This case details the new product development and approval of Posilac®, an animal drug product pioneered by the Monsanto Company. The product is a genetically engineered hormone known as bovine somatotropin (BST) and was targeted for sale to dairy farmers to enhance the milk production of their herds. At the time of its development and subsequent introduction to the market, Posilac® represented one the first applications of genetic engineering in food production and as such, it became a lightning rod for (...) controversy. As Monsanto sought approval for this product from the U.S. Food and Drug Administration (FDA), it encountered vigorous opposition from a variety of consumer and trade interests. The (A) case recounts the arduous approval process and explains how industry and public policy debates largely focused on issues of product labeling. (shrink)

This case details the new product development and approval of Posilac®, an animal drug product pioneered by the Monsanto Company. The product is a genetically engineered hormone known as bovine somatotropin (BST) and was targeted for sale to dairy farmers to enhance the milk production of their herds. At the time of its development and subsequent introduction to the market, Posilac® represented one the first applications of genetic engineering in food production and as such, it became a lightning rod for (...) controversy. As Monsanto sought approval for this product from the U.S. Food and Drug Administration (FDA), it encountered vigorous opposition from a variety of consumer and trade interests. The (A) case recounts the arduous approval process and explains how industry and public policy debates largely focused on issues of product labeling. (shrink)

This case details the new product development and approval of Posilac®, an animal drug product pioneered by the Monsanto Company. The product is a genetically engineered hormone known as bovine somatotropin (BST) and was targeted for sale to dairy farmers to enhance the milk production of their herds. At the time of its development and subsequent introduction to the market, Posilac® represented one the first applications of genetic engineering in food production and as such, it became a lightning rod for (...) controversy. As Monsanto sought approval for this product from the U.S. Food and Drug Administration (FDA), it encountered vigorous opposition from a variety of consumer and trade interests. The (A) case recounts the arduous approval process and explains how industry and public policy debates largely focused on issues of product labeling. (shrink)

This case details the new product development and approval of Posilac®, an animal drug product pioneered by the Monsanto Company. The product is a genetically engineered hormone known as bovine somatotropin and was targeted for sale to dairy farmers to enhance the milk production of their herds. At the time of its development and subsequent introduction to the market, Posilac® represented one the first applications of genetic engineering in food production and as such, it became a lightning rod for controversy. (...) As Monsanto sought approval for this product from the U.S. Food and Drug Administration, it encountered vigorous opposition from a variety of consumer and trade interests. The case recounts the arduous approval process and explains how industry and public policy debates largely focused on issues of product labeling. (shrink)

John Berry, a risk manager for a U.S.-based pharmaceutical firm (Best Co.), is assigned additional responsibilities when his territory is expanded to include the South America region. When an employee in one of Best Co.’s South American manufacturing facilities dies in a work-related incident, John must determine an appropriate response. In a business context that is increasingly global, ethical decisions are further complicated by cultural differences. This case considers thefactors influencing John as he weighs his options on how to resolve (...) this incident. The case further considers how cultural differences coupled with John’s limited cross-cultural sensitivities and personal viewpoint might inevitably skew his judgment. San Luis, the disguised name for this South American locale, is less litigious than John’s home country, the U.S. In light of these differences, the case raises a number of ethical questions. For example, how should an international corporation compensate an employee’s family for the employee’s work-related death – if at all? Are John’s own cultural limitations preventing him from doing the right thing? (shrink)

La Oroya, Peru, and Herculaneum, Missouri, USA, are two cities 4,000 miles apart but beset with common health and environmental risk: high levels of lead contamination. A key participant in this unfolding tale of environmental disaster has been The Renco Group, a privately held investment holding company based in New York. This case study sheds light on The Renco Group’s Corporate Social Responsibility (CSR) in a developing country (Peru) as distinct from CSR in a developed country (USA) by presenting the (...) distinctive set of formal and informal forces that shape the ethical outcome. The question – one which animates much of this case – is what mechanisms exist that work either collectively or individually to encourage or even require a privately-owned firm to act in a socially responsible manner or, more modestly, to cease activities that are deemed to harm society or the general welfare in a multi-country context? (shrink)

Numerous articles in the popular press together with an examination of websites associated with the medical, legal, engineering, financial, and other professions leave no doubt that the role of professions has been impacted by the Internet. While offering the promise of the democratization of expertise – expertise made available to the public at convenient times and locations and at an affordable cost – the Internet is also driving a reexamination of the concept of professional identity and related claims of expertise (...) and standards of integrity. This paper begins with a presentation of case studies illustrating the ease by which impostors infiltrate the ranks of professionals. Reports of individuals masquerading as professionals via the Internet often reveal that these imposters cause harm to the unwary victims who rely on assertions of professional expertise. Such reports motivated the authors to examine the origins and evolution of the traditional roles of professions and professionals in today’s society, as well as question how, or whether, the standards for professional practice have been adapted to the challenges posed by technology, i.e., do statements of professional ethics provide a ‘guiding light’ for practitioners and their clients in the cyber age? The authors challenge the professions to consider the notion that technology forces a confrontation between the guild-like aspects of a profession that have served, on the one hand, to protect a profession from encroachment and, on the other hand, have purportedly protected the public. (shrink)

This essay examines the origin of genotype-environment interaction, or G×E. "Origin" and not "the origin" because the thesis is that there were actually two distinct concepts of G×E at this beginning: a biometric concept, or \[G \times E_B\], and a developmental concept, or \[G \times E_D \]. R. A. Fisher, one of the founders of population genetics and the creator of the statistical analysis of variance, introduced the biometric concept as he attempted to resolve one of the main problems in (...) the biometric tradition of biology - partitioning the relative contributions of nature and nurture responsible for variation in a population. Lancelot Hogben, an experimental embryologist and also a statistician, introduced the developmental concept as he attempted to resolve one of the main problems in the developmental tradition of biology - determining the role that developmental relationships between genotype and environment played in the generation of variation. To argue for this thesis, I outline Fisher and Hogben's separate routes to their respective concepts of G × E; then these separate interpretations of G × E are drawn on to explicate a debate between Fisher and Hogben over the importance of G × E, the first installment of a persistent controversy. Finally, Fisher's \[G \times E_B\] and Hogben's \[G \times E_D \] are traced beyond their own work into mid-2Oth century population and developmental genetics, and then into the infamous IQ Controversy of the 1970s. (shrink)

BackgroundDespite rapid growth of the scientific literature, no consensus guidelines have emerged to define the optimal criteria for editors to grade submitted manuscripts. The purpose of this project was to assess the peer reviewer metrics currently used in the surgical literature to evaluate original manuscript submissions.MethodsManuscript grading forms for 14 of the highest circulation general surgery-related journals were evaluated for content, including the type and number of quantitative and qualitative questions asked of peer reviewers. Reviewer grading forms for the seven (...) surgical journals with the higher impact factors were compared to the seven surgical journals with lower impact factors using Fisher’s exact tests.ResultsImpact factors of the studied journals ranged from 1.73 to 8.57, with a median impact factor of 4.26 in the higher group and 2.81 in the lower group. The content of the grading forms was found to vary considerably. Relatively few journals asked reviewers to grade specific components of a manuscript. Higher impact factor journal manuscript grading forms more frequently addressed statistical analysis, ethical considerations, and conflict of interest. In contrast, lower impact factor journals more commonly requested reviewers to make qualitative assessments of novelty/originality, scientific validity, and scientific importance.ConclusionSubstantial variation exists in the grading criteria used to evaluate original manuscripts submitted to the surgical literature for peer review, with differential emphasis placed on certain criteria correlated to journal impact factors. (shrink)

I provide a history of research on G×E in this article, showing that there have actually been two distinct concepts of G×E since the very origins of this research. R. A. Fisher introduced what I call the biometric concept of G×E, or G×EB, while Lancelot Hogben introduced what I call the developmental concept of G×E, or G×ED. Much of the subsequent history of research on G×E has largely consisted in the separate legacies of these separate concepts, along with the (sometimes (...) acrimonious) disputes that have arisen time and again when employers of each have argued over the appropriate way to conceptualize the phenomenon. With this history in place, I then consider more recent attempts to distinguish between different concepts of G×E, paying particular attention to the commonly made distinction between “statistical interaction” and “interactionism,” and also Michael Rutter’s distinction between “statistical interaction” and “the biological concept of interaction.” I argue that the history of the separate legacies of G×EB and G×ED better supports Rutter’s analysis of the situation, and that this analysis best paves the way for an integrative relationship between the various scientists investigating the place of G×E in the etiology of complex traits. (shrink)

Review of Jaynes, Probability Theory: The Logic of Science; Marrison, The Fundamentals of Risk Management; and Hastie, Tibshirani and Friedman, The Elements of Statistical Learning. A standard view of probability and statistics centers on distributions and hypothesis testing. To solve a real problem, say in the spread of disease, one chooses a “model”, a distribution or process that is believed from tradition or intuition to be appropriate to the class of problems in question. One uses data to estimate the parameters (...) of the model, and then delivers the resulting exactly specified model to the customer for use in prediction and classification. As a gateway to these mysteries, the combinatorics of dice and coins are recommended; the energetic youth who invest heavily in the calculation of relative frequencies will be inclined to protect their investment through faith in the frequentist philosophy that probabilities are all really relative frequencies. Those with a taste for foundational questions are referred to measure theory, an excursion from which few return. That picture, standardised by Fisher and Neyman in the 1930s, has proved in many ways remarkably serviceable. It is especially reasonable where it is known that the data are generated by a physical process that conforms to the model. It is not so useful where the data is a large and little understood mess, as is typical in, for example, insurance data being investigated for fraud. Nor is it suitable where one has several speculations about possible models and wishes to compare them, or.. (shrink)

There has been considerable interest in the literature about how professions operate in both the private and public interest. This paper examines this issue in the context of the enforcement of the professional code of conduct of a particular professional accounting association. The paper explores whether certain enforcement actions of the association suggest behaviour motivated at least partially by private interest. It then considers whether the consequences of such behaviour or practices are troubling.

The contribution of this work is a classification of corporate social action underlying the Social Ratings Data compiled by Kinder Lydenburg Domini Analytics, Inc. We compare extant typologies of corporate social action to the results of our exploratory factor analysis. Our findings indicate four distinct latent constructs that bear resemblance to concepts discussed in prior literature. Akey finding of our research is that positive and negative social action are both empirically and conceptually distinct constructs and should not be combined in (...) future research. Additionally, we recommend that some prior research results be reconsidered to determine whether these newly derived measures might clarify some previous findings. (shrink)

In 2012, a U.S. Institute of Medicine report called for a different approach to health care: “Left unchanged, health care will continue to underperform; cause unnecessary harm; and strain national, state, and family budgets.” The answer, they suggested, would be a “continuously learning” health system. Ethicists and researchers urged the creation of “learning health organizations” that would integrate knowledge from patient‐care data to continuously improve the quality of care. Our experience with an ongoing research study on atrial fibrillation—a trial known (...) as IMPACT‐AFib—gave us some insight into one of the challenges that will have to be dealt with in creating these organizations. Although the proposed educational intervention study placed no restrictions on what providers and health plans could do, the oversight team argued that the ethical principle of beneficence did not allow the researchers to be “bystanders” in relation to a control group receiving suboptimal care. In response, the researchers designed a “workaround” that allowed the project to go forward. We believe the experience suggests that what we call “bystander ethics” will create challenges for the kinds of quality improvement research that LHOs are designed to do. (shrink)

"Cluster randomized trials," in which groups of patients are randomly assigned to different therapeutic interventions, provide a powerful way of evaluating drugs. CRTs have not been widely used, in good part because of concerns about whether patients must give informed consent to participate in them. A better understanding of how CRTs fit into clinical practice resolves the concerns.

The paper considers whether the British Government could make receiving a COVID-19 vaccine effectively legally mandatory. After considering the position in English law, it considers the ethical pos...

In this paper, rather than focusing on genes as an organising concept around which historical considerations of theory and practice in genetics are elucidated, we place genetic markers at the heart of our analysis. This reflects their central role in the subject of our account, livestock genetics concerning the domesticated pig, Sus scrofa. We define a genetic marker as a element existing in different forms in the genome, that can be identified and mapped using a variety of quantitative, classical and (...) molecular genetic techniques. The conjugation of pig genome researchers around the common object of the marker from the early-1990s allowed the distinctive theories and approaches of quantitative and molecular genetics concerning the size and distribution of gene effects to align in projects to populate genome maps. Critical to this was the nature of markers as ontologically inert, internally heterogeneous and relational. Though genes as an organising and categorising principle remained important, the particular concatenation of limitations, opportunities, and intended research goals of the pig genetics community, meant that a progressively stronger focus on the identification and mapping of markers rather than genes per se became a hallmark of the community. We therefore detail a different way of doing genetics to more gene-centred accounts. By doing so, we reveal the presence of practices, concepts and communities that would otherwise be hidden. (shrink)

In this paper, rather than focusing on genes as an organising concept around which historical considerations of theory and practice in genetics are elucidated, we place genetic markers at the heart of our analysis. This reflects their central role in the subject of our account, livestock genetics concerning the domesticated pig, Sus scrofa. We define a genetic marker as a element existing in different forms in the genome, that can be identified and mapped using a variety of quantitative, classical and (...) molecular genetic techniques. The conjugation of pig genome researchers around the common object of the marker from the early-1990s allowed the distinctive theories and approaches of quantitative and molecular genetics concerning the size and distribution of gene effects to align in projects to populate genome maps. Critical to this was the nature of markers as ontologically inert, internally heterogeneous and relational. Though genes as an organising and categorising principle remained important, the particular concatenation of limitations, opportunities, and intended research goals of the pig genetics community, meant that a progressively stronger focus on the identification and mapping of markers rather than genes per se became a hallmark of the community. We therefore detail a different way of doing genetics to more gene-centred accounts. By doing so, we reveal the presence of practices, concepts and communities that would otherwise be hidden. (shrink)

Given that university faculty members and supervisors practicing in the community have been involved in at least one research supervisor-graduate student relationship, it is surprising that so little attention has been paid to the ethical issues involved in such relationships. Indeed, as a student and her or his graduate research supervisor may be involved in a close working relationship for many years, it is understandable that several opportunities can arise that could be considered dual or multiple relationships. Examples of such (...) relationship issues discussed in this article include authorship matters, favoritism or inequitable treatment of students, and sexual relationships. Depending on the nature of the relationship, the impact on students can be quite severe; although, the effects on students have not been adequately studied. Existing ethical guidelines do not provide enough guidance in this area where students are in a position of diminished power with respect to the supervisor. Following the discussion of relationship issues, we suggest extensions of current guidelines to deal with these issues. (shrink)

This paper assesses the effect of DNA barcoding—the use of informative genetic markers to identify and discriminate between species—on taxonomy. Throughout, we interpret this in terms of _varipraxis_, a concept we introduce to make sense of the treatment of biological variation by scientists and other practitioners. From its inception, DNA barcoding was criticised for being reductive, in attempting to replace multiple forms of taxonomic evidence with just one: DNA sequence variation in one or a few indicative genes. We show, though, (...) how DNA barcoding has not narrowed or reduced taxonomy in the way it was projected to. We examine the development and implementation of DNA barcoding across three kingdoms of life: animals, plants, and protists. Through this, we demonstrate that for DNA barcoding to work, the range of acceptable intra-specific variation needs to be demarcated from variation deemed to be characteristic of inter-specific differences. Consequently, biological processes responsible for particular patterns of variation need to be investigated and understood. This encourages an integrative disposition towards understanding and explaining the evolutionary processes affecting the rate and nature of change at the nucleotide level. We detail how the impact of DNA barcoding has manifested differently across the three kingdoms we examine, assessing this in terms of the ontological commitments that are held and instantiated in practice. Based on this evaluation, we consider the problem of studying multi-kingdom communities, and assess the consequences of our analysis for understanding classification and taxonomy. (shrink)

From the 1980s onwards, the Roslin Institute and its predecessor organizations faced budget cuts, organizational upheaval and considerable insecurity. Over the next few decades, it was transformed by the introduction of molecular biology and transgenic research, but remained a hub of animal geneticists conducting research aimed at the livestock-breeding industry. This paper explores how these animal geneticists embraced genomics in response to the many-faceted precarity that the Roslin Institute faced, establishing it as a global centre for pig genomics research through (...) forging and leading the Pig Gene Mapping Project (PiGMaP); developing and hosting resources, such as a database for genetic linkage data; and producing associated statistical and software tools to analyse the data. The Roslin Institute leveraged these resources to play a key role in further international collaborations as a hedge against precarity. This adoption of genomics was strategically useful, as it took advantage of policy shifts at the national and European levels towards funding research with biotechnological potential. As genomics constitutes a set of infrastructures and resources with manifold uses, the development of capabilities in this domain also helped Roslin to diversify as a response to precarity. (shrink)

The study of bi- and multilingualism in the ancient Mediterranean has come into its own in recent decades. The evidence is far greater for the Hellenistic and Roman periods than the Classical, so naturally scholarly attention has focussed less on the earlier era. This has led to some enduring notions about bilingualism in the fifth century b.c.e. which are yet to be fully scrutinized, including the idea that a Greek's speaking another tongue was inherently transgressive. What did it mean for (...) a Greek to speak a second language? This article re-evaluates the evidence for individual bilingualism in Herodotus and Thucydides in their fifth-century context, focussed on our two best-documented examples of bilingual Greek individuals (Histiaeus of Miletus and Themistocles of Athens). Close reading of Herodotus and Thucydides suggests that not only does the notion of an inherently transgressive bilingualism hold little water for this period, but bilingualism may even be a sign of μῆτις. (shrink)

Briefly, I presented two distinct objections against the notion of an existence attribute, or for brevity, e-attribute: first, there is no way of adequately unpacking the analysans of ; but, second, even if there should be an acceptable formulation of, there is no general procedure for deciding which attributes satisfy this definition. Now the second of these objections, I want to say, remains sound for the reasons given in the paper cited above. Unfortunately my attempt to establish the first objection (...) fails and the reason for the failure should not go unnoticed. (shrink)

Although “rationing” continues to be a dirty word for the public in health policy discourse, Nir Eyal and colleagues handle the concept exactly right in their article in this issue of the Hastings Center Report. They correctly characterize rationing as an ethical requirement, not a moral abomination. They identify the key health policy question as how rationing can best be done, not whether it should be done at all. They make a cogent defense of what they call “rationing through inconvenience” (...) as a justifiable allocational technique. And they wisely call for research on the effectiveness and fairness of this approach and other methods of rationing. I fully agree with their approach to rationing and with their argument that the process they provocatively label “rationing through inconvenience” should not be rejected out of hand. But I believe they have underestimated two ways in which the practical impacts of rationing through inconvenience limit its potential usefulness: the asymmetry of its effect on patients and physicians and the way in which it reduces the capacity of health systems to learn from experience. (shrink)

Abstract:Sustainable development and built heritage are oft-naturalized hegemonic discourses of the dominant social class. However, under the lens of critical sociomateriality, these categories destabilize—and in Brexit-era London, epicenter of a financial and technological capitalist circulatory space, “all that is solid melts” into the scopal regime of London's View Management Framework (LVMF). Analyzing multiple discourses of Southwark's Strata SE1— billed London's first “sustainable tower”—and adaptive reuse of the historically preserved Lambeth Water Tower, I argue that these structures constitute ‘interface objects’ in (...) a broader relational geography imbricating physical material, social objects, gentrification and the naturalized epistemologies of hegemonic development within London's skyline itself. I offer a reading of critical sociomateriality which illuminates rhythms of daily life within spatial-technological systems of energy provision, urban metabolic processes, as well as “hegemonic premiums,” what Richard Barras terms expected return on symbolic capital vis-à-vis the dominant panopticism of the LVMF. This paper contributes a theorization of critical sociomateriality, operating across a diversity of scales, tactics, and disciplines, analyzing discourses and practices which insinuate politics, artifacts, and technologies across contested issues. Critical sociomateriality is presented as a methodology for deconstructing tactics for inhabiting and interfacing with ‘sustainability’ through London's skyline in an unequal capitalist system marked by dissensus over runaway development, social precarity, and inequality in lived experiences of the urban environment. (shrink)

The primary aim of this article is to develop and defend a conceptual analysis of safety. The article begins by considering two previous analyses of safety in terms of risk acceptability. It is argued that these analyses fail because the notion of risk acceptability is more subjective than safety, as risk acceptability takes into account potential benefits in a way that safety does not. A distinction is then made between two different kinds of safety—safety qua cause and safety qua recipient—and (...) both are defined in terms of the probability of a loss of value, though the relationship between safety and the probability of loss varies in each case. It is then shown that although this analysis is less subjective than the previously considered analyses, subjectivity can still enter into judgments of safety via the notions of probability and value. In the final section of this article, it is argued that the difference between safety and risk acceptability is important because it corresponds in significant ways to the difference between consequentialist and deontological moral viewpoints. (shrink)

The repair of chromosomal double‐strand breaks (DSBs) by homologous recombination is essential to maintain genome integrity. The key step in DSB repair is the RecA/Rad51‐mediated process to match sequences at the broken end to homologous donor sequences that can be used as a template to repair the lesion. Here, in reviewing research about DSB repair, I consider the many factors that appear to play important roles in the successful search for homology by several homologous recombination mechanisms.

King's has done it again. For the third year Peter Byrne has collected a series of essays which are topical, in that they address problems that judges and legislators should now be considering, while in no sense being ephemeral.

This essay uses a mental files theory of singular thought—a theory saying that singular thought about and reference to a particular object requires possession of a mental store of information taken to be about that object—to explain how we could have such thoughts about abstract mathematical objects. After showing why we should want an explanation of this I argue that none of three main contemporary mental files theories of singular thought—acquaintance theory, semantic instrumentalism, and semantic cognitivism—can give it. I argue (...) for two claims intended to advance our understanding of singular thought about mathematical abstracta. First, that the conditions for possession of a file for an abstract mathematical object are the same as the conditions for possessing a file for an object perceived in the past—namely, that the agent retains information about the object. Thus insofar as we are able to have memory-based files for objects perceived in the past, we ought to be able to have files for abstract mathematical objects too. Second, at least one recently articulated condition on a file’s being a device for singular thought—that it be capable of surviving a certain kind of change in the information it contains—can be satisfied by files for abstract mathematical objects. (shrink)

In Utilitarianism in the Early American Republic James E. Crimmins provides a fresh perspective on the history of antebellum American political thought. Based on a broad-ranging study of the dissemination and reception of utilitarian ideas in the areas of constitutional politics, law education, law reform, moral theory and political economy, Crimmins illustrates the complexities of the place of utilitarianism in the intellectual ferment of the times, in both its secular and religious forms, intersection with other doctrines, and practical outcomes. (...) The pragmatic character of American political thought revealed--culminating in the postbellum rise of Pragmatism--stands in marked contrast to the conventional interpretations of intellectual history in this period. Utilitarianism in the Early American Republic will be of interest to academic specialists, and graduate and senior undergraduate students engaged in the history of political thought, moral philosophy and legal philosophy, particularly scholars with interests in utilitarianism, the trans-Atlantic transfer of ideas, the American political tradition and modern American intellectual history. (shrink)