Friday, March 03, 2017

Patient or Corporate Advocacy Organizations? - New Studies Shed Some Light


On Health Care Renewal we frequently discuss how people and institutions entrusted to promote patients' and the public's health instead promote commercial interests. 

For example, health care corporations, particularly drug/ biotechnology/ device companies may enlist key opinion leaders (KOLs).  These are nominally learned academics and distinguished professionals, but who have been paid to market the companies' products.  KOLs often fail to disclose their financial relationships and hence loyalties to these companies.

We have also noted that top leaders of academic medical institutions often serve on the boards of directors of big health care corporations.  In that capacity, they have fiduciary responsibilities to the companies and their shareholders.  They thus are expected to be loyal to these companies, even when corporate interests conflict with their academic organizations' missions.  Again, these relationships may not be well publicized.

Health care leaders and institutions may profess lofty goals, while they cultivate financial relationships that lead to personal gain, but leave them divided and conflicting loyalties.  Furthermore, individuals and institutions may fail to fully disclose these relationships, and thus may deceive health care professionals, patients and the public about the nature of their loyalties.

Institutional Conflicts of Interest and Patient Advocacy Organizations

In the last month, two scholarly articles that show the prevalence of such conflicts of interest (COIs) affecting patient advocacy organizations (also called disease advocacy organizations) were published.

McCoy et al. Conflicts of Interest for Patient-Advocacy Organizations(1)

Published today, March 2, 2017, the article's introduction gives this excellent overview:

Patient-advocacy organizations are nonprofit groups whose primary mission is to combat a particular disease or disability or to work toward improving the health and well-being of a particular patient population. As political actors, such organizations play an influential role in shaping health policy, pursuing agendas that include expanding coverage for drugs, devices, and diagnostic procedures; increasing support for medical research; and streamlining approval of experimental therapies.

Reports by media and watchdog groups have drawn critical attention to financial relationships between patient-advocacy organizations and drug, device, and biotechnology companies. Industry support can be an important resource for patient-advocacy organizations but can also give rise to institutional conflicts of interest, which exist when 'an institution’s own financial interests or the interests of its senior officials pose risks to the integrity of the institution’s primary interests and missions.' In the context of organization–industry relations, concerns have been raised that industry-supported patient-advocacy organizations have spoken out for access to drugs with questionable therapeutic benefit and remained silent on policy proposals, such as drug-pricing reforms, that might benefit their constituents.

This study analyzed public records (US Internal Revenue Service form 990 tax reports, annual reports and website) on the largest US based patient advocacy organizations, that is, those with revenues of at least $7.5 million.  Its goal was to determine how well these organizations disclose conflicts of interests, and how they have COIs, and what policies they have to mitigate their effects.

Its main results were that:

- Disclosure was modest.  88% of organizations disclosed their donors, 52% disclosed approximate amounts of donations, but only 5% disclosed exact amounts.  74% provided some information about the employment of their board members.

- COIs were common.  83% got funding from drug, device, or biotechnology companies.  Of the 57% of organizations that disclosed any information about the amount of funding, 39% received at least $1 million a year.   Furthermore, at least 39% of the companies had at least one current or former drug, device, or biotechnology executive on their own board of directs.

- Policies governing conflicts of interest were infrequent and weak.  Only 26% had publicly available COI policies, and and only 12% of these policies addressed the organizations' instutional conflicts of interest.

Rose SL et al. Patient Advocacy Organizations, Industry Funding, and Conflicts of Interest(2)

This study, published online on January 17, 2017, surveyed "a nationally representative sample of 439 PAO [public advocacy organizations'] leaders," from September 1, 2013 to June 30, 2014.  The survey response rate was 65.8%.  Its main results were that:

COIs were common.  Of the 245 organizations whose leaders responded, 67.3% received industry funding; 33.8% received more than one quarter of their funding from industry, and 11.9% received more than half from industry.  Of those receiving funding, a median of 45% of that funding was from drug, device or biotechnology companies.

Policies governing conflicts of interest were common, but often did not require public disclosure of conflicts.  63.9% of the organizations said they had policies, but only 25.7% had policies that required public disclosure.  The number of organizations that made their policies public was not clear.

So in summary, there is new data obtained systematically from observational studies suggesting that most patient advocacy organizations get substantial funding from health care corporations, especially drug, device or biotechnology companies.  These companies may be marketing drugs and devices for use by patients with the diseases for which the organizations advocate.  Furthermore, many organizations may also be governed by boards which include leaders of these companies.  Finally, disclosure of these COIs may be unreliable.  So health care professionals, patients and the public may not understand where these organizations' loyalties lie. 

Putting Patients and the Public, or Corporate Interests First?

Patient advocacy organizations, like many other kinds of health care organizations claim to put patients and the public's health first.  However such organizations frequently have large institutional conflicts of interest, and may not be at all transparent about such conflicts. 

Such conflicts of interest clearly raise the risk that the organizations may be influenced to put their financial sponsors' interests ahead of those of patients and the public.  However, the articles discussed above were not designed to discover how often such conflicts actually lead to abuse of these organizations' power.  Such abuse could be health care corruption, since corruption is defined by Transparency International as abuse of entrusted power for private gain.

In a New York Times article discussing the most recent study, representives of patient advocacy organizations denied that they possibly could be affected by all those dollars flowing into their coffers.

'Patient advocacy organizations are driven by their missions — putting patients first,' said Marc M. Boutin, the chief executive of the National Health Council, an umbrella group for patient-advocacy groups. 'To say otherwise negates the extraordinary work achieved by these organizations on behalf of their patients.' The health council had previously said that pharmaceutical companies accounted for 62 percent of the council’s $3.5 million budget in 2015.

Furthermore, while "researchers pointed to the National Hemophilia Foundation as one group that is vague about its funding,"

the hemophilia foundation said it never allows its corporate sponsors to influence its decision-making, and that it also does not endorse specific products or favor certain companies.
But  as Joe Collier wrote, "In my experience, people who have conflicts of interest often find giving clear advice (or opinions) particularly difficult."(3) 

Furthermore, commonsense, history, and anecdotal evidence suggests that the conflicts of interest affecting patient advocacy organizations could influence their actions, and could at times lead to health care corruption.  For example, looking through our files, I found....

- Drug companies recruited patient advocacy organizations to advocate for less clinical trial transparency.  In a 2013 news article in the British Medical Journal, "a leaked memo sent to several drug companies from two trade association bodies ... showed that there were plans to recruit patient groups to resist moves that would force the companies to publish more raw trial data."

- Patient advocacy organizations advocated for pharmaceutical company donors' drugs. There are many anecdotes involving patient advocacy groups which receive money from specific drug companies strongly advocating for those companies' products. 

In 2014, a British Medical Journal article showed how two multiple sclerosis charities in the UK advocated that the British National Health Service pay for drugs manufactured by companies which contributed to those charities.

In 2016, two news articles (USA Today, NY Times) noted the curious silence of disease advocacy organizations on the then burning question of high and rising prices of drugs used for their diseases, but manufactured by their sponsors.  Yet the same organizations were quite vocal about the need for insurance companies to pay for these medications.

Furthermore, the NY Times article suggested that patient advocacy organizations which tried to protest high prices on behalf of patients might fight themselves in trouble:

And for patient groups, loudly addressing the issue can be perilous, as Cyndi Zagieboylo, the chief executive of the National Multiple Sclerosis Society, recently discovered.

She said members of her group, one of the most influential patient charities, had identified cost as a priority. The average annual cost for multiple sclerosis medications is $78,000 today, nearly 400 percent higher than the $16,000 average in 2004, the group says.

But as soon as Ms. Zagieboylo started discussing a plan — a modest proposal that involved bringing together drug makers, insurers and others to find solutions — she said she encountered resistance. Other patient groups would not join her, and she said she was told by members of Congress, as well as some of the pharmaceutical companies that donate to her group, to tread carefully.

'We were warned, you know, in a number of ways, just sort of to be careful about this,' Ms. Zagieboylo said. 'A couple of pharmaceutical companies mentioned, ‘Boy, we support you, why are you doing this to us?'

- Donors to patient advocacy organizations think they are buying influence.  An 2016 investigation by the Project on Government Oversight (POGO) showed that companies that fund patient advocacy organizations may think they are thus buying influence.  For example, the report noted vis a vis the National Health Council (whose CEO Marc Boutin was quoted defending its purity above):

In a filing with the Internal Revenue Service, the organization says its mission is 'TO PROVIDE A UNITED VOICE FOR PEOPLE WITH CHRONIC DISEASES AND DISABILITIES.' The filing says National Health Council is a tax-exempt 501(c)(3) corporation, otherwise known as a charitable organization.

The website of Pfizer, a big drug company, shows how Pfizer has categorized it.

Pfizer discloses its membership in National Health Council on a page headed 'Lobbying & Political Contributions,' listing National Health Council under 'Trade Association Memberships,' along with groups such as PhRMA, BIO, U.S. Chamber of Commerce, and Business Roundtable.
So while leaders of patient advocacy organizations may implausibly deny that they possibly could be influenced by corporate donations, there is certainly anecdotal evidence to suggest they may be very much influenced.  He who pays the piper....


We have often talked about the huge and complex web of conflicts of interest that binds many of the important decison makers and leaders in health care to each other, and to other large health care organizations, so that health care in the US has largely become a game for insiders.

This month, we see how frequently institutional conflicts of interest affect patient advocacy organizations, even though such organizations "wrap themselves in white as if they are pure," (per Dr Ezekiel Emanuel, author of the latest study, quoted in the NY Times).  Furthermore, there is ample reason to think that these conflicts often may influence these organizations to put their commercial sponsors' interests ahead of the patients for whom they ostensibly advocate.  Thus in some cases these conflicts may lead to health care corruption, keeping in mind that Transparency International defines corruption as abuse of entrusted power for private gain. 

Compounding it all is the propensity of these organizations to hide the details of their corporate funding.  It's not the crime, it's the coverup.....

Now we live in an era when conflicts of interest and corruption are in the headlines every day.  Maybe here in the USA we are starting to realize that conflicts of interest and corruption are not just some tiresome  concern of party poopers, wet blankets and curmudgeons.  We all have to wonder: are the people and institutions we think are sworn to uphold our interests are actually upholding someone else's interests?

As we have said again and again,...  The huge and complex web of individual and institutional conflicts of interest that binds much of the health care system, the government, and industry may be good for the insiders, but is stifling improvement in our dysfunctional health care system.  True health care reform would first expose these conflicts, then reduce or better yet, eliminate them, and make health care more about helping patients and less about making money by marketing commercial products.


1.  McCoy MS, Carniol M, Chockley K et al. Conflicts of interest for patient advocacy groups.  N Engl J Med 2017; 376: 880.  Link here.
2. Rose SL, Highland J, Karafa MT et al.  Patient advocacy organizations, industry funding, and conflicts of interest.  JAMA Intern Med 2017; doi:10.1001/jamainternmed.2016.8443.  Link here
3.  Collier J. The price of independence. Br Med J 2006; 332: 1447-9. Link here.


Afraid said...

This is expected behavior for Pharma. Paying for the copay is removing most pushback for pricing at pennies on the dollar. Of course it's going to happen. The only way to reduce the influence of money in medicine is to get the money out of medicine.

Judy B said...

I have found that any time I challenge the establishment on anything (guidelines, vaccination schedules, drug prices, appropriate labs, etc.) that I get tremendous push back from medical professionals and I am a mere mortal, not employed by any part of the medical industry...

Afraid said...

Absolutely Judy, only MDs can fix this messed up system.