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)

In Science as Social Knowledge, Helen Longino offers a contextual analysis of evidential relevance. She claims that this "contextual empiricism" reconciles the objectivity of science with the claim that science is socially constructed. I argue that while her account does offer key insights into the role that values play in science, her claim that science is nonetheless objective is problematic.

Drawing on their extensive research, Nichols and Berliner document and categorize the ways that high-stakes testing threatens the purposes and ideals of the American education system. For more than a decade, the debate over high-stakes testing has dominated the field of education. This passionate and provocative book provides a fresh perspective on the issue and powerful ammunition for opponents of high-stakes tests. Their analysis is grounded in the application of Campbell’s Law, which posits that the greater the social consequences associated (...) with a quantitative indicator, the more likely it is that the indicator itself will become corrupted—and the more likely it is that the use of the indicator will corrupt the social processes it was intended to monitor. Nichols and Berliner illustrate both aspects of this “corruption,” showing how the pressures of high-stakes testing erode the validity of test scores and distort the integrity of the education system. Their analysis provides a coherent and comprehensive intellectual framework for the wide-ranging arguments against high-stakes testing, while putting a compelling human face on the data marshalled in support of those arguments. (shrink)

It is predicted that the rapid acquisition of new genetic knowledge and related applications during the next decade will have significant implications for virtually all members of society. Currently, most people get exposed to information about genes and genetics only through stories publicized in the media. We sought to understand how individuals in the general population used and understood the concepts of ???genetics??? and ???genes.??? During in-depth one-on-one telephone interviews with adults in the United States, we asked questions exploring their (...) basic understanding of these terms, as well as their belief as to the location of genes in the human body. A wide range of responses was received. Despite conversational familiarity with genetic terminology, many noted frustration or were hesitant when trying to answer these questions. In addition, some responses reflected a lack of understanding about basic genetic science that may have significant implications for broader public education measures in genetic literacy, genetic counseling, public health practices, and even routine health care. (shrink)

Arthur Fine's Natural Ontological Attitude (NOA) is intended to provide an alternative to both realism and antirealism. I argue that the most plausible meaning of "natural" in NOA is "nonphilosophical," but that Fine comes to NOA through a particular conception of philosophy. I suggest that instead of a natural attitude we should adopt a philosophical attitude. This is one that is self-conscious, pragmatic, pluralistic, and sensitive to context. I conclude that when scientific realism and antirealism are viewed with a philosophical (...) attitude there are still legitimate philosophical questions to address. (shrink)

This Cambridge "little book" takes up residence in the influential aerie of psychoanalytic studies in Latin poetry, whose best-known members are the Lacanianists Paul Allen Miller and Micaela Janan. Oliensis' contribution is to introduce the father of psychoanalysis to the club. She rightly insists that "the 'Freud' of Freud's Rome is not just a synecdoche for psychoanalysis", and she carefully distinguishes Freud from Lacan. She focuses on mourning, motherhood, and sexual difference, and she studies what she calls the "textual unconscious," (...) looking at issues of sexuality in Catullus, Ovid, and Virgil, an approach she describes as "psychotextual criticism". (shrink)

Through a discussion of the way science has been used to address intersexuality, I explore an idea about how to understand science as objective and yet influenced by social, historical, and cultural factors. I propose that the Semantic View of theories provides a means of understanding how science describes reality, and I look at the way science has been used to distinguish the sexes to provide an illustration.

InScience as Social Knowledge, Helen Longino offers a contextual analysis of evidential relevance. She claims that this “contextual empiricism” reconciles the objectivity of science with the claim that science is socially constructed. I argue that while her account does offer key insights into the role that values play in science, her claim that science is nonetheless objective is problematic.

The eight essays contained in Philosophical Feminism and Popular Culture explore the portrayal of women and various philosophical responses to that portrayal in contemporary post-civil rights society. The essays examine visual, print, and performance media — stand-up comedy, movies, television, and a blockbuster trilogy of novel. These philosophical feminist analyses of popular culture consider the possibilities, both positive and negative, that popular culture presents for articulating the structure of the social and cultural practices in which gender matters, and for changing (...) these practices if and when they follow from, lead to, or perpetuate discrimination on the basis of gender. The essays bring feminist voices to the conversation about gender where is it taking place and attest to the importance of feminist critique in what is sometimes claimed to be a post-feminist era. (shrink)

The advent of formal definitions of the simplicity of a theory has important implications for model selection. But what is the best way to define simplicity? Forster and Sober ([1994]) advocate the use of Akaike's Information Criterion (AIC), a non-Bayesian formalisation of the notion of simplicity. This forms an important part of their wider attack on Bayesianism in the philosophy of science. We defend a Bayesian alternative: the simplicity of a theory is to be characterised in terms of Wallace's Minimum (...) Message Length (MML). We show that AIC is inadequate for many statistical problems where MML performs well. Whereas MML is always defined, AIC can be undefined. Whereas MML is not known ever to be statistically inconsistent, AIC can be. Even when defined and consistent, AIC performs worse than MML on small sample sizes. MML is statistically invariant under 1-to-1 re-parametrisation, thus avoiding a common criticism of Bayesian approaches. We also show that MML provides answers to many of Forster's objections to Bayesianism. Hence an important part of the attack on Bayesianism fails. (shrink)

From 1998 to 2005, six elections took place in postcommunist Europe that had the surprising outcome of empowering the opposition and defeating authoritarian incumbents or their designated successors. Valerie J. Bunce and Sharon L. Wolchik compare these unexpected electoral breakthroughs. They draw three conclusions. First, the opposition was victorious because of the hard and creative work of a transnational network composed of local opposition and civil society groups, members of the international democracy assistance community and graduates of successful electoral (...) challenges to authoritarian rule in other countries. Second, the remarkable run of these upset elections reflected the ability of this network to diffuse an ensemble of innovative electoral strategies across state boundaries. Finally, elections can serve as a powerful mechanism for democratic change. This is especially the case when civil society is strong, the transfer of political power is through constitutional means, and opposition leaders win with small mandates. (shrink)

Tokenistic short-term economic success is not good indicia of long-term success. Sustainable business success requires sustained existence in a corporation's political, economic, social, technological, legal and environmental contexts. Far beyond the traditional economic focus, consumers, governments and public interest groups alike increasingly expect the business sector to take on more social and environmental responsibilities. Corporate social responsibility (CSR) is the model in which economic, social and environmental responsibilities are fulfilled simultaneously. However, there is insufficient empirical evidence that demonstrates genuine widespread (...) adoption of CSR in practice, and its underlying reasons. Though research in CSR has been rapidly growing, its commercial reality and implications need to be further improved if it is to inspire corporations to voluntarily adopt CSR. In the literature, Carroll's four-dimensional (economic, legal, ethical and discretionary) CSR framework offers a theoretical basis for developing an empirically based model to explain why and how profit-motivated managers take up CSR voluntarily. Our study has developed a structural equation model to identify the key factors and their interactions that influence economically motivated managers to take on voluntary CSR, and validate Carroll's four-dimensional construct. The results support Carroll's four-dimensional CSR framework, with the exception of the link pertaining to the relationship between economic and discretionary/voluntary responsibility. This characterises the economic reality that financial market-driven economic responsibility does not automatically translate into social responsibility. Nevertheless, the empirical results demonstrate that corporations can be led to engage in more voluntary CSR activities to achieve social good when appropriate legal and ethical controls are in place. (shrink)

By ruling out questions of impairment from the social critique of disability, Disability Studies analyses establish a limit point in the field. Of course the setting of “limits” enables possibilities in multiple directions as well as fortifies boundaries of refusal. For instance, impairment becomes in DS simultaneously a productive refusal to interpret disabled bodies as inferior to non-disabled bodies and a bar to thinking through more active engagements with disability as materiality. Disability materiality such as conditions produced by ecological toxicities (...) serve as active switch-points for creative corporeal navigations of the interaction between bodies and environments.In fact in this paper we want to propose a more “lively” definition of disability materiality to existing definitions of impairment as limiting expressions of non-normative bodies. We have no useful ways of explaining disability as adaptation and it’s time we begin the process of theorizing more active ideas of materiality that extend existing ideas of disability beyond simplistic conceptions of socially rejected biologies made available by social constructivist thought. (shrink)

This collection showcases the work of 18 analytical feminists from a variety of traditional areas of philosophy. It highlights successful uses of concepts and approaches from traditional philosophy, and illustrates the contributions that feminist approaches have made and could make to the analysis of issues in key areas of traditional philosophy, while also demonstrating that traditional philosophy ignores feminist insights and feminist critiques of traditional philosophy at its own peril.

Volume 20, Issue 3, March 2020, Page 21-24.

Cognitive control refers to the regulation of mental activity to support flexible cognition across different domains. Cragg and Nation (2010) propose that the development of cognitive control in children parallels the development of language abilities, particularly inner speech. We suggest that children’s late development of cognitive control also mirrors their limited ability to revise misinterpretations of sentence meaning. Moreover, we argue that for certain tasks, a tradeoff between bottom-up (data-driven) and top-down (rule-based) thinking may actually benefit performance in both children (...) and adults. Specifically, we propose that a lack of cognitive control may promote important aspects of cognitive development, like language acquisition and creativity. (shrink)

Graduate students typically first experience research ethics when they submit their masters or doctoral research projects for ethics approval. Research ethics boards in Canada review and grant ethical approval for student research projects and often have to provide additional support to these novice researchers. Previous studies have explored curriculum content, teaching approaches, and the learning environment related to research ethics for graduate students. However, research does not exist that examines students’ actual experience with the research ethics process. Qualitative description was (...) used to explore the research ethics review experience of 11 masters and doctoral students in health discipline programs. Data analysis revealed four themes: curriculum, supervisor support, the ethics application process, and students’ overall experience. The results of this research suggest ideas for enhancing curriculum, deepening students’ relationships with supervisors, and developing the role of research ethics... (shrink)

Benchmarks against which healthcare ethics consultation (HCEC) services can assess their performance are needed. As first-generation benchmarks continue to be developed, it is the obligation of the field to continually evaluate how these measures reflect the performance of any single HCEC service. This will be possible only with widespread reporting of standardized data points. In their article in this issue of The Journal of Clinical Ethics, Glover and colleagues provide a valuable preliminary approach for assessing appropriate consult volumes for a (...) HCEC service. The limitations of their study read as a call to action for the field of clinical ethics to expand and standardize data reporting so that more robust metrics can be developed. In response to this call by Glover and colleagues, the Cleveland Clinic HCEC service provides consult data from 2015 through 2019 for one of its medical centers, and offers an additional volumebased metric, consult-to-ICU-to-bed ratio (CiBR), that may add nuance to any normative assessment of HCEC service consult volume. Given that volume-based metrics are the native language of the clinical environment, efforts to improve such metrics in the field through transparency and standardization are warranted. However, the expositive power of volume-based metrics is limited; additional domains related to quality and outcomes are needed. (shrink)

Volume 19, Issue 11, November 2019, Page 78-80.

The purpose of this study was to evaluate, revise, and extend the Informed Consent Ontology (ICO) for expressing clinical permissions, including reuse of residual clinical biospecimens and health data. This study followed a formative evaluation design and used a bottom-up modeling approach. Data were collected from the literature on US federal regulations and a study of clinical consent forms. Eleven federal regulations and fifteen permission-sentences from clinical consent forms were iteratively modeled to identify entities and their relationships, followed by community (...) reflection and negotiation based on a series of predetermined evaluation questions. ICO included fifty-two classes and twelve object properties necessary when modeling, demonstrating appropriateness of extending ICO for the clinical domain. Twenty-six additional classes were imported into ICO from other ontologies, and twelve new classes were recommended for development. This work addresses a critical gap in formally representing permissions clinical permissions, including reuse of residual clinical biospecimens and health data. It makes missing content available to the OBO Foundry, enabling use alongside other widely-adopted biomedical ontologies. ICO serves as a machine-interpretable and interoperable tool for responsible reuse of residual clinical biospecimens and health data at scale. (shrink)