ACC/AHA Guideline Authors Self-Disclosed Relationships Compared to the Open Payments Database: Do Discrepancies Represent Undisclosed Conflicts of Interest?

Background: In order to identify true conflicts of interest, accurate physician disclosures in clinical guidelines and research are necessary to characterize relationships with industry (RWI). The Patient Protection and Affordable Care Act’s “Sunshine Act” requires the Center for Medicare and Medicaid Services to display payment information made by pharmaceutical manufacturers and group purchasing organizations to physicians and teaching hospitals. We tested the hypothesis that there would be discrepancies between industry-reported payments and author disclosures. Methods: Authors of the fifteen ACC and AHA guidelines published in 2013 and 2014 were matched to payments made during the same time period in the government database, Open Payments. Duplicate authors across guidelines were assessed independently. In the guidelines, a significant payment is ≥$10,000 within 12 months; a modest payment is \u3c$10,000. Percent agreement was calculated; a chi square test was used to detect statistical significance. Results: Of the 203 guideline authors, 159 authors had relationships with industry. 65.4% of these relationships were disclosed representing a total of 575 disclosures. Of those disclosed relationships: 45.2% were for consulting, 39.7% were for related to research, and 5.2% were for speaking services. Industry reported 1,016 payments to these authors: 60.3% in the Other category (travel, meals, gifts, royalties), 20.5% for consulting, and 13.0% for research. These authors received a total of $16,540,202 in payments with research having the highest mean payment (Research$97,019 ± 297,923) and other having the lowest mean payment (Other $1,777 ± 9,720). Overall, mean payments were$78,888 ± 66,416 in cases of agreement and $10,775 ± 17,193 in cases of author error (P\u3c0.0001). In a multivariate regression, agreement was more likely if the payment was significant or in consulting and research categories. Disagreement was higher than agreement in every category (P\u3c0.0001). Conclusions: Our analysis shows extensive industry relationships among ACC and AHA guideline authors. There is significant disagreement in every category between author disclosures and company payments, regardless of category. The two parties are more likely to agree if the payment is significant or made for research or consulting. Although RWIs are rampant, it is impossible to discern true conflicts of interest, given the difficulty in discerning the exact nature of a relationship in the current reporting system. As such, caution is advised in interpreting RWIs as COIs

Patterns and gaps in guideline-directed statin use for atherosclerotic cardiovascular disease by race and ethnicity

Objective: There remain disparities by race and ethnicity in atherosclerotic cardiovascular disease (ASCVD). Statins reduce low-density lipoprotein cholesterol (LDL-c) and improve ASCVD outcomes. ASCVD treatment patterns across disaggregated race and ethnicity groups are incompletely understood. We aimed to evaluate statin use and LDL-c control for ASCVD by race and ethnicity. Methods: From an electronic health record (EHR)-based cohort from a multisite Northern California health system, we included adults with an ASCVD diagnosis from 2010 to 2021 and at least 2 primary care visits, stratified by race and ethnicity (Non-Hispanic White [NHW], Non-Hispanic Black [Black], Hispanic, and Asian). Hispanic (Mexican, Puerto Rican, Other) and Asian (Asian Indian, Chinese, Filipino, Japanese, Korean, Vietnamese, Other) groups were disaggregated. Primary outcomes were 1-year post-ASCVD statin use (prescription) and LDL-c control (at least one value <70 mg/dL). Adjusted odds ratios (ORs) were estimated using logistic regression. Results: Of 133,158 patients, there were 89,944 NHW, 6,294 Black, 12,478 (9.4 %) Hispanic and 13,179 (9.9 %) Asian patients. At 1 year after incident ASCVD, there was suboptimal statin use (any statins <60 %, high-intensity <25 %) and LDL-c control (<30 %) across groups, with lowest proportions in Black patients for statin use (46.7 %, any statin) and LDL-c control (10.7 %, OR 0.89 (0.81–0.97), referent NHW). Disaggregation of Asian and Hispanic groups unmasked within-group heterogeneity. Conclusions: In patients with incident ASCVD, we describe suboptimal and heterogenous 1-year post-ASCVD guideline-directed statin use and 1-year post-ASCVD LDL-c control across disaggregated race and ethnicity groups. Findings may improve understanding of ASCVD treatment disparities and guide implementation