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.

This paper develops the conceptual framework of ’sex contextualism’ for the study of sex-related variables in biomedical research. Sex contextualism offers an alternative to binary sex essentialist approaches to the study of sex as a biological variable. Specifically, sex contextualism recognizes the pluralism and context-specificity of operationalizations of ’sex’ across experimental laboratory research. In light of recent policy mandates to consider sex as a biological variable, sex contextualism offers constructive guidance to biomedical researchers for attending to sex-related (...) class='Hi'>biological variation. As an alternative to and critique of biological binary sex essentialism, sex contextualism contributes to current debates in philosophy of biology, feminist science studies, and social ontology on the construction of categories of gender/sex differences in scientific research. (shrink)

As COVID-19 keeps impacting the world, its impact is felt differently by people of different sexes and genders. International guidelines and research on gender inequalities and women’s rights during the pandemic have been published. However, data from Taiwan is lacking. This study aims to fill the gap to increase our knowledge regarding this issue and provide policy recommendations. This study is part of a more extensive project in response to the fourth state report concerning the implementation of the Convention on (...) the Elimination of All Forms of Discrimination against Women in Taiwan in 2022. We have drawn on the guidelines and documents published by the United Nations human rights bodies, conducted interviews with advocacy and professional practitioners, and hosted a study group comprising students and teachers from the National Taiwan University College of Public Health to supplement the interview data. The data were analyzed thematically. The results include five themes: (1) particular health risks to carers (primarily women); (2) COVID-related measures’ impact on women’s health and health behaviors; (3) highly gendered psychological maladjustment; (4) increase in gender-based violence and domestic violence; and (5) mental health inequities and intersectionality. The study has global implications for societies of similar sociopolitical contexts and developmental statuses. To truly live up to the standard of CEDAW and other international human rights principles, we ask that central and local government be more aware of these lived experiences and adjust their policies accordingly, accounting for gender sensitivity. (shrink)

A major challenge in neuroscience is to understand what happens to a brain as it ages. Such insights could make it possible to distinguish between individuals who will undergo typical aging and those at risk for neurodegenerative disease. Over the last quarter century, thousands of human brain imaging studies have probed the neural basis of age-related cognitive decline. “Aging” studies generally enroll adults over the age of 65, a historical precedent rooted in the average retirement age of U.S. wage-earners. A (...) consequence of this research tradition is that it overlooks one of the most significant neuroendocrine changes in a woman’s life: the transition to menopause. The menopausal transition is marked by an overall decline in ovarian sex steroid production – up to 90% in the case of estradiol – a dramatic endocrine change that impacts multiple biological systems, including the brain. Despite sex differences in the risk for dementia, the influence that biological sex and sex hormones have on the aging brain is historically understudied, leaving a critical gap in our understanding of the aging process. In this Perspective, we highlight the influence that endocrine factors have on the aging brain. We devote particular attention to the neural and cognitive changes that unfold in the middle decade of life, as a function of reproductive aging. Next, we consider emerging evidence from animal and human studies that other endocrine factors occurring earlier in life (e.g. pregnancy, hormonal birth control use) also shape the aging process. Applying a women’s health lens to. (shrink)

Women’s access to health and medicine in developed countries has been characterized by a range of inconsistent inclusions and exclusions. Health policy has been asymmetrically interested in women’s reproductive capacities and has sought to regulate, control, and manage aspects of women’s reproductive decision making in a manner unwitnessed in relation to men’s reproductive health and reproductive decision making. In other areas, research that addresses health concerns that affect both men and women sometimes is designed so as not to yield data (...) relating to the ways in which women’s physiology and gendered location may affect their experience of the condition and its response to treatment, despite a literature on the significance of sex and gender differences in health research. This paper draws on the situation in Australia to explore the ethical significance of these inconsistencies as failing the ideals of high-quality medical research and evidenced-based health care. (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)

Past research finds that after menopause some women experience negative changes such as vaginal dryness, decreased libido, and decreased orgasm quality; very little research inquires about positive changes. In contrast, this study shifts the research focus from whether women experience menopausal changes to how women view any changes in sex life. Based on 30 in-depth interviews with heterosexual and lesbian women, the author finds that most women emphasize cultural and social issues, such as relationship status and quality, health, and sexual (...) history, rather than menopausal changes when they describe sex after menopause. However, she finds a difference by sexual orientation in how women handle problems in sex. The author concludes by discussing the implication of this research for future menopause and sex research; most important, she emphasizes studying sex in the context of women's lives rather than as a result of the biological changes of menopause. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Women and Health Research:A Report from the Institute of MedicineAnna C. Mastroianni (bio), Ruth Faden (bio), and Daniel Federman (bio)In recent years, claims have been made by segments of the research community and by women's health advocacy groups that clinical research practices and policies have not benefitted women's health to the same extent as men's health. Central to these claims has been an assertion that women have (...) been inadequately represented as subjects of clinical studies and that as a result neither health conditions unique to women—e.g., menopause—nor women's manifestations of health problems affecting both sexes—e.g., heart disease—have been investigated sufficiently.The scientific community, including federal agencies that sponsor and regulate clinical studies, is increasingly responsive to these claims and is taking steps to raise the level of women's participation in clinical studies. Controversy and concern have surrounded these actions, however. Two of the claims that have been made are: (1) that women are more difficult to study than men because of their cyclical hormonal changes; and (2) that conducting gender-specific subgroup analyses would increase the size of study populations, raise the cost of studies, and thereby reduce the number of studies that could be performed with the limited resources available. In addition, controversy over the inclusion of women of childbearing potential and pregnant women has been particularly salient. Concerns have been expressed about avoiding potential harm to existing or potential fetuses and about the possible legal and financial ramifications of such harm. A further concern involves the perceived difficulties in enrolling women in studies and retaining them for the duration of the studies.Against this backdrop, the Office of Research on Women's Health at the National Institutes of Health (NIH) asked the Institute of Medicine (IOM) in October 1992 to establish the Committee on the Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies. The Committee's charge was to: (1) consider the ethical and legal implications of including women, particularly pregnant women and women of childbearing potential, in clinical studies; (2) examine known instances of litigation regarding injuries to research subjects [End Page 55] and describe existing legal liabilities and protections; and (3) provide practical advice on these issues for consideration by NIH, institutional review boards (IRBs), and clinical investigators.The 16 Committee members came from diverse backgrounds: bioethics, law, epidemiology and biostatistics, public health policy, obstetrics and gynecology, clinical research, pharmaceutical development, social and behavioral sciences, and clinical evaluative sciences.1 Chaired by two of the authors of this article, Ruth Faden and Daniel Federman, and coordinated by the third, IOM Study Director Anna Mastroianni, the Committee met five times over a fourteen-month period, convened a one-and-one-half day invitational workshop, and commissioned several background papers. The Committee's deliberations were complicated by the announcement of new federal policies late in its term. Specifically, the Food and Drug Administration (FDA) issued guidelines (FDA 1993) to replace its 1977 guidelines, which prohibited the inclusion of women of childbearing potential in early phases of most clinical drug trials. In addition, Congress passed the NIH Revitalization Act of 1993 (P.L. 103-43), which contains provisions mandating the inclusion of women and racial and ethnic minorities in NIH-sponsored clinical research. In February 1994, the IOM Committee publicly issued its final report and recommendations, Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, publishing the workshop presentations and commissioned papers in a separate volume.Deliberations of the CommitteeA number of issues arose at the outset as the Committee considered its charge. A few members initially believed that verification of the underrepresentation of women relative to men in clinical studies as a whole was a prerequisite to providing policy recommendations. Others believed that such an examination would be an important contribution to the knowledge base, but that it was not necessary for addressing the Committee's charge. As summarized in the Committee's report, the Committee's research indicated that firm conclusions about the relative underrepresentation of women could not be drawn from the available data because of the lack of systematic information... (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)

Numerous issues confront women's healthcare today, among them the medicalization of women's bodies, cosmetic genital surgery, violence against women, HIV, perinatal mental health disorders. This volume uniquely explores such difficult topics and others at the intersection of clinical practice, policy, and bioethics in women's health care through a feminist ethics lens. With in-depth discussions of issues in women's reproductive health, it also broadens scholarship by responding to a wider array of ethical challenges that many women experience (...) in accessing health care. Contributions touch on many themes previously tackled by feminist ethics, but in new, contemporary ways. Some chapters expand into new fields in the bioethics literature, such as the ethical issues related to the care of Indigenous women, uninsured refugees and immigrants, women engaged in sex work, and those with HIV at different life stages and perinatal mental health disorders. Authors seek to connect theory and practice with users of the health system by including women's voices in their research. Bringing to bear their experience in active clinical practice in medicine, nursing, and ethics, the authors contemplate new conceptual approaches to important issues in women's healthcare, and make ethical practice recommendations for those grappling with these issues. Topical and up-to-date, this book provides a valuable resource for physicians, nurses, clinical ethicists, and researchers working in some of the most critical areas of women's health and applied ethics today. (shrink)

Precision medicine promises to develop diagnoses and treatments that take individual variability into account. According to most specialists, turning this promise into reality will require adapting the established framework of clinical research ethics, and paying more attention to participants’ attitudes towards sharing genotypic, phenotypic, lifestyle data and health records, and ultimately to their desire to be engaged as active partners in medical research.Notions such as participation, engagement and partnership have been introduced in bioethics debates concerning genetics and large-scale biobanking (...) to broaden the focus of discussion beyond individual choice and individuals’ moral interests. The uptake of those concepts in precision medicine is to be welcomed. However, as data and medical information from research participants in precision medicine cohorts will be collected on an individual basis, translating a participatory approach in this emerging area may prove cumbersome. Therefore, drawing on Joseph Raz’s perfectionism, we propose a principle of respect for autonomous agents that, we reckon, can address many of the concerns driving recent scholarship on partnership and public participation, while avoiding some of the limitations these concept have in the context of precision medicine. Our approach offers a normative clarification to how becoming partners in precision is compatible with retaining autonomy.Realigning the value of autonomy with ideals of direct engagement, we show, can provide adequate normative orientation to precision medicine; it can do justice to the idea of moral pluralism by stressing the value of moral self-determination: and, finally, it can reconcile the notion of autonomy with other more communitarian values such as participation and solidarity. (shrink)

The first world wide symposium on the topic of gender-specific medicine provided the latest research on differences in sex and/or gender in medicine and medical care. The presentations ranged beyond the topic of reproduction to encompass the entire human organism. This report critically reviews three issues that emerged during the Conference: gender mainstreaming, the concept of sex/gender differences and the issue of men's health. It suggests that the interdisciplinary concept of gender-specific medicine has to be mirrored by the integration of (...) social and cultural studies into medical research and practice. (shrink)

Federal law often avoids setting minimum standards for women’s health and reproductive rights issues, leaving legislative and regulatory gaps for the states to fill as they see fit. This has mixed results. It can lead to state innovation that improves state-level health outcomes, informs federal health reform, and provides data on best practices for other states. On the other hand, some states may use the absence of a federal floor to impose draconian policies that pose risks to women’s and maternal (...) health. Health reforms at the federal level must trod carefully to enable state innovation, while imposing foundational safeguards for promoting women’s health nationwide. (shrink)

Although precision medicine cuts across a large spectrum of professions, interdisciplinary and cross-sectorial moral deliberation has yet to be widely enacted, let alone formalized in this field. In a recent research project on precision medicine, we designed a dialogical forum (i.e. ‘the Ethics Laboratory’) giving interdisciplinary and cross-sectorial stakeholders an opportunity to discuss their moral conundrums in concert. We organized and carried out four Ethics Laboratories. In this article, we use Simone de Beauvoir’s concept of moral ambiguity as (...) a lens to frame the participants’ experience with fluid moral boundaries. By framing our approach through this concept we are able to elucidate irremediable moral issues that are collectively underexplored in the practice of precision medicine. Moral ambiguity accentuates an open and free space where different types of perspectives converge and can inform each other. Based on our study, we identified two dilemmas, or thematic interfaces, in the interdisciplinary moral deliberations which unfolded in the Ethics Laboratories: (1) the dilemma between the individual and the collective good; and (2) the dilemma between care and choice. Through our investigation of these dilemmas, we show how Beauvoir’s concept of moral ambiquity not only serves as a fertile catalyst for greater moral awareness but, furthermore, how the concept can become an indispensable part of the practices of and the discourse about precision medicine. (shrink)

From the end of the First World War, a broad discussion took place within the framework of the revived German constitutional teaching on the question of the physical normality of man. The founder of the so-called statistical concept of normality, which preceded the still widespread normal (reference) interval concept, is H. Rautmann, who gave it the character of a tool for discriminating between health and disease. Among some of his successors (Bauer, Borchardt, Günther), however, it was considered more a means (...) of establishing a type, without supposing any precise relation between the frequency of a character in the population and the probability of the occurrence of disease. The concept of a statistical norm as a certain region of the variation range of a character determined by the parameters of Gaussian distribution was criticized both by the supporters of the ideal norm (Hildebrandt) and those who were in favour of a ‘personal’ norm (Grote). The underlying motifs of these three conceptions of normality influenced German constitutional doctrine until after the end of the Second World War, but without a satisfactory solution to the diagnosis of physical normality being found. Since the 1950s, world medicine has moved more and more in the direction of prevention, with the emphasis on a study of individual dispositions to disease and its precursors. In this connection a new view of health has gained importance whereby it is considered a smoothly gradated condition, not sharply distinguished from disease (‘continual’ model of health and disease as opposed to the previous ‘alternative’ model). The purpose of diagnostic characters is no longer merely to place patients in clearly defined categories as healthy or affected by one disease or another, but has taken on the function of indices of the disposition to disease among those who exhibit ‘gross normality’. Discrimination between the alternative and continuous models allows a clarification to be made of the sources of the confusion in which the pre-war concept of statistical normality had found itself. Today many exceptions are known to the rule that the functional optimum lies in the region of the population mean, both for the population as a whole and for individuals; and immense variability has been found in the manner in which individuals in the population attain health. Thus a distinction between health and disease by statistical means alone (such as establishing some sort of species design) is not possible at all. The ideal of a personal norm is pursued today through the concept of a multivariate norm backed up by modern data processing methods, though it was anticipated in principle by Kaup even in the 1920s. CiteULike Connotea Del.icio.us What's this? (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)

Contemporary processes of globalization have been accompanied by a serious deterioration in the health of many women across the world. Particularly disturbing is the drastic decline in the health status of many women in the global South, as well as some women in the global North. This paper argues that the health vulnerability of women in the global South is inseparable from their political and economic vulnerability. More specifically, it links the deteriorating health of many Southern women with the neo-liberal (...) economic policies that characterize contemporary economic globalization and argues that this structure is sustained by the heavy burden of debt repayments imposed on many Southern countries. In conclusion, it argues that many Southern debt obligations are not morally binding because they are not democratically legitimate. (shrink)

This is a response to a short communication on our research presented in Solbrække et al. (Med Health Care Philos 20(1):89–103, 2017), which raises a series of serious allegations. Our article explored the rise of ‘the breast cancer gene’ as a field of medical, cultural and personal knowledge. We used the concept biological citizenship to elucidate representations of, and experiences with, hereditary breast cancer in a Norwegian context, addressing a research deficit. In our response to Møller and Hovig’s (Med (...) Health Care Philos 21(2):239–242, 2018a) opinionated piece, we start by questioning on which scientific grounds they base their knowledge claims and situate their criticism in a pre-determined positivist script, which exposes their incompetency when it comes to establishing a useful critique of our research. We tie this to an attitude of scientific supremacy, which reduces the complexity and specificity of different knowledges into a clichéd divide between ‘hard evidence’ and ‘fiction’—presented in a predictable narrative which seeks to establish research protagonists and antagonists. We elaborate on the rationale of our qualitative approach to analyzing and interpreting situated and mediated aspects of BRCA 1/2. We counter claims that our research does harm to patients. We refer to a medical scandal emerging from Norway where 21 women were wrongfully diagnosed and surgically treated for a mis-interpreted cancer gene mutation. In conclusion, we stand by the integrity of our research as reported in the original paper. Scientific supremacy and pre-scripted criticism impose considerable obstacles for the possibility of establishing interdisciplinary dialogue across knowledge paradigms in health care and medicine. We therefore urge readers to reflect on how we can establish and sustain ethically careful and truthful dialogue—without doing violence to epistemological differences—to protect and advance the interdisciplinarity that constitutes the journal’s scope. (shrink)

A qualitative and quantitative understanding of disease variables in relation to local understandings and values is an important dimension that broadens traditional evidence-based medicine (EBM) and is necessary in order to navigate the social perspectives of policymakers. There are dimensions of this research that share the values and practices of feminist research. This paper offers an epistemological analysis of theory and practice that can provide more effective outcomes in women’s health. PATH (Policy Advisory Towards Health) for women, bridges the knowledge (...) gap between research and direct service by providing translational support for community organizations’ legislative policy agendas. (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)

Empirical evidence confirms the existence of health inequalities between women and men in developing countries, with women experiencing poorer health status than men, as well as less access to vital health services. These disparities have different sources and take different forms, some of which result from cultural factors, others from discriminatory laws and practices, and still others from the biological fact that only women undergo pregnancy and childbirth, a major cause of maternal mortality. The injustice lies in the fact (...) that many of these disparities result from socially controllable factors, while others could be remedied, especially in cases of violations of human rights. Past and recent policies and practices of the United States Government can be faulted for both actions and omissions that have contributed to such inequalities. Different conceptions of global justice are explored, with implications for who owes what to whom regarding these disparities. (shrink)

Background It has been well documented that patients can feel abused in health care and that many patients suffer from these experiences. Insight lacks into contributing factors behind such events. Silence surrounding the abuse has been suggested as a possible mechanism. The present study explores silence surrounding the abuse as a possible contributing factor. We have explored whether this silence is connected with the staff’s hierarchical position and with the staff’s own experiences as patients abused in health care. Methods During (...) January 2008, a paper questionnaire was sent to all staff members at a Swedish women’s clinic. The questionnaire included questions on sociodemography and profession and multiple questions about abuse in health care. After univariate testing, a binary logistic regression model including variables concerning profession and staff’s own experiences of abuse was built. Results Our data show that in contrast to midwives and gynaecologists, auxiliary nurses seldom report hearing about cases of abuse in health care. Staff who themselves experienced abuse in health care as patients, so-called wounded healers, were more likely to have heard about abuse in health care during the last 12 months. Conclusions This study suggests that a form of silence reigns over events of abuse in health care that is not randomly distributed over staff. Professional hierarchies and staff’s own experiences of abuse as patients could be considered in the design of interventions to break the silence surrounding patients’ experiences of abuse in health care. (shrink)

This article argues that in the quest for global bioethics in its relation to the promotion of women's health and women's rights, the main challenge is to, first, rise above the relativist trap and second, to solve the false dilemma between individualism and collectivism. Particularly in order to improve women's position and advance their well‐being in many developing countries with patriarchal cultural practices, there is an urgent need to introduce modern medicine and to share more evenly and (...) efficiently the health care resources of the industrialized societies. This presumes that we can find a normative bioethical approach that promotes the rights of individuals without striving for cultural assimilation and disrespect.From the philosophical point of view this means that we have to overcome the debate between the rival views of justice, and rather find the shared features of the various approaches, thus diminishing the exaggerated polarizations between them. The author claims that despite its importance in women's rights protection, feminist bioethics cannot remain as a normative alternative that can replace either liberal or communitarian approaches. Instead feminism needs to be part of both liberal and communitarian ethical thinking. Communitarianism, for its part, cannot offer an alternative to either liberalism or feminism, but it can function as an essential critical balancing force within these approaches. Individualist liberalism, on the other hand, has to find its way into collective social structures and accept their maintenance, instead of exhausting itself in its attempts to lift individuals above or beyond their social contexts. (shrink)

The perpetual decline of Zimbabwe’s socio-economic situation can be found in the country legalising prostitution, which it used to regard as an act of criminality. This legalisation promoted the trade from being an offense to a lifestyle and from being an act of immorality to a profession. Prostitutes were also advanced from being social outcasts to commercial sex workers. Although the law appeared to financially empower prostitutes, its negative impact is seen in the level it dehumanises teen girls as they (...) turn themselves into sex objects. Cases of school dropouts among teen girls and human immunodeficiency virus (HIV) and acquired immunodeficiency syndrome (AIDS) are some of the evidences of the negative impact of prostitution, caused by their belief that ‘unprotected sex pays more’. The location of the study was Epworth Booster in Harare, Zimbabwe. Using an African feminist theology framework, this article aims to analyse how women’s theology can be used as a panacea to restore dignity and hunhu-ism to the teen girls whose bodies have been exposed to abuse by their purported fathers. The article uses both unstructured and focus group interviews to collect data from three health personnel and 10 teen girls, respectively. The article grapples with the fact that the legalisation of prostitution in Zimbabwe seriously affected both the social and religious life of teen girls as they risk their lives in order to earn a living, and African feminist theology should be applied to defend these vulnerable girls.Contribution: In the context of socio-economic depletion and laws that suppress women in the name of empowering them, rereading and application of women’s theology should protect women and offer them a future with hope. (shrink)

The feminist movement was from its start in the 19th century involved in the struggle for better health care for women. The first feminists aimed at better information on birth control and sexuality. The second feminist wave focused on the unequal division of power roles between men and women. A lot of the problems women experienced could be seen as a consequence of their subordinate role in society. At the end of the 1980s and in the 1990s, the discipline women (...) and health or women and medicine was developed. In this introduction to the theme, the developments in this discipline are described. The starting points of the new discipline followed the principles of ‘women’s health care’. These principles can be summarized as the emphasis on control and autonomy by the patient, demedicalization, the importance of the psychosocial context of complaints, empowerment of women and good information and communication. The central issue of the article is: what is the actual scientific state of the art and what important changes have been made on the subject gender and health? The article ends with ideas for future research. (shrink)

The emerging concept of systems medicine (or ‘P4 medicine’—predictive, preventive, personalized and participatory) is at the vanguard of the post-genomic movement towards ‘precision medicine’. It is the medical application of systems biology, the biological study of wholes. Of particular interest, P4 systems medicine is currently promised as a revolutionary new biomedical approach that is holistic rather than reductionist. This article analyzes its concept of holism, both with regard to methods and conceptualization of health and disease. Rather than representing (...) a medical holism associated with basic humanistic ideas, we find a technoscientific holism resulting from altered technological and theoretical circumstances in biology. We argue that this holism, which is aimed at disease prevention and health optimization, points towards an expanded form of medicalization, which we call ‘holistic medicalization’: Each person’s whole life process is defined in biomedical, technoscientific terms as quantifiable and controllable and underlain a regime of medical control that is holistic in that it is all-encompassing. It is directed at all levels of functioning, from the molecular to the social, continual throughout life and aimed at managing the whole continuum from cure of disease to optimization of health. We argue that this medicalization is a very concrete materialization of a broader trend in medicine and society, which we call ‘the medicalization of health and life itself’. We explicate this holistic medicalization, discuss potential harms and conclude by calling for preventive measures aimed at avoiding eventual harmful effects of overmedicalization in systems medicine (quaternary prevention). (shrink)

Researchers in neuroscience and biomedicine tend to exclude female animal subjects from preclinical studies. As a result, they fail to consider sex as a biological variable (SABV) while testing some drug or treatment, and this in turn hinders the development of safer and more efficacious treatments for women patients (section 1.1). In section 2, I consider the proposal that this exclusion is an epistemic injustice to women patients and argue that it fails. More strongly, I show that if (...) we accept Miranda Fricker’s notion of epistemic subjectivity, we cannot account for the exclusion even as an epistemic wrong against women patients. To account for the intuition that the exclusion is an epistemic wrong, I briefly outline a broader notion of what it means to be an epistemic subject. In section 3, I argue that the exclusion is an epistemic wrong because it violates the epistemic claim-rights of women patients. For thisI use Lani Watson’s work on epistemic claim-rights. In 3.1, I defend the claim that women patients have an epistemic claim-right against researchers’ exclusion of female animal subjects from preclinical studies. Finally, in 3.2, I consider some important upshots of my thesis. (shrink)

Recent decades have witnessed a growing number of states around the world relying on border control measures, such as immigration detention, to govern human mobility and control the movements of those classified as “unauthorised non-citizens.” In response to this, an increasing number of scholars from several disciplines, including psychologists, have begun to examine this phenomenon. In spite of the widespread concerns raised, few studies have been conducted inside immigration detention sites, primarily due to difficulties in gaining access. This body of (...) research becomes even scanter when it comes to the experiences of detained women. This study is the first of its kind to have surveyed 93 women confined in an Italian immigration detention facility. A partial mediation model with latent variables was tested through partial least structural equation modelling (PLS-SEM). The findings revealed the negative impact that unfair immigration procedures have on detained women’s human dignity, which in turn negatively affects their self-rated physical and mental health. Overall, our study sheds light on the dehumanisation and damage to human dignity that immigration detention entails, as well as its negative impact on the health of those affected. This evidence reinforces the image of these institutions as sites of persistent injustice, while stressing the need to envision alternative justice-oriented forms to address human mobility. (shrink)

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)

In the initial phase of the COVID-19 pandemic, Sweden’s response stood out as an exception. For example, Sweden did not introduce any lockdowns, while many other countries did. In this paper I take the Swedish Corona Commission’s critique of the initial Swedish response as a point of departure for a general analysis of precaution in relation to pandemics. The Commission points out that in contrast to many other countries Sweden did not follow ‘the precautionary principle’. Based on this critique, the (...) Commission proposes that the precautionary principle should be included among Sweden’s guiding principles for crisis management. However, as the debate on this principle during the last 30 years indicates, the principle is loaded with problems. I discuss one of these problems, namely its lack of clarity. I argue, however, that this problem is not unsurmountable. A principle is lacking clarity precisely by being a principle and not a rule with a well-defined meaning. As a principle it indicates a direction but does not prescribe a specific action. However, to be action-guiding its content needs to be specified by rational deliberation. With this in mind, I propose a framework for specification of the precautionary principle as applied to pandemics. The framework focuses on the principle’s four key elements: threat, uncertainty, action and responsibility. I also suggest certain general ethical restrictions on specification. (shrink)

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)

This essay is an inquiry into the socio-cultural history of the use of forceps in 19th-century Mexico. It argues that the knowledge and practices that the use of such instruments implied were related to complex and controversial issues of the time regarding gender, race and national identity. In my study of operations involving forceps, I found that the adoption of medical instruments depended not only upon their supposedly greater operative efficiency but also upon the political and medical meanings attributed to (...) the pelves of Mexican women. Early 19th-century obstetrics conceived the womb as an example of ‘living nature’ whose qualities assured that births were ‘normally happy events’ making the use of forceps and other instruments unnecessary. However, by mid-century, in the aftermath of independence, Mexico was desperately attempting to forge its identity as a nation. Due to European theories of race, Mexican women came to be characterized as having pathologically deformed pelves that evidenced possible defects of racial formation. The analysis of operative practices involving forceps reveals just how strongly such medical instruments became charged with a complex political definition of the ‘mestizo race’, which was seen to hold political promise for the future. In this context, forceps ceased to symbolize the threat of death, with which they had been associated since colonial times, and became artefacts that helped to assure the safe delivery of newborn mestizos by overcoming the problems of Mexican women's pathological pelves; although by the same token, the status of women as biologically inferior beings in need of medical assistance was reconfirmed. (shrink)

Medicalization occurs when an aspect of embodied humanity is scrutinized by the medical industry, claimed as pathological, and subsumed under medical intervention. Numerous critiques of medicalization appear in academic literature, often put forth by bioethicists who use a variety of “lenses” to make their case. Feminist critiques of medicalization raise the concerns of the politically disenfranchised, thus seeking to protect women—particularly natal sex women—from medical exploitation. This article will focus on three feminist critiques of medicalization, which offer an alternative narrative (...) of sickness and health. I will first briefly describe the philosophical origins of medicalization. Then, I will present three feminist critiques of medicalization. Liberal feminism, trans feminism, and crip feminism tend to regard Western medicine with a hermeneutics of suspicion and draw out potential harms of medicalization of reproductive sexuality, gender, and disability, respectively. While neither these branches of feminism—nor their critiques—are homogenous, they provide much-needed commentaries on phallocentric medicine. I will conclude the paper by arguing for the continual need for feminist critiques of medicalization, using uterus transplantation as a relevant case study. (shrink)

Theoretical paradigms, the frameworks within which thinking occurs, never capture the complexity of reality and are necessarily selective. Factors most important to understanding the phenomenon in question will be included and explained in a coherent, meaningful manner. But facts and ideas inconsistent with underlying assumptions may then appear less plausible, and, indeed, may be systematically overlooked or ignored. Health-related paradigms have practical importance because they influence what counts as a fact, what theories appear plausible and important, what research questions should (...) be pursued, and, therefore, what health-care interventions make sense. They also contain implicit underlying ideas about .. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Editors' Introduction to the Special Issue on the Translational Work of BioethicsElizabeth Lanphier and Larry R. ChurchillRecent essays in Perspectives and Biology and Medicine, including "Can Clinical Ethics Survive Climate Change" by Andrew Jameton and Jessica Pierce and "Ethical Maxims for a Marginally Inhabitable Planet" by David Schenck and Larry R. Churchill, both appearing in the Autumn 2021 issue, inspired conversations between us, among our colleagues, and with various (...) contributors to this symposium. We asked of ourselves and each other: where can, should, or must bioethics as a field go to make what bioethicists know and publish about in the academic literature relevant to public policy decisions, health and technological innovation, and a general public? In other words, where do we, practically speaking, go with our bioethical insights and discoveries to make a tangible impact on issues like climate change—though that is only one of the various topics that the authors in this symposium tackle.This translational work of connecting scholarly innovation back to overt practical innovation is often peripheral to academic bioethics. It is not the work the academy typically recognizes in its credit system. Yet this translational work is becoming a critical, central duty of bioethics for the 21st century, while the kinds of work the academy most valorizes may be the least important at this time. In particular, the need for translational initiatives is increasingly evident as pandemics linger into a new normal, the long history and ongoing impacts of racism become even more evident at institutional levels, and the devastating health implications of global warming emerge. [End Page 515]Bioethicists function in privileged proximity to the deleterious effects of failed health and social policy, as well the interplay between seemingly personal health choices, such as those related to diet or lifestyle, and inequitable conditions that impact the options available to individuals and groups. We are increasingly distressed by what we see from this privileged window into health. The COVID-19 pandemic has made preexisting social and policy inequities impacting health impossible to ignore. At the same time, the patterns of carbon pollution portend health crises of unprecedent severity and magnitude in the near future—and will likely deepen inequities and disparities already occurring between those most contributing to, and those most harmed by, climate change.As a field, bioethics has, since its start, been at the intersection of theory and practice. But it is not sufficient for the field to reside passively at this crossroads. The field must be constantly innovating new byways and highways, new offshoots from existing pathways and connector roads between them, that build out both the theory and practice of bioethics in a mutually innovative relationship to each other. Bioethics does not make sense without attention to the real-world practices and the lived realities of health and care. The practical engagement is what deepens and enriches theory, in ways that are more responsive to the real world in which bioethicists toil. But it also is not enough to merely contribute to the body of bioethics scholarship. The translational bioethics we envision is also about using novel theories and concepts to actively shape practices and realities; it is a bioethics in which theory and practices mutually influence each other, each reaching out to generate and change the other.This collection of essays, drawn from a diverse number of scholars, offers several promising paths forward. The essays were written in the spring of 2022, two years into the COVID-19 pandemic, two years after the murder of George Floyd and international attention to the movement for Black lives, and for the most part in the weeks just prior to a set of US Supreme Court decisions with enormous impacts on health, including the June 24 Dobbs v. Jackson Women's Health Organization and the June 30 West Virginia v. EPA decisions.The authors are diverse in age, spheres of work, discipline, sex, race, and ethnicity. They expand our vision for what bioethics can and should be. While we have grouped the essays by subject matter, most of the pieces speak to the field as a whole and invite cross-fertilization. We hope readers will find new ideas, old ideas... (shrink)

Sex is a fundamentally important biological variable. Recent years have seen significant progress in the integration of sex in many aspects of basic and clinical research, including analyses of sex differences in brain function. Significant advances in the technology available for studying the endocrine and nervous systems are now coupled with a more sophisticated awareness of the interconnections of these two communication systems of the body. A thorough understanding of the current knowledge, conceptual approaches, methodological capabilities, and challenges is (...) a prerequisite to continued progress in research and therapeutics in this interdisciplinary area. Sex Differences in the Brain provides scientists with the basic tools for investigating sex differences in brain and behavior and insight into areas where important progress in understanding physiologically relevant sex differences has already been made. This book was edited and co-authored by members of the Isis Fund Network on Sex, Gender, Drugs and the Brain, sponsored by the Society for Womens Health Research. The book is arranged in three parts. The first part of the book introduces the study of sex differences in the brain, with an overview of how the brain, stress systems, and pharmacogenetics differ in males and females and how this information is important for the study of behavior and neurobiology of both genders. The second part presents examples of sex differences in neurobiology and behavior from both basic and clinical research perspectives, covering both humans and nonhuman animals. The final part discusses sex differences in the neurobiology of disease and neurological disorders. For interested individuals as well as those who are considering conducting research at the intersections of endocrinology, neuroscience, and other areas of biomedicine, the study of sex differences offers exciting and challenging questions and perspectives. This book is intended as a guide and resource for clinicians, scientists, and students. (shrink)

Evidence shows that during birth women frequently experience unconsented care, coercion, and a loss of autonomy. For many countries, this contradicts both the law and medical ethics guidelines, which emphasize that competent and fully informed women’s autonomy must always be respected. To better understand this discordance, we empirically describe perinatal maternity care providers’ and women’s moral deliberation surrounding coercive measures during birth. Data were obtained from 1-on-1 interviews with providers (N = 15) and women (N = 14), and a survey (...) of women (N = 118). Analyses focused on an in-depth exploration of responses to a question on the permissibility of coercion in birth whose wording was borrowed from a Swiss medical-ethical guideline. Reasons for and against a principle permissibility of coercive measures in birth were grouped into clusters of reasons to build a coherent explanatory framework. Factors considered morally relevant when deliberating on coercion included women’s decisional capacity, beneficence/non-maleficence, authority through knowledge on the part of providers, flaws of the medical system, or the imperative to protect the most vulnerable. Also, we identified various misconceptions, such as the conviction that a pathological birth can justify coercion or that fetal rights can justifiably infringe on women’s autonomy. Information and education on the issue of coercion in birth are urgently needed to enable women to fully exercise their reproductive autonomy, to prevent long-term adverse health outcomes of women and children, and to reconcile the medical vigilance which has lead to a reduction of perinatal morbidity and mortality with women’s enfranchisement in their own care. (shrink)

Definitions of health and disease are of more than theoretical interest. Understanding what it means to be healthy has implications for choices in medical treatment, for ethically sound informed consent, and for accurate assessment of policies or programs. This deeper understanding can help us create more effective public policy for health and medicine. It is notable that such contentious legal initiatives as the Americans with Disability Act and the Patients' Bill of Rights fail to define adequately the medical terms on (...) which their effectiveness depends. In Ethics and the Metaphysics of Medicine, Kenneth Richman develops an "embedded instrumentalist" theory of health and applies it to practical problems in health care and medicine, addressing topics that range from the philosophy of science to knee surgery."Embedded instrumentalist" theories hold that health is a match between one's goals and one's ability to reach those goals, and that the relevant goals may vary from individual to individual. This captures the normative implications of the term health while avoiding problematic relativism. Richman's embedded instrumentalism differs from other theories of health in drawing a distinction between the health of individuals as biological organisms and the health of individuals as moral agents. This distinction illuminates many difficulties in patient-provider communication and helps us understand conflicts between promoting health and promoting ethically permissible behavior. After exploring, expanding, and defending this theory in the first part of the book, Richman examines its ethical implications, discussing such concerns as the connection between medical beneficence and respect for autonomy, patient-provider communication, living wills, and clinical education. (shrink)

Women have a life-expectancy advantage over men, but a marked disadvantage with regards to morbidity. This is known as the female–male health-survival paradox in disciplines such as medicine, medical sociology, and epidemiology. Individual differences in physical and mental health are further notably explained by the degree of stress individuals endure, with women being more affected by stressors than men. Here, we briefly examine the literature on women’s disadvantage in health and stress. Beyond biological considerations, we follow with socio-cognitive explanations (...) of gender differences in health and stress. We show that gender roles and traits (masculinity in particular) explain part of the gender differences in stress, notably cognitive appraisal and coping. Stress in turn degrades health. Implications are discussed. In conclusion, traditional socialization is advantageous for men in terms of health. (shrink)

When Communism collapsed in Central and Eastern Europe women seemed to lose the control they had gained over their reproductive lives. Abortion rights became more limited as did access to childcare and maternity benefits. The authors argue that this picture conceals two key points. First, the effects of both Communism and post-Communism for women's reproductive lives need to be understood as byproducts of state initiatives geared towards the fulfilment of quite different political goals – and not attempts to intervene (...) in women's health and well-being per se. Second, these effects are very varied and cannot be attributed to a single cause. ‘Central and Eastern Europe’ comprises a whole range of political, ethnic and religious groupings, the result being that women's reproductive lives have been shaped within a diversity of political processes. Some women have faced pressures from the state to reproduce, some have lost the conditions necessary for them to continue paid work after childbirth, others have lost abortion rights. To understand these very different outcomes of post-Communism, this article looks beyond women's issues per se to unravel their role as symbolic resources which have been drawn upon in power struggles taking place in political arenas which exclude the majority of women. This argument is elaborated through empirical evidence from Poland, Serbia and East Germany. (shrink)

United States public health experts have long expressed concern about the prevalence of the human immunodeficiency virus among injection drug users. The United States has the largest reported IDU population in the world: 1.1 to 1.5 million. Recent estimates from the Centers for Disease Control and Prevention suggest that 50 percent of incident HIV infections occur among IDUs, with additional infections occurring among their sex partners and offspring. More than 33 percent of new AIDS cases occur in IDUs, their sexual (...) partners, and their children. Almost one half of all women diagnosed with AIDS in the United States are IDUS. Many of the remaining infected women were infected as a result of sex with a male IDU.While public health agencies, legislators, community leaders, and religious groups have engaged in vigorous debate over the merits of needle exchange programs as an intervention to reduce HIV transmission, the programs, some legal and some illegal, have been implemented in fifty-five cities across the country. (shrink)

Introduction A Brief Conceptual Framework for Biology PART ONE: UNDERSTANDING NATURE 1. The Antecedents of Scientific Thought Animism, Totemism, and Shamanism The Paleolithic View Mesopotamia Egypt 2. Aristotle and the Greek View of Nature The Science of Animal Biology The Parts of Animals The Classification of Animals The Aristotelian System Basic Questions 3. Those Rational Greeks? Theophrastus and the Science of Botany The Roman Pliny Hippocrates, the Father of Medicine Erasistratus Galen of Pergamum The Greek Miracle 4. The Judeo-Christian Worldview (...) The Bishop of Hippo Scholastic Thought Islamic Science Books on Beasts Antecedents of a Revolution 5. The Revival of Science Andreas Vesalius and the Study of Structure William Harvey and the Study of Function Sir Francis Bacon’s Great Instauration Induction, Hypothesis, Deduction The Very Small--Animalcules Robert Hooke and the Discovery of Cells 6. Figur’d Stones and Plastick Virtue Marine Life on Mountain Tops? Figured Stones of Unknown Creatures Baron Cuvier Quarries of the Paris Basin Catastrophism and Uniformitarianism William Smith and the Geological Column Understanding Nature in 1850 PART TWO: THE GROWTH OF EVOLUTIONARY THOUGHT 7. The Paradigm of Evolution First Questions The Paradigm of Natural Theology First Answers 8. Testing Darwins Hypotheses Have Life Forms Changed over Time? Do Species Evolve into Different Species over Time? Has There Been Time Enough for Evolution? Is Natural Selection the Mechanism of Change? The Genetic Basis of Natural Selection Accounting for the Diversity of Life 9. In the Light of Evolution Comparative Anatomy Embryonic Development Classification Microstructure Molecular Processes 10. Life over Time The Origin of Life The Rise of Multicelled Organisms What Is a Phylum? Burgess Shale Metazoans Early Evolution of the Vertebrates The Age of Dinosaurs Birds, Mammals, and Flowering Plants The Rancho La Brea Tar Pits Human Evolution The Role of Extinction in Evolution PART THREE: CLASSICAL GENETICS 11. Pangenesis What Is the Question? Hippocrates and Aristotle The Darwinian Answer Assembling the Data Formulating the Hypothesis by Induction Galton’s Rabbits 12. The Cell Theory The Discovery of Cells: Robert Hooke Schwann and Cells in Animals Gametes as Cells Omnis cellula e cellula? The Technology of Cell Research 13. The Hypothesis of Chromosomal Continuity The Ephemeral Nucleus Schneider, Flemming, and Cell Division The Chromosomes and inheritance Gamete Formation Fertilization 14. Mendel and the Birth of Genetics Model for Monohybrid Crosses Model for Dihybrid Crosses Mendel’s Laws Initial Opposition to Mendelism 15. Genetics + Cytology: 1900-1910 Sutton’s Model The Cytological Basis of Mendel’s Laws Boveri and Abnormal Chromosome Sets Variations in Mendelian Ratios The Discovery of Sex Chromosomes 16. The Genetics of the Fruit Fly Morgan’s First Hypothesis Morgan’s Second Hypothesis The Fly Room Linkage and Crossing-Over The Cytological Proof of Crossing-Over Mapping the Chromosomes The Final Proof The Determinants of Sex The Conceptual Foundations of Classical Genetics 17. The Structure and Function of Genes One Gene, One Enzyme The Substance of Inheritance The Watson-Crick Model of DNA Genes and the Synthesis of Proteins The Genetic Code PART FOUR: THE ENIGMA OF DEVELOPMENT 18. First Principles The Peripatetic Stagirite The Death and Rebirth of Scientific Thought Harvey and Malpighi A Two-Millennial Summing Up Preformation versus Epigenesis 19. The Century of Discovery Von Baer’s Discovery of the Mammalian Ovum Darwin’s Contribution to Embryology Haeckel and Recapitulation 20. Descriptive Embryology Germ Layers The External Development of the Amphibian Embryo The Internal Development of the Amphibian Embryo 21. The Dawn of Analytical Embryology His, Roux, and Mosaic Development Driesch and Regulative Development Novelty in Development Cell Lineage Nucleus or Cytoplasm? Fin de Siècle 22. Interactions during Development Amphibian Organizers Secondary Organizers The Reacting Tissue The Chemical Nature of the Organizer Putting It All Together Conclusion Further Reading References Illustration Credits Index. (shrink)

This article provides ethical guidance on using race in health research as a variable or in defining the study population. To this end, a plain, non-exhaustive checklist is provided for researchers and research ethics committees, preceded by a brief introduction on the need for justification when using race as a variable or in defining a study population, the problem of exoticism, that distinctions pertain between race, ethnicity and ancestry, the problematic naming of races, and that race does not serve well (...) as a presumed biological construct in genetic research. (shrink)

As the health care system transitions to a precision medicine approach that tailors clinical care to the genetic profile of the individual patient, there is a potential tension between the clinical uptake of new technologies by providers and the legal system's expectation of the standard of care in applying such technologies. We examine this tension by comparing the type of evidence that physicians and courts are likely to rely on in determining a duty to recommend pharmacogenetic testing of patients (...) prescribed the oral anti-coagulant drug warfarin. There is a large body of inconsistent evidence and factors for and against such testing, but physicians and courts are likely to weigh this evidence differently. The potential implications for medical malpractice risk are evaluated and discussed. (shrink)

A developmental theory of erotic/romantic attraction is presented that provides the same basic account for opposite-sex and same-sex desire in both men and women. It proposes that biological variables, such as genes, prenatal hormones, and brain neuroanatomy, do not code for sexual orientation per se but for childhood temperaments that influence a child's preferences for sex-typical or sex-atypical activities and peers. These preferences lead children to feel different from opposite-or same-sex peers — to perceive them as dissimilar, unfamiliar, and (...) exotic. This, in turn, produces heightened nonspecific autonomic arousal that subsequently gets eroticized to that same class of dissimilar peers: Exotic becomes erotic. Specific mechanisms for effecting this transformation are proposed. The theory claims to accommodate both the empirical evidence of the biological essen-. (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)

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)

Recent debate by feminist scholars in philosophy of sport has been focused on the status of women’s sport as a protected category. Positions have varied significantly, from no need for a protected category anymore—to allow women’s sport to flourish and to give them a fair opportunity, given that men’s sport still dominates, just as it has in the past.It will be argued that: i) the concept of a ‘protected category’ is tied logically to the concept of fair play and has (...) been defined and enforced through the rules in sport and generally requires some kind of certification for inclusion. These specific rules will be analyzed in detail. Having separate women’s events means that logically it must be possible to exclude, and exclusion is not a popular stance as many have argued that the onus is on inclusion from a human rights perspective. Thus, sport policy makers are truly in an intractable position. On the one hand, no qualifying athlete should have to ‘dope down’ (or ‘dope up’) to compete in the Olympic Games. On the other hand, women athletes have argued that sex equality in competitive sport is a legitimate goal and that separating athletes in competition by biological sex traits is the only way to achieve this goal. It seems criminal to ask athletes to ‘dope down’ to be able to compete in the Olympic Games, however, although a new auxiliary rule creating new sub-classification of women athletes with testosterone higher than the stipulated cut off seems logical on the face of it, these cases are statistically rare. It is concluded that the community of women athletes should have the most significant voice, as historically, the criteria for the women’s sport-protected category have been predominantly determined by men. That is not to say that men’s voices, or voices outside of the women’s sports community of practitioners, cannot be heard, but they should not be the deciding factor. (shrink)

This chapter sets forth a general theory of gender stratification. While both biological and ideological variables are taken into account, the emphasis is structural: It is proposed that the major independent variable affecting sexual inequality is each sex's economic power, understood as relative control over the means of production and allocation of surplus. For women, relative economic power is seen as varying-and not always in the same direction-at a variety of micro- and macrolevels, ranging from the household to the (...) state. A series of propositions links the antecedents of women's relative economic power, the interrelationship between economic and other forms of power, and the forms of privilege and opportunity into which each gender can translate its relative power. (shrink)

Before September 11, 2001, a mass-casualty terrorist attack on American soil was generally considered a remote possibility. Similarly, before October 4, 2001—the first confirmed case of anthrax caused by intentional release — widespread bioterrorism seemed implausible. Among the arguments that such a biological artack was unlikely included: the lack of a historical precedent; the technological and organizational challenges to acquiring and weaponizing a biological agent; and the almost universal moral opprobrium that would certainly accompany the use by terrorists (...) of such a weapon. In the wake of September 11th and October 4th, however, many are reconsidering the likelihood of a large-scale bioterrorist attack against civilians.The Centers for Disease Control and Prevention defines bioterrorism as the intentional release of viruses, bacteria, or toxins for the purpose of harming or killing civilian. One measurement of the public health system's level of bioterrorism preparedness is the quality and distribution of laws mandating the reporting of diseases caused by certain biological agents. (shrink)