Recognizing and Managing Our Conflict of Interest by Laura Jean Bierut

One day I found that I was listed as an inventor on a patent application, and this event has changed my view of conflict of interest in academic medicine and industry.

My patent grew out of my investigation into genetic contributions to the development of addiction. My colleagues and I successfully applied to a program offered through the National Institute on Drug Abuse (NIDA) for a large–scale genetic study of smoking. This project combined the skill of our academic research team with the expertise of our industry partner, a high tech genetics company, to search for genetic contributions to smoking. Our university–based academic team brought in knowledge of the disease under study (smoking and nicotine dependence) and DNA samples from subjects who consented to participate in genetic studies. The industry partner contributed the large–scale genotyping. NIDA played the role of matchmaker for this arranged marriage between academia and industry.

I entered this project with my background as a professor in psychiatry at Washington University School of Medicine. From my viewpoint in a medical school academic setting, the major products produced by professors were papers published in academic journals, research programs funded by grants, courses offered to students, and clinical training provided for residents. Though there are parallels with industry, many differences exist. The greatest contrast was in the speed of the project and the view on “products” which were to be developed. Our industry partner had clear short–term goals and milestones in this research program, and I was impressed with the pace of their work and the clarity of their vision. This speed was in contrast to the typical pace of scientific decision making in an academic medical center where many options must be carefully considered before action may be taken. With our industry partner, this project took less than two years from start to finish, which included publication.

Towards the end of our collaborative research project, our industry partner applied for a patent, “Markers for Addiction”, which described our genetic findings as a possible diagnostic test for a person’s addictive potential, and I was listed as an inventor. The patent application was initiated and submitted by our industry partner, and then my colleagues and I were informed of the application. This patent came as a surprise to me from my academic viewpoint. My academic colleagues and I considered our results in this study to be a discovery about the genetics of developing nicotine dependence, which added to scientific knowledge about addiction. We had not conceptualized the results of our study as an invention, and this patent application was a concrete example of the contrast of cultures between academia and industry. Our partner identified a potential product, a predictive test for developing a nicotine dependence that could someday be marketed, and the patent application reflected our industry partner’s logical goal of protecting the intellectual property from our discovery.

Once I was listed as an inventor, a cascade of events unfolded, which gave me further insights into the world of industry and issues in conflict of interest. After I informed my university oversight board about the patent, I was told that I had a conflict of interest. Prior to this patent, I viewed a conflict of interest as something which was improper and to be avoided. Overnight I became one of “those people” who had to add a disclaimer slide during presentations or publications. I was concerned that others would question my scientific judgment. However, my conflict of interest experience soon changed my viewpoint.

A conflict of interest is a situation where a personal interest presents a risk of influencing one’s professional duties. Once I started to examine my potential conflict of interest resulting from this patent, I began to realize that a conflict of interest was present in my academic job and did not require a connection with industry. We all know of famous cases of falsified scientific results which were published in high impact journals. The falsification of results is often the consequence of the inherent conflict of interest within research groups—a high impact publication is more likely to lead to further research funding and personal gain of the investigative team.

On a more personal level, I woke up one day to find that my own original data had been published in a prominent journal by another research team prior to the end of the NIH embargo period—the time an investigator has to publish her analysis of data before data sharing rules permit others to publish analyses of the same data (Holden, 2009). Perhaps the error was inadvertent, but it deprived me the opportunity to be the first to publish data I worked hard to collect, and it was likely driven by the same dynamics that drive data falsification: The desire to obtain the funding and recognition needed to sustain a lab in an academic environment.

Next, I came to understand that a conflict of interest may not represent a negative situation but can point to a productive research program. For example, we all hope that scientific research will lead to a new diagnostic test or treatment that lengthens life and reduces morbidity. A company may invest in this new test or treatment so that it can be marketed for patients, and a conflict of interest would arise for the investigators. The Bayh–Dole Act, adopted by Congress in 1980, is meant to encourage this entrepreneurial spirit in researchers and permits universities, small businesses, and non–profit institutions to pursue and retain ownership of inventions that arise from research funded by the U.S. government. For example, without the prospect of obtaining a patent for our discovery, it is unlikely that our industry partner would have invested time and money into this genetic study aimed at smoking prevention and cessation—important public health goals for the US.

So how have my views of conflict of interest changed? First, I believe we all have many potential conflicts of interest in our work. Secondly, instead of viewing a conflict of interest as a negative mark, I see that a potential conflict of interest can represent a successful research program that has moved out of academia into a useful product marketed by industry. One goal of academic medicine is for us to recognize and manage these potential conflicts of interest—regardless of whether they arise from collaboration with for–profit enterprises or from the competitive nature of academic medicine—and to manage them.

References

Holden, C (2009). Paper retracted following genome data breach. Science, 325, 5947: 1486–1487.

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