Can self-regulation deliver an ethical commercial literature? A critical reading of the “Good Publication Practice” (GPP3) guidelines for industry-financed medical journal articles

Much medical journal literature is developed by the pharmaceutical and device industries, sometimes with assistance from marketing agencies, writers, and academics. This literature is vulnerable to commercial bias. The publications trade issues self-regulatory ethical guidelines for its production, called “Good Publication Practice” (GPP). I evaluated the most recent iteration, GPP3. The most progressive recommendations in GPP3 call for complete publication of all clinical trials, and full data sharing. GPP3 makes numerous further recommendations more directly concerning the publications trade. Many of these repeat existing editorial requirements, chiefly those of the International Committee of Medical Journal Editors, but readers are not adequately advised of this. Despite its emphasis on ethical and transparent reporting, the detail of GPP3 enables continued use of academic medical literature for drug marketing, on the basis of commercial steerage of content, coupled with the attribution of published articles to collaborating academic authors. As such, GPP3 provides a de facto manual for how marketing through academic journal content can be conducted in compliance with contemporary editorial standards. Consequently, the self-regulatory GPP3 guidelines are not a sound basis for the production of unbiased industry-financed medical journal literature. I suggest improvements for future iterations of these influential guidelines.     

Under the Influence: The Interplay among Industry,Publishing, and Drug Regulation

The relationships among academe, publishing, and industry can facilitate commercial bias in how drug efficacy and safety data are obtained, interpreted, and presented to regulatory bodies and prescribers. Through a critique of published and unpublished trials submitted to the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for approval of a new antidepressant, vortioxetine, we present a case study of the “ghost management” of the information delivery process. We argue that currently accepted practices undermine regulatory safeguards aimed at protecting the public from unsafe or ineffective medicines. The economies of influence that may intentionally and unintentionally produce evidence-biased—rather than evidence-based—medicine are identified. This is not a simple story of author financial conflicts of interest, but rather a complex tale of ghost management of the entire process of bringing a drug to market. This case study shows how weak regulatory policies allow for design choices and reporting strategies that can make marginal products look novel, more effective, and safer than they are, and how the selective and imbalanced reporting of clinical trial data in medical journals results in the marketing of expensive “me-too” drugs with questionable risk/benefit profiles. We offer solutions for neutralizing these economies of influence.     

National Scientific Misconduct Policies in Argentina: Two Definitions of Research Misconduct

ABSTRACT

In “An International Study of Research Misconduct Policies”, Resnik et al. count Argentina in the list of countries without national research misconduct policies. In this paper, we clarify that Argentina has national policies of research misconduct and present the research misconduct definitions of two official science organisms: the National Scientific and Technical Research Council (CONICET) and the Ethics Committee of the Argentine Ministry of Science (MINCyT).     

Film,Television and Traditional Folk Culture in Bye Bye Brasil1

Brazilian Cinema Novo [New Cinema] has produced a number of films that have circulated in the United States but perhaps the most familiar to American audiences is Carlos Diegues' Bye Bye Brasil (1980). In his article, Randal Johnson focuses on this film which presents Brazil as a country in a process of rapid transformation, an agro-pastoral economy giving way to rapid industrialization. He notes that “running throughout [the work] is a subtext which constitutes a good-humored yet critical retrospective of the trajectory of Brazilian cinema over the last twenty years and its relationship to other conscious-forming media, notably television.” Johnson examines this subject as well as the complex relationship between cinema, television and popular culture as developed through the device of the Caravana Rolidei, a small-time circus troupe. Each of its characters represents a different aspect of contemporary Brazilian society, and the film as a whole presents the panoply of Brazilian culture, a mixture of elements from diverse sources, both foreign and domestic. Randal Johnson teaches literature and film at the University of Florida. He is the co-author of Brazilian Cinema (1982).     

Essay review

Sexuality, Poverty, and the Inner City. Elijah Anderson, Ph.D. (Monograph #2 from “Sexuality and American Social Policy: A Seminar Series,” Jayne Garrison, Mark D. Smith, & Douglas J. Besharov [Eds.].) (Menlo Park, CA: Henry J. Kaiser Family Foundation, 2400 Sand Hill Road, 1994.)     

Ideological Expectations for Value Consensus in Chinese Society

Surveys have shown that popular ideology has tended to move from pluralism to clustering around dualism at this sensitive and critical moment for the formation of value consensus in contemporary China. The formation of a “value consensus” or “common values” must answer three questions: “What is ‘common’ about this consensus?” How can ‘consensus’ be reached?” “How can ‘values’ be legitimated?” On the basis of survey information, this paper presents the basic argument that what is common lies in ethics; consensus in spirit; and value legitimacy in our national cultural home. Ordinary people have three major ideological expectations of value consensus in contemporary China: expectation of ethical enlightenment with the theme of turning “I” into “we”; expectation of a spiritual baptism with the value “unity of the individual and the universal” and expectation of the endeavor to “return home.” Specifically, their content is as follows: to protect ethical existence and undertake the re- enlightenment of ethical consciousness at the national, family and group levels; to sublate “atomistic exploration” of the theory and mode of rationalistic ethics and carry out the “spiritual’ construction of the three great ethical entities of society, state and family; and to “go back home” to national cultural traditions and ethics and build value legitimacy. These three major expectations can be condensed into three ideas: protecting ethics, reviving “spirit” and going back “home.”     

Correction to: Redistribution to the less productive: parallel characterizations of the egalitarian Shapley and consensus values

Theory and Decision - In sub-Sect. 3.3, the terms “one-person” and “(n-1)-person” were incorrectly updated by mistake during the correction stage in the online...     

From fun to fraught: marketing to kids and regulating “risky foods” in Canada

ABSTRACT

In an era of industrialized food production, ultra-processed foods, “Big Food” marketing, and growing obesity rates, food has come to be framed as an object of risk – and as an object of regulation. Such reframing has fascinating implications related to issues of responsibility and decision making, especially when it comes to children’s food. This article probes the relationship between representation, regulation and “risky” consumption with respect to children’s food. I examine how child-targeted foods become framed as “risky” and what counts as “risky” food messaging under Health Canada’s commitment to restrict the marketing of unhealthy foods to children. Detailing the tension between food as a risk object and food as a child object, I suggest how issues of semantic provisioning and the politics of the unseen work to complicate and destabilize the (seemingly) straightforward process of prohibiting unhealthy food marketing to children.     

The Canadian Agency for the Oversight of Research Involving Humans: A Reform Proposal

In this paper, I propose the creation of a Canadian agency for the oversight of research involving humans. I describe first a series of significant problems with Canada’s current system of oversight. I then argue for the creation of a national-level agency, covering all research involving humans, with three branches (policy and standards, education, and compliance). Of particular note, the proposed compliance branch consists of a number of independent national and regional Research Ethics Boards (i.e., REBs no longer reside within institutions). There is also an Audit Committee and a Non-compliance Committee (with supporting staff of auditors and compliance officers) to ensure compliance with the policies and standards set by the Policy and Standards Branch. Finally, I answer a series of “frequently asked questions” about the proposed agency design such as “What about ‘local context’?” and “Why not have a system of accreditation of institutional REBs instead?” In sum, radical reform is needed and, in this paper, I present a proposal for such reform.     

Minimal Risk in Pediatric Research: A Philosophical Review and Reconsideration

Despite more than thirty years of debate, disagreement persists among research ethicists about the most appropriate way to interpret the U.S. regulations on pediatric research, specifically the categories of “minimal risk” and a “minor increase over minimal risk.” Focusing primarily on the definition of “minimal risk,” we argue in this article that the continued debate about the pediatric risk categories is at least partly because their conceptual status is seldom considered directly. Once this is done, it becomes clear that the most popular strategy for interpreting “minimal risk”—defining it as a specific set of risks—is indefensible and, from a pragmatic perspective, unlikely to resolve disagreement. Primarily this is because judgments about minimal risk are both normative and heavily intuitive in nature and thus cannot easily be captured by reductions to a given set of risks. We suggest instead that a more defensible approach to evaluating risk should incorporate room for reflection and deliberation. This dispositional, deliberative framework can nonetheless accommodate a number of intellectual resources for reducing reliance on sheer intuition and improving the quality of risk evaluations.     

New Ethics and Old Roles: The Identity Dilemma of May Fourth New Women

五四新女性是在学校这一现代教育平台由新文化启蒙话语塑造而成, 她们的意识 形态认同来自新文化, 是以个人主义为核心的正义伦理; 而她们的性别认同及相应 的关怀伦理, 却使其对“旧道德”下的女性同类有更多同情。为实现个人权利、维护神 圣恋爱, 她们“忽略”名分、委屈尊严, 在新旧道德的模糊地带与有妇之夫结成特殊婚 姻。而非正常婚姻关系的缺憾, 爱情中隐含的性别等级, 个人自由与关怀伦理的对立 与冲突等, 都导致她们陷入认同危机。新女性身份认同的困境, 体现了“五四”正义伦 理的道德局限, 而五四文学表达的某种匮乏, 亦源自这个局限。

关键词: 五四文学 新女性 身份认同 正义伦理 关怀伦理

The new women of the May Fourth Movement were molded by the enlightenment discourse of the new culture in universities. The ideological identity they acquired from the new culture was an individualist ethics of justice. Their gender identity and the corresponding ethics of care, however, stirred their sympathy for other women shackled by the “old ethics.” To realize their human rights and maintain the sacredness of love, the new women were even prepared to “overlook” their social status and sacrifice their dignity to enter into special marriages with married men at the ambiguous interface of the old and the new ethics; but the shortcomings of an abnormal marriage, the gender hierarchy concealed behind love, and the antagonism and conflict between individual freedom and their ethics of care for others plunged these women into an identity crisis. Their identity dilemma reflects the moral limits of the justice ethic of the May Fourth new culture, limits that also account for a kind of deficiency in expression in May Fourth literature.     

Research Misconduct Definitions Adopted by U.S. Research Institutions

In 2000, the U.S. federal government adopted a uniform definition of research misconduct as fabrication, falsification, or plagiarism (FFP), which became effective in 2001. Institutions must apply this definition of misconduct to federally-funded research to receive funding. While institutions are free to adopt definitions of misconduct that go beyond the federal standard, it is not known how many do. We analyzed misconduct policies from 183 U.S. research institutions and coded them according to thirteen different types of behavior mentioned in the misconduct definition. We also obtained data on the institution’s total research funding and public vs. private status, and the year it adopted the definition. We found that more than half (59%) of the institutions in our sample had misconduct policies that went beyond the federal standard. Other than FFP, the most common behaviors included in definitions were “other serious deviations” (45.4%), “significant or material violations of regulations” (23.0%), “misuse of confidential information” (15.8%), “misconduct related to misconduct” (14.8%), “unethical authorship other than plagiarism” (14.2%), “other deception involving data manipulation” (13.1%), and “misappropriation of property/theft” (10.4%). Significantly more definitions adopted in 2001 or later went beyond the federal standard than those adopted before 2001 (73.2% vs. 26.8%), and significantly more definitions adopted by institutions in the lower quartile of total research funding went beyond the federal standard than those adopted by institutions in the upper quartiles. Public vs. private status was not significantly associated with going beyond the federal standard.     

“互联网+”时代出版营销模式探析

“互联网+”时代,互联网技术尤其是移动互联网技术的突飞猛进,为出版业注入了新的活力。出版营销与互联网技术的创造性结合,使出版业迎来了新的发展机遇。本文在总结出版营销领域现有的电子商务平台营销、社群营销、网络直播营销以及短视频营销四种主要营销模式的基础上,针对现有营销模式存在的问题,提出了一些展望与对策,旨在为出版营销的良性发展提供可行性建议。     

The nature and quality of engineering research

Engineering is the application oí science to design and development of products intended for useful social purposes. Engineering research consists of a wide variety of activities ranging from study of material properties for possible future application to the testing necessary to establish design parameters or to verify the adequacy of new design concepts. Professors of engineering are generally expected to conduct research, preferably in the “engineering sciences”; (e.g. thermodynamics, metallurgy), to publish their results, and find their own sources of funding. Many private corporations maintain departments of research and development, the findings of which are often proprietary and not subject to peer review. Managers of engineering research projects attempt to assure the quality of their results by “instrumental”; or “organizational”; methods. Instrumental methods assure accuracy in data collection and processing, while organization methods maintain a work environment conducive to creativity and integrity among researchers. Organizational conditions can affect research quality adversely, by giving rise to ethical problems associated with conflicts between corporate interests and those of individuals.     

Letter to the editor: On plurality and authorship in science

Moffatt argues that the “plurality of distinct accounts of scientific authorship” necessitates caution in attempts to identify unethical authorship practices, and urges that considerations be given to establishing a “single consensus account of authorship.” The revised International Committee of Medical Journal Editors (ICMJE) criteria do capture the essential features of authorship in terms of “intellectual contribution” and “responsibility and accountability,” which would clearly demarcate academically legitimate authorship from the common misdemeanors of ghost writing and honorary authorship. However, plurality in the practice of science and credit-sharing culture at the ground would likely render universal adoption or compliance of a single consensus account of authorship untenable.     

Three stories,two visions: the West and the building of the Canadian Pacific Railway in Canadian culture

Many now think the Canadian nation-state is entering a phase in its development that can be described as “postmodern” (Porter, 1995, pp. 91–106). Throughout the 1990s we have heard much talk of “asymmetrical federalism,” “bilateral federalism,” “successor states” and Quebec/ROC (Rest of Canada) polarities (Watts, 1991, pp. 1–7). In this time of constitutional and political ferment, commentators postulated the existence of as many as “seven incipient nations” within the borders of the present Canadian polity (Mahler and March, 1991, p. 16). There are resonances here within the field of literary criticism. Linda Hutcheon and Marion Richmond’s Other Solitudes: Canadian Multicultural Fictions (1990) highlight factors of paradox, contradiction, and extreme irony in the Canadian situation, factors they see as central to the postmodern world view. This paper examines two works of Canadian popular culture analyzed against E. J. Pratt’s Towards the Last Spike (1952) in an effort to suggest that a postmodern style may have something to offer our sociopolitical debate. The television dramatization of Pierre Berton’s two-volume work on the building of the Canadian Pacific Railway, The National Dream (1974), and the Canada Day Canadian Broadcasting Corporation (CBC) special “Murray McLauchlan’s Floating Over Canada” represent, with Pratt, two differing visions of Canada. The McLauchlan effort, I hope to show, when set against Berton and Pratt, represents an implied postmodern critique of modernism’s romantic faith in technological efficiency and cultural tradition. McLaughlan’s antiintentionalism and playfulness, I argue, offer a useful way to represent some of our present dilemmas and may even provide reasons for optimism about problems that have plagued Canadians for years.     

The Myth of “Security Moms” and “NASCAR Dads”: Parenthood,Political Stereotypes,and the 2004 Election*

Objective. The objective of this article is to explore the impact of being a parent on political views and to test the accuracy of the “Security Mom” and “NASCAR Dad” labels that were pervasively applied in the context of the 2004 presidential election. Methods. The methods we employed consist of using data primarily from the 2004 National Election Study to determine whether parents differ from nonparents in terms of their political attitudes on a wide range of issues. We argue that parenthood affects women and men differently, so we analyze the sexes separately. Results. Mothers have important political distinctions from women without children, mostly in the case of social welfare issues. They do not, however, appear to be “Security Moms” in the post‐9/11 world. As for fathers, for the most part it makes little sense to talk about dads as a distinct voting bloc, as in very few cases do their political attitudes differ from men without children. Conclusions. The media's use of the labels “NASCAR Dad” and Security Mom” promoted an inaccurate understanding of the political preferences of parents. Beyond debunking these media myths, our results provide one of the first comprehensive looks at the impact of parenthood on political attitudes, an overlooked area in the adult socialization literature.     

The aesthetic life of artificial flavors

Abstract

Artificiality is usually understood as that which is man-made and is in contraposition to the natural. The term itself is increasingly recognized as a negative pole, while the label of “natural” is exploited as guarantee of healthiness in marketing food campaigns. This article takes issue with the natural/artificial debate by emphasizing the aesthetic side of artificial flavorings – chemical substances designed to alter or enhance the taste of processed foods. Here, I reconsider the conception of artificiality as a poor imitation of nature and instead underline the link between technology and aesthetics, by examining the practice of flavorists. Through ethnographic detail I call for moving the synthetic out of the “inauthentic” and argue that the attempt to mimic natural flavors through synthesis is not only an act of imitation and resemblance (as critics exclusively contend) but can also be thought as an act of representation and interpretation (as my fieldwork illuminates).