Institutional mistrust in the organization of pharmaceutical clinical trials

In this paper I explore the politics of trust in the clinical testing of pharmaceuticals in the US. Specifically, I analyze trust in terms of its institutional manifestations in the pharmaceutical clinical trials industry. In the process of testing new drugs, pharmaceutical companies must (1) protect their proprietary information from the clinicians who conduct their studies, and (2) find a way to ensure human subjects’ compliance to study protocols. Concern with these two critical issues leads drug companies to approach clinicians and research subjects with an attitude of mistrust and the desire to exert control over their activities. This orientation results in an institutionalization of mistrust that structures the relationships and activities required for the clinical development of new pharmaceutical products.

Conceptualising Health: Insights from the Capability Approach

This paper suggests the adoption of a ‘capability approach’ to key concepts in healthcare. Recent developments in theoretical approaches to concepts such as ‘health’ and ‘disease’ are discussed, and a trend identified of thinking of health as a matter of having the capability to cope with life’s demands. This approach is contrasted with the WHO definition of health and Boorse’s biostatistical account. We outline the ‘capability approach’, which has become standard in development ethics and economics, and show how existing work in those areas can profitably be adapted to healthcare. Cases are used to illustrate the value of adopting a capability approach.

Residential Staff’s Changing Attitudes Toward Parents of Children in their Care: Rationale and Healing Effects on Children,Parents, and Staff

A pilot project in Israel, regarding parent’s involvement in their children’s education in residential care was evaluated. The dual goals were changing staff’s attitudes toward parents, and empowering parents. During the school year, parents were invited to participate in bi-weekly dynamic group workshops in the residence (parents only and parents–children), and to 3–4 “Family Days,” in addition to sharing special parent–child summer camps. Results indicate considerable success: children, parents, and staff felt that the project had improved their ability to deal successfully with their everyday challenges, with parents viewing themselves as having been most rewarded.

Ethics and Organ Transfer: A Merleau-Pontean Perspective

The article’s aim is to explore human hand allograft recipients’ postoperative experience of disownership and their gradual experience of their new hand as theirs, with the aid of the work of the French phenomenologist Maurice Merleau-Ponty. Many have used a Merleau-Pontinian perspective in the analysis of embodiment. Far fewer have used it in medico-ethical analysis. Drew Leder’s phenomenologically based ethics of organ donation and organ sale is an exception to this tendency. The article’s second aim is to examine Leder’s phenomenologically based ethics of organ donation and organ sale. Though I find parts of Leder’s approach promising, I also elaborate a line of reasoning that draws on Merleau-Ponty, that does allow us to argue for certain kinds of organ donation and against organ sale—and that avoids some of the problems with Leder’s approach. This alternative route builds on the concept of the integrity of the body-subject.

Human Health and the Environment: In Harmony or in Conflict?

Health policy frameworks usually construe environmental protection and human health as harmonious values. Policies that protect the environment, such as pollution control and pesticide regulation, also benefit human health. In recent years, however, it has become apparent that promoting human health sometimes undermines environmental protection. Some actions, policies, or technologies that reduce human morbidity, mortality, and disease can have detrimental effects on the environment. Since human health and environmental protection are sometimes at odds, political leaders, citizens, and government officials need a way to mediate and resolve conflicts between these values. Unfortunately, few approaches to applied bioethics have the conceptual tools to do accomplish this task. Theories of health care ethics have little to say about the environment, and theories of environmental ethics don’t say much about human health. In this essay, I defend an approach to ethical decision-making that gives policy-makers some tools for balancing promotion of human health and protection of the environment.

Epidemiology and causation

Epidemiologists’ discussions on causation are not always very enlightening with regard to the notion of ‘cause’ in epidemiology. Epidemiologists rightly work from a science-based approach to causation in epidemiology, but largely disagree about the matter. Disagreement may be partly due to confusion of the question of useful concepts for causal inference in epidemiological practice with the question of the metaphysical presuppositions of causal concepts used in epidemiology. In other words, epidemiologists seem to confuse the practical results of epidemiological research at the population level with the metaphysical views about the reality of disease causation at the individual level in their writings on causation.

Assessing the Impact of an Emotion Regulation Booster Program for Elementary School-aged Children

The purpose of this study was to determine whether children who participated in a booster program 3 years after completing an emotion regulation program show a greater increase between pretest and post-test in the development of emotion regulation skills than children in a comparison group. A booster program was implemented as a pilot project with seven children ages 12–14. The contrast group consisted of eight children ages 10–14. Results of the study showed that the booster group had significant increases on 4 of 10 outcome measures: emotional awareness, emotional expressiveness, number of identified body cues, and number of identified calming activities. The contrast group showed no significant pretest post-test changes on the outcomes measured. Editors’ strategic implications: Replication will be required with a larger sample size, but the emotion regulation results presented are encouraging. Program developers and evaluators will benefit from the authors’ discussion of the importance and role of booster programs.

Assessing Cultural Life Skills of American Indian Youth

While the global United States society emphasizes independence and emancipation from parents and families as appropriate transition tasks for adolescents in foster care, American Indian communities tend to stress interdependence and continuing youth, family, and community connections. The purpose of this naturalistic collective case study is to describe cultural life skills needed by American Indian youth to leave foster care and successfully transition into adulthood. Three Northern Plains Native reservations and two urban Indian communities participated. The research team partnered with the American Indian gatekeepers, elders, youth, and professional staff in efforts to embrace qualitative methods, considered the best way to legitimate and liberate Native ways of knowing. Findings take into account the subtleties of vast diversities among America’s First Nations’ people and support the importance of positive cultural influences in youth identity development.

The fragmented discourse of the ‘knowledgeable doer’: nursing academics’ and nurse managers’ perspectives on a master’s education for nurses

There has been a proliferation of taught masters’ degrees for nurses in recent years, and like masters’ programmes in other disciplines, the aspirations of such educational endeavours are far from unanimous. This article reports on part of a wider study, and focuses on a qualitative analysis of the perspectives of two key sets of stakeholders, namely academic education providers, and senior clinical nursing personnel, on masters’ education for nurses. Fifteen participants were interviewed in depth, and data were subjected to a qualitative content analysis. Findings indicated that while both sets of participants invoked the discourse of the ‘knowledgeable doer’, that is, the notion of amalgamating a high level of theoretical knowledge with practical know how, there were also differences in how each group deployed this discourse. Academics tended to emphasise the ‘knowing that’ or theoretical aspect of the discourse, whereas those in senior clinical roles adduced the practical component more strongly. We argue that the discourse of the ‘knowledgeable doer’ is far from stable, unified and universally agreed, but rather comprises competing elements with some emphasised over others according to the subject position of the particular individual. We locate the diverse perspectives of the two sets of stakeholders within debates about the status of masters’ programmes in relation to vocational and liberal education.

Viagra Selfhood: Pharmaceutical Advertising and the Visual Formation of Swedish Masculinity

Using material from the Pfizer sponsored website providing health information on erectile dysfunction to potential Swedish Viagra customers (), this article explores the public image of masculinity in relation to sexual health and the cultural techniques for creating pharmaceutical appeal. We zoom in on the targeted ideal users of Viagra, and the nationalized, racialized and sexualized identities they are assigned. As part of Pfizer’s marketing strategy of adjustments to fit the local consumer base, the ways in which Viagra is promoted for the Swedish setting is telling of what concepts of masculinity are so stable and unassailable that they can withstand the association with a drug that is, in essence, an acknowledgement of ‘failed’ masculinity and ‘dysfunctional’ sexuality. With comparative national examples, this study presents an interdisciplinary take on the ‘glocalized’ cultural imaginary of Viagra, and the masculine subject positions it engenders.

Medical students’ attitudes towards peer physical examination: findings from an international cross-sectional and longitudinal study

Although studies have begun to shed light on medical students’ attitudes towards peer physical examination (PPE), they have been conducted at single sites, and have generally not examined changes in medical students’ attitudes over time. Employing both cross-sectional and longitudinal designs, the current study examines medical students’ attitudes towards PPE at schools from different geographical and cultural regions and assess changes in their attitudes over their first year of medical study. Students at six schools (Peninsula, UK; Durham, UK; Auckland, New Zealand; Flinders, Australia; Sapporo, Japan and Li Ka Shing, Hong Kong) completed the Examining Fellow Students (EFS) questionnaire near the start of their academic year (T1), and students at four schools (Peninsula, Durham, Auckland and Flinders) completed the EFS for a second time, around the end of their academic year (T2). Univariate and multivariate analyses revealed a high level of acceptance for PPE of non-intimate body regions amongst medical students from all schools (greater than 83%, hips, at T1 and 94.5%, hips and upper body, at T2). At T1 and T2, students’ willingness to engage in PPE was associated with their gender, ethnicity, religiosity and school. Typically, students least comfortable with PPE at T1 and T2 were female, non-white, religious and studying at Auckland. Although students’ attitudes towards PPE were reasonably stable over their first year of study, and after exposure to PPE, we did find some statistically significant differences in attitudes between T1 and T2. Interestingly, attitude changes were consistently predicted by gender, even when controlling for school. While male students’ attitudes towards PPE were relatively stable over time, females’ attitudes were changeable. In this paper, we discuss our findings in light of existing research and theory, and discuss their implications for educational practice and further research.

School Climate and Teachers’ Beliefs and Attitudes Associated with Implementation of the Positive Action Program: A Diffusion of Innovations Model

Teacher- and school-level factors influence the fidelity of implementation of school-based prevention and social character and development (SACD) programs. Using a diffusion of innovations framework, the relationships among teacher beliefs and attitudes towards a prevention/SACD program and the influence of a school’s administrative support and perceptions of school connectedness, characteristics of a school’s climate, were specified in two cross-sectional mediation models of program implementation. Implementation was defined as the amount of the programs’ curriculum delivered (e.g., lessons taught), and use of program-specific materials in the classroom (e.g., ICU boxes and notes) and in relation to school-wide activities (e.g., participation in assemblies). Teachers from 10 elementary schools completed year-end process evaluation reports for year 2 (N = 171) and 3 (N = 191) of a multi-year trial. Classroom and school-wide material usage were each favorably associated with the amount of the curriculum delivered, which were associated with teachers’ attitudes toward the program which, in turn, were related to teachers’ beliefs about SACD. These, in turn, were associated with teachers’ perceptions of school climate. Perceptions of school climate were indirectly related to classroom material usage and both indirectly and directly related to the use of school-wide activities. Program developers need to consider the importance of a supportive environment on program implementation and attempt to incorporate models of successful school leadership and collaboration among teachers that foster a climate promoting cohesiveness, shared visions, and support.

Normalizing Medicine: Between “Intersexuals” and Individuals with “Disorders of Sex Development”

In this paper, I apply Michel Foucault’s analysis of normalization to the 2006 announcement by the US and European Endocrinological Societies that variations on the term “hermaphrodite” and “intersex” would be replaced by the term, “Disorders of Sex Development” or DSD. I argue that the change should be understood as normalizing in a positive sense; rather than fighting for the demedicalization of conditions that have significant consequences for individuals’ health, this change can promote the transformation of the conceptualization of intersex conditions from “disorders like no other” to “disorders like many others.” Understood in these terms, I conclude, medical attention to those with atypical anatomies should be recast from a preoccupation with “normal appearance” to the concern with human flourishing that is the proper object of medical attention.

Clarifying quality of life assessment: do theoretical models capture the underlying cognitive processes?

Objective  To develop an analysis scheme capturing the cognitive processes underlying QoL assessment to increase our understanding on how to interpret responses to QoL items. Tourangeau et al.’s (The psychology of survey response, 2000) and Rapkin and Schwartz’ (Health Qual Life Outcomes 2:14, 2004) cognitive process models form the basis for this analysis scheme. Methods  We conducted think aloud interviews with six cancer patients prior to and following radiotherapy to elicit the cognitive processes underlying the assessment of 7 EORTC QLQ-C30 items. Content analysis was carried out by two to four researchers independently. Eighty text fragments were analyzed inductively and combined in an iterative process with deductive analyses based on both models. Results  We have developed a comprehensive analysis scheme feasible for analyzing the cognitive processes underlying QoL assessment qualitatively. All cognitive components of both models could be distinguished in our data. The cognitive component ‘reporting and response selection’ needed extension to fully capture the cognitive processes used. Conclusion  The two models combined are useful in describing the cognitive processes cancer patients use in answering QoL items, and as such facilitate insight into patients’ self-reported QoL assessments. Interestingly, the content of the cognitive processes not only differed between patients but also between items within patients and over time.

Indirect Effects of Acute Alcohol Intoxication on Sexual Risk-taking: The Roles of Subjective and Physiological Sexual Arousal

Three experiments supported the idea that alcohol fosters sexual risk-taking in men and women, in part, through its effects on sexual arousal. In Experiment 1, increasing alcohol dosage (target blood alcohol levels of .00, .04, .08%) heightened men’s and women’s risk-taking intentions. Alcohol’s effect was indirect via increased subjective sexual arousal; also, men exhibited greater risk-taking than women. In Experiment 2, an extended dosage range (target blood alcohol levels of .00, .06, .08, .10%) heightened men’s risk-taking intentions. Alcohol’s effect again was indirect via subjective arousal. Physiological sexual arousal, which was unaffected by alcohol, increased risk-taking via increased subjective arousal. In Experiment 3, alcohol increased women’s risk-taking indirectly via subjective arousal, but alcohol-attenuated physiological arousal had no effect on risk-taking. Implications for alcohol myopia theory and prevention interventions are discussed.

Money,Case Complexity,and Wait Lists: Perspectives on Problems and Solutions at Children’s Mental Health Centers in Ontario

Senior managers of children’s mental health centers across Ontario, Canada were interviewed regarding the challenges and solutions of access and delivery of care. The central challenges—funding, case complexity, waitlists, staffing, and system integration—revealed a complex interplay between the policies and financing of children’s mental health services and the provision of clinical services at the agency level and within the community. The desire for integration and collaboration was countered by competition for funding and service demands. A need for policies that allow for local solutions while providing leadership for sustained improvements in the ease and timeliness of access to care and effective clinical services emerged.

Can Mediterranean diet really influence obesity? Evidence from propensity score matching

Worldwide obesity rates have stimulated interest in healthy dietary patterns. One well-known dietary pattern is the Mediterranean diet, which has been linked with several beneficial health effects. However, concerns have also been raised regarding the Mediterranean diet’s role in promoting weight gain. We explored the effect of the Mediterranean diet on body mass index using the propensity score matching approach. We found no statistically significant average treatment effect on the treated and therefore cannot confirm that a causal link exists between Mediterranean diet and body mass index.