Patient Advocacy Organizations: Institutional Conflicts of Interest,Trust,and Trustworthiness

I use the term Patient Advocacy Organizations (PAOs) for the organizaitons I discuss in this article. Other terms commonly used in the literature include: Simply “advocacy groups,” “disease advocacy groups,” “health advocacy groups,” and “health consumer groups.” I distinguish PAOs from professional organizations, which typically focus on advancing their profession as a primary goal. In this article I focus on the advocacy and educational activities, as opposed to focusing upon the more individual clinical services that many of these organizations also provide.

Markman M. , “The Increasingly Complex World of Cancer Patient Advocacy Organizations,” Current Oncology Reports 10, no. 1 (2008): 1–2; Dresser R. , When Science Offers Salvation: Patient Advocacy and Research Ethics (Oxford: New York: Oxford University Press, 2001); Rothman S. M. , “Health Advocacy Organizations and Evidence-Based Medicine,” JAMA 305, no. 24 (2011): 2569–2570, at 24; Rothman S. M. Raveis V. H. Friedman A. , “Health Advocacy Organizations and the Pharmaceutical Industry: An Analysis of Disclosure Practices,” American Journal of Public Health 101, no. 4 (2011): 602–609; Armstrong E. M. Carpenter D. P. Hojnacki M. , “Whose Deaths Matter? Mortality, Advocacy, and Attention to Disease in the Mass Media,” Journal of Health Politics, Policy & Law 31, no. 4 (2006): 729–772.

See Dresser , supra note 2; Rothman (2011), supra note 2; Armstrong Carpenter Hojnacki , supra note 2; Herxheimer A. , “Relationships between the Pharmaceutical Industry and Patients' Organisations,” BMJ 326, no. 7400 (2003): 1208–1210; Buttle F. Boldrini J. , “Customer Relationship Management in the Pharmaceutical Industry: The Role of the Patient Advocacy Group,” International Journal of Medical Marketing 1, no. 3 (2001): 203–214.

Hans L. , “Pharmaceuticals and the Consumer Movement: The Ambivalences of ‘Patient Power,’” Australian Health Review, no. 28 (2004): 228–237, at 2; Tomes N. , “The Patient as a Policy Factor: A Historical Case Study of the Consumer/Survivor Movement In Mental Health,” Health Affairs 25, no. 3 (2006): 720–729, at 3.

American Cancer Society, available at <http://www.cancer.org/> (last visited July 1, 2013).

See Rothman (2011), supra note 2; Tomes , supra note 5; Noordman J. van Dijk L. Friele R. , “Patient Organisations and the Reimbursement Process for Medicines: An Exploratory Study in Eight European Countries,” BMC Health Services Research,10 (2010): 45–51.

See Dresser , supra note 2.

Institute of Medicine, “About the IOM,” Institute of Medicine website, available at <http://www.iom.edu/About-IOM.aspx> (last visited July 1, 2013).

Lo B. Field M. J. , eds., Institute of Medicine, Committee on Conflict of Interest in Medical Research EaP et al., Conflict of Interest in Medical Research, Education, and Practice (Washington, D.C.: National Academies Press, 2009).

Id., at 82.

Thompson D. F. , “Understanding Financial Conflicts of Interest,” New England Journal of Medicine, no. 329 (1993): 573–576; I thank Dennis Thompson for helping me better understand the ethical and policy implications of conflicts of interest as proposed by the IOM, and the distinction between trust and trustworthiness as it applies to this definition.

See Lo Field , supra note 9.

See Markman , supra note 2; Dresser , supra note 2; Rothman (2011), supra note 2; Ball D. E. Tisocki K. Herxheimer A. , “Advertising and Disclosure of Funding on Patient Organisation Websites: A Cross-Sectional Survey,” BMC Public Health 6 (2006): 201–212; Mosconi P. , “Industry Funding of Patients' Support Groups: Declaration of Competing Interests Is Rare in Italian Breast Cancer Associations,” BMJ 327, no. 7410 (2003): 343–344; Baggott R. Forster R. , “Health Consumer and Patients' Organizations in Europe: Towards a Comparative Analysis,” Health Expectations 11, no. 1 (2008): 85–94; Colombo C. Mosconi P. Villani W. , “Patient Organizations' Funding from Pharmaceutical Companies: Is Disclosure Clear, Complete and Accessible to the Public? An Italian Survey,” PLoS One, no. 7 (2012): e34974–80.

See Rothman (2011), supra note 2.

Id., at 604.

Marshall J. Aldhous P. , “Swallowing the Best Advice?” New Scientist 192 (2006): 18–22, available at <http://www.newscientist.com/article/mg19225755.100-patient-groups-special-swallowing-the-best-advice.html> (last visited July 1, 2013).

See Lo Field , supra note 9.

Id., at 2; Rothman (2011), supra note 2.

See Marshall Aldous , supra note 17, at 22. It is important to note that Table 1 provides information on only a handful of the groups included in this investigation.

Brennan T. A. Mello M. M. , “Sunshine Laws and the Pharmaceutical Industry,” JAMA, no. 297 (2007): 1255–1257; Bass A. , Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial, 1st ed. (Chapel Hill, N.C.: Algonquin Books of Chapel Hill, 2008); Prescription Drug 2009 Enacted Laws, Compiled by Cauchi Richard Thangasamy Andrew , National Conference of State Legislatures (2010), available at <http://www.ncsl.org/issues-research/health/archive-2009-prescription-drug-enacted-state-laws.aspx> (last visited July 18, 2013).

GlaxoSmithKline, “Grants and Charitable Contributions,” 2009, available at <http://www.gsk.com/responsibility/responsibility-reports-and-resources/charitable-grants.html> (last visited July 1, 2013).

In order to obtain some estimates of how much GSK donated to PAOs, I reviewed all 689 donations and contributions listed in the 2009 report. Of these, I excluded donations made to universities, hospitals, continuing educational services, and other non-profits that are not considered PAOs. I included all organizations that focused on advocacy for people with a particular disease, or group of diseases. If there was a question about whether or not an organization met the criteria for being a PAO, I checked the organization's website, mission statement, and other materials. Organizations that specifically stated that they engaged in advocacy activities were included. A few did not use the word “advocacy,” but the descriptions of the activities and mission indicated that they did engage in such activities and, therefore were also included in the sample.

See Markman , supra note 2; Dresser , supra note 2; Mintzes B. , “Should Patient Groups Accept Money from Drug Companies? No,” BMJ, 334, no. 7600 (2007): 935; Kent A. , “Should Patient Groups Accept Money from Drug Companies? Yes,” BMJ 334, no. 7600 (2007): 934; Batt S. , “Marching to Different Drummers: Health Advocacy Groups in Canada and Funding from the Pharmaceutical Industry,” Women and Health Protection (2005), available at <http://www.whp-apsf.ca/pdf/corpFunding.pdf> (last visited July 18, 2013).

Angell M. , The Truth About the Drug Companies: How They Deceive Us and What to Do About It (New York: Random House, 2004).

Id.; see Mintzes , supra note 23; see Rothman (2011), supra note 2; Lo Field , supra note 9; Ball Tisocki Herxheimer , supra note 13.

Ornstein C. Weber T. , “The Champion of Painkillers,” in ProPublica (2011), available at <http://www.propublica.org/article/the-champion-of-painkillers> (last visited July 18, 2013).

Cain D. M. Detsky A. S. , “Everyone's a Little Bit Biased (Even Physicians),” JAMA 299, no. 24 (2008): 2893–2895; Kouchaki M. Smith-Crowe K. Brief A. P. , “Seeing Green: Mere Exposure to Money Triggers a Business Decision Frame and Unethical Outcomes,” Organizational Behavior and Human Decision Processes 121, no. 1 (2013): 53–61.

Id. (Cain and Detsky); Stelfox H. T. Chua G. O'Rourke K. , “Conflict of Interest in the Debate over Calcium-Channel Antagonists,” New England Journal of Medicine 338, no. 2 (1998): 101–106; Lundh A. Sismondo S. Lexchin J. , “Industry Sponsorship and Research Outcome,” Cochrane Database of Systematic Review 12 (2012): MR000033; Lexchin J. Bero L. A. Djulbegovic B. , “Pharmaceutical Industry Sponsorship and Research Outcome and Quality: Systematic Review,” BMJ 326 (2003): 1167–1170; Davidson R. A. , “Source of Funding and Outcome of Clinical Trials,” Journal of General Internal Medicine 1 (1986): 74–108, at 3; Perlis R. H. Perlis C. S. Wu Y. , “Industry Sponsorship and Financial Conflict of Interest in the Reporting of Clinical Trials in Psychiatry,” American Journal of Psychiatry 162, no. 10 (2005): 1957–1960; Rodwin M. A. , Medicine, Money, and Morals: Physicians' Conflicts of Interest (New York: Oxford University Press, 1993); Grande D. Frosch D. L. Perkins A. W. , “Effect of Exposure to Small Pharmaceutical Promotional Items on Treatment Preferences,” Archives of Internal Medicine,169, no. 9 (2009): 887–893; Wazana A. , “Physicians and the Pharmaceutical Industry: Is a Gift Ever Just a Gift?” JAMA 283, no. 3 (2000): 373–380.

See Lo Field , supra note 10.

Id.; Rothman D. J. McDonald W. J. Berkowitz C. D. , “Professional Medical Associations and Their Relationships with Industry: A Proposal for Controlling Conflict of Interest,” JAMA 301, no. 13 (2009): 1367–1372; Cosgrove L. Wheeler E. , “Drug Firms, the Codification of Diagnostic Categories, and Bias in Clinical Guidelines,” Journal of Law, Medicine & Ethics 41, no. 3 (2013): 644–653.

Established in 1979, NAMI provides education and advocates for people with mental illness and their families. It seeks to improve policies and research to help the mentally ill in the U.S. NAMI is a national organization, governed by a 16-member board of directors, with state and local chapters that focus on concerns of constituents' communities or states. The national office develops a strategic plan for the organization and provides financial and technical support to the local and state affiliates. NAMI receives donations from many sources, its revenue and support for 2011 was approximately $10,471,287.00.

See Bass , supra note 20; Bass A. , “NAMI Exposed: The Drug Money behind This Supposedly Grassroots Group,” 2009, available at <http://alison-bass.blogspot.com/2009/04/nami-exposed-drug-money-behind-this.html> (last visited July 1, 2013).

Harris G. , “Drug Makers Are Advocacy Group's Biggest Donors,” New York Times, October 21, 2009.

Id., at A23.

See Bass , supra note 20.

Id.

See Mintzes , supra note 23; Buttle Boldrini , supra note 3; Burton B. , “Drug Companies Told That Sponsoring Patients' Groups Might Help Win Approval for Their Products,” BMJ 331, no. 7529 (2005): 1359.

See Lo Field , supra note 9.

Ben-Ner A. Putterman L. , “Trusting and Trustworthiness,” Boston University Law Review, no. 81 (2001): 523–551. In addition to constituents, funders, legislators, the public and others can be considered “A.”; Bryce H. J. , “The Public's Trust in Nonprofit Organizations: The Role of Relationship Marketing and Management,” California Management Review 49, no. 4 (2007): 112–131; Herzlinger R. E. , “Can Public Trust in Nonprofits and Governments Be Restored?” Harvard Business Review 74, no. 2 (1996): 97–107; Kramer R. M. , “Trust and Distruct in Organizations: Emerging Perspectives, Enduring Questions,” Annual Review of Psychology 50 (1999): 569–598; Mechanic D. , “The Functions and Limitations of Trust in the Provision of Medical Care,” Journal of Health Politics, Policy & Law 23, no. 4 (1998): 661–686; Maloy J. S. , “Two Concepts of Trust,” Journal of Politics,71, no. 2 (2009): 492–505; Levi M. Stoker L. , “Political Trust and Trustworthiness,” Annual Review of Political Science 3 (2000): 475–508; Hardin R. , Trust and Trustworthiness (New York: Russell Sage Foundation, 2002); MacDonald C. McDonald M. Norman W. , “Charitable Conflicts of Interest,” Journal of Business Ethics 39 (2002): 67–74.

Id. ( Hardin ), at 526.

Id.

See Ben-Ner Putterman , supra note 39.

See Levi Stoker , supra note 39.

Id., at 476.

See Hardin , supra note 39.

See Rothman , supra note 31.

AAMC Task Force on Financial Conflicts of Interest in Clinical Research, Protecting Subjects, Preserving Trust, Promoting Progress II: Principles and Recommendations for Oversight of an Institution's Financial Interests in Human Subjects Research , Academic Medicine (2003), at 237–245.

See Lo Field , supra note 10; see AAMC Task Force, supra note 48; Campbell E. G. , “Public Disclosure of Conflicts of Interest: Moving the Policy Debate Forward,” Archives of Internal Medicine 170, no. 8 (2010): 667; Ehringhaus S. Korn D. , U.S. Medical School Policies on Individual Financial Conflicts of Interest: Results of an AAMC Survey, in Colleges, Association of American Medical Colleges (2004); McCrary S. V. Anderson C. B. Jakovljevic J. , “A National Survey of Policies on Disclosure of Conflicts of Interest in Biomedical Research,” New England Journal of Medicine 343 (2000): 1621–1626.

Fung A Graham M. Weil D. , Full Disclosure: The Perils and Promise of Transparency (Cambridge: Cambridge University Press, 2007).

Cain D. M. Loewenstein G. Moore D. A. , “The Dirt on Coming Clean: Perverse Effects of Disclosing Conflicts of Interest,” Journal of Legal Studies 34 (2005): 1–25; Weinfurt K. P. Friedman J. Y. Allsbrook J. S. , “Views of Potential Research Participants on Financial Conflicts of Interest: Barriers and Opportunities for Effective Disclosure,” Journal of General Internal Medicine 21, no. 9 (2006): 901–906; Weinfurt K. P. Hall M. A. Friedman J. Y. , “Effects of Disclosing Financial Interests on Participation in Medical Research: A Randomized Vignette Trial,” American Heart Journal 156, no. 4 (2008): 689–697; Pearson S. D. Kleinman K. Rusinak D. , “A Trial of Disclosing Physicians' Financial Incentives to Patients,” Archives of Internal Medicine,166, no. 6 (2006): 623–628; Hampson L. A. Agrawal M. Joffe S. , “Patients' Views on Financial Conflicts of Interest in Cancer Research Trials,” New England Journal of Medicine 355 (2006): 2330–2337; Licurse A. Barber E. Joffe S. , “The Impact of Disclosing Financial Ties in Research and Clinical Care: A Systematic Review,” Archives of Internal Medicine 170, no. 8 (2010): 675–682; Hall M. A. Dugan E. Balkrishnan R. , “How Disclosing HMO Physician Incentives Affects Trust,” Health Affairs 21, no. 2 (2002): 197–206; Loewenstein G. Sah S. Cain D. M. , “The Unintended Consequences of Conflict of Interest Disclosure,” JAMA 307, no. 7 (2012): 669–670. For discussions of the limitations of transparency, and its potential benefits, see in this issue of the Journal of Law, & Ethics 41, no. 3 (2013): Sismondo S. , “Key Opinion Leaders and the Corruption of Medical Knowledge: What the Sunshine Act Will and Won't Cast Light On,” at 635–643; Brown A. , “Understanding Pharmaceutical Research Manipulation in the Context of Accounting Manipulation,” at 611–619; Cosgrove L. Wheeler Emily E. , “Drug Firms, the Codification of Diagnostic Categories, and Bias in Clinical Guidelines,” at 644–654; Feldman Y. Gauthier R. Schuller T. , “Curbing Misconduct in the Pharmaceutical Industry: Insights from Behavioral Ethics and the Behavioral Approach to Law,” at 620–628.