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)

This book assesses how Vatican II opened up the Catholic Church to encounter, dialogue, and engagement with other world religions. Opening with a contribution from the President of the Pontifical Council for Interreligious Dialogue, Cardinal Jean-Louis Tauran, it next explores the impact, relevance, and promise of the Declaration Nostra Aetate before turning to consider how Vatican II in general has influenced interfaith dialogue and the intellectual and comparative study of world religions in the postconciliar decades, as well as the contribution (...) of particular past and present thinkers to the formation of current interreligious and comparative theological methods. Additionally, chapters consider interreligious dialogue vis-à-vis theological anthropology in conciliar documents; openness to the spiritual practices of other faith traditions as a way of encouraging positive interreligious encounter; the role of lay and new ecclesial movements in interreligious dialogue; and the development of Monastic Interreligious Dialogue. Finally, it includes a range of perspectives on the fruits and future of Vatican’s II’s opening to particular faiths such as Judaism, Islam, Hinduism, and Buddhism. (shrink)

Analyzing Mediumistic Mentation - Alvarado Proposal for Short List of Best Papers in Parapsychology - Levin Kauffman Stokes.

Entomophagy—the practice of eating insects—has been touted as a means to combat undernutrition and food insecurity globally. Insects offer a nutritious, environmentally friendly alternative to resource-intensive livestock. But the benefits of edible insects cannot be realized if people do not choose to eat them. We therefore examine the social acceptability of edible insects in rural Zambia, where entomophagy is common but underexplored. Through a village case study, we show that edible insects are not valued equally, are understood socially, and seem (...) to reflect and reinforce social values. We utilize grounded theory and ethnographic methods, including semi-structured interviews, focus groups, and observation to examine collective entomophagy beliefs. While we expected to see differentiation in perceptions across groups based on kinship, we demonstrate that social values related to class, urbanism, gender, and age emerge as more germane explanations for entomophagy perceptions, reflecting their social weight. By expanding on current apperception of entomophagy behavior, our findings inform future research and efforts to promote entomophagy through minilivestock farming. Systems designed to maximize output, minimize labor, and highlight benefits are more likely to be widely accepted. We do not anticipate tribal association will be the primary limitation on minilivestock adoption in this context. (shrink)

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)

Correspondence in Nature Human Behaviour.

Humanist sociologists are activists rooted in the reality of history and change and guided by a concern for the 'real life' problems of equality, peace, and social justice. They view people as active shapers of social life, capable of creating societies in which everyone's potential can unfold. Alfred McClung Lee introduces this volume with 'Sociology: Humanist and Scientific' and develops the theme that a sociology that is humanist is also scientific. The other nine selections are grouped into four parts: 'The (...) Individual and Social Life;' 'Social Institutions: Technology, Science, and Formal Organization;' 'Political Structures: Issues of Justice and Equality;' and 'Methodological Critiques and Counterproposals.'. (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)

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)

Negligence is a problematic basis for being morally blamed and punished for having caused some harm, because in such cases there is no choice to cause or allow—or risk causing or allowing—such harm to occur. The standard theories as to why inadvertent risk creation can be blameworthy despite the lack of culpable choice are that in such cases there is blame for: (1) an unexercised capacity to have adverted to the risk; (2) a defect in character explaining why one did (...) not advert to the risk; (3) culpably acquiring or failing to rid oneself of these defects of character at some earlier time; (4) flawed use of those practical reasoning capacities that make one the person one is; or (5) chosen violation of per se rules about known precautions. Although each of these five theories can justify blame in some cases of negligence, none can justify blame in all cases intuitively thought to be cases of negligence, nor can any of these five theories show why inadvertent creation of an unreasonable risk, pure and simple, can be blameworthy. (shrink)

Negligence is a problematic basis for being morally blamed and punished for having caused some harm, because in such cases there is no choice to cause or allow—or risk causing or allowing—such harm to occur. The standard theories as to why inadvertent risk creation can be blameworthy despite the lack of culpable choice are that in such cases there is blame for: (1) an unexercised capacity to have adverted to the risk; (2) a defect in character explaining why one did (...) not advert to the risk; (3) culpably acquiring or failing to rid oneself of these defects of character at some earlier time; (4) flawed use of those practical reasoning capacities that make one the person one is; or (5) chosen violation of per se rules about known precautions. Although each of these five theories can justify blame in some cases of negligence, none can justify blame in all cases intuitively thought to be cases of negligence, nor can any of these five theories show why inadvertent creation of an unreasonable risk, pure and simple, can be blameworthy. (shrink)

Institutional review board delays may hinder the successful completion of federally funded research in the U.S. military. When this happens, time-sensitive, mission-relevant questions go unanswered. Research participants face unnecessary burdens and risks if delays squeeze recruitment timelines, resulting in inadequate sample sizes for definitive analyses. More broadly, military members are exposed to untested or undertested interventions, implemented by well-intentioned leaders who bypass the research process altogether. To illustrate, we offer two case examples. We posit that IRB delays often appear in (...) the service of managing institutional risk, rather than protecting research participants. Regulators may see more risk associated with moving quickly than risk related to delay, choosing to err on the side of bureaucracy. The authors of this article, all of whom are military-funded researchers, government stakeholders, and/or human subject protection experts, offer feasible recommendations to improv... (shrink)

The adaptationist framework is necessary and sufficient for unifying the social and natural sciences. Gintis's “beliefs, preferences, and constraints” (BPC) model compares unfavorably to this framework because it lacks criteria for determining special design, incorrectly assumes that standard evolutionary theory predicts individual rationality maximisation, does not adequately recognize the impact of psychological mechanisms on culture, and is mute on the behavioural implications of intragenomic conflict. (Published Online April 27 2007).

In this paper, we report on the development and validity of the Professional Decision-Making in Research measure, a vignette-based test that examines decision-making strategies used by investigators when confronted with challenging situations in the context of empirical research. The PDR was administered online with a battery of validity measures to a group of NIH-funded researchers and research trainees who were diverse in terms of age, years of experience, types of research, and race. The PDR demonstrated adequate reliability and parallel form (...) correlation. As hypothesized, the PDR was significantly negatively correlated with narcissism, cynicism, moral disengagement, and compliance disengagement; it was not correlated with socially desirable responding. In regression analysis, the strongest predictors of higher PDR scores were low compliance disengagement, speaking English as a native language, conducting clinical research with human subjects, and low levels of narcissism. Given that the PDR was written at an eighth grade reading level to be suitable for use with English as a second language participants and that only one-fourth of items focused on clinical research, further research into the possible roles of culture and research ethics training across specialties is warranted. This initial validity study demonstrates the potential usefulness of the PDR as an educational outcome assessment measure and a research instrument for studies on professionalism and integrity in research. (shrink)

Is there really an ethical crisis? We propose that the situation is not as bad as many would have us believe. We have attempted to present an alternative explanation for some earlier reports of an ethical crisis. This has resulted in a number of research propositions. We are optimistic that there are, in spite of reports to the contrary, an overwhelming majority of ethical people populating our business community.

We present a new road map for research on “How the Brain Got Language” that adopts an EvoDevoSocio perspective and highlights comparative neuroprimatology – the comparative study of brain, behavior and communication in extant monkeys and great apes – as providing a key grounding for hypotheses on the last common ancestor of humans and monkeys and chimpanzees and the processes which guided the evolution LCA-m → LCA-c → protohumans → H. sapiens. Such research constrains and is constrained by analysis of (...) the subsequent, primarily cultural, evolution of H. sapiens which yielded cultures involving the rich use of language. (shrink)

The article examines what has come to be known as "the risk analysis" in Anglo-American tort law and contract law. The risk analysis essentially consists of: viewing negligence as a relational concept, so that a defendant is never simply negligent tout cour, but is negligent only with respect to certain persons and certain harms — other harms suffered by other persons are said not to be "within the risk" that makes the defendant negligent; and the supplanting of proximate cause doctrine (...) with doctrines of duty, the duty question being determined by the question of whether a certain person and a certain harm are within the risk that makes a defendant negligent. The article aims to explode entirely the risk analysis. After beginning with an examination of the historical roots of the risk analysis, we then seek to show that the risk analysis is: conceptually incoherent because it seeks to isolate a risk that makes someone negligent; normatively undesirable because it allows quite blameworthy actors not to pay for the harms they culpably cause; and descriptively inaccurate of the cases decided on the more traditional, proximate cause bases. (shrink)

This book declares that lifelong learning teaches values and wholeness and rejects inert ideas or fragmentation. Education plays a vital role in reorganizing and revitalizing the abundant facts from the information explosion. Specialization works at cross-purposes with liberal arts education, which discloses a holistic vision of each person’s being.

Deep brain stimulation is a well-established therapy for the motor symptoms of Parkinson’s disease, but there remains an opportunity to improve symptom relief. The temporal pattern of stimulation is a new parameter to consider in DBS therapy, and we compared the effectiveness of Temporally Optimized Patterned Stimulation to standard DBS at reducing the motor symptoms of PD. Twenty-six subjects with DBS for PD received three different patterns of stimulation while on medication and using stimulation parameters optimized for standard DBS. Side (...) effects and motor symptoms were assessed after 30 min of stimulation with each pattern. Subjects experienced similar types of side effects with TOPS and standard DBS, and TOPS were well-tolerated by a majority of the subjects. On average, the most effective TOPS was as effective as standard DBS at reducing the motor symptoms of PD. In some subjects a TOPS pattern was the most effective pattern. Finally, the TOPS pattern with low average frequency was found to be as effective or more effective in about half the subjects while substantially reducing estimated stimulation energy use. TOPS DBS may provide a new programing option to improve DBS therapy for PD by improving symptom reduction and/or increasing energy efficiency. Optimizing stimulation parameters specifically for TOPS DBS may demonstrate further clinical benefit of TOPS DBS in treating the motor symptoms of Parkinson’s disease. (shrink)

This volume is a newly revised and updated edition of _Evolution and Consciousness_ (Brill, 2019) and provides a comprehensive and accessible introduction to the emerging concept of the evolution of consciousness. It presents an overarching model that moves us to a new level of meaning and understanding of our place in the world.

We examine the ethical, social, and regulatory barriers that may hinder research on therapeutic potential of certain controversial controlled substances like marijuana, heroin, or ketamine. Hazards for individuals and society and potential adverse effects on communities may be good reasons for limiting access and justify careful monitoring of these substances. Overly strict regulations, fear of legal consequences, stigma associated with abuse and populations using illicit drugs, and lack of funding may, however, limit research on their considerable therapeutic potential. We review (...) the surprisingly sparse literature and address the particular ethical concerns pertinent to research with illicit and addictive substances, such as undue inducement, informed consent, therapeutic misconception, and risk to participants, researchers, and institutions. We consider the perspectives of key research stakeholders and explore whether they may be infected with bias. We conclude by proposing an empirical research agenda to provide an evidentiary basis for ethical reasoning. (shrink)

We argue that are no such things as literal categories in human cognition. Instead, we argue that there are merely temporary coalescences of dimensions of similarity, which are brought together by context in order to create the similarity structure in mental representations appropriate for the task at hand. Fodor contends that context‐sensitive cognition cannot be realised by current computational theories of mind. We address this challenge by describing a simple computational implementation that exhibits internal knowledge representations whose similarity structure alters (...) fluidly depending on context. We explicate the processing properties that support this function and illustrate with two more complex models, one applied to the development of semantic knowledge , the second to the processing of simple metaphorical comparisons . The models firstly demonstrate how phenomena that seem problematic for literal categorisation resolve to particular cases of the contextual modulation of mental representations; and secondly prompt a new perspective on the relation between language and thought: language affords the strategic control of context on semantic knowledge, allowing information to be brought to bear in a given situation that might otherwise not be available to influence processing. This may explain one way in which human thought is creative, and distinctive from animal cognition. (shrink)

Machine learning algorithms may radically improve our ability to diagnose and treat disease. For moral, legal, and scientific reasons, it is essential that doctors and patients be able to understand and explain the predictions of these models. Scalable, customisable, and ethical solutions can be achieved by working together with relevant stakeholders, including patients, data scientists, and policy makers.

This is a description of an avian-shaped feature that rests below a network of cellular structures found on a mound within the Argyre Basin of Mars in Mars Global Surveyor image M14-02185, acquired on April 30, 2000, and released to the public on April 4, 2001. The area examined is located near 48.0° South, 55.1° West. The formation is approximately 2,400 meters long from the tip of its beak to the tip of its farthest tail feather. There is a minimum (...) of six different variations in appearance of the surface material over this small area. Utilizing the public targeting request form provided on the Mars Global Surveyor (MGS) website, co-author Miller secured a second image of the area that was obtained on July 3, 2006, showing this feature under different conditions S20-00165. The new image was then released to the public on August 11, 2006. A third image of the formation identified as MGS S13-01480 was acquired on December 15, 2005, and although officially processed on June 20, 2006, it was not made available to the public until August 22, 2009, on NASA’s Planetary Data System (PDS) website. All three of the MGS images reveal defining aspects of this avian feature, including a head, beak, body, eye, leg, foot, toes, wing, and feathers. When taken together, these components induce the visual impression of an avian-shaped formation that exhibits a unique set of proportional features. Adjoining this formation is a composite of complex cellular features that form a compartmentalized infrastructure. The three authors who are veterinarians provide a critical analysis of the avian features, and the geologist and geoscientist authors examine natural mechanisms that could contribute to the formation of this feature. An extensive search of comparable regions within and beyond the area of the Argyre Basin was conducted. A list of these sites is provided, and terrestrial comparisons are also offered. (shrink)

This paper examines a proposal to make use of IVF techniques to provide an alternative to therapeutic abortion of fetuses with genetic abnormalities. We begin by describing the proposed procedure, and then show that, considered in itself, it is morally on a par with therapeutic abortion. However, once the wider practical implications are brought into view, the proposed new procedure loses its initial appeal. The pros and cons are not sufficiently clear-cut entirely to rule out the IVF procedure, so the (...) paper concludes by indicating some further complications which may follow, should the procedure come to be adopted. (shrink)

Poor ethical decision–making costs industry billions of dollars a year and damages the images of corporations. Thus, by answering the question ‘Why do individuals behave as they do when confronted with ethical issues?’ ethical theory can provide businesses with a means to create a more ethical climate and a more successful operation. This study tested the Ethical Decision–Making Model with accountability (Beu & Buckley 2001), which uses theory that suggests that ethical behavior is influenced by the individual, the issue, social (...) relationships (accountability), and the organization in which the employee is embedded (Brass, Butterfield & Skaggs 1988; Frink & Klimoski 1998). The results showed that individuals’ thought processes (cognitive moral development), personalities (locus of control, hostility and aggression, Machiavellianism), and gender influence how they respond to ethical dilemmas, as well as the salience of the moral issue (moral intensity) and the environmental context (work/school). (shrink)

Poor ethical decision–making costs industry billions of dollars a year and damages the images of corporations. Thus, by answering the question ‘Why do individuals behave as they do when confronted with ethical issues?’ ethical theory can provide businesses with a means to create a more ethical climate and a more successful operation. This study tested the Ethical Decision–Making Model with accountability (Beu & Buckley 2001), which uses theory that suggests that ethical behavior is influenced by the individual, the issue, social (...) relationships (accountability), and the organization in which the employee is embedded (Brass, Butterfield & Skaggs 1988; Frink & Klimoski 1998). The results showed that individuals’ thought processes (cognitive moral development), personalities (locus of control, hostility and aggression, Machiavellianism), and gender influence how they respond to ethical dilemmas, as well as the salience of the moral issue (moral intensity) and the environmental context (work/school). (shrink)

No consensus yet exists on how to handle incidental fnd-ings in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are fndings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. This paper reports recommendations of a two-year project group funded by NIH to study how to manage IFs in genetic and genomic research, as well as imaging research. We conclude that researchers (...) have an obligation to address the possibility of discovering IFs in their protocol and communications with the IRB, and in their consent forms and communications with research participants. Researchers should establish a pathway for handling IFs and communicate that to the IRB and research participants. We recommend a pathway and categorize IFs into those that must be disclosed to research participants, those that may be disclosed, and those that should not be disclosed. (shrink)