Industry links with patient organisations
BMJ 2017; 356 doi: https://doi.org/10.1136/bmj.j1251 (Published 14 March 2017) Cite this as: BMJ 2017;356:j1251
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We welcome the editorial from Jeremy Taylor and Simon Denegri on industry links with patient organisations and their criticism of our recent commentary (1), and would like to offer a brief response.
Firstly, while we appreciate the limitations of a short editorial, their piece failed to mention the very relevant recent study by Lin and colleagues, published in the same issue of JAMA Internal Medicine as our commentary. That study analysed public submissions about new guidelines to tackle overuse of opioids, and found advocacy groups funded by the drug manufacturers were much more likely to oppose the guidelines, than those without industry funding. (2) Similarly, industry sponsorship of advocacy groups in other sectors, such as tobacco control, has also been associated with statements that favour industry positions. (3)
While we respect the argument that advocacy groups can be independent from industry while at the same time accepting industry funding, as long as they stick to codes of conduct, in our view the evidence from healthcare and elsewhere strongly suggests money can and does bring influence (4)– which is why we now have such a strong global push for more transparency and more genuine independence.
The authors encourage patient voices to seek out appropriate relations with all players, including industry, and reject our call for disentanglement as “not realistic”. However, given the growing role and influence of the patient voice, true independence is not only realistic, but utterly vital to healthy undistorted debates about healthcare. We full acknowledge that disentangling will be challenging for some groups, but we see a need to help work towards solutions for groups seeking to gain independence from industry, rather than discounting the possibility.
And finally, we think it’s important to remind ourselves of the reality of the global pharmaceutical industry, which produces life-saving medicines, but suffers from a history of illegal behaviour and widespread influence-peddling. As recently as 2016 a report by Transparency International, funded by the UK government, found that within the health sector, “pharmaceuticals stands out as sub-sector that is particularly prone to corruption”, finding “there are abundant examples globally that display how corruption in the pharmaceutical sector endangers positive health outcomes.” (5) One of the key challenges, according to the report, is “the potential for undue influence from companies….on policy and regulation so profit maximisation goes beyond ethical norms and negatively impacts health outcomes and public health objectives.”
(1) Moynihan R, Bero L. Towards a healthier patient voice: more independence, less industry funding. JAMA Intern Med2017;356:350-1. doi:10.1001/jamainternmed.2016.9179 pmid:28114596.
(2) Lin DH, Lucas E, Murimi IB, Kolodny A, Alexander GC. Financial conflicts of interest and the Centers for Disease Control and Prevention’s 2016 Guideline for Prescribing Opioids for Chronic Pain [published online January 17, 2017]. JAMA Intern Med. doi:10.1001/jamainternmed.2016.8471
(3) Apollonio DE, Bero LA. The creation of industry front groups: the tobacco industry and "get government off our back". Am J Public Health. 2007 Mar; 97(3):419-27.
(4) Institute of Medicine, Committee on Conflict of Interest in Medical Research, Education, and Practice. Lo B, Field MJ, eds. Conflict of Interest in Medical Research, Education, and Practice: Summary. Washington, DC: National Academies Press; 2009.
(5) Transparency International, Corruption in the Pharmaceutical Sector. Transparency International. 2016 Available at http://www.transparency.org.uk/publications/corruption-in-the-pharmaceut... Accessed Monday April 3, 2017
Competing interests: No competing interests
Taylor and Denegri (1) are correct that surveys showing the prevalence of pharma funding in patient groups fall short of demonstrating that these groups do not represent the interests of patients. They are also correct that such collaborations are widespread among physicians, medical researchers, guideline writers, and other actors in the health sector. “Everybody’s doing it” is a weak moral justification, however, and unacceptable for a sector that identifies its core values as scientific and ethical.
Two questions are critical in assessing whether pharma funding of patient groups is a defensible practice. First, do such groups publicly advocate for policies favourable to the industry but detrimental to patients’ interests? Second, do they remain silent when the industry promotes policies contrary to patients’ interests? The available evidence is spotty but suggests the answer to both questions is yes. Among the former are campaigns in which patient advocacy groups argue to have drugs approved based on limited evidence (2,3); to have costly new drugs of uncertain or marginal benefit put on insurance formularies (4); to strengthen intellectual property rights (5), and to obstruct transparency in drug trials (6). In each instance, these policies are, if not clearly contrary to patients’ interests’, at least debatable.
Recent headlines point to the failure of pharma funded groups to protest drug prices that are ethically unjustified, unaffordable for many, and unsustainable from a systems perspective (7). Other issues that put patients’ lives in danger merit critical attention from patients, such as the many practices that undermine the clinical trials system (8). If pharma funded patient groups are protesting ghostwritten articles, surrogate end-points, placebo-controlled trials, trials ended too soon or carried on too long to provide answers, and reports that overemphasize benefits and under-report risks, they are doing so quietly.
The examples cited may be unfortunate exceptions to a wider pattern of exemplary advocacy. I argue otherwise (9,10), Rather, despite good intentions, a perfect storm of financial and political factors have created a culture in which most patient organizations now see their interests through the same lens as their corporate funders. Those prepared to critique the for-profit basis on which the industry rests are underfunded and outnumbered at consultations with drug regulators, if they are heard at all (11). Far from solving the problem, lofty-sounding codes for self-regulation developed in concert with industry take us further into Humpty Dumpty land, where words mean exactly what the parties bound by them want them to mean.
1. Taylor J, Denegri S. Industry links with patient organisations. BMJ 2017;356:j1251.
2. Woloshin S, and Schwartz L. US Food and Drug Administration approval of flibanserin: Even the Score does not add up. JAMA Internal Medicine 2016;176, 4:439-442. doi: 10.1001/jamainternmed.2016.0073
3. Davis C, Abraham, J. 2013. Unhealthy Pharmaceutical Regulation: Innovation, Politics and Promissory Science New York: Palgrave Macmillan.
4. Hughes D, Williams-Jones B. Coalition Priorité Cancer and the Pharmaceutical Industry in Quebec: Conflicts of interest in the Reimbursement of Expensive Cancer Drugs? Healthcare Policy 2013;9,1: 52-64.
5. Wibulpolprasert S, Moosa S, Satyanarayana K., Samarage S and Tangcharoensathien V. WHO’s Web-Based Public Hearings: Hijacked by Pharma? Lancet November 24, 2007, 370:1754.
6. Sample I. Big pharma mobilizing patients in battle over drugs trials data. The Guardian, July 19, 2013. https://www.theguardian.com/business/2013/jul/21/big-pharma-secret-drugs...
7. Thomas K. “Furor Over Drug Prices Puts Patient Advocacy Groups in Bind.” New York Times (September 27, 2016). https://www.nytimes.com/2016/09/28/business/furor-over-drug-prices-puts-...
8. Goldacre B. Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients. New York: Faber and Faber; 2012.
9. Batt S. A Community Fractured: Canada’s breast cancer movement, pharmaceutical company funding, and science-related advocacy. In The Public Shaping of Medical Research: Patient associations, health movements and biomedicine Wehling P, Viehöver W and Koenen S (eds.), 132-150. London: Routledge; 2015.
10. Batt S. Health Advocacy, Inc.: How Pharmaceutical Funding Changed the Breast Cancer Movement. Vancouver: UBC Press (forthcoming 2017).
11. Hilzenrath DS. In FDA meetings, “voice” of the patient often funded by drug companies. Washington DC: Project on Government Oversight. December 1, 2016. http://www.pogo.org/our-work/reports/2016/in-fda-meetings-voice-of-the-p...
Competing interests: No competing interests
Taylor and Denegri (1) argue that pharmaceutical industry support of patient organisations can be beneficial provided certain safeguards are in place, notably transparency and patient involvement in allocation of funds.
In making these recommendations, however, the authors ignore three key problems. First, it is now well established that gift recipients experience an unconscious obligation to reciprocate, which may manifest as alignment with benefactor interests. Just as recipients of an unsolicited, even unwanted gift, for example from a religious group, are inclined to donate money in return (2), patient groups funded by industry display attitudes favourable to donors (3).
Second, Taylor and Denegri put much emphasis on the value of transparency, maintaining that disclosure of financial relationships serves to “robustly” manage conflicts of interest. Much evidence now points to the naivety of this view and the fact that disclosure, while necessary, is not sufficient and can, perversely, exacerbate bias (4).
Third, limiting financial support, for example to 5% of total income as National Voices does, is thought to minimise the risk of influence by industry (1). It is now clear, however, that even small gifts can influence attitudes and behaviour (5); drug companies are delighted to see medical students and doctors using pens with their company logo.
Finally, the argument encouraging engagement and ‘appropriate’ financial ties between patient organisations and industry (1) must be challenged. The problem is not overt corruption by industry, but that the unconscious bias resulting from financial sponsorship of patient groups threatens their integrity and reputation. Patients are justifiably sceptical about doctors’ financial links to industry (6); the same scepticism and prudence should apply to their own organisations.
1. Taylor J, Denegri S. Industry links with patient organisations. BMJ 2017;356:j1251.
2. Cialdini RB. Influence: Science and practice. 4th ed. Boston: Allyn & Bacon; 2001.
3. Peredhudoff SK, Alves TL. The patient & consumer voice and pharmaceutical industry sponsorship. Amsterdam: Health Action International (HAI) Europe; 2011. http://haieurope.org/wp-content/uploads/2011/02/31-Jan-2011-HAI-EUROPE-R....
4. Cain DM, Loewenstein G, Moore DA. The Dirt on Coming Clean: Perverse Effects of Disclosing Conflicts of Interest. J Legal Studies 2005;34:1-25.
5. Grande D, Frosch DL, Perkins AW, Kahn BE. Effect of exposure to small pharmaceutical promotional items on treatment preferences. Arch Intern Med 2009;169:887-93.
6. Menkes DB. Industry sponsorship—what do patients think? BMJ 2016;355:i6010.
Competing interests: No competing interests
"Insanity: doing the same thing over and over again and expecting different results." Albert Einstein
Taylor and Denegri’s pledge for pharmaceutical industry funding of patient organisations deserved comment (1)
First, positive myths such as “Industry plays a valid and important role in the provision of medical education” and that “Medical representatives can be a useful resource for healthcare professionals” are still alive despite the robust evidence of the contrary.(2) Therefore, Taylor and Denegri’s naivety is excusable. Taylor and Denegri should: a) understand that industry’s first goal (whatever his business is) is and will always be to create value for its shareholders; b) look at the civil and criminal records of the pharmaceutical industry. (3) In my opinion, no spoon is long enough to sup with the devil.
Second, patient advocacy is not a gift. Independence is not only about funding but also about skills. Basic skills are prerequisites for advocating, they include medicine (public health, pharmacology, psychology, clinical trials methodology …) but also strategic planning, communication … Moreover, public outcry can be counterproductive, such as unduly precluding the use of safe alternatives.(4) AIDS activists developed such skills, better than many professionals and, without financing from the drug industry. That is why they produced new paradigms and why they succeeded.(5)
A charity should not be registered among patient organizations if accepting external funding, as healthcare professionals should not when participating to taskforces. But no problem if a company gave funds to a national charity, not specific to a disease, granting her support thorough a transparent bidding process.
1 Taylor J, Denegri S. Industry links with patient organisations. A healthy relationship is possible if based on integrity, independence, accountability, and transparency. BMJ 2017;356:j1251
2 Braillon A, Bewley S, Herxheimer A et al. Marketing versus evidence-based medicine. Lancet 2012;380:340
3 Braillon A. Drug industry is now biggest defrauder of US government. BMJ. 2012 Jan 10;344:d8219.
4 Tracy EE, Bortoletto P. The role of social networks, medical-legal climate, and patient advocacy on surgical options: A new era. Obstet Gynecol. 2016;127:758-62.
5 Cairney R. In back alleys near Vancouver's AIDS conference, the disease was gaining ground. CMAJ 1996;155:1160-3.
Competing interests: No competing interests
I suspect a lot of the cynicism and suspicion of Big Pharma involvement with and financial links to charitable organisations stem largely from the frequency with which those companies choose to donate to charities working in the same clinical area that they just happen to have a new drug. This also appears true of "educational meeting" invitations that my colleagues and I regularly get through the post- the subject matter is virtually always the same area as the sponsoring drug company's clinical area.
If charities only received funding from pharmaceutical companies with no clinical/financial interest in their particular area of work, there would be much less scope for a conflict of interest, and less suspicion. If charities worry that such a rule would massively reduce their funding they should perhaps question why that might be?
Competing interests: No competing interests
Humpty Dumpty was right!
RR author Batt(1) closes by alleging we’ve wandered into “Humpty Dumpty land, where words mean exactly what the parties bound by them want them to mean.”
I like to check sources, and here’s what I found:
Spot-on: who is to be master?
I haven’t met RR authors Batt, Menkes, Braillon and Wills, much less their scores of “like”rs, so I speak with respect, but I must insist that many of us in the patient community – especially e-patients (2) (empowered, engaged, etc) – are no longer content to have others decide what’s in our best interests, even when they do so with the best of intentions. As internet visionary Clay Shirky said at the Connected Health conference in 2008, "The patients on ACOR (3) don't need our permission, and they don't need our help."
It is particularly inappropriate to suggest (as all the RRs seem to) that we don’t realise what we’re doing, given that the authors seem not to have engaged in live conversation with us to get a sense of whether we’re astute or naïve.
As Master Dumpty said, the question is indeed which is to be master, and we on the patient end of things – for whose benefit your industry exists – are tired of the answer being you.
We are happy to collaborate, for sure, but not to be told what’s in our best interest.
Kindly also note that years ago the Institute of Medicine put a honed professional edge to it, saying “A learning health care system is anchored on patient needs and perspectives,” explicitly citing “Engaged, empowered patients” (4) – e-patients.
We are all in a time of crushing social change, through both the emergence of The Autonomous Patient (5) (catch up! That book was fifteen years ago!) and the dramatic changes in information flow and social connections enabled by the internet. (6) The present dissonance between patient-as-competent and patient-as-naïve should make this change-in-process clear. It’s nothing less than a full-on clash between old paradigm and the surge of competent patients that qualify as “anomalies” that demand change, in the framework of Thomas Kuhn in The Structure of Scientific Revolutions.(7)
It's also a classic blunder for Ms Batt to cite "most patient organizations," a form of blindness to the emergence of a new reality, and especially egregious of her to speak from presumed moral authority: “weak moral justification.” That is the sound of an expiring paradigm raising its head in a dying bellow. I refer Ms. Batt to the newly published “Patient-Driven Drug Development,” whose abstract ends: “In this essay I argue that patient-driven drug development is morally permissible.” (8) (emphasis added)
The sociological shift was exquisitely described eight years ago in Sarah Greene's excellent post Participatory Medicine as Revolution! Think Critically! Communicate!, which looks at Paulo Freire’s Pedagogy of the Oppressed (a revolutionary's view of education) and swaps patient for student, doctor for teacher. Two examples: (italics indicate her substitutions)
• To alienate patients from their own decision making is to change them into objects.
• It is only as patients rethink their assumptions in action that they can change. Understanding and acting upon their own health concerns—not consuming ideas of others—must constitute that process.
Comparable semantic precedents I myself have witnessed include women taking ownership of "girl" (formerly a diminishing term used by men; now a woman executive can talk of "going out with the girls") and Blacks taking ownership of “the n-word.”
I respectfully suggest you stuff that up your Humpty Dumpty allusion:-), because as he said, the question is indeed who’s to be master. Then please re-read Taylor and Denegri’s editorial from the perspective of the new-paradigm autonomous patient.
Thank you for your consideration.
(1) http://www.bmj.com/content/356/bmj.j1251/rr-2
(2) The first generation of e-patients. Ferguson & Frydman, BMJ, 2004 BMJ 2004;328:1148
(3) Association of Online Cancer Resources, now mostly migrated to SmartPatients.com
(4) IOM (Institute of Medicine). 2013. Best care at lower cost: The path to continuously learning health care in America. Washington, DC: The National Academies Press.
(5) Coulter A. The Autonomous Patient: Ending Paternalism in Medical Care. London: Stationery Office (for the Nuffield Trust), 2002. [128 pp; ISBN 0-11-703056-2 (p/b)]
(6) From patient centred to people powered: autonomy on the rise BMJ 2015;350:h148
(7) Kuhn T. The Structure of scientific revolutions. University of Chicago Press, 1962; 50th edition, 2012
(8) Flanigan J. This essay is the opening chapter in Philosophical Issues in Pharmaceutics. Ho, Dien, editor. Doi: 10.1007/978-94-024-0979-6
(9) Freire, Paulo. Pedagogy of the Oppressed. New York: Herder and Herder, 1972.
Competing interests: No competing interests