Drop in on any of the fierce debates about drug prices or the need for new medicines in the US, and you’ll find patient advocacy groups right in the middle, speaking up for the sick. These organizations represent millions of people with diseases like cancer, MS, and diabetes, and they are among the first places people turn to for help when they get sick.
But new research sheds light on a disturbing problem with these organizations: Their deep ties with industry may be compromising their ability to serve the very patients they’re supposed to help.
A new study from the New England Journal of Medicine found that 83 percent of the nation’s top 104 patient advocacy groups — like the American Diabetes Association and American Cancer Society — receive funding from drug and medical device companies. Nearly a quarter got more than $1 million each year from the industry.
The researchers also found that, in addition to the financial support, at least 39 percent of patient groups had current or former industry executives on their boards, meaning industry players are helping guide and govern these organizations.
Research for decades has shown that cozy relationships between doctors and industry — for instance, industry-sponsored medical education and free drug samples from pharmaceutical companies — can bias doctors’ judgment in all sorts of negative ways.
And now the authors of the NEJM paper are concerned about the influence of industry on patient advocacy groups, which have a history of pushing for the FDA to approve drugs like “pink Viagra” (of questionable benefit to women) or helping label sugary breakfast cereals as healthy food choices for Americans. Reports have also surfaced about other patient groups that failed to advocate about rising drug prices — and happened to get industry funding — suggesting they may be working more for companies than for the patients they represent.
Patient advocacy groups have eluded the transparency push in medicine
Medicine has become more transparent over the past decade, with drug and device makers now publishing information about which doctors and teaching hospitals they give money or gifts to, and medical journals and research institutions pushing for clear disclosures on conflicts of interest. The idea is that transparency is a disinfectant that reduces the risk of bias in research and medical practice.
Yet patient advocacy groups have mostly escaped scrutiny, said Ezekiel Emanuel, University of Pennsylvania researcher and co-author on the study.
“Patient groups have been seen to be knights in shining armor and above reproach,” Emanuel said. “They haven’t established [the conflict of interest] policies that everyone else — from major hospitals to researchers and journals — has had to.”
The new research suggests this has to change. For the NEJM paper, Emanuel and his co-authors looked at the Form 990 tax records, annual reports, and websites of the largest US-based patient advocacy groups, with annual revenues of at least $7.5 million. They found patient groups were failing miserably at managing their conflicts of interest. The vast majority took money from industry, and yet 88 percent of the organizations the authors looked at had not published policies for conflicts of interest.
More than 40 percent of the groups also didn’t publicly disclose the amounts of donations they received, and only 10 percent shared how their donations were used. So, in many cases, transparency about funding was a big problem.
Only one (the Child Mind Institute) had an explicit policy of no donations.
The American Diabetes Association got the most funding from the industry: more than $28 million in 2014 alone. Other groups got smaller amounts — that represented a huge portion of their annual revenue. The National Hemophilia Foundation listed contributions from drug and device makers between $8.5 million $14 million, for example. (The ambiguity there is the result of the fact that they only list ranges in their giving.) Their annual revenue is around $16.8 million, so the industry funding made up half to a majority of their earnings.
“A lot of people believe and really trust in patient advocacy groups,” said Susannah Rose, who authored another recent study in JAMA Internal Medicine on US patient advocacy groups, which came to similar conclusions. “These groups are often very powerful — not only providing care and direct access to patients and physicians — but they are also big players in national and state and local governments in terms of policy development and driving research agendas.”
And they need to maintain their independence from the industry to keep their credibility, she added.
Researchers say one solution to the problem is simply requiring disclosure from these groups, bringing them more in line with other medical stakeholders. The Sunshine law is part of the Affordable Care Act, passed by Congress in 2010. It mandates that every pharmaceutical and medical device company in the country annually disclose payments made to doctors and teaching hospitals for a range of activities — including promotional speaking, research grants, meals, and trips of at least $10 value. In addition, manufacturers and group purchasing organizations are required to report physician ownership or investment interests.
“We created a Sunshine Law for researchers that required full disclosure from the pharmaceutical and device industries about how they pay the doctors,” said Emanuel. “This needs to happen for patient advocacy groups.”