This past Sunday the New York Times published an extensive front-page article about the repeated failures of a prominent physician scientist to declare potential conflicts of interest on many of the research papers he published. This was even the case for papers in journals that explicitly query authors as to their outside interests. And his interests were considerable – in the millions of dollars – and obvious, including service on the boards of large pharmaceutical houses whose drugs were being tested. Although no one raised concerns in the article that the data in these papers were tainted, experts did question some of his interpretations.
Why should we care? For many reasons. We deal with the lives and health of human beings –therefore it is crucial that the science is accurate and the interpretations impeccable. Anything less than absolute integrity puts patients at risk. Beyond accurate data and reporting, we owe our patients and the scientific community full disclosure about information that may affect how we interpret our findings. Journal readers must be able to consider any possible biases that could influence our data analysis and interpretation. Meticulous attention to these precepts creates public confidence in our findings and recommendations.
What does CWRU expect? All investigators must submit a conflict of interest disclosure (COI) form to the University, even if no conflicts are present. A COI committee composed of faculty and staff members from different schools reviews the submission. If there are no conflicts, filling out the form is a breeze! If the researcher declares income or potential income from industry, consulting fees, or exchange of items of value, including sponsored research agreements, the COI committee recommends the means to manage the possible conflict. These stipulations vary from individual to individual, but always include the expectation that actual or potential conflicts are fully disclosed in grants, presentations, and publications. The individual faculty member is then honor-bound to follow the committee’s recommendations.
Studies on conflict of interest indicate that even seemingly trivial amounts of money or small gifts can have substantial influence on a person’s behavior. So the concerns expressed by the Times are relevant even in cases with minimal cash at stake, which may be the reality for most researchers. It’s not the cash, it’s the integrity.
In fact, the whole system rests on integrity. The article in the Times reminds us that the details are important and cannot be forgotten. The bedrock principles of patient protection, honest disclosure, and integrity must prevail.
Pamela B. Davis, MD, PhD
Dean, School of Medicine
Senior Vice President for Medical Affairs, Case Western Reserve University
Arline and Curtis Garvin Research Professor
2109 Adelbert Road, BRB 113
Cleveland, OH 44106