Patient Advocacy Organizations, Industry Funding, and Conflicts of Interest

Key Points

Question  What is the nature of industry funding of patient advocacy organizations in the United States?

Findings  This survey study found that 67% of a national sample of patient advocacy organizations, virtually all of which were not for profit, reported receiving funding from for-profit companies. Twelve percent received more than half of their funding from industry; a median proportion of 45% of industry funding was derived from the pharmaceutical, device, and/or biotechnology sectors.

Meaning  Most advocacy organizations receive money from industry; therefore, increased transparency and robust conflict of interest policies and practices are needed to help these non-profit organizations maintain their independence.

Importance  Patient advocacy organizations (PAOs) are influential health care stakeholders that provide direct counseling and education for patients, engage in policy advocacy, and shape research agendas. Many PAOs report having financial relationships with for-profit industry, yet little is known about the nature of these relationships.

Objective  To describe the nature of industry funding and partnerships between PAOs and for-profit companies in the United States.

Design, Setting, and Participants  A survey was conducted from September 1, 2013, to June 30, 2014, of a nationally representative random sample of 439 PAO leaders, representing 5.6% of 7865 PAOs identified in the United States. Survey questions addressed the nature of their activities, their financial relationships with industry, and the perceived effectiveness of their conflict of interest policies.

Main Outcomes and Measures  Amount and sources of revenue as well as organizational experiences with and policies regarding financial conflict of interest.

Results  Of the 439 surveys mailed to PAO leaders, 289 (65.8%) were returned with at least 80% of the questions answered. The PAOs varied widely in terms of size, funding, activities, and disease focus. The median total revenue among responding organizations was $299 140 (interquartile range, $70 000-$1 200 000). A total of 165 of 245 PAOs (67.3%) reported receiving industry funding, with 19 of 160 PAOs (11.9%) receiving more than half of their funding from industry. Among the subset of PAOs that received industry funding, the median amount was $50 000 (interquartile range, $15 000-$200 000); the median proportion of industry support derived from the pharmaceutical, device, and/or biotechnology sectors was 45% (interquartile range, 0%-100%). A total of 220 of 269 respondents (81.8%) indicated that conflicts of interest are very or moderately relevant to PAOs, and 94 of 171 (55.0%) believed that their organizations’ conflict of interest policies were very good. A total of 22 of 285 PAO leaders (7.7%) perceived pressure to conform their positions to the interests of corporate donors.

Conclusions and Relevance  Patient advocacy organizations engage in wide-ranging health activities. Although most PAOs receive modest funding from industry, a minority receive substantial industry support, raising added concerns about independence. Many respondents report a need to improve their conflict of interest policies to help maintain public trust.

Patient advocacy organizations (PAOs), such as the American Cancer Society, the American Heart Association, and the National Organization of Rare Disorders, are influential stakeholders in health and health care.^1,2 In addition to intervening at the individual level, many PAOs fund or conduct medical and health services research,^3-5 influence national policy, and play key roles in allocation decisions made by legislatures and government agencies.^2,6-8 Patient advocacy organizations need to secure financial support, which may come from many sources, including for-profit entities. However, relationships between PAOs and industry might influence PAOs’ activities in ways that might not align with the interests of the constituencies they represent.^9-15 There is increasing evidence that financial relationships can create bias in medical research and physicians,^16,17 and PAOs may be subject to the same concerns.

Despite the increasing role of PAOs in the biomedical ecosystem, few systematic investigations have focused on these health policy actors. Published studies have relied on industry disclosures and have been limited in scope.^18,19 Furthermore, PAOs do not routinely and publicly disclose all their sources of funding; this information is often not included on their websites, in their annual reports, or on their 990 tax forms.^18-21 Given the dearth of information about PAOs’ funding sources, we conducted a nationwide survey of leaders of PAOs in the United States to assess the nature of industry funding and partnerships among PAOs.

Closely following the method used by Armstrong et al,²² who investigated the effect of PAOs on media coverage of diseases, we used Gale’s Encyclopedia of Associations: National Organizations of the US²³ to identify eligible organizations. These databases contain a list and description of all for-profit and nonprofit organizations operating in the United States. We used 345 search terms to create a list of advocacy groups (eTable 1 in the Supplement). If new terms arose during the search, we added them to the list.

To ensure that our list was complete, we also searched the National Organization for Rare Disorders,²⁴ the United States Department of Health and Human Services Directory of Health Organizations,²⁵ and GuideStar.²⁶ These sources provided additional terms which we then iteratively used to search the Gale Databases; we judged the list complete when no new organizations were identified. Specific inclusion and exclusion criteria were applied to each organization (eTable 2 in the Supplement), resulting in 7865 eligible PAOs for inclusion in the survey.

When leadership contact information was not readily available from organizational websites, additional resources, such as GuideStar and LexisNexis,²⁷ were used to identify organizational leaders. When necessary, contact information was verified via telephone.

We selected the target sample size to achieve a prespecified degree of precision around estimates of continuous end points. With approximately 180 respondents, the half width of the 95% CI would be 0.15 SDs. For instance, if the SD of the responses to a particular item were 20%, then 180 completed surveys would provide a 95% CI with a width of 6%.

We randomly selected 550 PAOs from the 7865 eligible organizations and ordered them randomly. To conserve resources, we mailed the survey to the first 440 organizations on the list, with the plan to send the remaining 110 if we did not achieve the target 180 responses. Given the high response rate, the second mailing was not necessary. One organization was removed from the 440 because it closed before the survey was sent, resulting in a final denominator of 439.

The survey was developed by the primary research team (S.L.R., J.H., and S.J.) with assistance from the Survey Data and Management Core, a survey research consultation service at the Dana-Farber Cancer Institute in Boston, Massachusetts. We conducted cognitive interviews with the leaders of 8 PAOs. Specifically, we assessed comprehension of instructions, questions, and response options; recall of information necessary to answer questions; and deliberations used to answer questions. Furthermore, we evaluated the ease with which respondents progressed through the survey (eg, sequencing of topics and patterns of skipping questions). We revised the survey questions based on this feedback to ensure accurate understanding. The final survey included 44 closed and open-ended questions and 8 demographic questions addressing 4 domains: the organization’s characteristics, activities, finances, and conflict of interest policies. Specifically, the questions asked organizations to report whether or not they received any industry funding (defined below). If they did receive industry funding, they were asked to identify the amounts and from which industry sector(s) their funding came. The survey is available in the eFigure in the Supplement.

Data collection occurred between September 1, 2013, and June 30, 2014. Surveys were sent in 3 waves. Before each mailing, study staff sent an email that alerted recipients that they would be receiving the survey in the mail, provided a link to an online version of the survey, and requested alternative contact information if the individual had received the email in error. The first hard copy mailing was sent via an express shipping service. This mailing also included a $25 gift card, an invitation letter describing the study, and a prestamped return envelope.

After each round of mailing, study staff (S.L.R. and J.H.) telephoned nonresponding organizations. Returned surveys were reviewed to determine the degree of completion. We used confidential, as opposed to anonymous, survey methods to allow for follow-up of nonresponders and queries regarding missing or ambiguous responses. The data collected were entered into a separate REDCap²⁸ database by trained personnel from the Survey Data and Management Core. Ten percent of all data entered were checked for accuracy to reduce the likelihood of data entry errors. The Dana-Farber Cancer Institute and Cleveland Clinic Institutional Review Boards deemed the study exempt from the requirement for human participants research approval.

Data were analyzed using descriptive statistics with SAS, version 9.3 (SAS Institute Inc). For the purposes of analysis, PAOs are considered to have industry funding if they reported receiving any amount of industry funding. Those who reported $0 from industry are considered to have no industry funding. Industry is defined as any for-profit company from any sector.

Of the 439 surveys mailed, 298 were returned. At least 80% of the questions were complete in 289 surveys, which were included in the final analysis (response rate, 65.8%).

A total of 205 of 279 respondents (73.5%) were female and 257 of 277 (92.8%) were white. A total of 203 of 281 respondents (72.2%) had worked at the current organization for more than 5 years, and 244 of 287 (85.0%) held executive positions (Table 1). Respondents had been involved in advocacy for a median of 12 years (interquartile range [IQR], 7-20 years). There were few statistically significant differences between executive and nonexecutive respondents (eTable 3 in the Supplement).

Most PAOs (203 of 288 [70.5%]) indicated that they focus on 1 disease category, whereas the others indicated that they focus on a range of diseases. Genetic or rare disorders (89 [30.9%]), cancer (76 [26.4%]), and neurologic disorders (52 [18.1%]) were the most common disease areas (Table 1). Organizations ranged widely in size. Among the 205 PAOs (71.2%) with at least 1 employee, organizations had a median of 3 (IQR, 1-8) full-time staff. The median number of members was 18 (IQR, 8-1000). A total of 277 of 280 responding PAOs (98.9%) were tax-exempt nonprofit organizations.

Seventy-two respondents (24.9%) reported that their organization had an endowment, with wide variation in value. Among these PAOs, 21 (29.2%) had endowments of more than $1 million. Most respondents (244 of 284 [85.9%]) reported that they were very or moderately confident that their organizations would remain financially stable during the next 3 years. Eleven respondents (3.8%) indicated that their organization owned equity in for-profit companies.

Responding organizations reported participating in educational activities (286 [99.0%]), fundraising (277 [95.8%]), interacting with patients and families (270 [93.4%]), participating in research (233 [80.6%]), and engaging in policy and advocacy activities (218 [75.4%]) during the last complete fiscal year (Figure 1). A total of 116 organizations (40.1%) reported that they had funded biomedical and clinical research, with a median of approximately $200 000 (IQR, $40 000-$395 000) per organization that reported funding research. Nineteen organizations provided $1 million or more and 4 provided $10 million or more in research funding during the last fiscal year.

Responding organizations engaged in a wide range of fundraising activities. Most sought individual (245 [84.8%]) and corporate (213 [73.7%]) donations, whereas 78 (27.0%) collected membership dues (Figure 2).

A total of 272 PAOs (94.1%) provided information on their revenue during the last complete fiscal year. Revenue varied widely among groups, with a median of $299 140 (IQR, $70 000-$1 200 000). Many respondents reported financial support from diverse sources, with few stating that they relied entirely on a single source (Table 2). The main sources of revenue were individual donations, for-profit corporate donations, and fundraising events. The least frequently reported sources of revenue were membership dues and government grants.

A total of 165 of 245 PAOs (67.3%) reported receiving industry funding in the last fiscal year, with 54 of 160 (33.8%) receiving more than one-fourth and 19 of 160 (11.9%) receiving more than half of their funding from industry. The 240 PAOs that provided information on their funding from for-profit companies received a median of $15 000 (IQR, $0-$102 500). Among these 240 PAOs, 105 (43.8%) received less than $9999 in industry funding, whereas 21 (8.8%) received more than $1 million. Among the subset that reported receiving industry funding, the median amount was $50 000 (IQR, $15 000-$200 000).

A total of 156 of the 240 groups that received industry funding (65.0%) provided a detailed breakdown of their for-profit funding sources. These groups received a median of 45% (IQR, 0%-100%) of their industry support from pharmaceutical, device, and/or biotechnology companies. Companies in other sectors provided smaller amounts of support (Table 3).

A total of 220 of 269 respondents (81.8%) indicated that conflicts of interest are very or moderately relevant to PAOs, and 175 of 274 (63.9%) reported having a written organizational conflict of interest policy. When asked about the adequacy of their own conflict of interest policies, 94 of 171 (55.0%) believed that their written policies are very good at addressing key components of conflicts of interest. A total of 73 of 284 PAOs (25.7%) reported that their organizations have policies for public disclosure of financial relationships, such as on websites or annual reports. A total of 22 of 285 PAOs (7.7%) reported that their organization perceived pressure to conform its positions to the interests of corporate donors or partners, while 39 of 285 (13.7%) indicated that their organization had declined a contribution because of concerns about conflicts of interest.

Patient advocacy organizations play powerful roles in health policy, public education, and research, yet the nature and implications of their relationships with industry have received little systematic study. We therefore surveyed leaders of PAOs about their organizational activities and industry funding. We found that most PAOs are small, as measured by their annual revenues, number of employees, and size of membership. In addition, most leaders of PAOs believe that industry conflicts of interest are relevant to PAOs but acknowledge that their policies need to be strengthened.

Although most organizations reported receiving modest support from industry, 11.9% received more than half of their revenue from for-profit companies during the last complete fiscal year. The largest proportion of industry funding was derived from the pharmaceutical, device, and biotechnology sector (median, 45%). Such dependence on the financial support of companies whose interests may not always align with those of the organizations’ constituents has important implications for PAOs.²¹ Consistent with this concern, the National Alliance on Mental Illness,¹⁵ the American Diabetes Association,²⁹ the American Pain Foundation,³⁰ and other PAOs have been the focus of media investigations regarding their ties to industry and the integrity of their activities. Furthermore, that 8% of respondents reported pressure to conform their organizations’ positions to the interests of industry funders is of concern. How this pressure occurs and how to address it merits further study.

This study has several limitations. First, despite the high response rate, there is a potential for response bias. The PAOs with the most extensive industry ties may not have responded, or PAOs without industry ties may have considered the survey irrelevant. Second, such surveys are subject to social desirability bias and respondents’ concerns about confidentiality; however, these potential biases were minimized by using survey identification codes and by speaking directly with respondents who expressed such concerns. Third, this study is based on self-report; it does not directly examine funding sources or behaviors. Finally, despite the comprehensive nature of our sampling strategy, we may have failed to identify some PAOs, which limits generalizability. Nevertheless, the study includes a high response from a wide-ranging group of PAOs, representing the largest and most representative sample frame to date, to our knowledge. Furthermore, respondents’ seniority and experience permit confidence in the accuracy and insight of their responses.

This study advances our understanding of what PAOs do, how they are funded, and their policies regarding financial relationships with industry. Although the amounts and proportions of financial support from industry are modest, the pervasive nature of industry support suggests the need for robust public debate about how to ensure that PAOs serve the interests of their constituencies. In addition, although many PAOs are small (ie, the median revenue among organizations that responded to our survey was $299 140), their large numbers and credibility with policymakers and the public likely give even small PAOs extensive influence in specific disease areas. At the other end of the spectrum, large PAOs that receive considerable for-profit support and have sophisticated public relations and government affairs departments likely have a substantial effect on policies relevant to their industry sponsors.

Greater transparency is a first step to helping PAOs maintain independence. To achieve this goal, PAOs should add detailed information about industry funding on their websites, and pharmaceutical, device, and biotechnology companies should be required to disclose payments to PAOs on the federal government’s Open Payments website.³¹ In addition, more robust conflict of interest policies and practices, the development of consensus standards within the PAO community regarding relations with industry, and disengaging entirely from industry support also merit consideration. Patient advocacy organizations might consider blinding their leaders to the sources of for-profit funding.^21,32 However, this position is likely impractical and would diminish transparency.

Financial relationships between PAOs and industry demand effective steps to ensure that these groups serve their constituents’ interests while minimizing risks of undue influence and bias. Given the growing ability of PAOs to influence health care policy and practice, their financial practices and safeguards demand the same degree of scrutiny applied to other key actors in the health care landscape.

Accepted for Publication: October 28, 2016.

Corresponding Author: Susannah L. Rose, PhD, Office of Patient Experience, Department of Bioethics, Cleveland Clinic, 9500 Euclid Ave, Mail Code JJ60, Cleveland, OH 44195 (roses2@ccf.org).

Published Online: January 17, 2017. doi:10.1001/jamainternmed.2016.8443

Author Contributions: Dr Rose had full access to all 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: Rose, Highland, Joffe.

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

Drafting of the manuscript: Rose, Highland, Karafa.

Critical revision of the manuscript for important intellectual content: Rose, Karafa, Joffe.

Statistical analysis: Rose, Highland, Karafa.

Obtained funding: Rose.

Administrative, technical, or material support: Rose, Highland, Joffe.

Study supervision: Rose, Highland, Joffe.

Conflict of Interest Disclosures: Dr Joffe reported serving as a paid member of a data monitoring committee for Genzyme Sanofi until November 2012. No other conflicts were reported.

Funding/Support: This research was funded by the Edmond J. Safra Center for Ethics at Harvard University.

Role of the Funder/Sponsor: The funding source 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.

Additional Contributions: Michael Kattan, PhD, Cleveland Clinic, reviewed the data and analysis; he was not compensated for his contribution. Mary Beth Mercer, MPH, Cleveland Clinic, provided insights on survey development; she was not compensated for her contribution. Glen Taksler, PhD, Cleveland Clinic, provided comments on this manuscript; he was not compensated for his contribution. Ariane Mitchum, MA, Cleveland Clinic, assisted with preparation of the manuscript; she was not compensated for her contribution. We also thank the Survey and Data Management Core at the Dana-Farber Cancer Institute, Boston, Massachusetts. The Dana-Farber Cancer Institute is supported in part by the National Institutes of Health (NIH) through a National Cancer Institute Cancer Center support grant (5 P30 CA06516).