Erik Malmqvist

Randomized and double-blind clinical trials are widely regarded as the most reliable way of studying the effects of medical interventions. According to received wisdom, if a new drug or treatment is to be accepted in clinical practice, its safety and efficacy must first be demonstrated in such trials. For ethical and scientific reasons, it is generally considered necessary to monitor a trial in various ways as it proceeds and to analyze data as they accumulate. Monitoring and interim analyses are often conducted by a so-called data monitoring committee (DMC), a group of experts independent of both sponsors and investigators. On the basis of DMC recommendations, sponsors sometimes decide to discontinue trials ..

The concept of exploitation and potentially exploitative real-world practices are the subject of increasing philosophical attention. However, while philosophers have extensively debated what exploitation is and what makes it wrong, they have said surprisingly little about what might be required to remediate it. By asking how the consequences of exploitation should be addressed, this article seeks to contribute to filling this gap. We raise two questions. First, what are the victims of exploitation owed by way of remediation? Second, who ought to remediate? Our answers to these questions are connected by the idea that exploitation cannot be fully remediated by redistributing the exploiter's gain in order to repair or compensate the victim's loss. This is because exploitation causes not only distributive but also relational harm. Therefore, redistributive measures are necessary but not sufficient for adequate remediation. Moreover, this relational focus highlights the fact that exploitative real-world practices commonly involve agents other than the exploiter who stand to benefit from the exploitation. Insofar as these third parties are implicated in the distributive and relational harms caused by exploitation, there is, we argue, good reason to assign part of the burden of remediation to them.

This paper challenges the view that bans on kidney sales are unjustifiably paternalistic, that is, that they unduly deny people the freedom to make decisions about their own bodies in order to protect them from harm. I argue that not even principled anti-paternalists need to reject such bans. This is because their rationale is not hard paternalism, which anti-paternalists repudiate, but soft paternalism, which they in principle accept. More precisely, I suggest that their rationale is what Franklin Miller and Alan Wertheimer call ‘group soft paternalism’. Group soft paternalistic policies restrict the freedom of autonomous individuals, not for their own good (hard paternalism), but as an unavoidable consequence of seeking to protect other, non-autonomous individuals from harms that they have not voluntarily chosen (soft paternalism). Group soft paternalism supports prohibiting kidney sales on three conditions: (1) that such sales are potentially harmful to vendors, (2) that many vendors would suffer impaired autonomy, and (3) that distinguishing between autonomous and non-autonomous vendors and interfering only with the latter is unfeasible. I provide reasons for thinking that these conditions will often hold

Proponents of permitting living kidney sales often argue as follows. Many jobs involve significant risks; people are and should be free to take these risks in exchange for money; the risks involved in giving up a kidney are no greater than the risks involved in acceptable hazardous jobs; so people should be free to give up a kidney for money, too. This paper examines this frequently invoked but rarely analysed analogy. Two objections are raised. First, it is far from clear that kidney sales and dangerous jobs involve comparable risks on an appropriately broad comparison. Second, and more importantly, even if they do involve comparable risks it does not follow that kidney sales must be permitted because dangerous jobs are. The analogy assumes that kidney sales are banned for paternalistic reasons. But there may be other, non-paternalistic reasons for the ban. And paternalists, too, can consistently defend the ban even if kidney sales are no riskier than occupations that they find acceptable. Soft paternalists may want to protect would-be vendors from harms that they have not voluntarily chosen. Egalitarian hard paternalists may want to protect already badly off vendors from further worsening their situation. For neither species of paternalist is the size of the risk prevented decisive. I conclude that the analogy with dangerous jobs, while rhetorically powerful, pulls little real argumentative weight. Future debates on living kidney sales should therefore proceed without it

The influence of pervasive cultural norms on people’s actions constitutes a longstanding problem for autonomy theory. On the one hand, such norms often seem to elude the kind of reflection that autonomous agency requires. On the other hand, they are hardly entirely beyond the pale of autonomy: people do sometimes reflect critically on them and resist them. This paper draws on phenomenological accounts of embodiment in order to reconcile these observations. We suggest that pervasive cultural norms exert a strong and elusive, but occasionally resistible, influence because they are incorporated – they operate on the largely pre-reflective bodily level of human existence. As an illustration we discuss parental decisions about surgery for children born with unclear sex, decisions permeated by deeply entrenched norms about sexual difference and genital appearance.

It is often argued that it does not matter morally whether biomedical interventions treat or prevent diseases or enhance nondisease traits; what matters is whether and how much they promote well-being. Therapy and enhancement both promote well-being, the argument goes, so they are not morally distinct but instead continuous. I provide three reasons why this argument should be rejected when it is applied to choices concerning the genetic makeup of future people. First, it rests on too simple a conception of the badness of disease. Second, it wrongly assumes that disease avoidance and enhancement can proceed with similar accuracy. Third, it overlooks that disease avoidance tends to be more urgent than enhancement from the point of view of distributive justice. Although none of these reasons establishes a firm therapy-enhancement distinction, they show that a continuum model is not an attractive alternative

What, if anything, is wrong with taking advantage of people’s unjust circumstances when they both benefit from and consent to the exchange? The answer, some believe, is that such exchanges are wrongfully exploitative. I argue that this answer is incomplete at best, and I elaborate a different one: to take advantage of injustice is to become complicit in its reproduction. I also argue that the case for third-party interference with mutually beneficial and consensual exchanges, while normally considered weak, is strengthened once these exchanges are understood as implicated in broader unjust structures.

This study is a contribution to the bioethical debate about new and possibly emerging reproductive technologies. Its point of departure is the intuition, which many people seem to share, that using such technologies to select non-disease traits – like sex and emotional stability - in yet unborn children is morally problematic, at least more so than using the technologies to avoid giving birth to children with severe genetic diseases, or attempting to shape the non-disease traits of already existing children by environmental means, like education. The study employs philosophical analysis for the purpose of making this intuition intelligible and judging whether it is justified. Different ways in which the moral problems posed by reproductive technologies are often framed in bioethical debates are criticised as inadequate for this task. In particular, it is argued that the intuition cannot fully be made sense of in terms of harm to the children that such technologies help create. The study attempts to elaborate an alternative to that broadly consequentialist approach, by drawing on Martin Heidegger’s philosophy of technology, Hans Jonas’s ethics, and Aristotle’s practical philosophy, as it has been received and developed in the hermeneutical tradition. It is suggested that reproductive choices, unlike decisions for already born children, are characterised by a peculiar one-sidedness: the future child appears to the parents as something wholly theirs to decide about, not as a concrete other with whom they must interact in a responsive and attuned way. This is problematic because it means that such choices cannot call upon the particularised moral understanding only gained in interpersonal encounters. In particular, it makes them easily shaped by various tendencies, to which parents are always susceptible, to relate to children in instrumentalising ways, and at risk of reinforcing such tendencies. However, this does not mean that all uses of reproductive technologies are equally troubling. When selecting against severe disease the parents can rely on a widely shared illness experience to escape the dangers that one-sidedness involves. It is concluded that the intuition under discussion, thus explicated and in some ways qualified, makes sense morally.

Clinical research is increasingly ‘offshored’ to developing countries, a practice that has generated considerable controversy. It has recently been argued that the prevailing ethical norms governing such research are deeply puzzling. On the one hand, sponsors are not required to offshore trials, even when participants in developing countries would benefit considerably from these trials. On the other hand, if sponsors do offshore, they are required not to exploit participants, even when the latter would benefit from and consent to exploitation. How, it is asked, can it be worse to exploit the global poor than to neglect them when exploitation is voluntary and makes them better off? The present article seeks to respond to this challenge. I argue that mutually beneficial and voluntary exploitation can be worse than neglect when — as is typically true of exploitative international research — it takes advantage of unjust background conditions. This is because, in such cases, exploitation overlaps with another, less familiar wrong: complicity in injustice. Recognising complicity as a distinct wrong should make us judge exchanges arising from background injustice more harshly than we typically do, in research and elsewhere.

Human papillomavirus (HPV) infection is the world’s most common sexually transmitted infection. It is a prerequisite for cervical cancer, the second most common cause of death in cancer among women worldwide, and is also believed to cause other anogenital and head and neck cancers. Vaccines that protect against the most common cancer-causing HPV types have recently become available, and different countries have taken different approaches to implementing vaccination. This paper examines the ethics of alternative HPV vaccination strategies. It devotes particular attention to the major arguments for and against one strategy: voluntary, publicly funded vaccination for all adolescent boys and girls. This approach seems attractive because it would protect more people against cervical cancer and other HPV-related cancers than less inclusive alternatives, without the sacrifice of autonomy that a comparably broad compulsory programme would require. Also, the herd immunity that it would likely generate would protect those who remain unvaccinated, a major advantage from a justice perspective. However, there is a possibility that a HPV vaccination programme targeting all adolescents of both sexes is not considered sufficiently cost-effective. Also, it might pose more difficulties for achieving informed consent than comparable vaccination programmes against other diseases. Ultimately, society’s choice of HPV vaccination strategy requires careful consideration not only of the values at stake but also of available and emerging scientific evidence.

A growing literature documents the existence of individuals who make a living by participating in phase I clinical trials for money. Several scholars have noted that the concerns about risks, consent, and exploitation raised by this phenomenon apply to many (other) jobs, too, and therefore proposed improving subject protections by regulating phase I trial participation as work. This article contributes to the debate over this proposal by exploring a largely neglected worry. Unlike most (other) workers, subjects are not paid to produce or achieve anything but to have things done to them. I argue that this passivity is problematic for reasons of distributive justice. Specifically, it fails to enable subjects to realize what Gheaus and Herzog call “the goods of work”—a failure not offset by adequate opportunities to realize these goods outside of the research context. I also consider whether granting subjects worker-type protections would accommodate this concern.

Many countries are now implementing human papillomavirus vaccination. There is disagreement about who should receive the vaccine. Some propose vaccinating both boys and girls in order to achieve the largest possible public health impact. Others regard this approach as too costly and claim that only girls should be vaccinated. We question the assumption that decisions about human papillomavirus vaccination policy should rely solely on estimates of overall benefits and costs. There are important social justice aspects that also need to be considered. Policy makers should consider how to best protect individuals who will remain unvaccinated through no fault of their own. This is especially important if these individuals are already disadvantaged in other ways and if vaccinating other people increases their risk of infection

We propose a principle of sustainability to complement established principles used for justifying healthcare resource allocation. We argue that the application of established principles of equal treatment, need, prognosis and cost-effectiveness gives rise to what we call negative dynamics: a gradual depletion of the value possible to generate through healthcare. These principles should therefore be complemented by a sustainability principle, making the prospect of negative dynamics a further factor to consider, and possibly outweigh considerations highlighted by the other principles. We demonstrate how this principle may take different forms, and show that a commitment to sustainability is supported by considerations internal to the ethical principles already guiding healthcare resource allocation. We also consider two objections. The first of these, we argue, is either based on implausible assumptions or begs the question, whereas the second can be adequately accommodated by the principle we propose.

In the present paper it is argued that genetic interventions on human embryos are in principle permissible if they promote the health of the persons that these embryos will one day become and impermissible if they compromise their health. This so called health-intervention principle is reached by, inter alia, rejecting alternative approaches to the problem of the permissibility of genetic intervention. The health-intervention principle can be interpreted in different ways depending on how the notion of health is understood. The central part of the paper is an attempt to find a concept of health which is such that it makes the health-intervention principle normatively plausible. For this purpose I examine two influential competing theories of health: Cristopher Boorse’s biostatistical theory of health and Lennart Nordenfelt’s welfare theory of health. I argue that the health-intervention principle is more plausible if health is understood in the latter sense, although it is not ruled out that the principle may be given an even more plausible explication in terms of some other notion of health

Jules Salomone-Sehr argues that an activity is cooperative if and only if, roughly, it consists of several participants’ actions that are (i) coordinated for a common purpose (ii) in ways that do not undermine any participant’s agency. He argues that guidance by shared intention is neither necessary nor sufficient for cooperation. Thereby, he claims to “topple an orthodoxy of shared agency theory." In response, we argue that Salomone-Sehr’s account captures another notion of cooperation than the sociopsychological notion shared agency theory has focused on. Furthermore, we argue that Salomone-Sehr’s interpretation of (ii) is too demanding; it implausibly makes cooperation incompatible with exploitation.

Actually possible and conceivable future uses of preimplantation genetic diagnosis (PGD) and germ-line genetic intervention in assisted reproduction seem to offer increasing possibilities of choosing the kind of persons that will be brought to existence. Many are troubled by the idea of these technologies being used for enhancement purposes. How can we make sense of this worry? Why are our thoughts about therapeutic genetic interventions and non-genetic enhancement (for instance education) not accompanied by the same intuitive uneasiness? I argue that the concepts of autonomy and freedom of choice, typically invoked to delimit the morally acceptable uses of reproductive technologies, cannot fully answer these questions. Instead, I suggest that an alternative answer might begin with reflections on the notion of interfering with nature. Drawing on Martin Heidegger’s critique of modern technology and Hans Jonas’s moral philosophy, I outline an argument that attempts to capture what might be particularly troubling about the idea of “designing” future persons. At the core of the argument is the suggestion that enhancing selections and modifications on embryos might be bound up with an instrumentalising, non-responsive perspective on the future persons into which they are intended to grow

The target article challenges the increasingly popular portrayal of living kidney sale as potentially a mutually beneficial arrangement, capable not only of saving or improving the lives of patients in need of transplants but also of significantly benefiting poor vendors. Carefully reviewing the literature on harms to vendors in illegal kidney markets and in Iran’s legal market, Koplin argues that many of these harms would persist in the sort of legal regulated system that kidney sale advocates envision. This is an important argument. The kidney sales debate has been skewed in favor of permitting sales by a simplified view of the potential harms involved and excessive optimism about the capacity of regulation to prevent these harms. The article counterbalances these tendencies and thus considerably weakens the case for allowing sales. Nonetheless, some market proponents might remain unconvinced. I shall suggest that in addition to the lessons that Koplin draws from existing kidney markets, there is yet another one, which casts further doubt on the advisability of allowing kidney sales.

Parker’s article is a welcome attempt to address the importance of environmental sustainability in the realm of clinical ethics.1 We support the recent movement to seriously consider the environmental impact of healthcare institutions in bioethics.2 3 Still, we find two partly linked weaknesses of Parker’s analysis and guideline suggestion. These relate to a need in ‘green’ bioethics to see beyond the normal healthcare ethical focus on health-related values related to individual patients, and to primarily adopt institutional ways of framing central decision problems. Traditional bioethics applies a restricted scope of values to assess clinical decisions: primarily health-related patient well-being (including life) and patient autonomy. If a decision improves (or, as in Parker’s inhaler case, maintains) a patient’s health-related well-being, this supports it. However, if a decision improves a patient’s non health-related well-being, say, winning a beauty contest or securing a job by having cosmetic surgery, it is not supported. And so on. This idea of healthcare as, in Michael Walzer’s classic terminology, a separate ‘sphere of justice’ has two interrelated limitations: it reflects a bias towards individual patients over other people, and it restricts the scope of values allowed to influence healthcare ethical judgements. These limitations appear once we see that the issue addressed by Parker can be framed either as prescription decisions taken by individual doctors against the background of …

Human consumption of pharmaceuticals often leads to environmental release of residues via urine and faeces, creating environmental and public health risks. Policy responses must consider the normative question how responsibilities for managing such risks, and costs and burdens associated with that management, should be distributed between actors. Recently, the Polluter Pays Principle (PPP) has been advanced as rationale for such distribution. While recognizing some advantages of PPP, we highlight important ethical and practical limitations with applying it in this context: PPP gives ambiguous and arbitrary guidance due to difficulties in identifying the salient polluter. Moreover, when PPP does identify responsible actors, these may be unable to avoid or mitigate their contribution to the pollution, only able to avoid/mitigate it at excessive cost to themselves or others, or excusably ignorant of contributing. These limitations motivate a hybrid framework where PPP, which emphasizes holding those causing large-scale problems accountable, is balanced by the Ability to Pay Principle (APP), which emphasizes efficiently managing such problems. In this framework, improving wastewater treatment and distributing associated financial costs across water consumers or taxpayers stand out as promising responses to pharmaceutical pollution from human use. However, sound policy depends on empirical considerations requiring further study.

The idea of paying donors in order to make more human bodily material available for therapy, assisted reproduction, and biomedical research is notoriously controversial. However, while national and international donation policies largely oppose financial incentives they do not treat all parts of the body equally: incentives are allowed in connection to the provision of some parts but not others. Taking off from this observation, I discuss whether body parts differ as regards the ethical legitimacy of incentives and, if so, why. I distinguish two approaches to this issue. On a ”principled” approach, some but not all body parts are inherently special in a way that proscribes payment. On a ”pragmatic” approach, the appropriateness of payment in relation to a specific part must be determined through an overall assessment of e.g. the implications of payment for the health and welfare of providers, recipients, and third parties, and the quality of providers’ consent. I argue that the first approach raises deep and potentially divisive questions about the good life, whereas the second approach invokes currently unsupported empirical assumptions and requires difficult balancing between different values and the interests of different people. This does not mean that any attempt to distinguish between body parts in regard to the appropriateness of payment necessarily fails. However, I conclude, any plausible such attempt should either articulate and defend a specific view of the good life, or gather relevant empirical evidence and apply defensible principles for weighing goods and interests.

Antibiotic resistance is widely recognized as a major threat to public health and healthcare systems worldwide. Recent research suggests that pollution from antibiotics manufacturing is an important driver of resistance development. Using Sweden as an example, this article considers how industrial antibiotic pollution might be addressed by public actors who are in a position to influence the distribution and use of antibiotics in high-income countries with publicly funded health systems. We identify a number of opportunities for these actors to incentivize industry to increase sustainability in antibiotics production. However, we also show that each alternative would create tensions with other significant policy goals, necessitating trade-offs. Since justifiable trade-offs require ethical consideration, we identify and explore the main underlying normative issues, namely, the weighing of local versus global health interests, the weighing of present versus future health interests, and the role of individualistic constraints on the pursuit of collective goals. Based on this analysis, we conclude that the actors have weighty principled reasons for prioritizing the goal of addressing pollution, but that translating this stance into concrete policy requires accommodating significant pragmatic challenges.

Medical therapy, research and technology enable us to make our bodies, or parts of them, available to others in an increasing number of ways. This is the case in organ, tissue, egg and sperm donation as well as in surrogate motherhood and clinical research. Bringing together leading scholars working on the ethical, social and cultural aspects of such bodily exchanges, this cutting-edge book develops new ways of understanding them. Bodily Exchanges, Bioethics and Border Crossing both probes the established giving and selling frameworks for conceptualising bodily exchanges in medicine, and seeks to develop and examine another, less familiar framework: that of sharing. A framework of sharing can capture practices that involve giving up and giving away part of one's body, such as organ and tissue donation, and practices that do not, such as surrogacy and research participation. Sharing also recognizes the multiple relationalities that these exchanges can involve and invites inquiry into the context in which they occur. In addition, the book explores the multiple forms of border crossing that bodily exchanges in medicine involve, from the physical boundaries of the body to relational borders - as can happen in surrogacy - to national borders and the range of ethical issues that these various border-crossings can give rise to. Engaging with anthropology, sociology, philosophy, and feminist and postcolonical perspectives, this is an original and timely contribution to contemporary bioethics in a time of increasing globalization. It will be of use to students and researchers from a range of humanities and social science backgrounds as well as medical and other healthcare professionals with an interest in bioethics.

Biomedical research on human subjects involves exposing individuals to risks and burdens for the benefit of others, and therefore raises concerns about exploitation. While the concept of exploitation has received significant attention in recent research ethical literature, its relevance and implications in this area remain unclear and contested. This chapter explains how this concept is nonetheless important for understanding the ethical complexities of human subject research and the proper design of subject protections. The chapter provides an overview of research practices often thought to raise exploitation concerns and introduces philosophical exploitation theory, focusing on aspects relevant to research ethics. Against this background, the obligations of non-exploitation held by researchers, sponsors, and third parties such as ethics committees and regulators are outlined. The chapter ends by considering how exploitative research in the past can be retroactively remediated.