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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.

Background Many published accounts of clinical trials report no differences between the treatment arms, while being underpowered to find differences. This study determined how the authors of these reports interpreted their findings. Study Design We examined 54 reports of surgical trials chosen randomly from a database of 110 influential trials conducted in 2008. Seven that reported having adequate statistical power (β ≥ 0.9) were excluded from further analysis, as were the 32 that reported significant differences between the treatment arms. We examined the remaining 15 to see whether the authors interpreted their negative findings appropriately. Appropriate interpretations discussed the lack of power and/or called for larger studies. Results Three of the 7 trials that did not report an a priori power calculation offered inappropriate interpretations, as did 3 of the 8 trials that reported an a priori power Conclusions Negative findings in underpowered trials were often interpreted as showing the equivalence of the treatment arms with no discussion of the issue of being underpowered. This may lead clinicians to accept new treatments that have not been validated.

Background If trials of therapeutic interventions are to serve society9s interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical-trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods. Methods The authors rank-ordered the world9s nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental and other authoritative entities of the 31 countries were searched, and 1004 English-language documents containing ethical and/or methodological standards for clinical trials were identified. The authors extracted standards from 144 of those: 50 designated as ‘core’, 39 addressing trials of invasive procedures and a 5% sample (N=55) of the remainder. As the integrating framework for the standards we developed a coherent taxonomy encompassing all elements of a trial9s stages. Findings Review of the 144 documents yielded nearly 15 000 discrete standards. After duplicates were removed, 5903 substantive standards remained, distributed in the taxonomy as follows: initiation, 1401 standards, 8 divisions; design, 1869 standards, 16 divisions; conduct, 1473 standards, 8 divisions; analysing and reporting results, 997 standards, four divisions; and post-trial standards, 168 standards, 5 divisions. Conclusions The overwhelming number of source documents and standards uncovered in this study was not anticipated beforehand and confirms the extraordinary complexity of the clinical trials enterprise. This taxonomy of multinational ethical and methodological standards may help trialists and overseers improve the quality of clinical trials, particularly given the globalisation of clinical research.

LANGUAGE NOTE | Document text in Chinese本文將文獻中所提出的無效分為四種主要型：生理無效、臨死無效、致命性疾病無效和質量無效；提出了任何無效定義必須滿足的五個條件：精確性條件、預期性條件、社會認可條件、顯著性條件和不同意條件。文章認為，迄今文獻中所提出的無效定義無一滿足這五個條件，其主要原因是，定義的提出者未對支援其定義使用的資料的問題性給予足夠的重視。DOWNLOAD HISTORY | This article has been downloaded 24 times in Digital Commons before migrating into this platform.

Background. Utility techniques are the most commonly used means to assess patient preferences for health outcomes. However, whether utility techniques produce valid measures of preference has been difficult to determine in the absence of a gold standard. Objective. To introduce and demonstrate two methods that can be used to evaluate how well utility techniques measure patients' preferences. Subjects and Design. Patients treated for advanced prostate cancer (n = 57) first ranked eight health states in order of preference. Four utility techniques were then used to elicit patients' utilities for each health state. Measures. The rating scale, standard gamble, time trade-off, and a modified version of willingness-to-pay techniques were used to elicit patients' utilities. Technique performance was assessed by computing a differentiation and inconsistency score for each technique. Results. Differentiation scores indicated the rating scale permitted respondents to assign unique utility values to about 70% of the health states that should have received unique values. When the other techniques were used, about 40% or less of the health states that should have received unique utility scores actually did receive unique utility scores. Inconsistency scores, which indicate how often participants assign utility scores that contradict how they value health states, indicated that the willingness-to-pay technique produced the lowest rate of inconsistency (10%). However, this technique did not differ significantly from the rating scale or standard gamble on this dimension. Conclusions. Differentiation and inconsistency offer a means to evaluate the performance of utility techniques, thereby allowing investigators to determine the extent to which utilities they have elicited for a given decision problem are valid. In the current investigation, the differentiation and inconsistency methods indicated that all four techniques performed at sub-optimal levels, though the rating scale out-performed the standard gamble, time trade-off, and willingness-to-pay techniques.

Unlike medications, the dissemination of surgical procedures into practice is not regulated. Before marketing, pharmaceutical products are required to be shown safe and efficacious in comparative clinical trials which utilize bias-reducing strategies designed to reduce the distortion of estimates of treatment effect by predispositions towards the investigational intervention or control. Unless an investigational device is involved, the corresponding process for surgical innovations is usually unregulated and therefore may not be based upon adequate evidence. Given these differences, we sought to evaluate the state of clinical research on invasive procedures. We conducted a systematic review of publications from 1999–2008 that reported the results of studies evaluating the effects of invasive therapeutic procedures, focusing on trials which appeared to influence practice. Our objective was to determine what proportion of studies evaluating surgical procedures use a comparative clinical trial design and methods to control bias. This paper reports our results and raises concerns about the methodological, and therefore the ethical, quality of clinical research used to justify the implementation of surgical procedures into practice.

There has been a growing concern over establishing norms that ensure the ethically acceptable and scientifically sound conduct of clinical trials. Among the leading norms internationally are the World Medical Association's Declaration of Helsinki, guidelines by the Council for International Organizations of Medical Sciences (CIOMS), the International Conference on Harmonization's standards for industry (ICH), and the CONSORT group's reporting norms (Consolidated Standards of Reporting Trials), in addition to the influential U.S. Federal Common Rule, Food and Drug Administration's (FDA) body of regulations, and information sheets by the Department of Health and Human Services. There are also many norms published at more local levels by official agencies and professional groups.Any account of international standards should cover both scientific and ethical norms at once – the two are conceptually intertwined. Recent sources recognize that “[s]cientifically unsound research on human subjects is unethical in that it exposes research subjects to risks without possible benefit.”

Can a medical ethic be developed for a liberal state? This is the issue posed by the authors of both of the works under review. Brennan in Just Doctoring thinks that the answer is yes and that his theory of just doctoring provides just such an ethic. Emanuel in The Ends of Human Life thinks that the answer is no and that an adequate resolution of the dilemmas of medical ethics requires an alternative political philosophy, liberal commun itarianism.

This paper focuses on invasive therapeutic procedures, defined as procedures requiring the introduction of hands, instruments, or devices into the body via incisions or punctures of the skin or mucous membranes performed with the intent of changing the natural history of a human disease or condition for the better. Ethical and methodological concerns have been expressed about studies designed to evaluate the effects of invasive therapeutic procedures. Can such studies meet the same standards demanded of those, for example, evaluating pharmaceutical agents? This paper describes a research project aimed at examining the interplay and sometimes apparent conflict between ethical standards for human research and standards for methodological rigor in trials of invasive procedures. The paper discusses how the authors plan to develop a set of consensus standards that, if met, would result in substantial and much-needed improvements in the methodological and ethical quality of such trials.

This study examines the intravenous use of two thrombolytic agents [streptokinase (SK) and tissue plasminogen activator (tPA)] in the acute phase of myocardial infarction (MI). These two agents have very different costs and offer an excellent opportunity to study both the impact of economic factors on clinical decisionmaking and the potential for cost savings by limiting the use of expensive new therapeutic agents. A nationwide survey of the 5,792 acute care general hospitals listed in the American Hospital Association's 1988 data file was responded to by 2,651 hospitals (46%) and revealed that 2,384 of these responding hospitals (90%) were using thrombolytic therapy. For 2,200 of these 2,384 hospitals (92%), the respondent was a physician who primarily used one of the two drugs. Eight hundred eighty-six of these 2,200 physicians (40%) primarily used SK while 1,314 (60%) primarily used tPA. SK users were more concentrated in federal public hospitals (69% used SK) than in nonfederal public hospitals (47% used SK), and were least concentrated in private hospitals (36% used SK). There was no difference between the rate of SK vs tPA use in investor-owned and not-for-profit private hospitals. SK users most often (62%) cited various economic factors as the reason for their choice. The users of tPA primarily (73%) cited clinical preferability as the reason for their choice even though trials are still ongoing to see which drug is preferable. Several multivariate analyses shed light upon the association between choice of thrombolytic agent and various additional physician and hospital characteristics. These data clearly indicate that while new therapies are rapidly implemented by the medical community, considerations of cost have a substantial impact upon the pattern of implementation and reflect a desire to implement cost savings in the use of new drugs.

Substantial progress has been made in developing treatments that reduce the risk of fractures in osteoporosis. However, available treatments are only partially effective, they are not widely used, and there is need to search for more effective means of fracture prevention. Currently known effective means of reducing fractures were found using randomized placebo-controlled trials. The use of placebo controls in clinical trials has been a subject of significant controversy in recent years. The Declaration of Helsinki revision of October 2000 caused great concern among clinical investigators about the future use of placebo controls if known effective therapeutic agents are available. A working group of ethicists, clinical trial design experts, and clinical investigators examined the current state of knowledge of osteoporosis treatment and trials. They concluded that if placebo controls put subjects at substantial risk of serious outcomes, they are not ethically permissible. Placebo controls in osteoporosis trials with fracture as the measured outcome are permissible only under narrowly defined conditions. Placebo controls may be used if competent, well-informed patients refuse approved therapies for sound reasons, there is a reasonable basis for substantial disagreement or lack of consensus among professionals about whether approved treatments are better than placebos, or subjects are refractory to known effective agents. Active control trials are permissible and desirable if they can be designed and conducted in ways that overcome the interpretive difficulties often associated with such trials.

Successful practice of cardiovascular medicine requires familiarity with the complex ethical issues that accompany therapeutic innovation and diffusion. Even as technologies transition from experimental to standard care, challenges remain. Mechanical circulatory support devices, for instance, are increasingly conceptualized as conventional therapies. Despite this, or perhaps because of it, the ethical issues surrounding the use of these devices in patients with end-stage organ dysfunction are becoming increasingly apparent. In this paper, we provide an introduction to ethical considerations related to the use of ventricular assist devices (VADs) in end-stage organ failure, focusing on three stages or decision points: initiation, continued use, and deactivation. Our goal is not to exhaustively resolve these dilemmas but to illustrate how ethical considerations relate to decision making.

Clinical sites have in their databases the names of many patients with specific conditions, and researchers have often requested direct access to those databases to get the names of potential subjects for their studies. They then contact those subjects to request their consent to participate in research. However, in getting the names of the potential subjects from the database, the researchers have received confidential information about the

n the early 199os, the National Institutes of Health (NIH) adopted a policy for the management of conflicts of interest on the part of clinical investigators (45 CFR 50.6045). This policy emphasized disclosure of potential or actual conflicts to institutional officials who would then develop strategies for managing them. The policy was adopted as an alternative to an earlier proposal that had emphasized mandated standards and mandated external disclosures.' Recent studies of the actual operation of conflict of interest policies cast doubt on the adequacy of the approach adopted by the NIH.',3 They indicate that as a result of the discretion allowed to institutional officials, there currently exist few uniform standards and very little accountability. These studies have suggested that to increase accountability, the scope of disclosure should be widened.

In the management of short gut, alternatives to long term total parenteral nutrition (TPN) exist, ranging from enteral feeding only to interventional, surgical management such as gut transplant or gut lengthening procedures. To understand attitudes and practice concerning short gut management, a survey was sent in the spring of 1997 to the directors of 102 Neonatology (Neo) and 47 Gastroenterology (GI) fellowship programs with 70% and 85% response respectively. Chi square with Yates correction and Wilcoxon matched paired analysis are used as appropriate.

A recent controversy concerning the pricing of drugs and other technological innovations funded by public dollars raised profound m,oral and social questions, questions the bioethics community has long overlooked. The scope of bioethics has expanded over the years from its original emphasis on questions arising out of clinical encounters and biomedical research to an increasing emphasis on questions about health policy and health care reform. I have long been convinced, however, that even this expanded scope is still conceived far too narrowly. While few technological advances in medicine take place without public commentary by bioethicists, major structural changes in the delivery of health care or in the conduct of biomedical research often go unnoticed by the bioethics community, despite the fact that these changes often raise profound moral and social issues. A splendid example of this neglect was the silence of the bioethics community about the announcement on 11 April 1995 by Harold Varmus, the director of the National Institutes of Health, that the NIH would no longer insist on a "reasonable pricing clause" in Cooperative Research and Development Agreements and in Exclusive license Agreements between industry and government in the process of technology transfer.[1] This decision reversed a policy adopted in 1989 as a result of a public outcry over the pricing by Burroughs-Wellcome of AZT, which had been developed in part by researchers at the National Cancer Institute. This was an issue much debated in the research and biotechnology community for six years, with two major meetings at the NIH in 1994 devoted to it. There was no bioethics input at either of those meetings, despite the fact that the issue raises many important questions to which both moral theory and political philosophy have much to contribute. It is time for the bioethics community to expand its focus and jorovide input to many more issues. The Technology Transfer Background In the 1980s, the U.S. Congress passed two major acts[2] the designed to promote collaboration between the federal research effort and the development of useful technologies, the process that has come to be called technology transfer[3]. The thinking behind these statutes is clearly articulated in the following congressional statement explaining the second act: The United States can no longer afford the luxury of isolating its government laboratories from university and industry laboratories. Already endowed with the best research institutions in the world, this country is increasingly challenged in its military and economic competitiveness. The national interest demands that the federal laboratories collaborate with universities and industry to ensure continued advances in scientific knowledge and its translation into useful technology. The Federal laboratories must be more responsive to national needs.[4] The first of the two acts was the Bayh-Dole Act of 1980. It addressed the ownership of inventions made by researchers using federal funds from contracts or grants. Since 1963, when President Kennedy issued a memorandum on this question, the patents were held by the government when the resulting products were to be used by the general public, when the research concerned public health or welfare, when the government was the principal developer in the field, or when the contractor was running a federally owned facility. There was a widespread conviction that this policy often resulted in potentially useful government-owned inventions not being developed into useful products. Those who might develop useful products, it was felt, did not do so because they didn't own the technology and couldn't be assured of an adequate and safe return on their investment. The 1980 Bayh-Dole Act changed this situation. …

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

This paper describes the activities of the Center for Ethics, Medicine, and Public Issues, a joint project of Baylor College of Medicine, the Institute of Religion of the Texas Medical Center, and Rice University. The center focuses on the clinical teaching of medical ethics, collaborative teaching and research involving ethicists and clinicians, and the training of future practitioners in the field. Problems as well as achievements in each of these areas are discussed.

impact on women's experience of birth. Martin points out that women's ability to resist medical treatment during birth is also obviously affected by their race and their class. The Woman in the Body is a very different book than In Search of Parenthood. It sets an ideological context for women's experiences. It does not accept at face value the medical constructions of that experience, and it analyzes rather thanjust repeats women's quotations, so that the thoughts and constructions women put on their own lives are reconstructed for us in the text. Martin leaves us with a powerful set of images relating to the medical profession and to women's lived experience; a strong faith in women's resistance; and an uneasy anticipation of the future for women and birth as technology takes more and more control.

Ethical Questions Raised by the Persistent Vegetative Patient Ms. T is a twenty-eight-year-old patient diagnosed in a persistent vegetative state who has been in a hospital and/or its affiliated nursing home for the last two and one-half years. When she was twenty-five, she was in a motorcycle accident in which she suffered extensive head injuries. While she is able to breathe on her own and has some brainstem reflexes, she has been unresponsive since the time of her accident and has shown no other evidence of higher brain functioning, although she is certainly not brain dead. Most of the time she receives only nursing care: she regularly needs to have her airway suctioned to prevent secretions from blocking it, and she is regularly turned in bed to avoid bed sores. She is fed and she excretes through tubes. Her major medical needs arise from serious infections that require a careful workup and extensive antibiotic treatment. When necessary, she is transferred from the affiliated nursing home to the hospital, as was recently the case. Ms. T's parents have been devastated since their daughter's accident. Ms. T is their only child, and they had taken great pride in all of her achievements. They cannot bring themselves to accept the fact tht she will never recover. They feel certain that with full and comprehensive treatment, she can survive for years. Hoping for an eventual miracle or for some medical advance, they want this level of treatment to continue. As things stand now, the family's life centers around their regular extended daily visit, where they sit at their daughter's bedside. Often they talk to her, begging her to respond to them. The futility of the situation has been repeatedly conveyed to Ms. T's parents, but they have insisted in the past, and continue to insist in this hospitalization, that their daughter's infection be managed aggressively. They report no conversations with their daughter about these matters prior to her accident. Those who have to care for Ms. T are frustrated by the situation; they see her care as a waste of their time and a misuse of their abilities. They also feel her parents would benefit from Ms. T's death, as they then could attend to their own lives. Finally, they are worried about the cost to society of continuing to provide care to Ms. T. Since her insurance coverage expired long ago, the entire cost of Ms. T's care now falls upon a public hospital with a limited budget. The staff believes that the provision of care to many other patients is impeded because of the allocation of time and resources to Ms. T. This story is actually a composite of several real cases that I have been following for some years. The account brings together most of the special features of each case that give rise to major ethical issues. Among the most prominent issues raised by Ms. T's case are the following: (1) Regardless of how the current statutes define brain death, is this patient really dead? What are the implications of such a determination? Would that at least mean that all further care could be withdrawn? What if the parents continue to object? (2) Suppose the parents agreed with the staff that their daughter should be allowed to die. What forms of care could be withdrawn? Antibiotics? Food and fluids? (3) If the parents do not change their minds, and Ms. T does not satisfy criteria for determination of death, could care be withdrawn against the parental wishes? Could the parents be requested to find other caregivers to provide the desired level of care? Pluralistic Casuistry In thinking about serious ethical issues raised by real medical cases, it is important to ground the process of reasoning in some basic theoretical structure. The approach that seems most useful is the model of conflicting values. According to this model, there are a number of very distinct but equally legitimate and nonreducible moral appeals that need to be employed in the evaluation of a particular case. …

One of the most frustrating aspects of discussions about abortion is the way in which they rapidly turn into a discussion of the status of the foetus and of whether destroying the foetus constitutes the taking of a human life. Since these latter questions seem difficult, if not impossible, to resolve upon rational grounds, frustration results. It therefore seems desirable to find aspects of the abortion problem that can be resolved independently of the status of the foetus problem. One such possibility is the question of whether there should be a law against abortions performed by licensed physicians upon the request of the mother (or perhaps the parents). There are, after all, many people who, while opposed to abortion on the grounds that it involves the taking of a human life, maintain that it would still be wrong (or at least inappropriate) for a state to legislate against such abortions. If their claim can be shown to be right, then we could at least resolve the legal problem about abortion. This paper is an attempt to assess their claim.

I should like in this paper to explain and defend a theory of essentialism that I have briefly set out elsewhere.' In particular, I would like to show that (a) it is based upon a simple distinction that we can often employ without any difficulty, (b) it is open to none of the standard objections to essentialism, and (c) it recognizes as essential significant properties of particular physical objects, most importantly, the ones that correspond to the intuitively appropriate Aristotelian secondary substances. If all of this can be done, then there will be no reason to offer, as recent defenders of essentialism like Kaplan and Plantinga have, some de dicto reinterpretation of essentialist claims. This is fortunate, for the theory in question does not seem to lend itself to such reinterpretations. In short, then, I will be arguing for an unabashed traditional theory of Aristotelian essentialism.