Prevalence and Disclosure of Potential Conflicts of Interest in Dermatology Patient Advocacy Organizations | Dermatology | JAMA Dermatology | JAMA Network
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Figure.  Selection of Patient Advocacy Organizations in Dermatology
Selection of Patient Advocacy Organizations in Dermatology
Table 1.  List of Patient Advocacy Organizations in Dermatology
List of Patient Advocacy Organizations in Dermatology
Table 2.  Characteristics of PAOs in Dermatology
Characteristics of PAOs in Dermatology
Table 3.  Disclosure of Information by PAOs in Dermatology
Disclosure of Information by PAOs in Dermatology
1.
Koay  PP, Sharp  RR.  The role of patient advocacy organizations in shaping genomic science.  Annu Rev Genomics Hum Genet. 2013;14(1):579-595. doi:10.1146/annurev-genom-091212-153525PubMedGoogle ScholarCrossref
2.
Rose  SL, Highland  J, Karafa  MT, Joffe  S.  Patient advocacy organizations, industry funding, and conflicts of interest.  JAMA Intern Med. 2017;177(3):344-350. doi:10.1001/jamainternmed.2016.8443PubMedGoogle ScholarCrossref
3.
Biotechs leverage patient groups in drug development. The Boston Globe. https://www.bostonglobe.com/business/2016/09/28/biotechs-leverage-patient-groups-drug-development/zn7EGHg2jJXjZOl8dBu3GM/story.html. Accessed May 26, 2018.
4.
Public Citizen.  Patients’ Groups and Big Pharma Three in Four Patients’ Groups That Sided With the Pharmaceutical Industry Against Medicare Drug Price Reforms Received Industry Money. Washington, DC: Public Citizen; 2016.
5.
McCoy  MS, Carniol  M, Chockley  K, Urwin  JW, Emanuel  EJ, Schmidt  H.  Conflicts of interest for patient-advocacy organizations.  N Engl J Med. 2017;376(9):880-885. doi:10.1056/NEJMsr1610625PubMedGoogle ScholarCrossref
6.
Pre$cription For Power: KHN Patient Advocacy Database. https://khn.org/patient-advocacy/#all-organizations. Accessed May 20, 2018.
7.
National Center for Charitable Statistics. National taxonomy of exempt entities. http://nccs.urban.org/classification/national-taxonomy-exempt-entities. Accessed May 20, 2018.
8.
GuideStar nonprofit reports and Forms 990 for donors, grantmakers, and businesses. https://www.guidestar.org/Home.aspx. Accessed May 20, 2018.
9.
Pre$cription For Power: KHN Patient Advocacy Database: Kaiser Health News. Full methodology. https://khn.org/patient-advocacy/#methodology. Accessed May 20, 2018.
10.
Lim  HW, Collins  SAB, Resneck  JS  Jr,  et al.  The burden of skin disease in the United States.  J Am Acad Dermatol. 2017;76(5):958-972.e2. doi:10.1016/j.jaad.2016.12.043PubMedGoogle ScholarCrossref
11.
Inflation Calculator CPI. https://data.bls.gov/cgi-bin/cpicalc.pl. Accessed August 15, 2017.
12.
LinkedIn. https://www.linkedin.com. Accessed May 28, 2018.
13.
Rose  SL.  Patient advocacy organizations: institutional conflicts of interest, trust, and trustworthiness.  J Law Med Ethics. 2013;41(3):680-687. doi:10.1111/jlme.12078PubMedGoogle ScholarCrossref
14.
Wilson  M.  The Sunshine Act: commercial conflicts of interest and the limits of transparency.  Open Med. 2014;8(1):e10-e13.PubMedGoogle Scholar
15.
CMS’ Open Payments Rules and Database; Conflicts of Interest in Academic Medicine; Medical Research; Initiatives; AAMC. https://www.aamc.org/initiatives/research/coi/386774/sunshineact.html. Accessed May 23, 2018.
16.
Kreis  J, Schmidt  H.  Public engagement in health technology assessment and coverage decisions: a study of experiences in France, Germany, and the United Kingdom.  J Health Polit Policy Law. 2013;38(1):89-122. doi:10.1215/03616878-1898812PubMedGoogle ScholarCrossref
Original Investigation
January 30, 2019

Prevalence and Disclosure of Potential Conflicts of Interest in Dermatology Patient Advocacy Organizations

Author Affiliations
  • 1Department of Dermatology, Brigham & Women's Hospital, Harvard Medical School, Boston, Massachusetts
  • 2Tufts University School of Medicine, Boston, Massachusetts
JAMA Dermatol. 2019;155(4):460-464. doi:10.1001/jamadermatol.2018.5102
Key Points

Question  What is the current state of industry-related conflicts of interest and disclosure practices among patient advocacy organizations with dermatology?

Findings  In this study of 24 dermatology patient advocacy organizations with annual revenues that exceeded $500 000, though 71% of organizations in dermatology acknowledged receiving donations from industry sources, none reported the exact amount. A total of 13% of organizations reported a current or former industry executive on their governing board in annual reports or on public websites, whereas online searches identified a minimum of 54% with industry ties.

Meaning  The findings suggest that among patient advocacy organizations in dermatology, there are inconsistent disclosure practices regarding industry-derived financial support and board membership that may represent or give impressions of conflicts of interest.

Abstract

Importance  Patient advocacy organizations are nonprofit organizations that represent patients with medical conditions. Although these organizations may increase disease awareness and influence health care policy, reports have suggested financial relationships between organizations and drug, device, and biotechnology companies, which may lead to potential conflicts of interest. The extent of these conflicts has not been explored among patient advocacy organizations in dermatology.

Objective  To examine potential financial conflicts of interest and characterize disclosure practices among dermatology patient advocacy organizations.

Design, Setting, and Participants  This cross-sectional study of the largest dermatology patient advocacy organizations using the Kaiser Health News database acquired data on total revenue from each organization’s Form 990 for the year 2015. Tax forms and annual reports from 2017 were used for 2 organizations that were missing donor information for 2015. Annual reports, websites, and LinkedIn profiles were manually examined to ascertain donations and determine disclosure practices pertaining to financial support and board membership.

Main Outcomes and Measures  The amount and minimum proportion of donations attributable to industry sponsorship among organizations as well as the proportion of organizations disclosing (1) industry-sponsored financial support, (2) the amount of industry-derived donations, and (3) current and past relationships between governing board members and industry sponsors.

Results  This study identified 24 dermatology patient advocacy organizations with annual revenues that exceeded $500 000. Of these, 5 (21%) had total donations that exceeded $5 million and 4 (17%) reported industry donations that exceeded $500 000. Two organizations (8%) reported having at least 40% of total donations from industry sponsorship. Overall, 17 organizations (71%) reported receiving donations from industry on the annual report or the website and 12 (50%) reported the amount of donations in ranges. None of the organizations reported the exact amount or use of donations. On the basis of annual reports and websites, 3 organizations (13%) reported having a current or former industry executive on the organization’s governing board. When this search was replicated using LinkedIn, this figure was at least 54%.

Conclusions and Relevance  These findings suggest inconsistent disclosure of industry-derived financial support and board membership that may represent conflicts of interest. Policies that support the transparency and consistency of disclosure practices between industry and patient advocacy organizations appear to be needed to fully characterize the extent of conflicts of interest among patient advocacy organizations in dermatology and maintain trust in these important institutions.

Introduction

Patient advocacy organizations (PAOs) are nonprofit entities that represent patients.1 Beyond increasing disease awareness, these organizations may fund research and influence health care policy.2 Despite these benefits, reports have unveiled financial relationships between PAOs and drug, device, and biotechnology companies that may compromise the integrity of PAOs.3,4 One study5 suggested that at least 83% of the largest PAOs receive financial support from industry, with 39% reporting a current or former industry executive on its board.

In dermatology, PAOs help patients cope with skin conditions while providing a platform for physicians to share insights for disease management. To date, the relationship between dermatology PAOs and external interests has not been evaluated. In this study, we used a nonprofit database, tax forms, annual reports, and websites to examine financial conflicts of interest (COIs) and disclosure practices among PAOs in dermatology.

Methods
Sample

We identified dermatology-related PAOs using the Kaiser Health News (KHN) database, which compiled nonprofit organizations (using the National Taxonomy of Exempt Entities) and included only PAOs based on mission and activities.6-8 The KHN compiled nonprofits using the National Taxonomy of Exempt Entities and GuideStar, which classify organizations based on activities and missions.7-9 The KHN then examined mission statements and programs to include only PAOs. We manually reviewed all PAOs listed in the KHN database and excluded organizations not encompassed by the 24 major skin disease classifications.10 We also excluded subchapters and organizations without valid websites or Form 990 filings. We classified the remaining PAOs into 6 categories: autoimmune, cancer, congenital, inflammatory, infectious, and general for analysis. This study was deemed to be exempt from review board approval by the Partners Healthcare Institutional Review Board.

Data Collection and Analysis

We systematically reviewed the tax forms, annual reports, and websites of each PAO, mirroring the methods of McCoy et al.5 Total revenue was acquired from each PAO’s Form 990 (2015), an Internal Revenue Service form that publicly discloses financial information of nonprofit organizations. Total donations and contributions were acquired from the annual reports and financial statements corresponding to the time frame of reported revenue.

Using annual reports and websites, we determined whether the organization reported a donor list and acknowledged receiving donations from a drug, device, or biotechnology company. To isolate industry donations, we excluded donations from foundations, skin care companies not subsidiaries of a pharmaceutical company, trade organizations, and retail pharmacies. We used tax forms and annual reports from 2017 for 2 organizations (Lupus Foundation of America, Scleroderma Research Foundation) that were missing donor information for 2015.

We recorded the amounts (range or exact figure) and uses of the donations (eTable in the Supplement). When ranges were reported (eg, $10 000-$49 999), we used the minimum value of the range for our calculations. We could not calculate maximum donations because the upper bound of the highest tier of donations was usually reported without a range (eg,>$500 000). We then calculated the minimum proportion of total donations attributable to industry sponsorship. Currency values were adjusted for inflation and reported in 2018 US dollars.11

We also examined whether the organizations reported names and employment information of board members on the annual report or website and whether board members were current or former industry executives. Finally, we searched all board members using LinkedIn, a professional networking site, and reviewed relevant work experience.12 To ensure correct identification, we searched by full name and included the search only if the profile included the board membership status of the corresponding PAO.

Results
Characteristics of PAOs in Dermatology

Of 1215 PAOs in the KHN database, 1183 were excluded because they were nondermatology PAOs, leaving 32 (2.6%) related to dermatology. Of these, 6 (19%) were excluded for being subchapters and 2 (6%) for having invalid Form 990 files and websites (Figure). Therefore, 24 dermatology PAOs were available for analysis. The most common disease focus among the 24 remaining organizations were autoimmune (9 [38%]), cancer (5 [21%]), and congenital (5 [21%]). The names and donation-related details of each dermatology PAO are reported in Table 1.

Overall, 5 organizations (21%) had total donations exceeding $5 million and 4 (17%) reported industry donations of at least $500 000 (Table 2). Although 8 organizations (33%) reported less than 10% of total donations from industry sources, 2 (8%) acknowledged having at least 40% of total donations from industry sponsors (National Eczema Association and National Psoriasis Foundation).

Disclosure Practices

Overall, 17 PAOs (71%) reported receiving donations from industry on the annual report or website (Table 3). Twelve organizations (50%) disclosed these donations in ranges, whereas 12 (50%) did not report the amount of these donations. None of the organizations disclosed the exact amount of industry-related donations on the annual report or the website. In addition, none of the organizations specified the use of industry-derived donations.

Twenty-three organizations (96%) reported board member names, and 6 (25%) provided board members’ employment information. On the basis of the annual report and website, 2 (8%) reported having only a current industry executive, whereas 1 (4%) reported having both a current and former industry executive on the governing board. With use of LinkedIn, we found that 13 organizations (54%) had a current or former industry executive as a member. Of these, 7 organizations (29%) reported having only a current industry executive on the governing board and 1 (4%) reported having a former industry executive on the governing board, whereas 5 (21%) reported having both a current and former industry executive on the governing board.

Discussion

These findings suggest that industry-derived financial support of dermatology PAOs is common and inconsistently reported. Overall industry funding was lower among dermatology PAOs (71%) than that reported for other medicine PAOs (83%).5 Four dermatology PAOs reported donations that exceeded $500 000, with 2 organizations having more than 40% of total donations from industry sponsorship.

Potential COIs may also result from competing interests of board members. Three organizations (13%) reported a current or former industry executive on the governing board, lower than the 39% reported by nondermatology PAOs.5 Our analysis revealed that at least 13 boards (54%) had a current or former industry executive as a member. Given variable disclosure practices, this rate may underestimate the relationship between industry and PAOs.

Together, these findings support previous data demonstrating the variability and lack of transparency in disclosure practices among US PAOs and expand these findings to dermatology.5 Although industry support is common among dermatology PAOs, we cannot evaluate the extent of COIs with greater granularity because organizations presented ranges of donations, not exact values.

The goal of PAOs is to allow patients to organize around disease entities and support efforts to improve health. These nonprofit organizations require substantial financial resources to provide support to patients, to educate the public at large, to promote research aimed at improving treatments or preventing disease, and to lobby government officials to redirect research funding.5,13 Although financial sponsorship from industry sources is a critical resource to facilitate the activities of PAOs, industry-PAO interactions may give rise to COIs, and the efforts of PAOs have the potential to be influenced by parties with alternative agendas. Without clear and consistent reporting of COIs, the positions and interests of PAOs are not known and efforts of PAOs may be called into question.

Clear standards of reporting with an emphasis on consistent, specific disclosure of industry-PAO interactions financially or with governing boards would provide transparency. Although the Physician Payments Sunshine Act enacted by the Centers for Medicare & Medicaid Services requires drug, device, and biotechnology companies to report payments made to physicians or teaching hospitals, this policy does not extend to PAOs.14-16 Until a more transparent and systematic disclosure of financial and board member information is provided, it is difficult to ascertain the full scope of industry involvement.

Limitations

These findings must be interpreted in the context of our study design. Because the KHN database screened organizations with a reported annual revenue of greater than $500 000, our findings may not be representative of disclosure practices among smaller organizations. In addition, we were unable to capture the upper bound of donations because of disclosure limitations. Organizations frequently did not report the highest tier of donations (ie, greater than $500 000), which restricted our ability to ascertain a maximum range of industry-related donations. Thus, we could accurately report only the minimum value and proportion of donations attributable to industry sponsorship. In addition, because we limited the scope of the study to focus on industry-related donations, we cannot comment on other potential sources of financial COIs. Also, we acknowledge that some of the data presented in this article may be subject to duplicate reporting because there was minor overlap between the organizations included in our study and those of McCoy et al.5

Conclusions

The findings suggest that there is a lack of transparency in disclosure practices among PAOs in dermatology. Without clear and complete reporting, we are unable to determine the potential COIs that may exist with regard to industry-derived financial support and board membership. Policies that support the transparency and uniformity of industry-related disclosure practices appear to be needed to fully assess the extent of COIs among PAOs and maintain public confidence in these institutions.

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Article Information

Accepted for Publication: November 14, 2018.

Corresponding Author: Arash Mostaghimi, MD, MPH, MPA, Department of Dermatology, Brigham and Women’s Hospital, Harvard Medical School, 221 Longwood Ave, Boston, MA 02115 (amostaghimi@bwh.harvard.edu).

Published Online: January 30, 2019. doi:10.1001/jamadermatol.2018.5102

Author Contributions: Messrs Li and Singer contributed equally to this work. Messrs Li and Singer and Dr Mostaghimi had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Li, Mostaghimi.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: All authors.

Critical revision of the manuscript for important intellectual content: Li, Mostaghimi.

Statistical analysis: All authors.

Obtained funding: Li.

Administrative, technical, or material support: Singer, Mostaghimi.

Supervision: Mostaghimi.

Conflict of Interest Disclosures: None reported.

Funding/Support: This study was supported by award TL1TR001062 from the National Center for Advancing Translational Sciences, National Institutes of Health (Mr Li).

Role of the Funder/Sponsor: The funding had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

References
1.
Koay  PP, Sharp  RR.  The role of patient advocacy organizations in shaping genomic science.  Annu Rev Genomics Hum Genet. 2013;14(1):579-595. doi:10.1146/annurev-genom-091212-153525PubMedGoogle ScholarCrossref
2.
Rose  SL, Highland  J, Karafa  MT, Joffe  S.  Patient advocacy organizations, industry funding, and conflicts of interest.  JAMA Intern Med. 2017;177(3):344-350. doi:10.1001/jamainternmed.2016.8443PubMedGoogle ScholarCrossref
3.
Biotechs leverage patient groups in drug development. The Boston Globe. https://www.bostonglobe.com/business/2016/09/28/biotechs-leverage-patient-groups-drug-development/zn7EGHg2jJXjZOl8dBu3GM/story.html. Accessed May 26, 2018.
4.
Public Citizen.  Patients’ Groups and Big Pharma Three in Four Patients’ Groups That Sided With the Pharmaceutical Industry Against Medicare Drug Price Reforms Received Industry Money. Washington, DC: Public Citizen; 2016.
5.
McCoy  MS, Carniol  M, Chockley  K, Urwin  JW, Emanuel  EJ, Schmidt  H.  Conflicts of interest for patient-advocacy organizations.  N Engl J Med. 2017;376(9):880-885. doi:10.1056/NEJMsr1610625PubMedGoogle ScholarCrossref
6.
Pre$cription For Power: KHN Patient Advocacy Database. https://khn.org/patient-advocacy/#all-organizations. Accessed May 20, 2018.
7.
National Center for Charitable Statistics. National taxonomy of exempt entities. http://nccs.urban.org/classification/national-taxonomy-exempt-entities. Accessed May 20, 2018.
8.
GuideStar nonprofit reports and Forms 990 for donors, grantmakers, and businesses. https://www.guidestar.org/Home.aspx. Accessed May 20, 2018.
9.
Pre$cription For Power: KHN Patient Advocacy Database: Kaiser Health News. Full methodology. https://khn.org/patient-advocacy/#methodology. Accessed May 20, 2018.
10.
Lim  HW, Collins  SAB, Resneck  JS  Jr,  et al.  The burden of skin disease in the United States.  J Am Acad Dermatol. 2017;76(5):958-972.e2. doi:10.1016/j.jaad.2016.12.043PubMedGoogle ScholarCrossref
11.
Inflation Calculator CPI. https://data.bls.gov/cgi-bin/cpicalc.pl. Accessed August 15, 2017.
12.
LinkedIn. https://www.linkedin.com. Accessed May 28, 2018.
13.
Rose  SL.  Patient advocacy organizations: institutional conflicts of interest, trust, and trustworthiness.  J Law Med Ethics. 2013;41(3):680-687. doi:10.1111/jlme.12078PubMedGoogle ScholarCrossref
14.
Wilson  M.  The Sunshine Act: commercial conflicts of interest and the limits of transparency.  Open Med. 2014;8(1):e10-e13.PubMedGoogle Scholar
15.
CMS’ Open Payments Rules and Database; Conflicts of Interest in Academic Medicine; Medical Research; Initiatives; AAMC. https://www.aamc.org/initiatives/research/coi/386774/sunshineact.html. Accessed May 23, 2018.
16.
Kreis  J, Schmidt  H.  Public engagement in health technology assessment and coverage decisions: a study of experiences in France, Germany, and the United Kingdom.  J Health Polit Policy Law. 2013;38(1):89-122. doi:10.1215/03616878-1898812PubMedGoogle ScholarCrossref
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