In bioethics, discussions of justice have tended to focus on questions of fairness in access to health care: is there a right to medical treatment, and how should priorities be set when medical resources are scarce. But health care is only one of many factors that determine the extent to which people live healthy lives, and fairness is not the only consideration in determining whether a health policy is just. In this pathbreaking book, senior bioethicists Powers and Faden confront foundational (...) issues about health and justice. How much inequality in health can a just society tolerate. The audience for the book is scholars and students of bioethics and moral and political philosophy, as well as anyone interested in public health and health policy. (shrink)
Vulnerability is one of the least examined concepts in research ethics. Vulnerability was linked in the Belmont Report to questions of justice in the selection of subjects. Regulations and policy documents regarding the ethical conduct of research have focused on vulnerability in terms of limitations of the capacity to provide informed consent. Other interpretations of vulnerability have emphasized unequal power relationships between politically and economically disadvantaged groups and investigators or sponsors. So many groups are now considered to be vulnerable in (...) the context of research, particularly international research, that the concept has lost force. In addition, classifying groups as vulnerable not only stereotypes them, but also may not reliably protect many individuals from harm. Certain individuals require ongoing protections of the kind already established in law and regulation, but attention must also be focused on characteristics of the research protocol and environment that present ethical challenges. (shrink)
In this article, we address the relevance of J.S. Mill’s political philosophy for a framework of public health ethics. In contrast to some readings of Mill, we reject the view that in the formulation of public policies liberties of all kinds enjoy an equal presumption in their favor. We argue that Mill also rejects this view and discuss the distinction that Mill makes between three kinds of liberty interests: interests that are immune from state interference; interests that enjoy a presumption (...) in favor of liberty; and interests that enjoy no such presumption. We argue that what is of focal importance for Mill in protecting liberty is captured by the essential role that the value of self-determination plays in human well-being. Finally, we make the case for the plausibility of a more complex and nuanced Millian framework for public health ethics that would modify how the balancing of some liberty and public health interests should proceed by taking the thumb off the liberty end of the scale. Mill’s arguments and the legacy of liberalism support certain forms of state interference with marketplace liberties for the sake of public health objectives without any presumption in favor of liberty. (shrink)
Though much progress has been made on inclusion of non-pregnant women in research, thoughtful discussion about including pregnant women has lagged behind. We outline resulting knowledge gaps and their costs and then highlight four reasons why ethically we are obliged to confront the challenges of including pregnant women in clinical research. These are: the need for effective treatment for women during pregnancy, fetal safety, harm from the reticence to prescribe potentially beneficial medication, and the broader issues of justice and access (...) to benefits of research participation. Going forward requires shifting the burden of justification from inclusion to exclusion and developing an adequate ethical framework that specifies suitable justifications for excluding pregnant women from research. (shrink)
As concerns about the negative health effects of unhealthy eating, overweight and obesity have increased, so too have policy efforts to promote healthy eating. Federal, state, and local governments have proposed and implemented a variety of healthy eating policies. Many of these policies are controversial, facing objections that range from the practical (e.g., the policy won’t succeed at improving people’s diets) to the ethical (e.g., the policy is paternalistic or inequitable). Especially controversial have been policies limiting the options offered in (...) the marketplace, limiting access to certain options, or providing disincentives for the purchase of certain options. Examples of such policies include proposed .. (shrink)
A new study published in Journal of Medical Ethics by van der Zande et al 1 further highlights why classifying pregnant women as a ‘vulnerable population’ in the context of research is deeply problematic. Because the designation of ‘vulnerable’ is otherwise applied to populations whose decision-making capacity about research participation is somehow compromised—such as children and adults of limited cognitive ability—many of us have been arguing for some time that using this designation for pregnant women is inappropriate and disrespectful.2–4 There (...) is nothing about the state of pregnancy that renders pregnant women incapable of offering valid research consents or refusals. Moreover, rather than protecting the health interests of pregnant women and their offspring, this designation has had the opposite effect. It has contributed to the widespread exclusion of pregnant women from research activities, which is itself pernicious to the health of pregnant women.5 We know that pregnant women encounter a range of health needs across their pregnancies. In the USA, for example, approximately 9 out of every 10 women use some kind of medication during pregnancy to manage health conditions.6 Yet because pregnant women have largely been …. (shrink)
Articles by Lyn Horn and Alison Thompson highlight several points crucial to understanding how our theory figures in wider debates about social justice as well as the particular relevance of our theory for assessing the overall practice of public health (Horn, 2013; Thompson, 2013). We begin with these two articles, first to respond to and concur with many of their central points, and second to set the stage for dealing more efficiently with some points raised in the other articles.
Television medical dramas frequently depict the practice of medicine and bioethical issues in a strikingly realistic but sometimes inaccurate fashion. Because these shows depict medicine so vividly and are so relevant to the career interests of medical and nursing students, they may affect these students' beliefs, attitudes, and perceptions regarding the practice of medicine and bioethical issues. We conducted a web-based survey of medical and nursing students to determine the medical drama viewing habits and impressions of bioethical issues depicted in (...) them. More than 80% of medical and nursing students watch television medical dramas. Students with more clinical experience tended to have impressions that were more negative than those of students without clinical experience. Furthermore, viewing of television medical dramas is a social event and many students discuss the bioethical issues they observe with friends and family. Television medical dramas may stimulate students to think about and discuss bioethical issues. (shrink)
: Because an influenza pandemic would create the most serious hardships for those who already face most serious hardships, countries should take special measures to mitigate the effect of a pandemic on existing social inequalities. Unfortunately, there is little evidence that anybody is thinking about that.
If stem cell-based therapies are developed, we will likely confront a difficult problem of justice: for biological reasons alone, the new therapies might benefit only a limited range of patients. In fact, they might benefit primarily white Americans, thereby exacerbating long-standing differences in health and health care.
As interest in comparative effectiveness research grows, questions have emerged regarding whether it is ever acceptable to alter informed consent requirements for research when patients are randomly assigned to widely-used therapies. This paper reports on interviews with Institutional Review Board members and researchers and on focus groups with patients from Geisinger and Johns Hopkins health systems. The objective was to elicit participants' views of the acceptability of four different disclosure and authorization models for low-risk pragmatic comparative effectiveness trials of widely-used (...) therapies. Results suggest that although participants valued autonomous choice, many also believed that it was acceptable to streamline information disclosure and to use an opt-out process for eligible individuals who would prefer not to participate. This provides some preliminary evidence that relevant stakeholders find alternatives to traditional informed consent acceptable for low-risk pragmatic comparative effectiveness trials of widely-used therapies as long as a sufficient amount of choice is preserved. (shrink)
The goal of this article is to explore how a social justice framework can help illuminate the role that consent should play in health and science policy. In the first section, we set the stage for our inquiry with the important case of Henrietta Lacks. Without her knowledge or consent, or that of her family, Mrs. Lacks’s cells gave rise to an enormous advance in biomedical science—the first immortal human cell line, or HeLa cells.
: The focus of questions of justice in health policy has shifted during the last 20 years, beginning with questions about rights to health care, and then, by the late 1980s, turning to issues of rationing. More recently, attention has focused on alternatives to cost-effectiveness analysis. In addition, health inequalities, and not just inequalities in access to health care, have become the subject of moral analysis. This article examines how such trends have transformed the philosophical landscape and encouraged some in (...) bioethics to seek guidance on normative questions from outside of the contours of traditional philosophical arguments about justice. (shrink)
New biotechnologies have the potential to both dramatically improve human well-being and dramatically widen inequalities in well-being. This paper addresses a question that lies squarely on the fault line of these two claims: When as a matter of justice are societies obligated to include a new biotechnology in a national healthcare system? This question is approached from the standpoint of a twin aim theory of justice, in which social structures, including nation-states, have double-barreled theoretical objectives with regard to human well-being. (...) The first aim is to achieve a sufficient level of well-being in each of six core dimensions. In the special case of healthcare systems, this aim is focally but not exclusively attentive to achieving health sufficiency as one of the core dimensions. The second aim is to combat the emergence and persistence of densely woven patterns of systematic disadvantage that tend to undermine the achievement of a sufficient level of health and the other core elements of well-being of some persons and groups. Judgments about entitlements to health related resources, including new biotechnologies, are made in light of a threshold notion of health sufficiency. What is enough or sufficient health? The answer that is defended here is that sufficient health is enough health for a decent human life, understood as enough health to live a full life course without preventable, significant functional disability or decrement in health, or treatable pain or suffering. When a state must include a new biotechnology in its national healthcare system is also influenced by ancillary concerns about the connection between health and other core dimensions of well-being. What counts as a significant functional impairment or health decrement is thus explicated, in part, in relation to the theory’s sufficiency aim for the other essential dimensions of well-being, and thus for a decent life, overall. Those elements of health that play a critical role in the experience of sufficient reasoning, affiliation, security, respect and self determination are especially important; any loss of health function or capacity that threatens the individual’s prospects for sufficiency in these other dimensions, including the relational egalitiarian concerns they entail, constitutes a significant functional impairment. Within national borders, individuals are thus entitled to those health-related goods and services that are essential for a sufficiency of each of the dimensions of well-being; with regard to self determination and respect, what is sufficient by way of guaranteed access to specific goods and services is going to depend on the implications of such access for where an individual stands in relation to her co-nationals. The content of any entitlement to health-related goods and services is also necessarily dynamic. What can be done for health and the other core dimensions of well-being as a function of technological innovation and diffusion is in constant flux. The paper concludes by considering the implications of this analysis for the conditions under which states are obligated to include access in their healthcare systems to one biotechnology, deep brain stimulation. (shrink)
The use of aggregated quality of life estimatesin the formation of public policy and practiceguidelines raises concerns about the moralrelevance of variability in values inpreferences for health care. This variabilitymay reflect unique and deeply held beliefs thatmay be lost when averaged with the preferencesof other individuals. Feminist moral theorieswhich argue for attention to context andparticularity underline the importance ofascertaining the extent to which differences inpreferences for health states revealinformation which is morally relevant toclinicians and policymakers. To facilitatethese considerations, we present (...) an empiricalstudy of preferences for the timing andoccurrence of health states associated withhormone replacement therapy (HRT). Sixteenwomen between the ages of 45 and 55 wereenrolled in this pilot study. Theirpreferences regarding five health statesassociated with HRT (menopausal symptoms, sideeffects of HRT, breast cancer, myocardialinfarction, and osteoporosis) were assessed inquantitative terms known as utilities. Twostandard methods, the visual analog scale (VAS) and the standard gamble (SG), were used toassess utility and time preference (calculatedas a discount rate). The wide variability ofresponses underlines the importance oftailoring health care to individual women'spreferences. Policy guidelines whichincorporate utility analysis must recognize thenormative limitations of aggregatedpreferences, and the moral relevance ofindividual conceptions of health. (shrink)
U.S. researchers and scholars often point to two legal factors as significant obstacles to the inclusion of pregnant women in clinical research: the Department of Health and Human Services’ regulatory limitations specific to pregnant women's research participation and the fear of liability for potential harm to children born following a pregnant woman's research participation. This article offers a more nuanced view of the potential legal complexities that can impede research with pregnant women than has previously been reflected in the literature. (...) It reveals new insights into the role of legal professionals throughout the research pathway, from product conception to market, and it highlights a variety of legal factors influencing decision-making that may slow or halt research involving pregnant women. Our conclusion is that closing the evidence gap created by the underrepresentation and exclusion of pregnant women in research will require targeted attention to the role of legal professionals and the legal factors that influence their decisions. (shrink)
Current strategies to address global inequities in access to life-saving vaccines use averaged national income data to determine eligibility. While largely successful in the lowest income countries, we argue that this approach could lead to significant inefficiencies from the standpoint of justice if applied to middle-income countries, where income inequalities are large and lead to national averages that obscure truly needy populations. Instead, we suggest alternative indicators more sensitive to social justice concerns that merit consideration by policy-makers developing new initiatives (...) to redress health inequities in middle-income countries. (shrink)
: Arguments for efficiency in health care delivery have been used to support some level of withholding of information about available treatment options from patients in managed care systems. To the extent that such arguments prevail, they may necessitate changes in the established understanding of and commitment to informed consent and the disclosure of information to patients.