The U.S. Food and Drug Administration's rationale for supporting the development and approval of BiDil for heart failure specifically in black patients was based on under-powered, post hoc subgroup analyses of two relatively old trials , which were further complicated by substantial covariate imbalances between racial groups. Indeed, the only statistically significant difference observed between black and white patients was found without any adjustment for potential confounders in samples that were unlikely to have been adequately randomized. Meanwhile, because the accepted (...) baseline therapy for heart failure has substantially improved since these trials took place, their results cannot be combined with data from the more recent trial amongst black patients alone. There is therefore little scientific evidence to support the approval of BiDil only for use in black patients, and the FDA's rationale fails to consider the ethical consequences of recognizing racial categories as valid markers of innate biological difference, and permitting the development of group-specific therapies that are subject to commercial incentives rather than scientific evidence or therapeutic imperatives. This paper reviews the limitations in the scientific evidence used to support the approval of BiDil only for use in black patients; calls for further analysis of the V-HeFT I and II data which might clarify whether responses to H-I vary by race; and evaluates the consequences of commercial incentives to develop racialized medicines. We recommend that the FDA revise the procedures they use to examine applications for race-based therapies to ensure that these are based on robust scientific claims and do not undermine the aims of the 1992 Revitalization Act. (shrink)

Because of his preoccupation with the formal aspects of music and literature, Theodor W. Adorno is often regarded as the most aesthetically oriented thinker of the Frankfurt School theorists. It is Adorno’s perceived commitment to aestheticism—the study of art for art’s sake and the study of art as a source of sensuous pleasure, rather than as a vehicle for culturally constructed morality or meaning—that many scholars have criticized as hostile to genuine, concrete, substantive political, social, and ethical engagement with the (...) arts. _Adorno and Ethics_—the first issue of _New German Critique_ to be published by Duke University Press—takes issue with Adorno’s critics. These essays reconsider Adorno’s unique brand of aestheticism, revealing a “politics of aestheticism” and exploring the political and ethical dimensions of his writings. One contributor links the ethical turn taken in Adorno criticism with related developments in American poetry and poetics. Another examines Adorno’s aphorism “Gold Assay” for the ways in which it anticipates one of his seminal works, _The Jargon of Authenticity_. Focusing on Auschwitz and the testimony of its survivors, one contributor explores the impact of the Holocaust on modern philosophy and reason, a relationship that he argues Adorno never specified. Another contributor considers the figure of the animal in the writings of Kant, Adorno, and Lévinas, exploring what it might mean to live, as Adorno suggests, as “a good animal.” _Contributors_. J. M. Bernstein, Detlev Claussen, Samir Gandesha, Alexander García Düttmann, Christina Gerhardt, Martin Jay, Robert Kaufman, Michael Marder, Gerhard Richter. (shrink)

Managers vs. Owners: The Struggle for Corporate Control in American Democracy deals with a subject of profound importance: understanding the place of the modern corporation in a democratic society. This latest volume in the acclaimed Ruffin Series in Business Ethics describes how the balance between corporate power and government regulation has changed with the interests of society as a whole. The first section examines the debates over the rules that individuals or organized groups would agree to follow in their interactions (...) to accrue social advantages. The second section looks at management's point of view and tells how law promotes the need for managerial collective action and provides a vocabulary for articulating management as a profession. The authors conclude by looking at the impact of collective investor action - especially institutional investors - on the efforts by managers to preserve their autonomy. This examination of the inherent conflicts between the interests of corporate owners, the interests of the larger society, and the interests of managers who run corporations will be essential reading for students, scholars, and professionals concerned with the place of the large corporation in a democratic society. (shrink)

In six compelling chapters, this book recounts conversations that discuss what is ethical, why it does not occur more often, and how can we improve ethical conduct in our personal and public lives. The conversations include Knowing Ethical Principles, Learning How to Apply Principles in Practice, Moral Reminders, Accountability for Conduct, Addressing Structural Problems, and Ethical Vigilance. Major ethical perspectives are discussed in conversational format, as are fascinating ethical dilemmas taken from actual cases to evaluate and improve our ability to (...) identify ethical principles and make decisions that reflect concerns beyond self-interest. (shrink)

RationaleSurrogates of critically ill patients often have inaccurate expectations about prognosis. Yet there is little research on how intensive care unit clinicians should discuss prognosis, and existing expert opinion-based recommendations give only general guidance that has not been validated with surrogate decision makers.ObjectiveTo determine the perspectives of key stakeholders regarding how prognostic information should be conveyed in critical illness.MethodsThis was a multicenter study at three academic medical centers in California, Pennsylvania, and Washington. One hundred eighteen key stakeholders completed in-depth semistructured (...) interviews. Participants included 47 surrogates of adult patients with acute respiratory distress syndrome; 45 clinicians working in study ICUs, including physicians, nurses, social workers, and spiritual care providers; and 26 experts in health communication, decision science, ethics, family-centered care, geriatrics, healthcare disparities, palliative care, psychology, psychiatry, and critical care.Measurements and main resultsThere was broad support among surrogates for existing expert recommendations, including truthful prognostic disclosure, emotional support, tailoring the disclosure strategy to each family's needs, and checking for understanding. In addition, stakeholders offered suggestions that add specificity to existing recommendations, including: In addition to conveying prognostic estimates, clinicians should help families "see the prognosis for themselves" by showing families radiographic images and explaining the clinical significance of physical manifestations of severe disease at the bedside. Many physicians did not support using numeric estimates to convey prognosis to families, whereas many surrogates, clinicians from other disciplines, and experts believed numbers could be helpful. Clinicians should conceptualize prognostic communication as an iterative process that begins with a preliminary mention of the possibility of death early in the ICU stay and becomes more detailed as the clinical situation develops. Although prognostic information should be initially disclosed by physicians, other members of the multidisciplinary team-nurses, social workers, and spiritual care providers-should be given explicit role responsibilities to reinforce physicians' prognostications and help families process a poor prognosis emotionally.ConclusionsFamily members, clinicians, and experts identified specific communication behaviors that clinicians should use to discuss prognosis in the critical care setting. These findings extend existing opinion-based recommendations and should guide interventions to improve communication about prognosis in ICUs. (shrink)

The False Claims Act, 31 U.S.C. § 3729, a post-Civil War law inspired by cases of defense contracting fraud, was revitalized in 1986. Since then it has been used to sue both manufacturers and providers of pharmaceuticals. In some cases, these suits were meant to target offlabel marketing of pharmaceuticals. In 2009, the 11th Circuit rendered a decision in Hopper v. Solvay Pharmaceuticals that dramatically limits the ability of private plaintiff whistle-blowers to bring qui tam suits under the FCA for (...) such marketing. In June 2010, the Supreme Court denied certiorari, making the Circuit court decision final. The Solvay decision creates a significant barrier to certain kinds of qui tam suits, requiring the plaintiff to demonstrate the intent to market off-label, including by showing specific prescriptions that were written as a result of efforts to do so. (shrink)

The arguments contained in books criticizing American social scientists by C. Wright Mills ( The Sociological Imagination) and Bernard Crick (The Science of American Politics) are discussed, compared and criticized. It is argued that Mills' criteria of evaluation and constructive alternatives to the tendencies he criticizes are immeasurably sounder than those found in Crick's book. An effort to supplement Mills' argument by providing a more explicit statement of its moral underpinnings is made. Finally, it is argued that though both critiques (...) have serious empirical flaws, the authors have undeniably demonstrated that important tendencies for irresponsible thought and action do exist within the American social sciences. (shrink)

In this empirical paper, Jay, Stone, Meksin, Merck, Gordon and Hirst examine whether jury deliberations, in which individuals collaboratively recall and discuss evidence of a trial, shape the jurors’ memories. In doing so, Jay and colleagues provide a highly ecologically valid baseline for future investigation into why, how and when selective recall either facilitates remembering or leads to forgetting during jury deliberations. In particular, Jay et al. explore the specific social and cognitive mechanisms that might lead to either memory facilitation (...) (RIFA – Retrieval Induced Facilitation) and forgetting (RIF ‐ Retrieval Induced Forgetting) during jury deliberation. (shrink)

Examination of human activities and their outcomes is a basic function of philosophy. Historically such examination has tended to conform to one of two patterns.

The first longevity revolution began in the middle of the 19th century, accelerated through the first half of the 20th century, and led to the first and only quantum leap in human life expectancy.In the 20th century alone, life expectancy at birth in most developed nations rose by about 30 years. The first three quarters of the century were notable for gains made at younger and middle ages, and in the last quarter century, old age mortality declined. Nothing in history (...) has ever come close to the magnitude of this benefit to humanity. The rise in life expectancy occurred swiftly because the primary beneficiaries of advances in public health and... (shrink)

Spiritual messages of Jayēntira Sarasvati, Jagatguru Sankaracharya of Kamakoti, b. 1935, Hindu religious leader.

A definition of ?alienation? is proposed which is a rational reconstruction of the term as it is used in primarily moral contexts. Special attention is given to the Marxist tradition. It is argued that the earliest, moral form of Marx's economic determinism can be expressed in terms of the principle of the sufficiency of unalienated labor. In this connection four main kinds of alienation are distinguished. In the final section, it is argued that while ?alienation? has and should have an (...) important theoretical role in the context of moral discourse, social scientists, and in particular sociologists, would be better off if they eliminated ?alienation? from their scientific vocabulary. (shrink)

The stakeholder perspective has provided a rich forum for a variety of debates at the intersection of business and society. Scholars gathered for two consecutive years, first in North America, and then in Europe, to discuss the major issues surrounding what has come to be known as stakeholder theory, to attempt to find common ground, and to uncover areas in need of further inquiry. Those meetings led to a list of “tensions” and a call for papers for this special issue (...) to help address them. In this article, we introduce the resulting articles and provide some brief commentary on their importance. We end with a few of our own observations about the stakeholder perspective and stakeholder research. (shrink)

Light effects on the activity of several genes have recently been exploited in studies of plant gene expression. We discuss here some examples involving nuclear genes of higher plants, with emphasis on responses mediated by the phytochrome system. Recent work has revealed considerable diversity in the responses of different genes, indicating that several different regulatory programs are probably involved. A start has been made in studies of nuclear events associated with the changes in expression. Transcriptional regulation almost certainly occurs, although (...) many details remain to be studied and effects on mRNA processing and turnover have not been ruled out. Recent in vitro mutagenesis and gene transfer experiments with the gene for the small subunit of RuBP carboxylase indicate that sequences involved in regulating the level of expression in the light are located 5′ to the gene within about 1 kb of the start of transcription. (shrink)

(2006). James Hillman's A Terrible Love of War Chris Hedges’ War Is A Force That Gives Us Meaning and Barbara Ehrenreich's Blood Rites. Journal of Military Ethics: Vol. 5, No. 1, pp. 67-73.

This book compares two competing theories of human nature: the more traditional theory espoused in different forms by centuries of western philosophy and the newer, Darwinian model. In the traditional view, the human being is a hybrid being, with a lower, animal nature and a higher, rational or “spiritual” component. The competing Darwinian account does away with the idea of a higher nature and attempts to provide a complete reduction of human nature to the evolutionary goals of survival and reproduction. (...) Whitley Kaufman presents the case that the traditional conception, regardless of one's religious views or other beliefs, provides a superior account of human nature and culture. We are animals, but we are also rational animals. Kaufman explores the most fundamental philosophical questions as they relate to this debate over human nature—for example: Is free will an illusion? Is morality a product of evolution, with no objective basis? Is reason merely a tool for promoting reproductive success? Is art an adaptation for attracting mates? Is there any higher meaning or purpose to human life? Human Nature and the Limits of Darwinism aims to assess the competing views of human nature and present a clear account of the issues on this most pressing of questions. It engages in a close analysis of the numerous recent attempts to explain all human aims in terms of Darwinian processes and presents the arguments in support of the traditional conception of human nature. (shrink)

For decades, policy-makers in government, development banks and foundations, NGOs, researchers and students have struggled with the problem of how to protect people who are displaced from their homes and livelihoods by development projects. This book addresses these concerns and explores how debates often become deadlocked between 'managerial' and 'movementist' perspectives. Using development ethics to determine the rights and responsibilities of various stakeholders, the authors find that displaced people must be empowered so as to share equitably in benefits rather than (...) being victimized. They propose a governance model for development projects that would transform conflict over displacement into a more manageable collective bargaining process and would empower displaced people to achieve equitable results. Their book will be valuable for readers in a wide range of fields including ethics, development studies, politics and international relations as well as policy making, project management and community development. (shrink)

Christie, Jaye; Stuart, Stephen The United States have experienced devastating attacks on church-state separation in recent decades. The intrusion of religion into affairs of state is more blatant than in Australia, but there is mounting evidence that the religious right is gaining momentum here. As former Australian High Court judge, Michael Kirby, has said, 'The principle of secularism is one of the greatest developments in human rights in the world. We must safeguard and protect it, for it can come under (...) threat in contemporary Australia.'. (shrink)

I think that Alzheimer's disease and all neurological disabilities of this kind, degenerative conditions, are of the most intense intellectual interest and importance … because these people are taking us to places we would rather not think about and what these people have to say—to the degree that they can say anything at all—should teach us something about what a person is, what human identity is.What could it mean in general to say that possible ways to be a person can (...) from time to time come into being or disappear?What can we learn about the experience of dementia and about ways of being human when a poet describes her forgetting? My mother, the poet Shirley Kaufman, died in 2016 at the age of 93. She had... (shrink)

Philosophy of science has the potential to enhance scientific practice, science policy, and science education; moreover, recent research indicates that many philosophers of science think we ought to increase the broader impacts of our work. Yet, there is little to no empirical data on how we are supposed to have an impact. To address this problem, our research team interviewed 35 philosophers of science regarding the impact of their work in science-related domains. We found that face-to-face engagement with scientists and (...) other stakeholders was one of the most—if not the most—effective pathways to impact. Yet, working with non-philosophers and disseminating research outside philosophical venues is not what philosophers are typically trained or incentivized to do. Thus, there is a troublesome tension between the activities that are likely to lead to broader uptake of one’s work and those that are traditionally encouraged and rewarded in philosophy. We suggest several ways that philosophers of science, either as individuals or as a community, can navigate these tensions. (shrink)

Written by researchers in their field, this book is about the skills beyond basic word recognition that are necessary for the processing and comprehension of spoken and written language. It offers topics such as: language and text analysis; cognitive processing and comprehension; development of literacy; literacy and schooling; and more.