BackgroundThe U.S. Food and Drug Administration traditionally has kept confidential significant amounts of information relevant to the approval or non-approval of specific drugs, devices, and biologics and about the regulatory status of such medical products in FDA’s pipeline.ObjectiveTo develop practical recommendations for FDA to improve its transparency to the public that FDA could implement by rulemaking or other regulatory processes without further congressional authorization. These recommendations would build on the work of FDA’s Transparency Task Force in 2010.MethodsIn 2016-2017, we convened (...) a team of academic faculty from Harvard Medical School, Brigham and Women’s Hospital, Yale Medical School, Yale Law School, and Johns Hopkins Bloomberg School of Public Health to develop recommendations through an iterative process of reviewing FDA’s practices, considering the legal and policy constraints on FDA in expanding transparency, and obtaining insights from independent observers of FDA.ResultsThe team developed 18 specific recommendations for improving FDA’s transparency to the public. FDA could adopt all these recommendations without further congressional action.FundingThe development of the Blueprint for Transparency at the U.S. Food and Drug Administration was funded by the Laura and John Arnold Foundation. (shrink)

"All life upon the stage"; the Theatrum Mundi. In this volume, a seventeenth century metaphor is revisited and is seen as applying to all art in all times. In the "magic mirror of art" the human being discerns the hidden spheres of human life and commemorates and celebrates its glorious victories and mourns its ignominious defeats. Let us rediscover Art as a witness to the human predicament as well as a celebrant of humanity's most sublime moments. This is the invitation (...) of this collection of studies by A-T. Tymieniecka, Hanna Scolnicov, Muella Erkilic, Matt Landrus, Patricia Trutty-Coohill, Monika Bakke, David Brubaker, Tammy Knipp, Howard Pearce, Ellen J. Burns, G. Backhaus, Ethan J. Leib, Lawrence Kimmel, Ingrid Scheibler, Gottfried Scholz, L.F. Werth, A. Carillo, M. Statkiewicz, K. O'Rourke, B. Meyler, H. Meltzer, Jiuan Heng, W.V. Davies. Art as mirror of life, human life as participating in a stage play, corresponds to the fervent search human being of the causes, reasons, puzzles of our existence which elude us in the concrete life. This XVII c. conception of Theatrum Mundi opens as this volume shows a fascinating field of investigation for our times. (shrink)

George Annas serves a critical function as an incisive commentator on the interactions between law and medicine and law and public health. Along with Alex Capron, Dena Davis, Rebecca Dresser, and Larry GostinProfessor Annas analyses legal aspects of a spectrum of medicolegal issues both in a forum and in a manner that makes them accessible and understandable to a broad community of healthcare providers. His latest book, SomeChoice, continues that valuable tradition. The bulk of the volume (17 out of (...) 22 chapters) is drawn from essays originally published as the feature of the NewEnglandJournalofMedicine. The topics include such staples of patients' rights debate as the boundaries of informed consent, authorization of medical experiments, and physician-assisted suicide. A treat is the inclusion of less frequently covered issues, such as access to health information concerning presidential candidates and constitutional bounds of limits on cigarette advertising. (shrink)

Pleiotropy, in which one mutation causes multiple phenotypes, has traditionally been seen as a deviation from the conventional observation in which one gene affects one phenotype. Epistasis, or gene–gene interaction, has also been treated as an exception to the Mendelian one gene–one phenotype paradigm. This simplified perspective belies the pervasive complexity of biology and hinders progress toward a deeper understanding of biological systems. We assert that epistasis and pleiotropy are not isolated occurrences, but ubiquitous and inherent properties of biomolecular networks. (...) These phenomena should not be treated as exceptions, but rather as fundamental components of genetic analyses. A systems level understanding of epistasis and pleiotropy is, therefore, critical to furthering our understanding of human genetics and its contribution to common human disease. Finally, graph theory offers an intuitive and powerful set of tools with which to study the network bases of these important genetic phenomena. (shrink)

This study examined patterns of auxiliary provision and omission for the auxiliaries BE and HAVE in a longitudinal data set from 11 children between the ages of two and three years. Four possible explanations for auxiliary omission—a lack of lexical knowledge, performance limitations in production, the Optional Infinitive hypothesis, and patterns of auxiliary use in the input—were examined. The data suggest that although none of these accounts provides a full explanation for the pattern of auxiliary use and nonuse observed in (...) children's early speech, integrating input-based and lexical learning-based accounts of early language acquisition within a constructivist approach appears to provide a possible framework in which to understand the patterns of auxiliary use found in the children's speech. The implications of these findings for models of children's early language acquisition are discussed. (shrink)

For most people, animals are the most significant aspects of the nonhuman world. They symbolize nature in our imaginations, in popular media and culture, and in campaigns to preserve wilderness, yet scholars habitually treat animals and the environment as mutually exclusive objects of concern. Conducting the first examination of animals' place in popular and scholarly thinking about nature, Anna L. Peterson builds a nature ethic that conceives of nonhuman animals as active subjects who are simultaneously parts of both nature (...) and human society. Peterson explores the tensions between humans and animals, nature and culture, animals and nature, and domesticity and wildness. She uses our intimate connections with companion animals to examine nature more broadly. Companion animals are liminal creatures straddling the boundary between human society and wilderness, revealing much about the mutually constitutive relationships binding humans and nature together. Through her paradigm-shifting reflections, Peterson disrupts the artificial boundaries between two seemingly distinct categories, underscoring their fluid and continuous character. (shrink)

In this study, we test a number of predictions concerning children's knowledge of the transitive Subject-Verb-Object (SVO) construction between two and three years on one child (Thomas) for whom we have densely collected data. The data show that the earliest SVO utterances reflect earlier use of those same verbs, and that verbs acquired before 2;7 show an earlier move towards adult-like levels of use in the SVO construction and in object argument complexity than later acquired verbs. There is not a (...) close relation with the input in the types of subject and object referents used, nor a close adherence to Preferred Argument Structure (PAS) before 2;7, but both early and late acquired verbs show a simultaneous move towards PAS patterns in selection of referent type at 2;9. The event semantics underpinning early transitive utterances do not straightforwardly fit prototype (high or inalienable) notions of transitivity, but rather may reflect sensitivity to animacy and intentionality in a way that mirrors the input. We conclude that children's knowledge of the transitive construction continues to undergo significant development between 2;0 and 3;0, reflecting the gradual abstraction and integration of the SVO and VO constructions, verb semantics, discourse pragmatics, and the interactions between these factors. These factors are considered in the context of a prototype for the transitive construction. (shrink)

Cannabis sativa L. is grown and marketed under a large number of named strains. Strains are often associated with phenotypic traits of interest to consumers, such as aroma and cannabinoid content. Yet genetic inconsistencies have been noted within named strains. We asked whether genetically inconsistent samples of a commercial strain also display inconsistent aroma profiles. We genotyped 32 samples using variable microsatellite regions to determine a consensus strain genotype and identify genetic outliers for four strains. Results were used to select (...) 15 samples for olfactory testing. A genetic outlier sample was available for all but one strain. Aroma profiles were obtained by 55 sniff panelists using quantitative sensory evaluation of 40 odor descriptors. Within a strain, aroma descriptor frequencies for the genetic outlier were frequently at odds with those of the consensus samples. It appears that within-strain genetic differences are associated with differences in aroma profile. Because these differences were perceptible to untrained panelists, they may also be noticed by retail consumers. Our results could help the cannabis industry achieve better control of product consistency. (shrink)

Environmental ethics has been dominated by an idealist logic that limits its positive impact on the natural world about which environmental philosophers care deeply. Environmental ethicists need to alter the ways we think and talk about what we value and the relations among ideas, values, and actions. Drawing on the sociology of religion and Marxian philosophy among other sources, a new approach may increase our understanding of how ideas are lived out and how we might increase the impact of our (...) ideas about the value of nature. (shrink)

Bianchi et al. argue that for some patients with severe and enduring anorexia nervosa approaches that do not aim for complete clinical recovery are ethically warranted. We believe tha...

Productivity is a central concept in the study of language and language acquisition. As a test case for exploring the notion of productivity, we focus on the noun slots of verb frames, such as __want__, __see__, and __get__. We develop a novel combination of measures designed to assess both the flexibility and creativity of use in these slots. We do so using a rigorously controlled sample of child speech and child directed speech from three English-speaking children between the ages of (...) 2–3 years and their caregivers. We find different levels of creativity and flexibility between the adult and child samples for some measures, for some slots, and for some developmental periods. We discuss these differences in the context of verb frame semantics, conventionality versus creativity and child errors, and draw some tentative conclusions regarding developmental changes in children's early grammatical representations. (shrink)

Objective The UK Human Papillomavirus (HPV) vaccine programme commenced in the autumn of 2008 for year 8 (age 12–13 years) schoolgirls. We examine whether the vaccine should be given when there is a difference of opinion between daughters and parents or guardians. Design Qualitative study using semi-structured interviews. Participants A sample of 25 stakeholders: 14 professionals involved in the development of the HPV vaccination programme and 11 professionals involved in its implementation. Results Overriding the parents' wishes was perceived as problematic (...) and could damage the relationship between school and parents. A number of practical problems were raised in relation to establishing whether parents were genuinely against their daughter receiving the vaccine. Although many respondents recognised that the Gillick guidelines were relevant in establishing whether a girl could provide consent herself, they still felt that there were significant problems in establishing whether girls could be assessed as Gillick competent. In some areas school nurses had been advised not to give the vaccine in the absence of parental consent. None of the respondents suggested that a girl should be vaccinated against her consent even if her parents wanted her to have the vaccine. Conclusions While the Gillick guidelines provide a legal framework to help professionals make judgements about adolescents consenting to medical treatment, in practice there appears to be variable and confused interpretation of this guidance. Improved legal structures, management procedures and professional advice are needed to support those who are assessing competence and establishing consent to vaccinate adolescents in a school setting. (shrink)

School gardens and garden-based learning continue to gain great popularity in the United States, and their pedagogical potential, and ability to impact students’ fruit and vegetable consumption and activity levels have been well-documented. Less examined is their potential to be agents of food system reskilling and transformation. Though producer and consumer are inextricably linked in the food system, and deskilling of one directly influences the other, theorists often focus on production-centered and consumption-centered deskilling separately. However, in a school garden, the (...) production/consumption disconnect is erased, by virtue of the design of the site itself and how it is utilized by the actors within it. School gardens provide the critical component of education in alternative food networks, and contribute to the producer/consumer reskilling that is a necessary part of food system transformation. We conducted a case study of an established school garden program during its transition from autonomous non-profit to official, district-funded program of a rural school district in the Midwest. By participating in the full “seed to plate” life cycle of a garden crop, students in the garden were actively involved in the reconnection of producer and consumer, while educators were fostering in students an appreciation for fresh, healthy foods and actively challenging the “McDonaldization” of both students’ diets and education. Based upon these findings, we argue that school gardens in rural areas could leverage the dominant role of rural America in developing and shifting food system paradigms. (shrink)

Schober et al. describe two studies on how survey interview respondents misunderstand interview questions. After answering a survey, participants are given standardized definitions of the questions they have just answered. Even apparently simple questions such as “Have you smoked more than 100 cigarettes?” are interpreted very differently by participants. Moreover, clarifying the meaning of the definitions with the interviewer does not always help resolve the miscommunication.

How do English‐speaking children inflect nouns for plurality and verbs for the past tense? We assess theoretical answers to this question by considering errors of omission, which occur when children produce a stem in place of its inflected counterpart (e.g., saying “dress” to refer to 5 dresses). A total of 307 children (aged 3;11–9;9) participated in 3 inflection studies. In Study 1, we show that errors of omission occur until the age of 7 and are more likely with both sibilant (...) regular nouns (e.g., dress) and irregular nouns (e.g., man) than regular nouns (e.g., dog). Sibilant nouns are more likely to be inflected if they are high frequency. In Studies 2 and 3, we show that similar effects apply to the inflection of verbs and that there is an advantage for “regular‐like” irregulars whose inflected form, but not stem form, ends in d/t. The results imply that (a) stems and inflected forms compete for production and (b) children generalize both product‐oriented and source‐oriented schemas when learning about inflectional morphology. (shrink)

This paper investigates whether an abstract linguistic construction shows the kind of prototype effects characteristic of non-linguistic categories, in both adults and young children. Adapting the prototype-plus-distortion methodology of Franks and Bransford (1971), we found that whereas adults were lured toward false-positive recognition of sentences with prototypical transitive semantics, young children showed no such effect. We examined two main implications of the results. First, it adds a novel data point to a growing body of research in cognitive linguistics and construction (...) grammar that shows abstract linguistic categories can behave in similar ways to non-linguistic categories, for example, by showing graded membership of a category. Thus, the findings lend psychological validity to the existing cross-linguistic evidence for prototypical transitive semantics. Second, we discuss a possible explanation for the fact that prototypical sentences were processed differently in adults and children, namely, that children’s transitive semantic network is not as interconnected or cognitively coherent as adults’. (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)

An experimental study was conducted on children aged 2;6–3;0 and 3;6–4;0 investigating the priming effect of two WANT-constructions to establish whether constructional competition contributes to English-speaking children's infinitival to omission errors. In two between-participant groups, children either just heard or heard and repeated WANT-to, WANT-X, and control prime sentences after which to-infinitival constructions were elicited. We found that both age groups were primed, but in different ways. In the 2;6–3;0 year olds, WANT-to primes facilitated the provision of to in target (...) utterances relative to the control contexts, but no significant effect was found for WANT-X primes. In the 3;6–4;0 year olds, both WANT-to and WANT-X primes showed a priming effect, namely WANT-to primes facilitated and WANT-X primes inhibited provision of to. We argue that these effects reflect developmental differences in the level of proficiency in and preference for the two constructions, and they are broadly consistent with “priming as implicit learning” accounts. The current study shows that children as young as 2;6–3;0 years of age can be primed when they have only heard particular constructions, children are acquiring at least two constructions for the matrix verb WANT, and that these two WANT-constructions compete for production. (shrink)

With their comprehensive categorization of “ambivalence-related phenomena,” Moore et al. helpfully clarify and contextualize these decisional states as they arise in patient care. Given the...