In 2004 Emanuel et al. published an influential account of exploitation in international research, which has become known as the 'fair benefits account'. In this paper I argue that the thin definition of fairness presented by Emanuel et al, and subsequently endorsed by Gbadegesin and Wendler, does not provide a notion of fairness that is adequately robust to support a fair benefits account of exploitation. The authors present a procedural notion of fairness – the fair distribution of the benefits of (...) research is to be determined on a case-by-case basis by the parties involved in each study. The fairness of the distribution of benefits is not assessed against an independent normative standard. Emanuel et al.'s account of fairness provides a framework for objecting only to transactions that occur without the fully informed consent of the weaker party. As a result, a debate about exploitation collapses into a debate about consent. This is problematic because, as the proponents of the fair benefits framework acknowledge, neither the trial participants' consent nor the host community's consent preclude exploitation. Attempts to stipulate normative standards of fairness to protect research subjects in developing countries have been controversial and divisive, and it is therefore understandable that bioethicists would be tempted to develop accounts of exploitation that are independent of such prescriptive principles. I conclude, however, that the utility of the fair benefits model of exploitation as a policy tool will ultimately depend on whether a substantive principle of fairness can be developed to underpin it. (shrink)

Book reviewed in this article: Principles of Biomedical Ethics. By Tom L. Beauchamp and James F. Childress.

ABSTRACT Many recent articles argue that participants who seroconvert during HIV prevention trials deserve treatment when they develop AIDS, and there is a general consensus that the participants in HIV/aids treatment trials should have continuing post‐trial access. As a result, the primary concern of many ethicists and activists has shifted from justifying an obligation to treat trial participants, to working out mechanisms through which treatment could be provided. In this paper I argue that this shift frequently conceals an important assumption: (...) that if there is an obligation to supply treatment, then any party who could provide it may be prevailed upon to discharge the obligation. This assumption is false. The reasons why trial participants should get ART affect who has the duty to provide it. We should not burden governments with the obligations of sponsors, nor researchers with the obligations of the international community. And we should not deprive a group of treatment because their need is less salient than that of research participants. Insisting otherwise may lead to people being wrongfully deprived of access to antiretrovirals. (shrink)

There is currently no international consensus around post-trial obligations toward research participants, community members, and host countries. This literature review investigates arguments and attitudes toward post-trial access. The literature review found that academic discussions focused on the rights of research participants, but offered few practical recommendations for addressing or improving current practices. Similarly, there are few regulations or legislation pertaining to post-trial access. If regulatory changes are necessary, we need to understand the current arguments, legislation, and attitudes towards post-trial access (...) and participants and community members. Given that clinical trials conducted in low-income countries will likely continue, there is an urgent need for consideration of post-trial benefits for participants, communities, and citizens of host countries. While this issue may not be as pressing in countries where participants have access to healthcare and medicines through public schemes, it is particularly important in regions where this may not be available. (shrink)

The year 2014 brought a new development in the bioethics “laboratory of the states.” Five states adopted “right to try” laws intended to promote terminally ill patients' access to investigational drugs. Many more state legislatures are now considering such laws. The campaign for right to try laws is the latest move in an ongoing effort to give seriously ill patients access to drugs whose safety and effectiveness remain largely unknown. Although scientists and policy‐makers oppose the right to try approach, it (...) has proven quite popular among state legislators and the public. (shrink)

Withholding and withdrawing treatment are widely regarded as ethically equivalent in medical guidelines and ethics literature. Health care personnel, however, widely perceive moral differences between withholding and withdrawing. The proponents of equivalence argue that any perceived difference can be explained in terms of cognitive biases and flawed reasoning. Thus, policymakers should clear away any resistance to accept the equivalence stance by moral education. To embark on such a campaign of changing attitudes, we need to be convinced that the ethical analysis (...) is correct. Is it? In this article, I take a closer look at the moral relation between withholding and withdrawing. My conclusion is that withholding and withdrawing are not in general ethically equivalent. Thus, medical guidelines should be rewritten, and rather than being “educated” away from their sound judgments, medical professionals and patients should have nuanced medico-ethical discussions regarding withholding and withdrawing treatment. (shrink)

Many medical ethicists accept the thesis that there is no moral difference between withholding and withdrawing life-sustaining therapy. In this paper, we offer an interesting counterexample which shows that this thesis is not always true. Withholding is distinguished from withdrawing by the simple fact that therapy must have already been initiated in order to speak coherently about withdrawal. Provided that there is a genuine need and that therapy is biomedically effective, the historical fact that therapy has been initiated entails a (...) claim to continue therapy that cannot be attributed to patients who have not yet received therapy. This intrinsic difference between withholding and withdrawing therapy is of moral importance. In many instances, patients will waive this claim. But when one considers withdrawing therapy from one patient to help another in a setting of scarce resources, this intrinsic moral difference comes into sharp focus. In an era of shrinking medical resources, this difference cannot be ignored. (shrink)

Increasing ethical attention and debate is focusing on whether individuals who take part in clinical trials should be given access to post-trial care. However, the main focus of this debate has been upon drug trials undertaken in low-income settings. To broaden this debate, we report findings from interviews with individuals (n = 24) who participated in a clinical trial of a closed-loop system, which is a medical device under development for people with type 1 diabetes that automatically adjusts blood glucose (...) to help keep it within clinically recommended ranges. Individuals were recruited from UK sites and interviewed following trial close-out, at which point the closed-loop had been withdrawn. While individuals were stoical and accepting of the requirement to return the closed-loop, they also conveyed varying degrees of distress. Many described having relaxed diabetes management practices while using the closed-loop and having become deskilled as a consequence, which made reverting back to pre-trial regimens challenging. Participants also described unanticipated consequences arising from using a closed-loop. As well as deskilling, these included experiencing psychological and emotional benefits that could not be sustained after the closed-loop had been withdrawn and participants reevaluating their pre- and post-trial life in light of having used a closed-loop and now perceiving this life much more negatively. Participants also voiced frustrations about experiencing better blood glucose control using a closed-loop and then having to revert to using what they now saw as antiquated and imprecise self-management tools. We use these findings to argue that ethical debates about post-trial provisioning need to be broadened to consider potential psychological and emotional harms, and not just clinical harms, that may result from withdrawal of investigated treatments. We also suggest that individuals may benefit from information about potential nonclinical harms to help make informed decisions about trial participation. (shrink)

If a doctor is trying to decide whether or not to provide a medical treatment, does it matter ethically whether that treatment has already been started? Health professionals sometimes find it harder to stop a treatment (withdraw) than to refrain from starting the treatment (withhold). But does that feeling correspond to an ethical difference? In this article, we defend equivalence—the view that withholding and withdrawal of treatment are ethically equivalent when all other factors are equal. We argue that preference for (...) withholding over withdrawal could represent a form of cognitive bias—withdrawal aversion. Nevertheless, we consider whether there could be circumstances in which there is a moral difference. We identify four examples of conditional nonequivalence. Finally, we reflect on the moral significance of diverging intuitions and the implications for policy. We propose a set of practical strategies for helping to reduce bias in end-of-life decision making, including the equivalence test. (shrink)

Ethical analyses, professional guidelines and legal decisions support the equivalence thesis for life-sustaining treatment: if it is ethical to withhold treatment, it would be ethical to withdraw the same treatment. In this paper we explore reasons why the majority of medical professionals disagree with the conclusions of ethical analysis. Resource allocation is considered by clinicians to be a legitimate reason to withhold but not to withdraw intensive care treatment. We analyse five arguments in favour of non-equivalence, and find only relatively (...) weak reasons to restrict rationing to withholding treatment. On the contrary, resource allocation provides a strong argument in favour of equivalence: non-equivalence causes preventable death in critically ill patients. We outline two proposals for increasing equivalence in practice: (1) reduction of the mortality threshold for treatment withdrawal, (2) time-limited trials of intensive care. These strategies would help to move practice towards more rational treatment limitation decisions. (shrink)

Ethics guidance increasingly recognises that researchers and sponsors have obligations to consider provisions for post-trial access to interventions that are found to be beneficial in research. Yet, there is little information regarding whether and how such plans can actually be implemented. Understanding practical experiences of developing and implementing these plans is critical to both optimising their implementation and informing conceptual work related to PTA. This viewpoint is informed by experiences with developing and implementing PTA plans for six large-scale multicentre HIV (...) prevention trials supported by the HIV Prevention Trials Network. These experiences suggest that planning and implementing PTA often involve challenges of planning under uncertainty and confronting practical barriers to accessing healthcare systems. Even in relatively favourable circumstances where a tested intervention medication is approved and available in the local healthcare system, system-level barriers can threaten the viability of PTA plans. The aggregate experience across these HIV prevention trials suggests that simply referring participants to local healthcare systems for PTA will not necessarily result in continued access to beneficial interventions for trial participants. Serious commitments to PTA will require additional efforts to learn from future approaches, measuring the success of PTA plans with dedicated follow-up and further developing normative guidance to help research stakeholders navigate the complex practical challenges of realising PTA. (shrink)

The American Board of Internal Medicine (ABIM) Foundation has recently initiated a campaign called “Choosing Wisely,” which is aimed at reducing “low-value” care services. Lists of low-value care services are being developed and the ABIM Foundation is urging the American Medical Association and other organizations to get behind the lists, disseminate them, and implement them. Yet, there are many ethical questions that remain about the development, dissemination, and implementation of these low-value care lists. In this paper I argue for conceptual (...) clarity with respect to the label “low-value care.” Thus far it has not been precisely defined, and I argue that there are actually 10 distinct categories of low-value care. I discuss the ethical challenges and considerations associated with each category. I also provide arguments that can be used to justify the reduction of some of these categories of low-value care. These arguments rely on Rawlsian and Hegelian notions of justice, as well as on concepts about the fiduciary obligations of physicians. Finally, I outline the various mechanisms that could be utilized for the reduction of low-value care (i.e., incentives, punishments, nonrational influences such as appeals to social norms, emotions, or ego, and creation of conditions that make avoidance easy such as defaults and reminders). I provide normative guidelines for the use of each. (shrink)

Policy‐makers, bioethicists, and patient advocates have been engaged in a fierce battle about the merits and potential harms of a federal right‐to‐try law. This debate about access to investigational medical products has raised profound questions about the limits of patient autonomy, appropriate government regulation, medical paternalism, and political rhetoric. For example, do patients have a right to access investigational therapies, as the right‐to‐try movement asserts? What is government’s proper role in regulating and facilitating access to drugs that are still in (...) development? In this review, we analyze the history of the right‐to‐try movement, review the arguments put forth by supporters and opponents of the legislation, and consider the movement’s consequences. Two possible scenarios may emerge. One is that the right‐to‐try pathway may fail to meaningfully increase patient access to investigational products. Alternatively, certain companies may attempt to rely on the federal right‐to‐try legislation to sell investigational products, taking advantage of the provision that allows for direct costs, as there is currently no clear mechanism for enforcement or monitoring of cost calculations. (shrink)