GP indicates general payments; RP, research payments.
eTable 1. General payments and research payments received by NCCN guideline authors in 2014
eTable 2. Sensitivity analysis with regard to low-value industry-physician general payment
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Mitchell AP, Basch EM, Dusetzina SB. Financial Relationships With Industry Among National Comprehensive Cancer Network Guideline Authors. JAMA Oncol. 2016;2(12):1628–1631. doi:10.1001/jamaoncol.2016.2710
Copyright 2016 American Medical Association. All Rights Reserved.
What is the prevalence of financial conflicts of interest with industry among National Comprehensive Cancer Network guideline authors?
In this cross-sectional analysis of Open Payments data, 86% had financial conflicts of interest, including 84% who accepted general payments and 47% who accepted research payments.
The potential for undue influence of industry in oncology clinical practice guidelines should be addressed.
Financial conflicts of interest (FCOIs) among authors of clinical practice guidelines have the potential to influence treatment recommendations.
To quantify FCOIs with industry among authors of the National Comprehensive Cancer Network (NCCN) guidelines.
Design, Setting, and Participants
We assessed FCOIs occurring during 2014 among NCCN guideline authors in the United States. All were physician members of the NCCN guideline committees for lung, breast, prostate, and colorectal cancer as of the end of 2014. The data source for FCOIs was Open Payments, which is publically reported by the Centers for Medicare and Medicaid Services. This study was cross-sectional.
Main Outcomes and Measures
The proportion of NCCN authors having FCOIs with industry; the average amount received from industry sources per author.
Of 125 guideline authors, 108 (86%) had at least 1 reported FCOI. Authors received an average of $10 011 (range, $0-$106 859) in general payments (GPs), which include consulting, meals, lodging, and similar transfers of value, and $236 066 (range $0-$2 756 713) in industry research payments (RPs), including funding associated with clinical trials. Approximately 84% of authors received GPs, while 47% received RPs. Eight (6%) had FCOIs in excess of the $50 000 net and/or $20 000 single-company maximums stipulated by NCCN.
Conclusions and Relevance
Among NCCN guideline authors, FCOIs involving RPs were of greater value, while those involving GPs were more prevalent. Although FCOIs may result from engaging in important scholarship, FCOIs may still influence guideline authors in counterproductive ways. Research is needed to understand how best to manage author FCOIs during guideline creation.
Clinical practice guidelines (CPGs) are highly influential within medicine, defining the standard of care for many ailments. Ideally, they should be based on a comprehensive evaluation of available data and unbiased expert opinion.1 However, financial conflicts of interest (FCOIs) between guideline authors and industry create the potential for undue influence of for-profit companies in medical practice.2
Published evidence on the effects of FCOIs on guideline recommendations is limited,3 but suggests that authors with industry FCOIs are more likely to recommend specific drugs4 and assess clinical trial results more favorably.5 In addition, FCOIs influence physician prescribing practices, as physicians with FCOIs are more likely to prescribe brand-name drugs.6 The Open Payments Provision (“Sunshine Act”) of the Affordable Care Act recently made public all FCOIs between industry and US physicians, facilitating systematic study of FCOIs and ending reliance on self-reporting.
Within oncology, the National Comprehensive Cancer Center (NCCN) guidelines influence clinician practice and define which drugs are reimbursable through Medicare.7 The goal of this study is to quantify the presence and extent of FCOIs among authors of recent NCCN guidelines for the treatment of breast, colon, prostate, and lung cancer.
Since August, 2013 the Sunshine Act has required that all US drug and device manufacturers disclose transfers of financial value greater than $10 to physicians and teaching hospitals. Payments are reported either as “general payments,” including gifts, consultancy and/or speaker fees, meals, and investment interests,8 or as “research payments,” including “any direct compensation, funding for coordination or implementation, or study participant expense”9 related to preclinical research, US Food and Drug Administration phase 1 to 4 trials, and investigator-initiated studies.10
We identified the authors who were active on the NCCN guideline panels for lung, colon, breast, and prostate cancer as of the end of 2014. These were selected as the malignant neoplasms with the highest incidence in the United States. Using the public Open Payments database (https://www.cms.gov/openpayments/), FCOIs for each author were manually abstracted. We included all payments occurring in 2014, excluded disputed payments, and calculated payment averages and ranges for general payments and research payments both together and separately. Authors active on multiple guidelines were counted only once. In sensitivity analysis we excluded FCOIs that fell below different dollar value thresholds (eg, <$100), as physicians receiving such payments may be unaware of and/or less influenced by such payments. The study was reviewed by the University of North Carolina Office of Human Research Ethics and was found not to constitute human subjects research.
We identified 125 authors across the 4 guidelines, of whom 108 (86%) had at least 1 reported FCOI, with no significant differences in frequency or monetary value of FCOIs among the 4 cancer types (eTable 1 in the Supplement). The total value of FCOIs reported in 2014 among these authors was $30 287 549, representing $29 036 127 in RPs and $1 251 422 in general payments (Table).
Authors received a mean of $10 011 in general payments (range, $0-$106 859) (Table). Most authors (70 [56%]) received $1000 or more in general payments (Figure 1). These results were not sensitive to the inclusion of low-value FCOIs (eTable 2 in the Supplement).
Research payments were of much higher monetary value than general payments, but were less common among NCCN guideline authors. Authors received a mean of $236 066 in research payments (range, $0-$2 756 713) (Table). Of the 125 authors, 84% received 1 or more general payments from industry while only 47% received any research payments. While a substantial portion of authors received general payments alone without also receiving research payments, the reverse was not true; only 3 authors (2%) received research payments without also receiving at least some general payments (Figure 2).
There were 8 authors (6%) whose FCOIs exceeded the $50 000 net and/or $20 000 single-company maximum stipulated by the NCCN guideline policy.
Through recent federal initiatives to increase transparency of FCOIs between physicians and the pharmaceutical industry, there has been growing awareness of and debate over the role and influence of FCOIs in medicine. Some have resisted blanket condemnation of all apparent conflicts, many of which represent important scholarly activity.11Others remain concerned, given prior work suggesting that industry FCOIs can influence physician prescribing behavior,6 recommendations,4 and interpretation of clinical data.5
Our study demonstrates the high prevalence and significant monetary value of FCOIs among oncology guideline authors. Several findings are noteworthy. First, most of the dollar value of industry FCOIs was contained in research payments. While these payments support research and are often paid to the physician’s institution, physicians accrue other, indirect benefits by procuring outside research funding. Therefore, research payments as well as general payments have the potential to create conflicts of interest. More investigation is needed on the relative influence of general payments and research funding on physician practice and guideline recommendations.
Second, we must consider the reasons that FCOIs emerge and their potential benefits. With the bulk of research funding coming from industry, accepting research funding is all but mandatory for an academic clinical trialist. In addition, there may be societal value in having physicians who bridge the space between academia and industry, advising on areas of medical need, and then furthering such ideas into clinical research through involvement in research studies.
However, our data suggest that not all academic oncologists accrue FCOIs with industry as a result of research endeavors. A significant portion (39% of authors studied) accepted general payments in the absence of any research payments to indicate active research participation.
Guideline-writing bodies are aware of FCOIs, and some have taken action to moderate the influence of potentially conflicted authors. For example, the American Society of Clinical Oncology restricts authors with FCOIs to less than 50% of each guideline committee.12 Indeed, the NCCN guidelines panels recuse members with “meaningful conflicts of interest” from discussion on specific topics and require members not to exceed annually $20 000 in FCOIs with an individual corporation or $50 000 in total FCOIs. Our findings suggest that most, but not all, NCCN authors comply with these requirements.
Our study was limited in that Open Payments collects data only on physicians, and so FCOIs of nonphysician NCCN guideline authors were not available; having such data would increase the average and total payments to authors we reported. While Open Payments data undergo a thorough validation process, including an opportunity for physicians to dispute reported payments before public release,13 there remain ways in which they may be imprecise or inaccurate. The dispute process is difficult to navigate, potentially preventing physicians from correcting reporting errors.14 Because Open Payments is limited to US physicians, these findings would not be generalizable outside of the United States. In addition, physicians may have payments reported for participating in the National Institutes of Health or cooperative group trials using donated drugs,8 receiving grants from charitable organizations such as the Conquer Cancer Foundation, or coauthoring manuscripts,15 without having had direct interaction with any corporation.
How best to manage the FCOIs in oncology practice and clinical practice guidelines remains an area of open discussion and research. Practically, the high prevalence of FCOIs among physician field experts makes identifying individuals without FCOIs difficult, with the potential unwanted outcome of excluding valuable expertise. More research is needed to determine which kinds of relationships are more likely to produce the unwanted consequence of physician bias to create rational, evidence-based policies that allow for the participation of key clinical experts while managing real or perceived conflicts. Given the prevalence of FCOIs reported here, finding the answer to this question is critical.
Corresponding Author: Aaron P. Mitchell, MD, Department of Hematology/Oncology, University of North Carolina Hospital, 170 Manning Dr, Third Floor, Physicians Office Building, Chapel Hill, NC 27514 (firstname.lastname@example.org).
Accepted for Publication: June 2, 2016.
Published Online: August 25, 2016. doi:10.1001/jamaoncol.2016.2710
Author Contributions: Dr Mitchell had full access to all of the data in the study, and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: All authors.
Acquisition, analysis, or interpretation of data: Mitchell, Dusetzina.
Drafting of the manuscript: Mitchell.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Dusetzina.
Study supervision: Basch, Dusetzina.
Conflict of Interest Disclosures: None reported.
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