Patient advocacy organizations, such as the American Cancer Society and the Cystic Fibrosis Foundation, play an important role in healthcare: they provide patients with educational materials and resources to better understand their disease, connect patients to one another as well as to clinicians and healthcare organizations, and advocate on their behalf to research funders and policymakers.
Importantly, these organizations differ in size and scope. Some are large, with chapters across every state, others are small and focus on rare diseases, and still others are issue specific, more akin to a Washington, D.C., lobbying firm. Often unknown to patients, however, is that many of these organizations have deep ties to the pharmaceutical and medical device industries, potentially influencing their recommendations and advocacy.
According to a Kaiser Family Foundation published in 2018, pharmaceutical companies donated at least $116 million to patient advocacy organizations in a single year (2015), nearly double the amount they spent on lobbying. Funding from these companies -- which nearly half of these organizations accept -- raises many concerns about their independence, including whether they are fully representing the interests of patients or those of the companies that sell the medicines. These ties to industry may color patient advocacy organizations' recommendations, such as endorsements of legislative proposals or of specific drug or device approvals, even when they could potentially run counter to patients' interests.
Crucially, industry influence does not end with financial support. A revolving door exists between industry and advocacy groups, further tying the two together. Our recently published research in JAMA Internal Medicine illustrates just how intertwined these organizations are with industry, not just in terms of the money they receive directly from companies, but also through their leadership and staff. Focusing on the 50 highest-revenue patient advocacy organizations in the U.S., we found that nearly three-quarters (74%) had members on their board with industry ties, and half (50%) had executive leadership with industry ties.
Overall, around 11% of all the board members and executive leaders of these 50 organizations had former or current ties to the pharmaceutical or medical device industries, highest among organizations focused on cancer (18%) and cardiovascular disease (15%). Moreover, nearly a quarter of organization CEOs/executive directors had industry ties, including those of 4 of the 5 with the largest revenues. These findings likely understate the true extent of these organizations' ties to industry, as we were hindered by limited biographies and opaque disclosure statements, which leave out important information including whether they own industry stocks or are also paid to consult for companies.
Can organizations truly represent the best interests and well-being of patients -- especially in situations when patients' and companies' interests are not aligned -- with such significant industry influence among their leadership? In the setting of skyrocketing drug and device costs, rising medical bankruptcies, and more treatments being accelerated to approval with greater uncertainty of patient benefit, these ties raise concerns.
The new targeting beta-amyloid to treat Alzheimer's disease illustrate these concerns. During the regulatory review of the first of these treatments, aducanumab (Aduhelm), an advisory committee of outside experts to the FDA overwhelmingly recommended against approval. Despite over the drug's , the Alzheimer's Association its eventual approval. The organization's advocacy may have been driven by a broad support for any approval of new therapies for Alzheimer's disease. But casting a shadow was the group's acceptance of at least in pharmaceutical funding in 2021 alone, including more than $750,000 from aducanumab's developers, Biogen and Eisai.
There are benefits to including industry perspectives in organizations' discussions: they bring deep knowledge of drug and device development and an understanding of regulators and payers. As companies embark on drug or device approval efforts, they could benefit from the voices of patients in designing clinical trials that measure meaningful outcomes. However, we believe patient advocacy organizations are stronger as independent advocates for patients, without additional industry influence through their boards or leadership.
At a minimum, patient advocacy organizations must be transparent: both industry funding and industry ties among staff as well as board members should be clearly disclosed on organization websites. Congress could also facilitate transparency by broadening the to apply to patient advocacy organizations. This would be similar to the requirements for public disclosure of payments from the pharmaceutical and medical device industry to hospitals, physicians, and other prescribers.
Patient advocacy organizations must also go beyond transparency; they must disentangle from industry. Our findings include numerous organizations with leadership and executive directors currently working for industry -- this presents significant conflicts of interest and any paid engagement should be precluded, particularly given that most are considered charities. Industry influence on boards should also be minimized: members with industry ties should be non-voting or comprise a small minority, and organizations should ensure that board presidents do not have industry ties.
Clinicians and patients rely on patient advocacy organizations to be a trusted, dependable source of information. They expect that these organizations will fight for patients' interests, especially when those interests do not align with companies' bottom lines. As it stands today, entanglements with industry and poor transparency are jeopardizing this trust. Advocacy where patients are truly centered and put before profits requires complete independence from industry. Until then, the actions and recommendations of patient advocacy organizations may continue to be shrouded in skepticism.
Shamik Bhat is a medical student at Yale School of Medicine in New Haven, Connecticut. Joseph S. Ross, MD, MHS, is a professor of medicine and public health at Yale School of Medicine. Reshma Ramachandran, MD, MPP, MHS, is an assistant professor at Yale School of Medicine within the Department of Internal Medicine. She also chairs the FDA Task Force for Doctors for America and is a board member for Universities Allied for Essential Medicines North America.
Disclosures
Ross and Ramachandran co-direct the Yale Collaboration for Regulatory Rigor, Integrity, and Transparency (CRRIT), which receives grant funding from Arnold Ventures.