Laurence McCullough

On February 3, 2010, a “Letter of Concern from Bioethicists,” organized by fetaldex.org, was sent to report suspected violations of the ethics of human subjects research in the off-label use of dexamethasone during pregnancy by Dr. Maria New. Copies of this letter were submitted to the FDA Office of Pediatric Therapeutics, the Department of Health and Human Services Office for Human Research Protections, and three universities where Dr. New has held or holds appointments. We provide a critical appraisal of the Letter of Concern and show that it makes false claims, misrepresents scientific publications and websites, fails to meet standards of evidence-based reasoning, makes undocumented claims, treats as settled matters what are, instead, ongoing controversies, offers “mere opinion” as a substitute for argument, and makes contradictory claims. The Letter of Concern is a case study in unethical transgressive bioethics. We call on fetaldex.org to withdraw the letter and for co-signatories to withdraw their approval of it.

Philosophy textbooks typically treat bioethics as a form of "applied ethics"-i.e., an attempt to apply a moral theory, like utilitarianism, to controversial ethical issues in biology and medicine. Historians, however, can find virtually no cases in which applied philosophical moral theory influenced ethical practice in biology or medicine. In light of the absence of historical evidence, the authors of this paper advance an alternative model of the historical relationship between philosophical ethics and medical ethics, the appropriation model. They offer two historical case studies to illustrate the ways in which physicians have "appropriated" concepts and theory fragments from philosophers, and demonstrate how appropriated moral philosophy profoundly influenced the way medical morality was conceived and practiced

: Medical ethics often is treated as applied ethics, that is, the application of moral philosophy to ethical issues in medicine. In an earlier paper, we examined instances of moral philosophy's influence on medical ethics. We found the applied ethics model inadequate and sketched an alternative model. On this model, practitioners seeking to change morality "appropriate" concepts and theory fragments from moral philosophy to valorize and justify their innovations. Goldilocks-like, five commentators tasted our offerings. Some found them too cold, since they had already abandoned applied ethics; others too hot, since they still find the applied ethics model to their taste. We reply that the appropriation model offers an empirically testable account of the historical relationship between moral philosophy and medical ethics that explains why practitioners appropriate concepts and fragments from moral philosophy. In contrast, the now fashionable common morality theory neither explains moral change nor why practitioners turn to moral philosophy

On February 3, 2010, a “Letter of Concern from Bioethicists,” organized by fetaldex.org, was sent to report suspected violations of the ethics of human subjects research in the off-label use of dexamethasone during pregnancy by Dr. Maria New. Copies of this letter were submitted to the FDA Office of Pediatric Therapeutics, the Department of Health and Human Services (DHHS) Office for Human Research Protections, and three universities where Dr. New has held or holds appointments. We provide a critical appraisal of the Letter of Concern and show that it makes false claims, misrepresents scientific publications and websites, fails to meet standards of evidence-based reasoning, makes undocumented claims, treats as settled matters what are, instead, ongoing controversies, offers “mere opinion” as a substitute for argument, and makes contradictory claims. The Letter of Concern is a case study in unethical transgressive bioethics. We call on fetaldex.org to withdraw the letter and for co-signatories to withdraw their approval of it

Moral concerns about the authority, power, and trustworthiness of physicians have become important topics in clinical ethics during the past three decades. These concerns have come to greater prominence with the increasing involvement of large-scale private institutions in the organization and delivery of medical services, especially managed care organizations, and with the increasing involvement of government in the payment for and organization and delivery of medical services. When physicians act as the agents of large institutions or governments, the power of physicians over their patients increases. The purposes of this article are (1) to reflect briefly on the historical origins of the moral problem of physicians' power in medicine, and (2) to introduce the articles in the 1999 annual number of the Journal of Medicine and Philosophy on topics in clinical ethics.

The papers in this number of the Journal originated in a session sponsored by the American Philosophical Association's Committee on Philosophy and Medicine in 1999. The four papers and two commentaries identify and address philosophical challenges of how we should understand and teach bioethics in the liberal arts and health professions settings. In the course of introducing the six papers, this article explores themes these papers raise, especially the relationship among professional medical ethics, the "long history" of medical ethics, and bioethics. The tendency of bioethics to deprofessionalize medical ethics is rejected, in favor of an historically informed professional medical ethics. It is suggested that bioethics should be critically reconsidered from the perspective of medical ethics as professional ethics.

Some problems that arise in the account given by Thomasma and Pellegrino [6] of the foundations of medical ethics in a philosophy of medicine are addressed, in particular questions of a conceptual character about treating therelatum of medicine as health. Which concept of health is appropriate and which will bear the burden of the position thomasma and Pellegrino advance? It is argued that the proper relationship of medicine is one between a healer and developing embodied minds. As a consequence, the project of providing a univocal account of the nature of medicine fails. Instead, pluralism infects philosophy and medicine, resulting in different philosophies of medicine. From these philosophies of medicine will follow not a single medical ethics but a variety.

The clinical application of the concept of patient autonomy has centered on the ability to deliberate and make treatment decisions (decisional autonomy) to the virtual exclusion of the capacity to execute the treatment plan (executive autonomy). However, the one-component concept of autonomy is problematic in the context of multiple chronic conditions. Adherence to complex treatments commonly breaks down when patients have functional, educational, and cognitive barriers that impair their capacity to plan, sequence, and carry out tasks associated with chronic care. The purpose of this article is to call for a two-component re-conceptualization of autonomy and to argue that the clinical assessment of capacity for patients with chronic conditions should be expanded to include both autonomous decision-making and autonomous execution of the agreed-upon treatment plan. We explain how the concept of autonomy should be expanded to include both decisional and executive autonomy, describe the biopsychosocial correlates of the two-component concept of autonomy, and recommend diagnostic and treatment strategies to support patients with deficits in executive autonomy.

Moral distress is one of the core topics of clinical ethics. Although there is a large and growing empirical literature on the psychological aspects of moral distress, scholars, and empirical investigators of moral distress have recently called for greater conceptual clarity. To meet this recognized need, we provide a philosophical taxonomy of the categories of what we call ethically significant moral distress: the judgment that one is not able, to differing degrees, to act on one’s moral knowledge about what one ought to do. We begin by unpacking the philosophical components of Andrew Jameton’s original formulation from his landmark 1984 work and identify two key respects in which that formulation remains unclear: the origins of moral knowledge and impediments to acting on that moral knowledge. We then selectively review subsequent literature that shows that there is more than one concept of moral distress and that explores the origin of the values implicated in moral distress and impediments to acting on those values. This review sets the stage for identifying the elements of a philosophical taxonomy of ethically significant moral distress. The taxonomy uses these elements to create six categories of ethically significant moral distress: challenges to, threats to, and violations of professional integrity; and challenges to, threats to, and violations of individual integrity. We close with suggestions about how the proposed philosophical taxonomy of ethically significant moral distress sheds light on the concepts of moral residue and crescendo effect of moral distress and how the proposed taxonomy might usefully guide prevention of and future qualitative and quantitative empirical research on ethically significant moral distress

Despite its prominence in the abortion debate and in public policy, the discourse of 'unborn patient' has not been subjected to critical scrutiny. We provide a critical analysis in three steps. First, we distinguish between the descriptive and normative meanings of 'unborn child.' There is a long history of the descriptive use of 'unborn child.' Second, we argue that the concept of an unborn child has normative content but that this content does not do the work that opponents of abortion want it to do, namely, to establish the independent moral status of fetuses and their rights, the right to life in particular. Third, we argue that the normative content of 'unborn child' should be dependent moral status, not independent moral status. We conclude that the ethical concept of the fetus as a patient should replace the discourse of “unborn child” when that phrase is used normatively

The clinical ethics literature is striking for the absence of an important genre of scholarship that is common to the literature of clinical medicine: systematic reviews. As a consequence, the field of clinical ethics lacks the internal, corrective effect of review articles that are designed to reduce potential bias. This article inaugurates a new section of the annual "Clinical Ethics" issue of the Journal of Medicine and Philosophy on systematic reviews. Using recently articulated standards for argument-based normative ethics, we provide a systematic review of the literature on concealed medication for the management of psychiatric disorders. Four steps are completed: identify a focused question; conduct a literature search using key terms relevant to the focused question; assess the adequacy of the argument-based methods of the papers identified; and identify conclusions drawn in each paper and whether they apply to the focused question. We identified seven papers and provide an assessment of them. While none of the papers fully meet the standards of argument-based ethics, they did provide rationales for the use of concealed medications, with the important requirement such a practice be accountable in explicit organizational policy to prevent abuse of patients with mental illness or dementia.

Research to improve the health of pregnant and fetal patients presents ethical challenges to clinical investigators, institutional review boards, funding agencies, and data safety and monitoring boards. The Common Rule sets out requirements that such research must satisfy but no ethical framework to guide their application. We provide such an ethical framework, based on the ethical concept of the fetus as a patient. We offer criteria for innovation and for Phase I and II and then for Phase III clinical trials to improve the health of pregnant patients and of fetal patients and also criteria to responsibly manage the transition from investigation to clinical practice. Basing ethical criteria for research involving pregnant women on the ethical concept of the fetus as a patient insulates the proposed ethical framework and therefore research on pregnant women from the divisive and politicized concepts and discourses of personhood, fetal rights, and unborn child.

Bioethics has a founding story in which medical paternalism, the interference with the autonomy of patients for their own clinical benefit, was an accepted ethical norm in the history of Western medical ethics and was widespread in clinical practice until bioethics changed the ethical norms and practice of medicine. In this paper I show that the founding story of bioethics misreads major texts in the history of Western medical ethics. I also show that a major source for empirical claims about the widespread practice of medical paternalism has been misread. I then show that that bioethics based on its founding story deprofessionalizes medical ethics. The result leaves the sick exposed to the predatory power of medical practitioners and healthcare organizations with only their autonomy-based rights to non-interference, expressed in contracts, to protect them. The sick are stripped of the protection afforded by a professional, fiduciary relationship of physicians to their patients. Bioethics based on its founding story reverts to the older model of a contractual relationship between the sick and medical practitioners not worthy of intellectual or moral trust (because such trust cannot be generated by what I call ‘deprofessionalizing bioethics’). On closer examination, bioethics based on its founding story, ironically, eliminates paternalism as a moral category in bioethics, thus causing bioethics to collapse on itself because it denies one of the necessary conditions for medical paternalism. Bioethics based on its founding story should be abandoned

Taking the critical turn is one of the main tools of the humanities and inculcates an intellectual discipline that prevents ossification of thinking about issues and of organizational policies in clinical ethics. The articles in this "Clinical Ethics" number of the Journal take the critical turn with respect to cherished ways of thinking in Western clinical ethics, life extension, the clinical determination of death, physicians' duty to treat even at personal risk, clinical ethics at the interface of research ethics, and the pertinence of the Hippocratic Oath to clinical ethics. These articles challenge clinical ethicists to inculcate the intellectual discipline of the critical turn into everyday practice and continuous quality enhancement of clinical ethics.

Research to improve the health of pregnant and fetal patients presents ethical challenges to clinical investigators, institutional review boards, funding agencies, and data safety and monitoring boards. The Common Rule sets out requirements that such research must satisfy but no ethical framework to guide their application. We provide such an ethical framework, based on the ethical concept of the fetus as a patient. We offer criteria for innovation and for Phase I and II and then for Phase III clinical trials to improve the health of pregnant patients and of fetal patients and also criteria to responsibly manage the transition from investigation to clinical practice. Basing ethical criteria for research involving pregnant women on the ethical concept of the fetus as a patient insulates the proposed ethical framework and therefore research on pregnant women from the divisive and politicized concepts and discourses of personhood, fetal rights, and unborn child.

The Cambridge World History of Medical Ethics is the first comprehensive scholarly account of the global history of medical ethics. Offering original interpretations of the field by leading bioethicists and historians of medicine, it will serve as the essential point of departure for future scholarship in the field. The volumes reconceptualize the history of medical ethics through the creation of new categories, including the life cycle; discourses of religion, philosophy, and bioethics; and the relationship between medical ethics and the state, which includes a historical reexamination of the ethics of apartheid, colonialism, communism, health policy, imperialism, militarism, Nazi medicine, Nazi "medical ethics," and research ethics. Also included are the first global chronology of persons and texts; the first concise biographies of major figures in medical ethics; and the first comprehensive bibliography of the history of medical ethics. An extensive index guides readers to topics, texts, and proper names