Too Many Conflicts of Interest Found in HCV Management Guidelines

A group of researchers recently published a study in Journal of the American Medical Association (JAMA), examining conflicts of interest (COIs) among committee members who set hepatitis C (HCV) and cholesterol management guidelines. They found that there, in fact, were COIs among committee members setting HCV management guidelines.

Akilah Jefferson, MD, MSc, and Steven Pearson, MD, MSc, set out to see if the Institute of Medicine’s (IOM) standards for managing conflicts were met in the final September 2015 print version of the HCV guideline. Clinical HCV guidelines describe protocols on testing, management, treatment, and additional aspects of the disease. They are meant to be evidence-based and free from bias. The IOM is one division of the National Academies of Sciences, Engineering, and Medicine, which is made up of private, nonprofit institutions. In their article, the physicians analyzed whether the guidelines met IOM COI standards based on the Clinical Practice Guidelines We Can Trust published in 2011.

In order for an individual to qualify to be a guideline committee member or a chair or co-chair, she or he must meet the following IOM standards: 1) the guideline committee chair or co-chair must not have any commercial COIs; 2) among committee members, less than 50% of the individuals are permitted to have any commercial COIs.

Jefferson and Pearson examined disclosure statements to determine if guidelines were adhering to those standards. They used evidence from the 2014 American Association for the Study of Liver Diseases and Infectious Diseases Society of America HCV management guidelines.

“Little is known regarding whether IOM standards for managing COI have been met in development of recent important clinical guidelines,” the team wrote in JAMA.

There was a total of 29 committee members involved in deciding the HCV guidelines. Of those:

• 72% of members (21) had commercial COI
• 62% of members (18) disclosed industry-sponsored research
• 34% of members (10) served on advisory boards
• 17% of members (5) served on data safety monitoring boards
• 10% of members (3) were consultants
• 10% of members (3) reported other honoraria

Out of the six guideline co-chairs:

• 67% of co-chairs (4) had commercial COI and had additional COI in other publications which were not revealed in the disclosures

The researchers also discovered that another co-chair had a commercial COI.

The HCV guideline met all nine of the IOM guideline for development and evidence standards. However, it did not fully meet standards for commercial COI management. It was common for committee member disclosures to be inconsistent in guidelines disclosures and contemporaneous articles.

“Adoption of consistent COI frameworks across specialty societies may help ensure that clinical guidelines are developed in a transparent and trustworthy manner,” the physicians concluded.