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.

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)

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 will take up the first two questions. With the first question, invited commentators express a range of opinion regarding the nature of psychiatric disorders, loosely divided into a realist position that the diagnostic categories represent real diseases that we can accurately name and know with our perceptual abilities, a middle, nominalist position that psychiatric disorders do exist in the real world but that our diagnostic categories are constructs that may or may not accurately represent the disorders out there, and finally a purely constructivist position that the diagnostic categories are simply constructs with no evidence of psychiatric disorders in the real world. The second question again offers a range of opinion as to how we should define a mental or psychiatric disorder, including the possibility that we should not try to formulate a definition. 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)

After outlining an enactive account of fact perception, I consider J. L. Austin's discussion of the argument from illusion. From it I draw the conclusion that when fact perception is primary the objects perceived are those involved in the fact. A consideration of Adelson's checkershadow illusion shows that properties as basic as luminance are perceived in the contexts of facts as well. I thus conclude that when facts are perceived they structure our perception of objects and properties. I then argue (...) that which facts are perceived is determined by contexts which are themselves determined by our interests. Here I appeal to Heidegger's views on everyday coping as a foundational form of intentional directedness. A discussion of Simons and Chabris? gorilla experiment provides contemporary empirical support of the Heideggerian analysis. Finally, I argue that there cannot be context-free perception on the enactive account inasmuch as perception, qua action, is always permeated with the interests of the subject. (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)

Part of Sellars's general attack on the Myth of the Given is his endorsement of psychological nominalism, a view that implies that awareness of our own mental states is not given but must be earned. Sellars provides an account of how such awareness might have been earned with the Myth of Jones. Such an account is important for Sellars, for without it the Given can look necessary after all. But a problem with such accounts is that they can look extremely (...) implausible. Sellars himself seems unconcerned to make his account plausible, and so others have stepped in here. But, I argue, they have done so in ways that fail to respect his psychological nominalism. This evinces, as well as reinforces, a lack of sensitivity to the scope of Sellars's attack on the Given, the aim of which is the dismantling of “the entire framework of givenness.” In this essay, I show how one can make Sellars's Myth of Jones plausible, while still respecting his psychological nominalism, by seeing how Jones's thought is governed by the norms of rationality as interpretability. (shrink)

At the head of The Colbert Report, one of the most popular shows on television, Stephen Colbert is a pop culture phenomenon. More than one million people backed his fake candidacy in the 2008 U.S. presidential election on Facebook, a testament to the particularly rich set of issues and emotions Colbert brings to mind. Stephen Colbert and Philosophy is crammed with thoughtful and amusing chapters, each written by a philosopher and all focused on Colbert's inimitable reality — from his word (...) creations (truthiness, wikiality, freem, and others) to his position as a faux-pundit who openly mocks Fox News and CNN. Although most of the discussion is centered around The Colbert Report, this collection does not neglect either his best-selling book, I Am America (And So Can You!), or his public performances, including his incendiary 2006 White House Press Correspondents' Dinner speech. (shrink)

It is not uncommon to hear that poor school performance, welfare dependancy, youth unemployment, and criminal activity result more from shortcomings in the personal makeup of individuals than from societal forces beyond their control. Are American values declining as so many suggest? And are those values at the root of many social problems today?Shaped by experience and public policies, people's values and social norms do change. What role can or should a democratic government play in shaping values? And how do (...) these values conditon the efficacy of public policy?In this book, six distinguished social scientists identify trends in America's values and their consequences, and consider public policy tools with which some of those values might be changed.Daniel Yankelovich begins with a discussion of how American values have shifted in the last half-century, and argues that affluence is the driving force behind these changes in values. James Q. Wilson argues that destructive habits which can lead to social pathologies, like crime and drug use, are set early in life; he examines how public policy might intervene when children are young to promote better values. David Popenoe maintains that America has veered too far towards industrialist values, and explores the resulting decline of families and many attendant social ills. Nathan Glazer describes the history and present status of the dispute over multicultural education. Jane Mansbridge examines the process of building cooperation, consensus, and public spirit. And George Akerlof and Janet L. Yellen discuss the problem of gang criminality.Inthe past, social scientists have often sidestepped questions about values as undefinable, unquantifiable, and somehow unscientific. The essays in this volume address these questions at last.Henry J. Aaron, director of the Economic Studies program at Brookings, is the authorof numerous books, including most recently Serious and Unstable Condition: Financing America's Health Care (1991), and coeditor of Setting Domestic Priorities (1992). Thomas E. Mann is director of the Brookings Governmental Studies program, coeditor of Media Polls in American Politics (1992), and coauthor of the Renewing Congress series (1993). Timothy Taylor is managing editor of the Journal of Economic Perspectives at Stanford University. (shrink)

Is there a contradiction in Stephen Colbert’s attitudes towards race? How can he consistently claim to be colorblind and yet hold a national search for a new "black friend"? I argue that Stephen is trying to claim rights and shirk responsibilities on matters of race relations in America, and that his famous notion of "truthiness" is an extension of this attitude to other areas of social and political discourse.

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)

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 1 of this article took up the first two questions. Part 2 took up the second two questions. Part 3 now deals with Questions 5 & 6. Question 5 confronts the issue of utility, whether the manual design of DSM-III and IV favors clinicians or researchers, and what that means for DSM-5. Our final question, Question 6, takes up a concluding issue, whether the acknowledged problems with the earlier DSMs warrants a significant overhaul of DSM-5 and future manuals. As in Parts 1 & 2 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)

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)

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...

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)

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)

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.

It has become increasingly difficult for individuals to exercise meaningful control over the personal data they disclose to companies or to understand and track the ways in which that data is exchanged and used. These developments have led to an emerging consensus that existing privacy and data protection laws offer individuals insufficient protections against harms stemming from current data practices. However, an effective and ethically justified way forward remains elusive. To inform policy in this area, we propose the Ethical Data (...) Practices framework. The framework outlines six principles relevant to the collection and use of personal data—minimizing harm, fairly distributing benefits and burdens, respecting autonomy, transparency, accountability, and inclusion—and translates these principles into action-guiding practical imperatives for companies that process personal data. In addition to informing policy, the practical imperatives can be voluntarily adopted by companies to promote ethical data practices. (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)

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 US has found it hard to establish competition in the market for biologics, which are therapeutics derived from living cells. In the case of small-molecule drugs, the emergence of direct competition from generic drugs at the end of the exclusivity period has provided the impetus for price competition, leading to lower spending. In 2010, to spur competition in the biologics market, Congress created a simplified pathway for the US Food and Drug Administration (FDA) to approve comparable versions of biologic (...) drugs called biosimilars. Biosimilar competition in the US has nonetheless remained weaker than in European peer countries. For example, as of August 2020, there were 52 biosimilars available in Germany, and only 15 in the US.1 An important contributor to this “biosimilar gap” has been the fact that biosimilars to biologic blockbusters such as adalimumab (Humira) and etanercept (Enbrel) were only (or will only become) commercially available in the US several years after receiving FDA approval, while they were available in Europe years earlier.2 Through the end of 2021, it took biosimilars a median of 301 days between receiving FDA approval and becoming available for use.3 In one recent study, the median length of time between when a biologic drug was approved and when its first biosimilar was made available to US patients was 21.5 years.4 This paucity of competition has contributed to high US spending on biologics. According to the Department of Health and Human Services, in 2022 41% of US drug expenditures was spent on biologics, which represented 16% of US prescriptions.5. (shrink)

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)

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)

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)

The discovery and development of new therapeutics has always been central to improving health worldwide. However, there is ongoing concern regarding the current state of medical innovation. Output from the pharmaceutical industry has been criticized for not being “transformative,” that is, offering substantial improvements in patient outcomes over existing therapeutics. While the cost of drug development continues to rise, breakthrough therapies remain elusive and one half of Phase 3 studies fail. Venture capital, a traditional source of funding for new breakthrough (...) biomedical innovations, has decreased investment by 30% in the biotechnology and medical device sectors from 2007 to 2013. Stakeholders question whether the new drugs approved each year by the FDA —many criticized as marginal improvements over existing therapies — justify the enormous investment. (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.

In many countries, health technology assessment organizations determine the economic value of new drugs and make recommendations regarding appropriate pricing and coverage in national health systems. In the US, recent policy proposals aimed at reducing drug costs would link drug prices to six countries: Australia, Canada, France, Germany, Japan, and the UK. We reviewed these countries’ methods of HTA and guidance on price and coverage recommendations, analyzing methods and guidance documents for differences in the methodologies HTA organizations use to conduct (...) their evaluations and considerations they use when making recommendations. We found important differences in the methods, interpretations of HTA findings, and condition-specific carve-outs that HTA organizations use to conduct evaluations and make recommendations. These variations have ethical implications because they influence the recommendations of HTA organizations, which affect access to the drug through national insurance and price negotiations with manufacturers. The differences in HTA approaches result from the distinct political, social, and cultural contexts of each organization and its value judgments. New cost-containment policies in the US should consider the ethical implications of the HTA reviews that they are considering relying on to negotiate drug prices and what values should be included in US pricing policy. (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.

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.

Glucagon-like peptide-1 receptor agonists are effective for treating obesity, but the high cost of these medications endangers the financial viability of our health care system. To ensure that these drugs are available to Medicare beneficiaries, pharmaceutical manufacturers must lower their prices.

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)

Conflicts of Interest and the Future of Medicine: The United States, France, and Japan Content Type Journal Article Category Book Review Pages 383-386 DOI 10.1007/s11673-011-9326-y Authors Adam Licurse, Division of Internal Medicine, Department of Medicine, Brigham and Women’s Hospital, Boston, MA, USA Aaron S. Kesselheim, Harvard Medical School, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, 1620 Tremont St. Suite 3030, Boston, MA, USA Journal Journal of Bioethical Inquiry Online ISSN 1872-4353 Print ISSN 1176-7529 Journal (...) Volume Volume 8 Journal Issue Volume 8, Number 4. (shrink)