In a recent article (Brody 2010), I analyzed the debates surrounding charges of biopiracy, that is, charges that developed countries use biotechnology patents to expropriate the biological/genetic heritage of less developed countries. Such charges often are accompanied by the additional charge that biotechnology patents are used to expropriate the traditional knowledge about the use of these resources possessed by indigenous communities in less developed countries. It is this second charge that is the focus of this essay, which will develop (...) both narrative and normative claims. The narrative claim is that various context specific principles about justice relating to traditional knowledge were adopted during the .. (shrink)
: The European patent system allows for the introduction of moral issues into decisions about the granting of patents. This feature has greatly impacted European debates about the patenting of biotechnology. This essay explores the European experience, in both the European Union and the European Patent Organization. It argues that there has been great confusion surrounding these issues primarily because the Europeans have not developed a general theory about when exclusion from patentability is the best social mechanism for dealing with (...) morally offensive technologies. (shrink)
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)
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)
: In the development of biotechnology in the United States, many questions were raised about the appropriateness of applying to this area a traditional robust system of intellectual property rights. Despite these hesitations, the U.S. rejected suggested modifications. This was a mistake, and there is a need to develop a modified system that promotes more of the relevant ethical values.
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)
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)
In this paper, I make a case for interpreting the Lysis as a dialogue of definition, designed to answer the question of “What is a friend?” The main innovation of my interpretation is the contention – and this is argued for in the paper – that Socrates hints towards a definition of being a friend that applies equally to mutual friendship and one-way attraction – the two kinds of friend relation very clearly identified by Socrates in the dialogue. The key (...) to understanding how the two different kinds of friendship can have a common definition is to appreciate that the property of being a friend has a relational character. (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)
This easy challenges the view that the provision of health care must take place within a competitive-free system. The author argues that, presuming that there is a requirement to meet the demands of those who cannot pay for health care, a competitive market provides a good way to deal with injustices within the health care system. The author concludes that the demands for justice are best met when indigent individuals use some portion of the funds they receive from the government (...) to purchase one of the many competing forms of health care. This scheme requires a competitive market in the delivery of health care. Keywords: justice, competition, for-profit medicine CiteULike Connotea Del.icio.us What's this? (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)
: Continuing the discussion begun in the March 2006 issue of the Kennedy Institute of Ethics Journal, this paper further documents the failure of the United States to adequately consider possible modifications in the traditional robust system of intellectual property rights as applied to biotechnology. It discusses concrete suggestions for alternative disclosure requirements, for exemptions for research tools, and for improved access to clinical advances. In each of these cases, the modifications might be more responsive to the full set of (...) relevant values. (shrink)
: 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: (1) regulatory oversight, (2) confidentiality and privacy, (3) informed consent, (4) availability of drugs, (5) access, and (6) 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)
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)
Family medicine has grown as a specialty from its early days of general practice. It was established as a Board Certified specialty in 1969. This growth and maturation can be traced in the philosophy of family medicine as articulated by Edmund D. Pellegrino, M.D. Long before it was popular to do so, Pellegrino supported the development of family medicine. In this essay I examine the development of Pellegrino's philosophical thought about family practice, and contrast it to other thinkers like Ian (...) McWhinney, Kerr White, Walter Spitzer, Donald Ransom, and Hebert Vandervoort. The arguments focus on whether the goals of family medicine and family practice (possibly two distinct entities) can be articulated, especially considering the definitional problems of family and community. I conclude by echoing Pellegrino's hope that family medicine can contribute a fresh alternative to isolated, individualistic and technological thinking in medicine. (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)
In this paper questions are raised about the use of Halakhic material discussions of medical ethics. Three ways in which one might use Halakhic material in such discussions are distinguishes: (a) as a source for ideas about medical ethics which can be defended independently of their origin; (b) as a basis for mandating certain forms of behaviour for members of the Jewish faith; (c) as the basis for claims about the Jewish view on disputed topics in medical ethics. The first (...) two raise no methodical problems. The third use raises a number of theoretical and practical issues, with which the paper is concerned. Several problems stem from the fact that Halakhah distinguishes between obligations, fulfilment of which is required for all people. With rare exceptions, the obligations imposed up on the Jewish people are more stringent. The pitfall lurking the in third of the three uses is that authors using Halakhic material may correctly conclude that obligations that are supposed to fall only upon the Jewish people fall upon all people. An analysis of this problem follows, along with a plea for a responsible use of Halakhic material in the third way, so as to avoid certain real pitfalls. CiteULike Connotea Del.icio.us What's this? (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)
Sixty-five undergraduates participating in a wide range of psychological research experiments were interviewed in depth about their research experiences and their views on the process of informed consent. Overall, 32% of research experiences were characterized positively and 41 % were characterized negatively. One major theme of the negative experiences was that experiments were perceived as too invasive, suggesting incomplete explication of negative aspects of research during the informed consent process. Informed consent experiences were viewed positively 80% of the time. However, (...) most of the participants had a limited view of the purpose of informed consent: Less than 20% viewed the process as a decision point. Results suggest a number of common pitfalls to standard informed consent practices that have not generally been recognized. Results are discussed in terms of both ethical and methodological implications. Suggestions for improving the informed consent process are also provided. (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.
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.
Schizophrenia affects more than 1% of the world's population, causing great personal suffering and socioeconomic burden. These costs associated with schizophrenia necessitate inquiry into the causes and treatment of the illness but generate ethical challenges related to the specific nature and deficits of the illness itself. In this article, we present a systematic analysis of narrative data from 63 people living with the illness of schizophrenia collected through semistructured interviews about their attitudes, beliefs, and experiences related to psychiatric research. In (...) the comments of these individuals, half of whom had had prior personal experience in research protocols, we identified factors influencing openness toward research involvement as well as deterrents that appear to lessen interest in participation. Clear response pattern differences emerged between those with prior research experience and those without such experience. In the discussion, we explore these key findings and outline the implications for safeguards in mental illness research. (shrink)
Minogue's criticism of MacIntyre and Gorovitz's concept of medicine as a science of individuals is flawed by an assumption of the perfectibility of science that is not well supported by experience to date. More significantly, both Minogue and MacIntyre and Gorovitz have been led astray by choosing to use the malpractice issue as a philosophical point of departure for an inquiry into medical error. The problem of error in medicine, and moral culpability for error, is of great philosophical interest but (...) requires a more detailed contextual approach than these two studies provide. CiteULike Connotea Del.icio.us What's this? (shrink)
In a broad-based study of experiences in psychological research, 65 undergraduates participating in a wide range of psychological experiments were interviewed in depth. Overall findings demonstrated that participants hold varying views, with only 32% of participants characterizing their experiences as completely positive. Participants' descriptions of their debriefing experiences suggest substantial variability in the content, format, and general quality of debriefing practices. Just over 40% of the debriefing experiences were viewed favorably. Positive debriefing experiences were described as including a thorough explanation (...) of the study and detailed information concerning the broader relevance of the experiment to the field of psychology. The most common complaint, characterizing 28.8% of the responses, was that the debriefing was unclear and that insufficient information was provided. Participants' views of psychological research and the discipline of psychology were also elicited. Results are discussed in terms of ethical and methodological implications. (shrink)
This paper argues, contrary to what has sometimes been claimed, that public commissions need to be more philosophical than they have been in analyzing crucial bioethical issues. It argues (a) that the failure of the President's Commission to develop and use even simple distinctions between life and personhood led to flaws in both its discussion of death and its discussion of persistent vegetative patients, and (b) that its treatment of access to health care fails to develop a coherent approach precisely (...) because it is based on no serious philosophical reflections about justice in health care. Keywords: justice in health care, life, persistent vegetative patients, personhood, President's Commission on Bioethics CiteULike Connotea Del.icio.us What's this? (shrink)
The adaptive trade-offs between long- and short-term matings may be mediated or at least reflected partially by the trade-offs between the relative reinforcement obtained through a greater frequency of intercourse (typically greater among cohabitants) versus a greater frequency of partner change. The differing correlates of each approach and meshing with the Sexual Strategies Theory of Gangestad & Simpson are discussed.
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)
The effects of research ethics training on medical students' attitudes about clinical research are examined. A preliminary randomized controlled trial evaluated 2 didactic approaches to ethics training compared to a no-intervention control. The participant-oriented intervention emphasized subjective experiences of research participants (empathy focused). The criteria-oriented intervention emphasized specific ethical criteria for analyzing protocols (analytic focused). Compared to controls, those in the participant-oriented intervention group exhibited greater attunement to research participants' attitudes related to altruism, trust, quality of relationships with researchers, desire (...) for information, hopes about participation and possible therapeutic misconception, importance of consent forms, and deciding quickly about participation. The participant-oriented group also agreed more strongly that seriously ill people are capable of making their own research participation decisions. The criteria-oriented intervention did not affect learners' attitudes about clinical research, ethical duties of investigators, or research participants' decision making. An empathy-focused approach affected medical students' attunement to research volunteer perspectives, preferences, and attributes, but an analytically oriented approach had no influence. These findings underscore the need to further examine the differential effects of empathy-versus analytic-focused approaches to the teaching of ethics. (shrink)
Knight has shown how the moral growth of medical students involves a spiritual journey. He may, however, present too sanguine a portrayal of the extent to which the medical education environment promotes this moral and spiritual growth. Medical school may indeed be more abusive than supportive. Admitting more women to medical school and teaching more humanities courses, while worthwhile, will not necessarily promote the goals that Knight appropriately advocates.
The physician in Erde's clinical case study performed poorly in a number of aspects of informed consent and good physician-patient communication. However, the patient also failed to perform some of his own duties to participate in effective communication and so shares at least some responsibility for the bad outcome.
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)
Utilizing a sorted compendium of international clinical trial standards, investigators identified 15 conflicts among ethical and methodological guidance. Analysis distinguishes interpretational issues, lack of clarity, and contradiction as factors to be addressed if international trial guidance is to be improved.
Responsible conduct of research (RCR) 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 (undergraduate and graduate students, post-doctoral fellows and faculty, staff and researchers) 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 (P<0.0001). 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: (1) a wide variety of positive outcomes for research ethics courses, but that (2) the impact on knowledge was greater than that for changes in skills or attitudes. (shrink)