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.

Baruch Brody contends that the fundamental assumption on which the tradition is based is erroneous and that once this assumption is shown to be in error, all philosophical problems in this area have to be rethought. Originally published in 1980. The Princeton Legacy Library uses the latest print-on-demand technology to again make available previously out-of-print books from the distinguished backlist of Princeton University Press. These editions preserve the original texts of these important books while presenting them in durable paperback and (...) hardcover editions. The goal of the Princeton Legacy Library is to vastly increase access to the rich scholarly heritage found in the thousands of books published by Princeton University Press since its founding in 1905. (shrink)

A broad critical review of national policies on biomedical research - human, epidemiologic, clinical trials, genetic, reproductive, etc.

Integrating theory with case studies, this book examines the practical application of moral theory in clinical decision-making through 40 composite cases based on actual clinical experience. Complex, realistic, and challenging, these examples contain the multiplicity of factors faced in clinical crises, making this a superb exploration of the ways in which theory relates to actual life-or-death situations.

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)

Smith, Glass, and Miller have reported a meta-analysis of over 500 studies comparing some form of psychological therapy with a control condition. They report that when averaged over all dependent measures of outcome, psychological therapy is. 85 standard deviations better than the control treatment. We examined the subset of studies included in the Smith et al. metaanalysis that contained a psychotherapy and a placebo treatment. The median of the mean effect sizes for these 32 studies was. 15. There was a (...) nonsignificant inverse relationship between mean outcome and the following: sample size, duration of therapy, use of measures of outcome other than undisguised self-report, measurement of outcome at follow-up, and use of real patients rather than subjects solicited for the purposes of participation in a research study. A qualitative analysis of the studies in terms of the type of patient involved indicates that those using psychiatric outpatients had essentially zero effect sizes and that none using psychiatric inpaticnts provide convincing evidence for psychotherapeutic effectiveness. The onty studies clearly demonstrating significant effects of psychotherapy were the ones that did not use real patients. For the most part, these studies involved small samples of subjects and brief treatments, occasionally described in quasibeliavioristic language. It was concluded that for real patients there is no evidence that the benefits of psychotherapy are greater than those of placebo treatment. (shrink)

: 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)

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)

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)

Responsible conduct of research courses are widely taught, but little is known about the purposes or effectiveness of such courses. As one way to assess the purposes of these courses, students were surveyed about their perspectives after recent completion of one of eleven different research ethics courses at ten different institutions. Participants enrolled in RCR courses in spring and fall of 2003 received a voluntary, anonymous survey from their instructors at the completion of the course. Responses were received from 268 (...) participants. Seventy-seven percent of open-ended responses listed specific kinds of information learned; only a few respondents talked about changes in skills or attitudes. The perception that courses did more to provide information than to foster skills or attitudes was verified in quantitative responses. Over 75% of the respondents specifically noted that courses were useful in preparing them to recognize, avoid, and respond to research misconduct. The two principal findings of this multi-institutional study are that respondents reported: a wide variety of positive outcomes for research ethics courses, but that the impact on knowledge was greater than that for changes in skills or attitudes. (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)

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.

In this paper, I consider a variety of objections against the covering-law model of scientific explanation, show that Aristotle was already aware of them and had solutions for them, and argue that these solutions are correct. These solutions involve the notions of nonHumean causality and of essential properties. There are a great many familiar objections, both methodological and epistemological, to introducing these concepts into the methodology of science, but I show that these objections are based upon misunderstandings of these concepts.

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.

Based on the existence of polysemy (e.g., lunch can refer to both food and events), it is argued that central tenets of externalist semantics and Fodorian concept atomism, an externalist theory on which words lack semantic structure, are unsound. We evaluate the premise that these arguments rely on—that polysemous words have separate, finer‐grained senses. We survey the evidence across psychology and linguistics and argue that it shows that polysemy does not exist, at least not in this “sense”. The upshot is (...) that if polysemy does not exist, it cannot pose a problem for atomism or externalism. (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.

Despite strong growth in scientific investigation of the placebo effect, understanding of this phenomenon remains deeply confused. We investigate critically seven common conceptual distinctions that impede clear understanding of the placebo effect: (1) verum/placebo, (2) active/inactive, (3) signal/noise, (4) specific/nonspecific, (5) objective/subjective, (6) disease/illness, and (7) intervention/context. We argue that some of these should be eliminated entirely, whereas others must be used with caution to avoid bias. Clearing away the conceptual underbrush is needed to lay down a path to understanding (...) and harnessing placebo effects in clinical medicine. (shrink)

This paper distinguishes four major types of futility (physiological, imminent demise, lethal condition, and qualitative) that have been advocated in the literature either in a patient dependent or a patient independent fashion. It proposes five criteria (precision, prospective, social acceptability, significant number, and non-agreement) that any definition of futility must satisfy if it is to serve as the basis for unilaterally limiting futile care. It then argues that none of the definitions that have been advocated meet the criteria, primarily because (...) their proponents have not paid sufficient attention to the problematic nature of the data supporting the use of their definitions. (shrink)

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 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)

New edition (previously 1971) of an anthology for an undergraduate course. Comprises four parts: theories, explanation and causality, confirmation of scientific hypotheses, selected problems of particular sciences. Annotation copyrighted by Book News, Inc., Portland, OR.

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)

An individual's health, genetic, or environmental-exposure data, placed in an online repository, creates a valuable shared resource that can accelerate biomedical research and even open opportunities for crowd-sourcing discoveries by members of the public. But these data become “immortalized” in ways that may create lasting risk as well as benefit. Once shared on the Internet, the data are difficult or impossible to redact, and identities may be revealed by a process called data linkage, in which online data sets are matched (...) to each other. Reidentification, the process of associating an individual's name with data that were considered deidentified, poses risks such as insurance or employment discrimination, social stigma, and breach of the promises often made in informed-consent documents. At the same time, re-ID poses risks to researchers and indeed to the future of science, should re-ID end up undermining the trust and participation of potential research participants. The ethical challenges of online data sharing are heightened as so-called big data becomes an increasingly important research tool and driver of new research structures. Big data is shifting research to include large numbers of researchers and institutions as well as large numbers of participants providing diverse types of data, so the participants’ consent relationship is no longer with a person or even a research institution. In addition, consent is further transformed because big data analysis often begins with descriptive inquiry and generation of a hypothesis, and the research questions cannot be clearly defined at the outset and may be unforeseeable over the long term. In this article, we consider how expanded data sharing poses new challenges, illustrated by genomics and the transition to new models of consent. We draw on the experiences of participants in an open data platform—the Personal Genome Project—to allow study participants to contribute their voices to inform ethical consent practices and protocol reviews for big-data research. (shrink)

Empirical research can aid ethical reflection in bioethics by identifying issues, by seeing how they are currently resolved, and by assessing the consequences of these current resolutions. This potential can be misused when the ethical issues in question are fundamentally non-consequentialist or when they are consequentialist but the empirical research fails to address the important consequences. An example of the former problem is some recent studies about bad consequences resulting from commercialized living kidney donor programs. These consequences could be avoided, (...) but the crucial non-consequentialist ethical issues about exploitation and commercialization would still remain. Examples of the latter problem are provided by recent studies of the allocation of ICU beds and of physician deception, where important consequences were not adequately studied. (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)

"When it comes to morality as it is practiced in medicine, Brody makes clear that the ethical issues are never as simple as black and white - that there are myriad factors and fine nuances that can and should challenge decision making as it is commonly practiced in difficult medical cases. In this collection, delving thoughtfully and systematically into methodology, research ethics, clinical ethics, and Jewish medical ethics, he tackles thorny life-and-death questions head-on and fearlessly. He casts a light into (...) all the corners of end-of-life decisions - a field in which he has exemplary credentials - while illuminating a new understanding of morality and ethics." "The introduction outlines much of Brody's approach, defines the terminology used, and contrasts his ethical positions with much of the competing literature, Taking Issue will be invaluable to students and scholars in medical ethics, bioethics, and the philosophy of medicine." "Baruch A. Brody is the Leon Jaworski Professor Biomedical Ethics and director of the Center for Medical Ethics and Health Policy at Baylor College of Medicine. He is also a professor of philosophy at Rice University and director of the Ethics program at the Methodist Hospital."--BOOK JACKET. (shrink)

The focus of this paper is the syntax of inverse scope in Hungarian, a language that largely disambiguates quantifier scope at spell-out. Inverse scope is attributed to alternate orderings of potentially large chunks of structure, but with appeal to base-generation, as opposed to nonfeature-driven movement as in Kayne 1998. The proposal is developed within mirror theory and conforms to the assumption that structures are antisymmetrical. The paper also develops a matching notion of scope in terms of featural domination, as opposed (...) to c-command, and applies it to otherwise problematic cases of pied piping. Finally, the interaction of different quantifier types is examined and the patterns are explained invoking morphological considerations on one hand and A-bar reconstruction on the other. (shrink)

The timing of this special issue of AJOB probing whether public engagement (PE)1 might help achieve equity in genomics is no coincidence. While many issues discussed by the authors are not entirely...

: Pharmacogenetics offers the prospect of an era of safer and more effective drugs, as well as more individualized use of drug therapies. Before the benefits of pharmacogenetics can be realized, the ethical issues that arise in research and clinical application of pharmacogenetic technologies must be addressed. The ethical issues raised by pharmacogenetics can be addressed under six headings: regulatory oversight, confidentiality and privacy, informed consent, availability of drugs, access, and clinicians' changing responsibilities in the era of pharmacogenetic medicine. We (...) analyze each of these categories of ethical issues and provide policy approaches for addressing them. (shrink)

A traditional ethic of medicine asserts that physicians have special obligations to individual patients with whom they have a clinical relationship. Contemporary trends in US healthcare financing like bundled payments seem to threaten traditional conceptions of special obligations of individual physicians to individual patients because their population-based focus sets a tone that seems to emphasise responsibilities for groups of patients by groups of physicians in an organisation. Prior to undertaking a cogent debate about the fate and normative weight of special (...) obligations and a traditional ethic for contemporary healthcare, we need a deeper examination of what the traditional ethic of special obligations really means. Here we offer a conception of ‘doubly distributed’ special obligations. Physicians and similarly minded healing professionals abiding by a traditional ethic have always spread their devotion and attention across multiple patients and have shared responsibilities with physician and non-physician colleagues in much the same way devoted parents have frequently distributed their special obligations across multiple children and across multiple parents. By taking up the extended analogy of parent we argue that doubly distributing special obligations need not contradict the possibility of special obligations in restructured collective forms of healthcare delivery and financing. (shrink)

Book reviewed in this article: Morality, Mortality: Death and Whom to Save from It. By Frances Kamm.

This paper identifies four major forms of scholarship in bioethics: empirical research, the articulation of mid-level principles of bioethics, the relating of these principles to fundamental moral theories, and discussions of the bioethical implications of legal principles and health delivery policies. It develops a reflective equilibrium approach to the relation between these four forms of scholarship. It then presents, in light of this approach, criteria for quality research in each of these forms of scholarship in bioethics. Keywords: quality of scholarship, (...) reflective equilibria in bioethics, research in bioethics CiteULike Connotea Del.icio.us What's this? (shrink)