title: The 2013 cholesterol guideline controversy: Would better evidence prevent pharmaceuticalization?
abstract: Cardiovascular disease (CVD) remains the leading cause of death globally. A class of medications, known as statins, lowers low-density lipoprotein cholesterol levels, which are associated with CVD. The newest 2013 U.S. cholesterol guideline contains an assessment of risk that greatly expands the number of individuals without CVD for whom statins are recommended. Other countries are also moving in this direction. This article examines the controversy surrounding these guidelines using the 2013 cholesterol guidelines as a case study of broader trends in clinical guidelines to use a narrow evidence base, expand the boundaries of disease and overemphasize pharmaceutical treatment. We find that the recommendation in the 2013 cholesterol guidelines to initiate statins in individuals with a lower risk of CVD is controversial and there is much disagreement on whether there is evidence for the guideline change. We note that, in general, clinical guidelines may use evidence that has a number of biases, are subject to conflicts of interest at multiple levels, and often do not include unpublished research. Further, guidelines may contribute to the "medicalization" or "pharmaceuticalization" of healthcare. Specific policy recommendations to improve clinical guidelines are indicated: these include improving the evidence base, establishing a public registry of all results, including unpublished ones, and freeing the research process from pharmaceutical sector control.
authors.affiliation: Health Services Administration, Department of Health Management & Informatics, University of Central Florida, Orlando, FL 32816-2200, United States. Electronic address: lynn.unruh@ucf.edu.
authors.forename: Lynn
authors.initials: L
authors.lastname: Unruh
authors.affiliation: Health Policy and Management, UCLA Fielding School of Public Health, Los Angeles, CA 90095-1772, United States. Electronic address: trice@ucla.edu.
authors.forename: Thomas
authors.initials: T
authors.lastname: Rice
authors.affiliation: School of Public Health, University of Texas Health Science Center Houston, TX 77030, United States. Electronic address: Pauline.Rosenau@uth.tmc.edu.
authors.forename: Pauline Vaillancourt
authors.initials: PV
authors.lastname: Rosenau
authors.affiliation: Healthcare Policy and Research, Virginia Commonwealth University, United States. Electronic address: Abarnes3@vcu.edu.
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Barnes
mesh_terms: D002318:Cardiovascular Diseases / Q000188:drug therapy / Q000517:prevention & control*; D002784:Cholesterol / Q000097:blood; D016265:Conflict of Interest; D004345:Drug Industry; D019317:Evidence-Based Medicine; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use; D017410:Practice Guidelines as Topic; D012307:Risk Factors
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D002784:Cholesterol
keywords: Cardiovascular disease; Cholesterol guidelines; Clinical guidelines; Conflict of interest; Lifestyle changes; Pharmaceuticalization