Patients have received experimental pharmaceuticals outside of clinical trials for decades. There are no industry-wide best practices, and many companies that have granted compassionate use, or ‘preapproval’, access to their investigational products have done so without fanfare and without divulging the process or grounds on which decisions were made. The number of compassionate use requests has increased over time. Driving the demand are new treatments for serious unmet medical needs; patient advocacy groups pressing for access to emerging treatments; internet platforms (...) enabling broad awareness of compelling cases or novel drugs and a lack of trust among some that the pharmaceutical industry and/or the FDA have patients’ best interests in mind. High-profile cases in the media have highlighted the gap between patient expectations for compassionate use and company utilisation of fair processes to adjudicate requests. With many pharmaceutical manufacturers, patient groups, healthcare providers and policy analysts unhappy with the inequities of the status quo, fairer and more ethical management of compassionate use requests was needed. This paper reports on a novel collaboration between a pharmaceutical company and an academic medical ethics department that led to the formation of the Compassionate Use Advisory Committee. Comprising medical experts, bioethicists and patient representatives, CompAC established an ethical framework for the allocation of a scarce investigational oncology agent to single patients requesting non-trial access. This is the first account of how the committee was formed and how it built an ethical framework and put it into practice. (shrink)

Traditional pharmacy education emphasizes the biological processes of diseases and their pharmacological treatments. While the intense focus on biomedical aspects of disease is vital to educating pharmacy students, this focus is often insufficient in conveying what patients experience. The humanities, however, offer powerful characterizations of the disease experience for individuals as well as its impact on the human condition more generally. In this essay, I describe how using literary texts with pharmacy students provides them with a fuller appreciation of what (...) patients face with their diseases. The goal of this endeavor is to make students more effective as pharmacists in detecting and responding to their patients’ problems and needs by connecting their biomedical knowledge to depictions and meanings of illness experiences. (shrink)

Health care costs have been rising steadily in most industrialized countries. These increases are driven primarily by technological advances and, to a lesser degree, by aging of the population. Many factors make it unlikely that market forces alone will limit increases in the costs of health care. These unremitting increases make health care rationing appear both necessary and inevitable.One of the least controversial mechanisms for rationing could be to allow patients to make their own choices as to which kinds of (...) care they would be willing to forgo. This is appealing because it preserves individual freedom of choice regarding health care in a way that other rationing mechanisms often do not. Rationing by patient choice, however, can only happen if patients recognize that resources are limited and need to be conserved, and are willing to forgo marginal benefits. (shrink)

This new edition of Law and Medical Ethics continues to chart the ever-widening field that the topics cover. The interplay between the health caring professions and the public during the period intervening since the last edition has, perhaps, been mainly dominated by wide-ranging changes in the administration of the National Health Service and of the professions themselves but these have been paralleled by important developments in medical jurisprudence.

The philosophical literature on sport and games has had little to say about boredom beyond presuming that sports and games can be important ways of overcoming or preventing it. But boredom is an interesting and often misunderstood phenomenon with overlooked implications in this context. Boredom has significant human value and motivates play in ways that contribute to well-being and culture, often through encouraging engaged agency and exploration of novelty. Understanding boredom can also help to clarify problems and tendencies in sports (...) and games that qualify them as havens from boredom. (shrink)

This collection of 21 essays explores the creative interaction among the cognitive neurosciences, philosophy, and theology. It is the result of an international research conference co-sponsored by the Vatican Observatory, Rome, and the Center for Theology and the Natural Sciences, Berkeley.

Hackforth and Menn make a strong case for the identity of nous and the demiurge in Plato, but I argue that it does not hold in the case of the Philebus, where the demiurge is kept in the background, and the world-soul is in fact the referent in the passage assigning nous to the class of cause as governor of the universe. In the Statesman, the world-soul had had to own the problem of natural catastrophe, and I suggest that in (...) the Philebus the role and functions of the world-soul are enhanced in an attempt to make it the basis for a solution to that problem. (shrink)

The present study was designed to explore the relationship between self-reported dissociative experiences and performance in tasks eliciting right-hemisphere processing load. Thirty-four participants performed a vigilance task in two conditions: with task-irrelevant negative-arousing pictures and task-irrelevant neutral pictures. Dissociation was assessed with the Dissociative Experience Scale. Consistent with theories positing right-hemisphere deregulation in high non-clinical dissociators, dissociative experiences correlated with greater vigilance decrement only in the negative picture condition. As both the vigilance task and negative picture processing are right lateralized, (...) this result provides support for a right-hemisphere dysfunction in high dissociators, at least in negative conditions. (shrink)

Though academic debate over gender-inclusive God-talk seems to have fizzled, the issue is a pressing one within many Christiandenominations today—both within and outside the Church—and for that reason deserves to be briefly revisited. Accordingly, althoughin this essay we approach the issue as professional philosophers, our focus is on the life of the Church—more specifically, those no doubt sizable segments of the Church for which a personal God and Satan exist and evangelism matters. Running an elimination argument, we contend that if (...) a certain sort of feminist concern about traditional God-talk is well-directed, the best response is to speak of not only God but also Satan in both masculine and feminine terms. And in closing, we address the possible worry that this response to the God-talk problem would not be Christian enough. (shrink)

In this book, the authors present current research in the study of the philosophy of the mind. Topics discussed in this compilation include the concepts of hope and belief; how consciousness builds the subject through relating and human behaviour; analysing the neurophysiological mechanism of qigong on the mind and brain activity; the conscious and unconscious mind and implications for society, religion, and disease; how the mind is shaped by culture; and the power of computational mathematics to explore some of the (...) universal ways by which each human mind builds its image of the world. (shrink)

Over 40 years ago, Daniel Bell made the provocative claim that ideological polarization was diminishing in Western democracies, but new ideologies were emerging and driving politics in developing nations. This article tests the EndofIdeology thesis with a new wave of public opinion data from the World Values Survey (WVS) that covers over 70 nations representing more than 80 per cent of the world's population. We find that polarization along the Left/Right dimension is substantially greater in the less affluent and less (...) democratic societies than in advanced industrial democracies. The correlates of Left/Right orientations also vary systematically across regions. The twin pillars of economic and religious cleavages remain important in European states; cultural values and nationalism provide stronger bases of ideology in Asia and the Middle East. As Bell suggested, social modernization does seem to transform the extent and bases of ideological polarization within contemporary societies. (shrink)