A valuable perspective on regulatory capture is provided in 'Pharmaceutical Ethics and Grassroots Activism in the United States: A Social History Perspective' by Sharon Batt, Judy Butler, Olivia Shannon and Adriane Fugh-Berman in (2020) 17 Journal of Bioethical Inquiry 49-60 which comments
Women’s health activists laid the ground-work for passage of the law that created the U.S. Food and Drug Administration in 1906. The pharmaceutical and food industries fought regulatory reforms then and continue to do so now. We examine public health activism in the Progressive Era, the postwar era and the present day. The women’s health movement began in the 1960s, and criticized both the pharmaceutical industry and the medical establishment. In the 1990s, patient advocacy groups began accepting industry funds; thousands of commercially-funded groups now dominate the advocacy landscape. As pharma funding became normalized, concerns arose regarding a) the lack of transparency and public accountability regarding funding, b) the distortion of groups’ agendas, and c) the ability of pharma-funded groups to dominate the discourse and override less well-resourced patient and health advocacy groups. Although industry-funded groups argue that funding allows them to provide useful services, the trade-off in health risks, exorbitant prices and distorted information is far too high. Sincerity is beside the point; patients and the industry have differing interests when it comes to drug safety and efficacy, drug information and drug prices. A growing resistance movement is asserting the values of its activist predecessors and opposing the prevailing culture of pharma-funded advocacy.
After a cogent historical analysis the authors state
By the end of the decade, patient groups existed for every major disease and had gained status within the policy community. Industry recognized the potential marketing advantages and “pharma partnerships” (Batt 2017) gradually became normalized and formalized, with codes of ethics governing the relationships set out by organizations and industry groups (PhRMA 2014). Pharmaceutical industry publications and presentations showed a transition from a haphazard “spray and pray” method of corporate giving to a more strategic approach designed to advance corporate goals (Cox 2002; Best Practices 2004). Companies gave larger sums of money to key organizations; ongoing relationships helped the companies gain faster drug approvals, place expensive new drugs on formularies, and achieve rapid recruitment into clinical trials. Public relations companies played matchmaker, introducing companies to “the right partner” (Breitstein 2002) and framing core messages for national and regional audiences.
Today, thousands of patient advocacy groups operate within the United States and studies estimate that at least two-thirds accept funds from the pharmaceutical industry. Studies over thirteen years using different methodologies reveal a consistent pattern. A 2006 New Scientist survey sampled twenty U.S. patient advocacy groups with annual revenues over $100,000 and found that sixteen (80 per cent) received industry funding (Marshall and Aldhous 2006). Only two, the National Women's Health Network and Breast Cancer Action, had an explicit policy against taking money from pharmaceutical companies (Marshall and Aldhous 2006). Kaiser Health News and The Washington Post found that pharmaceutical companies gave at least $116 million to American patient advocacy groups in 2015 alone (Kopp, Lupkin, and Lucas 2018). A 2017 study utilized an encyclopedic directory of U.S. national organizations to count up 7,865 patient advocacy groups (Rose et al. 2017). A sample of 289 of these organizations found that 67.3% reported receiving funds from a pharmaceutical company in the past year, with a median gift of $50,000. A recent study of twenty-four patient advocacy organizations concerned with dermatologic conditions and with annual revenues over $500,000 found that seventeen (71%) received industry funding; four received donations of more than $800,000 (Li, Singer, and Mostaghimi 2019). This study also independently checked organizational boards and found that more than half (thirteen of twenty-four) had a current or former industry executive as a board member.
Pharmaceutical industry funding of these groups often comprises a significant proportion of their total budget. For example, three-quarters of the Depression and Bipolar Support Alliance’s 2005 revenue was from fifteen major donors, twelve of which were drug or device companies (Marshall and Aldhous 2006, 20). Furthermore, sponsors made drugs that treated relevant conditions. Almost half of the Restless Legs Syndrome Foundation’s $1.4 million revenues came from GlaxoSmithKline ($450,000) and Boehringer Ingelheim (about $178,000): both companies manufacture restless legs syndrome drugs (Marshall and Aldhous 2006).
The investigative magazine Mother Jones reported that, between 1996 and mid-1999, eighteen drug companies gave The National Alliance on Mental Illness (NAMI) $11.72 million, with the largest amount coming from Eli Lilly, the manufacturer of Prozac (fluoxetine) (Silverstein 1999). Several years later a committee headed by Senator Charles Grassley found that, between 2006 and 2008, NAMI received more than $23 million—three quarters of the organization’s budget— from pharmaceutical companies (Harris 2009).
Industry funding of patient advocacy has become normalized. It is unclear how pharmaceutical funding became so widespread, but the phenomenon was well established by 2000 (Mills 2000). Some groups were funded in the early 1990s. In 1992, Burroughs Wellcome, the company that developed AZT (the first AIDS treatment), funded several AIDS groups. Project Inform, in San Francisco, and The New York-based Treatment Action Group (TAG), received $150,000 and $1 million, respectively (Epstein 1996, 299). Breast Cancer Action (BCA) received several small grants from pharmaceutical companies in the early 1990s, including $1,000 from Genentech, maker of Herceptin (Batt 2017), but in 1998, BCA established a policy that it would no longer take industry funds (Brenner 2000). ... As pharma funding became the norm, the debate about conflicts of interest entered the health policy and public discourse. Concerns include a) the lack of transparency and therefore public accountability with respect to funding, b) the loss of independence of the groups and the distortion of their agendas, and c) the ability of pharma-funded groups to dominate the discourse and override less resourced patient and health advocacy groups with traditional consumer rights perspectives.
The following sample of the many studies and reports in the past fifteen years illustrate the three problems.
Transparency and Public Accountability
Many advocacy groups do not adequately acknowledge their corporate funders. An international study of groups in the United States, United Kingdom, Australia, Canada, and South Africa found that the extent of relationships with industry was inadequately disclosed in websites that addressed ten health conditions: cancer, heart disease, diabetes, asthma, cystic fibrosis, epilepsy, depression, Parkinson's disease, osteoporosis, and rheumatoid arthritis (Ball, Tisocki, and Herxheimer 2006). A U.S. study found that only one quarter of organizations that received Eli Lilly grants acknowledged the company’s contributions on their websites. One out of ten organizations acknowledged Eli Lilly as an event sponsor, and none disclosed the exact amount of the grant (Rothman et al. 2011). A study of 104 patient advocacy organizations found that although 88% published lists of donors on either their website or in their annual report, only 57% indicated amounts of the donations (half of these provided only ranges, not actual amounts). Only ten of 104 disclosed how funds were used (McCoy et al. 2017). A study of organizations in Washington, D.C., found that eighteen (31.0%) of the fifty-eight professional organizations and research, education, and advocacy organizations that received $25,000 or more in 2012 failed to disclose the names of corporate donors on their websites or in online 2012 annual reports (Borkowski et al. 2015). Only eight of forty organizations that disclosed provided the information both on their websites and in their online 2012 annual reports (Borkowski et al. 2015).
In April 2018, Kaiser Health News launched the database “Pre$cription for Power” using IRS documents and reports from company websites to document payments from pharmaceutical companies to advocacy group (Kopp, Lupkin, and Lucas 2018). Although the database is incomplete, it is a start.
Loss of Independence and Distortion of Agendas, Including Silence About Pharmaceutical Harms and High Prices
In a report about industry funding of non-profits, Michael Jacobson, head of the Center for Science in the Public Interest, notes that “industry appears either to influence an organization's positions or to limit an organization's freedom to speak out on matters of interest to the funders” (Jacobson 2005). Instead of critiquing dangerous drugs or protesting high drug prices, patient groups argued for expanded access to expensive, sometimes minimally effective, treatments.
Groups in partnerships with industry have been silent on drug harms and rising prices. The American Diabetes Association (ADA) takes more than a million dollars annually in support from Eli Lilly, Novo Nordisk, and Sanofi, the three top insulin manufacturers (Kopp, Lupkin, and Lucas 2018). In 2015, the ADA took $2.9 million from Eli Lilly alone. The ADA has not criticized any company for rising insulin prices. Additionally, when legislators in Nevada passed a bill in 2017 requiring insulin manufacturers to publicly disclose their profits to the public, the organization did not comment (Kopp, Lupkin, and Lucas 2018).
Patient groups were also silent about the sudden rise in the price of EpiPens, automatic injectors used to treat severe allergic reactions. EpiPen manufacturer Mylan funds several advocacy groups, including Food Allergy Research & Education (FARE) and the Asthma and Allergy Foundation of America (AAFA). Both FARE and AAFA were silent about Mylan tripling the price of EpiPens. Neither advocacy group informed their members about the availability of less expensive epinephrine injectors or prefilled epinephrine syringes (Batt and Fugh-Berman 2016). In 2016, Mylan used the Allergy and Asthma Network and other advocacy organizations to campaign to add EpiPens to the federal preventive drug list (McCoy 2018); this would have eliminated patient copayments while leaving payers on the hook for an expensive device that contains two dollars worth of medication. In 2017, Mylan made about twelve billion dollars in revenue.
In a third example, a coalition of advocacy organizations that hid their ties to the pharmaceutical industry opposed a demonstration project testing lower payment rates for some drugs covered by Medicare. The project would have reduced industry profits (McCoy 2018). A subsequent report by Public Citizen showed that industry funded 75% of the 147 organizations that signed at least one letter opposing the project (Public Citizen 2016).
Some groups even oppose the provision of important safety information. NAMI, which receives three-quarters of its funding from industry, not only promoted its sponsor’s medications but opposed FDA black box warnings on serotonin reuptake inhibitor antidepressants that would have informed patients that the drugs increased the risk of suicide in adolescents (Rose 2013).
Distortion of the Public Discourse
Biologics, made from lab-altered cell lines rather than chemicals, are setting new price records. AbbVie, whose drug Humira makes up two-thirds of its revenue, gave $2.7 million to the Crohn’s & Colitis Foundation and $1.6 million to the Arthritis Foundation in 2015 (Kopp, Lupkin, and Lucas 2018). Humira, which treats autoimmune diseases, is the highest-grossing drug in the United States. Although the drug costs almost five thousand dollars a month, neither the Crohn’s & Colitis Foundation nor the Arthritis Foundation has protested its price. Moreover, both groups have raised non-evidence-based safety concerns about biosimilars (the biologics equivalent of generic drugs) and both belong to Patients for Biologics Safety and Access, a coalition that opposes pharmacist substitution of a biosimilar for a prescribed biologic. The coalition’s funders include AbbVie and Johnson & Johnson, a subsidiary of which, Janssen, makes the biologic Remicade. Although biosimilars would save money for patients and payers, the Arthritis Foundation has been a vocal supporter of state legislation that makes it more difficult for patients to receive biosimilars (Kopp, Lupkin, and Lucas 2018). Opposing, rather than supporting, biosimilar access is an excellent example of industry distortion of the public health discourse.
The story has striking parallels to an account in the Canadian Globe and Mail about two projects in Canada on biosimilars involving patient groups that receive funding from biosimilar manufacturers. (Grant 2018). In 2016 and 2017, Crohn’s and Colitis Canada spearheaded a national letter campaign called “No Forced Switch.” Patients and their supporters bombarded officials across the country with 4,500 form letters that opposed compelling patients to switch to biosimilars. In March 2017, the Arthritis Society of Canada led a focus group project on biosimilars for members of patient advocacy groups, with funding from AbbVie and Janssen (the manufacturer of Remicade). A report from the focus group prepared for Health Canada (the Canadian regulatory equivalent of the FDA) said that patients “strongly opposed” switching from their brand-name drug to a biosimilar (Biosimilar Focus Group 2017).
Upon seeing a draft report, one advocacy group withdrew its support, objecting to the fact that the findings aligned with the viewpoint of the drug companies. The group that withdrew from the report had previously received 90% of its funding from Janssen and AbbVie. In a stark example of the unspoken restrictions attached to pharmaceutical funding, Janssen subsequently rejected the group’s funding requests (Grant 2018).