Jill A. Fisher

Benefits of ‘observer effects’: lessons from the field

This article responds to the criticism that ‘observer effects’ in ethnographic research necessarily bias and possibly invalidate research findings. Instead of aspiring to distance and detachment, some of the greatest strengths of ethnographic research lie in cultivating close ties with others and collaboratively shaping discourses and practices in the field. Informants’ performances — however staged for or influenced by the observer — often reveal profound truths about social and/or cultural phenomena. To make this case, first we mobilize methodological insights from the field of science studies to illustrate the contingency and partiality of all knowledge and to challenge the notion that ethnography is less objective than other research methods. Second, we draw upon our ethnographic projects to illustrate the rich data that can be obtained from ‘staged performances’ by informants. Finally, by detailing a few examples of questionable behavior on the part of informants, we challenge the fallacy that the presence of ethnographers will cause informants to self-censor.

Evaluation of real-time location systems in their hospital contexts.

OBJECTIVE The purpose of the research was to assess real-time location systems (RTLS) that have been implemented in U.S. hospitals. We examined the type of uses to which RTLS have been put, the degree of functionality of the various technologies and software, and the organizational effects of implementing RTLS. METHODS The project was a 3-year qualitative study of 23 U.S. hospitals that had implemented RTLS for the purpose of tracking assets, personnel, and/or patients. We observed the systems in use and conducted 80 semi-structured interviews with hospital personnel and vendors. In order to protect the confidentiality of the hospitals and vendors in our sample, we conducted an aggregate analysis of our findings rather than providing evaluations of specific technologies or hospital case studies. RESULTS The most important findings from our research were (1) substandard functionality of most real-time location systems in use and (2) serious obstacles to effective deployment of the systems due to the material and organizational constraints of the hospitals themselves. We found that the current best use of RTLS is for asset tracking, but importantly it requires whole-hospital deployment as well as centralized control of the system, preferably by materials management or biomedical engineering departments. DISCUSSION There are serious technological, material, and organizational barriers to the implementation of RTLS, and these barriers need to be overcome if hospitals are to maximize the potential benefits of these systems. CONCLUSION In addition to considering the available technological options, hospitals must assess their unique environments, including the myriad material and organizational constraints that will affect the success of RTLS implementation.

United States Private-Sector Physicians and Pharmaceutical Contract Research: A Qualitative Study

Jill Fisher and Corey Kalbaugh describe their findings from a qualitative research study evaluating the motivations of private-sector physicians conducting contract research for the pharmaceutical industry.

Implanting inequality: Empirical evidence of social and ethical risks of implantable radio-frequency identification (RFID) devices

OBJECTIVES The aim of this study was to assess empirically the social and ethical risks associated with implantable radio-frequency identification (RFID) devices. METHODS Qualitative research included observational studies in twenty-three U.S. hospitals that have implemented new patient identification systems and eighty semi-structured interviews about the social and ethical implications of new patient identification systems, including RFID implants. RESULTS The study identified three primary social and ethical risks associated with RFID implants: (i) unfair prioritization of patients based on their participation in the system, (ii) diminished trust of patients by care providers, and (iii) endangerment of patients who misunderstand the capabilities of the systems. CONCLUSIONS RFID implants may aggravate inequalities in access to care without any clear health benefits. This research underscores the importance of critically evaluating new healthcare technologies from the perspective of both normative ethics and empirical ethics.

Sex, gender, and pharmaceutical politics: From drug development to marketing

BACKGROUND Biological sex differences and sociocultural gender norms affect the provision of health care products and services, but there has been little explicit analysis of the impact of sex differences and gender norms on the regulation of pharmaceutical development and marketing. OBJECTIVES This article provides an overview of the regulation of pharmaceuticals and examines the ways that regulatory agencies account for sex and gender in their review of scientific data and marketing materials. METHODS The primary focus is on the US context, but information is also included about regulatory models in Europe, Canada, and Japan for comparative purposes. Specific examples show how sex differences and gender norms influence scientific and policy decisions about pharmaceuticals. RESULTS The United States and Canada were found to be the only countries that have explicit requirements to include women in clinical trials and to perform sex-based subgroup analysis on study results. The potential influence of politics on regulatory decisions may have led to an uneven application of standards, as seen through the examples of mifepristone (for abortion) and sildenafil citrate (for erectile dysfunction). Three detailed case studies illustrate the importance of considering sex and gender in pharmaceutical development and marketing: Phase I clinical trials; human papillomavirus quadrivalent vaccine; and tegaserod, a drug for irritable bowel syndrome. CONCLUSIONS Sex and gender play important roles in pharmaceutical regulation, from the design of clinical trials and the approval of new drugs to advertising and postmarketing surveillance. However, regulatory agencies pay insufficient attention to both biological sex differences and sociocultural gender norms. This disregard perpetuates inequalities by ignoring drug safety problems that predominate in women and by allowing misleading drug marketing that reinforces gender stereotypes. Recommendations have been made to improve the regulation of pharmaceuticals in regard to sex and gender.

Direct to consumer responsibility: Medical neoliberalism in pharmaceutical advertising and drug development

Purpose – This chapter explores the pharmaceutical industrys strategic utilization of empowerment discourse in two realms: direct-to-consumer advertising (DTCA) and clinical drug development. Methodology – It draws upon two research projects that examine the role of the pharmaceutical industry in the political economy of healthcare in the United States: Ronalds policy analysis and participant observation of DTCA policy hearings and Fishers participant observation and interviewing of the clinical trials industry. Findings – Empowerment rhetoric is mobilized by the pharmaceutical industry to create specific expectations about patient-consumer behavior, particularly the responsibilities associated with the consumption of drugs. Research implications – The social and economic implications of DTCA and drug trials must be understood within their broader historical and contemporary contexts of health advocacy, consumerism, and medical neoliberalism. Practical implications – The chapter offers alternative constructions of healthcare subjects and pharmaceutical practices that can mitigate the power of the pharmaceutical industry and bring about better pharmaceutical governance. Originality/value of chapter – By analyzing findings from two empirical projects, this chapter is able to shed light on trends in the pharmaceutical industrys discourse about empowerment and consumption from the clinical testing to marketing of new drugs.

Altruism in Clinical Research: Coordinators’ Orientation to their Professional Roles

OBJECTIVE Research coordinators have significant responsibilities in clinical trials that often require them to find unique ways to manage their jobs, thus reshaping their professional identities. The purpose of this study was to identify how research coordinators manage role and ethical conflicts within clinical research trials. METHODS A qualitative study combining observation and 63 semistructured interviews at 25 research organizations was used. RESULTS Altruism is a recurring theme in how research coordinators define and view their work. CONCLUSION Altruism is adopted by research coordinators to: (1) Teach patient-subjects the appropriate reasons to participate in clinical research, (2) minimize the conflict between research and care, and (3) contest the undervaluation of coordinating. Altruism is a strategy used to handle the various conflicts they experience in a difficult job, and it has become part of the professional identity of clinical research coordinators.

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.