Phoebe Friesen

ABSTRACT: Abilify MyCite was granted regulatory approval in 2017, becoming the world’s first “smart pill” that could digitally track whether patients had taken their medication. The new technology was introduced as one that had gained the support of patients and ethicists alike, and could contribute to solving the widespread and costly problem of patient nonadherence. Here, we offer an in-depth exploration of this narrative, through an examination of the origins and development of Abilify, the drug that would later become MyCite. This history illuminates how an antipsychotic can become a top-selling drug and maintain its blockbuster status for more than a decade. It also provides a detailed case study for how knowledge is constructed within the logic of biomedical capitalism, providing impetus to reexamine claims regarding how MyCite addresses patient nonadherence, engenders patient support, and is ethicist-approved.

This article identifies and examines a tension in mental health researchers’ growing enthusiasm for the use of computational tools powered by advances in artificial intelligence and machine learning (AI/ML). Although there is increasing recognition of the value of participatory methods in science generally and in mental health research specifically, many AI/ML approaches, fueled by an ever-growing number of sensors collecting multimodal data, risk further distancing participants from research processes and rendering them as mere vectors or collections of data points. The imperatives of the “participatory turn” in mental health research may be at odds with the (often unquestioned) assumptions and data collection methods of AI/ML approaches. This article aims to show why this is a problem and how it might be addressed.

This paper examines the controversial diagnosis of excited delirium, which is often employed after individuals die during an encounter with the police. Rather than asking the important, and widely explored, question of whether the diagnosis is real or not, here, we consider how it operates in the world and why it seems to stick around, despite growing controversy and resistance to its use. First, we consider the question of what kinds of people are made up through the diagnosis of excited delirium, exploring how racial stereotypes are exploited and certain behaviors are engendered through the illness script offered by excited delirium. Next, we ask what work excited delirium doing is doing in the world, unpacking how it tends to justify force and redirect responsibility, as well as who is it serving, and who is it not benefitting. Finally, we interrogate the slippery logic of excited delirium, examining how the way it is employed renders it non-falsifiable, and therefore impossible to uncover as real or unreal.

In lieu of an abstract, here is a brief excerpt of the content:Excited DeliriumFalsifiability, Causality, and the Importance of AdvocacyArjun Byju, MD (bio) and Phoebe Friesen, PhD (bio)We want to begin by thanking both Kathryn Petrozzo and Paul B. Lieberman for taking the time to read and respond to our article, “Making Up Monsters, Redirecting Blame: An Examination of Excited Delirium,” so thoughtfully. They each offered us an opportunity to consider dimensions of excited delirium that we had not encountered as of yet and encouraged us to think more carefully about them. In our response, we consider each of their commentaries in turn, given that, as a philosopher and a psychiatrist, they each speak to different aspects of our argument.First, we turn to Kathryn Petrozzo’s commentary “Excited Delirium: The Self-Fulfilling Prophecy of Police Brutality.” We are grateful for her generous comments and careful engagement with our arguments. While much of the commentary is supportive of our piece, Petrozzo makes three critical and insightful points that we hope to respond to here.The first point Petrozzo makes is that our assertion that excited delirium is non-falsifiable is not supported. She suggests that those “seeking to exonerate the police/first responders responsible for these deaths, are not accepting this evidence leading them to reject the excited delirium diagnosis, but rather, are crafting an incorrect causal narrative. This is deeply problematic, but it does not necessarily render excited delirium as nonfalsifiable.”Although we are intrigued by this challenge, we would like to hear more about what it would look like to falsify the phenomenon of excited delirium. The way that the causal theories related to it are structured are such that if one causal factor is not present (e.g., drug use), then another causal factor can be located (e.g., mental health), and if that is not found, another may be simply made up (e.g., genetic predisposition), making excited delirium multiply realizable in a seemingly endless fashion. This is precisely what took place in the case of Anthany Dawson, who was initially said to have been experiencing a mental health crisis, but was later said to have died from excited delirium related to a genetic condition never identified before (Hon, 2004; Razack, 2015). [End Page 361]In practice, confirmations of excited delirium are found on the basis of various unrelated factors, such that after a death involving police force, there is almost always the option to reach for excited delirium as an explanation/exoneration. According to proponents, there is no factor that could be present that could rule out the diagnosis of excited delirium as it is currently constructed. Indeed, even in the presence of video evidence showing police officers choking an individual until they stop breathing, these deaths are still attributed to excited delirium. This seems like a clear instance of non-falsifiability.Although Petrozzo might maintain that this is simply “an incorrect causal narrative,” it is a causal narrative that aligns with the current theoretical scaffolding surrounding excited delirium.The second point Petrozzo makes is regarding widespread criticisms of Popper’s demarcation criterion of falsifiability. Indeed, this criterion has been called too inclusive, in that any empirical claim can be called falsifiable in principle—even if it refers to a future apocalypse or a UFO landing. It has also been criticized for being too exclusive, in that it ignores the “remarkable tenacity of scientific theories,” as Lakatos puts it (2009, p. 516). In practice, scientists do not merely abandon a theory if it is not supported by facts; they tend to find other explanations (e.g., the measurement was faulty) rather than accept an instance of falsification.Despite this, we believe it is still worth discussing falsifiability in the context of excited delirium for two reasons. First, while falsifiability may not be successful as a criterion that draws a line between science and pseudoscience, in this case, we argue, it still works well as a signifier of pseudoscience. Recently, many interested in the demarcation question have turned towards pluralism as a way to identify pseudoscientific practices (Pigliucci & Boudry, 2013). And excited delirium offers an excellent example of a phenomenon that bumps up against many of the features that might indicate a pseudoscientific practice...

Urban communities experiencing marginalization often disproportionately bear the risks and burdens of research and are left out of research ethics governance processes. To address this, many communities have created place-based and community-led research ethics governance initiatives to ensure that community voice is included in discussions surrounding research conduct. Place-based strategies in the Vancouver Downtown Eastside, the Bronx, and the Philadelphia Promise Zone successfully mobilize community perspectives in research ethics, filling in a significant gap in our current system of institutional research ethics review and oversight. These cases demonstrate that place-based research ethics governance has the potential to account for the community-level risks posed by research projects and to ensure communities receive more felt benefits. Place-based communities sidestep simplistic notions of identity based on single shared features and make space for intersectional analyses and diverse community viewpoints to be considered. Such communities have a unique claim to expertise given their shared experience of place, which grants them the ability to see problematic assumptions embedded in scientific projects as well as community-level concerns within research. Despite this, many marginalized communities are excluded from current research ethics oversight processes. This exclusion demands critical examination and a way forward to facilitate the integration of place-based community oversight strategies within research ethics governance.

Racial disparities in pain treatment are well documented. Such disparities are explained with reference to factors related to providers, health care structures, and patient behaviors. Racial differences in pain experiences, although well documented, are less well understood. Explanations for such differences usually involve genetic or psychological factors. Here, we argue that racial differences in pain experiences might also be explained by disparities in pain treatment. Based on what we know about the nature of pain, particularly the cognitive and affective aspects of the phenomenon, it is likely that disparities in the treatment of racialized patients can lead to significant racial differences in pain experience that show up at the population level. We argue that the failure of research programs to consider this causal factor is an example of white ignorance. We also consider several implications of the link between racial disparities in pain treatment and racial differences in pain experience.

Population-level biomedical research offers new opportunities to improve population health, but also raises new challenges to traditional systems of research governance and ethical oversight. Partly in response to these challenges, various models of public involvement in research are being introduced. Yet, the ways in which public involvement should meet governance challenges are not well understood. We conducted a qualitative study with 36 experts and stakeholders using the World Café method to identify key governance challenges and explore how public involvement can meet these challenges. This brief report discusses four cross-cutting themes from the study: the need to move beyond individual consent; issues in benefit and data sharing; the challenge of delineating and understanding publics; and the goal of clarifying justifications for public involvement. The report aims to provide a starting point for making sense of the relationship between public involvement and the governance of population-level biomedical research, showing connections, potential solutions and issues arising at their intersection. We suggest that, in population-level biomedical research, there is a pressing need for a shift away from conventional governance frameworks focused on the individual and towards a focus on collectives, as well as to foreground ethical issues around social justice and develop ways to address cultural diversity, value pluralism and competing stakeholder interests. There are many unresolved questions around how this shift could be realised, but these unresolved questions should form the basis for developing justificatory accounts and frameworks for suitable collective models of public involvement in population-level biomedical research governance.

Background Institutional Review Boards (IRBs) are federally mandated to include both nonscientific and unaffiliated representatives in their membership. Despite this, there is no guidance or policy on the selection of unaffiliated or non-scientist members and reports indicate a lack of clarity regarding members’ roles. In the present study we sought to explore processes of recruitment, training, and the perceived roles for unaffiliated and non-scientist members of IRBs.Methods We distributed a self-administered REDCap survey of members of the Association for the Accreditation of Human Research Protection Programs familiar with IRB member recruitment. The survey included closed and open-ended questions regarding: the operation of the HRPP/IRB(s), how unaffiliated and non-scientist members are recruited, whether they had faced challenges recruiting for these roles, and training and mentorship offered. The survey also collected information regarding the perceived value and roles of unaffiliated and non-scientist members.Results 76 responses were included in the analysis (38% completion rate). The most common approach for recruitment was referral from current IRB members, with almost half of respondents indicating challenges recruiting unaffiliated members. Over 75% indicated no additional training was provided to unaffiliated or non-scientist members compared to affiliated or scientist members. Most common supports provided were travel/parking expenses and honoraria. Commonly perceived roles were to provide an independent voice from the participant perspective, notably regarding consent processes and materials.Conclusions Respondents indicated challenges in defining unaffiliated and non-scientist members and limited practices toward recruitment and support. Future work should more closely examine the challenges in defining these roles and applying the definitions in practice, as well as strategies that may improve recruitment and retention of unaffiliated and non-scientist members.

As participatory research practices are increasingly taken up in health research, claims related to experiential authority and expertise are frequently made. Here, in an exploration of what grounds such claims, we consider how feminist standpoint theory might apply to the psy sciences (psychiatry, psychology, psychotherapy, psychoanalysis, and so on). Standpoint theory claims that experiences of marginalization and critical engagement can lead to a standpoint that offers an epistemic advantage within a domain of knowledge. We examine experiences of marginalization and critical engagement in the mental health system, as well as evidence for epistemic advantages resulting from these experiences. This evidence, found in the identification of problematic assumptions and the development of new tools and theories in the field, grounds our argument that standpoint theory is indeed relevant to the psy sciences and that many of those who have experienced marginalization and have engaged critically have an epistemic advantage when it comes to knowledge-production. The implications of this argument are significant: those who have attained a standpoint within the psy sciences ought to be included in research and given both tools and funding to develop research programs. However, we must be wary of the risks of tokenization, cooptation, and essentialization that are likely to accompany such a transformation.

Institutional review boards, tasked with facilitating ethical research, are often pulled in competing directions. In what we call the protection-inclusion dilemma, we acknowledge the tensions IRBs face in aiming to both protect potential research participants from harm and include under-represented populations in research. In this manuscript, we examine the history of protectionism that has dominated research ethics oversight in the United States, as well as two responses to such protectionism: inclusion initiatives and critiques of the term vulnerability. We look at what we know about IRB decision-making in relation to protecting and including “vulnerable” groups in research and examine the lack of regulatory guidance related to this dilemma, which encourages protection over inclusion within IRB practice. Finally, we offer recommendations related to how IRBs might strike a better balance between inclusion and protection in research ethics oversight.

During the COVID-19 pandemic, several hospitals implemented “birthing alone” policies, banning companions from accompanying individuals giving birth. We offer an ethical analysis of these policies. First, we examine them through a consequentialist framework of risks and benefits. Second, we consider the significance of birth, highlighting the unique ways in which risks, relationships, and rights are understood in the context of obstetrics. We conclude that birthing alone policies are largely unjustified, as the harm they are certain to cause outweighs their possible benefits and because they fail to take into account what matters to mothers.

Well before the COVID-19 pandemic, proponents of digital psychiatry were touting the promise of various digital tools and techniques to revolutionize mental healthcare. As social distancing and its knock-on effects have strained existing mental health infrastructures, calls have grown louder for implementing various digital mental health solutions at scale. Decisions made today will shape the future of mental healthcare for the foreseeable future. We argue that bioethicists are uniquely positioned to cut through the hype surrounding digital mental health, which can obscure crucial ethical and epistemic gaps that ought to be considered by policymakers before committing to a digital psychiatric future. Here, we describe four such gaps: The evidence gap, the inequality gap, the prediction-intervention gap, and the safety gap.

BackgroundEthics review is the process of assessing the ethics of research involving humans. The Ethics Review Committee (ERC) is the key oversight mechanism designated to ensure ethics review. Whether or not this governance mechanism is still fit for purpose in the data-driven research context remains a debated issue among research ethics experts.Main textIn this article, we seek to address this issue in a twofold manner. First, we review the strengths and weaknesses of ERCs in ensuring ethical oversight. Second, we map these strengths and weaknesses onto specific challenges raised by big data research. We distinguish two categories of potential weakness. The first category concerns persistent weaknesses, i.e., those which are not specific to big data research, but may be exacerbated by it. The second category concerns novel weaknesses, i.e., those which are created by and inherent to big data projects. Within this second category, we further distinguish between purview weaknesses related to the ERC’s scope (e.g., how big data projects may evade ERC review) and functional weaknesses, related to the ERC’s way of operating. Based on this analysis, we propose reforms aimed at improving the oversight capacity of ERCs in the era of big data science.ConclusionsWe believe the oversight mechanism could benefit from these reforms because they will help to overcome data-intensive research challenges and consequently benefit research at large.

Advancements in novel neurotechnologies, such as brain computer interfaces and neuromodulatory devices such as deep brain stimulators, will have profound implications for society and human rights. While these technologies are improving the diagnosis and treatment of mental and neurological diseases, they can also alter individual agency and estrange those using neurotechnologies from their sense of self, challenging basic notions of what it means to be human. As an international coalition of interdisciplinary scholars and practitioners, we examine these challenges and make recommendations to mitigate negative consequences that could arise from the unregulated development or application of novel neurotechnologies. We explore potential ethical challenges in four key areas: identity and agency, privacy, bias, and enhancement. To address them, we propose democratic and inclusive summits to establish globally-coordinated ethical and societal guidelines for neurotechnology development and application, new measures, including “Neurorights,” for data privacy, security, and consent to empower neurotechnology users’ control over their data, new methods of identifying and preventing bias, and the adoption of public guidelines for safe and equitable distribution of neurotechnological devices.

Many are calling for concrete mechanisms of oversight for health research involving artificial intelligence (AI). In response, institutional review boards (IRBs) are being turned to as a familiar model of governance. Here, we examine the IRB model as a form of ethics oversight for health research that uses AI. We consider the model's origins, analyze the challenges IRBs are facing in the contexts of both industry and academia, and offer concrete recommendations for how these committees might be adapted in order to provide an effective mechanism of oversight for health‐related AI research.

A recent systematic review of Machine Learning (ML) approaches to health data, containing over 100 studies, found that the most investigated problem was mental health (Yin et al., 2019). Relatedly, recent estimates suggest that between 165,000 and 325,000 health and wellness apps are now commercially available, with over 10,000 of those designed specifically for mental health (Carlo et al., 2019). In light of these trends, the present chapter has three aims: (1) provide an informative overview of some of the recent work taking place at the intersection of text mining and mental health so that we can (2) highlight and analyze several pressing ethical issues that are arising in this rapidly growing field and (3) suggest productive directions for how these issues might be better addressed within future interdisciplinary work to ensure the responsible development of text mining approaches in psychology generally, and in mental health fields, specifically. In Section 1, we review some of the recent literature on text-mining and mental health in the contexts of traditional experimental settings, social media, and research involving electronic health records. Then, in Section 2, we introduce and discuss ethical concerns that arise before, during, and after research is conducted. Finally, in Section 3, we offer several suggestions about how ethical oversight of text-mining research might be improved to be more responsive to the concerns mapped out in Section 2.

There is compelling evidence that pain experience is influenced by cognitive states. We explore one specific form of such influence, namely placebo analgesia, and examine its relevance for the cognitive penetration debate in philosophy of mind. We single out as important a form of influence on experience that we term radical cognitive penetration, and argue that some cases of placebo analgesia constitute compelling instances of this phenomenon. Still, we urge caution in extrapolating from this to broader conclusions about cognitive penetration in perceptual experience. Instead, we suggest that the cognitive penetration of pain raises distinctive psychological, epistemological, and ethical issues.

When it comes to using patient data from the National Health Service for research, we are often told that it is a matter of trust: we need to trust, we need to build trust, we need to restore trust. Various policy papers and reports articulate and develop these ideas and make very important contributions to public dialogue on the trustworthiness of our research institutions. But these documents and policies are apparently constructed with little sustained reflection on the nature of trust and trustworthiness, and therefore are missing important features that matter for how we manage concerns related to trust. We suggest that what we mean by ‘trust’ and ‘trustworthiness’ matters and should affect the policies and guidance that govern data sharing in the NHS. We offer a number of initial, general reflections on the way in which some of these features might affect our approach to principles, policies and strategies that are related to sharing patient data for research. This paper is the outcome of a ‘public ethics’ coproduction activity which involved members of the public and two academic ethicists. Our task was to consider collectively the accounts of trust developed by philosophers as they applied in the context of the NHS and to coproduce an argumentative position relevant to this context.

The practice of medically assisted dying has long been contentious, and the question of what to call it has become increasingly contentious as well. Particularly among U.S. proponents of legalizing the practice, there has been a growing push away from calling it “physician‐assisted suicide,” with assertions that medically assisted dying is fundamentally different from suicide. Digging deeper into this claim about difference leads to an examination of the difference between two kinds of suffering—suffering from physical conditions and suffering from psychological conditions—and therefore leads also toward an examination of whether requests for medical assistance in dying by those suffering from psychological conditions and those suffering from physical conditions should be painted with the same brush. In this article, I aim both to illuminate some of the considerations that ought to be included in discussions related to medically assisted dying and to shed light on what the indirect effects of such discussions can be. I consider some of the reasons commonly given for holding that suicide and medically assisted dying differ fundamentally and then whether the conclusion that medically assisted dying should not be called “suicide” follows from the premises. I ask what else might justify the conclusion that the two acts ought to be called by different names, and I examine possible justifications for accepting this premise, as well as what justifications might exist for emphasizing how the acts are alike. Finally, I argue that we should be cautious before concluding that medically assisted dying should not be called “suicide.” We need more evidence either that the two acts are fundamentally different or that emphasizing differences between them is not likely to do more harm than good.

This paper offers a critical analysis of several accounts of the placebo effect that have been put forward. While the placebo effect is most often thought of as a control in research and as a deceptive tool in practice, a growing body of research suggests that it ought to be thought of as a powerful phenomenon in its own right. Several accounts that aim to draw boundaries around the placebo effect are evaluated in relation to current evidence and it is argued that none of them adequately capture the variability and potency of the phenomenon. Two accounts, however, that point towards the underlying mechanisms of the placebo effect, are shown to offer promise in terms of developing a more comprehensive account of the placebo effect.

In the introduction to a recent anthology of contemporary issues in philosophy of psychiatry, editors Jeffrey Poland and Şerife Tekin declare this to be a moment of crisis within the field. They suggest that the state of psychiatry today reflects Thomas Kuhn's conception of a period of extraordinary science, which occurs when anomalies begin to build up, confidence in the dominant paradigm is shook, competing theories arise, and philosophical questions come to the fore. Although perhaps not all would agree that the field is in crisis, there is certainly an abundance of pessimism. Within the realm of research, a mood of explanatory pessimism has been growing, characterized by a...