Evidence Underlying Recommendations and Payments from Industry to Authors of the National Comprehensive Cancer Network Guidelines

Abstract

Background. The National Comprehensive Cancer Network (NCCN) guidelines are among the most widely used guidance in oncology. It is critical to understand the extent to which the recommendations in these guidelines are supported by evidence and to investigate whether these recommendations have been influenced by payments from industry to authors. Materials and Methods. We examined the quality and consistency of evidence, as scored by guidelines authors, for systemic treatment incorporated in the NCCN guidelines. Payments data in 2015 were manually abstracted using the Open Payments database, which discloses all payments between the industry and American physicians. Correlations between the percentage of authors who received payments and the proportion of recommendations developed from low-level evidence per guideline were calculated using Spearman rank correlation. Results. In total, 1,782 recommendations were identified in 29 guidelines, of which 1,282 (71.9%) were based on low-quality or low-consistency evidence (low-level evidence), including "case reports or clinical experience only" (18.9%). A substantial proportion (31/143, 21.7%) of category 1 (the highest level) recommendations were based on lowlevel evidence. The majority of authors (87.1%) received payments from industry. However, no association was found between the prevalence of payments among authors and the percentage of recommendations developed from low-level evidence per guideline. Conclusion. The majority of systemic treatment recommendations in the NCCN guidelines are based on low-level evidence, including more than one in five category 1 recommendations. Payments from industry were prevalent among authors. However, industrial payments among authors were not associated with inclusion of regimen/ agent for which there is no conclusive evidence in the guidelines. The Oncologist 2019;24:498-504 Implications for Practice: The authors found that the majority (71.9%) of systemic treatment recommendations issued in the current National Comprehensive Cancer Network guidelines were based on low-level evidence. Physicians should remain cautious when using current guidelines as the sole source guiding patient care decisions.

Financial Conflicts of Interest in Clinical Practice Guidelines: A Systematic Review

“…[10][11][12][13][14][15][16]24,29,31,32,34,[37][38][39][40]43 Eleven studies evaluated conflict of interest using the CMS-OP or other national databases. 8,9,17,18,[25][26][27]30,33,44,45 Seven studies evaluated conflicts of interest through external searches. [20][21][22][23]28,35,42 Four of these studies searched through guideline authors' academic publications in which financial ties with industry were disclosed, US Patent and Trademark Office records that signaled patents pending or awarded for intellectual property in a drug or device whose sales could be affected by guideline recommendations, and disclosures made at peer-reviewed conferences.…”

“…Four studies reported median payments per guideline author of $578 (interquartile range, $0-$19,228), 25 $1000 ($0-$39,938), 33 $522 ($0-$40,444), 8 and $3233 ($506-$10,873). 44 Five studies reported mean payments of $67,547 (SD ¼ $125,751), 23 $93,537 ($415,203), 26 $157,777 ($332,829), 27 $219,557 (no SD data provided), 17 and $242,300 (no SD data provided). 30…”

“…37 Another study reported that among National Comprehensive Cancer Network guidelines, there was no association between the prevalence of general or research payments among authors and the percentage of recommendations derived from low-level evidence per guideline. 17…”

Evidence-Based Medicine in Oncology: Commercial Versus Patient Benefit

“…7. Oncology guidelines 72%of recommendations based on weak evidence Dominated by a few key opinion leaders with conflict of interest Often used as reference for reimbursement [43] 1 Fragility index = a statistical measure to evaluate the reliability of study results. A factor of 1 means that study results are fragile and not reliable; 2 = Evaluation of new cancer drugs approved by the FDA (2014-2018); 3 OS = Overall Survival; 4 = Evaluation of new cancer drugs approved by the EMA (2009-2013); 5 NNT = Number to treat.…”

“…The results from a review of the oncology guidelines published by the National Comprehensive Cancer Network are shown at the bottom of Table 3. The content of conventional guidelines is dominated by a few "key opinion leaders" who are likely to have conflicts of interest [43].…”