Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials

Chapter 8: Cultivating Pharmaceutical “Compliance”

180 Although the majority of my informants seemed to be people who really enjoyed their jobs in the clinical trials industry or who had positive experiences participating in drug studies, I occasionally interviewed someone who was dissatisfied with contract research. One such informant was Anne,1 a veteran nurse turned disillusioned research coordinator. At the time of our interview, she had been working as a coordinator for eighteen months; she had been in her current position eight months, a personal record for her given that she was already on her third coordinator job. During the interview , it was obvious that she was frustrated and unhappy, not with her current position but with being a coordinator. It was no surprise a few months later when she contacted me to tell me that she had quit her job and was leaving the industry altogether. Anne felt like she could not “cut it” as a coordinator, and she blamed herself for her “bad fit” in clinical research. Anne, like the majority of coordinators , experienced a role conflict as a nurse conducting clinical trials, yet attention to research ethics did not sufficiently mitigate that conflict. For her, ethics simply could not account for the larger structure of pharmaceutical drug development over which she had no control. Specifically, she could not “stomach” working for the benefit of large pharmaceutical companies instead of working to help individual patients. The conflict was greatest for her when patients who enrolled in studies were not doing particularly well, but she had to encourage them to remain in the studies and be compliant with the research protocols. Anne simply could not separate the aims of research from Chapter 8 Cultivating Pharmaceutical “Compliance” Cultivating Pharmaceutical “Compliance” 181 those of care. Not only could she not prioritize the retention of individual patient-subjects, she could not adapt herself to the industry. While the recruitment and enrollment of subjects can be difficult because sites need to identify appropriate patient-subjects for clinical trials, study maintenance can be even more challenging, particularly when patient-subjects’ conditions are worsening on the protocols. As long as patient-subjects’ are not in danger, it is the duty of investigators and coordinators to encourage subjects to continue in the studies regardless of whether those subjects are benefiting from the clinical trial. To do so, coordinators and investigators must develop techniques that will motivate subjects to remain in studies for the sake of the data and drug development. These approaches often end up simultaneously motivating research staff to be more compliant with the goals of the pharmaceutical industry. Anne, too, became familiar with these various approaches, but she could not implement them effectively because she did not buy into the whole enterprise. Indeed, the clinical trials industry mobilizes a discourse of medical progress to encourage the retention and compliance of patient-subjects in studies. This same discourse also serves to reinforce the commitment of research staff—coordinators, investigators, and site administrators—to the goals of drug development. Importantly, this process of cultivating the trust and loyalty both of patient-subjects and research staff succeeds in obscuring their role in pharmaceutical profit by underscoring instead their contributions to medical progress. Political Economy of Pharmaceutical Trial Results The retention of human subjects—and their compliance with study protocols —is inflected by the broader political economy. Like recruitment and informed consent practices, pharmaceutical companies’ approaches to subject retention and compliance are structured to support financial gain. Profit is tied to retention and compliance at both the site and industry levels. The more compliant subjects retained in studies, the more revenue sites will generate. They are paid by pharmaceutical companies based on the number of subjects in studies, and they are more likely to receive future studies when they perform well. In addition, the pharmaceutical industry has the most potential for profit when patient-subjects are compliant because their data will be more robust. Even when drugs cannot be proven efficacious through clinical trials, the clinical data must nonetheless be accurate for companies to decide how to proceed with research and development in the therapeutic area under investigation. 182 Medical Research for Hire Compliance is important to drug development because it can greatly influence the results of clinical trials. There are two primary ways of analyzing data from clinical trials: “per protocol” and “intent-to-treat...