Under the Physician Payments Sunshine Act, the more than $34 million paid in 2014 to dermatologists by industry sources was made public through the Centers for Medicare and Medicaid Services Open Payments Database (OPD).1.2 It is now mandatory to disclose payments made by industry to physicians across multiple categories, including payments for consulting, research, food and beverages, travel, and honoraria.
The Sunshine Act was enacted in 2010 as part of the Affordable Care Act and became federal law in the United States in 2012.
The primary goal of the Act was to address issues of commercial conflicts of interest (COI) by increasing the transparency of the relationships between US physicians and teaching hospitals and manufacturers of drugs, biologics, and medical devices, and thereby increase public trust and confidence in medical care.3,4
The law was enacted amid mounting pressure that rewards in the form of gifts, financial or in kind, can exert undue influence on clinical judgment or bias the conduct of clinical research or the medical information provided to patients. For example, payments, gifts, or meals provided by pharmaceutical companies may increase physicians’ likelihood to be less critical of a clinical trial or to prescribe specific drugs manufactured by the gifting pharmaceutical company, and therefore can directly or indirectly have a negative impact on scientific integrity and patient care.5-7
Conflict of interest and the Sunshine Act goes beyond clinical research and the provision of medical services, and includes objectivity in the design and delivery of medical education. Therefore, included in the recommendations of the Sunshine Act is that medical education should be free of industry sponsorship and that experts on panels who develop clinical practice guidelines be prohibited from having commercial COIs.4 As a result, providers of medical education and authors of clinical practice guidelines (CPG) have come under scrutiny.
With regard to the dermatology CPGs, this scrutiny was explored by Checketts and colleagues in a cross-sectional study of 3 American Academy of Dermatology (AAD) guidelines — acne vulgaris, local anesthesia in office-based dermatologic surgery, and atopic dermatitis — published between 2013 and 2016. The study evaluated discrepancies between payments received from pharmaceutical companies, as published in the OPD, and the authors’ disclosure statements.8 One of the goals of the study was to determine whether the payments received by the authors were from pharmaceutical companies with products in the guidelines, and therefore have the potential to influence the authors’ recommendations for specific agents in the guidelines.
Among the 3 guidelines and 49 CPG authors evaluated, Checketts, et al reported that 40 authors received at least one industry payment, with values of $1,000 (63% of physicians), $10,000 (51%), $50,000 (36.7%) and $100,000 (24%). The total industry payments made to the authors between 2013 and 2015 was $7,701,681. The study further reported that of the 40 authors receiving payments, 22 did not accurately disclose industry relationships. The study also reported that payments were received from companies with products directly related to the guideline topic, and recommended that the AAD adopt stricter policies or new standards with respect to COI among guideline authors receiving payments from industry.8
The suggestion of bias in the development of dermatology clinical practice guidelines emerging from the study by Checketts and colleagues has attracted several critical responses, including citing methodological flaws, limitations of the OPD as the data source, and data analysis that is inconsistent with the available evidence.9-11 A letter by Glazer and colleagues specifically points out that in the Atopic Dermatitis Guidelines there are more instances of over-disclosure of COI, in contrast with the under-disclosure suggested by Checketts and colleagues.10 Further, in their response to the study, the AAD clarifies its approach to the development of AAD CPG, noting their strict adherence to the recommendations from the Institute of Medicine and the Council of Medical Specialty Societies for the development of CPGs, including the management of COI.11
Henry W. Lim, MD, FAAD, the AAD’s immediate past president, told Dermatology Advisor, “COI needs to be managed, and there is a process to do so that conforms with IOM and CMSS recommendations.” Dr Lim added, “Using the inaccurate Open Payments Database would result in the exclusion of subject topic experts, which would affect the quality of the guidelines.” The AAD emphasized that the process for developing a dermatology CPG is multifaceted, bringing together a balanced team of clinical experts, a diverse group of physicians from a variety of practice settings, and patient representatives, and emphasized that industry representatives have no involvement in CPG development.
The study by Checketts, et al highlights the unintended consequences of the Sunshine Act and COI reporting.12 Craig A. Elmets, MD, FAAD, who is Chair of the AAD’s Council on Science and Research, told Dermatology Advisor, “The series of articles by Checketts, et al raises the important point of conflict of interest in the development of clinical practice guidelines. By relying on flawed information (ie, OPD), it validates the use of this instrument and discourages efforts to improve the accuracy of the conflict of interest reporting process.”
“Innovative, breakthrough discoveries or new treatments such as biologics or biosimilars for the treatment of dermatological diseases require experts working closely with industry to provide guidance for the optimal use of new devices, products, or medicines to improve patient outcomes. Compensation for their time and expertise is acceptable, in accordance with the Sunshine Act. With regard[s] to AAD CPG development, the unintended consequence of the suggestion of industry-driven bias due to failure to fully disclose COI, as reported by Checketts and colleagues, is a reluctance of experts to engage in the development of future guidelines,” he said. “Their articles have the potential to discourage physicians from participating in guideline development and thus restrict guideline development to those who lack the experience and expertise to make informed, evidence-based decisions about what should and should not be included in guidelines,” adding, “This is particularly true of small specialties such as dermatology, [and] undermines the efforts of the medical community to distill knowledge and establish principles by which health care providers can offer high-quality, evidence-based medicine to patients.”
- Feng H, Wu P, Leger M. Exploring the industry-dermatologist financial relationship: Insight from the Open Payment Data. JAMA Dermatol. 2016;152(12):1307-1313.
- Centers for Medicare & Medicaid Services. Open payments. www.cms.gov/openpayments/. Accessed March 6, 2018.
- Toroser D, Robinson M, Gegner J, et al. Systematic review of reports describing potential impact of the Sunshine Act on peer-reviewed medical publications. Curr Med Res Opin. 2016;32(3):547-553.
- Wilson M. The Sunshine Act: commercial conflicts of interest and the limits of transparency. Open Med. 2014;8(1):e10-3.
- Mitchell AP, Basch EM, Dusetzina SB. Financial relationships with industry among National Comprehensive Cancer Network guideline authors. JAMA Oncol. 2016;2(12):1628-1631.
- DeJong C, Aguilar T, Tseng CW, Lin GA, Boscardin WJ, Dudley RA. Pharmaceutical industry-sponsored meals and physician prescribing patterns for Medicare Beneficiaries. JAMA Intern Med. 2016;176(8):1114-1122.
- Jones RG, Ornstein C. Matching industry payments to Medicare prescribing patterns: an analysis. ProPublica. https://static.propublica.org/projects/d4d/20160317-matching-industry-payments.pdf?22. Published March 17, 2016. Accessed March 6, 2018.
- Checketts JX, Sims MT, Vassar M. Evaluating industry payments among dermatology clinical practice guidelines authors. JAMA Dermatol. 2017;153(12):1229-1235.
- Katz KA. Industry influence in dermatology clinical practice guideline development. JAMA Dermatol. 2017;153(12):1219-1220.
- Glazer AM, Siegel DM, Rigel DS. Evaluating industry payments among dermatology clinical practice guideline authors. JAMA Dermatol. 2018;154(3):373-374.
- Lim HW, Elmets CA, Begolka WS. Addressing potential conflicts of interest in dermatology clinical practice guidelines. JAMA Dermatol. 2018;154(3):259-260.
- Ratain MJ. Forecasting unanticipated consequences of “The Sunshine Act”: mostly cloudy. J Clin Oncol. 2014;32(22):2293-2295.