Marcia Hams, Wells Wilkinson, and Susannah Rose -- Measuring the Perceived Effectiveness of Conflict-of-Interest Policies at Academic Medical Schools

On November 25th 2014, Marcia Hams and Wells Wilkinson from Community Catalyst and Susannah Rose from the Cleveland Clinic presented their ongoing collaborative project for the Edmond J. Safra Center’s tenth seminar of the year. Their project analyzes the results of a survey developed to help academic medical centers assess their policies on conflicts of interest (COI).

In order to provide a framework for their project, Hams started off the seminar with a brief description of conflicts of interest in medicine. According to the Association of American Medical Colleges, a conflict of interest is “a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest.” This is an extremely pervasive problem for medical education and research. In a study done in 2010, 84% of physicians reported having financial or other interactions (such as samples, meals, or gifts) with industry. Drug companies spent $24 billion in 2012 alone on physician marketing.

Hams then used the Warner-Lambert/Pfizer’s illegal promotion of Neurontin as an example. Warner-Lambert/Pfizer was fined $430 million in 2004 for a $40 million per year campaign that dramatically increased “off-label” prescribing of Neurontin for psychiatric disorders, migraines, and other pain, even though Neurontin was only FDA approved for seizures and shingles-related pain. They were able to increase prescriptions from 100,000 per year in 1993 to 3.8 million per year in 2001. Neurontin makes a good case study because of the ways in which funding was used specifically for medical education and research. The details of these strategies are spelled out very clearly in publically available court documents. Illegal Neurontin promotional tactics included paying “thought leaders” (department chairs) anywhere from $10,000 to $160,000 per year, educating residents through videos and courses, disseminating information through the world’s medical literature, and suppressing negative studies.

After the Neurontin case there were both public policy as well as institutional responses. In terms of public policy responses there were congressional investigations, new state laws on gifts and disclosure, updates to the Public Health Service regulations for NIH investigators, and the Physician Payments Sunshine Act was passed as a part of the Affordable Care Act. There were also various levels of institutional responses, from industry guidelines to individual academic medical center conflict of interest policies.

Now that participants were armed with a better understanding of COI, particularly as they pertain to medical education and research, Rose continued the seminar by explaining how they developed the survey. The overarching problem that needed to be solved was that many academic medical centers have COI policies but have no way of measuring their effectiveness or finding out if people actually know about them. The survey aimed to assess physician, faculty, and staff knowledge about the institution’s COI policies; assess physician, faculty, and staff perceptions of the effectiveness of specific COI policies; and assess physician, faculty, and staff compliance with the institution’s COI policies. In terms of the technical aspects of the survey, they chose to use mainly closed-ended questions to make data analysis easier and developed it in RedCap because most institutions already have access to it. They also needed to develop a survey that was flexible enough to allow different institutions to modify it to their needs.

The survey was tested at three pilot sites with three different fielding strategies, which could explain the variation seen in response rates between the three sites. The responses from the surveys still need to be fully analyzed but they discussed preliminary analyses. They found that Redcap is a good platform for the survey and that the survey is in fact adaptable to diverse institutions, although the length of the survey may be too long. The content of the survey does seem to provide usable and very helpful information to institutions as it can be used to target education on policies, provide support for compliance administrators who encounter resistance to policies, and allow institutions to assess their policies and make changes to increase their effectiveness. The survey pilot investigation was limited in scope, and only included three pilot sites, was implemented at the sites differently with differing response rates, and used self-reporting to assess compliance.

In the future the team plans to conduct analyses on differences in policy perspectives at the institutional level and conduct exploratory analysis of the best predicators of policy satisfaction and the best predictors of perceptions of the effectiveness in reducing risk of harm. They also hope to combine the datasets from pilot sites, and refine recommendations for survey use, which will finally lead to the survey becoming available for free use by U.S. Academic Medical Centers.

- Summary composed by Lianna Llewellyn