Commercial genetic testing offered over the internet, known as direct-to-consumer genetic testing (DTC GT), currently is under ethical attack. A common critique aims at the limited validation of the tests as well as the risk of psycho-social stress or adaption of incorrect behavior by users triggered by misleading health information. Here, we examine in detail the specific role of advertising communication of DTC GT companies from a medical ethical perspective. Our argumentative analysis departs from the starting point that DTC (...) GT operates at the intersection of two different contexts: medicine on the one hand and the market on the other. Both fields differ strongly with regard to their standards of communication practices and the underlying normative assumptions regarding autonomy and responsibility. Following a short review of the ethical contexts of medical and commercial communication, we provide case examples for persuasive messages of DTC GT websites and briefly analyze their design with a multi-modal approach to illustrate some of their problematic implications. We observe three main aspects in DTC GT advertising communication: (1) the use of material suggesting medical professional legitimacy as a trust-establishing tool, (2) the suggestion of empowerment as a benefit of using DTC GT services and (3) the narrative of responsibility as a persuasive appeal to a moral self-conception. While strengthening and respecting the autonomy of a patient is the focus in medical communication, specifically genetic counselling, persuasive communication is the normal mode in marketing of consumer goods, presuming an autonomous, rational, independent consumer. This creates tension in the context of DTC GT regarding the expectation and normative assessment of communication strategies. Our analysis can even the ground for a better understanding of ethical problems associated with intersections of medical and commercial communication and point to perspectives of analysis of DTC GT advertising. (shrink)

The ongoing bioethical debate about organ markets rests not only on theoretical premises, but also on assumptions regarding public views of and attitudes toward organ donation that need closer socioempirical examination. Summarizing results from our previous qualitative social research in this field, this paper illustrates the ethical significance of such public moralities in two respects: On one hand, it analyzes the implicit bias of the common rhetoric of “organ scarcity” which motivates much of the commercialization debate. On the other (...) hand, it explores the blind spots of the paradigm of “altruistic donation” which informs many arguments against commercialization. We conclude that the ethical discourse has to appreciate the social nature of organ donation as a reciprocal interaction between different parties with irreducibly different but equally relevant viewpoints. We criticize the neglect of such well-founded public considerations in certain philosophical-ethical approaches and stress the need for further systematic and comparative socioempirical studies about peoples’ actual perspectives in bioethics. (shrink)

When a new intervention or drug is developed, this has to pass through various phases of clinical testing before it achieves market approval, which can take many years. This raises an issue for drugs which could benefit terminally ill patients. These patients might set their hopes on the experimental drug but are unable to wait since they are likely to pass away before the drug is available. As a means of nevertheless getting access to experimental drug, many seriously ill (...) and terminally ill patients are therefore very willing to participate in randomised controlled trials. However, only very few terminally ill patients are able to actually participate, and those that do participate are at risk of participating solely as a way of getting experimental drugs. Currently, there are, however, ways of getting access to drugs that have not gained market approval. One such mean is via expanded access or compassionate use programs where terminally ill patients receive experimental new drugs that are not yet market approved. In this paper, I examine some of the common justifications for such programs. The most frequently voiced justifications for compassionate use or expanded access programs could be put in one of three categories. First, there are justifications of justice, where compassionate use programs could be seen as a just or fair way to distribute experimental new drugs to patients who are denied access to RCT’s through no fault of their own. Second, such programs could be justified by reference to the ethical principle of beneficence where it could be claimed that terminally ill patients stand to benefit greatly at very little risk. Third, there are considerations of autonomy where, it is claimed, patients should be able to exercise their autonomy and have access to such drugs if that is there free choice and they are fully aware of the risks associated with that choice. In this paper, I argue currently all justifications are potentially problematic. If they truly form the basis for justification, compassionate use programs should be designed to maximize justice, beneficence and autonomy. (shrink)

There are quite a number of rocky roads on which the old continent has embarked. There is, first, a harmonization of cultures and attitudes in the creation of a common European market of values and valuables, a harmonization undertaken in order to survive in an increasingly competitive global market. Second, there is a reactivation of specific European traditions in discourse, peaceable hermeneutics, solidarity, subsidiarity, tolerance in both conflict reduction and solution, and respect for self-determination and self-responsibility. Third, (...) there is an integration of theory and practice, of visions and reality, of national identity or pride and common European rights, and of obligations and cultural heritages. Last but not least, there is a question about the definition of European in a world which, at least in part, has been developed by successful European missionary work in the distribution of Age-of-Reason principles such as personal autonomy and social and ideational tolerance, the promotion of science-based technologies, and the creation of global markets for goods and services. (shrink)

“Medical Tourism” is the travel of residents of one country to another country for treatment. In this article I focus on travel abroad to purchase organs for transplant, what I will call “Transplant Tourism.” With the exception of Iran, organ sale is illegal across the globe, but many destination countries have thriving black markets, either due to their willful failure to police the practice or more good faith lack of resources to detect it. I focus on the sale of kidneys, (...) the most common subject of transplant tourism, though much of what I say could be applied to other organs as well. Part I briefly reviews some data on sellers, recipients, and brokers. Part II discusses the bioethical issues posed by the trade, and Part III focuses on potential regulation to deal with these issues. (shrink)

In this paper, I argue that companies who use functional Magnetic Resonance Imaging (fMRI) scans for lie detection encounter the same basic ethical stumbling blocks as commercial companies that market traditional polygraphs. Markets in traditional voluntary polygraphs are common and fail to elicit much uproar among ethicists. Thus, for consistency, if markets in polygraphs are ethically unproblematic, markets using fMRIs for lie detection are equally as acceptable. Furthermore, while I acknowledge two substantial differences between the ethical concerns involving (...) polygraphs and fMRI lie detection, I argue that these concerns can be overcome and do not lead to the conclusion that markets in fMRI lie detection are ethically dubious. It is my conclusion that voluntary markets in fMRI lie detection can be justified by consumer autonomy and should be allowed to persist. (shrink)

Three widely accepted principles – autonomy, beneficence and justice – provide a useful analytic framework for considering controversies and conflicts in bioethics. Since these principles capture key concepts found in diverse normative theories they provide a starting point from which consistent ethical analysis and comparison can begin. While justice is commonly discussed in the business ethics literature, the other two principles are not widely discussed. This paper investigates whether the principles of autonomy and beneficence provide a framework that is (...) equally useful for framing issues in business ethics. It is argued that they do. First, the principle of autonomy, with its associated notions of informed consent, privacy, confidentiality, voluntariness, self-mastery, and so on, provides a consistent approach to the analysis of diverse issues that arise in business ethics from market research to recruitment practices. Second, it is argued that the relationships between a business and its stakeholders ground duties of beneficence. The principle of beneficence provides a framework for considering the issues that arise in these relationships. (shrink)

This paper examines the arguments presented by the Roman Catholic Bishops in their 1993 Pastoral Resolution, Comprehensive Health Care Reform: Protecting Human Life, Promoting Human Dignity, Pursuing the Common Good, concerning health care reform. Focusing on the meaning of equality in health care and traditional Roman Catholic doctrine, it is argued that the Bishops fail to grasp the force of the differences among persons, the value of the market, and traditional scholastic arguments concerning obligatory and extraordinary health care. (...) To attempt to equalize the distribution of health care would be ruinous. A more traditional understanding of Christian thought reveals an acceptance of inequality in health care distribution and a bias against using the secular state to coerce a solution to such concerns for social justice. (shrink)

One of the areas of concern raised by cross-border reproductive travel regards the treatment of women who are solicited to provide their ova or surrogacy services to foreign consumers. This is particularly troublesome in the context of developing countries where endemic poverty and low standards for both medical care and informed consent may place these women at risk of exploitation and harm. We explore two contrasting proposals for policy development regarding the industry, both of which seek to promote ethical outcomes (...) and social justice: While one proposal advocates efforts to minimize cross-border demand for female reproductive resources through the pursuit of national self-sufficiency, the other defends cross-border trade as a means for meeting the needs of vulnerable groups. Despite the conflicting objectives of the proposed strategies, the paper identifies common values and points of agreement between the two, including the importance of regulations to safeguard those providing ova or surrogacy services. (shrink)

The institutionalization of systems of informed consent in market economies has exaggerated rather than minimized the meritocractic effect of such economies. In developing economies, it may help reduce both inherent economic gaps and effects of inherited wealth. In both cases, the highest paid people are those whose performances evidence the highest hierarchical complexity, and lowest paid people have the lowest stages of performance. Society is stratified according to stage of performance. Postformal thought is more likely to develop in graduate (...) level education. Higher education has the effect of further stratifying individuals by stage of performance, rather than equalizing opportunity. (shrink)

Erik Malmqvist defends the prohibition on kidney sales as a justifiable measure to protect individuals from harms they have not autonomously chosen. This appeal to ‘group soft paternalism’ requires that three conditions be met. It must be shown that some vendors will be harmed, that some will be subject to undue pressure to vend, and that we cannot feasibly distinguish between the autonomous and the non-autonomous. I argue that Malmqvist fails to demonstrate that any of these conditions are likely to (...) obtain. His argument involves two common errors. First, he, like many, proceeds on a mistaken understanding of how to assess harm. What matters is not the balance of costs and benefits of vending, but a comparison of potential vendors’ welfare across two possible courses of action. Second, Malmqvist's concerns about third-party pressure are predicated on an empirically unrealistic understanding of the operation of a regulated market. A widely underappreciated fact is that kidney sales will be relatively rare, and most who try to vend will be unable to. Because pressure on another to vend will not result in the desired outcome, few will exert it. (shrink)

An increasingly common objection to kidney sales holds that the introduction of monetary incentives may undermine potential donors’ altruism, discourage donation, and possibly result in a net reduction in the supply of kidneys. To explain why incentives might be counterproductive in this way market opponents marshal evidence from behavioral economics. In particular, they claim that the context of kidney sales is ripe for motivational crowding. This reasoning, if sound, would have a profound influence on the debate over kidney (...) sales. What’s perhaps the principal reason to favor a market – the increase in supply it would bring – would be called into doubt. However, on inspection it becomes apparent that the evidence touted by market opponents not only lends no credence to their claims, but also provides some positive reason to doubt them. The near-ubiquitous references to motivational crowding in the literature on kidney sales are fundamentally misplaced. (shrink)

An innovative program recently initiated at the University of California, Los Angeles Medical Center allows people to donate a kidney in exchange for a voucher that a loved one can redeem for a kidney if and when needed. As a relatively new practice, the ethical implications of advanced kidney donation have not yet been widely discussed. This paper reflects on some of the bioethical issues at stake in this new donation program, as well as some broader philosophical issues related to (...) the meaning and moral salience of commodification. I first consider whether the literature on commercial markets in organs––a longstanding topic of bioethical debate––can meaningfully inform ethical analysis of kidney voucher programs. Specifically, I consider whether and to what extent common objections to the exchange of kidneys for cash also apply to the exchange of kidneys for “kidney vouchers.” Second, I argue that the contrast between the ethical issues raised by these two practices highlights the need to understand commodification as existing on a continuum, with different degrees of commodification giving rise to different ethical issues. Doing so can help sharpen our understanding of commodification as a moral concept, as well as its relevance to broader debates about the moral limits of markets. (shrink)

Umbilical cord blood has become the focus of intense efforts to collect, screen and bank haematopoietic stem cells in hundreds of repositories around the world. UCB banking has developed through a broad spectrum of overlapping banking practices, sectors and institutional forms. Superficially at least, these sectors have been widely distinguished in bioethical and policy literature between notions of the ‘public’ and the ‘private’, the commons and the market respectively. Our purpose in this paper is to reflect more critically on (...) these distinctions and to articulate the complex practical and hybrid nature of cord blood as a ‘bio-object’ that straddles binary conceptions of the blood economies. The paper draws upon Roberto Esposito’s reflections on biopolitics and his attempt to transcend the dualistic polarisations of immunity and community, or the private and the public. We suggest that his thoughts on immunitary hospitality resonate with many of the actual features and realpolitik of a necessarily internationalised and globally distributed UCB ‘immunitary regime’. (shrink)

The datafication and digitalization of health and medicine has engendered a proliferation of new collaborations between public health institutions and data corporations like Google, Apple, Microsoft and Amazon. Critical perspectives on these new partnerships tend to frame them as an instance of market transgressions by tech giants into the sphere of health and medicine, in line with a “hostile worlds” doctrine that upholds that the borders between market and non-market spheres should be carefully policed. This article seeks (...) to outline the limitations of this common framing for critically understanding the phenomenon of the Googlization of health. In particular, the mobilization of a diversity of non-market value statements in the justification work carried out by actors involved in the Googlization of health indicates the co-presence of additional worlds or spheres in this context, which are not captured by the market vs. non-market dichotomy. It then advances an alternative framework, based on a multiple-sphere ontology that draws on Boltanski and Thevenot’s orders of worth and Michael Walzer’s theory of justice, which I call a normative pragmatics of justice. This framework addresses both the normative deficit in Boltanski and Thevenot’s work and provides an important emphasis on the empirical workings of justice. Finally, I discuss why this framework is better equipped to identify and to address the many risks raised by the Googlization of health and possibly other dimensions of the digitalization and datafication of society. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Reviewed by:Too Expensive to Treat? Finitude, Tragedy, and the Neonatal ICU by Charles C. CamosyAutumn Alcott RidenourReview of Too Expensive to Treat? Finitude, Tragedy, and the Neonatal ICU CHARLES C. CAMOSY Grand Rapids, MI: Eerdmans, 2010. 208 pp. $18.00In Too Expensive to Treat? Charles Camosy makes an important contribution to bioethics and Christian ethics by making the case for the need to consider social factors when treating imperiled (...) newborns. Arguing for both the full moral status of newborns and Roman Catholic social teaching’s emphasis on the just allocation of resources, Camosy calls the medical community, bioethicists, and [End Page 209] Christian ethicists to account for current practices that disproportionately favor exorbitant costs for imperiled infants over other even more basic medical needs within the US health care system. Written before the adoption of the Affordable Care Act under the Obama administration, Camosy’s argument has only increased in significance given the national need to prioritize resources in view of the government’s expansion of health care coverage.Born within twenty-two to twenty-four weeks of gestation and weighing between 500 and 850 grams, some imperiled infants absorb hundreds of thousands of dollars in short-term care that may extend into millions of dollars given long-term costs (146, 171–93). Recognizing the tragic reality in which “we have virtually unlimited health care needs” coupled with “limited health care resources,” Camosy contends that current Medicaid funds that privilege the NICU (neonatal intensive care unit) should be reevaluated (1–3). In an effort to temper the “autonomous,” patient-driven principle with “justice,” Camosy poses a challenging philosophical, theological, and practical proposal for what he identifies as the “gray area” of the NICU.Maintaining a twofold commitment to human dignity that values the moral worth of the infant, on the one hand, and the common good that privileges a preferential option for the poor, on the other, Camosy develops his argument in four major steps. First, he validates the moral status of newborn infants and rejects social quality of life models that dismiss their intrinsic status as “persons.” Second, he dismisses arguments that emphasize personal dignity at the expense of considering the social quality of life, pointing out that such arguments disregard Catholic social teaching’s emphasis on the link between relational anthropology and human personhood (100). Third, he contends that “weak” social quality of life models that privilege the patient or individual over social considerations do not take seriously either Catholic social teaching’s emphasis on the common good or the potentially overwhelming economic and practical burdens they might place on families and society as a whole. Finally, Camosy presents a constructive proposal for limiting NICU resources that seeks to counter a culture of overtreatment that idolizes technology and is at the mercy of an unrestrained free market (162). Emphasizing the need for a just allocation of resources, he supports withholding and withdrawing life-sustaining treatment in some cases, thus foreseeing the possible death of some infants. Although he does not accept the direct killing of these infants, he does maintain that Catholic social teaching would allow for the withdrawal of life-sustaining treatment based on certain criteria.Camosy raises a host of important considerations relevant to decisions about imperiled infants. Yet a few questions remain. First, from a Christian point of view, does he not fall into a kind of soft utilitarianism, even though he himself desires to avoid the pitfalls of utilitarianism? Second, how might Camosy envision Christian practices that care for “exposed” infants left without life-sustaining treatment? Finally, what about the difficult emotions that accompany [End Page 210] the death of an infant or child? Do certain kinds of grief complicate our rationing choices that appear to pit the old against the young? While perhaps unanswerable, these questions merit further discussion.Autumn Alcott RidenourMerrimack CollegeCopyright © 2015 Society of Christian Ethics... (shrink)

Background In an effort to improve the quality of medical care, the philosophy of patient-centered care has become integrated into almost every aspect of the medical community. Despite its widespread acceptance, among patients and practitioners, there are concerns that rapid advancements in artificial intelligence may threaten elements of patient-centered care, such as personal relationships with care providers and patient-driven choices. This study explores the extent to which patients are confident in and comfortable with the use of these technologies when it (...) comes to their own individual care and identifies areas that may align with or threaten elements of patient-centered care. Methods An exploratory, mixed-method approach was used to analyze survey data from 600 US-based adults in the State of Florida. The survey was administered through a leading market research provider (August 10–21, 2023), and responses were collected to be representative of the state’s population based on age, gender, race/ethnicity, and political affiliation. Results Respondents were more comfortable with the use of AI in health-related tasks that were not associated with doctor-patient relationships, such as scheduling patient appointments or follow-ups (84.2%). Fear of losing the ‘human touch’ associated with doctors was a common theme within qualitative coding, suggesting a potential conflict between the implementation of AI and patient-centered care. In addition, decision self-efficacy was associated with higher levels of comfort with AI, but there were also concerns about losing decision-making control, workforce changes, and cost concerns. A small majority of participants mentioned that AI could be useful for doctors and lead to more equitable care but only when used within limits. Conclusion The application of AI in medical care is rapidly advancing, but oversight, regulation, and guidance addressing critical aspects of patient-centered care are lacking. While there is no evidence that AI will undermine patient-physician relationships at this time, there is concern on the part of patients regarding the application of AI within medical care and specifically as it relates to their interaction with physicians. Medical guidance on incorporating AI while adhering to the principles of patient-centered care is needed to clarify how AI will augment medical care. (shrink)

Two arcas of continuing interest to direct marketing professionals are the perceived myths and unethical practices in the field. Documentation of specific cases and more abstract discussion of these two points of interest frequently appear in the direct marketing literature (e.g. Gitlitz and Barton, 1983; Lewis, 1982; Pierce, 1985). Indeed, the Direct Marketing Association (DMA) has promulgated specific guidelines (DMA, 1985) for ethical business practices within the industry. Up to this point, however, there has been no attempt at a systematic (...) evaluation of the perceptions of professionals in the field.Such an evaluation of these two areas of practice would appear to beg the following questions: (1) What are the major common myths which abound in direct marketing as perceived by professionals who come into direct contact with the operations of direct marketing organizations? (2) Which of these so-called myths are most requently mentioned? (3) What are the most commonly perceived unethical practices? (4) Which of these unethical practices are most frequently mentioned by direct marketing professionals? (5) To what extent do these perceived unethical practices coincide with the industry's own guidelines? (shrink)

Neurotherapies for diagnostics and treatment—such as electroencephalography (EEG) neurofeedback, single-photon emission computerized tomography (SPECT) imaging for neuropsychiatric evaluation, and off-label/experimental uses of brain stimulation—are continuously being offered to the public outside mainstream healthcare settings. Because these neurotherapies share many key features of complementary and alternative medicine (CAM) techniques—and meet the definition of CAM as set out in Kaptchuk and Eisenberg—here we refer to them as “alternative neurotherapies.” By explicitly linking these alternative neurotherapy practices under a common conceptual framework, this (...) paper draws attention to, and critically considers, the cross-cutting ethical and legal issues related to the provision of these services. The first section of this paper provides an updated empirical overview of uses of SPECT neuropsychiatric evaluations, EEG neurofeedback, and experimental/off-label forms of brain stimulation. Next, drawing on CAM bioethics scholarship, we highlight the pertinent ethical issues in the alternative neurotherapy context, including the truthful representation of evidence base, marketing to vulnerable populations, potential harms, provider competency, and conflicts of interest. Finally, we consider the principal legal issues at stake for the provision of alternative neurotherapies in the U.S., namely those related to licensing and scope-of-practice considerations. We conclude with recommendations for future research in this domain. (shrink)

Many critics of commercial surrogate motherhood argue that it violates the rights of children. In this paper, I respond to several versions of this objection. The most common version claims that surrogacy involves child‐selling. I argue that while proponents of surrogacy have generally failed to provide an adequate response to this objection, it can be overcome. After showing that the two most prominent arguments for the child‐selling objection fail, I explain how the commissioning couple can acquire parental rights by (...) paying the surrogate only for her reproductive labor. My explanation appeals to the idea that parental rights are acquired by those who have claims over the reproductive labor that produces the child, not necessarily by those who actually perform the labor. This account clarifies how commercial surrogacy differs from commercial adoption. In the final section of the paper, I consider and reject three further child‐based objections to commercial surrogacy: that it establishes a market in children's attributes, that it requires courts to stray from the best interests standard in determining custodial rights, and that it requires the surrogate to neglect her parental responsibilities. Since each of these objections fails, children's rights probably do not pose an obstacle to the acceptability of commercial surrogacy arrangements. (shrink)

ABSTRACT I argue that this examination and appreciation for the shift to abductive reasoning should be extended to the intersection of neuroscience and novel brain-computer interfaces too. This paper highlights the implications of applying abductive reasoning to personalized implantable neurotechnologies. Then, it explores whether abductive reasoning is sufficient to justify insurance coverage for devices absent widespread clinical trials, which are better applied to one-size-fits-all treatments. INTRODUCTION In contrast to the classic model of randomized-control trials, often with a large number of (...) subjects enrolled, precision medicine attempts to optimize therapeutic outcomes by focusing on the individual.[i] A recent publication highlights the strengths and weakness of both traditional evidence-based medicine and precision medicine.[ii] Plus, it outlines a tension in the shift from evidence-based medicine’s inductive reasoning style (the collection of data to postulate general theories) to precision medicine’s abductive reasoning style (the generation of an idea from the limited data available).[iii] The paper’s main example is the application of precision medicine for the treatment of cancer.[iv] I argue that this examination and appreciation for the shift to abductive reasoning should be extended to the intersection of neuroscience and novel brain-computer interfaces too. As the name suggests, brain-computer interfaces are a significant advancement in neurotechnology that directly connects someone’s brain to external or implanted devices.[v] Among the various kinds of brain-computer interfaces, adaptive deep brain stimulation devices require numerous personalized adjustments to their settings during the implantation and computation stages in order to provide adequate relief to patients with treatment-resistant disorders. What makes these devices unique is how adaptive deep brain stimulation integrates a sensory component to initiate the stimulation. While not commonly at the level of sophistication as self-supervising or generative large language models,[vi] they currently allow for a semi-autonomous form of neuromodulation. This paper highlights the implications of applying abductive reasoning to personalized implantable neurotechnologies. Then, it explores whether abductive reasoning is sufficient to justify insurance coverage for devices absent widespread clinical trials, which are better applied to one-size-fits-all treatments.[vii] ANALYSIS I. The State of Precision Medicine in Oncology and the Epistemological Shift While a thorough overview of precision medicine for the treatment of cancer is beyond the scope of this article, its practice can be roughly summarized as identifying clinically significant characteristics a patient possesses (e.g., genetic traits) to land on a specialized treatment option that, theoretically, should benefit the patient the most.[viii] However, in such a practice of stratification patients fall into smaller and smaller populations and the quality of evidence that can be applied to anyone outside these decreases in turn.[ix] As inductive logic helps to articulate, the greater the number of patients that respond to a particular therapy the higher the probability of its efficacy. By straying from this logical framework, precision medicine opens the treatment of cancer to more uncertainty about the validity of these approaches to the resulting disease subcategories.[x] Thus, while contemporary medical practices explicitly describe some treatments as “personalized”, they ought not be viewed as inherently better founded than other therapies.[xi] A relevant contemporary case of precision medicine out of Norway focuses on the care of a patient with cancer between the ventricles of the heart and esophagus, which had failed to respond to the standard regimen of therapies over four years.[xii] In a last-ditch effort, the patient elected to pay out-of-pocket for an experimental immunotherapy (nivolumab) at a private hospital. He experienced marked improvements and a reduction in the size of the tumor. Understandably, the patient tried to pursue further rounds of nivolumab at a public hospital. However, the hospital initially declined to pay for it given the “lack of evidence from randomised clinical trials for this drug relating to this [patient’s] condition.”[xiii] In rebuttal to this claim, the patient countered that he was actually similar to a subpopulation of patients who responded in “open‐label, single arm, phase 2 studies on another immune therapy drug” (pembrolizumab).[xiv] Given this interpretation of the prior studies and the patient’s response, further rounds of nivolumab were approved. Had the patient not had improvements in the tumor’s size following a round of nivolumab, then pembrolizumab’s prior empirical evidence in isolation would have been insufficient, inductively speaking, to justify his continued use of nivolumab.[xv] The case demonstrates a shift in reasoning from the traditional induction to abduction. The phenomenon of ‘cancer improvement’ is considered causally linked to nivolumab and its underlying physiological mechanisms.[xvi] However, “the weakness of abductions is that there may always be some other better, unknown explanation for an effect. The patient may for example belong to a special subgroup that spontaneously improves, or the change may be a placebo effect. This does not mean, however, that abductive inferences cannot be strong or reasonable, in the sense that they can make a conclusion probable.”[xvii] To demonstrate the limitations of relying on the abductive standard in isolation, commentators have pointed out that side effects in precision medicine are hard to rule out as being related to the initial intervention itself unless trends from a group of patients are taken into consideration.[xviii] As artificial intelligence (AI) assists the development of precision medicine for oncology, this uncertainty ought to be taken into consideration. The implementation of AI has been crucial to the development of precision medicine by providing a way to combine large patient datasets or a single patient with a large number of unique variables with machine learning to recommend matches based on statistics and probability of success upon which practitioners can base medical recommendations.[xix] The AI is usually not establishing a causal relationship[xx] – it is predicting. So, as AI bleeds into medical devices, like brain-computer interfaces, the same cautions about using abductive reasoning alone should be carried over. II. Responsive Neurostimulation, AI, and Personalized Medicine Like precision medicine in cancer treatment, computer-brain interface technology similarly focuses on the individual patient through personalized settings. In order to properly expose the intersection of AI, precision medicine, abductive reasoning, and implantable neurotechnologies, the descriptions of adaptive deep brain stimulation systems need to deepen.[xxi] As a broad summary of adaptive deep brain stimulation, to provide a patient with the therapeutic stimulation, a neural signal, typically referred to as a local field potential,[xxii] must first be detected and then interpreted by the device. The main adaptive deep brain stimulation device with premarket approval, the NeuroPace Responsive Neurostimulation system, is used to treat epilepsy by detecting and storing “programmer-defined phenomena.”[xxiii] Providers can optimize the detection settings of the device to align with the patient’s unique electrographic seizures as well as personalize the reacting stimulation’s parameters.[xxiv] The provider adjusts the technology based on trial and error. One day machine learning algorithms will be able to regularly aid this process in myriad ways, such as by identifying the specific stimulation settings a patient may respond to ahead of time based on their electrophysiological signatures.[xxv] Either way, with AI or programmers, adaptive neurostimulation technologies are individualized and therefore operate in line with precision medicine rather than standard treatments based on large clinical trials. Contemporary neurostimulation devices are not usually sophisticated enough to be prominent in AI discussions where the topics of neural networks, deep learning, generative models, and self-attention dominate the conversation. However, implantable high-density electrocorticography arrays (a much more sensitive version than adaptive deep brain stimulation systems use) have been used in combination with neural networks to help patients with neurologic deficits from a prior stroke “speak” through a virtual avatar.[xxvi] In some experimental situations, algorithms are optimizing stimulation parameters with increasing levels of independence.[xxvii] An example of neurostimulation that is analogous to the use of nivolumab in Norway surrounds a patient in the United States who was experiencing both treatment-resistant OCD and temporal lobe epilepsy.[xxviii]Given the refractory nature of her epilepsy, implantation of an adaptive deep brain stimulation system was indicated. As a form of experimental therapy, her treatment-resistant OCD was also indicated for the off-label use of an adaptive deep brain stimulation set-up. Another deep brain stimulation lead, other than the one implanted for epilepsy, was placed in the patient’s right nucleus accumbens and ventral pallidum region given the correlation these nuclei had with OCD symptoms in prior research. Following this, the patient underwent “1) ambulatory, patient-initiated magnet-swipe storage of data during moments of obsessive thoughts; (2) lab-based, naturalistic provocation of OCD-related distress (naturalistic provocation task); and (3) lab-based, VR [virtual reality] provocation of OCD-related distress (VR provocation task).”[xxix] Such signals were used to identify when to deliver the therapeutic stimulation in order to counter the OCD symptoms. Thankfully, following the procedure and calibration the patient exhibited marked improvements in their OCD symptoms and recently shared her results publicly.[xxx] In both cases, there is a similar level of abductive justification for the efficacy of the delivered therapy. In the case study in which the patient was treated with adaptive deep brain stimulation, they at least had their neural activity tested in various settings to determine the optimum parameters for treatment to avoid them being based on guesswork. Additionally, the adaptive deep brain stimulation lead was already placed before the calibration trials were conducted, meaning that the patient had already taken on the bulk of the procedural risk before the efficacy could be determined. Such an efficacy test could have been replicated in the first patient’s cancer treatment, had it been biopsied and tested against the remaining immunotherapies in vitro. Yet, in the case of cancer with few options, one previous dose of a drug that appeared to work on the patient may justify further doses. However, as the Norwegian case presents, corroboration with known responses to a similar drug (from a clinical trial) could be helpful to validate the treatment strategy. (It should be noted that both patients were resigned to these last resort options regardless of the efficacy of treatment.) There are some elements of inductive logic seen with adaptive deep brain stimulation research in general. For example, abductively the focus could be that patient X’s stimulation parameters are different from patient Y’s and patient Z’s. In contrast, when grouped as subjects who obtained personalized stimulation, patients X, Y, and Z demonstrate an inductive aspect to this approach’s safety and/or efficacy. The OCD case holds plenty of abductive characteristics in line with precision medicine’s approach to treating cancer and as more individuals try the method, there will be additional data. With the gradual integration of AI into brain-computer interfaces in the name of efficacy, this reliance on abduction will continue, if not grow, over time. Moving forward, if a responsive deep brain stimulation treatment is novel and individualized (like the dose of nivolumab) and there is some other suggestion of efficacy (like clinical similarities to other patients in the literature), then it may justify insurance coverage for the investigative intervention, absent other unrelated reasons to deny it. III. Ethical Implications and Next Steps While AI’s use in oncology and neurology is not yet as prominent as its use in other fields (e.g., radiology), it appears to be on the horizon for both.[xxxi] AI can be found in both the functioning of the neurotechnologies as well as the implementation of precision medicine. The increasing use of AI may serve to further individualize both oncologic and neurological therapies. Given these implications and the handful of publications cited in this article, it is important to have a nuanced evaluation of how these treatments, which heavily rely on abductive justification, ought to be managed. The just use an abductive approach may be difficult as AI infused precision medicine is further pursued. At baseline, such technology relies on a level of advanced technology literacy among the general public and could exclude populations who lack access to basic technological infrastructure or know-how from participation.[xxxii] Even among nations with adequate infrastructure, as more patients seek out implantable neurotechnologies, which require robust healthcare resources, the market will favor patient populations that can afford this complex care.[xxxiii] If patients already have the means to pay for an initial dose/use of a precision medicine product out of pocket, should insurance providers be required to cover subsequent treatments?[xxxiv] That is, if a first dose of a cancer drug or a deep brain stimulator over its initial battery life is successful, patients may feel justified in having the costs of further treatments covered. The Norwegian patient’s experience implies there is a precedent for the idea that some public insurance companies ought to cover successful cancer therapies, however, insurance companies may not all see themselves as obligated to cover neurotechnologies that rely on personalized settings or that are based on precision/abductive research more than on clinical trials. CONCLUSION The fact that the cases outlined above rely on abductive style of reasoning implies that there may not be as strong a justification for coverage by insurance, as they are both experimental and individualized, when compared to the more traditional large clinical trials in which groups have the same or a standardized protocol (settings/doses). If a study is examining the efficacy of a treatment with a large cohort of patients or with different experimental groups/phases, insurance companies may conclude that the resulting symptom improvements are more likely to be coming from the devices themselves. A preference for inductive justification may take priority when ruling in favor of funding someone’s continued use of an implantable neurostimulator. There are further nuances to this discussion surrounding the classifications of these interventions as research versus clinical care that warrant future exploration, since such a distinction is more of a scale[xxxv] than binary and could have significant impacts on the “right-to-try” approach to experimental therapies in the United States.[xxxvi] Namely, given the inherent limitations of conducting large cohort trials for deep brain stimulation interventions on patients with neuropsychiatric disorders, surgically innovative frameworks that blend abductive and inductive methodologies, like with sham stimulation phases, have traditionally been used.[xxxvii] Similarly, for adaptive brain-computer interface systems, if there are no large clinical trials and instead only publications that demonstrate that something similar worked for someone else, then, in addition to the evidence that the first treatment/dose worked for the patient in question, the balance of reasoning would be valid and arguably justify insurance coverage. As precision approaches to neurotechnology become more common, frameworks for evaluating efficacy will be crucial both for insurance coverage and for clinical decision making. ACKNOWLEDGEMENT This article was originally written as an assignment for Dr. Francis Shen’s “Bioethics & AI” course at Harvard’s Center for Bioethics. I would like to thank Dr. Shen for his comments as well as my colleagues in the Lázaro-Muñoz Lab for their feedback. - [i] Jonathan Kimmelman and Ian Tannock, “The Paradox of Precision Medicine,” Nature Reviews. Clinical Oncology 15, no. 6 (June 2018): 341–42, https://doi.org/10.1038/s41571-018-0016-0. [ii] Henrik Vogt and Bjørn Hofmann, “How Precision Medicine Changes Medical Epistemology: A Formative Case from Norway,” Journal of Evaluation in Clinical Practice 28, no. 6 (December 2022): 1205–12, https://doi.org/10.1111/jep.13649. [iii] David Barrett and Ahtisham Younas, “Induction, Deduction and Abduction,” Evidence-Based Nursing 27, no. 1 (January 1, 2024): 6–7, https://doi.org/10.1136/ebnurs-2023-103873. [iv] Vogt and Hofmann, “How Precision Medicine Changes Medical Epistemology,” 1208. [v] Wireko Andrew Awuah et al., “Bridging Minds and Machines: The Recent Advances of Brain-Computer Interfaces in Neurological and Neurosurgical Applications,” World Neurosurgery, May 22, 2024, S1878-8750(24)00867-2, https://doi.org/10.1016/j.wneu.2024.05.104. [vi] Mark Riedl, “A Very Gentle Introduction to Large Language Models without the Hype,” Medium (blog), May 25, 2023, https://mark-riedl.medium.com/a-very-gentle-introduction-to-large-language-models-without-the-hype-5 f67941fa59e. [vii] David E. Burdette and Barbara E. Swartz, “Chapter 4 - Responsive Neurostimulation,” in Neurostimulation for Epilepsy, ed. Vikram R. Rao (Academic Press, 2023), 97–132, https://doi.org/10.1016/B978-0-323-91702-5.00002-5. [viii] Kimmelman and Tannock, 2018. [ix] Kimmelman and Tannock, 2018. [x] Simon Lohse, “Mapping Uncertainty in Precision Medicine: A Systematic Scoping Review,” Journal of Evaluation in Clinical Practice 29, no. 3 (April 2023): 554–64, https://doi.org/10.1111/jep.13789. [xi] Kimmelman and Tannock, “The Paradox of Precision Medicine.” [xii] Vogt and Hofmann, 1206. [xiii] Vogt and Hofmann, 1206. [xiv] Vogt and Hofmann, 1206. [xv] Vogt and Hofmann, 1207. [xvi] Vogt and Hofmann, 1207. [xvii] Vogt and Hofmann, 1207. [xviii] Vogt and Hofmann, 1210. [xix] Mehar Sahu et al., “Chapter Three - Artificial Intelligence and Machine Learning in Precision Medicine: A Paradigm Shift in Big Data Analysis,” in Progress in Molecular Biology and Translational Science, ed. David B. Teplow, vol. 190, 1 vols., Precision Medicine (Academic Press, 2022), 57–100, https://doi.org/10.1016/bs.pmbts.2022.03.002. [xx] Stefan Feuerriegel et al., “Causal Machine Learning for Predicting Treatment Outcomes,” Nature Medicine 30, no. 4 (April 2024): 958–68, https://doi.org/10.1038/s41591-024-02902-1. [xxi] Sunderland Baker et al., “Ethical Considerations in Closed Loop Deep Brain Stimulation,” Deep Brain Stimulation 3 (October 1, 2023): 8–15, https://doi.org/10.1016/j.jdbs.2023.11.001. [xxii] David Haslacher et al., “AI for Brain-Computer Interfaces,” 2024, 7, https://doi.org/10.1016/bs.dnb.2024.02.003. [xxiii] Burdette and Swartz, “Chapter 4 - Responsive Neurostimulation,” 103–4; “Premarket Approval (PMA),” https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100026. [xxiv] Burdette and Swartz, “Chapter 4 - Responsive Neurostimulation,” 104. [xxv] Burdette and Swartz, 126. [xxvi] Sean L. Metzger et al., “A High-Performance Neuroprosthesis for Speech Decoding and Avatar Control,” Nature 620, no. 7976 (August 2023): 1037–46, https://doi.org/10.1038/s41586-023-06443-4. [xxvii] Hao Fang and Yuxiao Yang, “Predictive Neuromodulation of Cingulo-Frontal Neural Dynamics in Major Depressive Disorder Using a Brain-Computer Interface System: A Simulation Study,” Frontiers in Computational Neuroscience 17 (March 6, 2023), https://doi.org/10.3389/fncom.2023.1119685; Mahsa Malekmohammadi et al., “Kinematic Adaptive Deep Brain Stimulation for Resting Tremor in Parkinson’s Disease,” Movement Disorders 31, no. 3 (2016): 426–28, https://doi.org/10.1002/mds.26482. [xxviii] Young-Hoon Nho et al., “Responsive Deep Brain Stimulation Guided by Ventral Striatal Electrophysiology of Obsession Durably Ameliorates Compulsion,” Neuron 0, no. 0 (October 20, 2023), https://doi.org/10.1016/j.neuron.2023.09.034. [xxix] Nho et al. [xxx] Nho et al.; Erik Robinson, “Brain Implant at OHSU Successfully Controls Both Seizures and OCD,” OHSU News, accessed March 3, 2024, https://news.ohsu.edu/2023/10/25/brain-implant-at-ohsu-successfully-controls-both-seizures-and-ocd. [xxxi] Awuah et al., “Bridging Minds and Machines”; Haslacher et al., “AI for Brain-Computer Interfaces.” [xxxii] Awuah et al., “Bridging Minds and Machines.” [xxxiii] Sara Green, Barbara Prainsack, and Maya Sabatello, “The Roots of (in)Equity in Precision Medicine: Gaps in the Discourse,” Personalized Medicine 21, no. 1 (January 2024): 5–9, https://doi.org/10.2217/pme-2023-0097. [xxxiv] Green, Prainsack, and Sabatello, 7. [xxxv] Robyn Bluhm and Kirstin Borgerson, “An Epistemic Argument for Research-Practice Integration in Medicine,” The Journal of Medicine and Philosophy: A Forum for Bioethics and Philosophy of Medicine 43, no. 4 (July 9, 2018): 469–84, https://doi.org/10.1093/jmp/jhy009. [xxxvi] Vijay Mahant, “‘Right-to-Try’ Experimental Drugs: An Overview,” Journal of Translational Medicine 18 (June 23, 2020): 253, https://doi.org/10.1186/s12967-020-02427-4. [xxxvii] Michael S. Okun et al., “Deep Brain Stimulation in the Internal Capsule and Nucleus Accumbens Region: Responses Observed during Active and Sham Programming,” Journal of Neurology, Neurosurgery & Psychiatry 78, no. 3 (March 1, 2007): 310–14, https://doi.org/10.1136/jnnp.2006.095315. (shrink)

The market for kidneys offers a case study of Baptists and Bootleggers. In almost every country, sales are currently illegal and donated organs are allocated by a central planner. Thousands of people die every year, because of the shortage caused by the absence of markets. This paper starts by examining the free-market alternative, and shows that a market would solve the shortage. It then uses gains-from-trade analysis to explain why current vested interests oppose a move to a (...) market, despite the immense potential for saved lives. In a shift to a market, gains from trade would be distributed away from lucky patients and various industries that benefit from the shortage ; these “Bootleggers” form an alliance with “Baptists”. (shrink)

Every year, hundreds of patients in England die whilst waiting for a kidney transplant, and this is evidence that the current system of altruistic-based donation is not sufficient to address the shortage of kidneys available for transplant. To address this problem, we propose a monopsony system whereby kidney donors can opt-in to receive financial compensation, whilst still preserving the right of individuals to donate without receiving any compensation. A monopsony system describes a market structure where there is only one (...) ‘buyer’—in this case the National Health Service. By doing so, several hundred lives could be saved each year in England, wait times for a kidney transplant could be significantly reduced, and it would lessen the burden on dialysis services. Furthermore, compensation would help alleviate the common disincentives to living kidney donation, such as its potential associated health and psychological costs, and it would also help to increase awareness of living kidney donation. The proposed system would also result in significant cost savings that could then be redirected towards preventing kidney disease and reducing health disparities. While concerns about exploitation, coercion, and the ‘crowding out’ of altruistic donors exist, we believe that careful implementation can mitigate these issues. Therefore, we recommend piloting financial compensation for living kidney donors at a transplant centre in England. (shrink)

Even if there is a common morality, many would argue that it provides little guidance in resolving moral disputes, because universally accepted norms are both general in content and few in number. However, if we supplement common morality with commonly accepted factual beliefs and culture-specific norms and utilize coherentist reasoning, we can limit the range of acceptable answers to disputed issues. Moreover, in the arena of public policy, where one must take into account both legal and moral norms, (...) the constraints on acceptable answers will narrow the extent of reasonable disagreement even further. A consideration of the debate over legalization of assisted dying supports this claim. (shrink)

Consumer demand for health information and health services has rapidly evolved to capture and even propel the movement to online health information seeking. Seventeen percent of health information internet users will look for information about memory loss, dementia and Alzheimer’s disease. We examined the content of the 25 most frequently retrieved websites marketing AD dietary supplements. We found that the majority of websites and their products claimed AD-related benefits, including improvement and enhancement of function, treatment for AD, prevention of AD, (...) maintenance of function, delayed progression of AD, and decreased symptoms. Supplements were described as effective, natural, powerful or strong, dependable and pure or of high quality. Peer reviewed references to proper scientific studies were infrequent on websites. Statements highlighting the risks of dietary supplements were as common as statements mitigating or minimizing these risks. Different strategies were used to promote supplements such as popular appeals and testimonials. Further enforcement of relevant policy is needed and preparation of clinicians to deal with requests of patients and caregivers is indicated. (shrink)

The financial crisis of 2008–2009 presents us with the opportunity to not only understand what has happened in the markets but also to reflect on the purpose of the marketplace. Drawing from expert economic analyses, we first assess the central lesson of the crisis—the failure of self-regulation by rational self-interest to moderate externalized risk in financial markets. Second, we ask the philosophical question occasioned by the crisis concerning the moral meaning of economic activity: Is market exchange solely for the (...) sake of self-interest? Reflecting on the poetry of Kahlil Gibran and engaging with the recent encyclical of Pope Benedict XVI, we turn our attention from political economy to moral economy: the relationships among market exchange, self-interest, and the common good—and, in particular, the prior conditions of market exchange and their moral significance for the present crisis. (shrink)

Qualitative studies on assisted reproductive technology commonly focus on the perspectives of participants living in major metropolises. In doing so, the experiences of those living outside major cities, and the unique way conditions of spatiality shape access to treatment, are elided. In this paper, we examine how location and regionality in Australia impact upon access and experience of reproductive services. We conducted twelve qualitative interviews with participants residing in regional areas across Australia. We asked participants to discuss their experience with (...) assisted reproduction services and the impacts of location on access, service choice, and experience of care, and analysed the data using reflexive thematic analysis, as outlined by Braun and Clarke (2006, 2019). Participants in this study reported that their location impacted the services available to them, required considerable time in travel, and reduced continuity of care. We draw on these responses to examine the ethical implications of uneven distribution of reproductive services in commercial healthcare settings which rely on market-based mechanisms. (shrink)

Many political theorists take the phenomenon of market failure to show that arguments for libertarianism fail in a straightforward way. This chapter explains why the most common form of this objection depends on invalid reasoning, and why a more sophisticated examination of the relevant economics has led most contemporary economists and policy experts to a view that might be called Default Libertarianism, according to which the strong default for public policy—even in response to market failures—should be toward (...) decentralized, pro-individual freedom policies that involve minimal government intervention in markets. Some experts (but by no means all) similarly believe that even in the face of substantial market failures, libertarian policies are generally best all things considered. This shift toward more libertarian policy represents an important change from the middle of the twentieth century. This chapter explains the structure of the arguments that have led to this shift. (shrink)

How do markets principally contribute to society, and do they all contribute in the same ways? The logic of common and private goods provides much-needed clarity in grappling with the constitution and contribution of markets. The root challenge of the market is that impersonal private exchange cannot directly promote any common goods, so it appears only capable of promoting the flourishing of society “by accident,” as it were. As responses, the “spontaneous” approach regards both markets and politics (...) as unintended orders of private ends, while a “instituted” model subordinates thin exchange to the thick communal goals of sustaining politics, and the “civil” economy claims that market exchange is itself a form of fraternal solidarity around common goods. All three rival models capture some exchange contexts, but none works for all markets. I advocate a meta stance of “market pluralism,” acknowledging that different markets’ moral architectures could match any of the three models, in line with empirical findings that different industries and market systems vary significantly in their modes of coordination, human relations, and major objectives. (shrink)

The debate over financial incentives and market models for organ procurement represents a key trend in recent bioethics. In this paper, we wish to reassess one of its central premises—the idea of organ shortage. While the problem is often presented as an objective statistical fact that can be taken for granted, we will take a closer look at the underlying framework expressed in the common rhetoric of “scarcity”, “shortage” or “unfulfilled demand”. On the basis of theoretical considerations (...) as well as a socioempirical examination of public attitudes, we will argue that this rhetoric has an economic subtext that imbues the debate with normative premises that have far-reaching social and ethical consequences and need to be made explicit and discussed. (shrink)

BackgroundTo help inform the development of more accessible, acceptable, and effective ethics consultation (EC) training programs, we conducted an EC training needs assessment, exploring ethics practitioners’ opinions on: the relative importance of various EC practitioner competencies; the potential market for EC training (that is, how many individuals would benefit and how much individuals and hospitals would be willing to pay); and the preferred content, format, and characteristics of EC training.MethodsAs part of a multipart study, we surveyed “best informants” who (...) self-identified as the person most actively involved in EC or healthcare ethics in a random sample of 600 U.S. general hospitals, stratified for bed size.ResultsThe competency that was ranked most important for a lead or solo ethics consultant was knowledge of ethics, while common sense was ranked least important. The median estimated number of individuals at each hospital who would benefit from EC training was six at the basic level, three at the advanced level, and two for EC management training. In 19.1 percent of hospitals, respondents thought their hospital would not be willing to pay anything for EC training within the next two years. Respondents thought potential trainees would be likely to participate in EC training on multiple different topics. Opinions varied widely on preferred formats. Most respondents thought it very important to be able to interact with instructors and with other trainees, practice EC skills, receive a certificate for completing EC training, and complete EC training during work hours.ConclusionsThese findings provide U.S. population data that may be useful to healthcare educators and bioethics leaders in their efforts to develop EC training programs and products that match trainees’ preferences and needs. (shrink)

Catholic ethical teaching has increasingly relied on a concept of the common good for making and evaluating social decisions. The authors have argued that the common good is a maximal and ideal concept about which people and communities differ fundamentally. In practice, it does not resolve moral and social disagreements. The concept of the common harm is preferable because it is a minimal standard that can be more clearly identified and agreed for individuals and society, providing a (...) basis for legislative and social action. Bioethics and public health both have strong roots in doing no harm and preventing harm to both individuals and communities in society. The authors argue that the application of the concept of the common harm from these disciplines into wider use in the health professions and public policy would be beneficial. National Catholic Bioethics Quarterly 14.3 : 449–455. (shrink)

Macromarketing attempts to address issues that engage marketing and society and previous ethical scholarship has focused on distributive justice and on exchanges that occur in conventional markets. As our research highlights, however, the distributive justice approach alone is insufficient for managing the complexities, ethical paradoxes, and out-of-market conditions associated with wicked, cross-national social concerns. In this article, we integrate macromarketing with the theory of the common good in order to provide a foundation for framing societal change that can (...) encompass nonmarket value, stakeholder rights, collective social priorities, organizational responsibilities, and political action. (shrink)

Interactions with global markets offer development opportunities for Indigenous communities. They also place pressure on the natural resources that communities depend upon for their livelihood and, in many cases, their political and cultural autonomy. These markets often interact with family-based enterprises embedded within commons, with important implications for the social relationships and shared territorial resources that characterise such regimes. In this paper, we analyse the relationships that exist between commons, global markets, and small-scale family enterprises, using the case of mezcal (...) production—an alcoholic beverage made from agave—in an Indigenous community in Oaxaca, Mexico. Most mezcal production is organized at the family level; yet the raw materials and inputs necessary for making mezcal are held communally and regulated by locally-crafted institutions. Empirical data show that as family enterprises engage with an emergent global market for mezcal, the commons become essential for not only protecting territorial resources but also maintaining a degree of autonomy from powerful global markets and value chains. However, this requires substantial investment in monitoring and enforcement, and for community members to value sustainable commons management over short-term economic self-interest. To seek autonomy while participating in global markets, producer families also join together to develop cooperative strategies to access markets on better terms. (shrink)