Tuesday, January 29, 2013

A Change of Heart by Andre N. Sofair

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 and my other research colleagues, I decided that the research question was an important one and that, as a group, we would be able to conduct the work in a rigorous manner. Merck reserved the right to review the manuscript and to have authorship; they could not refuse to allow the data to be published. Additionally, involvement of a ghostwriter, or one who writes the paper but gives credit for authorship to another person, was never suggested by Merck.

Over the course of two years, our group worked together successfully on study design, data acquisition and analysis, as well as in the writing and publication of the manuscript (Morgan et al., 2005). Dr. Teutsch was involved at every step but never directed the process towards a pre–specified outcome. I always found him to be scientifically rigorous, unbiased, and a reliable colleague. His expertise was critical to the success of the work, especially as we encountered challenges in the assembly of control groups and as we embarked on the data analysis. Not surprisingly, we found that patients hospitalized with bloodstream fungal infections were more likely to have a longer hospitalization and to die than their uninfected controls. The unique contribution of this work was that we were able to quantify all of these attributes in a population–based, and therefore representative, manner.

Although still against the practices of gifts or meals being given from the pharmaceutical industry to physicians, my personal experience working with Dr. Teutsch reversed many of my preconceived ideas of how this interaction would proceed. Over the two years that we worked together, I can only describe our relationship as cordial, professional, and scientific. Given a similar opportunity to collaborate in unrestricted and unbiased scientific inquiry, I would not hesitate to work again with colleagues from industry as I have learned that their unique background and expertise can strengthen the collaboration. I have also found that both my prior exposure and discussions as a medical resident, coupled with this more recent research collaboration, has given me a more balanced perspective. With this I am better able to teach and counsel my medical residents and students about working productively with professionals from the pharmaceutical industry.


Coleman, D. L. (2008) Establishing policies for the relationship between industry and clinicians: Lessons learned from two academic health centers. Academic Medicine, 83, 882–887.

Coleman, D. L., Kazdin, A. E., Miller, L. A., Morrow, J. S., & Udelsman, R. (2006) Guidelines for the interactions between clinical faculty and the pharmaceutical industry: One medical school’s approach. Academic Medicine, 81, 154–160.

Hajjeh, R. A., Sofair, A. N., Harrison, L. H., et al. (2004) Incidence of bloodstream infections due to Candida species and in vitro susceptibilities of isolates collected from 1998 to 2000 in a population-based active surveillance program. Journal of Clinical Microbiology, 42, 1519–1527.

Morgan, J., Meltzer, M. I., Plikaytis, B. D., et al. (2005) Excess mortality, hospital stay, and cost due to candidemia : A case-control study using data from population-based candidemia surveillance, Infection Control and Hospital Epidemiology, 26, 540–547.

Copyright © 2011 The Johns Hopkins University Press. Narrative Inquiry in Bioethics, volume 1, issue 2. Used with permission.

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