Franklin Miller

Drawing the line on physician assistance in physician-assisted death (PAD) continues to be a contentious issue in many legal jurisdictions across the USA, Canada and Europe. PAD is a medical practice that occurs when physicians either prescribe or administer lethal medication to their patients. As more legal jurisdictions establish PAD for at least some class of patients, the question of the proper scope of this practice has become pressing. This paper presents an argument for restricting PAD to the terminally ill that can be accepted by defenders as well as critics of PAD for the terminally ill. The argument appeals to fairness-based paternalism and the social meaning of medical practice. These two considerations interact in various ways, as the paper explains. The right way to think about the social meaning of medical practice bears on fair paternalism as it relates to PAD and vice versa. The paper contends that these considerations have substantial force when directed against proposals to extend PAD to non-terminally ill patients, but considerably less force when directed against PAD for the terminally ill. The paper pays special attention to the case of non-terminally ill patients who suffer from treatment-resistant depression, as these patients present a potentially strong case for extending PAD beyond the terminally ill.

The placebo effect, in recent years, has been the focus of extensive scientific inquiry and public fascination, as reflected in articles in the news media. Authors writing about placebo effects often mention the goal of harnessing the placebo effect for the benefit of patients in clinical practice. This suggests that the placebo effect is like a powerful horse, which needs to be put in harness in order to do useful work. However, developing an accurate understanding of what has been labelled, often misleadingly, as the "placebo effect" and taking advantage of this phenomenon have been hampered by the conceptual muddle surrounding this topic. To continue the equine metaphor...

I’m writing to underscore one point, which should be obvious, but which all too often has been neglected in the literature on medical futility. The futility of an action or an intervention is always relative to some goal. Consider the classical example of futility: carrying water in a sieve. If your goal is to transport a quantity of water without spilling some or all of it, then it is futile to do so by placing it in a sieve. But we can readily imagine children carrying water in the backyard in a sieve, enjoying the water spilling out on the grass and trickling down their legs. It’s not futile to serve that goal of having fun. The salience of this point can be tested by examining its relevance to...

Kierkegaard famously declared that life is lived forwards but understood backwards. The retrospective look at one's career necessarily takes the form of a narrative reconstruction. Our lives are messier than the stories we tell about them.I first took up serious study of philosophy as a sophomore at Columbia College in 1967. The extensive core curriculum at Columbia exposes all students to a sampling of classic texts in philosophy. Some inkling of a more than passing interest in philosophy, which I can't now recall, must have induced me take an elective course devoted to that subject. It was taught in the old-fashioned way of detailed examination of classic texts—the way that I believe it is best to learn about...

Bioethics has been an interdisciplinary field since its inception. From the founding of the Hastings Center in 1969 and the Kennedy Institute of Ethics in 1971, scholars from many disciplines have come together to create a field of study strengthened by its interdisciplinarity. In this special issue of Perspectives in Biology and Medicine, we celebrate the interdisciplinary character of bioethics by means of essays by eight distinguished bioethics scholars hailing from backgrounds in philosophy, law, medicine, nursing, public health, history, sociology, and narrative methods. Each contributor offers a personal perspective on their journey into bioethics from a particular disciplinary background...

Something has changed in America with respect to facing death. As I write this review of When Breath Becomes Air by Paul Kalanithi, it is number one on the New York Times nonfiction bestseller's list; number 10 is Being Mortal by Atul Gawande, on the list for 62 weeks. A few years ago, Christopher Hitchens's Mortality, a remarkable narrative of his living in the face of dying from esophageal cancer, also was a bestseller. While denial of death was thought to be an American characteristic, this may be true no longer; or at least the public shows a strong interest in narratives about mortality.To what extent does the appetite of the reading public signify a changed perspective on mortality?...

Mood disorders, including major depressive disorder and bipolar disorder, are highly prevalent, frequently disabling, and sometimes deadly. Additional research and more effective medications are desperately needed, but clinical trials research in mood disorders is fraught with ethical issues. Although many authors have discussed these issues, most do so from a theoretical viewpoint. This manuscript uses available empirical data to inform a discussion of the primary ethical issues raised in mood disorders research. These include issues of consent and decision-making capacity, including patients’ motivations for participating in research. We also address drug withdrawals, placebo controls, and the overall safety of research. Finally, we examine the extant literature for studies discussing potential indirect benefits of clinical trials research to participants. Taken together, the evidence suggests that clinical trials research incorporating drug withdrawals and placebo controls can be conducted safely and ethically, even in patients with severe or treatment-resistant mood disorders. In fact, given the dearth of effective treatment options for this population, it is our opinion that a moral imperative exists to extend the offer of research participation to severely ill or treatment-resistant groups.

Recently, Canada’s National Post described in detail the death by lethal injection of a 94-year-old man, living alone, who had multiple medical problems but was not terminally ill. His son helped find a physician willing to administer lethal medication soon after his father told him he “wasn’t planning on adding another digit” to his age. The physician who complied with the request is a leading advocate for assisted death in Canada, who reportedly has been responsible for more than 30 life-terminating acts within the few months since the law was passed in June 2016. The son of the man who died by active euthanasia declared, “Dad got the death he wanted.” Should a legal option of...

Advances in life-saving technologies in the past few decades have challenged our traditional understandings of death. Traditionally, death was understood to occur when a person stops breathing, their heart stops beating and they are cold to the touch. Today, physicians determine death by relying on a diagnosis of ‘total brain failure’ or by waiting a short while after circulation stops. Evidence has emerged, however, that the conceptual bases for these approaches to determining death are fundamentally flawed and depart substantially from the established biological conception of death. We argue that the current approach to determining death consists of two different types of unacknowledged legal fictions. These legal fictions were developed for practices that are largely ethically legitimate but need to be reconciled with the law. The considerable debate over the determination of death in the medical and scientific literature has not informed the public that vital organs are being procured from still-living donors and it seems unlikely that this information can remain hidden for long. Given the instability of the status quo and the difficulty of making the substantial legal changes required by complete transparency, we argue for a second-best policy solution: acknowledging the legal fictions involved in determining death to move in the direction of greater transparency. This may someday result in more substantial legal change to directly confront the challenges raised by life-sustaining and life-preserving technologies without the need for fictions

Although established in the law and current practice, the determination of death according to neurological criteria continues to be controversial. Some scholars have advocated return to the traditional circulatory and respiratory criteria for determining death because individuals diagnosed as ‘brain dead’ display an extensive range of integrated biological functioning with the aid of mechanical ventilation. Others have attempted to refute this stance by appealing to the analogy between decapitation and brain death. Since a decapitated animal is obviously dead, and ‘brain death’ represents physiological decapitation, brain dead individuals must be dead. In this article we refute this ‘decapitation gambit.’ We argue that decapitated animals are not necessarily dead, and that, moreover, the analogy between decapitation and the clinical syndrome of brain death is flawed

Many research ethics guidelines now oblige researchers to offer research participants the results of research in which they participated. This practice is intended to uphold respect for persons and ensure that participants are not treated as mere means to an end. Yet some scholars have begun to question a generalised duty to disclose research results, highlighting the potential harms arising from disclosure and questioning the ethical justification for a duty to disclose, especially with respect to individual results. In support of this view, we argue that current rationales for a duty of disclosure do not form an adequate basis for an ethical imperative. We review policy guidance and scholarly commentary regarding the duty to communicate the results of biomedical, epidemiological and genetic research to research participants and show that there is wide variation in opinion regarding what should be disclosed and under what circumstance. Moreover, we argue that there is fundamental confusion about the notion of “research results,” specifically regarding three core concepts: the distinction between aggregate and individual results, amongst different types of research, and across different degrees of result veracity. Even where policy guidance and scholarly commentary have been most forceful in support of an ethical imperative to disclose research results, ambiguity regarding what is to be disclosed confounds ethical action

Transplantation of vital organs has been premised ethically and legally on "the dead donor rule" (DDR)—the requirement that donors are determined to be dead before these organs are procured. Nevertheless, scholars have argued cogently that donors of vital organs, including those diagnosed as "brain dead" and those declared dead according to cardiopulmonary criteria, are not in fact dead at the time that vital organs are being procured. In this article, we challenge the normative rationale for the DDR by rejecting the underlying premise that it is necessarily wrong for physicians to cause the death of patients and the claim that abandoning this rule would exploit vulnerable patients. We contend that it is ethical to procure vital organs from living patients sustained on life support prior to treatment withdrawal, provided that there is valid consent for both withdrawing treatment and organ donation. However, the conservatism of medical ethics and practical concerns make it doubtful that the DDR will be abandoned in the near future. This leaves the current practice of organ transplantation based on the "moral fiction" that donors are dead when vital organs are procured

Deception is a useful methodological device for studying attitudes and behavior, but deceptive studies fail to fulfill the informed consent requirements in the U.S. federal regulations. This means that before they can be approved by Institutional Review Boards, they must satisfy the four regulatory conditions for a waiver or alteration of these requirements. To illustrate our interpretation, we apply the conditions to a recent study that used deception to show that subjects judged the same wine as more enjoyable when they believed it had a higher price

In lieu of an abstract, here is a brief excerpt of the content:“Unduly Iterative Ethical Review?”Franklin G. MillerMadam:Renée C. Fox and Nicholas A. Christakis have written a provocative article, “Perish and Publish: Non-Heart-Beating Organ Donation and Unduly Iterative Ethical Review” (KIEJ, December 1995). The language of their argument and some of the implicit assumptions on which it rests deserve critical scrutiny. They describe the articles presenting and commenting on the University of Pittsburgh protocol as “disquieting” because the display “trial-and-error ethics.” To dismiss “trial-and-error ethics” implies that we antecedently possess all the moral knowledge we need to evaluate and regulate developments in medicine. Should we summarily reject experimentation in ethics, particularly with respect to complex issues involving scientific and technological changes? For if we need to reconsider and possibly revise what counts as moral knowledge, the proposing an experimental approach to the ethics of a novel practice, which is presented publicly and made open to revision, as in the Pittsburgh protocol, may be precisely the best way to proceed.Fox and Christakis resort to invidious insinuation in their criticism of ethicists who have written, and journals that have published, articles about non-heart-beating organ donation. Publication on this issue has given ethicists the opportunity of “adding numerous items to their vitae.” Their appraisal of the vitae-boosting behavior represents an interesting rhetorical specimen: “Although there is nothing inherently dishonorable about this it does create tension between two motives: conviction about the importance of perfecting ethical conduct, on the one hand, and the desire to advance one’s professional career, on the other” (p. 340). I am not sure what the authors mean by “perfecting ethical conduct.” Yet they suggest that a group of reputable scholars, who have taken diverse positions on the ethics of non-heart-beating organ donation, have come perilously close to venality.Finally, in order to avoid further legitimating what they consider to be an ethically objectionable practice, the authors advocate that journals exercise “restraint” in publishing articles about this topic. Perhaps in a future pronouncement they will enlighten us about how enforcing a publication policy that avoids the vice of “unduly iterative ethical review” might work without compromising freedom of discussion. Moral dogmatism and censorship have a long history of association.Franklin G. MillerCenter for Biomedical Ethics University of Virginia Charlottesville, VACopyright © 1996 The Johns Hopkins University Press...

Henry Beecher was a distinguished professor of anesthesia and clinical investigator at Harvard Medical School. He became an iconic figure in bioethics, best known for his 1966 article describing 22 examples of unethical clinical research. This is one of the most frequently cited articles on ethics in the medical literature. Indeed, it may be seen as marking a watershed in the moral climate of medical research. In his history of bioethics, Albert Jonsen characterized Beecher as one of the “stars in the bioethical firmament”. Daniel Callahan, founder of the Hastings Center, explained Beecher’s impact in a 1991 interview:“I think the role of Henry Beecher was very important in the mid 60s when he blew the...

Franklin Miller's thoughtful reply to our paper asks pointed questions about the role of the physician qua physician in physician-assisted death. Would making assisted dying available to treatment-resistant depressed people necessarily affect the professional integrity of healthcare professionals, as Dr Miller asserts? Dr Miller agrees with us on a number of crucial points: It is possible that some patients with treatment-resistant major depression are competent to make the decision to ask for assisted dying; it is possible that some such patients could make a rational choice if they requested such assistance. He also is generally supportive of physician-assisted death, at least for ‘terminally ill’ patients. He defines a terminally ill patient as someone who has a ‘predictable short life span and will die soon regardless of medical intervention’. We disagree with his conceptualisation of ‘terminal illness’ as requiring that death occurs within 6–12 months, given the existence of illnesses like Amyotrophic lateral sclerosis (ALS) or certain prostate cancers that are commonly considered to be terminal illnesses and that are taking their predictable course sometimes over years. If, all other things being equal, an illness is going to kill a patient at some point down the track, it surely should qualify for the label ‘terminal illness’. However, we will accept his definition for the sake of the argument. Dr Miller supports the availability of assisted dying for patients likely to die from that illness within 6 months from the day their request for assisted dying has been made. He broadly holds the kind of view we aimed to sway with our analysis. Apparently, we failed. Dr Miller thinks that physician-assisted death must be consistent with professional integrity, requiring that it is consistent with ‘the proper goals of medicine and the specific duties incumbent on clinicians in acting to realize …

A special report of The Hastings Center and the Association of American Medical Colleges addressed the ethical oversight of learning health systems, which seek to combine high‐quality patient care with routine data collection aimed at improving patient outcomes. The report contained two position papers, authored by a number of distinguished bioethicists, and several commentaries. The position papers urged two changes. First, they urged a rethinking of our approach to the regulation of human subjects research, so as to make it easier in the future for learning health systems to function well. Second, they argued that the rethinking required dispensing with a strict distinction between research and therapy, which has been a major tenet of bioethics since the Belmont Report, which explicated basic ethical principles governing human subjects research. We fully support the objectives of the authors, and we agree that the learning health system is an important advance that serves patients well. Unnecessary regulatory burden ought not impede this progress. We disagree, however, that the best way to bring about these needed changes in the regulatory environment is to reject the basic distinction between research and treatment. Unfortunately, we find the arguments in favor of that strategy to be, in places, reminiscent of what we take to be basic conceptual errors that hampered the ethical understanding of human subjects research prior to adoption of the Belmont Report. To see why one need not reject the research‐treatment distinction in order to promote learning health systems, we first investigate in some detail the arguments offered for eliminating the distinction. We next turn to an issue not addressed by those authors, namely, the relationship between the physician or investigator and the patient or subject, to illustrate why the distinction is important and what is lost if it is jettisoned.

The doctrine of clinical equipoise is appealing because it appears to permit physicians to maintain their therapeutic obligation to offer optimal medical care to patients while conducting randomized controlled trials (RCTs). The appearance, however, is deceptive. In this article we argue that clinical equipoise is defective and incoherent in multiple ways. First, it conflates the sound methodological principle that RCTs should begin with an honest null hypothesis with the questionable ethical norm that participants in these trials should never be randomized to an intervention known to be inferior to standard treatment. Second, the claim that RCTs preserve the therapeutic obligation of physicians misrepresents the patient-centered orientation of medical care. Third, the appeal to clinical equipoise as a basic principle of risk-benefit assessment for RCTs is incoherent. Finally, the difficulties with clinical equipoise cannot be resolved by viewing it as a presumptive principle subject to exceptions. In the final sections of the article, we elaborate on the non-exploitation framework for the ethics clinical research and indicate issues that warrant further inquiry.