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

Chapter 3: Pursuing Contract Research

33 On my first visit to a large practice, I interviewed Richard,1 a white male physician in his mid-forties who was actively involved in pharmaceutical contract research and had conducted roughly 250 studies since the early 1990s. That day, there were nearly forty studies operating out of his private practice with a dedicated research staff to oversee them. In addition to his impressive experience with drug studies, Richard had a range of organizational and business experiences in the clinical trials industry: he had worked on clinical trials in an academic setting as part of his residency training, in his private practice operating as an independent site, and most recently in his private practice operating as part of a site management organization (SMO). Richard’s involvement with pharmaceutical studies began when he and his partner were seeking ways to augment the revenue generated by their private practice. They had begun to see their incomes diminish as payments from managed care organizations and Medicare dipped, malpractice insurance premiums swelled, and overhead costs for maintaining their office tripled. Initially, both physicians became involved with extracurricular promotional activities for the pharmaceutical industry, including consultant work and paid speaking engagements.2 Soon, several pharmaceutical companies began offering them contracts to conduct clinical trials out of their practice. Because he had worked on studies during his residency,3 Richard felt that adding pharmaceutical studies to their practice would be a natural progression of his training and clinical experience. Chapter 3 Pursuing Contract Research 34 Medical Research for Hire In spite of his preparation, conducting clinical trials was not as easy a source of income as the pharmaceutical companies had promised. In the beginning , before he and his partner had enough experience to know what kind of infrastructure was necessary to make the studies profitable, they debated the wisdom of accepting more studies simply because they were offered. They were not prepared for the amount of management and business skills necessary to run clinical trials compared to their regular practice. After almost two years of persisting, they came to the decision to split the pharmaceutical studies from their practice by forming a separate company (yet still located within the physical space of the practice) with separate staff to manage the business and conduct the studies. This did not prove to be the solution they had been hoping for either, so when several years later, an SMO offered to buy the clinical trials company and hire them as salaried investigators, both physicians jumped at the deal. The transaction meant that they could continue to “be their own bosses” in the private practice and augment their total income with the salaries they were bringing in as “corporate” investigators for the SMO. Through navigation of different organizational structures, Richard began to see himself as an entrepreneur in medicine. While this identity at first hinged on the economic aspects of conducting pharmaceutical studies, it morphed to include other, often less tangible, benefits. As his experience with studies grew, he said that his participation in clinical trials gave him the opportunity to have firsthand experience with new drugs before they became available on the market. He argued that he could then apply his direct knowledge of the products to treatment decisions for his private-practice patients rather than relying on the information provided by pharmaceutical companies and their sales force. Richard’s interest in and commitment to clinical trials work was atypical for physicians conducting pharmaceutical studies. While Richard took an incredibly active role in the quotidian operation of the studies he was overseeing , his partner was the epitome of what the industry calls “phantom investigators ”; although his partner was quite willing to sign on to trials, he seemed equally unwilling to invest much time in study-related activities. In fact, after their company was acquired by the SMO and both physicians were put on salary , Richard’s partner became increasingly absent from the clinic, from seeing both patients in their private practice and subjects for clinical trials. While his partner is an easy target for criticism due to his lack of active participation in the pharmaceutical studies for which he is responsible, Richard’s enthusiasm for conducting clinical trials may not capture the full picture of Pursuing Contract Research 35 the work he himself described. He discussed during the interview the incredible constraints placed upon investigators that might encourage physicians to disconnect from the...