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)

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)

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.

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)

Three main ethical issues involved in the management of whales and small cetaceans are examined: ethical values concerning extinction and their implications for consumptive management regimes, the humaneness of current and feasible future harvesting techniques, and the ethical propriety of killing cetaceans for various uses. I argue that objections to human-caused extinction are primarily ethical, and that the ethical discussion must be expanded to include greater consideration of acceptable risks and problems associated with extinction due to human-caused genetic selection. Whaling (...) methods are objectively described including death times for whales. I show that the debate on humaneness is not about the facts of the hunt, but about the appropriate standard for judging whether or not a technique ishumane. Economic and ecological arguments which attempt to preempt the ethical questions are discussed and dismissed as specious. Arguments which attempt to distinguish ethically human relations with cetaceans from relations with other wildlife species are reviewed critically. (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.

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)

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)

The New Atheists The New Atheists are authors of early twenty-first century books promoting atheism. These authors include Sam Harris, Richard Dawkins, Daniel Dennett, and Christopher Hitchens. The “New Atheist” label for these critics of religion and religious belief emerged out of journalistic commentary on the contents and impacts of their books. A standard observation is … Continue reading New Atheists →.

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)

We give a formalism for approximate isomorphism in continuous logic simultaneously generalizing those of two papers by Ben Yaacov [2] and by Ben Yaacov, Doucha, Nies, and Tsankov [6], which are largely incompatible. With this we explicitly exhibit Scott sentences for the perturbation systems of the former paper, such as the Banach‐Mazur distance and the Lipschitz distance between metric spaces. Our formalism is simultaneously characterized syntactically by a mild generalization of perturbation systems and semantically by certain elementary classes of two‐sorted (...) structures that witness approximate isomorphism. As an application, we show that the theory of any ‐tree or ultrametric space of finite radius is stable, improving a result of Carlisle and Henson [8]. (shrink)

ABSTRACT:It may be too late to avoid the climate crisis, likely to be humanity's most expensive, widespread, and enduring catastrophe. This is a qualitatively different kind of catastrophe, in which increased costs, decreased revenue, and no possibility of bailout force communities to harshly cut budgets, especially in health care. Little is known about making such brutal cuts fair or efficient, nor how to help the public accept them. The crisis presents an opportunity for bioethicists to play a crucial role, but (...) one for which traditional approaches are inherently inadequate. Although often dismissed as heartless, Garrett Hardin's "lifeboat ethics" started a conversation about making ethical choices in global disasters—where all options are painful and unacceptable—and may provide guidance. Bioethics during the climate crisis must focus on communities rather than individuals and help survivors grieve the terrible consequences. Because today's choices will affect many generations, with the burdens falling most heavily on poor communities, we have to construct a radical bioethics to help tomorrow's health care become green, efficient, and fair. (shrink)

Hollywood movies can be deeply engaging and easy to understand. To succeed in this manner, feature-length movies employ many editing techniques with strong psychological underpinnings. We explore the origins and development of one of these, the reaction shot. This shot typically shows a single, unspeaking character with modest facial expression in response to an event or to the behavior or speech of another character. In a sample of movies from 1940 to 2010, we show that the prevalence of one type (...) of these shots—which we call the cryptic reaction shot—has grown dramatically. These shots are designed to enhance viewers’ emotional involvement with characters. They depict a facial gesture that reflects a slightly negative and slightly aroused emotional state. Their use at the end of conversations, and typically at the end of scenes, helps to leave viewers in a state of speculation about what the character is thinking and what her thoughts may mean for the ongoing narrative. (shrink)