The “right to repair” movement highlights opportunities to reduce health care costs and promote public health resilience through increased competition in the way in which medical devices are serviced and updated over their lifespan. We review legislative and legal facets of third-party repair of medical devices, and conclude with specific recommendations to help this market function more efficiently to the benefit of patients and health care systems.

The Covid‐19 pandemic highlighted the need to examine public trust in the U.S. Food and Drug Administration (FDA) vaccine approval process and the role of political influence in the FDA's decisions. Ensuring that the FDA is itself trustworthy is important for justifying public trust in its actions, like vaccine approvals, thereby promoting public health. We propose five conditions of trustworthiness that the FDA should meet when it reviews vaccines, even during emergencies: consistency with rules, proper expert or political decision‐makers, proper (...) decision‐making and noninterference, connection to public preference, and transparency of both reasons and procedures. The five conditions provide a road map of procedural and substantive requirements, which the FDA has variably implemented, focused on ensuring appropriate influence of political interests. While being a trustworthy agency cannot guarantee the public's trust, implementing these conditions builds a groundwork for public trust. (shrink)

Public discussions of political and social issues are often characterized by deep and persistent polarization. In social psychology, it’s standard to treat belief polarization as the product of epistemic irrationality. In contrast, we argue that the persistent disagreement that grounds political and social polarization can be produced by epistemically rational agents, when those agents have limited cognitive resources. Using an agent-based model of group deliberation, we show that groups of deliberating agents using coherence-based strategies for managing their limited resources tend (...) to polarize into different subgroups. We argue that using that strategy is epistemically rational for limited agents. So even though group polarization looks like it must be the product of human irrationality, polarization can be the result of fully rational deliberation with natural human limitations. (shrink)

ABSTRACT This article distinguishes nine senses of polarization and provides formal measures for each one to refine the methodology used to describe polarization in distributions of attitudes. Each distinct concept is explained through a definition, formal measures, examples, and references. We then apply these measures to GSS data regarding political views, opinions on abortion, and religiosity—topics described as revealing social polarization. Previous breakdowns of polarization include domain-specific assumptions and focus on a subset of the distribution’s features. This has conflated multiple, (...) independent features of attitude distributions. The current work aims to extract the distinct senses of polarization and demonstrate that by becoming clearer on these distinctions we can better focus our efforts on substantive issues in social phenomena. (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)

ObjectiveCochlear explantation for purely elective (e.g. psychological and emotional) reasons is not well studied. Herein, we aim to provide data and expert commentary about elective cochlear implant (CI) removal that may help to guide clinical decision-making and formulate guidelines related to CI explantation.Data sourcesWe address these objectives via three approaches: case report of a patient who desired elective CI removal; review of literature and expert discussion by surgeon, audiologist, bioethicist, CI user and member of Deaf community.Review methodsA systematic review using (...) three scientific online databases was performed. Included articles addressed the benefits and/or complications of cochlear implantation in young children, CI explantation with or without revision surgery and the ethical debate between the medical and Deaf communities on cochlear implantation and explantation.ConclusionsThe medical and audiological perspectives identify a host of risks related to implant removal without reimplantation, including risk from surgery, general anaesthesia, cochlear ossification and poor audiometric outcomes. The member of the deaf community and bioethicist argue that physicians need to guide the principles of beneficence, non-maleficence and patient autonomy. Taken together, patient desires should be seen as paramount, if the patient is otherwise fit for surgery and well informed.Implications for practiceSimilar to the case of device implantation, device explantation should be a multidisciplinary and collaborative decision with the patient and the family’s desires at the centre. While every case is different, we offer a CI explantation discussion to assist in clinical decision-making, patient counselling and education. (shrink)

Moses Maimonides' Guide of the Perplexed is the greatest and most influential text in the history of Jewish philosophy. Controversial in its day, the Guide directly influenced Aquinas, Spinoza, and Leibniz, and the history of Jewish philosophy took a decisive turn after its appearance. While there continues to be keen interest in Maimonides and his philosophy, this is the first scholarly collection in English devoted specifically to the Guide. It includes contributions from an international team of scholars addressing the most (...) important philosophical themes that range over the three parts of this sprawling work - including topics in the philosophy of language, metaphysics, epistemology, philosophy of law, ethics, and political philosophy. There are also essays on the Guide's hermeneutic puzzles, and on its overall structure and philosophical trajectory. The volume will be of interest to philosophers, Judaists, theologians, and medievalists. (shrink)

A new translation of two essential works on Deleuze, written by one of his contemporaries. From the publication of Deleuze: A Philosophy of the Event to his untimely death in 2006, Francois Zourabichvili was regarded as one of the most important new voices of contemporary philosophy in France. His work continues to make an essential contribution to Deleuze scholarship today. This edition makes two of Zourabichvili's most important writings on the philosophy of Gilles Deleuze available in a single volume. A (...) Philosophy of the Event is an exposition of Deleuze's philosophy as a whole, while the complementary Deleuze's Vocabulary approaches Deleuze's work through an analysis of key concepts in a dictionary form. This new translation is set to become an event within Deleuze Studies for many years to come. Key Features: Distinguishes Deleuze's notion of the event from the phenomenological, ontological and voluntarist conceptions that continue to lay claim to it today; With an introduction by Gregg Lambert and Daniel W. Smith, two of the world's leading commentators on Deleuze, explaining the key themes and arguments of Zourabichvili's work. (shrink)

The Hong and Page ‘diversity trumps ability’ result has been used to argue for the more general claim that a diverse set of agents is epistemically superior to a comparable group of experts. Here we extend Hong and Page’s model to landscapes of different degrees of randomness and demonstrate the sensitivity of the ‘diversity trumps ability’ result. This analysis offers a more nuanced picture of how diversity, ability, and expertise may relate. Although models of this sort can indeed be suggestive (...) for diversity policies, we advise against interpreting such results overly broadly. (shrink)

We explain how the work of Charles Sanders Peirce (1839–1914) – the founder of semiotics and of the pragmatist tradition in philosophy – contributes an epistemological, metaphysical, and ethical foundation to some key transhumanist ideas, including the following claims: technological cognitive enhancement is not only possible but a present reality; pursuing more sweeping cognitive enhancements is epistemically rational; and current humans should try to evolve themselves into posthumans. On Peirce’s view, the fundamental aim of inquiry is truth, understood in terms (...) of a stage of ideal cognition (what he calls the “final opinion”). As current human cognitive abilities are insufficient to achieve this stage, Peirce’s views on cognition support a variety of ways in which they might be enhanced. Finally, we argue that what Peirce describes as our ethical summum bonum seems remarkably similar to what Bostrom (2005) argues to be the core transhumanist value: “the exploration of the posthuman realm.”. (shrink)

In this astonishingly rich volume, experts in ethics, epistemology, philosophy of mind, political theory, aesthetics, history, critical theory, and hermeneutics bring to light the best philosophical scholarship on what is arguably Nietzsche's most rewarding but most challenging text. Including essays that were commissioned specifically for the volume as well as essays revised and edited by their authors, this collection showcases definitive works that have shaped Nietzsche studies alongside new works of interest to students and experts alike. A lengthy introduction, annotated (...) bibliography, and index make this an extremely useful guide for the classroom and advanced research. (shrink)

ABSTRACT:A wide range of research uses patterns of genetic variation to infer genetic similarity between individuals, typically referred to as genetic ancestry. This research includes inference of human demographic history, understanding the genetic architecture of traits, and predicting disease risk. Researchers are not just structuring an intellectual inquiry when using genetic ancestry, they are also creating analytical frameworks with broader societal ramifications. This essay presents an ethics framework in the spirit of virtue ethics for these researchers: rather than focus on (...) rule following, the framework is designed to build researchers’ capacities to react to the ethical dimensions of their work. The authors identify one overarching principle of intellectual freedom and responsibility, noting that freedom in all its guises comes with responsibility, and they identify and define four principles that collectively uphold researchers’ intellectual responsibility: truthfulness, justice and fairness, anti-racism, and public beneficence. Researchers should bring their practices into alignment with these principles, and to aid this, the authors name three common ways research practices infringe these principles, suggest a step-by-step process for aligning research choices with the principles, provide rules of thumb for achieving alignment, and give a worked case. The essay concludes by identifying support needed by researchers to act in accord with the proposed framework. (shrink)

This volume contains thirteen papers that were presented at the 2017 Annual Meeting of the Canadian Society for History and Philosophy of Mathematics/Société canadienne d’histoire et de philosophie des mathématiques, which was held at Ryerson University in Toronto. It showcases rigorously reviewed modern scholarship on an interesting variety of topics in the history and philosophy of mathematics from Ancient Greece to the twentieth century. A series of chapters all set in the eighteenth century consider topics such as John Marsh’s techniques (...) for the computation of decimal fractions, Euler’s efforts to compute the surface area of scalene cones, a little-known work by John Playfair on the practical aspects of mathematics, and Monge’s use of descriptive geometry. After a brief stop in the nineteenth century to consider the culture of research mathematics in 1860s Prussia, the book moves into the twentieth century with an examination of the historical context within which the Axiom of Choice was developed and a paper discussing Anatoly Vlasov’s adaptation of the Boltzmann equation to ionized gases. The remaining chapters deal with the philosophy of twentieth-century mathematics through topics such as an historically informed discussion of finitism and its limits; a reexamination of Mary Leng’s defenses of mathematical fictionalism through an alternative, anti-realist approach to mathematics; and a look at the reasons that mathematicians select specific problems to pursue. Written by leading scholars in the field, these papers are accessible to not only mathematicians and students of the history and philosophy of mathematics, but also anyone with a general interest in mathematics. (shrink)

In a series of formal studies and less formal applications, Hong and Page offer a ‘diversity trumps ability’ result on the basis of a computational experiment accompanied by a mathematical theorem as explanatory background (Hong & Page 2004, 2009; Page 2007, 2011). “[W]e find that a random collection of agents drawn from a large set of limited-ability agents typically outperforms a collection of the very best agents from that same set” (2004, p. 16386). The result has been extremely influential as (...) an epistemic justification for diversity policy initiatives. Here we show that the ‘diversity trumps ability’ result is tied to the particular random landscape used in Hong and Page’s simulation. We argue against interpreting results on that random landscape in terms of ‘ability’ or ‘expertise.’ These concepts are better modeled on smother and more realistic landscapes, but keeping other parameters the same those are landscapes on which it is groups of the best performing that do better. Smoother landscapes seem to vindicate both the concept and the value of expertise. Change in other parameters, however, also vindicates diversity. With an increase in the pool of available heuristics, diverse groups again do better. Group dynamics makes a difference as well; simultaneous ‘tournament’ deliberation in a group in place of the ‘relay’ deliberation in Hong and Page’s original model further emphasizes an advantage for diversity. ‘Tournament’ 2 dynamics particularly shows the advantage of mixed groups that include both experts and non-experts. As a whole, our modeling results suggest that relative to problem characteristics and conceptual resources, the wisdom of crowds and the wisdom of the few each have a place. We regard ours as a step toward attempting to calibrate their relative virtues in different modelled contexts of intellectual exploration. (shrink)

Alison Gopnik and her collaborators have recently proposed a bold and intriguing hypothesis about the relationship between scientific cognition and cognitive development in childhood. According to this view, the processes underlying cognitive development in infants and children and the processes underlying scientific cognition are _identical_. We argue that Gopnik’s bold hypothesis is untenable because it, along with much of cognitive science, neglects the many important ways in which human minds are designed to operate within a social environment. This leads to (...) a neglect of _norms_ and the processes of _social_ _transmission_ which have an important effect on scientific cognition and cognition more generally. (shrink)

This article aims to describe the last 10 years of the collaborative scientific endeavors on polarization in particular and collective problem-solving in general by our multidisciplinary research team. We describe the team’s disciplinary composition—social psychology, political science, social philosophy/epistemology, and complex systems science— highlighting the shared and unique skill sets of our group members and how each discipline contributes to studying polarization and collective problem-solving. With an eye to the literature on team dynamics, we describe team logistics and processes that (...) we believe make our multidisciplinary team persistent and productive. We emphasize challenges and difficulties caused by disciplinary differences in terms of terminology, units/levels of analysis, methodology, and theoretical assumptions. We then explain how work disambiguating the concepts of polarization and developing an integrative theoretical and methodological framework with complex systems perspectives has helped us overcome these challenges. We summarize the major findings that our research has produced over the past decade, and describe our current research and future directions. Last, we discuss lessons we have learned, including difficulties in a “three models” project and how we addressed them, with suggestions for effective multidisciplinary team research. (shrink)

Ibn Mattawayh, al-Tadhkira fī aḥkām al-jawāhir wa-l-aʿrāḍ. Edited by Daniel Gimaret. 2 vols. Cairo: IFAO, 2009. Pp. 818. €89. Kausalität in der muʿtazilitischen Kosmologie: Das Kitāb al-Muʾaṯṯirāt wa-miftāḥ al-muškilāt des Zayditen al-Ḥasan ar-Raṣṣāṣ. By Jan Thiele. Islamic Philosophy, Theology, and Science, vol. 84. Leiden: Brill, 2011. Pp. x + 155 + 57. $136.

Traditionally, theories of concepts in psychology assume that concepts are a single, uniform kind of mental representation. But no single kind of representation can explain all of the empirical data for which concepts are responsible. I argue that the assumption that concepts are uniformly the same kind of mental structure is responsible for these theories’ shortcomings, and outline a pluralist theory of concepts that rejects this assumption. On pluralism, concepts should be thought of as being constituted by multiple representational kinds, (...) with the particular kind of concept used on an occasion being determined by the context. I argue that endorsing pluralism does not lead to eliminativism about concepts as an object of scientific interest. (shrink)

In Sounds, Ecologies, Musics, authors pose exciting challenges and provide fresh opportunities for scholars, scientists, environmental activists, and musicians to consider music and sound from ecological standpoints. The book covers topics such as how environment enables music and sound, how music and sound relate to Western environmental science, and mutidisciplinary collaborations among scholars.

Philosophers have historically been concerned with concepts and their analysis, and in recent decades psychologists have also begun to speculate on what kinds of structures concepts might be. I take concepts to satisfy three core desiderata: they are mental representations, they are the constituents of thoughts, and they are centrally employed in categorization. There are four major theories of concepts currently in play: definitionism, prototype and exemplar theory, the 'theory theory', and conceptual atomism. I survey these theories and argue that (...) none of them adequately satisfies all three of the core properties. The reasons for these failures are principled, and generalize to many other positions that share their assumptions. Concepts do not form a unitary psychological natural kind. I propose taking a pluralist view of concepts. Conceptual representations are adaptively constructed and used by a set of processes that vary with elements of the task, subject, domain, and wider context. (shrink)

Svirsky, Howard, and Berman address the U.S. Food and Drug Administration ’s oversight of tobacco products, the newest major area of regulation Congress assigned to the FDA. They discus...

Propositional attitude verbs, such as think and want, have long held interest for both theoretical linguists and language acquisitionists because their syntactic, semantic, and pragmatic properties display complex interactions that have proven difficult to fully capture from either perspective. This paper explores the granularity with which these verbs’ semantic and pragmatic properties are recoverable from their syntactic distributions, using three behavioral experiments aimed at explicitly quantifying the relationship between these two sets of properties. Experiment 1 gathers a measure of 30 (...) propositional attitude verbs’ syntactic distributions using an acceptability judgment task. Experiments 2a and 2b gather measures of semantic similarity between those same verbs using a generalized semantic discrimination task and an ordinal scale task, respectively. Two kinds of analyses are conducted on the data from these experiments. The first compares both the acceptability judgments and the semantic similarity judgments to previous classifications derived from the syntax and semantics literature. The second kind compares the acceptability judgments to the semantic similarity judgments directly. Through these comparisons, we show that there is quite fine-grained information about propositional attitude verbs’ semantics carried in their syntactic distributions—whether one considers the sorts of discrete qualitative classifications that linguists traditionally work with or the sorts of continuous quantitative classifications that can be derived experimentally. (shrink)

Through an absorbing investigation into recent, high-profile scandals involving one of the largest kosher slaughterhouses in the world, located unexpectedly in Postville, Iowa, Aaron S. Gross makes a powerful case for elevating the category of the animal in the study of religion. Major theorists have almost without exception approached religion as a phenomenon that radically marks humans off from other animals, but Gross rejects this paradigm, instead matching religion more closely with the life sciences to better theorize human nature. Gross (...) begins with a detailed account of the scandals at Agriprocessors and their significance for the American and international Jewish community. He argues that without a proper theorization of "animals and religion," we cannot fully understand religiously and ethically motivated diets and how and why the events at Agriprocessors took place. Subsequent chapters recognize the significance of animals to the study of religion in the work of Ernst Cassirer, Emile Durkheim, Mircea Eliade, Jonathan Z. Smith, and Jacques Derrida and the value of indigenous peoples' understanding of animals to the study of religion in our daily lives. Gross concludes by extending the Agribusiness scandal to the activities at slaughterhouses of all kinds, calling attention to the religiosity informing the regulation of "secular" slaughterhouses and its implications for our relationship with and self-imagination through animals. (shrink)

Only 19 new molecular entities and 3 biologics were approved by the Food and Drug Administration in 2007, the lowest rate in 24 years. This disappointing output occurred despite steady clinical trial and regulatory review times, the FDA maintaining high approval rates, and the pharmaceutical industry consistently reporting increasing revenues. A government report suggests that fewer new drug applications have been submitted to the FDA by the pharmaceutical industry in recent years. These data have rekindled the debate as to the (...) origins of pharmaceutical innovation and the comparative importance of public and private sources in contributing to drug discovery. The pharmaceutical industry contends that its research is responsible for most new medicines, and that the primary public institution supporting U.S. biomedical research, the National Institutes of Health, supports medical innovation “distinct from the process of drug development.”. (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)

Though many more patents emerge from industry sources, drug-related patents generated in the non-profit setting appear to have greater importance than patents arising from the commercial sector, which helps demonstrate the value non-profit research institutions can have in driving drug development.

The US government supports drug innovation. It is therefore crucial that it distinguish between high-value and low-value innovation in purchasing expensive prescription drugs and medical devices and ensure the continued discovery of transformative drugs and that patient and taxpayer funds are not wasted.

Teachers not only serve as caretakers for the students in their classroom but also serve as stewards for society's next generation. In this way, teachers are charged with responsibility for the present and the future of their world. Shouldering this responsibility is no less than an existential dilemma that requires not only professional solutions but also personal responsibility rooted in subjective authenticity. In the edited volume, authors will explore how the philosophy of Existentialism can help teachers, teacher educators, educational researchers, (...) and policymakers better understand the existential responsibility that teachers shoulder. The core concepts of Existential philosophy explored in this edited volume imply that a teacher's lived experience cannot be defined solely by professional knowledge or dictates. Teachers have the capacity to create subjective meaning through their own agency, and there is no guarantee that those subjective meanings will accord with professional dictates. Furthermore, there is no guarantee that professional dictates are more valid than the existential realities of individual teachers. The philosophy of Existentialism encourages individuals to reflect on the existential realities of isolation, freedom, meaninglessness, and death in an effort to propel individuals towards more authentic ways of engaging in the world. The chapters of this edited volume advance the argument that being and becoming a teacher must be understood - at least in part - from the subjective perspective of the individual and that teachers are responsible for authoring the meaning of their lives and of their work. (shrink)

Glenberg's theory is rich and provocative, in our view, but we find fault with the premise that all memory representations are embodied. We cite instances in which that premise mispredicts empirical results or underestimates human capabilities, and we suggest that the motivation for the embodiment idea – to avoid the symbol-grounding problem – should not, ultimately, constrain psychological theorizing.

From the earliest application of modern randomized controlled trials in medical research, scientists and observers have deliberated the ethics of randomly allocating study participants to trial control arms. Adaptive RCT designs have been promoted as ethically advantageous over conventional RCTs because they reduce the allocation of subjects to what appear to be inferior treatments. Critical assessment of this claim is important, as adaptive designs are changing medical research, with the potential to significantly shift how clinical trials are conducted. Policy-makers are (...) swiftly moving to encourage greater use of adaptive designs. In 2016, the newly enacted 21st Century Cures Act instructed the Food and Drug Administration to help product sponsors incorporate adaptive methods into proposed clinical trial protocols and applications for investigational drugs and also biological products. In this article, we review the ethical justifications commonly offered for adaptive designs, explore these arguments in the context of actual trials, and contend that clinical equipoise is a useful standard for adaptive-trial ethics. We distinguish between theoretical and clinical equipoise and explain why ethical arguments related to adaptive trials tend to focus on the former. Yet we contend that theoretical equipoise can be an unreliable standard for adaptive ethics. While we contend that clinical equipoise is the most critical principle for the primary ethical concerns posed by adaptive trials, we suggest ethical approaches to deal with some additional concerns unique to adaptive designs. (shrink)

The rising cost of the opioid antagonist and overdose reversal agent naloxone is an urgent public health problem. The recent and dramatic price increase of Evzio, a naloxone auto-injector produced by Kaléo, shows how pharmaceutical manufacturers entering the naloxone marketplace rely on market exclusivity guaranteed by the patent system to charge prices at what the market can bear, which can restrict access to life-saving medication. We argue that 28 U.S.C. § 1498, a section of the federal code that allows the (...) government to use patent-protected products for its own purposes in exchange for reasonable compensation, could be used to procure generic naloxone auto-injectors, or at least bring Kaléo to the negotiating table. Precedent exists for the use of § 1498 to procure pharmaceuticals, and it could give meaning to the federal government's recent declaration of a public health emergency around the opioid epidemic, discourage new market entrants from charging exorbitant prices, and yield important public health benefits. (shrink)

Many hold that the so-called golden era of antibiotic discovery has passed, leaving only a limited clinical pipeline for new antibiotics. A logical conclusion of such arguments is that we need to reform the current system of antibiotic drug research—including clinical trials and regulatory requirements—to spur activity in discovery and development. The United States Congress in the past few years has debated a number of bills to address this crisis, including the 2012 Generating Antibiotic Incentives Now Act and the 2016 (...) 21st Century Cures Act. Experts have also sought to advance antibiotic development by encouraging greater use of trials with noninferiority hypotheses, which are thought to be easier to conduct. The goal underlying these proposals is to stave off the post-antibiotic era by expanding the pharmaceutical armamentarium as quickly as possible. But although new antibiotic agents are necessary to combat the long-term threat of drug-resistant disease, we argue that these research policies, which effectively lower the bar for antibiotic approval, are ethically problematic. Rather, given broader public health considerations related to the full lifecycle of antibiotic use—including development of resistance—we should reject an overly permissive approach to new antibiotic approval and instead set the bar for regulatory approval at a point that will naturally direct research resources toward the most transformative chemical or social interventions. (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)

Legal challenges to the FDA’s approval of mifepristone have destabilized patients’ ability to access controversial medicines like medication abortion. We argue that federal courts’ receptiveness to this litigation undermines the coherence and integrity of prescription drug regulation in the U.S.

Over-the-counter drugs are ubiquitous in the US. Policymakers have long debated how to modernize the system for making determinations of safety and effectiveness and addressing safety issues with OTC drugs.

Effective medical innovation is a common goal of policymakers, physicians, researchers, and patients both in the private and public sectors. With the recent slowdown in approval of new transformative prescription drugs, many have looked back to the “golden years” of the 1980s and 1990s when numerous breakthrough products emerged. We conducted a qualitative study of innovators directly involved in creation of groundbreaking drugs during that era to determine what made their work successful and how the process of conducting medical innovation (...) has changed over the past 3 decades. Transcripts were analyzed using standard coding techniques and the constant comparative method of qualitative data analysis to identify the positive features of and challenges posed by the past and present therapeutic innovation environments . Interviewees emphasized the continued central role played by individuals and the institutions they were a part of in driving innovation. In addition, respondents discussed the importance of collaboration between individuals and institutions to share resources and expertise. Strong underlying basic science was also cited to be a major contributing factor to the success of an innovation. The climate for modern-day medical innovation involves a greater emphasis on patenting in academia, difficulty negotiating the technology transfer process, and funding constraints. Regulatory demands or reimbursement concerns were not commonly cited as factors that influenced transformative innovation. This study suggests that generating future transformative innovation will require a simplification of the current technology transfer process, continued commitment to basic science research, and policy changes that promote meaningful collaboration between individuals from disparate institutions. (shrink)