A predominant ethical view holds that physician‐investigators should conduct their research with therapeutic intent. And since a physician offering a therapy wouldn't prescribe second‐rate treatments, the experimental intervention and the best proven therapy should appear equally effective. "Clinical equipoise" is necessary. But this perspective is flawed. The ethics of research and of therapy are fundamentally different, and clinical equipoise should be abandoned.

This book explores the controversial relationship between physicians and the pharmaceutical industry, identifies the ethical tensions and controversies, and proposes numerous reforms both for medicine's own professional integrity and for effective public regulation of the industry.

Cosmetic surgery is a fast-growing medical practice. In 1997 surgeons in the United States performed the four most common cosmetic procedures443,728 times, an increase of 150% over the comparable total for 1992. Estimated total expenditures for cosmetic surgery range from $1 to $2 billion. As managed care cuts into physicians' income and autonomy, cosmetic surgery, which is not covered by health insurance, offers a financially attractive medical specialty.

The leading ethical position on placebo-controlled clinical trials is that whenever proven effective treatment exists for a given condition, it is unethical to test a new treatment for that condition against placebo. Invoking the principle of clinical equipoise, opponents of placebo-controlled trials in the face of proven effective treatment argue that they (1) violate the therapeutic obligation of physicians to offer optimal medical care and (2) lack both scientific and clinical merit. We contend that both of these arguments are mistaken. (...) Clinical equipoise provides erroneous ethical guidance in the case of placebo-controlled trials, because it ignores the ethically relevant distinction between clinical trials and treatment in the context of clinical medicine and the methodological limitations of active-controlled trials. Placebo controls are ethically justifiable when they are supported by sound methodological considerations and their use does not expose research participants to excessive risks of harm. (shrink)

Although the physician’s use and misuse of power have been discussed in the social sciences and in literature, they have never been explored in medical ethics until now. In this book, Dr. Howard Brody argues that the central task is not to reduce the physician’s power, as others have suggested, but to develop guidelines for its use, so that the doctor shares with the patient both information and the responsibility for deciding on appropriate treatment. Dr. Brody first (...) reviews literary works dealing with medical power, from Dostoevsky’s “The Grand Inquisitor” to stories by William Carlos Williams, Vonda McIntyre, and Richard Selzer. These works, he shows, reveal the healers’ ambivalence over their own powers and patients’ fears of the abuse of power. Dr. Brody then points out important but neglected ethical issues that emerge from an analysis of power, such as the tension between care of individual patients and the pressures of the doctor’s workload; the rescue fantasy that impels some physicians to extraordinary lengths to save a life; and the economic system, which rewards surgeons and other specialists more than it does physicians who spend time talking with patients about their problems. He also shows how the perspective of shared power can shed new light on standard topics in medical ethics—from informed consent and confidentiality to resource allocation and cost containment. (shrink)

Among those who criticize the concept of a common refrain is that we really have no idea what futility means. For example, physicians seem to disagree on whether a treatment being futile means that it has a less than 5% chance of working or a 20% chance of working. If the concept is so unclear, then it seems a thin reed upon which to base a momentous ethical decision—namely, that the physician's judgment should be allowed to override the wishes of (...) the competent patient or the patient's duly appointed surrogate. (shrink)

A basic question of medical ethics is whether the norms governing medical practice should be understood as the application of principles and rules of the common morality to medicine or whether some of these norms are internal or proper to medicine. In this article we describe and defend an evolutionary perspective on the internal morality of medicine that is defined in terms of the goals of clinical medicine and a set of duties that constrain medical practice in pursuit of these (...) goals. This perspective is developed by means of a critical examination of the essentialist conception of the internal morality of medicine advocated by Edmund Pellegrino and the critique of internal morality approaches by Robert Veatch and Tom Beauchamp. (shrink)

The practice of voluntary physician‐assisted death as a last resort is compatible with doctors' duties to practice competently, to avoid harming patients unduly, to refrain from medical fraud, and to preserve patients' trust. It therefore does not violate physicians' professional integrity.

: The "difference position" holds that clinical research and therapeutic medical practice are sufficiently distinct activities to require different ethical rules and principles. The "similarity position" holds instead that clinical investigators ought to be bound by the same fundamental principles that govern therapeutic medicine—specifically, a duty to provide the optimal therapeutic benefit to each patient or subject. Some defenders of the similarity position defend it because of the overlap between the role of attending physician and the role of investigator in (...) a research trial. This overlap is maximal when the same physician occupies both roles with respect to a particular patient-subject. We address the ethical tensions inherent in that role conflict and argue that the tensions are real but manageable. The difference position provides a sound ethical framework within which to manage those tensions, while the similarity position is unsatisfactory because it seeks to deny the existence of the tensions. (shrink)

Current legal standards of informed consent send the wrong message to physicians about their moral and legal expectations. A “transparency” model that sees consent as a conversation process can enhance good medical practice and patient autonomy without foreclosing appropriate judicial review.

Once upon a time, medicine dismissed narrative as unimportant and uninteresting. Then, in the late 1980s, physicians and scholars became interested in how the study of narrative could enhance our understanding of illness and health care, and the field that came to be known as “narrative medicine” developed. Some of this scholarly activity focused on the idea of narrative ethics.After a flurry of activity around the turn of the twenty‐first century, narrative ethics seemed to stall. The general interest in narrative (...) in medicine continued but with few new ideas on how one might use narrative toward ethical ends. In the last few years, however, forward momentum has returned. The timing seems appropriate, therefore, for a “state of the field” report of sorts. (shrink)

As the debate over how to manage or discourage physicians? financial conflicts of interest with the drug and medical device industries has become more heated, critics have questioned or dismissed the concept of ?conflict of interest? itself. A satisfactory definition relates conflict of interest to concerns about maintaining social trust and distinguishes between breaches of ethical duty and temptations to breach duty. Numerous objections to such a definition have been offered, none of which prevails on further analysis. Those concerned about (...) conflicts of interest have contributed to misunderstandings, however, by failing to demonstrate when social arrangements leading to temptations to breach duties are in themselves morally blameworthy. Clarifying ?conflict of interest? is important if we are eventually going to develop productive modes of engagement between medicine and for-profit industry that avoid the serious ethical pitfalls now in evidence. (shrink)

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. (shrink)

Bioethics' interdisciplinary base -- Patient-centered care -- Evidence-based medicine and pay-for-performance -- Community dialogue -- Overview : bioethics, power, and learning to see -- Cross-cultural concerns -- Race and health disparities -- Disabilities -- Environmental and global issues -- New technologies -- Conclusion.

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. (shrink)

Most accounts of why physicians have a duty to treat patients during a pandemic look to the special ethical standards of the medical profession. An adequate account must be deeper and broader: it must set the professional duty alongside other individual commitments and broader social values.

We argue that a turn toward virtue ethics as a way of understanding medical professionalism represents both a valuable corrective and a missed opportunity. We look at three ways in which a closer appeal to virtue ethics could help address current problems or issues in professionalism education—first, balancing professionalism training with demands for professional virtues as a prerequisite; second, preventing demands for the demonstrable achievement of competencies from working against ideal professionalism education as lifelong learning; and third, avoiding temptations to (...) dismiss moral distress as a mere “hidden curriculum” problem. As a further demonstration of how best to approach a lifelong practice of medical virtue, we will examine altruism as a mean between the extremes of self-sacrifice and selfishness. (shrink)

I am grateful to Drs. Richard Bukata and Jerome Hoffman and the staff of Primary Care Medicals for retrieving and analyzing some of the references used in this paper.

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. (shrink)

In 1945–46, representatives of the U.S. government made similar discoveries in both Germany and Japan, unearthing evidence of unethical experiments on human beings that could be viewed as war crimes. The outcomes in the two defeated nations, however, were strikingly different. In Germany, the United States, influenced by the Canadian physician John Thompson, played a key role in bringing Nazi physicians to trial and publicizing their misdeeds. In Japan, the United States played an equally key role in concealing information about (...) the biological warfare experiments and in securing immunity from prosecution for the perpetrators. The greater force of appeals to national security and wartime exigency help to explain these different outcomes. (shrink)

With breathtalung speed, traditional criminal prohibitions against assisted suicide have been declared unconstitutional in twelve states, including California and New York. This poses great promise and great peril. The promise is that competent terminally ill patients, as a compassionate measure of last resort, will have the option of putting an end to their suffering by physician-assisted suicide. More sigmficant, legally permitting this controversial option may be a catalyst for doctors, health care institutions, and society to improve the care of the (...) dying. PAS should be limited only to those relatively few competent patients who continue to suffer intolerably despite unrestrained efforts to palliate and who face a continued existence that they regard as worse than death. When dying patients know they will not be abandoned to miserable and pointless suffering if palliative care fails, they will be fortified to cope better with the process of dying.The immediate peril is that PAS will become a quick fix, available on demand to any patient diagnosed as terminally ill, thus bypassing palliative care and producing premature deaths. (shrink)

Book reviewed in this article: The Healer's Power. By Howard Brody.

A commentary on “What's Not Being Shared in Shared Decision‐Making?” from the July‐August 2013.

A less analytic and more wholistic approach to philosophy, described as best overall fit or seeing how things all hang together, is defended in recent works by John Rawls and Richard Rorty and can usefully be applied to problems in philosophy of medicine. Looking at sickness and its impact upon the person as a central problem for philosophy of medicine, this approach discourages a search for necessary and sufficient conditions for being sick, and instead encourages a listing of true and (...) interesting observations about sickness which reflect the convergence of a number of different viewpoints. Among the relevant viewpoints are other humanities disciplines besides philosophy and the social sciences. Literature, in particular, provides insights into the meaning and the uniqueness of episodes of sickness in a way that philosophers may otherwise fail to grasp. (shrink)

A review of the philosophical debate on theoretical models for the physician-patient relationship over the past fifteen years may point to some of the more productive questions for future research. Contractual models have been criticized for promoting a legalistic and minimalistic image of the relationship, such that another form of model (such as convenant) is required. Shifting from a contractual to a contractarian model (in keeping with Rawls' notion of an original position) provides an adequate response to many criticisms of (...) this type. A deeper criticism, however, is one that advocates a shift to a virtue-based approach. A creative amalgam between a contractarian model and elements of the virtue-based approach, combined with appropriate empirical investigation, may yield richer models in the future. (shrink)

Before asking what U.S. bioethics might learn from a more comprehensive and more nuanced understanding of Islamic religion, history, and culture, a prior question is, how should bioethics think about religion? Two sets of commonly held assumptions impede further progress and insight. The first involves what “religion” means and how one should study it. The second is a prominent philosophical view of the role of religion in a diverse, democratic society. To move beyond these assumptions, it helps to view religion (...) as lived experience as well as a body of doctrine and to see that religious differences and controversies should be welcomed in the public square of a diverse democratic society rather than merely tolerated. (shrink)

*The opinions expressed are the views of the author and do not necessarily reflect the policy of the National Institutes of Health, the Public Health Service, or the U.S. Department of Health and Human Services.

Those concerned over the excessive commercialization of health care, to the detriment of both professional and patient-centered values, commonly propose remedies that assume that meaningful change can occur largely within the health care sector. I argue instead that a major shift in the public culture and political discourse of the U.S. will be required if the commercialization of health care is to be adequately addressed. The notion that health and health care are commodities to be bought and sold in the (...) market is encouraged by the ideology that is preferably called economism, though also today labeled neoliberalism, market fundamentalism, market triumphalism, and other terms. This ideology has been successful in pushing aside alternative accounts and policies over the past four decades, so that economism-inspired policies seem both commonsensical and inevitable. This dominance of the public political discourse hides two important facts about economism — it is a quasi-religious ideology that pretends to be a reflection of economic science; and it is shot through with internal contradictions that ultimately render it self-defeating as a guide to policy. Advocates for reduced commercialism in health care must directly address economism and attempt to educate the public and policymakers about its flaws. (shrink)

Pay-for-performance represents an effort to improve the quality of health care by paying physicians more if they meet specified target measures. There are both empirical and theoretical reasons to be deeply suspicious of P4P schemes applied at the level of the individual physician or health provider. Most P4P programs were implemented before there were any good data to demonstrate that they achieved the desired results. Once such schemes were in use, the available data are far from reassuring. Common findings are (...) that providers may do more of the specific procedure that is being measured, but in the process may neglect to do other things that equally affect quality of care. Payers often find that the cost of implementing a P4P program far exceeds the value of the very modest resulting improvements; and payments may unfairly benefit providers who are already meeting quality targets while disadvantaging those who make the most strenuous efforts to improve. (shrink)

A recent statement from multiple critical care societies appropriately focuses on communication and negotiation as the major approach to the sorts of cases that have previously been labeled with the term futility. Unfortunately, the statement persists in addressing futility in a way that I have argued is unsatisfactory. Schneiderman, Jecker, and Jonsen now respond to the statement and make a number of helpful points. However, in a few ways, I also find their response off target. I will address the key (...) points of the discussion in a way that is consistent with a position I took some years ago and that I still believe to be appropriate. I... (shrink)

In 1964, anesthesiologists at Harvard Medical School studied a group of patients about to undergo major abdominal surgery. Half the patients got the standard preoperative visit. The other half received an enhanced visit dealing with postoperative pain. That half were told that pain is normal and expected, that they would receive medications as ordered by their physicians, that they could also use several self-help techniques to relieve pain, and that nurses and physicians would be standing by to assist them if (...) needed. The enhanced-visit group ended up requesting half as many opioid analgesics as the other group, and they were discharged an average of two days earlier, despite successful blinding (Egbert et al.... (shrink)