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Health Advocacy Organizations: Patients’ Voices or Corporate Front Groups?

Health Letter, October 2013

If you or a loved one has ever been diagnosed with a severe disease, such as cancer, it is likely that one of your first responses was to seek out a support group or other organization of patients with the same condition. Some of these patient groups, known as health advocacy organizations (HAOs), are among the most visible public voices influencing health policy in this country. HAOs are a diverse collection of nonprofit groups covering a wide range of diseases and agendas, which give a human face to disease-related advocacy. They range in size from small teams of a few full-time staff focused on rare diseases (such as the Trisomy 18 Foundation) to influential national organizations with millions of volunteers and supporters (such as the American Heart Association and American Cancer Society).

Many HAOs play a vital role in promoting public health through raising disease awareness, holding mass screenings, funding research and advocating for public policy in the perceived best interest of their members. However, a series of recent studies have found that HAOs often accept large sums of money from the drug industry and that a glaring lack of transparency characterizes most of these financial ties. Such relationships inevitably raise questions about potential conflicts of interest at play in the operations and policy positions of these highly influential, trusted organizations.

Can HAOs be trusted to provide fair and balanced information?

Lack of transparency

In 2011, Dr. Sheila Rothman and colleagues at Columbia University and New York University analyzed the financial records of Eli Lilly, one of the world’s largest pharmaceutical companies, to tabulate the number of HAOs to which the company had given a grant, as well as the extent to which the HAOs disclosed these ties. The researchers found that during the first six months of 2007, Eli Lilly had given grants to a total of 188 HAOs, primarily to organizations that worked in diseases related to its bestselling products. A total of 94 percent of the grants went to HAOs working in the three therapeutic areas (neurosciences, oncology and endocrinology) that generated 87 percent of Eli Lilly’s U.S. sales at the time.

This was not surprising given Eli Lilly’s stipulation in its guiding principles for grant-making that it expects to “build long term relationships [with grantees] … based on mutual support,” while offering the disclaimer that those receiving grants are not “obligated or directed to use these funds in a manner that benefits the company or its products.”

Although the financial ties were pervasive, in most cases they were not disclosed anywhere on the HAOs’ websites. Of the 161 HAOs for whom the researchers had found a website, only 25 percent disclosed that they had received grant money from Eli Lilly, including only 18 percent of HAOs working in the neurosciences, Eli Lilly’s most lucrative therapeutic area. None of the 161 HAOs disclosed on their websites the exact amounts received from the company.

Extensive industry-HAO relationships are not unique to the U.S. In 2010, the nonprofit group Health Action International-Europe (HAI-Europe) surveyed the 23 patient groups (itself included) eligible to participate in the European Medicines Agency’s (EMA’s) Patient and Consumer work group, which advises and makes policy-related recommendations to the agency. HAI reviewed the organizations’ annual financial statements to determine the share of their funding from health care companies from 2006 to 2008. Fifteen of the 23 organizations (65 percent) received funding from health care companies. Over the three-year period studied, corporate funding made up an increasing proportion of the organizations’ annual budgets, rising from 47 percent in 2006 to 57 percent by 2008.

As with the Rothman study of U.S. HAOs, a lack of full transparency also was apparent. Fewer than half of all the European organizations (including HAI-Europe, though the organization accepts no corporate money) disclosed their financial data in the format mandated by the EMA, which requires names of individual donors and the corresponding contributions relative to the organization’s annual budget. The European Union’s (EU’s) Executive Agency for Health and Consumers (EAHC), a research-funding arm of the EU, gives grants only to organizations that receive less than 20 percent of their funding from industry. However, HAI-Europe noted that while the EAHC has created guidelines requiring financial transparency, it did not stipulate any mechanisms for holding organizations accountable for noncompliance with the guidelines, presenting an enforcement challenge.

Corporate funding and public policy

Though it is self-evident that companies would not continue to give money to HAOs unless they perceived some financial benefit from the arrangement, it is difficult to prove empirically whether HAOs respond to funding by changing their advocacy approach. However, in 2011, HAI-Europe attempted to do just that. The group examined whether organizations’ industry ties correlated with their positions on key policies affecting patients (and the drug industry). HAI-Europe surveyed the same European HAOs (this time excluding itself) it had earlier studied, eliciting their views on pending EU legislation (since approved) that would expand the type of drug-specific information that pharmaceutical companies could communicate directly to European consumers (though the law purportedly preserves the European ban on pharmaceutical direct-to-consumer advertising, which is legal in the U.S.).

Among the organizations that responded, a striking correlation was seen between their views of the proposed legislation and their financial connections with drug companies. All six of the organizations that received money from the drug industry were in favor of allowing companies to distribute more information to the public, while none of the five companies without industry backing supported such a move.

Anecdotally, such bias also is reflected in public debates concerning important health regulatory decisions. Public Citizen’s Health Research Group (HRG) routinely testifies at Food and Drug Administration advisory committees on important matters before the agency, such as new drug approvals or serious safety issues concerning a drug or class of drugs. Usually during the public hearings, HRG is the lone voice warning of the dangers of a new and often ineffective medicine. And many of those speaking in favor of the drugs are patients or other representatives of industry-funded HAOs, whose travel expenses are paid for by the drug manufacturer and who give harrowing testimony about their conditions, imploring the committee to vote in favor of the drug in question.

These patients’ stories are true, and their concerns are entirely understandable. Anyone who has ever been diagnosed, or has known someone diagnosed, with a debilitating or life-threatening condition can empathize with these stories and identify with the desperation for any treatment that promises to alleviate their condition. Yet it also is true that the patients’ and HAOs’ wishes for more treatment options happen to coincide with the financial interests of drug companies. And all too often, the patients are only able to tell their stories because of the financial largesse of those same companies eager to present a compelling case to the committees on whom the fate of their lucrative medicines hinge.

Are these patients therefore being co-opted, or is underwriting the patients’ presentations a legitimate and necessary means that justify the ends of more life-saving therapies for these patients and others?

Shareholder versus patient interests

HAOs that accept drug industry money understandably cry foul at suggestions that the money influences their actions in any way. Such was the case in 2011, when a public spat between the French nonprofit pharmaceutical information publication Prescrire and the French Diabetic Association highlighted the arguments at the heart of this debate. The row concerned a French law that allowed pharmaceutical companies to underwrite “therapeutic education programs” and “patient assistance” initiatives, as long as patient groups and health care professionals designed and managed the programs.

A Prescrire editorial in 2009 criticized French HAOs that supported the law and took money from the drug industry rather than lobby more strongly for public money to fund their activities, citing the French Diabetic Association as an example. In a combative open letter responding to the allegation, the French Diabetic Association maintained that patient groups play a vital role in educating the general public about health issues. The association also alluded to the limited financial resources of some HAOs, such as itself, as a reason why so many feel compelled to turn to industry funding, and it insisted that corporate money had not compromised its mission or positions on the issues affecting its members.

The Prescrire editors countered that the nature of the influence of donor companies on HAOs is much more subtle than the image of a nefarious quid pro quo relationship evoked by the French Diabetic Association. Accepting money from a drug company does not result in night-and-day differences in the policies and actions of the organizations, they argued. Rather, a company only gives to organizations that it perceives as favorable to its products and, in turn, the organizations may slowly, over time, adapt their operations due to “subtle feelings of gratitude for receiving a benefit rather than to blatant corruption.”

This is not to say that HAOs do not do good work. There is no shortage of HAOs that do not accept money from corporate interests, and many HAOs play a crucial role in raising awareness of, and directing crucial research money to, devastating diseases that affect millions of people. Dr. Rothman opened a critique of HAOs published in the Journal of the American Medical Association with the following observation: “Strong and independent [emphasis added] not-for-profit advocacy organizations are vital to a democratic society. At their best, they stand apart from the interests of the marketplace and the government, helping to promote diverse public concerns.”

But creeping corporate influence — in the form of financial ties — can compromise this core mission of the organizations and, in subtle but real ways, direct their energies toward strengthening the bottom lines of large pharmaceutical companies rather than enhancing the health of the patients whose interests they claim to represent. In other words, such ties serve only to corrupt HAOs’ otherwise laudable and often life-saving activities.

In the original editorial that triggered the confrontation with the French Diabetic Association, Prescrire reminded its readers of the simple, overarching truism that governs corporate-HAO relationships: “One thing is certain: drug company shareholders will only tolerate spending on patient education if it increases profits. To lose sight of this fact would be naive, hypocritical or cynical.”