Americans are big boosters of patient advocacy organizations (PAOs). They contribute hundreds of millions of dollars to nonprofits like the American Heart Association, the American Cancer Society and the Alzheimer Association. We suspect that most people admire such PAOs for their commitment to promoting disease awareness. These charities also support research and development and advocate on behalf of their members. What most people do not realize, however, is that there are potential conflicts of interest with big-buck patient advocacy organizations (JAMA Internal Medicine, Aug. 21, 2023).
The Close Ties Between PAOs and Industry:
Here are some basics that we did not know about. Nonprofit patient charities take in a lot of money each year. According to the research letter in JAMA Internal Medicine (Aug. 21, 2023) the top PAOs annual revenue looks impressive:
- American Heart Association ($1.1 billion)
- American Cancer Society ($576 million)
- Leukemia and Lymphoma Society ($478 million)
- Alzheimer’s Association ($405 million)
- American Kidney Fund (337 million)
More shocking are the close connections between patient advocacy organizations and the industries that are involved in the treatment of the diseases these PAOs represent.
The authors of this study note that:
“Among the 50 highest-revenue PAOs in the US, three-fourths had board members, senior paid staff, or executives with prior or current ties to the pharmaceutical and medical device industries. These findings are consistent with a 2016 study that found at least 39% of the largest 104 US-based PAOs had industry executives on their boards. The present study builds on this work by characterizing ties beyond board membership, including senior paid staff and executives.”
Conflicts of Interest with Nonprofits:
I was surprised but not totally shocked to learn about this very close relationship between industry and the nonprofit disease charities the public enthusiastically supports. Many years ago I served briefly on a nonprofit asthma organization.
I was disappointed to learn that drug companies with a strong interest is asthma meds were big contributors to this charity. Meetings were held at one of the pharmaceutical company’s corporate offices. Once I sensed the very close connections between this nonprofit and the pharmaceutical industry, I bailed.
Do Big Bucks from Industry Create Conflicts of Interest?
It is worrisome to have board members, executives, paid staff and other leadership positions of nonprofit charities associated with industry. I am also alarmed by the money connection. According to the research in JAMA Internal Medicine, nearly half of the PAOs accept industry financial support.
Have you ever heard the phrase?:
“He who pays the piper calls the tune”
Everyone knows what that means. If a nonprofit patient advocacy organization receives millions of dollars from drug companies that make medications to treat the health condition it represents, how likely is it for that PAO to criticize any of those pharmaceuticals because of serious adverse effects?
If a new class of pharmaceuticals is up for FDA review, what are the chances that a nonprofit will be cautious about encouraging FDA approval? What we have seen is often enthusiastic encouragement for the FDA to green-light the new meds.
There is rarely any mention of potential conflicts of interest in this decision-making process. And once a new medication is approved, the nonprofit patient advocacy organization is more likely to endorse the new drug rather than urge slow adoption or caution.
Ongoing Disagreements with the AHA:
We have been bumping heads with the American Heart Association for years. Check out this article about saturated fat. The AHA recommends substituting fat-free skim or “light” milk for “regular” milk. The nonprofit also promotes low-fat yogurt or cheese. We cite research that contradicts those recommendations, but this PAO is unlikely to change its tune anytime soon.
We have had similar disagreements with the AHA about low salt recommendations. You can read our position and the AHA recommendations at this link.
What About Statins and Conflicts of Interest?
You probably won’t be surprised to learn that there are questions about the AHA’s recommendations about statins.
The January/February 2014 issue of the Women’s Health Activist Newsletter describes the controversy:
“More and more people have become eligible for treatment with cholesterol-lowering medications, especially statins, over the last 25 years. The new guidelines recommend statin use for 33 million Americans — twice as many as were eligible under previous guidelines.”
“The group that created the recent guidelines is rife with conflicts of interest. Although the AHA and ACC (American College of Cardiology) are legitimate medical societies, both take industry money. One of the panel’s two co-chairs, six of fifteen panel members, and half of the ten expert reviewers have conflicts of interest with pharmaceutical manufacturers that make or plan to release cholesterol medications. The committee chair had relationships with six statin manufacturers when he was asked to take on the job. And, although he dropped those connections before assuming the chair’s position in 2008, he failed to disclose his recent conflicts of interest in forms he filled out from 2008 to 2012.”
The AHA downplays the risk of statin side effects in its “Statement on the Safety Profile of Statins: Big Benefit with Low Risk” (Jan. 31, 2023):
“High quality evidence from large randomized control trials (RCTs) have shown statins effectively reduce LDL-C and cardiovascular risk, are generally well-tolerated with low rates of adverse effects, and are easily accessible to patients as generic drugs for about $11 per patient per year.
“One major limitation to statin adherence is the persistent concern about adverse effects largely from case reports and reports on the internet. Given that statin therapy is a cornerstone of ASCVD prevention, it is essential for clinicians to understand statin safety issues and the available evidence supporting the incorrect perception that statins have common adverse effects.
“The adverse effects of statins are generally minor and the majority of evidence does not support the misguided perception of frequent adverse-effects. Improved awareness and recognition of the rarity of adverse effects with statin use among clinicians and patients will bolster cardiovascular prevention efforts as well as support patient adherence to guideline-directed therapy.”
Conflicts of Interest Are Nothing New:
Lest you think the most recent research about conflicts of interest with patient advocacy organization is a recent phenomenon, let us assure you that this has been going on for quite some time. We suspect that drug companies love the perception that these nonprofits are focused on the patients’ best interests.
An article in the Journal of Law, Medicine & Ethics (Fall, 2013) reveals that:
“According to the handful of studies that have investigated the financial ties between PAOs and the pharmaceutical industry, between 30 and 71 percent of PAOs have such relationships… Lilly donated $3,211,144 to advocacy groups during the first two quarters of 2007, and ‘the funding was closely aligned with the company’s therapeutic areas of interest…. Neurosciences, endocrinology, and oncology received 94% of Lilly’s grants.’”
“Further evidence of the significant financial ties between PAOs and industry comes from the public donation disclosures recently provided by several drug makers as a result of lawsuits and new laws affecting the drug companies’ donations to physicians, researchers, and others. For example, GlaxoSmithKline (GSK), one of the largest drug companies in the U.S., states that it works closely with many PAOs…”
Nonprofit PAOs and Conflicts of Interest:
If patient advocacy organizations want the public to trust them and to donate hard-earned dollars to causes like Alzheimer’s disease, cancer or heart disease, then there needs to be more transparency and trust.
The article in JAMA Internal Medicine (Aug. 21, 2023) calls for more openness:
“Close leadership ties of PAOs with industry raise questions about industry’s influence on these organizations’ patient education, policy recommendations, and treatment guidelines. In representing patients across health policy forums, PAOs should make their industry relationships transparent in terms of both finances and leadership to foster trust in their independence.”
I would go even further. I do not think nonprofit charities should allow industry executives to serve on their boards of directors or in any leadership capacity. The pharmaceutical and medical device industries should not be allowed to influence decisions or oversee guidelines.
Research dollars that are distributed by such PAOs should be overseen by investigators without ties to industry. There should be independent patient representatives at all levels of such organizations and they too should be free of conflicts of interest.
What Do You Think About Conflicts of Interest?
Please share your thoughts about this complex but very important topic in the comment section below.