The left ventricular assist device was originally designed to be surgically implanted as a bridge to transplantation for patients with chronic end-stage heart failure. On the basis of the REMATCH trial, the US Food and Drug Administration and the US Centers for Medicare & Medicaid Services approved permanent implantation of the left ventricular assist device as a destination therapy in Medicare beneficiaries who are not candidates for heart transplantation. The use of the left ventricular assist device as a destination therapy (...) raises certain ethical challenges. Left ventricular assist devices can prolong the survival of average recipients compared with optimal medical management of chronic end-stage heart failure. However, the overall quality of life can be adversely affected in some recipients because of serious infections, neurologic complications, and device malfunction. Left ventricular assist devices alter end-of-life trajectories. The caregivers of recipients may experience significant burden (e.g., poor physical health, depression, anxiety, and posttraumatic stress disorder) from destination therapy with left ventricular assist devices. There are also social and financial ramifications for recipients and their families. We advocate early utilization of a palliative care approach and outline prerequisite conditions so that consenting for the use of a left ventricular assist device as a destination therapy is a well informed process. These conditions include: (1) direct participation of a multidisciplinary care team, including palliative care specialists, (2) a concise plan of care for anticipated device-related complications, (3) careful surveillance and counseling for caregiver burden, (4) advance-care planning for anticipated end-of-life trajectories and timing of device deactivation, and (5) a plan to address the long-term financial burden on patients, families, and caregivers. Short-term mechanical circulatory devices (e.g. percutaneous cardiopulmonary bypass, percutaneous ventricular assist devices, etc.) can be initiated in emergency situations as a bridge to permanent implantation of ventricular assist devices in chronic end-stage heart failure. In the absence of first-person (patient) consent, presumed consent or surrogate consent should be used cautiously for the initiation of short-term mechanical circulatory devices in emergency situations as a bridge to permanent implantation of left ventricular assist devices. Future clinical studies of destination therapy with left ventricular assist devices should include measures of recipients' quality of end-of-life care and caregivers' burden. (shrink)

"This book is a practical business guide for managers and executives covering bribery and FCPA compliance issues that they need to understand to ensure they are ...

Volume 20, Issue 7, July 2020, Page 128-132.

Our aims are to set forth a multiprinciple system for selecting among clinical trials competing for limited space in an immunotherapy production facility that supplies products under investigation by scientific investigators; defend this system by appealing to justice principles; and illustrate our proposal by showing how it might be implemented. Our overarching aim is to assist manufacturers of immunotherapeutic products and other potentially breakthrough experimental therapies with the ethical task of prioritizing requests from scientific investigators when production capacity is limited.

Taste-aversion learning has been a popular paradigm for examining associative processes because it often produces outcomes that are different from those observed in other classical conditioning paradigms. One such outcome is taste-mediated odor potentiation in which aversion conditioning with a weak odor and a strong taste results in increased or synergistic conditioning to the odor. Because this strengthened odor aversion was not anticipated by formal models of learning, investigation of taste-mediated odor potentiation was a hot topic in the 1980s. The (...) present manuscript reviews the history of potentiation research with particular focus given to the stimuli that produce potentiation, the conditions that produce potentiation, the possible mechanism of this phenomenon, and possible reasons for the decline of research in this area. Although the number of published reports of potentiation has decreased since the 1980s, recent physiological and behavioral assessments have advanced the field considerably, and the opportunities for future research are bountiful. Recent physiological experiments, for example, have identified the basolateral nucleus of the amygdala as the key brain region to produce taste-mediated odor potentiation (e.g., Hatfield andGallagher, 1995). Also, recent behavioral experiments have extended the generality of synergistic conditioning effects. Studies have shown that odor can potentiate responding to taste (Slotnick, Westbrook and Darling, 1997) and that augmented responding can be produced in the A+/AX+blocking design (e.g., Batsell and Batson, 1999). With the current understanding of where synergistic conditioning may occur in the brain and the new tools to explore synergistic conditioning, we propose various directions for future research to determine whether taste-aversion learning and synergistic conditioning require unique explanations. (shrink)

Timothy Williamson has argued that a person S ’s total evidence is constituted solely by propositions that S knows. This theory of evidence entails that a false belief can not be a part of S ’s evidence base for a conclusion. I argue by counterexample that this thesis (E = K for now) forces an implausible separation between what it means for a belief to be justified and rational from one’s perspective and what it means to base one’s beliefs on (...) the evidence. Furthermore, I argue that E = K entails the implausible result that there are cases in which a well-evidenced belief necessarily can not serve as evidence for a further proposition. (shrink)

Pragmatic Encroachment, Religious Belief and Practice engages several recent and important discussions in the mainstream epistemological literature surrounding 'pragmatic encroachment'. It has been argued that what is at stake for a person in regards to acting as if a proposition is true can raise the levels of epistemic support required to know that proposition. Do the high stakes involved in accepting or rejecting religious beliefs raise the standards for knowledge that 'God exists', 'Jesus rose from the dead' and other propositions? (...) Professor Rizzieri also examines whether or not knowledge and justification norms of belief and action undermine the pragmatic grounds for religious belief suggested by William James. Rizzieri argues that such norms favor an attitude of hope, as opposed to belief, under conditions of uncertainty. Finally, Rizzieri argues the connections between knowledge and rational action undermine radically externalist accounts of religious knowledge and proposes an alternative account of the justification of religious beliefs. (shrink)

It is commonly held that epistemic standards for S ’s knowledge that p are affected by practical considerations, such as what is at stake in decisions that are guided by that p . I defend a particular view as to why this is, that is referred to as “pragmatic encroachment.” I then discuss a “new argument against miracles” that uses stakes considerations in order to explore the conditions under which stakes affect the level of epistemic support that is required for (...) knowledge. Finally, I generalize my results to include other religiously significant propositions such as “God exists” and “God does not exist.”. (shrink)

I argue that embryonic stem cell research is fair to the embryo, even on the assumption that the embryo has attained full personhood and an attendant right to life at conception. This is because the only feasible alternatives open to the embryo are to exist briefly in an unconscious state and be killed or to not exist at all. Hence, one is neither depriving the embryo of an enduring life it would otherwise have had nor is one causing the embryo (...) pain. I also argue that a rational agent in a situation relevantly similar to that of the embryo would consent to such research, and I use this insight to ground two justice-based arguments in favor of this research. (shrink)

The knowledge and attendant justification norms of belief and assertion serve to regulate our doxastic attitudes towards, and practices of asserting, various propositions. I argue that conforming to these norms under conditions of religious ignorance promotes responsible acts of assertion, epistemic humility, and non–dogmatic doxastic attitudes towards the content of one’s own faith. Such conformity also facilitates the formation of the religious personality in a healthy direction in other ways. I explore these ideas in relation to the Christian faith tradition, (...) but my reflections generalize. (shrink)

I present three versions of the argument from divine hiddenness that are grounded in moral considerations regarding how a just deity would act and auxiliary commitments that theists often have. First, I argue that the problem of hiddenness is made worse if one also holds that many will suffer in the afterlife due to not achieving a proper orientation towards God and the demands of morality in this life. Second, I argue that if any version of the moral argument for (...) theism is successful, then God has a very good reason to not remain hidden. Third, I argue that a just God would not allow people to do evil in her name. (shrink)

Comment by Aaron L. Mackler on “‘Through Her I Too Shall Bear a Child’: Birth Surrogates in Jewish Law” by Elie Spitz Reply by Elie Kaplan Spitz Research Note by G. Scott Davis.

Research examining firm and industry effects on performance has primarily focused on the financial aspects of firm performance. Corporate social performance is a major aspect of firm performance that has been under-examined empirically in the literature to date. Adding to the fundamental debate regarding firm versus industry effects on performance, this study uses data drawn from the Kinder, Lydenberg and Domini Co. database to examine the degree to which CSP is related to firm, industry, and temporal factors. The results of (...) these analyses suggest that CSP tends to change in a linear manner over time; however, the slope of this line varies across firms and industries. These findings are supported by several robustness checks accounting for autocorrelation, alternative measures of industry, different samples commonly used when using KLD data to measure CSP, and alternative measures of CSP when using the KLD database. The authors also directly compare firm, industry, and temporal effects between CSP and financial performance. (shrink)

Hannah Arendt's essays about the 1957 crisis over efforts of a group of youth, the “Little Rock Nine,” to desegregate a high school in Little Rock, Arkansas, reveal a tension in her vision of the “public.” In this article Aaron Schutz and Marie Sandy look closely at the experiences of the youth desegregating the school, especially those of Elizabeth Eckford, drawing upon them to trace a continuum of forms of public engagement in Arendt's work. This ranges from arenas of (...) “deliberative friendship,” where unique individuals collaborate on common efforts, to a more conflictual “public stage,” where groups act in solidarity to change aspects of the public world. While Arendt famously asserted in her essay “The Crisis in Education” that political capacities should not be taught in schools, it makes more sense to see this argument as focused on what she sometimes called the conflictual “public stage,” reflecting the experience of the Little Rock Nine. In contrast, Schutz and Sandy argue that Arendt's own work implies that “deliberative friendship,” as described in her essay “Philosophy and Politics” and elsewhere, should be part of everyday practices in classrooms and schools. (shrink)

Drug Safety Communications are used by the Food and Drug Administration to inform health care providers, patients, caregivers, and the general public about safety issues related to FDA-approved drugs. To assess patient knowledge of the messaging contained in DSCs related to the sleep aids zolpidem and eszopiclone, we conducted a large, cross-sectional patient survey of 1,982 commercially insured patients selected by stratified random sampling from the Optum Research Database who had filled at least two prescriptions for either zolpidem or eszopiclone (...) between July 1, 2012 and June 30, 2013. Among the 594 respondents, two-thirds reported hearing generally about drug safety information prior to starting a new drug, with the remaining one-third “rarely” or “never” hearing such information. Providers and pharmacists were primary sources of drug safety information. Two-thirds of zolpidem users and half of eszopiclone users reported having heard about the related DSC messages, ability to accurately identify the major factual messages was limited. Respondents reacted to new drug safety information about their sleep aids by reporting that they would want to learn about alternative ways to help them sleep and seek out more information about the safety of their specific sleeping pill. Opportunities may exist for the FDA to work with providers and pharmacies to help ensure the DSC information is more widely received and is more fully understood by those taking the affected medications. (shrink)

Comment by Aaron L. Mackler on “‘Through Her I Too Shall Bear a Child’: Birth Surrogates in Jewish Law” by Elie Spitz Reply by Elie Kaplan Spitz Research Note by G. Scott Davis.

Bigotry distractions are strategic invocations of racism, transphobia, or negative stigma toward other marginalized groups to shape political discourse. Although the vast majority of Americans agree on large policy issues ranging from reducing air pollution to prosecuting corporate crime, bigotry distractions divert attention from areas of agreement toward divisive identity issues. This article explores how the nefarious targeting of identity groups through bigotry distractions may be the tallest barrier to health reform, and social change more broadly. The discussion extends the (...) literature on dog whistles, strategic racism, and scapegoating. (shrink)

Why decolonize knowledge and philosophy? Pascah Mungwini proposes that epistemic decolonization should be implemented to remain true to the spirit of philosophy and to the idea of humanity. Aaron Creller, Michael Monahan, and Esme Murdock focus on different aspects of Mungwini’s proposal in their individual responses. Creller suggests some “best practices” so that comparative epistemology can take into account the parochial embeddedness of universal reason. While Monahan underscores that world philosophy as a project must openly acknowledge its own incompleteness (...) and its instantiation in different world philosophies, Esme Murdock uses Glissant’s thoughts to make a case for the right to opacity as a strategy for subverting the dominating power of Euroamerican reason. In his reply, Mungwini underscores that philosophy will be able to increase the amount of justice, beauty, and truth in this world only when its practitioners begin to exhibit genuine pluralism in their work. (shrink)

Genome editing with engineered nucleases (GEENs) introduce site‐specific DNA double‐strand breaks (DSBs) and repairs DSBs via nonhomologous end‐joining (NHEJ) pathways that eventually create indels (insertions/deletions) in a genome. Whether the features of indels resulting from gene editing could be customized is asked. A review of the literature reveals how gene editing technologies via NHEJ pathways impact gene editing. The survey consolidates a body of literature that suggests that the type (insertion, deletion, and complex) and the approximate length of indel edits (...) can be somewhat customized with different GEENs and by manipulating the expression of key NHEJ genes. Structural data suggest that binding of GEENs to DNA may interfere with binding of key components of DNA repair complexes, favoring either classical‐ or alternative‐NHEJ. The hypotheses have some limitations, but if validated, will enable scientists to better control indel makeup, holding promise for basic science and clinical applications of gene editing. Also see the video abstract here https://youtu.be/vTkJtUsLi3w. (shrink)

North America is in the grips of an epidemic of opioid-related poisonings. Overdose education and naloxone distribution programmes emerged as an option for structurally vulnerable populations who could not or would not access mainstream emergency medical services in the event of an overdose. These task shifting programmes utilize lay persons to deliver opioid resuscitation in the context of longstanding stigmatization and marginalization from mainstream healthcare services. OEND programmes exist at the intersection of harm reduction and emergency services. One goal of (...) OEND programmes is to help redress the health-related inequities common among people who use drugs, which include minimizing the gap between people who use drugs and the formal healthcare system. However, if this goal is not achieved these inequities may be entrenched. In this article, we consider the ethical promises and perils associated with OEND as task shifting. We argue that public health practitioners must consider the ethical aspects of task shifting programmes that may inadvertently harm already structurally vulnerable populations. We believe that even if OEND programmes reduce opioid-related deaths, we nevertheless question if, by virtue of its existence, OEND programmes might also unintentionally disenfranchise structurally vulnerable populations from comprehensive healthcare services, including mainstream emergency care. (shrink)

We describe two unusual cases of cardiopulmonary death in mechanically ventilated patients in the neurological intensive care unit. After cardiac arrest, both patients were pulseless for a protracted period. Upon extubation, both developed agonal movements (gasping respiration) resembling life. We discuss these cases and the literature on the ethical and medical controversies associated with determining time of cardiopulmonary death. We conclude that there is rarely a single moment when all of a patient’s physiological functions stop working at once. This can (...) pose a challenge for determining the exact moment of death. (shrink)

Graphical AbstractGene editing with engineered nucleases introduce double-strand breaks that are repaired by error-prone nonhomologous end-joining (NHEJ). In article number 1900126, Sara G. Trimidal et al. propose that the length and type or resulting indels can now be controlled by editing with different engineered nucleases or by manipulating the expression of NHEJ genes.

The goal of this paper is to make headway on a metaphysics of social construction. In recent work, I’ve argued that social construction should be understood in terms of metaphysical grounding. However, I agree with grounding skeptics like Wilson that bare claims about what grounds what are insufficient for capturing, with fine enough grain, metaphysical dependence structures. To that end, I develop a view on which the social construction of human social kinds is a kind of realization relation. Social kinds, (...) I argue, are multiply realizable kinds. I depart from the Wilson by further arguing that an appeal to grounding is not otiose when it comes to social construction. Social construction, I claim, belongs to the “big-G” Grounding genus, but it is the specific “small-g” relation of realization at work in cases of human kind social construction. (shrink)

Many philosophers have been interested in aesthetics, but Collingwood was passionate about art. His theories were never merely theoretical: aesthetics for him was a vivid, vibrant thing, to be experienced immediately in worked paint and in sculptured stones, in poetry and music. Art and life were no dichotomy for Collingwood - for how could you have one without the other? Works of art were created in and for the real world, to be enjoyed by real people, to enchant to enhance. (...) Aaron Ridley's fascinating introduction opens up the work of this most rewarding of aesthetic thinkers, tracing his thought from its philosophic origins through to its practical consequence and ethical implications. The man who saw art as 'the community's medicine for the worst disease of mind' had a sense of its urgent importance which we ignore at our peril today. (shrink)

This paper reviews the AWARE(TM) software distributed by the Electric Power Research Institute (EPRI). The program is designed to facilitate the Federal Energy Regulatory Commission (FERC) license renewal process for US hydropower installations. The discussion reviews the regulatory, legal, and social contexts that give rise to the creation and distribution of AWARE(TM). The principal legal impetus for AWARE(TM) is the Electric Consumer Protection Act (ECPA) of 1986 that directs FERC to give equal consideration to power and non-power resources during relicensing. (...) The software is reviewed in this paper from several perspectives including those of natural resource economics, systems modeling, and the social context within which FERC licensing decisions are made. We examine both the software and its underlying methodology and find significant problems with each. Because of its flaws, AWARE(TM) does little to further ECPA's equal consideration requirement. We find that the conservation and restoration impact of ECPA for US fisheries could be seriously hampered by the widespread use of AWARE(TM). (shrink)

In defending his interest-relative account of knowledge in Knowledge and Practical Interests (2005), Jason Stanley relies heavily on intuitions about several bank cases. We experimentally test the empirical claims that Stanley seems to make concerning our common-sense intuitions about these bank cases. Additionally, we test the empirical claims that Jonathan Schaffer seems to make in his critique of Stanley. We argue that our data impugn what both Stanley and Schaffer claim our intuitions about such cases are. To account for these (...) results, one must develop a better conception of the connection between a subject's interests and her body of knowledge than those offered by Stanley and Schaffer. (shrink)

BackgroundThe U.S. Food and Drug Administration traditionally has kept confidential significant amounts of information relevant to the approval or non-approval of specific drugs, devices, and biologics and about the regulatory status of such medical products in FDA’s pipeline.ObjectiveTo develop practical recommendations for FDA to improve its transparency to the public that FDA could implement by rulemaking or other regulatory processes without further congressional authorization. These recommendations would build on the work of FDA’s Transparency Task Force in 2010.MethodsIn 2016-2017, we convened (...) a team of academic faculty from Harvard Medical School, Brigham and Women’s Hospital, Yale Medical School, Yale Law School, and Johns Hopkins Bloomberg School of Public Health to develop recommendations through an iterative process of reviewing FDA’s practices, considering the legal and policy constraints on FDA in expanding transparency, and obtaining insights from independent observers of FDA.ResultsThe team developed 18 specific recommendations for improving FDA’s transparency to the public. FDA could adopt all these recommendations without further congressional action.FundingThe development of the Blueprint for Transparency at the U.S. Food and Drug Administration was funded by the Laura and John Arnold Foundation. (shrink)

Recent advances in the field of statistical learning have established that learners are able to track regularities of multimodal stimuli, yet it is unknown whether the statistical computations are performed on integrated representations or on separate, unimodal representations. In the present study, we investigated the ability of adults to integrate audio and visual input during statistical learning. We presented learners with a speech stream synchronized with a video of a speaker’s face. In the critical condition, the visual (e.g. /gi/) and (...) auditory (e.g. /mi/) signals were occasionally incongruent, which we predicted would produce the McGurk illusion, resulting in the perception of an audiovisual syllable (e.g. /ni/). In this way, we used the McGurk illusion to manipulate the underlying statistical structure of the speech streams, such that perception of these illusory syllables facilitated participants’ ability to segment the speech stream. Our results therefore demonstrate that participants can integrate audio and visual input to perceive the McGurk illusion during statistical learning. We interpret our findings as support for modality-interactive accounts of statistical learning. (shrink)

New research and a government investigation have shed light on an anticompetitive practice called “Product Hopping” and specifically how it was employed in the case of the multiple sclerosis treatment glatiramer acetate beginning in 2014, which cost payers billions of dollars. We examine this case as well as a separate, impending instance of product hopping.

In the conclusion to this multi-part article I first review the discussions carried out around the six essential questions in psychiatric diagnosis – the position taken by Allen Frances on each question, the commentaries on the respective question along with Frances’ responses to the commentaries, and my own view of the multiple discussions. In this review I emphasize that the core question is the first – what is the nature of psychiatric illness – and that in some manner all further (...) questions follow from the first. Following this review I attempt to move the discussion forward, addressing the first question from the perspectives of natural kind analysis and complexity analysis. This reflection leads toward a view of psychiatric disorders – and future nosologies – as far more complex and uncertain than we have imagined. (shrink)

The aim of this paper is to bring recent work on metaphysical grounding to bear on the phenomenon of social construction. It is argued that grounding can be used to analyze social construction and that the grounding framework is helpful for articulating various claims and commitments of social constructionists, especially about social identities, e.g., gender and race. The paper also responds to a number of objections that have been leveled against the application of grounding to social construction from Elizabeth Barnes, (...) Mari Mikkola, and Jessica Wilson. (shrink)

In face of the multiple controversies surrounding the DSM process in general and the development of DSM-5 in particular, we have organized a discussion around what we consider six essential questions in further work on the DSM. The six questions involve: 1) the nature of a mental disorder; 2) the definition of mental disorder; 3) the issue of whether, in the current state of psychiatric science, DSM-5 should assume a cautious, conservative posture or an assertive, transformative posture; 4) the role (...) of pragmatic considerations in the construction of DSM-5; 5) the issue of utility of the DSM - whether DSM-III and IV have been designed more for clinicians or researchers, and how this conflict should be dealt with in the new manual; and 6) the possibility and advisability, given all the problems with DSM-III and IV, of designing a different diagnostic system. Part I of this article took up the first two questions. Part II will take up the second two questions. Question 3 deals with the question as to whether DSM-V should assume a conservative or assertive posture in making changes from DSM-IV. That question in turn breaks down into discussion of diagnoses that depend on, and aim toward, empirical, scientific validation, and diagnoses that are more value-laden and less amenable to scientific validation. Question 4 takes up the role of pragmatic consideration in a psychiatric nosology, whether the purely empirical considerations need to be tempered by considerations of practical consequence. As in Part 1 of this article, the general introduction, as well as the introductions and conclusions for the specific questions, are written by James Phillips, and the responses to commentaries are written by Allen Frances. (shrink)

Reflection in medical education is becoming more widespread. Drawing on our Jesuit Catholic heritage, the Loyola University Chicago Stritch School of Medicine incorporates reflection in its formal curriculum and co–curricular programs. The aim of this type of reflection is to help students in their formation as they learn to step back and analyze their experiences in medical education and their impact on the student. Although reflection is incorporated through all four years of our undergraduate medical curriculum, this essay will focus (...) on three areas where bioethics faculty and medical educators have purposefully integrated reflection in the medical school, specifically within our bioethics education and professional development efforts: 1) in our three–year longitudinal clinical skills course Patient Centered Medicine (PCM), 2) in our co–curricular Bioethics and Professionalism Honors Program, and 3) in our newly created Physician’s Vocation Program (PVP). (shrink)

This paper concerns the ontological status of ontological categories (e.g., universal, particular, substance, property, relation, kind, object, etc.). I consider E.J. Lowe’s argument for the view that ontological categories do not exist and point out that it has some undesirable consequences for his realist ontology. I go on to argue that the main premise in Lowe’s argument—that ontological categories cannot be categorized—is false and then develop a conception of ontological categories as formal ontological kinds.

I criticize the idea that theories of ‘fragmented’ or ‘compartmentalized’ belief (as found in, e.g., Lewis 1982, Egan 2008) can help to account for the puzzling phenomena they are often taken to account for. After introducing fragmentationalism and a paradigm case that purportedly motivates it, I criticize the view primarily on the grounds that the models and explanations it offers are at best trivial—as witnessed by examples of over-generation—and should be seen as merely re-describing in figurative terms the phenomena it (...) is designed to account for. I also point out that fragments, as used in these theories, are not likely to be psychologically real in any robust sense and so cannot be appealed to on such grounds. (shrink)