A Change of Heart

I was a resident and chief resident in the Department of Internal Medicine at the Yale University School of Medicine. Here, the relationship between physicians, the pharmaceutical industry, and particular pharmaceutical representatives was a common topic of discussion. Training and later practicing at Yale has had a large influence on how I have chosen to interact with the pharmaceutical industry as a physician.

Early in my training, which took place in the late 1980s, it was not unusual for us to have lectures or to be invited to a soiree sponsored by a pharmaceutical company. Many of us, including me, would avoid these venues for a number of reasons. First, we were concerned that any data presented would inherently be biased towards presenting the sponsor’s product in a more favorable light, even if unwarranted. Secondly, we felt that the representatives were trying to bribe us, hawking pens, books, and other wares in hopes of convincing us to preferentially prescribe their medication to our patients. Lastly, and most important to us, we felt that the companies were taking money from our patients, in the form of escalated purchase prices, in order to sponsor these affairs for physicians or physicians–in–training, a group not generally in need of subsidies.

At our department and school, these discussions progressed and ultimately evolved to a degree that two papers were published which outlined our policies for the relationship between our faculty and the pharmaceutical industry (Coleman, 2008; Coleman, Kazdin, Miller, Morrow, & Udelsa, 2006). These documents banned us from receiving any form of gift, meal, or free drug sample (for personal use) from industry, and set more stringent standards for the disclosure and resolution of financial conflict of interest in our educational programs. After my residency, I received further training in epidemiology, biostatistics, and public health and was ultimately able to procure government funding to direct several large scale population–based epidemiologic studies of domestic emerging infectious diseases. One of these was a 2–year study of new cases of fungal bloodstream infections that I conducted along with a group of colleagues from the Centers for Disease Control and Prevention as well as the Johns Hopkins Bloomberg School of Public Health, where we captured over 1100 cases from the entire State of Connecticut and Baltimore County, Maryland from 1998–2000 (Hajjeh et al. 2004). Because of the unique nature of this study, a number of local and outside researchers contacted us for permission to collaborate with us to answer a variety of clinical questions using our database.

One researcher who approached us was Steven Teutsch, MD, MPH, from Merck and Company’s Outcomes Research and Management group. His group was charged with developing evidence–based clinical management programs, conducting outcomes–based research studies, and ultimately to enhance quality of care. He was a recognized expert in this field of work, having published over 100 related articles.

At that time, Merck was working on caspofungin, a medication in a new class of antifungal medications, called echinocandins, which ultimately became FDA–approved in 2001. Teutsch’s goal was for us to use our database to assemble a group of cases with bloodstream fungal infections to then compare with a group of controls, or hospitalized patients with the same medical or surgical conditions as our cases but without known fungal infection, in order to determine the marginal impact that these fungal infections had on length of hospital stay and mortality. In Connecticut, we had a unique opportunity to design and conduct this additional study because of the existence of the Connecticut Hospital Association, which captured data on all acute care hospitalizations throughout our State. With their participation, assembling a group of control patients was feasible without contacting each individual hospital.

Merck offered to pay Yale University 10% of my overall salary, which would be proportionate to my time spent on data acquisition and analysis. This was the first time that I had ever worked with anyone in the pharmaceutical industry and I was initially reluctant to enter into this relationship given my prior background and perspective, developed as a resident. However, after several discussions with Dr. Teutsch...