Transitions/Translations/Gaps: Ethnographic Representations in the Pharmaceutical Industry

Introduction

The process of bringing a product to market involves the transition of ideas and knowledge between socially differentiated actors. These actors play prescribed roles in pushing a product through the pipeline towards the marketplace. We position this pipeline as a “chain,” with ideas and knowledge that need to be translated as they move between the different groups or “links”. Also, “gaps” can develop in the chain where translation is less than perfect, potentially resulting in failed products. In this case study, we show that by viewing domains of the pharmaceutical industry and their subjects of study through the lens of concepts of personhood, we are able to show how attention to specific “links” of the research process can allow construction of a more coherent “chain.” We feel that this approach may be useful for helping to explain ethnographic findings across domains of our clients’ worlds, and potentially prevent the difficulties that may arise in these many transitions. Further, ethnographic data in the form of visual documentary reports allow us to bring our concept of a whole person in context to view in each link of the chain, challenging abstracted and domain specific views on personhood and bodies.

Most anthropological discussions of personhood typically begin with Mauss’ (1938) essay, where he questions the supposedly innate nature of personhood and instead shows how it has taken different forms over time and in various places. Mauss’ argument was that earlier societies had a more socio-centric concept of personhood premised on relational bonds of kinship and clanship, which differed with the concept of the “individual” in the West. Personhood entails specific notions of the body and how it relates to the self and the larger society. In our analysis of pharmaceutical research, we draw on notions of the body, and literature on anthropology of the body to explore how members of each link in the chain perceive of consumers of pharmaceutical products. Secondly, these concepts of personhood are models that people use to make sense of their worlds, and can be in viewing the ways that people adhere or do not adhere to the model.

In the US and other western nations, the dominant model of personhood involves the notion of the “possessive individual,” the person as the “proprietor of the self” negotiated through property relations¹. The possessive individual is thus the prototypical consumer in the Western imagination, as well as the self-actualizing subject in a political climate where people are responsible only for their own actions, free from social constraints.

In this work we show that paying specific attention to link specific notions of personhood regarding the body, and social contexts can help ethnographers be more deliberate in uncovering the assumptions our clients make about their customers, as well revealing how those customers do and do not “match up” with the notions of personhood ascribed to them by our clients.

Background: Gaps in the Pipeline

Our discussion about concepts of personhood and the body in the pharmaceutical industry begins with neither a person nor a body. Instead, our story begins with what is called a recombinant human platelet-derived growth factor, created by placing human DNA into a type of yeast. This disembodying process resulted in a pharmaceutical wound care product that those in the pharmaceutical industry generally term a “dog” – a poor selling product not fulfilling its promise as a novel and needed drug. Our role as ethnographers arose when another company had begun early-stage development of a product similar to the product currently on the market. A market research analyst called on us to conduct ethnographic research after a disagreement between the clinical developers (“the scientists”) and product management (“the marketers”) at the company over how to set up Phase III clinical trials. Looking back, we interpreted this disagreement as having its roots in the different concepts of personhood and the body apparent in the two groups’ (or two links) constructions of the end users of their potential product.

Our client informed us that these disagreements arose in discussions between the two links, whereby the clinical scientists stated that they wanted to structure the Phase III clinical trials exactly as those of the competing product, following tried and true pharmaceutical practice in developing a “me too” (or copycat) drug. The marketers, however had expressed some concerns with this approach. They felt that maybe the competing product’s lack of success was related to the people using it, rather than any inherent lack of efficacy with the product itself. Importantly, neither group identified physician prescribing practices or instructions as problematic.

From past experience conducting research on clinical trial design, we were aware that scientists have a very specific and narrow task in bringing a product to market. They are responsible for producing extremely structured and constrained sets of data needed to fulfill FDA requirements for drug approval. The Phase III trials are the most stringent and important, being the final stage needed to actually market a drug to physicians and patients. As a result, the scientist’s perspective on the body begins with a highly abstracted view of skin, body parts and biochemical reactions, which only later become attached to human “subjects.” They may perceive of potential users of the product as a “bag of chemicals,” or measurable endpoints needed to fulfill FDA requirements. Here bodies are abstracted to separate body parts that function on their own, often removed not only from a system and other parts, but also from the people with whom they are associated. This economically driven, compartmentalized model of the body allows for an abstraction of parts that are not “surplus” parts, but parts that have specific value based on their reactions to certain drugs.² So in the case of a product that deals primarily with a pancreas, for example, scientists may view potential consumers only as a pancreas and all possible associated physical side effects, isolated entirely from a person with a lifestyle, socioeconomic standing, social networks and everything else which may affect how people understand, use and experience a pharmaceutical drug. In one sense it could be argued that clinical trials are set-up to remove the “messiness” of real people from the equation of producing pharmaceutical products.

Once a drug makes it through Phase III clinical trials, marketers face the challenge of providing materials and instructions to ease the transition between physicians and patients when administering the drug. While marketers do think about social worlds to some extent, many view physicians and consumers, or users as “possessive individuals.” Interestingly, physicians also view themselves as possessive individuals during more traditional market research stating in some way or another that they choose products based on science and “evidence based medicine,” rather than economic or social factors, for example. Users also may imagine themselves as possessive individuals when asked in quantitative research.

Findings

Since our client’s drug had not yet received FDA approval, our research focused on the use of the future rival product. We observed physician-patient interaction in the exam room and also went to the patient’s homes to talk about and observe how they cared for their wounds and used the product. By viewing our findings through disjunctures in concepts of personhood, we were able to connect the disparate aspects of the consumption “chain” of those we studied.

Our clients were surprised to find that physicians completely disregarded the tiny and meticulous detailed instructions for using the product that were included in the product insert. The process for using the drug (a gel) involves patients painstakingly measuring their wound (using a mathematical formula that could be calculated in either centimeters or inches), then squeezing out onto a clean surface a specific amount of gel which would exactly fill that specific surface area measurement. Then, using an “application aid,” the gel would be applied to the wound to “approximately 1/16^th of an inch,” and there was yet another mathematical formula to calculate how much the amount of gel actually weighed, which was calculated in grams.

Why did the physicians ignore the instructions? After conducting research with physicians and patients, we found that physicians understood the on-the-ground use of the product in a different way than scientists or marketing professionals. Physicians did not view their prescribing practices as insufficient. Instead they considered the social context of their patients as they made choices around how to administer and instruct them on how to use the drug. In practice, physicians realized that demographics also made the application process problematic for many users of the product, who were elderly, obese, low income, had poor eyesight and were physically unable to reach many of the areas of the body where they were supposed to apply the product. Many needed help to apply the product and would enlist family members and visiting nurses; however economic limitations of some the people and their families left them with few options for assistance. Further, when we observed professionals dressing wounds, we found that the sheer awkwardness of the process was apparent, as they often struggled to dress the wound after application of the drug, dropping scissors and sterile gauze on the ground as often as the patients and their family members. Given these limitations, it was unrealistic to expect users to measure and apply the gel in the most sterile and precise way, and essentially, the most effective way. Further, some physicians would resist prescribing the product at all if they knew the patient had a lack of social networks, realizing that without assistance, a bed ridden, obese, elderly patient would have little to no chance of applying the costly drug in an effective way. Many physicians also considered the insurance status of their patients or their ability to pay out of pocket or enlist people in their social networks who could purchase the product for them. Physicians knew that misuse of the drug due to such limitations might result in misuse of the costly drug, removing its efficacy altogether and leaving the patient with an untreated wound.

Patients themselves then did not view their wounds as an isolated part of their bodies either. Instead, many considered the use of this product to be one step in their complicated health care related and troublesome lifestyles. Dealing with hardships of everyday life often trumped their ability and their desire to take the time and energy necessary to thoroughly learn the intricacies of “correct” product use. Even in cases where patients experienced extreme concern and anxiety over the care of their wounds, they were overwhelmed by the realities of dealing with other life threatening health issues, insurance companies, social services, transportation options and basic needs. Scientist and marketer expectations—that wound care occurred daily in a sterile and concentrated vacuum in which the patient was focused directly on his/her wound as a separate object or part—were unrealistic.

Notes

The ideas presented here are solely the responsibility of the authors and do not reflect the official position of Integrated Marketing Associates.

John P. Wendel is Director of Ethnographic Research at Integrated Marketing Associates. He has also held administrative positions at Fordham and Temple Universities and conducted several years of field research in Micronesia. John earned his B.A. from Fordham University and Ph.D. in anthropology from the University of Rochester.

Lisa Jane Hardy is completing her Ph.D. in anthropology at Temple University on Philadelphia dog/human interactions, space and place, biology, and political economy. She earned her MA in applied anthropology at Northern Arizona University in 2001 and has been working as a consultant with non-profit and industry clients for over six years.