Parsing the guidelines on guidelines: Balancing sensibility and conflict of interest

The formulation and publishing of clinical guidelines (and guidances) by institutions and societies generally have been motivated by a desire to help enable practicing physicians to make sense of and assimilate the rapidly burgeoning, and sometimes contradictory, developments in clinical medicine. Because they sometimes rely on imperfect medical evidence and expert opinion, guidelines should not be considered foolproof nor should they substitute for sound medical judgment in an individual case. However, their exponential proliferation not only attests to their utility, but also to their potential to influence the clinical management of large populations of patients. For this reason, legitimate concerns have been raised regarding the risk that guideline development processes could be co-opted by individuals, industries, and/or societies to promote direct financial (or intellectual) gain. In this regard, it is notable that French Health Authority guidelines on type 2 diabetes mellitus and Alzheimer’s disease were withdrawn by court order because of concerns about potential bias among the authors. To mitigate this hazard, a number of organizations, including the Institute of Medicine (IOM), the Guidelines International Network, and the Appraisal of Guidelines, Research and Evaluation (AGREE) Collaboration have issued (what else but) guidelines for the proper appraisal of medical literature, and for the appropriate management of conflicts of interest (COI) of members of the committees charged with implementing and summarizing recommendations. While these publications have focused attention and provided important guidance on this serious issue, it also has spawned a sizeable literature decrying the failure of writing groups and societies to fully comply with procedural and COI recommendations. Unfortunately, the American Association for the Study of Liver Diseases (AASLD) recently found itself ensnared by one of these investigative studies. In a recent article in JAMA Internal Medicine, Jefferson and Pearson performed a retrospective document review of the American College of Cardiology and the American Heart Association cholesterol management guideline, as well as the September 2015 print version of the hepatitis C virus (HCV) management guidance conjointly put forth by the AASLD and the Infectious Diseases Society of America (IDSA). After assessing the COI disclosures for the AASLD/IDSA HCV guidance panel, these authors noted that 67% of the six co-chairs and 72% of the other 23 panel members had reported potential commercial COI, which failed to comply with the recommended IOM standards of 0% and 50%, respectively. The authors added an additional admonition that COI disclosures by committee chairs did not match those identified in Abbreviations: AASLD, American Association for the Study of Liver Diseases; COI, conflicts of interest; HCV, hepatitis C virus; IDSA, Infectious Diseases Society of America; IOM, Institute of Medicine; VA, Veterans Affairs.