria, thus providing a positive answer to these two questions (Ad Hoc Committee 1968). According to the position of this committee, patients diagnosed with the cessation of brain function are dead, despite the fact that they breathe and circulate blood with the aid of mechanical ventilation. [End Page 185] Because they are dead, it is appropriate, indeed imperative, to stop mechanical ventilation. And because they are dead, it becomes ethical to procure vital organs for transplantation before stopping what otherwise would be life-sustaining treatment. Remarkably, this innovative neurological determination of death became, with little debate or controversy, the established position in medical ethics and the law throughout the United States.The Harvard Committee articulated the diagnosis of “irreversible coma,” but merely asserted that this condition constituted death. No explanatory rationale was provided. It fell to the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research to provide an authoritative rationale in its 1981 report, Defining Death. The second paragraph of the report set the stage as follows: “The question addressed here is not inherently difficult or complicated. Simply, it is whether the law ought to recognize new means for establishing that the death of a human being has occurred” (President’s Commission 1981, p. 3). The Commission claimed that “death is a unitary phenomenon” (p. 7) and that the determination of death by neurological criteria, in terms of the absence of all brain function, is consistent with the traditional conception of death as the cessation of vital functioning of the organism as a whole. The key issue is the integrative functioning of the human organism, which ceases to exist, according to the Commission, when the whole brain, including higher cortical areas and the brain stem, fails to function. Although “brain-dead” patients do not appear to be dead—i.e., the reality of their death is “masked” by the activity of mechanical ventilation—the patient’s body has irreversibly lost all capacity for integrative functioning. In the words of the Commission: “When artificial means of support mask this loss of integration as measured by the old methods [cessation of respiration and heart beat], brain-oriented criteria and tests provide a new window on the same phenomenon” (p. 33). The President’s Commission was instrumental in developing and establishing “The Uniform Definition of Death Act”: “An individual who has sustained either (1) irreversible cessation of circulatory and respiratory functions, or (2) irreversible cessation of all functions of the entire brain, including the brain stem, is dead” (p. 2).Although the question posed by the President’s Commission was easy to articulate, the answer, over time, has proved complicated and controversial. The coherence and cogency of determining death by neurological criteria has been challenged. Various experts have demonstrated that “brain-dead” patients maintained on mechanical ventilation display a range of vital, integrative, functioning, which conflicts with the judgment that they are dead (Truog and...