Abstract
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.
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Notes
The pharmaceutical industry’s investment in research and development (R&D) has grown exponentially since the 1980s. For example, in 1990, the industry’s annual R&D expenditure was $8.4 billion. In 2004, it spent nearly $39 billion, which was a 12.6% increase from the previous year (Parexel 2005).
Most pharmaceutical studies are placebo-control clinical trials. This type of study design is favored over studies which compare an investigational drug to other products already on the market because it is easier to prove efficacy (i.e., the new drug is better than nothing as opposed to better than an existing treatment) and these studies are considerably less expensive because they require fewer human subjects and less infrastructure (Tereskerz 2003).
In the last decade, clinical trials have received significant attention from the mass media because of high-profile cases of studies gone awry. Examples include the death of Jesse Gelsinger in a University of Pennsylvania gene-therapy experiment (Stolberg 1999) and the near fatal injuries to six healthy subjects in a first-in-human study on an experimental product tested in London (Rosenthal 2006). See O’Neill (2002) for an analysis of the public’s deficit of trust in science and medicine as a result of the media.
The research was supported by the National Institutes of Health under Ruth L. Kirschstein National Research Service Award 5F31MH070222 from the National Institute of Mental Health.
This paper concentrates primarily on Phase III clinical trials, which are designed to test the efficacy of new pharmaceutical products. For discussions of other types of studies, their organization, and the human subjects who enroll in them, see Fisher (forthcoming).
Kassirer (2005) discusses the extent to which physicians accept gifts and income from the pharmaceutical industry as a routine part of the contemporary practice of medicine.
For more on audit culture, see Strathern (2000).
Sztompka (1998) similarly argues that democracies are founded on an ‘institutionalization of distrust’ that enables citizens to trust.
Shapiro (1987) also describes how the social organization of distrust creates new markets for ‘trust production.’ This seems to be particularly true in the clinical trials industry given the development of ancillary companies that share risk with pharmaceutical companies by taking on some of the control functions in drug development.
Shapiro (1987) uses the term ‘distrust’ in her writing. I prefer the term ‘mistrust’ because it implies a lack of trust, rather than the more explicit suspicion and doubt implied in the former.
Anderson et al. (2007) provide a nuanced exploration of the effects of competition on science, especially in terms of research ethics.
In one important respect, all drugs that compete in a certain class are ‘me-too’ drugs. This is because they are each trying to get the most market share whether they were first, second, or even tenth to become available by prescription. See Angell (2004) for more discussion on the politics of me-too drugs in pharmaceutical R&D and in US health care.
In addition, many pharmaceutical companies choose to outsource the management of clinical trials to independent companies called contract research organizations (CROs). In those cases, proprietary information is then shared with those CRO employees assigned to the trials. For more information on CROs, see Mirowski and Van Horn (2005) and Fisher (forthcoming).
In fact, one informant asked me not to sign in when I met her in the lobby of her office building because she preferred that there be no record of my visit to the company. We then proceeded to a nearby restaurant so that she was not questioned by any of her supervisors about the interview.
Seligman (1998) discusses how contracts are a result of the changing character of trust in the modern era.
This is also true for the human subjects who participate in the studies. Subjects rarely receive information about the outcome of clinical trials, and when they do, the information comes informally from clinicians, not officially from pharmaceutical companies.
None of the clinicians with whom I spoke ever discussed writing papers to be published. Two things seem to be taken for granted. First, publishing is the kind of activity reserved for academic physicians and their teams. Second, the pharmaceutical industry hires ghostwriters to put together papers for publication (see Sismondo 2007). As a result, physicians dismissed writing articles as an activity that was simply not in their purview.
Some clinical trials include in-patient study protocols in which human subjects are confined to the clinic for the length of the study. These are most common as part of first-in-human or other early clinical studies. In-patient studies are a particularly important trial design when subjects must follow strict dosing schedules, require many medical procedures, and/or consume set diets (e.g, high-fat or high-calorie) that are mandated by the FDA.
‘Smart’ pill bottles and blister packs have now been introduced to clinical trials in order to more precisely monitor subjects’ compliance (Goldfarb 2007). These new technologies are designed to collect data on when bottles are opened or pills are pushed out of their packaging. Currently, these technologies are not widely integrated into clinical studies, but pharmaceutical companies may start adopting them in the near future.
Some within the industry argue that an active role is empowering for subjects, but this view neglects the myriad ways in which the context of human subjects’ decision-making about trial participation and the structure of study protocols actually limits subjects’ authority over their bodies and well-being (Fisher and Ronald forthcoming).
A coordinator said, “I thought the older people would not do well, having to put electronic data into a Palm Pilot, but they have surprised us, haven’t they? We were so scared to give a 69-year-old a Palm Pilot and try to educate them on how to do it, but they’re the ones that are on time for their appointments and use the Palm Pilots perfectly.”
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Fisher, J.A. Institutional mistrust in the organization of pharmaceutical clinical trials. Med Health Care and Philos 11, 403–413 (2008). https://doi.org/10.1007/s11019-008-9154-y
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DOI: https://doi.org/10.1007/s11019-008-9154-y