Delaying approval of a critical drug: Safety,efficacy, economics,compassion

Biotechnological advance is speeding the development of drugs. The approval processes for new drugs will inevitably involve a regulatory agency in making political-economic and scientific choices. Interests of specific patients and the public in general are to be considered, and enormous stakes are involved for companies concerned. A medical regulatory authority must be at once insulated from and responsive to many different mixes of singular and general interests and pressures. Access to new drugs can be spurred by the press of patient advocacy groups, but if there are well organized groups to monitor the testing and approval process for such as AIDS or cancer drugs there is often no similar group to represent patient needs. If there is no organized patient advocacy group, compassionate responsibility by a medical regulatory authority is indeed called for. Delay in the approval of new drugs for fighting severe blood infections raises the question of how to insure the compassionate responsibility of a regulatory authority.     

Endless Qualifications,Restless Consumption: The Governance of Novel Foods in Europe

Functional foods and foods derived from genetically modified organisms represent two forms of intervention in the design of foodstuffs that have given rise to distinct political and regulatory dynamics. In Europe, regulatory agencies have tried, unsuccessfully, to affix a definitive legal meaning to these categories of food artificiality. This incomplete process of legal disambiguation has gone hand in hand with the delegation of the responsibility for overseeing new products to consumers, who are asked to continuously consider and assess the qualities of foods when making their choices in the marketplace. In the case of genetically modified foods, we have witnessed strategies of avoidance premised on the consideration of genetic modification as a blemish on the conventional character of foodstuffs. Functional foods, on the other hand, are increasingly mobilized in practices of naturalistic enhancement. What both examples have in common is the open-ended character of their respective regulatory regimes, and the continuous prodding of consumers to involve themselves more intensely in the weighing of their food choices. The result is a particular mode of market activism that we describe as restless consumption.     

Veggies and visceralities: A political ecology of food and feeling

The ‘alternative food’ movement (encompassing both organic and local foods) has been critiqued for its racial and economic homogeneity, as well as its focus on individual choice and ‘correct’ knowledge. Nevertheless, the movement continues to gain in popularity within certain segments of the North American population (especially among white, middle class residents). In recent years, alternative food has also made its way into public schools – most notably through the guise of healthy eating. School Garden and Cooking Programs (SGCPs) are one way in which a more diverse demographic can become exposed to the claims, practices and tastes of alternative food. Program advocates claim that such exposure equalizes the student body, by giving all students access to healthy food. This paper examines this claim through a political ecology of the body (PEB) framework. Particularly, we use theories of the material, emotional body to explore how motivation to eat ‘healthy’ and ‘alternative’ food is a matter of affective relation, emerging differentially from a rhizome of structural and haphazard forces. By relating alternative food and healthy eating to research on emotion and affect, we expand upon the traditions of political ecology in ways that help to stretch the field into issues of bodies and health.     

Human food preferences and cultural identity: The case of Aragón (Spain)

This research aims to analyze the relationship between sociocultural values and human food preferences. The latter, as shown in this paper, are greatly influenced by cultural identity. This work stems from a theoretical context that originated in Europe and the United States towards the mid‐twentieth century, within the field of the anthropology of food. A qualitative and quantitative analysis has been performed in the Comunidad Autónoma de Aragón (Spain). Research methods include focus groups, in‐depth interviews, participant observation, and a questionnaire that was handed out to a representative sample of the Aragonese population (816 people over 21 years of age; confidence level of 95.5% and error margin of ±3.5). Regarding the research outcome, a highly significant qualitative and quantitative connection has been found between food selection and cultural identity. In other words, people prefer to consume foods that are symbolically associated with their own culture, in order to reinforce their sense of belonging. Although this study has been carried out in Aragón, it is our belief that the results can be generalized to other areas. The originality and interest of our findings are notable considering that, to date, few works have analyzed the sociocultural factors motivating food behavior. Moreover, these results could be used by public and private organizations to meet objectives such as health promotion and product marketing.     

The Light = Healthy Intuition

This research documents a “light = healthy” intuition, such that consumers perceive foods that weigh less are healthier than their heavier counterparts with the same serving size. Subsequently, consumers consume a larger quantity of lighter-weight foods. The intuition is based on a coactivation of two meanings of the word “light”: light in physical weight and light in calorie content. An implicit attitude test finds support for this association between physical weight and food healthiness. ​Subsequently, physically lighter foods are perceived to be healthier because they are assumed to contain fewer calories. In line with the proposed coactivation mechanism, the intuition is bidirectional, where consumers also expect healthier foods to weigh less. Consequently, they discredit health claims issued for heavier foods. Finally, it was found that activating a competing intuition is effective at debiasing the “light = healthy” intuition.     

A Brunswik lens model of consumer health judgments of packaged foods

Consumer health judgments of packaged food were compared with an objective healthfulness criterion using a Brunswik lens model. Consumer judgments were obtained from a representative consumer sample (N = 1329) who evaluated the healthfulness of 198 packaged food products. The objective healthfulness criterion was calculated for each product according to its specific nutrition values using a validated nutrition profile. The lens model included explicit cues such as nutrition values, nutrition and health claims, food category, and brand and implicit cues such a packaging design and category representativeness. The study revealed that the objective healthfulness criterion is highly predictable on the basis of cues such as the food category, brand, carbohydrate content, and whether the food is a typical “light” product. However, consumer judgments of food healthfulness are based almost entirely on the food category and to a lesser extent on the brand and consumer familiarity with the product. The results are in conflict with consumers' self‐reported use of nutrition information but are in accordance with findings from studies using implicit methods. Copyright © 2014 John Wiley & Sons, Ltd.     

The color–flavor incongruency effect in product evaluation and brand perception

Crossmodal correspondences refer to the tendency to associate a pair of features across different senses; specifically, consumers can associate the color of packaging with a certain flavor label for packaged foods after repeated exposure to the packaging of mainstream, everyday products. We conducted two studies to examine how the incongruency between packaging color and flavor labeling influences consumers' evaluations of a food product and their perceptions of a brand. The results revealed that the participants liked a food product less when its packaging color was incongruent with its flavor label, but the magnitude of this color–flavor incongruency effect decreased after participants repeatedly searched for these products on the shelves of a virtual supermarket. Participants also considered the brand of packaged foods to be more innovative when the products' packaging colors were incongruent with flavor labels, and the magnitude of this color–flavor incongruency effect on brand perception was not influenced by their experience of searching for a product in virtual reality. Together, these results suggested that crossmodal congruency is an important factor to consider in packaging design and can be used as a marketing tool to increase product likability and attract consumers' attention.     

Cognitive, motivational, social, and environmental influences on children's food choices

This study tested the applicability of a cognitive-motivational model of health behavior to children's food choices. A sample of 107 elementary schoolchildren provided ratings of 15 foods in terms of possible choice criteria (e.g., how tasty or healthful specific foods were) and social or environmental influences (e.g., whether foods were eaten by friends or were easy to get). Several measures of food consumption were taken, and cognitive-developmental level was assessed. Within-person correlations were calculated between food choices and each choice criterion and social/environmental factor. These "correlational indices" of influences on food choice subsequently were used to identify five distinct subgroups in the sample. Children at the operational level of cognitive development tended to be in one of three groups characterized by health orientation in food choice, taste orientation, or multiple-motive orientation. Dietary quality was poorest in the taste-oriented group. Children at the preoperational level tended to have one of two undifferentiated patterns of values across the correlational indices. Results provide evidence of: the viability of cognitive-motivational models to explain children's food choices, the promise of within-person research methodology, and the potential for enhanced health behavior-change programs by use of population segmentation and tailored interventions.     

Beyond Affect and Cognition: Identification of the Informational Bases of Food Attitudes1

Two studies were conducted to identify the informational bases of food attitudes. Study 1 was an exploratory study in which participants indicated the importance of food characteristics and emotional reactions for determining their attitudes toward a variety of foods. On the basis of a series of exploratory factor analyses, 5 informational bases of food attitudes were identified: positive affect, negative affect, specific sensory qualities, abstract cognitive qualities, and general sensory qualities. A second confirmatory study corroborated the appropriateness of this 5‐factor structure. Furthermore, the food‐specific attitude structure model was found to have better fit than a more traditional attitude structure model. The implications of these findings for attitude theory, understanding eating behavior, and changing food selection are discussed.     

Essentialism and graded membership in animal and artifact categories

A number of studies have argued that people view membership in animal and artifact categories as a matter of degree. These studies have generally failed to distinguish between the issues of typicality and category membership. Thus, data which have been taken to demonstrate that membership is a matter of degree may only demonstrate that typicality is graded. Partly on the basis of these findings, it has been argued that some categories are organized around an underlying essence. The essence determines membership absolutely. The present paper reports a series of studies that reexamine the question of graded membership. In the first study, subjects were asked to rate both typicality and category membership for the same stimuli as a way of distinguishing the two questions. A second method relied on the intuition that disagreements about membership in all-or-none and graded categories may have different qualities. Results from both studies suggest some support for claims that membership in animai and artifact categories is a matter of degree. A third study explored the possibility that graded responses were due to conflicting, or ambiguous, sets of criteria. A task focusing on biological features did not lead to more absolute categorization. These results contradict essentialist predictions.     

Governing with Ignorance: Understanding the Australian Food Regulator’s Response to Nano Food

This paper examines regulatory responses to the presence of previously undetected and unlabelled nanoparticles in the Australian food system. Until 2015, the Australian regulatory body Food Standards Australia New Zealand (FSANZ) denied that nanoparticles were present in Australian food. However, and despite repeated claims from Australia’s food regulator, research commissioned by civil society group Friends of the Earth has demonstrated that nanoparticles are deliberately included as ingredients in an array of food available for sale in Australia. This paper critically examines how nanoparticles have come to be integrated into Australia’s food system under the radar of Australia’s food regulator. Our case study of FSANZ—including its responses to the civil society-led science that determined the existence of nanoparticles in Australian food—raises a number of important questions about the governance of risk in relation to emerging technologies such as nanotechnology. In this paper, we argue that FSANZ’ response to the presence of nanotechnology in Australia’s food system is an example of ‘governing with ignorance’. This is demonstrated via the denial and dismissal of science claims as a basis for limited regulatory intervention. FSANZ’ response intersects with the centrality of commercial interests in shaping science research and commercialisation, alongside the ‘hands off’ approach to regulation that is characteristic of neoliberal governance approaches. We conclude by arguing that in the current food governance framework, and alongside a paucity of impact science, civil society plays a vital role in attempts to democratise the Australian food system.     

Ethical aspects of the safety of medicines and other social chemicals

The historical background of the discovery of adverse health effects of medicines, food additives, pesticides, and other chemicals is reviewed, and the development of national and international regulations and testing procedures to protect the public against the toxic effects of these drugs and chemicals is outlined. Ethical considerations of the safety evaluation of drugs and chemicals by human experimentation and animal toxicity studies, ethical problems associated with clinical trials, with the falsification of clinical and toxicological data, and with inadequate experimental methodology, are reviewed, and the ethics of the marketing of drugs and their post-marketing surveillance, are similarly considered. These ethical problems are illustrated with many specific examples, including the drugs neoarsphenamine, chloramphenicol, thalidomide, diethyl stilboestrol and benoxaprofen.     

Prepurchase Attribute Verifiability,Source Credibility,and Persuasion

Recent research has found that search and experience attribute claims are processed differently by consumers, with search attribute claims typically being more believable than experience attribute claims. It is, however, routinely the case that marketers desire to promote a product by making a claim featuring an experience attribute. The marketing literature has largely neglected the issue of how to enhance persuasion of experience attribute claims. The purpose of this research was to fill this void. We reason that source credibility impacts the receipt of experience claims and search claims differently. We then report results of 2 experiments featuring 2 different types of sources in the context of 2 different categories that suggest a source high in credibility can be employed to make experience claims more persuasive. The contributions our study makes to the persuasion literature and avenues for future research are discussed.     

The need for public policies to promote healthier food consumption: A comment on Wansink and Chandon (2014)

Current approaches to addressing obesity have fallen short. This is largely due to the many environmental forces that undermine people's self-regulatory capacity to be personally responsible for their food choices. Novel insights from the social sciences are needed to inform voluntary, health-promoting actions by companies, institutions, and citizens as well as the design of public health policies. Voluntary interventions that rely on nudges should complement traditional public health strategies such as taxation and restriction of child-targeted marketing in schools. In this commentary, we discuss four food policy issues that would benefit from consumer psychology research: (a) the restriction of food marketing to children, (b) provision of nutrition information through food labels, (c) improving school food environments, and (d) placing limits on portion sizes. Identifying effective solutions for obesity will require approaches that integrate psychological, public health, and legal perspectives and methods.     

Effectiveness of antidepressants: an evidence myth constructed from a thousand randomized trials?

Antidepressants, in particular newer agents, are among the most widely prescribed medications worldwide with annual sales of billions of dollars. The introduction of these agents in the market has passed through seemingly strict regulatory control. Over a thousand randomized trials have been conducted with antidepressants. Statistically significant benefits have been repeatedly demonstrated and the medical literature is flooded with several hundreds of "positive" trials (both pre-approval and post-approval). However, two recent meta-analyses question this picture. The first meta-analysis used data that were submitted to FDA for the approval of 12 antidepressant drugs. While only half of these trials had formally significant effectiveness, published reports almost ubiquitously claimed significant results. "Negative" trials were either left unpublished or were distorted to present "positive" results. The average benefit of these drugs based on the FDA data was of small magnitude, while the published literature suggested larger benefits. A second meta-analysis using also FDA-submitted data examined the relationship between treatment effect and baseline severity of depression. Drug-placebo differences increased with increasing baseline severity and the difference became large enough to be clinically important only in the very small minority of patient populations with severe major depression. In severe major depression, antidepressants did not become more effective, simply placebo lost effectiveness. These data suggest that antidepressants may be less effective than their wide marketing suggests. Short-term benefits are small and long-term balance of benefits and harms is understudied. I discuss how the use of many small randomized trials with clinically non-relevant outcomes, improper interpretation of statistical significance, manipulated study design, biased selection of study populations, short follow-up, and selective and distorted reporting of results has built and nourished a seemingly evidence-based myth on antidepressant effectiveness and how higher evidence standards, with very large long-term trials and careful prospective meta-analyses of individual-level data may reach closer to the truth and clinically useful evidence.     

Building and Maintaining Clinical Programs

This paper describes the basic elements of practice development and management within the academic medical setting. These include assessment of the market environment, both in the community and within the medical setting, product development, marketing, budget basics, quality, managed care negotiations, and finding time to do research in a financially-driven health care system.     

Comparison of price change and health message interventions in promoting healthy food choices.

This study examines the feasibility and effectiveness of an environmental intervention for improving diet by comparing the impact of health messages, lowered prices, and their combination on the purchase of healthy food items in a restaurant. Price decreases alone, rather than a combination of price decreases and health messages, were associated with a higher level of increased purchases of some healthy food items as compared with control items over a 4-month period. Price decreases may be a more powerful means than health messages of increasing consumption of healthy foods. Health messages may have paradoxical effects if foods labeled as healthy are assumed to taste bad.     

Employee assistance programmes: The emperor's new clothes of stress management?

The employee assistance programme (EAP) is a benefit increasingly provided by UK employers that claims to reduce the effects of 'stress' on individuals and organisations, provide a 'management tool' to improve workplace performance and productivity, and respond to critical incidents. Although the marketing literature describes services as workplace-based counselling, there is evidence to suggest what they actually offer is consultation, assessment, referral and short-term treatment to clients experiencing a wide range of serious psychological and mental health difficulties. This article describes EAPs, their history, development and operation, and reviews the evidence to support their claims for effectiveness. Because employee distress is often the result of an interaction between organisational and individual factors, the role and claims of EAPs as organisational interventions are also critically examined.