Ethics Forum: Beware Your Intellectual Conflicts of Interest

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?

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.

Solution

Dr. Mulvihill

Physicians are trained to avoid the appearance of bias by politely refusing gifts from pharma­ceutical representatives and by posting a generic slide in all of our talks that quickly states our disclosures or lack thereof. What is not emphasized, however, is the importance of reflecting on our own internal preferences and biases to understand how they may affect the way we teach trainees, counsel patients, enroll study participants or offer our expert opinions in various professional settings. How can we address this issue as individuals and as a medical community?

In general, physicians and researchers of all experience levels should be encouraged to develop clinical interests and participate in projects that move their field forward. 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 and less robust. Instead, all potential conflicts should be acknowledged at the start of a talk or project and should be mentioned intermittently to ensure they are not forgotten.

In our opening example, the physician could state she has no financial disclosures but that her years of experience have shaped some of the studies and recommendations she will highlight in her talk. Referring to these experiences throughout the lecture would reassure the audience the speaker has considered her internal biases, allowing them to evaluate the content more appropriately.

To fully disclose internal biases, physicians must first be aware of them. This requires internal reflection that does not always come easy. One proposed method is for hospitals or professional organizations to encourage reflexivity, a process in which a physician considers their own professional and personal identities and how their work may be affected by those identities.⁵ Engag­ing in this process may occur individually basis or in a professional workshop.

Conclusion

All physicians should be encouraged to pursue areas of clinical interest and to participate in the advancement of their field. At the same time, they should recognize that with development of clinical interests is likely to come at least a small amount of internal bias. For that reason, clinicians and researchers should be trained to actively reflect on internal biases and openly address those biases while performing their work. Establishing this expectation early in medical training could go a long way toward moving our field forward in a way that is efficient, robust and transparent.

Evan Mulvihill, MD, MPH, is a pediatric rheumatologist at Nemours/Alfred I. duPont Hospital for Children in Wilmington, Del. He recently completed his clinical fellowship at Nationwide Children’s Hospital, Columbus, Ohio. During that time, he also earned a Master of Public Health degree from Ohio State University. His clinical and research interests include medical education, cardiovascular disease in patients with lupus and mental health in patients with chronic diseases.

References

1. Miyazaki K. Overdiagnosis or not? 2017 ACC/AHA high blood pressure clinical practice guideline: Consequences of intellectual conflict of interest. J Gen Fam Med. 2018 May 31;19(4):123–126.
2. Neumann I, Karl R, Rajpal A, et al. Experiences with a novel policy for managing conflicts of interest of guideline developers: A descriptive qualitative study. Chest. 2013;144(2):398–404.
3. American College of Rheumatology Policy and Procedure Manual for Clinical Practice Guidelines. 2015 Jan.
4. Ngo-Metzger Q, Moyer V, Grossman D, et al. Conflicts of interest in clinical guidelines: Update of U.S. Preventive Services Task Force policies and procedures. Am J Prev Med. 2018 Jan;54(1S1):S70–S80.
5. Bero LA, Grundy Q. Why having a (nonfinancial) interest is not a conflict of interest PLoS Biol. 2016 Dec; 14(12): e2001221.

Editor’s note: Do you have an ethical dilemma you’d like to see discussed in this forum? Contact us via email at [email protected].