A senior rheumatologist with extensive experience in the management of systemic lupus erythematosus is asked to help draft clinical guidelines for the treatment of lupus nephritis. Neither she nor her family members receive grant funding nor does she consult with any pharmaceutical or biotechnology companies. She does have strong clinical opinions based on current evidence and her years of clinical experience. Does she have any conflicts of interest? If so, how should they be managed?
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Explore This IssueJuly 2019
Intellectual Conflict of Interest
Whether discussing treatment options with patients, allotting funds for new clinical trials or shaping clinical guidelines for the ACR, we are all asked to give our opinions on a daily basis. While the aim is to base these opinions on evidence, there is no doubt we all develop habits and biases based on our own clinical and personal experiences. Such biases, known as intellectual conflicts of interest (COI), can be subtle. If left undisclosed, they can also erode the patient-physician relationship, undermine the hard work done by a research group and halt the progress of medicine.
In 2017, the American Heart Association and the American College of Cardiology announced a more stringent cutoff for treatment of high blood pressure in adults. The American Academy of Family Practice subsequently rejected the guidelines, citing the perceived presence of intellectual COI on the guideline panel as a “fatal problem.”1 Specifically, it noted the chair of the guideline panel had also chaired the steering committee of a large clinical trial upon which the new guidelines were, at least partially, based.
What is the solution to a problem in which both parties are ostensibly working toward the best interest of their patients?
The American College of Chest Physicians attempted to address the issue when updating its guidelines for anti-thrombotic therapy and prevention of thrombosis in 2013.2 Content experts with potential financial and/or intellectual COI were involved in collecting and summarizing evidence. However, only non-biased methodologists with training in health research methodology were involved in determining the strength of the final recommendations. The result: Only 33% of recommendations were categorized as strong, compared with 64% in the previous version.
Methodologists were generally positive about the experience, although some noted concerns about the decreased richness of the guidelines. Content experts had mixed experiences, noting the methodologists may have had their own biases toward validation of the specific methodology used in the guideline development.
Attempting to form the perfect committee or to recruit the perfect speaker by excluding anyone with the slightest perception of conflict, financial or otherwise, would result only in outcomes that are delayed & less robust.
The ACR & Intellectual COI
In its 2015 Policy and Procedure Manual for Clinical Practice Guidelines, the ACR acknowledges the challenges of intellectual COI, requests that all relationships be disclosed and emphasizes disclosure of financial COI.3 When developing clinical guidelines, for example, the ACR requires that at least 51% of the development group be “free of conflicts of interest relevant to the subject matter” for a specific time period. The ACR also notes intellectual COI is “ubiquitous” and “should be disclosed.”
The general ACR Disclosure Statement prompts disclosure of sources of personal income, intellectual property, research grants and investments.
The U.S. Preventive Services Task Force, a group whose primary aim is to provide clinical recommendations, recently updated its practices to require disclosure of any history of “public comments and testimony, leadership role on a panel, substantial career efforts/interests, previously published opinions and advocacy or policy opinions.”4 Perhaps these discrete prompts could serve as an example for future ACR disclosure practices.