Who's Bankrolling Patient Advocacy?

A Cleveland Clinic study finds that patient advocacy groups often receive funding from for-profit industry, raising questions about independence and conflicts of interest.

In the name of transparency, Sunshine Laws have required physicians, academic medical centers and other providers to disclose funding from for-profit companies. Non-profit patient advocacy groups have been ignored.

A national survey of 439 patient advocacy groups, led by Cleveland Clinic bioethicist Susannah Rose, PhD, found that 67% receive funding from for-profit companies, with 12% receiving over half of their funding from industry. The research was published in the Jan. 17 issue of the Journal of the American Medical Association Internal Medicine.

Rose spoke with HealthLeaders Media about her findings. The following is a lightly edited transcript.

HLM: What prompted this study?

Rose: There were to things that came together for me. I worked with cancer patients at Sloan Kettering for about a decade as a social worker. I linked up with hundreds if not thousands of patients with these advocacy organizations for education, counseling and a lot of things.

When I started to do more research on conflicts of interest when I went to Harvard, I realized there were a lot more investigations related to industry funding of clinical and medical research and physicians and academic medical centers, but I didn't find anything related to patient advocacy groups, despite their powerful role in the biomedical realms of policy making, research, and direct patient care.

HLM: Why have PAGs received no scrutiny?

Rose: In the last decade there has been attention from the media who have looked into these issues more on a case-by-case basis. To my knowledge, before this there were no systematic, scientific, published studies looking at this in the United States.

I think a lot of people just assumed that these non-profit advocacy groups are independent and aren't aware of their industry funding.

HLM: Are for-profit companies using PAGs to exploit the public trust that these groups hold?

Rose: I can't speak on the industry perspective because we didn't look at in this study. However, you can find them quite easily. There are reports published in the marketing literature written by industry representatives who use that approach.

HLM: Relatively speaking, it's not a lot of money, but it seems like PAG funding provides lot of bang for the buck.

Rose: That's right. There are a couple of surprising things about this to me. Two-thirds of patient advocacy groups have industry money. The second issue is that on average, the amounts are not overwhelming in terms of the median amounts.

However, if you look at subgroups, for example [you'll see that] 12% receive over half of their funding from industry. If you are worried about the independence of these organizations, you might be worried about their dependence on certain funding sources.

Receiving more than half of one's funding from industry may be a concern for questioning an organization's independence. 

HLM: Has this reliance on industry money been used improperly?

Rose: Our paper doesn't disclose names because of confidentiality. We did include three citations in the discussion section of the paper that focused on the American Diabetes Association, the National Alliance of Mental Illness, and the American Pain Foundation, using journalists who looked at, for example, the American Diabetes Association and their role with Cadbury and other food companies and putting their logo on sugary snacks, things that may not be so good for people with diabetes.

Another concern is the mental health and pain groups that testify in Food and Drug Administration committees in support of approvals for certain medications, but they receive funding from that exact company that makes the medication, and that isn't being disclosed.

There is also the issue of looking for coverage for insurance companies, Medicare and private insurers, to cover very expensive but maybe even potentially harmful medications to certain populations. NAMI in particular was involved in the controversy over the black box warnings with SSRIs and their use in adolescents.

HLM: Should PAGs have uniform disclosure requirements?

Rose: I think so. In terms of disclosure, the only and best way to do this is to set a standard that all of them must meet, for instance, including in the Sunshine Act that currently reports industry funding to all physicians and academic medical centers and some other medical entities.

The Institute of Medicine actually suggested that quite a long time ago in their report on conflict of interests, but the Sunshine Act excluded patient advocacy groups from this legislation.

Industry groups are unlikely to be motivated to do this on their own because, if one organization does it and another one doesn't, it diminishes the returns on being transparent.

The policy advancements on this would be to make standardizations across all nonprofits, including patient advocacy groups.

HLM: Who would do this?

Rose: Congress. They could amend the Sunshine Act, especially as we are not talking about revisions to the Affordable Care Act. It may or may not be possible now given the current political environment. On the other hand, the ACA is open for a lot of potential changes and the Sunshine Act is a provision under the ACA.

HLM: Your study suggests that PAGs would welcome more transparency.

Rose: They would like to learn how to strengthen their policies. These advocacy groups do great things. They drive research. They raise awareness to important issues that maybe nobody would be paying attention to.

They have to get money from somewhere, and industry funding is a main source of income. The question is how can we help them be transparent, and how can they maintain their independence? Because, if they lose public trust, then I worry that we lose a major voice for patients in the public arena.