Laurence McCullough

In lieu of an abstract, here is a brief excerpt of the content:Laying Medicine Open: Understanding Major Turning Points in the History of Medical EthicsLaurence B. McCullough (bio)AbstractAt different times during its history medicine has been laid open to accountability for its scientific and moral quality. This phenomenon of laying medicine open has sometimes resulted in major turning points in the history medical ethics. In this paper, I examine two examples of when the laying open of medicine has generated such turning points: eighteenth-century British medicine and late twentieth-century American medicine. In the eighteenth century, the Scottish physician-philosopher, John Gregory (1724–1773), concerned with the unscientific, entrepreneurial, self-interested nature of then current medical practice, laid medicine open to accountability using the tools of ethics and philosophy of medicine. In the process, Gregory wrote the first professional ethics of medicine in the English-language literature, based on the physician’s fiduciary responsibility to the patient. In the late twentieth century, the managed practice of medicine has laid medicine open to accountability for its scientific quality and economic cost. This current laying open of medicine creates the challenge of developing medical ethics and bioethics for population-based medical science and practice.Reading the Histories of Medicine, Bioethics, and Medical EthicsThere are many ways in which to read the history of medi-cine and therefore of medical ethics and bioethics. For example, the history of medicine can be usefully understood in terms of successive advances or revolutions in biomedical science and its clinical applications, with medical ethics understood as a moral response to scientific and technological change. On this reading, which has been common in the history of bioethics for the past three decades, moral response is required to address scientific and technological changes that are unprecedented and therefore threaten to outstrip society’s moral capacities [End Page 7] to understand and manage those changes well. Much recent work on the ethical, legal, and social issues raised by the genome project appeals to this reading. The history of medicine can also be read in social terms, with medicine understood as a major social institution shaped by various factors, not limited to science. In this perspective, medicine and society are understood in terms of a complex and dynamic synergy. Bioethics and medical ethics become part of this synergy and are to be explained—perhaps even explained away—by social historical factors. There are, of course, other ways to read the history of medicine and therefore of bio-ethics and medical ethics—e.g., in terms of key figures and movements that are thought to have shaped developments in crucial ways.I want to suggest another way to read these histories, namely, the successive laying open of medicine to accountability that sometimes results in key turning points in the development of medical ethics and bioethics. On this reading, ethics is understood as an intellectual and practical discipline that makes medicine as a social institution and its practitioners, physicians, morally accountable for their clinical judgment, decision making, and behavior. This differs from Robert Veatch’s (1981) reading of the history of medical ethics either as particular—informed by intellectual, moral, and experiential resources thought to be available only to physicians—or universal—informed by intellectual, moral, and experiential resources generally available in the culture (present and past). Veatch sees medical ethics as open when it is universal and closed, and unacceptable, when it is particular. I read the history of medical ethics as always universal and medicine as a social institution and practice as sometimes closed—i.e, not accountable for its scientific and moral integrity—and sometimes as open, accountable for such integrity. When medicine is “laid open,” medical ethics itself is sometimes transformed. The same may well be the case for the other health care professions. The histories of medical ethics and bioethics, therefore, can be usefully read as responses to the laying open of medicine and the health care professions generally at various times in their histories. In what follows, I examine two important examples of laying medicine open that create key turning points in the history of medical ethics—Scottish medicine from the eighteenth century and American medicine from the end of the twentieth century.The...

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 concept of medicine as a profession in the English-language literature of medical ethics is of recent vintage, invented by the Scottish physician and medical ethicist, John Gregory (1724-1773). Gregory wrote the first secular, philosophical, clinical, and feminine medical ethics and bioethics in the English language and did so on the basis of Hume's principle of sympathy. This paper provides a brief account of Gregory's invention and the role that Humean sympathy plays in that invention, with reference to key texts in Gregory's work. The paper also considers two interesting and perhaps provocative ways in which Hume can be read through Gregory: first, sympathy as a principle of scientific discovery in Hume's science of man and moral physiology; and sympathy as gendered feminine in Hume's moral philosophy. Hume's principle of sympathy is at the core of Gregory's medical ethics and the histories of Western medical ethics and bioethics pivot on Gregory - and, therefore, on Hume - as it does on few other figures.

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.

Sildenafil citrate (Viagra) and other newly released pharmaceuticals that assist erectile dysfunction may be one of the most important categories of drugs released in the past decade. Sildenafil is distinctive because it creates a new therapeutic relationship not only between patient and physician, but also with sexual partner(s). Physicians must first evaluate the patient comprehensively, addressing not only erectile function and sexual performance, but overall physical and mental health. Since the drug does impact others, an expanded model for informed consent needs to be considered. Three models to consider include the public health one, ethically justified limits on confidentiality, and a biopsychosocial one. The biopsychosocial model may be preferred because it expands the patient-physician dyad to directly include others. Physicians also need to distinguish between professional, role-related obligations and personal conscience when treating patients whose sexual beliefs and practices differ from their own. Other ethical issues include inappropriate prescribing over the Internet, dealing with unrealistic patient expectations, and fairness in paying for treatment for sexual conditions in both men and women. With these proposed guidelines, physicians can continue to provide steady, reliable guidance for patients while working with yet another scientific advance in medicine.

The six papers in the 2014 clinical ethics number of the Journal get us back to the basics in the work of clinical ethics and clinical ethicists: getting clear about concepts that should be used in achieving deliberative clinical ethics. The papers explore the concepts of the best interests of the patient, health and disease understood in their proper relationship to autonomy in our species, the therapeutic obligation, and the therapeutic imperative. The final paper appraises the systematic review, a scholarly tool for tracking the basic concepts of clinical ethics in the literature

The daily work of the clinical ethics teacher and clinical ethics consultant falls into the routine of classifying clinical cases by ethical type and proposing ethically justified alternatives for the professionally responsible management of a specific type of case. Settling too far into this routine creates the risk of philosophical inertia, which is not good either for the clinical ethicist or for the field of clinical ethics. The antidote to this philosophical inertia and resultant blinkered vision of clinical ethics is sustained, willing exposure to philosophical provocation. The papers in this clinical ethics issue of the Journal of Medicine and Philosophy provide just such philosophical provocation related to core topics in clinical ethics: the distinction between clinical practice and clinical research; telemedicine, or medicine at a distance; illness narratives; the concept of the placebo effect; and sex reassignment.

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.

The clinical application of the concept of patient autonomy has centered on the ability to deliberate and make treatment decisions to the virtual exclusion of the capacity to execute the treatment plan. 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.

The pluralism of methodologies and severe time constraints pose important challenges to pedagogy in clinical ethics. We designed a step-by-step student handbook to operate within such constraints and to respect the methodological pluralism of bioethics and clinical ethics. The handbook comprises six steps: Step 1: What are the facts of the case?; Step 2: What are your obligations to your patient?; Step 3: What are your obligations to third parties to your relationship with the patient?; Step 4: Do your obligations converge or conflict?; Step 5: What is the strongest objection that could be made to the identification of convergence in step 4 or the arguments in step 4? How can this objection be effectively countered?; and Step 6: How could the ethical conflict, or perceived ethical conflict, have been prevented?

When healthcare resources become overwhelmed in medical disasters, as they inevitably will, we have to ask, in an unflinching fashion, the question: “What then?” or more precisely, “What should we do when we run out of resources?” In a mass casualty event worthy of the designation, we will indeed run out of resources, perhaps quite quickly. This article provides an ethical framework for the responsible management of medical disasters in which the “What then?” question must be asked. The framework begins with a critique of existing guidance from professional associations of physicians and then argues for an alternative approach that qualifies the obligation to preserve life, takes seriously the ethical challenges of overwhelmed healthcare resources, and countenances physician-assisted suicide as a last resort.

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

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.

Making finely crafted distinctions and deploying them in intellectually rigorous and clinically applicable judgments define, to a considerable degree, the art of clinical ethics. The papers in this Clinical Ethics number of the Journal of Medicine and Philosophy demonstrate the art of clinical ethics in their consideration of respect for autonomy vs. respect for persons, the role of risk in triggering assessment of decisional capacity vs. the role of risk in the concept and assessment of decisional capacity, intention vs. foresight in the clinical management of ectopic pregnancy, preserving life vs. relieving suffering in physician-assisted suicide, and what is essential vs. non-essential in defining the core areas of ethics education for members of hospital ethics committees.

Physicians make some medical decisions without disclosure to their patients. Nondisclosure is possible because these are silent decisions to refrain from screening, diagnostic or therapeutic interventions. Nondisclosure is ethically permissible when the usual presumption that the patient should be involved in decisions is defeated by considerations of clinical utility or patient emotional and physical well-being. Some silent decisions - not all - are ethically justified by this standard. Justified silent decisions are typically dependent on the physician's professional judgment, experience and knowledge, and are not likely to be changed by patient preferences. We condemn the inappropriate exclusion of the patient from the decision-making process. However, if a test or treatment is unlikely to yield a net benefit, disclosure and discussion are at times unnecessary. Appropriate silent decisions are ethically justified by such considerations as patient benefit or economy of time.

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.

Managed care employs two business tools of managed practice that raise important ethical issues: paying physicians in ways that impose conflicts of interest on them; and regulating physicians' clinical judgment, decision making, and behavior. The literature on the clinical ethics of managed care has begun to develop rapidly in the past several years. Professional organizations of physicians have made important contributions to this literature. The statements on ethical issues in managed care of four such organizations are considered here, the American Medical Association, the American College of Physicians, the American College of Obstetricians and Gynecologists, and the American Academy of Pediatrics. Three themes common to these statements are identified and critically assessed: the primacy of meeting the medical needs of each individual patient; disclosure of conflicts of interest in how physicians are paid; and opposition to gag orders. The paper concludes with an argument for a basic concept in the clinical ethics of managed care: physicians and institutions as economically disciplined moral co-fiduciaries of populations of patients.

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.

Clinical ethics, like bioethics more generally, until recently has tended to focus on the present and future, with little attention to the history of moral thought about health care that preceded bioethics. As a consequence, clinical ethics and bioethics lack maturity as fields of the humanities. The papers in this year's clinical ethics issue of the Journal put contemporary clinical ethics in critical dialogue with the past, making the former accountable to the latter. The six papers in this issue of the Journal are briefly described, with an emphasis on how they contribute to the maturation of clinical ethics as a field of the humanities.