Hepatitis C Guidelines May Have Too Many Conflicts of Interest

Conflicts of interest (COI) among committee members who set hepatitis C treatment guidelines could be influencing the selection of these suggested rules, according to a new study in the Journal of the American Medical Association (JAMA).

Clinical hepatitis C guidelines describe protocols on testing, management, treatment, and additional aspects of the disease. They are meant to be evidence-based and free from bias.

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 hepatitis C virus guideline. The physicians analyzed whether the guidelines met IOM COI standards based on the Clinical Practice Guidelines We Can Trust published in 2011.

IOM standards call for:

• No commercial COI among guideline committee chairs and co-chairs
• Less than 50% of committee members have commercial COI

Jefferson and Pearson looked at 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 hepatitis C 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 hepatitis C guidelines. Of those:

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

Out of the six guideline co-chairs:

• Four co-chairs (67%) 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 hepatitis C 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.

The IOM is one division of the National Academies of Sciences, Engineering, and Medicine, which is made up of private, nonprofit institutions.

The study, “Conflict of Interest in Seminal Hepatitis C Virus and Cholesterol Management Guidelines,” was published in the JAMA Internal Medicine.

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