In this paper, I defend an account of the ethics of precision medicine that can explain both its possibilities and limits. Creating a new conceptual and normative model of the ethics of precision health can ensure that good medicine is also excellent and that excellent medicine is also good by providing a resource to scientists and clinicians. First, I propose a new conceptual analysis of precision health. I argue that precision health is defined (...) primarily by targeted medical interventions and not by stratification, as others have asserted. Next, I argue that failure to be adequately responsive to this conceptual analysis explains common ethical abuses in the field. Third, I argue that this conceptual analysis can also pave the way for future research heretofore overlooked. Thus, we can limit abuses in precision health research and care while at the same time opening new avenues to help historically oppressed communities. (shrink)

The rise of genomic technologies has catalyzed shifts in the health care landscape through the commercialization of genome sequencing and testing services in the genomics marketplace. The development of consumer genomics into a growing array of information technologies aimed at collecting, curating, and broadly sharing personal data and biological materials reconstitutes the meaning of health and reframes patients into biocitizens. In this context, the good biocitizen is expected to assume personal responsibility for health through consumption of genomic (...) information and acquiescence to public and private efforts at data surveillance and aggregation. These shifts raise fundamental questions about how competing interests of the public, the state, and corporate entities will be reconciled and what trade‐offs are demanded for the promise of precision health. (shrink)

This paper problematizes the precision medicine approach embraced by the All of Us Research Program (US) and by Genomics England (UK) in terms of benefits distribution, by arguing that current “diversity and inclusion” efforts do not prevent exclusiveness, unless the framing and scope of the projects are revisited in public health terms. Grounded on document analysis and fieldwork interviews, this paper analyzes efforts to address potential patterns of exclusion upstream (from participating in precision medicine research) and downstream (...) (from benefitting from precision medicine outputs). It argues that efforts for inclusion upstream are not corresponded downstream, and this unbalance jeopardizes the equitable capacities of the projects. It concludes that enhanced focus on socio-environmental determinants of health and aligned public health interventions as precision medicine outputs would be to the benefit of all and especially of those who are most at risk of (upstream as well as downstream) exclusion. (shrink)

Precision medicine and digital phenotyping are two prominent data-based approaches within digital medicine. While precision medicine historically used primarily genetic data to find targeted treatment options, digital phenotyping relies on the usage of big data deriving from digital devices such as smartphones, wearables and other connected devices. This paper first focusses on the aspect of data type to explore differences and similarities between precision medicine and digital phenotyping. It outlines different ways of data collection and production and (...) the consequences thereof. Second, it shows how these sorts of data influence dominant beliefs in the field: The field of precision medicine relying on the dominant understanding of ‘genetic determinism’ imported from genetics, digital phenotyping building on the logic of ‘data fundamentalism’. In the end, the analysis shows how digital data informs potentials as well as challenges of precision medicine and digital phenotyping: a better health care for individuals connected with individualisation and responsibilisation for all, with a prognosed shift from reactive to preventive medicine. Additionally, data-based approaches might facilitate epistemological and ontological redirections for the whole field of medicine that will also affect knowledge production and a reassessment of the value of different types of knowledge with all its consequences. Institutionally, it might lead to shifts in distribution of power to experts in big data related technologies, i.e. private companies. (shrink)

As opposed to a ‘one size fits all’ approach, precision medicine uses relevant biological, medical, behavioural and environmental information about a person to further personalize their healthcare. This could mean better prediction of someone’s disease risk and more effective diagnosis and treatment if they have a condition. Big data allows for far more precision and tailoring than was ever before possible by linking together diverse datasets to reveal hitherto-unknown correlations and causal pathways. But it also raises ethical issues (...) relating to the balancing of interests, viability of anonymization, familial and group implications, as well as genetic discrimination. This article analyses these issues in light of the values of public benefit, justice, harm minimization, transparency, engagement and reflexivity and applies the deliberative balancing approach found in theEthical Framework for Big Data in Health and Research to a case study on clinical genomic data sharing. Please refer to that article for an explanation of how this framework is to be used, including a full explanation of the key values involved and the balancing approach used in the case study at the end. Our discussion is meant to be of use to those involved in the practice as well as governance and oversight of precision medicine to address ethical concerns that arise in a coherent and systematic manner. (shrink)

Discovery science in health over the past two decades has embraced, with considerable enthusiasm, the potential of two movements: precision medicine and the ascent of big data. Each of these developments has been suggested to hold substantial promise both to advance our health science and to lead to the development of approaches that can improve health.Precision medicine—emerging naturally from the Human Genome Project almost two decades ago—promises to use genomic and molecular approaches to identify the (...) causes of disease particular to individuals with the end of helping develop tailored treatments and interventions. This approach builds on what is perhaps a deeply held... (shrink)

Amid public health concerns over climate change, “precision public health” is emerging in next generation approaches to practice. These novel methods promise to augment public health operations by using ever larger and more robust health datasets combined with new tools for collecting and analyzing data. Precision strategies to protecting the public health could more effectively or efficiently address the systemic threats of climate change, but may also propagate or exacerbate health disparities for (...) the populations most vulnerable in a changing climate. How PPH interventions collect and aggregate data, decide what to measure, and analyze data pose potential issues around privacy, neglecting social determinants of health, and introducing algorithmic bias into climate responses. Adopting a health justice framework, guided by broader social and climate justice tenets, can reveal principles and policy actions which may guide more responsible implementation of PPH in climate responses. (shrink)

Galasso calls for “the actualization of the public health potential of precision medicine….as the best realistic contribution to health equity” (Galasso 2024, 83). Unfortunately, this is wishful th...

This book presents the promises of Precision Medicine (PM) and the challenges of its implementation in daily clinical routine, while addressing the anticipated ethical and social implications. It is the first book that critically analyzes the potential and the dilemmas relevant to genomics and precision medicine from healthcare, public health and global perspectives. The nine chapters presented in this book elaborate on pharmacogenomics' crucial role in maximizing the potential benefits and minimizing medication's potential risks in groups of (...) people, especially in cancer treatment and other health conditions. Infectious and non-communicable diseases (NCDs) are also discussed in this book by identifying challenges and ways to overcome them. Essential concepts are addressed, such as health-related benefits and harm to individuals and the broader community, including threats to individual privacy and autonomy, which warrant just distribution of scarce resources. The book also identifies and addresses the lack of competency in the healthcare workforce in the era of PM and discusses the path to laying the ethical foundation for the implementation of PM in healthcare organizations. (shrink)

Background We aimed to examine the ethical concerns Singaporeans have about sharing health-data for precision medicine and identify suggestions for governance strategies. Just as Asian genomes are under-represented in PM, the views of Asian populations about the risks and benefits of data sharing are under-represented in prior attitudinal research. Methods We conducted seven focus groups with 62 participants in Singapore from May to July 2019. They were conducted in three languages and analysed with qualitative content and thematic analysis. (...) Results Four key themes emerged: nuanced understandings of data security and data sensitivity; trade-offs between data protection and research benefits; trust in the public and private sectors; and governance and control options. Participants were aware of the inherent risks associated with data sharing for research. Participants expressed conditional support for data sharing, including genomic sequence data and information contained within electronic medical records. This support included sharing data with researchers from universities and healthcare institutions, both in Singapore and overseas. Support was conditional on the perceived social value of the research and appropriate de-identification and data security processes. Participants suggested that a data sharing oversight body would help strengthen public trust and comfort in data research for PM in Singapore. Conclusion Maintenance of public trust in data security systems and governance regimes can enhance participation in PM and data sharing for research. Contrary to themes in much prior research, participants demonstrated a sophisticated understanding of the inherent risks of data sharing, analysed trade-offs between risks and potential benefits of PM, and often adopted an international perspective. (shrink)

Dr. Galasso’s (2024) insightful article expands the ongoing debate on the utility and equity of precision medicine in public and population health. The initiatives mentioned, Genomics England and t...

Precision medicine is an emerging approach to treatment and disease prevention that relies on linkages between very large datasets of health information that is shared amongst researchers and health professionals. While studies suggest broad support for sharing precision medicine data with researchers at publicly funded institutions, there is reluctance to share health information with private industry for research and development. As the private sector is likely to play an important role in generating public benefits from (...) precision medicine initiatives, it is important to understand what the concerns are and how they might be mitigated. This study reports outcomes of a deliberative method of citizen engagement in Singapore that asked whether sharing precision medicine data with private industry would be permissible, and if so, under what circumstances. Findings from this citizens’ jury suggest sharing with industry would be permissible under certain conditions that are set out in nine recommendations. Implications of the recommendations and their underlying assumptions for policy decision makers are discussed. This study aligns with prior international studies which found conditional acceptance for data sharing with private industry, a public benefit requirement, specific reluctance to share with insurance companies and an emphasis on accountability and transparency to demonstrate trustworthiness. However, our results differ from prior studies in that opt-in consent did not dominate the deliberations as jurors were able to set it aside as an assumed prerequisite for participation in a precision medicine programme. (shrink)

The United States’ ambitious Precision Medicine Initiative proposes to accelerate exponentially the adoption of precision medicine, an approach to health care that tailors disease diagnosis, treatment, and prevention to individual variability in genes, environment, and lifestyle. It aims to achieve this by creating a cohort of volunteers for precision medicine research, accelerating biomedical research innovation, and adopting policies geared toward patients’ empowerment. As strategies to implement the PMI are formulated, critical consideration of the initiative's ethical and (...) sociopolitical dimensions is needed. Drawing on scholarship of nationalism and democracy, we discuss the PMI's construction of what we term “genomic citizenship”; the possible normative obligations arising therefrom; and the ethical, legal, and social challenges that will ensue. Although the PMI is a work in progress, discussion of the existing and emerging issues can facilitate the development of policies, structures, and procedures that can maximize the initiative's ability to produce equitable and socially sensitive outcomes. Our analysis can also be applied to other population-based, precision medicine research programs. (shrink)

The inclusion of members of structurally marginalized communities in data-intensive innovation initiatives, such as precision medicine projects, is an urgent contemporary issue. On the one hand, th...

Galasso (2024) provides a strong critique of precision medicine research initiatives regarding their potential for the exclusion of populations based on upstream and downstream factors with “Genomi...

Precision Medicine has become a common label for data-intensive and patient-driven biomedical research. Its intended future is reflected in endeavours such as the Precision Medicine Initiative in the USA. This article addresses the question whether it is possible to discern a new ‘medical cosmology’ in Precision Medicine, a concept that was developed by Nicholas Jewson to describe comprehensive transformations involving various dimensions of biomedical knowledge and practice, such as vocabularies, the roles of patients and physicians and the (...) conceptualisation of disease. Subsequently, I will elaborate my assessment of the features of Precision Medicine with the help of Michel Foucault, by exploring how precision medicine involves a transformation along three axes: the axis of biomedical knowledge, of biomedical power and of the patient as a self. Patients are encouraged to become the managers of their own health status, while the medical domain is reframed as a data-sharing community, characterised by changing power relationships between providers and patients, producers and consumers. While the emerging Precision Medicine cosmology may surpass existing knowledge frameworks; it obscures previous traditions and reduces research-subjects to mere data. This in turn, means that the individual is both subjected to the neoliberal demand to share personal information, and at the same time has acquired the positive ‘right’ to become a member of the data-sharing community. The subject has to constantly negotiate the meaning of his or her data, which can either enable self-expression, or function as a commanding Superego. (shrink)

Precision medicine (PM) and genomics are increasingly scrutinized through the lens of health inequities. This is a welcome development for a field that, while concerned with health-related differen...

Recent studies highlight the need for ethical and equitable digital health research that protects the rights and interests of racialized communities. We argue for practices in digital health that promote data self-determination for these communities, especially in data collection and management. We suggest that researchers partner with racialized communities to curate data that reflects their wellness understandings and health priorities, and respects their consent over data use for policy and other outcomes. These data governance approach honors and (...) builds on Indigenous Data Sovereignty (IDS) decolonial scholarship by Indigenous and non-indigenous researchers and its adaptations to health research involving racialized communities from former European colonies in the global South. We discuss strategies to practice equity, diversity, inclusion, accessibility and decolonization (EDIAD) principles in digital health. We draw upon and adapt the concept of Precision Health Equity (PHE) to emphasize models of data sharing that are co-defined by racialized communities and researchers, and stress their shared governance and stewardship of data that is generated from digital health research. This paper contributes to an emerging research on equity issues in digital health and reducing health, institutional, and technological disparities. It also promotes the self-determination of racialized peoples through ethical data management. (shrink)

This paper argues that Zika virus infection has its ethical implications beyond the reproductive health of women. It claims that Zika virus infection like public health emergency exposes the underlying health determinants and health status of women. Therefore, ethical mitigation of Zika like public health emergencies should consider these underlying health determinants and health status of women. For, undermining and overlooking these underlying determinants and health status of women, during the public (...) class='Hi'>health emergencies, enhance the health inequities. The recent Zika virus infection in Brazil has triggered different ethics consultation and has prompted to outline ethical recommendations. However, the recommendations have either focused on the reproductive health of women or on the core strategies of public health emergency. Considering this as a gap in perspective to prepare for Zika like public health emergencies, this paper argues that it is the underlying holistic health of women, precisely, health capability, which should be given due ethical consideration. Finally, the paper concludes highlighting the fact that focusing on the holistic health of the women during Zika like public health emergencies and beyond can bring in long-term benefits for global health equity. (shrink)

In “Obligations of the Gift,” Lee argues that ethical thinking regarding return of genetic research results has been too narrowly focused on individual consent and participants’ “right to kn...

Solidarity is a fundamental social value in many European countries, though its precise practical and theoretical meaning is disputed. In a health care context, I agree with European writers who take solidarity normatively to mean roughly equal access to effective health care for all. That is, solidarity includes a sense of justice. Given that, I will argue that precision medicine represents a potential weakening of solidarity, albeit not a unique weakening. Precision medicine includes 150 targeted cancer (...) therapies (mostly for metastatic cancer), all of which are extraordinarily expensive. Our critical question: Must a commitment to solidarity as defined mean that all these targeted cancer therapies should be guaranteed to all within each country in the European Union, no matter the cost, no matter the degree of effectiveness? Such a commitment would imply that cancer was ethically special, rightfully commandeering unlimited resources. That in itself would undermine solidarity. I offer multiple examples of how current and future dissemination of these targeted cancer drugs threaten a commitment to solidarity. An alternative is to fund more cancer prevention efforts. However, that too proves a threat to solidarity. Solidarity, with or without a sense of justice, is too abstract a notion to address these challenges. Further, we need to accept that we can only hope to achieve “rough justice” and “supple solidarity.” The precise practical meaning of these notions needs to be worked out through a fair and inclusive process of rational democratic deliberation, which is the real and practical foundation of just solidarity. (shrink)

I Several years ago, when the Carter administration announced that it would support congressional action to end the public fund ing of abortions, the President was asked at a press conference whether he thought that such a policy was unfair; he responded, "Life is unfair." His remarks provoked a storm of controversy. For other than those who, for principled reasons, opposed abor tion on any grounds, it seemed that the President's comments were cruel, violating what was thought to be an (...) American com mitment to providing equal access to health services to all citi zens, regardless of their capacity to pay. Those sentiments had, in fact, been reflected in public opinion polls that had, for at least three decades, indicated that Americans supported the propo sition that the government should guarantee health care to all. Ultimately, those beliefs had been translated into the oft-ex 1 pressed political demand for a one-class system of health care. This commitment to equality is rather remarkable. American society evidences a striking willingness to tolerate vast inequal ities with regard to income and wealth. While it guarantees ed ucation to all children, there is not even a pretense that the children of the wealthy and the children of the poor ought to get precisely the same kind of schooling. While some commitment 'Hazel Erskine. "The Polls: Health Insurance," Public Opinion Quarterly, XXXIX (Spring, 1975), 128-143. (shrink)

Warwick Heale has recently defended the notion of individualized and personalized Quality-Adjusted Life Years in connection with health care resource allocation decisions. Ordinarily, QALYs are used to make allocation decisions at the population level. If a health care intervention costs £100,000 and generally yields only two years of survival, the cost per QALY gained will be £50,000, far in excess of the £30,000 limit per QALY judged an acceptable use of resources within the National Health Service in (...) the United Kingdom. However, if we know with medical certainty that a patient will gain four extra years of life from that intervention, the cost per QALY will be £25,000. Heale argues fairness and social utility require such a patient to receive that treatment, even though all others in the cohort of that patient might be denied that treatment. Likewise, Heale argues that personal commitments of an individual, that determine how they value a life-year with some medical intervention, ought to be used to determine the value of a QALY for them. I argue that if Heale’s proposals were put into practice, the result would often be greater injustice. In brief, requirements for the just allocation of health care resources are more complex than pure cost-effectiveness analysis would allow. (shrink)

Precision medicine (PM) aims to revolutionise healthcare, but little is known about the role religion and spirituality might play in the ethical discourse about PM. This Perspective reports the outcomes of a knowledge exchange fora with religious authorities in Singapore about data sharing for PM. While the exchange did not identify any foundational religious objections to PM, ethical concerns were raised about the possibility for private industry to profiteer from social resources and the potential for genetic discrimination by private (...) health insurers. According to religious authorities in Singapore, sharing PM data with private industry will require a clear public benefit and robust data governance that incorporates principles of transparency, accountability and oversight. (shrink)

In Tyranny of the Gene: Personalized Medicine and Its Threat to Public Health (Knopf, 2023), James Tabery traces the ascendance of personalized or precision medicine in America, arguing that America's emphasis on genetics offers more hype than transformational power. In his examination of the power struggles, social relationships, and technological advances that centered the gene in American health policy, Tabery demonstrates how an intensive focus on genetics draws attention away from both the fundamental causes of health (...) disparities and more‐effective changes that could be made to developmental, physical, and social environments. American policy‐makers, health care institutions, funders, and bioethicists should not let the technological shine and attractive politics of personalized medicine continue to replace the hard but necessary work of addressing sociopolitical causes of disease and illness. (shrink)

Since the late 1980s, the human genetics and genomics research community has been promising to usher in a “new paradigm for health care”—one that uses molecular profiling to identify human genetic variants implicated in multifactorial health risks. After the completion of the Human Genome Project in 2003, a wide range of stakeholders became committed to this “paradigm shift,” creating a confluence of investment, advocacy, and enthusiasm that bears all the marks of a “scientific/intellectual social movement” within biomedicine. Proponents (...) of this movement usually offer four ways in which their approach to medical diagnosis and health care improves upon current practices, arguing that it is more “personalized,” “predictive,” “preventive,” and “participatory” than the medical status quo. Initially, it was personalization that seemed to best sum up the movement's appeal. By 2012, however, powerful opinion leaders were abandoning “personalized medicine” in favor of a new label: “precision medicine.” The new label received a decisive seal of approval when, in January 2015, President Obama unveiled plans for a national “precision medicine initiative” to promote the development and use of genomic tools in health care. (shrink)

In addressing the question of what mental health is we might proceed as if there is a single phenomenon – mental health – denoted by a single overarching concept. The task, then, is to provide an informative analysis of this concept which applies to all and only instances of mental health, and which illuminates what it is to be mentally healthy. In contrast, mental health pluralism is the idea that there are multiple mental health phenomena (...) denoted by multiple concepts of mental health. Analysis and illumination of mental health may still be possible, but there isn’t a single phenomenon or concept to be analysed in addressing the question of what mental health is. The question of pluralism has been overlooked in the philosophy of mental health. The discussion to follow is an attempt to get us to take mental health pluralism seriously. To that end, in this essay I have three primary goals: (1) to give a precise account of what mental health pluralism is, (2) to show that the question of pluralism should not be neglected in debate about what mental health is, and (3) to argue for mental health pluralism. I also draw out some implications of this discussion for philosophy, science, and psychotherapy. (shrink)

This paper analyses the role chaplaincy plays in providing religious and spiritual care in the UK’s National Health Service. The approach considers both the current practice of chaplains and also the wider changes in society around beliefs and public service provision. Amid a small but growing literature about spirituality, health and illness, I shall argue that the role of the chaplain is changing and that such change is creating pressures on the identity and performance of the chaplain as (...) a religiously authorised health worker. I shall question whether either orthodox belief or religious belonging have any significant bearing on the patients’ demand for chaplaincy services. Utilising an example of chaplaincy work I shall argue that patient need constitutes the strongest platform for both practice development and an articulated understanding of what chaplains bring to health care. Drawing on a case study the definition and interpretation of spiritual need will be discussed in relation to chaplaincy practice. In conclusion, I shall set out the case for effective research to establish with greater precision the detail of the chaplain’s practice within a state-funded health system. (shrink)

abstract The argument that scarce health care resources should be distributed so that patients in ‘need’ are given priority for treatment is rarely contested. In this paper, we argue that if need is to play a significant role in distributive decisions it is crucial that what is meant by need can be precisely articulated. Following a discussion of the general features of health care need, we propose three principal interpretations of need, each of which focuses on separate intuitions. (...) Although this account may not be a completely exhaustive reflection of what people mean when they refer to need, the three interpretations provide a starting‐point for further debate of what the concept means in its specific application. We discuss combined interpretations, the meaning of grading needs, and compare needs‐based priority setting to social welfare maximisation. (shrink)

Medicine and health are surprisingly separate. In the introduction to his 1963 master work on medical economics, Kenneth Arrow acknowledged that “the subject is the medical-care industry, not health.” In the 50 years that followed, researchers, policymakers, and public health professionals generated valuable and varied insights into health, impacting both behaviors and environments while addressing social determinants and demographic trends. Yet medical care has followed an even steeper upward trajectory, growing rapidly in scientific precision, public (...) esteem, and technical sophistication.As a result, the economic gap between the two domains has widened. The U.S. health care system spends almost $3 trillion annually. Preventive screening and early intervention bridge medical care and health, as do nutrition, behavioral health, aging, and a few other fields. But the money is overwhelmingly in medical care, particularly rescue care for those with acute illnesses or serious complications of chronic disease. (shrink)

The standard approach to protecting privacy in healthcare aims to control access to personal information. We cannot regain control of information after it has been shared, so we must restrict access from the start. This ‘control’ conception of privacy conflicts with data-intensive initiatives like precision medicine and learning health systems, as they require patients to give up significant control of their information. Without adequate alternatives to the control-based approach, such data-intensive programmes appear to require a loss of privacy. (...) This paper argues that the control view of privacy is shortsighted and overlooks important ways to protect health information even when widely shared. To prepare for a world where we no longer control our data, we must pursue three alternative strategies: obfuscate health data, penalise the misuse of health data and improve transparency around who shares our data and for what purposes. Prioritising these strategies is necessary when health data are widely shared both within and outside of the health system. (shrink)

Electronic Health Records (EHRs) are organized around two kinds of statements: those reporting observations made, and those reporting acts performed. In neither case does the record involve any direct reference to what such statements are actually about. They record not: what is happening on the side of the patient, but rather: what is said about what is happening. While the need for a unique patient identifier is generally recognized, we argue that we should now move to an EHR regime (...) in which all clinically salient particulars – from the concrete disorder on the side of the patient and the body parts in which it occurs to the concrete treatments given – should be uniquely identified. This will allow us to achieve interoperability among different systems of records at the level where it really matters: in regard to what is happening in the real world. It will also allow us to keep track of particular disorders and of the effects of particular treatments in a precise and unambiguous way. We discuss the ontological and epistemological aspects of our claim and describe a scenario for implementation within EHR systems. (shrink)

One of the lessons of the COVID-19 pandemic is that the lay public relies immensely on the knowledge of public health officials. At every phase of the pandemic, the testimony of public health officials has been crucial for guiding public policy and individual behavior. The reason is simple: public health officials know a lot more than you and I do about public health. As lay people, we rely on experts. This seems straightforward. But the COVID-19 pandemic (...) has shown that public health officials seem undecided as to what, precisely, their role is; are they providing the public information as it presents itself, or are they informing the public in a way that produces a desired or optimal outcome? In this article, I answer the following question: what are public health officials morally obligated to tell the public? As I see it, these are the main options: (1) public health officials should tell the full truth, regardless of outcome; or (2) they should tell partial truths or lies that are aimed to promote a socially optimal outcome. My answer to this question is that public health officials are only allowed to lie under very narrow and rare conditions. -/- . (shrink)

Few now question that population health is significantly shaped by social ecology. Power, wealth, and social status clearly matter: Their enactment in daily life makes them fundamental social determinants of health. Important as it is that we accept the broad importance of social factors in health, it is not enough. Our current grasp of the importance of social factors in health has to be strengthened by research that more precisely delineates the workings of social health (...) through social processes, and the investment in research must in turn be vindicated by interventions that make a difference. The work presented in this issue of the Journal of Law, Medicine & Ethics is intended to advance the agenda for research and action.An ecological theory puts health everywhere. Population health is shaped in the hierarchies of the workplace, the neighborhood, and the home. (shrink)

Precision medicine is an emerging approach to individualized care. It aims to help physicians better comprehend and predict the needs of their patients while effectively adopting in a timely manner the most suitable treatment by promoting the sharing of health data and the implementation of learning healthcare systems. Alongside its promises, PM also entails the risk of exacerbating healthcare inequalities, in particular between ethnoracial groups. One often-neglected underlying reason why this might happen is the impact of structural racism (...) on PM initiatives. Raising awareness as to how structural racism can influence PM initiatives is paramount to avoid that PM ends up reproducing the pre-existing health inequalities between different ethnoracial groups and contributing to the loss of trust in healthcare by minority groups. We analyse three nodes of a process flow where structural racism can affect PM’s implementation. These are: the collection of biased health data during the initial encounter of minority groups with the healthcare system and researchers, the integration of biased health data for minority groups in PM initiatives and the influence of structural racism on the deliverables of PM initiatives for minority groups. We underscore that underappreciation of structural racism by stakeholders involved in the PM ecosystem can be at odds with the ambition of ensuring social and racial justice. Potential specific actions related to the analysed nodes are then formulated to help ensure that PM truly adheres to the goal of leaving no one behind, as endorsed by member states of the United Nations for the 2030 Agenda for Sustainable Development. Structural racism has been entrenched in our societies for centuries and it would be naïve to believe that its impacts will not spill over in the era of PM. PM initiatives need to pay special attention to the discriminatory and harmful impacts that structural racism could have on minority groups involved in their respective projects. It is only by acknowledging and discussing the existence of implicit racial biases and trust issues in healthcare and research domains that proper interventions to remedy them can be implemented. (shrink)

This reply addresses observations of Drs. Larsen, Kruse, and Sweeny, and Scherer in their reviews of our published work on the link between positive psychological assets and outcomes of physical health. Inspired by Obama’s Precision Medicine Initiative we argue that the interplay between the emotion spectrum and health is likely a complex and heterogeneous amalgam of known and yet unidentified elements melding at the individual level. When exploring the emotion–health link, researchers are challenged to grapple with (...) complex system models by considering multiple hierarchies of information that span individual-level factors, genetic blueprints, and cultural and environmental context. Research is needed to more fully elucidate the mechanism through which emotion influences health, with careful consideration of differences across race/ethnicity, culture, and context. (shrink)

Since the human genome was sequenced in 2003, exploding knowledge and new technologies in the field of genomics have given rise to the new field of precision medicine, whereby treatment is individualized to patients based on their genomic information. However, as with any new scientific advancement and technology, precision medicine has the potential to improve health outcomes but raises ethical questions, particularly in children. Using pediatric precision oncology as an example, this paper focuses on the ethical (...) issues in the integration of genomic information in the management of children with cancer. Pediatric precision oncology encompasses the use of the child’s cancer genomic information and sometimes germline genomic information to aid in diagnosis, risk stratification, and prognostication, as well as “precisely” treating the cancer using genomically guided targeted therapies. The main ethical issues discussed in this paper include the difficulty in obtaining informed consent from parents and assent from the child, due to information overload, emotional overwhelm, cognitive biases, among others; the ambiguity between research and clinical care, leading to therapeutic misconception and mis-estimation; the utility of this novel technology and its impact on scarce resources; and the potential to widen health disparities thus affecting justice. Recognizing and addressing these ethical challenges will help guide the responsible implementation and integration of precision medicine into routine pediatric clinical care. (shrink)

The everyday harms of structural racism and discrimination, perpetuated through institutions, laws, policies, and practices, constitute social determinants of health, but measures that account for their debilitating effects are largely missing in genetic studies of complex diseases. Drawing on insights from the social sciences and public health, we propose critical methodologies for incorporating tools that measure structural racism and discrimination within genetic analyses. We illustrate how including these measures may strengthen the accuracy and utility of findings for diverse (...) communities, clarify elusive relationships between genetics and environment in a racialized society, and support greater equity within genomics and precision health research. This approach may also support efforts to build and sustain vital partnerships with communities and with other fields of research inquiry, centering community expertise and lived experiences and drawing on valuable knowledge from practitioners in the social sciences and public health to innovate biomedical and genomic study designs aimed at community health priorities. (shrink)

Many countries currently invest in technologies and data infrastructures to foster precision medicine (PM), which is hoped to better tailor disease treatment and prevention to individual patients. But who can expect to benefit from PM? The answer depends not only on scientific developments but also on the willingness to address the problem of structural injustice. One important step is to confront the problem of underrepresentation of certain populations in PM cohorts via improved research inclusivity. Yet, we argue that the (...) perspective needs to be broadened because the (in)equitable effects of PM are also strongly contingent on wider structural factors and prioritization of healthcare strategies and resources. When (and before) implementing PM, it is crucial to attend to how the organisation of healthcare systems influences who will benefit, as well as whether PM may present challenges for a solidaristic sharing of costs and risks. We discuss these issues through a comparative lens of healthcare models and PM-initiatives in the United States, Austria, and Denmark. The analysis draws attention to how PM hinges on—and simultaneously affects—access to healthcare services, public trust in data handling, and prioritization of healthcare resources. Finally, we provide suggestions for how to mitigate foreseeable negative effects. (shrink)

Effectively addressing ethical issues in precision medicine research in Africa requires a holistic social contract that integrates biomedical knowledge with local cultural values and Indigenous knowledge systems. Drawing on African epistemologies such as ubuntu and ujamaa and on our collective experiences in genomics and big data research for sickle cell disease, hearing impairment, and fragile X syndrome and the project Public Understanding of Big Data in Genomics Medicine in Africa, we envision a transformative shift in health research data (...) governance in Africa that could help create a sense of shared responsibility between all stakeholders in genomics and data‐driven health research in Africa. This shift includes proposing a social contract for genomics and data science in health research that is grounded in African communitarianism such as solidarity, shared decision‐making, and reciprocity. We make several recommendations for a social contract for genomics and data science in health, including the coproduction of genomics knowledge with study communities, power sharing between stakeholders, public education on the ethical and social implications of genetics and data science, benefit sharing, giving voice to data subjects through dynamic consent, and democratizing data access to allow wide access by all research stakeholders. Achieving this would require adopting participatory approaches to genomics and data governance. (shrink)

In addressing the question of what mental health is we might proceed as if there is a single phenomenon—mental health—denoted by a single overarching concept. The task, then, is to provide an informative analysis of this concept which applies to all and only instances of mental health, and which illuminates what it is to be mentally healthy. In contrast, mental health pluralism is the idea that there are multiple mental health phenomena denoted by multiple concepts (...) of mental health. Analysis and illumination of mental health may still be possible, but there isn’t a single phenomenon or concept to be analysed in addressing the question of what mental health is. The question of pluralism has been overlooked in the philosophy of mental health. The discussion to follow is an attempt to get us to take mental health pluralism seriously. To that end, in this essay I have three primary goals: (1) to give a precise account of what mental health pluralism is, (2) to show that the question of pluralism should not be neglected in debate about what mental health is, and (3) to argue for mental health pluralism. I also draw out some implications of this discussion for philosophy, science, and psychotherapy. (shrink)

The emergence of a global industry of digital health platforms operated by Big Tech corporations, and its growing entanglements with academic and pharmaceutical research networks, raise pressing questions on the capacity of current data governance models, regulatory and legal frameworks to safeguard the sustainability of the health research ecosystem. In this article, we direct our attention toward the challenges faced by the European General Data Protection Regulation in regulating the potentially disruptive engagement of Big Tech platforms in (...) class='Hi'>health research. The General Data Protection Regulation upholds a rather flexible regime for scientific research through a number of derogations to otherwise stricter data protection requirements, while providing a very broad interpretation of the notion of “scientific research”. Precisely the breadth of these exemptions combined with the ample scope of this notion could provide unintended leeway to the health data processing activities of Big Tech platforms, which have not been immune from carrying out privacy-infringing and socially disruptive practices in the health domain. We thus discuss further finer-grained demarcations to be traced within the broadly construed notion of scientific research, geared to implementing use-based data governance frameworks that distinguish health research activities that should benefit from a facilitated data protection regime from those that should not. We conclude that a “re-purposing” of big data governance approaches in health research is needed if European nations are to promote research activities within a framework of high safeguards for both individual citizens and society. (shrink)

In this paper, we discuss how access to health-related data by private insurers, other than affecting the interests of prospective policy-holders, can also influence their propensity to make personal data available for research purposes. We take the case of national precision medicine initiatives as an illustrative example of this possible tendency. Precision medicine pools together unprecedented amounts of genetic as well as phenotypic data. The possibility that private insurers could claim access to such rapidly accumulating biomedical Big (...) Data or to health-related information derived from it would discourage people from enrolling in precision medicine studies. Should that be the case, the economic value of personal data for the insurance industry would end up affecting the public value of data as a scientific resource. In what follows we articulate three principles – trustworthiness, openness and evidence – to address this problem and tame its potentially harmful effects on the development of precision medicine and, more generally, on the advancement of medical science. (shrink)

Do doctors fix patients? Or do they heal them? For all of modern medicine’s many successes, discontent with the quality of patient care has combined with a host of new developments, from aging populations to the resurgence of infectious diseases, which challenge medicine’s overreliance on narrowly mechanistic and technical methods of explanation and intervention, or “fixing’ patients. The need for a better balance, for more humane “healing” rationales and practices that attend to the social and environmental aspects of health (...) and illness and the experiencing person, is more urgent than ever. Yet, in public health and bioethics, the fields best positioned to offer countervailing values and orientations, the dominant approaches largely extend and reinforce the reductionism and individualism of biomedicine. The collected essays in To Fix or To Heal do more than document the persistence of reductionist approaches and the attendant extension of medicalization to more and more aspects of our lives. The contributors also shed valuable light on why reductionism has persisted and why more holistic models, incorporating social and environmental factors, have gained so little traction. The contributors examine the moral appeal of reductionism, the larger rationalist dream of technological mastery, the growing valuation of health, and the enshrining of individual responsibility as the seemingly non-coercive means of intervention and control. This paradigm-challenging volume advances new lines of criticism of our dominant medical regime, even while proposing ways of bringing medical practice, bioethics, and public health more closely into line with their original goals. Precisely because of the centrality of the biomedical approach to our society, the contributors argue, challenging the reductionist model and its ever-widening effects is perhaps the best way to press for a much-needed renewal of our ethical and political discourse. (shrink)

Background Over the last decade, the return of results (ROR) in precision medicine research (PMR) has become increasingly routine. Calls for individual rights to research results have extended the “duty to report” from clinically useful genetic information to traits and ancestry results. ROR has thus been reframed as inherently beneficial to research participants, without a needed focus on who benefits and how. This paper addresses this gap, particularly in the context of PMR aimed at increasing participant diversity, by providing (...) investigator and researcher perspectives on and questions about the assumed value of ROR in PMR.Methods Semi-structured interviews with a purposive sample of investigators and researchers across federally funded PMR studies in three national consortia, as well as observations of study activities, focused on how PM researchers conceptualize diversity and implement inclusive practices across research stages, including navigating ROR.Results Interviewees (1) validated the value of ROR as a benefit of PMR, while others (2) questioned the benefit of clinically actionable results to individuals in the absence of sufficient resources for translating findings into health care for diverse and disadvantaged populations; (3) expressed uncertainties in applying the presumed value of ROR as a benefit for non-clinical results; and (4) and debated when the promise of the value of ROR may undermine trust in PMR, and divert efforts to return value beyond ROR.Conclusions Conceptualizations of diversity and inclusion among PM researchers and investigators raise unique ethical questions where unexamined assumptions of the value of ROR inform study recruitment efforts to enroll minoritized and under-represented populations. A lack of consideration for resources and infrastructure necessary to translate ROR into actionable information may hinder trustworthy community-research relationships. Thus, we argue for a more intentional interrogation of ROR practices as an offer of benefit and for whom. (shrink)

Policies that require male-female sex comparisons in all areas of biomedical research conflict with the goal of improving health outcomes through context-sensitive individualization of medical care. Sex, like race, requires a rigorous, contextual approach in precision medicine. A “sex contextualist” approach to gender-inclusive medicine better aligns with this aim.