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)

Donation after circulatory determination of death (DCDD) is an accepted practice in the United States, but heart procurement under these circumstances has been debated. Although the practice is experiencing a resurgence due to the recently completed trials using ex vivo perfusion systems, interest in thoracoabdominal normothermic regional perfusion (TA-NRP), wherein the organs are reanimated in situ prior to procurement, has raised many ethical questions. We outline practical, ethical, and equity considerations to ensure transplant programs make well-informed decisions about TA-NRP. We (...) present a multidisciplinary analysis of the relevant ethical issues arising from DCDD-NRP heart procurement, including application of the Dead Donor Rule and the Uniform Definition of Death Act, and provide recommendations to facilitate ethical analysis and input from all interested parties. We also recommend informed consent, as distinct from typical “authorization,” for cadaveric organ donation using TA-NRP. (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)

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)

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)

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)

Media exposure can shape audience perceptions surrounding novel innovations, such as artificial intelligence (AI), and could influence whether they share information about AI with others online. This study examines the indirect association between exposure to AI in the media and information sharing about AI online. We surveyed 567 US citizens aged 18 and older in November 2020, several months after the release of Open AI’s transformative GPT-3 model. Results suggest that AI media exposure was related to online information sharing through (...) psychological proximity to the impacts of AI and positive AI performance expectancy in serial mediation. This positive indirect association became stronger the more an individual perceived society to be changing due to new technology. Results imply that public exposure to AI in the media could significantly impact public understanding of AI, and prompt further information sharing online. (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)

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)

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)

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)

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)

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)

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)

This chapter focuses on the “America” part of Captain America's name and explores the more political aspects of his life and character. It looks at patriotism in general and how to characterize Captain America's brand of it; Cap's uneasy relationship with politics and the United States government; and how Cap puts principles above politics, even if it means defying his own government and giving up the shield and the title. The chapter explains that Cap's devotion to his country is based (...) on the principles and ideals upon which it was founded, and he regularly holds his government accountable to those same standards, which he interprets as inclusive and cosmopolitan, applying to the world outside America as well as everybody within it. It dispels any illusions that Captain America is a jingoist flag‐waver, and explains instead that he embodies an inclusive and cosmopolitan patriotism that balances idealism with clear‐eyed pragmatism. (shrink)

The first look at the philosophy behind the _Captain America_ comics and movies, publishing in advance of the movie release of _Captain America: The Winter Solider_ in April 2014. In _The Virtues of Captain America_, philosopher and long-time comics fan Mark D. White argues that the core principles, compassion, and judgment exhibited by the 1940’s comic book character Captain America remain relevant to the modern world. Simply put, "Cap" embodies many of the classical virtues that have been important to (...) us since the days of the ancient Greeks: honesty, courage, loyalty, perseverance, and, perhaps most importantly, honor. Full of entertaining examples from more than 50 years of comic books, White offers some serious philosophical discussions of everyone’s favorite patriot in a light-hearted and accessible way. Presents serious arguments on the virtues of Captain America while being written in a light-hearted and often humorous tone Introduces basic concepts in moral and political philosophy to the general reader Utilizes examples from 50 years of comics featuring Captain America, the Avengers, and other Marvel superheroes Affirms the value of "old-fashioned" virtues for the modern world without indulging in nostalgia for times long passed Reveals the importance of the sound principles that America was founded upon Publishing in advance of _Captain America: The Winter Soldier _out in April 2014. (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)

This chapter provides a quick primer on the volumes of the comic titles Captain America and Avengers. It talks about the beginnings and endings of which usually coincide with major events in the Marvel Universe. The story starts with the first volume of Avengers, since it was in the classic issue #4 of that title that Captain America was found in a block of ice and revived. These long‐running volumes of Captain America and Avengers lasted until 1996. Both series ended (...) when the Avengers were apparently killed in a battle with the villainous Onslaught. After the Avengers vs. X‐Men event, Marvel Comics relaunched many of its books and introduced new ones. The Watcher only knows what volume Captain America and the various Avengers titles are on, but Cap will live in on comics, movies, and TV long after this book has changed the course of American history. (shrink)