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)

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)

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)

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)

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)

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)

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)

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 role of power in healthcare can raise many ethical challenges. Power is ownership, whether given, ceded, or taken of another person’s autonomy. When a person has power over someone else, they can control or strongly influence the decision-making freedom of that person. From the principalist perspective1,2 of healthcare ethics, denying a person their freedom to choose, should only occur when justifying conditions related to beneficence and nonmaleficence are sufficiently satisfied. In healthcare, it is rare to be able to identify (...) situations where paternalism is justified. However, experience suggests that abusive power in healthcare is used too frequently without justifying criteria. (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)

'This volume provides major texts of the eighteenth-century religious exponents of utilitarianism, three of Bentham's important works on religion, and neglected essays by James Mill and by John Stuart Mill on utilitarianism and religion. No better guide and editor for these texts could be found than James Crimmins, the world's leading scholar on this subject. Since most of these writings are quite scarce, the collection is an indispensable resource for every student of the history of British moral, political, (...) and religious thought.' - J. B. Schneewind This publication represents the most complete collection ever of original writings on religion and utilitarianism. Illustrating both the sympathetic and antagonistic relationships between the principle of utility and religious beliefs in the eighteenth and nineteenth centuries, this is a work that no scholar of modern political thought should be without. Divided into two parts, religious and secular, the collection reprints the most important and salient contributions to the debate. It includes both the well-known writers and the lesser-known but equally important contributors, making this volume the best one-stop resource for undergraduates, graduates, scholars in the field, and all those interested in the relation of politics to religious belief. All materials are newly typeset. As well as two general introductions the collection features a biographical note on each author and detailed notes on each text. --all texts are reset and fully indexed --11 new introductions --features key writings and extracts long out of print. (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.

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)

Institutional Review Board decisions hinge on the availability and interpretation of information. This is demonstrated by the following well-known historical example. In 2001, 24-year-old Ellen Roche died from respiratory distress and organ failure as a result of her participation in a study at Johns Hopkins Asthma and Allergy Center. The non-therapeutic physiological study, “Mechanisms of Deep Inspiration-Induced Airway Relaxation,” was designed to examine airway hyperresponsiveness in healthy individuals in order to better understand the pathophysiology of asthma. Participants inhaled hexamethonium, a (...) chemical ganglionic blocker that was not FDA-approved for use as specified in the experimental protocol. Risks of inhaling hexamethonium, including lung damage, had been reported in the 1950s and ‘60s. An investigation conducted after Roche's death determined that the study's principal investigator had failed to adequately search the medical literature; the protocol submitted for IRB review cited articles indexed in online literature databases that went back only as far as the 1970s. (shrink)

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...

The Metaphysical Club, a gathering of intellectuals in the 1870s associated with Harvard, is widely recognized as the crucible where pragmatism, America's distinctively original philosophy, was refined and proclaimed. Louis Menand's bestseller about the group was a dramatic publishing success. However, only three actual members - Oliver Wendell Holmes Jr., Charles S. Peirce, and William James - appear in this book, alongside other thinkers such as John Dewey who were never in the Club. The Real Metaphysical Club tells the (...) full story of how this influential group shifted the course of philosophy in America. In addition to pioneering pragmatism, the group explored radical empiricism and idealism, and formulated personalism and process philosophy, equally important developments. This volume contains thirty-seven important writings dating from 1870 to 1885 by the real members of the Metaphysical Club. The first section centers on pragmatism and science; the second part collects writings of the lawyers; and the third part covers idealist and personalist philosophers. Many of these writings have never been reprinted before, and nothing like this impressive collection has ever been attempted. A general introduction provides a narrative history, and the editors' three introductions to the volume's sections vividly bring to life the intense meetings, sustained debates, and pioneering thought from the Metaphysical Club. (shrink)

Quarantine and spatial distancing measures associated with COVID-19 resulted in substantial changes to individuals’ everyday lives. Prominent among these lifestyle changes was the way in which people interacted with media—including music listening. In this repeated assessment study, we assessed Australian university students’ media use throughout early stages of the COVID-19 pandemic in Australia, and determined whether media use was related to changes in life satisfaction. Participants were asked to complete six online questionnaires, capturing pre- and during-pandemic experiences. The results indicated (...) that media use varied substantially throughout the study period, and at the within-person level, life satisfaction was positively associated with music listening and negatively associated with watching TV/videos/movies. The findings highlight the potential benefits of music listening during COVID-19 and other periods of social isolation. (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)

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)

[full article, abstract in English; abstract in Lithuanian] Constructionists operationalize a powerful notion they share with constructivists: individual learning is facilitated by building models of specific ideas, concepts, methods, objects, environments, feelings, dreams, memories and sounds using the learner’s current stock of knowledge. Constructionists do this by building models or artifacts that can be externally manipulated, interrogated by their builder, and verbally shared with others. Constructionists believe that new knowledge is created during these discussions. Constructionism is rich with heuristic methods (...) for both finding and constructing artifacts and for discussing these artifacts privately and publicly. Constructionists argue that both constructing and discussing are necessary for deep sense-making. This paper describes one specific constructionist learning method: visual modeling. It illustrates one educator’s approach, developed in the classroom over a 40-year period. It references the relevant literature; describes its pedagogic approach, materials and outcomes; and it offers a step-by-step example of one student’s thinking process. Finally, it presents – in appropriate narrative form – 15 arguments why the visual component extends the constructionist project and should be integrated into more educational programs. (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)