Marci D. Cottingham

Peering into the pharmaceutical "pipeline": investigational drugs, clinical trials, and industry priorities.

In spite of a growing literature on pharmaceuticalization, little is known about the pharmaceutical industrys investments in research and development (R&D). Information about the drugs being developed can provide important context for existing case studies detailing the expanding--and often problematic--role of pharmaceuticals in society. To access the pharmaceutical industrys pipeline, we constructed a database of drugs for which pharmaceutical companies reported initiating clinical trials over a five-year period (July 2006-June 2011), capturing 2477 different drugs in 4182 clinical trials. Comparing drugs in the pipeline that target diseases in high-income and low-income countries, we found that the number of drugs for diseases prevalent in high-income countries was 3.46 times higher than drugs for diseases prevalent in low-income countries. We also found that the plurality of drugs in the pipeline was being developed to treat cancers (26.2%). Interpreting our findings through the lens of pharmaceuticalization, we illustrate how investigating the entire drug development pipeline provides important information about patterns of pharmaceuticalization that are invisible when only marketed drugs are considered.

Recruiting Men, Constructing Manhood How Health Care Organizations Mobilize Masculinities as Nursing Recruitment Strategy

Despite broader changes in the health care industry and gender dynamics in the United States, men continue to be a minority in the traditionally female occupation of nursing. As a caring profession, nursing emphasizes empathy, emotional engagement, and helping others—behaviors and skills characterized as antithetical to hegemonic notions of a tough, detached, and independent masculine self. The current study examines how nursing and related organizations “mobilize masculinities” in their efforts to recruit men to nursing. Analyzing recruitment materials, I assess the mobilization and construction of masculinities in the context of textual, spoken, and visual content. Results reveal how organizations simultaneously mobilize aspects of hegemonic and nonhegemonic masculinities through ideological gendering practices. I identify three distinct types of mediated mobilization: full hegemonic co-option, partial hegemonic co-option, and alternative construction of masculinities. Empirically, the study illustrates the content of nursing recruitment material aimed at men and the ongoing contradictions endemic to men’s entry into caring professions. Complementing existing structural and interactional approaches, the study advances theory on how the mobilization of masculinities operates as an ideological gendering practice at the organizational level.

Risk and Emotion Among Healthy Volunteers in Clinical Trials

Theorized as objective or constructed, risk is recognized as unequally distributed across social hierarchies. Yet the process by which social forces shape risk and risk emotions remains unknown. The pharmaceutical industry depends on healthy individuals to voluntarily test early-stage, investigational drugs in exchange for financial compensation. Emblematic of risk in late modernity, Phase I testing is a rich site for examining how class and race shape configurations of emotion and risk. Using interview data from 178 healthy trial participants, this article examines emotion and risk as mutually constituting processes linked to biographical context and social structure. Biographical events like economic insecurity and incarceration influence how risk is felt by providing comparative experiences of felt risk and felt benefits. Such events, in turn, are structured by class-based and racial inequalities, linking class and race positions to primary emotional experiences of risk.

The makings of a modern epidemic: Endometriosis, gender, and politics

Kate Seears The Makings of a Modern Epidemic offers readers an in-depth critical examination of a modern illness from the perspective of the medical profession and the community of women who suffer its symptoms. She combines interview data alongside analysis of self-help and historical medical literature to tell the story of this contested illness and the dynamics of gender and discourse that it reveals. Estimated to affect 5–15% of all women, endometriosis involves the migration of menses tissue outside of the uterus causing severe cramping, bleeding and pain. Women may spend years suffering before receiving a diagnosis and treatment. More than just a case study of this gendered modern ailment, Seear provides an inspiring synthesis of constructionist theorising to reveal its foundational binaries. She examines the constructionist paradigm in contrast to realist and objectivist frames and explores the conceptual dimensions of risk, agency and the performative nature of disease. Methodologically, the analysis takes the form of a ‘pastiche’ of seemingly disconnected data points, unranked by hierarchy or narrative connection. While her analysis does not provide, nor claims to provide, a comprehensive overview of endometriosis, the portrait of the disease and the discourses surrounding its aetiology and symptomology cover a variety of sources making for a compelling analysis. Physicians have struggled to understand the underlying mechanisms that lead to endometriosis. In the absence of clear facts and medical certainty, practitioners and patients alike turn to assumptions about women and the body. Historically, the disease has been thought to strike primarily ‘career women’ who delay having children, thus allowing menstrual tissue to build up as they experience a greater number of cycles throughout their lives. This classic victim-blaming approach leads to some disturbing ‘interventions’ – namely, the prescription of pregnancy as the solution to womens suffering regardless of economic or fertility status. Beyond the discourse of the medical literature and the stories of women themselves, Seear turns to the surprisingly large self-help literature that has grown around the issue of endometriosis. Here, like her treatment of womens narratives, she questions the notion of empowerment. It is difficult to view the medical communitys failure to diagnose or effectively treat the illness as a catalyst for empowering women. Self-help literature ‘performs’ endometriosis and the women who suffer it by portraying the disease as stable and surmountable. Women are individually advised to avoid the seemingly limitless substances in their environment that may contain harmful chemicals. Calls for political action that might compel government regulation of these numerous toxins are scant. But medical experts and practitioners are not the only source of gendered discourse. Through technologies of the self, patients themselves call upon conflations of femininity with emotional instability and biological abnormality that gridlock them into the unfortunate position of renouncing the self as either delusional or incurable. Regardless of their resolve, the women in Seears sample are forced to grapple with the always-lurking assumption that their illness is an illusion of the mind. Often told that the pain is in their head, women with endometriosis have to become rather demanding and headstrong if they are to convince physicians to take their symptoms seriously. This leads physicians to profile the ‘typical’ endometriosis patient as a defiant, headstrong woman. The patient–physician interaction itself constructs the portrait of a ‘typical’ patient, rather than this configuration of patient characteristics pre-existing the medical encounter. Self-care – another concept that emerges in the analysis – refers to the myriad of practices that women engage in as they seek to ‘take charge’ of their health. When interventions such as surgery and drug therapies fail to provide some women with relief, they understandably turn to alternative treatments in the form of psychotherapy, acupuncture and other dietary and lifestyle modifications. Taking their treatment into their own hands may appear empowering, but Seear astutely questions the equation of self-care with empowerment. Underneath the notion of self-care lies the neoliberal assumption that the burden of care, even for the self, should fall back on individual women. To characterise this as ‘empowerment’ rings rather hollow. In the way of weaknesses, Seears subscription to a ‘pastiche’ method that suggests data remain only loosely connected, uncategorised by rank or narrative smacks of analytic timidity. Her account avoids this pitfall precisely because she does not allow data to ‘sit’ unanalysed in connection with the larger themes. While her openness to loose coherence and a plurality of views is laudable, the findings are most compelling when she situates her analysis against prior work in the study of endometriosis. Furthermore, it was unclear at times how her findings are unique to endometriosis medicine versus medicine overall. She states that an endometriosis epidemiologist ‘both assumes and reproduces “women with endometriosis” as a largely homogenous group, through seeking out patterns and connections regarding the kinds of women that are likely to develop the disease’ (p. 117, italics in original). This would seem to be the case for any disease in which physicians seek to identify ‘at-risk’ populations. Her analysis suggests that previous categorisation of patients emphasised the life choices of ‘career women’ over more physiologically based characteristics such as heavy menstrual flow. I wanted to better understand how these shifts took place – from emphasising the lifestyle of the ‘career woman’ to a focus on physiological ‘risk factors’ and back again to lifestyle characteristics implicated in diet and environmental factors. On the whole, Seear offers a compelling angle on this understudied topic. Her analysis of risk, the constitution of the patient through the medical encounter and the ambiguities of self-care all have important implications for the sociology of medicine and gender. Marci D. Cottingham Department of Social Medicine, University of North Carolina – Chapel Hill, Chapel Hill, NC, USA cottingham@unc.edu

Serial Participation and the Ethics of Phase 1 Healthy Volunteer Research

Phase 1 healthy volunteer clinical trials-which financially compensate subjects in tests of drug toxicity levels and side effects-appear to place pressure on each joint of the moral framework justifying research. In this article, we review concerns about phase 1 trials as they have been framed in the bioethics literature, including undue inducement and coercion, unjust exploitation, and worries about compromised data validity. We then revisit these concerns in light of the lived experiences of serial participants who are income-dependent on phase 1 trials. We show how participant experiences shift attention from discrete exchanges, behaviors, and events in the research enterprise to the ongoing and dynamic patterns of serial participation in which individual decision-making is embedded in collective social and economic conditions and shaped by institutional policies. We argue in particular for the ethical significance of structurally diminished voluntariness, routine powerlessness in setting the terms of exchange, and incentive structures that may promote pharmaceutical interests but encourage phase 1 healthy volunteers to skirt important rules.

This isn’t going to end well: Fictional representations of medical research in television and film

Fictional television shows and films convey cultural assumptions about scientists and the research enterprise. But how do these forms of entertainment portray medical research participants? We sampled 65 television shows and films released between 2004 and 2014 to determine the ways in which medical research and human participants are represented in popular media. We found that research participants are largely represented as White, male, and lower or working class and that 40% of the participants depicted in these fictional accounts were seeking financial compensation, 34% were hoping for a therapeutic benefit, and 15% were coerced into participation. Regardless of participant motivation, media representations tended to portray a negative outcome of medical research. Interpreting the themes in these media, we argue that these fictional portrayals might provide the public with valuable representations of medical research, especially in terms of risks to research participants, scientific failure, and researchers’ conflicts of interest.

Caring moments and their men: masculine emotion practice in nursing*

ABSTRACT Theory on men and masculinities has emphasized practice—situated action—as the key site to analyze masculinity. Individual and organizational practices as well as cultural resources are sites to investigate gender dominance. Similarly, though more recently, theory on emotion has called for a shift toward an emotion-as-practice approach in which emotion is seen as both an outcome and resource situationally activated and embodied by constrained actors. Using empirical work on men in nursing, this article develops a synthesis of masculine and emotion practice. Bourdieu’s [(1990). The logic of practice. (R. Nice, Trans.). Stanford, CA: Stanford University Press] broader notion of social practice provides a link between the two fields. Reflections from men in nursing suggest a new masculine ideal centered on the emotionally adept man. Rather than signal an alternative form of masculinity that challenges gender dominance, these changes might signal a new hegemony—a reconfiguration of practices better suited to an era of post-industrialization. Economic shifts, including an increase in both the number of middle-class women in the labor force and the number of emotionally demanding, service-based jobs, may be the catalyst for a new ideal, particularly for white, middle-class men.

Families and Emotions

As attention to the emotional dimensions of social structure, culture, and individual development has grown, scholars have renewed their interest in the emotional lives of family members. The current chapter examines three key areas of interdisciplinary research on emotion within families. It first explores how biological predispositions are activated and shaped through processes of emotional socialization within families. The chapter then examines the gendered performance of emotion work, demonstrating how family-related emotion management connects embodied experience with the maintenance of social systems over time. And finally, the chapter concludes with a discussion of how emotional capital links emotion in families with members’ experiences in other institutions. Given that families are charged with passing on emotion knowledge, skills, and capacities to the next generation, the chapter highlights the ways that families are critical for understanding how emotions contribute to the reproduction of inequalities as well as having the potential to mobilize transformational social practice.

Tracking the Pharmaceutical Pipeline: Clinical Trials and Global Disease Burden

Aggregate data about pharmaceutical research and development (R&D) tend to examine Phase III trials. Hence, there are few published data about investigational drugs in earlier phases of clinical development that might fail. It is also unclear how well R&D corresponds to disease burden. We track the pharmaceutical pipeline using data from industry publications that provide otherwise unreported information about industry‐sponsored clinical trials. The sample includes 2,477 unique drug entities in 4,182 clinical trials. The majority of drugs targeted neoplasms (26.20%), neurological diseases/diseases of the sense organs (13.48%), infectious and parasitic diseases (10.5%), and endocrine, metabolic, nutrition, and immunity disorders (9.45%). Less than 6% of drugs targeted diseases of the circulatory system, which represent the most prevalent causes of global mortality. Detailing the pharmaceutical pipeline, our findings suggest that pharmaceutical development does not adequately address global disease burden. Future research on the under‐reported details of Phase I and II clinical trials is needed to understand how the industry operates and how its resource‐allocation matches global health concerns.

“I Can Never Be Too Comfortable”: Race, Gender, and Emotion at the Hospital Bedside:

In this article, we examine how race and gender shape nurses’ emotion practice. Based on audio diaries collected from 48 nurses within two Midwestern hospital systems in the United States, we illustrate the disproportionate emotional labor that emerges among women nurses of color in the white institutional space of American health care. In this environment, women of color experience an emotional double shift as a result of negotiating patient, coworker, and supervisor interactions. In confronting racist encounters, nurses of color in our sample experience additional job-related stress, must perform disproportionate amounts of emotional labor, and experience depleted emotional resources that negatively influence patient care. Methodologically, the study extends prior research by using audio diaries collected from a racially diverse sample to capture emotion as a situationally emergent and complex feature of nursing practice. We also extend research on nursing by tracing both the sources and consequences of unequal emotion practices for nurse well-being and patient care.