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)

Polyphenic differences between individuals arise not through differences at the genome level but as a result of specific cues received during development. Polyphenisms often involve entire suites of characters, as shown dramatically by the polyphenic castes found in many social insect colonies. An understanding of the genetic architecture behind polyphenisms provides a novel means of studying the interplay between genomes, gene expression and phenotypes. Here we discuss polyphenisms and molecular genetic tools now available to unravel their developmental bases in insects. (...) We focus on several recent studies that have tracked gene-expression patterns during social insect caste determination. BioEssays 23:62–68, 2001. Published 2001 John Wiley & Sons, Inc. (shrink)

Polyphenic differences between individuals arise not through differences at the genome level but as a result of specific cues received during development. Polyphenisms often involve entire suites of characters, as shown dramatically by the polyphenic castes found in many social insect colonies. An understanding of the genetic architecture behind polyphenisms provides a novel means of studying the interplay between genomes, gene expression and phenotypes. Here we discuss polyphenisms and molecular genetic tools now available to unravel their developmental bases in insects. (...) We focus on several recent studies that have tracked gene‐expression patterns during social insect caste determination. BioEssays 23:62–68, 2001. Published 2001 John Wiley & Sons, Inc. (shrink)

Medical ghostwriting is the practice in which pharmaceutical companies engage an outside writer to draft a manuscript submitted for publication in the names of “honorary authors,” typically academic key opinion leaders. Using newly-posted documents from paroxetine litigation, we show how the use of ghostwriters and key opinion leaders contributed to the publication of a medical journal article containing manipulated outcome data to favor the proprietary medication. The article was ghostwritten and managed by SmithKline Beecham, now GlaxoSmithKline (GSK) and Scientific Therapeutics (...) Information, Inc. without acknowledging their contribution in the published article. The named authors with financial ties to GSK, had little or no direct involvement in the paroxetine 352 bipolar trial results and most had not reviewed any of the manuscript drafts. The manuscript was originally rejected by peer review; however, its ultimate acceptance to the American Journal of Psychiatry was facilitated by the journal editor who also had financial ties to GSK. Thus, GSK was able to take an under-powered and non-informative trial with negative results and present it as a positive marketing vehicle for off-label promotion of paroxetine for bipolar depression. In addition to the commercial spin of paroxetine efficacy, important protocol-designated safety data were unreported that may have shown paroxetine to produce potentially harmful adverse events. (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)

Mary Poppins is a magical film and a story of redemption that might be placed alongside the Parable of the Prodigal Son or A Christmas Carol. Mary may be the star of the film, but George Banks is its subject. If the world ever seemed wonderful and filled with surprises for George Banks as a child, it has since been supplanted by a world that is mechanical, predictable, and subject to the demands of business and of propriety. From Jack the (...) Giant Killer people learn that when pride has grown to gigantic proportions it ought to be killed; Cinderella teaches that the humble are exalted; Beauty and the Beast demonstrates the principle that loving the unlovable may result in the transformation from the beastly to the beautiful; and Mary Poppins reminds them that “There is no greater joy than that seen through the eyes of a child,” as Walt Disney observes in Saving Mr. Banks. (shrink)

The medical biography of Ludwig van Beethoven remains enigmatic. Some of his health problems, such as his early and eventually profound deafness, are well documented and extensively discussed, although not necessarily well explained . Other medical problems, and his ultimate cause of death, remain unclear. Perhaps unsurprisingly for such an important musical figure, there has been no dearth of speculation about the illnesses that may have befallen Beethoven. Medical historians and physicians have suggested a myriad of illnesses, including but hardly (...) limited to .. (shrink)

The coronavirus disease 2019 (COVID-19) pandemic has motivated medical ethicists and several task forces to revisit or issue new guidelines on allocating scarce medical resources. Such guidelines are relevant for the allocation of scarce therapeutics and vaccines and for allocation of ICU beds, ventilators, and other life-sustaining treatments or potentially scarce interventions. Principles underlying these guidelines, like saving the most lives, mitigating disparities, reciprocity to those who assume additional risk (eg, essential workers and clinical trial participants), and equal access may (...) compete with one another. We propose the use of a “categorized priority system” (also known as a “reserve system”) as an improvement over existing allocation methods, particularly because it may be able to achieve disparity mitigation better than other methods. (shrink)

Political corruption imposes substantial costs on shareholders in the U.S. Yet, we understand little about the basic factors that exacerbate or mitigate the value consequences of political corruption. Using federal corruption convictions data, we find that firm-level economic rents and monitoring mechanisms moderate the negative relation between corruption and firm value. The value consequences of political corruption are exacerbated for firms operating in low-rent product markets and mitigated for firms subject to external monitoring by state governments or monitoring induced by (...) disclosure transparency. Our results should inform managers and policymakers of the tradeoffs imposed on firms operating in politically corrupt districts. (shrink)

In many research studies, tumor biopsies are an unavoidable requirement for achieving key scientific aims. Yet some commentators view mandatory research biopsies as coercive and suggest they should be optional, or at least optional until further data are obtained regarding their scientific usefulness. Further complicating the ethical picture is the fact that some research biopsies offer a potential for clinical benefit to trial participants. We interviewed and surveyed a convenience sample of participants in phase I clinical trials at a single (...) institution. Our primary aim was to describe phase I participants’ understanding of whether a research biopsy offered them the prospect of medical benefit. We also endeavored to describe participants’ views about biopsies—specifically, the benefits of biopsies, if any, and whether biopsies were acceptable, risky, or discouraged trial participation. Finally, we collected data on demographics and attitudes to see if any strong correlations with misunderstanding, acceptability, or riskiness existed. Overall, the respondents tended to view research biopsies as acceptable, though they did not succeed in identifying the lack of benefit of a research biopsy. These findings call for renewed efforts in consent conversations and documents to carefully describe the benefits, or lack thereof, of research biopsies. (shrink)

The first look at the philosophy behind the Iron Man comics and movies, timed for the release of Iron Man 2 in March 2010 On the surface, Iron Man appears to be a straightforward superhero, another rich guy fighting crime with fancy gadgets. But beneath the shiny armor and flashy technology lies Tony Stark, brilliant inventor and eccentric playboy, struggling to balance his desires, addictions, and relationships with his duties as the Armored Avenger. Iron Man and Philosophy explores the many (...) philosophical issues that emerge from the essential conflicts found in the decades of Iron Man stories in comics and movies. What kind of moral compass does Tony Stark have? Is Iron Man responsible for the death of Captain America after the Marvel Universe “Civil War”? Should people like Stark run the world? How does Tony’s alcoholism impact his performance as Iron Man, and what does it say about moral character? Ultimately, what can Iron Man teach us about the role of technology in society? As absorbing as Iron Man comic books and movies, Iron Man and Philosophy: Gives you a new perspective on Iron Man characters, story lines, and themes Shows what philosophical heavy hitters such as Aristotle, Locke, and Heidegger can teach us about Tony Stark/Iron Man Considers issues such as addiction, personal responsibility, the use of technology, and the role of government Whether you've been reading the comic books for years or have gotten into Iron Man through the movies, Iron Man and Philosophy is a must-have companion for every fan. (shrink)

The current study uses a sensemaking model and thinking strategies identified in earlier research to examine ethical decision making. Using a sample of 163 undergraduates, a low-fidelity simulation approach is used to study the effects personal involvement (in causing the problem and personal involvement in experiencing the outcomes of the problem) could have on the use of cognitive reasoning strategies that have been shown to promote ethical decision making. A mediated model is presented which suggests that environmental factors influence reasoning (...) strategies, reasoning strategies influence sensemaking, and sensemaking in turn influences ethical decision making. Findings were mixed but generally supported the hypothesized model. It is interesting to note that framing the outcomes of ethically charged situations in terms of more global organizational outcomes rather than personal outcomes was found to promote the use of pro-ethical cognitive reasoning strategies. (shrink)

Insights from First Amendment considerations and from developmental psychology are utilized in suggesting that whatever value codes of ethics may hold for the mass media, they represent serious difficulties in inculcating substantial ethical values in individual journalists and in the profession as a whole. Evidence from developmental psychology suggests that codes are probably of some limited value to the neophyte working in the media. Codes also help assure non?journalists that the industry really is concerned about ethics. However, codes probably should (...) be relegated to a framed wall hanging for any journalists who have advanced beyond their internships. Confusion reigns because codes are often founded on moralistic rather than moral?philosophical bases, and there is a blurring between general precepts and specific practices covered in codes. As individual professionals mature intellectually and ethically, they should transcend socially?approved conventions codified by ?regulators,?; and begin to become social catalysts in their own rights, according to this essay. (shrink)

This volume collects essays by philosophers and scholars working at the interface of Western philosophy and Buddhist Studies. Many have distinguished scholarly records in Western philosophy, with expertise in analytic philosophy and logic, as well as deep interest in Buddhist philosophy. Others have distinguished scholarly records in Buddhist Studies with strong interests in analytic philosophy and logic. All are committed to the enterprise of cross-cultural philosophy and to bringing the insights and techniques of each tradition to bear in order to (...) illuminate problems and ideas of the other. These essays address a broad range of topics in the philosophy of mind, philosophy of language, logic, epistemology, and metaphysics, and demonstrate the fecundity of the interaction between the Buddhist and Western philosophical and logical traditions. (shrink)

Loneliness in medicine is a serious problem not just for patients, for whom illness is intrinsically isolating, but also for physicians in the contemporary condition of medicine. We explore this problem by investigating the ideal physician-patient relationship, whose analogy with friendship has held enduring normative appeal. Drawing from Talbot Brewer and Nir Ben-Moshe, we argue that this appeal lies in a dynamic form of companionship incompatible with static models of friendship-like physician-patient relationships: a mutual refinement of embodied virtue that draws (...) both persons together. The ideal physician-patient relationship has a dialectical character that fosters each member's improvement of phenomenologically recognizing and embodying moral virtues. A key component of this dynamic is a commitment to the common goal of the patient's health, realized through joint interactivities and conversations over time. The physician's presence to the patient's suffering—understood best as an alienating phenomenological condition for the patient—orients and discloses possibilities for virtuous caregiving by structuring the meanings of the goals, conversations, and joint narrative constitutive of their relationship. Presence to suffering, paradoxically, is perhaps an important prerequisite for this dynamic partnership. These activities dialectically build an interpretive horizon of understanding through which moral goods and character refinement—in and for the other—may become revealed for both persons in their shared being-in-the-world. This analysis of suffering, mood, and revealing of (possible) moral goods has implications for addressing the modern problem of loneliness for patients and physicians, who are increasingly inhibited from building flourishing relationships with each other. (shrink)

This volume collects essays by philosophers and scholars working at the interface of Western philosophy and Buddhist Studies. Many have distinguished scholarly records in Western philosophy, with expertise in analytic philosophy and logic, as well as deep interest in Buddhist philosophy. Others have distinguished scholarly records in Buddhist Studies with strong interests in analytic philosophy and logic. All are committed to the enterprise of cross-cultural philosophy and to bringing the insights and techniques of each tradition to bear in order to (...) illuminate problems and ideas of the other. These essays address a broad range of topics in the philosophy of mind, philosophy of language, logic, epistemology, and metaphysics, and demonstrate the fecundity of the interaction between the Buddhist and Western philosophical and logical traditions. (shrink)

“Clinical ethics consultants” have been practicing in the United States for about 50 years. Most of the earliest consultants—the “pioneers”—were “outsiders” when they first appeared at patients' bedsides and in the clinic. However, if they were outsiders initially, they acclimated to the clinical setting and became “insiders” very quickly. Moreover, there was some tension between traditional academics and those doing applied ethics about whether there was sufficient “critical distance” for appropriate reflection about the complex medical ethics dilemmas of the day (...) if one were involved in the decision making. Again, the pioneers deflected concerns by identifying and instituting safeguards to assure professional objectivity in clinical ethics consultation services. One might suggest that in moving inside and establishing normative practices, the pioneer clinical ethics consultants anticipated adoption of their routines and professionalization of the field. (shrink)

As clinical ethics consultants move toward professionalization, the process of certifying individual consultants or accrediting programs will be discussed and debated. With certification, some entity must be established or ordained to oversee the standards and procedures. If the process evolves like other professions, it seems plausible that it will eventually include a written examination to evaluate the core knowledge competencies that individual practitioners should possess to meet peer practice standards. The American Society for Bioethics and Humanities has published core knowledge (...) competencies for many years that are accepted by experts as the prevailing standard. Probably any written examination will be based upon the ASBH core knowledge competencies. However, much remains to be done before any examination may be offered. In particular, it seems likely that a recognized examining board must create and validate examination questions and structure the examination so as to establish meaningful, defensible parameters after dealing with such challenging questions as: Should the certifying examination be multiple choice or short-answer essay? How should the test be graded? What should the pass rate be? How may the examination be best administered? To advance the field of health care ethics consultation, thought leaders should start to focus on the written examination possibilities, to date unaddressed carefully in the literature. Examination models—both objective and written—must be explored as a viable strategy about how the field of health care ethics consultations can grow toward professionalization. (shrink)

In "Behavioral Law and Economics: The Assault on Consent, Will, and Dignity," Mark D. White uses the moral philosophy of Immanuel Kant to examine the intersection of economics, psychology, and law known as "behavioral law and economics." Scholars in this relatively new field claim that, because of various cognitive biases and failures, people often make choices that are not in their own interests. The policy implications of this are that public and private organizations, such as the state and employers, (...) can and should design the presentation of options and default choices in order to "steer" people to the decision they would make, were they able to make choices in the absence of their cognitive biases and failures. Such policies are promoted under the name "libertarian paternalism," because choice is not blocked or co-opted, but simply "nudged." White argues that such manipulation of choice is impossible to conduct in people's true interests, and any other goal pursed by policymakers substitutes their own ends, however benevolent they may be, for people's true ends. Normatively, such manipulation should not be conducted because it fails to respect the dignity and autonomy of persons, what some hold to be the central idea in Kant's ethical system, and which serves to protect the individual from coercion, however subtle, from other persons or the state. (shrink)

The Book Provides A Genealogy Of `Dialectical Materialism` By Tracing The Development Of Marxist Ideas From Their Origins In German Philosophical Thought To The Ideology Of The Socio-Democratic Groups In Russia In The 1890S, From Which Lenin And The Revolutionary Generation Emerged. It Reconstructs Marx`S Original Conceptions And Examines The Modifications That Were Made To Them By Himself And By His Russian Followers, Which Eventually Gave Rise To The Doctrine Of `Dialectical Materialism`, Expounded By Plekhanov. Condition Good.

Fins and colleagues rightly note that “clinical ethics consultation is a high-stakes endeavor with an increasing prominence in health care systems” for which “progress in developing standards for q...

This edited volume starts in on the task of integrating the problem of procrastination into philosophical inquiry.

This book explores the steady decline in the status of the individual in recent years and addresses common misunderstandings about the concept of individuality. Drawing from psychology, neuroscience, technology, economics, philosophy, politics, and law, White explains how and why the individual has been devalued in the eyes of scholars, government leaders, and the public. He notes that developments in science have led to doubts about our cognitive competence, while assumptions made in the humanities have led to questions about our (...) moral competence. In this book, White goes on to argue that both of these views are mistaken and that they stem from overly simplistic ideas about how individuals make choices, however imperfectly, in their interests, which are multifaceted and complex. In response, he proposes a new way to look at individuals that preserves their essential autonomy while emphasizing their responsibility to others, inspired by the moral philosophy of Immanuel Kant and the legal and political philosophy reflected in the Bill of Rights to the U.S. Constitution. This book explains how individuality combines both rights and responsibilities, reconciles the popular yet false dichotomy between individual and society, and provides the basis for a humane and respectful civil society and government. This book is part of White's trilogy on the individual and society, which includes The Manipulation of Choice and The Illusion of Well-Being. (shrink)

Shortages of new therapeutics to treat coronavirus disease (COVID-19) have forced clinicians, public health officials, and health systems to grapple with difficult questions about how to fairly allocate potentially life-saving treatments when there are not enough for all patients in need (1). Shortages have occurred with remdesivir, tocilizumab, monoclonal antibodies, and the oral antiviral Paxlovid (2) -/- Ensuring equitable allocation is especially important in light of the disproportionate burden experienced during the COVID-19 pandemic by disadvantaged groups, including Black, Hispanic/Latino and (...) Indigenous communities, individuals with certain disabilities, and low-income persons. However, many health systems have resorted to first-come, first-served approaches to allocation, which tend to disadvantage individuals with barriers in access to care (3). There is mounting evidence of racial, ethnic, and socioeconomic disparities in access to medications for COVID-19 (4, 5). -/- One potential method to promote equitable allocation is to use a weighted lottery, which is an allocation strategy that gives all eligible patients a chance to receive the scarce treatment while also allowing the assignment of higher or lower chances according to other ethical considerations (6). We sought to assess the feasibility of implementing a weighted lottery to allocate scarce COVID-19 medications in a large U.S. health system and to determine whether the weighted lottery promotes equitable allocation. (shrink)