Industry funding of patient and health consumer organisations: systematic review with meta-analysis
BMJ 2020; 368 doi: https://doi.org/10.1136/bmj.l6925 (Published 22 January 2020) Cite this as: BMJ 2020;368:l6925Linked Editorial
Corporate sponsorship of patient groups
Linked Opinion
The prevalence of industry funding of patient groups
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Dear Editor,
As discussed by Fabbri, Parker, Colombo, et al. (BMJ 2020;368:l6925), industry financial support of patient advocacy organizations (PAOs) has become very common in recent years, yet robust efforts to mitigate financial conflicts of interest (FCOI) are still limited. This is a very important topic to consider and one that the Crohn’s & Colitis Foundation has taken very seriously.
Like many other PAOs, the Crohn’s & Colitis Foundation has developed a deep relationship of trust with patient and provider communities involved in inflammatory bowel disease (IBD) and agrees with the authors that transparency is a key component of preserving this relationship. In fact, the Foundation has a dedicated page on our web site outlining how we do business (https://www.crohnscolitisfoundation.org/about/transparency). Clearly, succinctly, and for all to see, the transparency page details our patient-first policy, how we work with corporate partners, and our engagement with IBD experts and outside ethics advisors.
As catalyst and convener for the IBD community, it is imperative that we maintain the foundation of trust built in the 50 years since our inception. In 2016 the Foundation created a standing, independent ethics committee to bring independent expertise to guide the Foundation, in a systematic manner, as it weighs collaboration opportunities with industry. With the guidance of the ethics committee and through our commitment to transparency, we maintain this critical relationship while continuing to serve the IBD community to advance the field through research, education, support, and advocacy.
The Crohn’s & Colitis Foundation, in collaboration with our Ethics Committee Chair, recently published a paper in BMC Medical Ethics (1) to provide background on the changing role of industry-PAO relationships in recent years, including the benefits and concerns of these relationships. The goal of the article is to provide an overview of how the Foundation has worked to mitigate financial conflicts of interest through the creation of our ethics committee and details on how other PAOs can consider this strategy for improving their processes.
For instance, our ethics committee is charged with:
• Assessing collaborations with industry, including policies for these initiatives;
• Providing input and guidance on our programs and policies regarding interactions with patients, providers, and sponsors, including human subjects protections and mechanisms for recruitment of research participants;
• Ensuring any conflicts of interest in the activities performed by the Foundation are appropriately managed, including the level or type of involvement by the supporter.
While collaborations with industry can result in conflicts of interest, PAOs can develop strategies to address those conflicts. We encourage other PAOs to consider ways to address financial conflicts of interest, including creating an ethics committee and reviewing the best practices that we provide in the article.
Caren Heller, MD, MBA
Chief Scientific Officer
Crohn’s & Colitis Foundation
www.crohnscolitisfoundation.org
Laura Wingate
Senior Vice President, Education, Support, & Advocacy
Crohn’s & Colitis Foundation
www.crohnscolitisfoundation.org
Orna Ehrlich, MPH
Senior Director, Professional Education & Innovative Programs
Crohn’s & Colitis Foundation
www.crohnscolitisfoundation.org
Inmaculada de Melo-Martin, PhD, MS
Division of Medical Ethics
Weill Cornell Medicine
Chair, Crohn’s & Colitis Foundation Ethics Committee
References:
1. Ehrlich, O., Wingate, L., Heller, C. et al. When patient advocacy organizations meet industry: a novel approach to dealing with financial conflicts of interest. BMC Med Ethics 20, 96 (2019). https://doi.org/10.1186/s12910-019-0435-1
Competing interests: Laura Wingate declares involvement on advisory boards: UC (Ulcerative Colitis) Narrative, Inflammatory Bowel Diseases Global Assessment of Patient and Physician Unmet Needs Survey (IBD GAPPS). Orna Ehrlich, Caren Heller, and Inmaculada de Melo-Martín declare that they have no competing interests.
Dear Editor:
Patient organizations exist to support and improve the lives of people with chronic diseases and disabilities. The article (https://www.bmj.com/content/368/bmj.l6925) by Fabbri, Parker, Colombo, et al., “Industry funding of patient and health consumer organisations: systematic review with meta-analysis,” published online on January 22, 2020, highlights the importance of transparency and addressing potential conflicts of interest by patient organizations. The National Health Council (NHC) and our more than 60 patient-organization members (https://nationalhealthcouncil.org/members/?f_tax=41&f_key=) have been leading the way in transparency and managing conflicts for decades. Our Standards of Excellence® (Standards) (https://nationalhealthcouncil.org/standards-of-excellence/), which all our patient-organization members must meet, address governance, human resources, programs, fundraising, finance, accounting and reporting, transparency, conflict of interest, and evaluation. While our Standards are not mandatory for nonmembers, many organizations voluntarily follow them.
We would like to express several concerns regarding the study by Fabbri, et al., and accompanying opinion piece. Both fail to acknowledge that these voluntary standards already exist and have been in place for over 10 years, and that many legitimate patient groups adhere to them. Failing to acknowledge their existence and to attempt stratify the analyses by groups that follow them versus groups that do not, is a missed opportunity to highlight the impact the standards can have.
The NHC Standards require patient-organization members to publicly disclose (typically on their website) the name of each life-science company sponsor and the amount of financial support identified on their tax Form 990 and/or the total amount of corporate support as a percentage of total revenue. They also are required to have a written agreement with any life-science company prior to entering a relationship; that agreement must ensure the organization maintains its independence and control, and ensures the funds received provide a direct mission-related benefit. In addition, they must publicly disclose their board members and make their Conflict-of-Interest policies available via their website.
It also seems that the study conflates true patient organizations with “astroturf,” or fake, advocacy organizations (https://medium.com/@cleodan/astroturf-lobbying-technically-legal-ethical...). It does not appear a differentiation was made between them in this study or in the studies included in the analysis. This is an important differentiation. The principles embedded in the NHC Standards could be used as a guide to help differentiate “astroturf” patient groups from mission-driven organizations that strive to put patients first. To imply otherwise, negates the extraordinary work achieved by these organizations on behalf of patients.
In analyzing the relationships between industry and patient organizations, we must exercise caution so that we do not paint all “patient” groups with the same brush and minimize the valuable, mission-driven work of true patient advocacy organizations.
Marc M. Boutin, JD
Chief Executive Officer
National Health Council
The National Health Council is a stakeholder-informed, patient-focused organization that forges consensus among diverse organizations and drives patient-centered health policy. For more information, visit our website at www.nationalhealthcouncil.org.
Competing interests: No competing interests
Re: Industry funding of patient and health consumer organisations: systematic review with meta-analysis
We thank Dr Heller and colleagues of the Crohn’s & Colitis Foundation’s and Dr Marc Boutin and the National Health Council for their comments on our systematic review, and for sharing their experiences and approaches to management of conflicts of interest.
We agree with Dr Boutin that voluntary codes, including that developed by the National Health Council,(1) represent a valuable step towards establish principles for governance of sponsorship relationships. We thank Dr Heller for the example of the Crohn’s and Colitis Foundation’s creation of an ethics committee to manage the level and type of involvement of sponsors.(2)
In the Introduction of our systematic review we mentioned some examples of the currently available codes and guidelines developed by patient groups and the pharmaceutical industry.(References 8-11) However, the extent to which jointly developed voluntary standards can ensure independence depends both on the specific included standards and implementation procedures. One example of a standard to protect independence would be a firewall to prevent pharmaceutical company employees from participating in governance of a patient group. As described in our review, McCoy et al. found that 36% of major US patient groups had industry executives on their governing boards.(3) Most current joint industry-patient group voluntary codes and standards do not explicitly bar industry employees from participating in patient groups’ governing boards. This could be an important area for further development.
One of the key principles enshrined in the National Health Council’s standards is transparency of funding arrangements. In our review, we found limited evidence of transparency, with just over one fourth of patient groups in included studies disclosing funding information on their websites. However, we noted that the four studies included in the meta-analysis were published between 2008 and 2012, and disclosure of financial relationships might have changed since that period. Similarly, when we presented the data on prevalence of organisational policies that govern corporate sponsorship, we pointed out that the highest prevalence of policies was reported in two 2017 US studies, which possibly reflects recent shifts in disclosure of financial relationships with industry.
Finally, Dr Boutin raises an important point about “astroturfing”. We agree that the issue of ‘astroturf’ organisations, or those that are created by manufacturers to appear to represent patient or consumer interests, is important in its own right. The studies in our review did not focus explicitly on this issue. One indirect measure might be proportion of funding from industry, for example organisations with funding nearing 100%. As is noted in our review, little relevant information was available. Additionally, issues of transparency and governance mechanisms for independence within sponsorship relationships are broader in scope than the subset of organisations that might be characterised as ‘astroturf’.
In conclusion, our aim was to assess the currently available evidence on industry funding of patient groups. By identifying grey areas and gaps in the literature, we hope that our review will stimulate further discussion, research and actions on this topic. We are currently working with a team of patient groups to organise a public meeting that will be held in Sydney in March 2020 to discuss pharmaceutical industry sponsorship of patient groups. Starting from the research evidence and from patient groups’ experiences, we will share ideas and talk about solutions.
The Authors
References:
1. National Health Council. Standards of Excellence Certification Program for Voluntary Health Agencies, January 2017.
2. Ehrlich, O., Wingate, L., Heller, C. et al. When patient advocacy organizations meet industry: a novel approach to dealing with financial conflicts of interest. BMC Med Ethics 2019; 20, 96.
3. 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: 8805.
Competing interests: PM and CC report an unconditional grant from the Smith Kline Foundation outside the submitted work; PM and CC are authors of some of the studies included in the systematic review and were not involved in extracting data from or assessing the quality of their own studies; PM is a member of the Board of Europa Donna, the European Breast Cancer Coalition; BM is a member of the European network of Health Action International (HAI-Europe) and given this relationship she was not involved in extracting data from or assessing the quality of the two studies published by HAI-Europe2041; BM acted as an expert witness on behalf of plaintiffs in a Canadian class action suit on cardiovascular risks of testosterone; the remaining authors declare no other relationships or activities that could appear to have influenced the submitted work.