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Beyond Disclosure: Developing Law and Policy to Tackle Corporate Influence

Published online by Cambridge University Press:  01 January 2021

Jonathan H. Marks*
Affiliation:
Director of the Bioethics Program at the Pennsylvania State University, and Affiliate Faculty in Law, Philosophy, Public Policy, and International Affairs. The author is also a barrister and academic member of Matrix Chambers, London and Geneva.

Abstract

Corporate influence is one of the most pressing issues in public health. It cuts across many of our most intractable problems—from obesity to the opioid epidemic. Companies develop close relationships with public health agencies, research universities, academic medical centers, professional societies, and patient advocacy organizations—often funding medical research and public health interventions intended to address the very challenges these corporations are creating or exacerbating. How we view relationships with industry, including how these relationships are framed in ethical discourse, shapes our legal and policy responses to them. In recent years, fueled in part by the opioid epidemic, the ethical framing of industry relationships has begun to evolve in significant ways. But legal and policy responses have not yet caught up. In this article, I develop a temporal account of corporate influence, and legal and policy responses to corporate influence. This account clarifies the limitations and adverse effects of conflicts of interest disclosure, especially when implemented as the sole legal or policy response. Disclosure can illuminate corporate influence—but policymakers cannot and should not rely on disclosure to eliminate corporate influence or its effects. Nor should we allow disclosure to crowd out structural and systemic responses to corporate influence—including sequestration of and separation from private-sector entities.

Type
Articles
Copyright
Copyright © 2020 American Society of Law, Medicine & Ethics Boston University School of Law

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References

1 See generally Jonathan H. Marks, The Perils of Partnership: Industry Influence, Institutional Integrity, and Public Health (2019).

2 See section I infra and accompanying notes. For a brief overview, see also Jonathan H. Marks, The Perils of Partnership in Public Health (June 30, 2019), https://conwayhall.org.uk/event/the-perils-of-partnership-in-public-health/ (last accessed May 1, 2020).

3 See, e.g., Nicholas Freudenberg, Lethal but Legal: Corporations, Consumption, and Protecting Public Health (2014); Marks, supra note 1; Jonathan Gornall, Sugar: Spinning a Web of Influence, 350 BMJ h231 (2015).

4 Ilona Kickbusch et al., The Commercial Determinants of Health, 4 Lancet Global Health e895, e895 (2016).

5 Daniel S. Goldberg, The Shadows of Sunlight: Why Disclosure Should Not Be a Priority in Addressing Conflicts of Interest, 12 Pub. Health Ethics 202 (2019).

6 Sergio Sismondo, Ghost-Managed Medicine: Big Pharma's Invisible Hands 20-24 (2018).

7 David Michaels, Doubt Is Their Product: How Industry's Assault on Science Threatens Your Health 45-60 (2008) [hereinafter Doubt Is Their Product]; David Michaels, The Triumph of Doubt: Dark Money and the Science of Deception (2020) [hereinafter The Triumph of Doubt].

8 See generally Marks, supra note 1; Daniel S. Goldberg, supra note 5, at 209-11; Joshua M. Sharfstein & Yngvild Olsen, Lessons Learned from the Opioid Epidemic, 322 JAMA 809 (2019).

9 Sharfstein & Olsen, supra note 8, at 810.

10 Ray Moynihan et al., Pathways to Independence: Towards Producing and Using Trustworthy Evidence, 367 BMJ, no. I6576, at 1 (2019).

11 See, e.g., The Triumph of Doubt, supra note 7, at 15-21.

12 Id. at 15-26.

13 Sismondo, supra note 6, at 112-13, 136-37.

14 See, e.g., Kearns, Cristin E. et al., Sugar Industry and Coronary Heart Disease Research: A Historical Analysis of Internal Industry Documents, 176 JAMA Internal Med. 1680, 1681-82 (2016)CrossRefGoogle ScholarPubMed; Cristin Kearns et al., Sugar Industry Influence on the Scientific Agenda of the National Institute of Dental Research's 1971 National Caries Program: A Historical Analysis of Internal Documents, 12 PLoS Med. e1001798 (2015).

15 Neal D. Barnard et al., Industry Funding and Cholesterol Research: A Systematic Review, 20 Am. J. Lifestyle Med., no. 10, 2019, at 1.

16 Penders, Bart & Nellis, Annemiek P., Credibility Engineering in the Food Industry: Linking Science, Regulation, and Marketing in a Corporate Context, 24 Science in Context 487, 505-08 (2011)CrossRefGoogle Scholar. Cf. Kelly D. Brownell & Kenneth E. Warner, The Perils of Ignoring History: Big Tobacco Played Dirty and Millions Died. How Similar Is Big Food?, 87 Milbank Q. 259 (2009) (comparing the strategies of companies in the food industry with the tobacco industry's successful efforts to influence public health).

17 Relman, Arnold S., The New Medical-Industrial Complex, 303 New Eng. J. Med. 963, 966-67 (1980)CrossRefGoogle ScholarPubMed.

18 Id. at 963.

19 Relman, Arnold S., Dealing with Conflicts of Interest, 310 New Eng. J. Med. 1182, 1182 (1984)CrossRefGoogle ScholarPubMed. See also Marc Rodwin, Physicians' Conflicts of Interest, 321 New Eng. J. Med. 1405 (1989) (articulating concerns about the limitations of disclosure as a way of dealing with conflicts).

20 Patent & Trademark Law Amendments Act, 96 Pub. L. No. 96-517, §202, 94 Stat. 3015, 3020 (1980).

21 See, e.g., Arthur Schafer, Biomedical Conflicts of Interest: A Defense of the Sequestration Thesis—Learning from the Cases of Nancy Olivieri and David Healy, 30 J. Med. Ethics 8 (2004). I was counsel for Nancy Olivieri in litigation in the European Court of Justice related to her dispute with the industry sponsor of her clinical drug trials.

22 Lewis, Steven et al., Dancing with the Porcupine: Rules for Governing the University-Industry Relationship, 165 Canadian Med. Ass'n J. 783, 784 (2001)Google ScholarPubMed.

23 Marks, supra note 1, at 69.

24 See, e.g., Jon Thompson et al., The Olivieri Report: The Complete Text of the Report of the Independent Inquiry Commissioned by the Canadian Association of University Teachers 239-46 (2001).

25 The often undisclosed drug company authors or consultants hired by the companies are the “ghosts.” Sismondo, supra note 6, at 15-16.

26 In the United States, for the last two decades, these strategies have been coupled with promotional opportunities afforded by direct-to-consumer (“DTC”) advertising of prescription drugs. I briefly discuss the history and ethical implications of DTC advertising in the United States in Jonathan H. Marks, The Price of Seduction: Direct-to-Consumer Advertising of Prescription Drugs in the U.S., 64 N.C. J. Med. 292 (2003).

27 See generally Marion Nestle, Food Politics: How the Food Industry Influences Nutrition and Health (Univ. of Cal. Press rev. ed. 2013); Marion Nestle, Soda Politics: Taking on Big Soda (And Winning) (2015) [hereinafter Nestle, Soda Politics]; Marion Nestle, Unsavory Truth: How Food Companies Skew the Science of What We Eat (2018).

28 See generally Doubt Is Their Product, supra note 7; The Triumph of Doubt, supra note 7.

29 See Marks, supra note 1, 67-73 (broadly outlining industry strategies to influence academic institutions and civil society groups, as well as governments). See also The Triumph of Doubt, supra note 7, at 199-216 (providing examples of strategies of influence employed by the food and soda industry).

30 Rose, Susannah L. et al., Patient Advocacy Organizations, Industry Funding, and Conflicts of Interest, 177 JAMA Internal Med. 344, 347 (2017)CrossRefGoogle ScholarPubMed.

31 McCoy, Matthew S. et al., Conflicts of Interest for Patient Advocacy Organizations, 376 New Eng. J. Med. 880, 882 (2017)CrossRefGoogle ScholarPubMed.

32 Aaron, David G. & Siegel, Michael B., Sponsorship of National Health Organizations by Two Major Soda Companies, 52 Am. J. Preventive Med. 20, 21 (2017)CrossRefGoogle ScholarPubMed.

33 See David S. Hilzenrath, In FDA Meetings, ‘Voice’ of the Patient Often Funded by Drug Companies, Project on Gov't Oversight (Dec. 1, 2016), http://pogo.production.vigetx.com/investigation/2016/12/in-fda-meetings-voice-of-patient-often-funded-by-drug-companies [https://perma.cc/3KVW-9HE8].

34 Id.

35 Kate L. Mandeville et al., Financial Interests of Patient Advocacy Organizations Contributing to Technology Assessment at England's National Institute for Health and Care Excellence: Policy Review, 364 BMJ, no. 5300, at 1 (2019). The study also found that the NICE decision-making committees were aware of fewer than a quarter of the relationships, and that disclosure of almost two-thirds of these relationships was not required by NICE policy.

36 See infra notes 41-47 and accompanying text.

37 Marks, supra, note 1, at 68-82.

38 Conflicts of Interest in Medical Research, Education, and Practice 46 (Bernard Lo & Marilyn Field eds., 2009). The definition in this report draws on one by Dennis Thompson, published in the New England Journal of Medicine in 1993 in response to growing recognition that the concerns flagged by Arnold Relman in the same journal a decade earlier had become even more problematic. See Thompson, Dennis F., Understanding Financial Conflicts of Interest, 329 New Eng. J. Med. 573, 573 (1993)CrossRefGoogle ScholarPubMed.

39 Rodwin, Marc A., Attempts to Redefine Conflicts of Interest, 25 Accountability Res. 67, 70 (2018)CrossRefGoogle ScholarPubMed [hereinafter Rodwin, Attempts to Redefine Conflicts of Interest]. Rodwin has also written about the negative effects of disclosure and alternative policy responses. See Marc A. Rodwin, Conflicts of Interest and the Future of Medicine: The United States, France, and Japan 208-20 (2011); Rodwin, Marc A., Conflict of Interest in the Pharmaceutical Sector: A Guide for Public Management, 21 DePaul J. Health Care L. 1, 14-27 (2019)Google Scholar.

40 See, e.g., Marks, supra note 1, at 23; Jonathan H. Marks, Lessons from Corporate Influence in the Opioid Epidemic: Toward a Norm of Separation, 17 J. Bioethical Inquiry (forthcoming 2020) [hereinafter Marks, Lessons from Corporate Influence]. On the third concern, see also Rodwin, Attempts to Redefine Conflicts of Interest, supra note 39, at 73-75.

41 Krimsky, Sheldon, Journal Policies on Conflict of Interest: If This Is the Therapy, What's the Disease?, 70 Psychotherapy & Psychosomatics 115, 116 (2001)CrossRefGoogle ScholarPubMed. Policies are one thing; compliance is quite another. The same study found that of the 220 journals with disclosure policies, only 0.5% of articles had disclosures of conflicts and 66% of the journals had no conflicts of interest disclosures for that year. Id.

42 Rafael Dal-Ré & Ana Marušić, Letter to the Editor, Are Journals Following the ICMJE Recommendations Complying with Conflicts of Interest Disclosure Policies, 57 Eur. J. Internal Med. e17, e17 (2018).

43 Rose Ahn et al., Financial Ties of Principal Investigators and Randomized Controlled Trial Outcomes: Cross Sectional Study, 356 BMJ i6770, at 4 (2017). Cf. Grundy, Quinn et al., Prevalence of Disclosed Conflicts of Interest in Biomedical Research and Associations with Journal Impact Factors and Altmetric Scores, 319 JAMA 408, 408-09 (2018)CrossRefGoogle ScholarPubMed (finding that close to one in four articles published in journals that purport to conform with the ICMJE policy had disclosures of conflicts of interest, but excluding industry funding of the study and industry employment from that assessment).

44 Dal-Ré & Marušić (2018), supra note 42, at e17. See also Dal-Ré et al., Editors' and Authors' Individual Conflicts of Interest Disclosure and Journal Transparency. A Cross-Sectional Study of High-Impact Medical Specialty Journals, 9 BMJ Open, no. 029796, at 1-2 (2019); Waqas Haque et al., Conflicts of Interest of Editors of Medical Journals, 13 PLoS ONE, May 2018, at 1, 2; Victoria S. S. Wong et al., Industry Payments to Physician Journal Editors, 14 PLoS ONE, Feb. 2019, at 2-9.

45 Duff Wilson, Harvard Medical School in Ethics Quandary, N.Y. Times, Mar. 2, 2009, at B1.

46 AMSA Scorecard, Am. Med. Student Ass'n, https://www.amsa.org/scorecard [https://perma.cc/64YQ-QXCX]. AMSA abandoned its scorecard in 2018, when it decided to switch its efforts to monitoring conflicts of interest in Congress instead. See AMSA Takes a Deeper Look into Conflicts of Interest as It Relates to Health Policy, Am. Med. Student Ass'n (Oct. 15, 2018), https://www.amsa.org/about/amsa-press-room/conflicts-of-interest-relates-to-health-policy [https://perma.cc/R3GD-8EEU].

47 See Wilson, supra note 45.

48 Physician Payments Sunshine Act of 2010, Pub. L. No. 111-148, § 6002, 124 Stat. 689.

49 Genevieve P. Kanter et al., Effect of the Public Disclosure of Industry Payments Information on Patients: Results from a Population-Based Natural Experiment, 2019 BMJ Open, no. 024020, at 3 (2019).

50 SUPPORT for Patients and Communities Act, Pub. L. No. 115-271, 132 Stat. 3894 (2018).

51 §6111, 132 Stat. at 4006-07.

52 A recent study revealed that, in Australia, clinicians who receive payments from industry include nurses, physical therapists, and dietitians. See Karanges, Emily A. et al., Understanding the Nature and Extent of Pharmaceutical Industry Payments to Nonphysician Clinicians, 179 JAMA Inteneral Med. 1430, 1430-32 (2019)CrossRefGoogle ScholarPubMed. There is good reason to anticipate similar practices especially among multinational drug companies in the United States.

53 See, e.g., Nestle, Soda Politics, supra note 27, at 252-56; Marks, Lessons from Corporate Influence, supra note 40.

54 Ray Moynihan et al., Undisclosed Financial Ties Between Guidelines Writers and Pharmaceutical Companies: A Cross-Sectional Study Across 10 Disease Categories, 9 BMJ Open, no. 025864, at 4-6 (2019).

55 See discussion infra Sections III.A, III.B, III.C, and IV.

56 See, e.g., Cain, Daylian M. et al., The Dirt on Coming Clean: Perverse Effects of Disclosing Conflicts of Interest, 34 J. Legal Stud. 1, 9 (2005)CrossRefGoogle Scholar, and Church, Bryan K. & Kuang, Xi (Jason), Conflicts of Interest, Disclosure, and (Costly) Sanctions: Experimental Evidence, 38 J. Legal Studies 505, 513-4 (2009)CrossRefGoogle Scholar.

57 See, e.g., Leslie K. John et al., Effect of Revealing Authors' Conflicts of Interest in Peer Review: Randomized Control Trial, 367 BMJ, no. 5896, at 1 (2019).

58 See, e.g., Sunita Sah & George Lowenstein, Nothing to Declare: Mandatory and Voluntary Disclosure Leads Advisors to Avoid Conflicts of Interest 25 Psychol. Sci. 575, 575 (2014).

59 John et al., supra note 57, at 1-2 (using the term “convenience sample” in the discussion of a study that deliberately avoids using such a sample).

60 See, e.g., Tim Schwab, U.S. Opioid Prescribing: The Federal Government Advisers with Recent Ties to Big Pharma, 366 BMJ I5167 (2019) (expressing concern that members of panels convened by the National Academies of Science, Engineering, and Medicine, including one commissioned to advise policymakers on clinical practice guidelines for prescribing opioids, had received payments from opioid companies), and Michael J. Hayes & Vinay Prasad, Financial Conflicts of Interest at FDA Drug Advisory Committee Meetings, 48 Hastings Ctr. Rep. 10 (2018) (discussing conflicts of interest among voting members and invited expert speakers at meetings of the Oncologic Drugs Advisory Committee).

61 See, e.g., Marks, supra note 1, at 68-71.

62 See, e.g., Marks, Lessons from Corporate Influence, supra note 40 (discussing a 2018 congressional report by the Minority Staff of the U.S. Senate Homeland Security & Governmental Affairs Committee on the financial relationships between patient advocacy groups and the opioid industry).

63 See, e.g., Institute of Medicine, On Being a Scientist: A Guide to Responsible Conduct in Research 2-3 (2009).

64 See John et al., supra note 57, at 1-2 (discussing the range of reviewers studied in prior conflict of interest disclosure studies).

65 For a study exploring the impact of funding disclosures on physicians, see Aaron S. Kesselheim et al., A Randomized Study of How Physicians Interpret Research Funding Disclosures, 367 New Eng. J. Med. 1119 (2012).

66 For the 2016 CDC guideline for opioid prescription for chronic pain and a summary of its development, see Deborah Dowell et al., CDC Guideline for Prescribing Opioids for Chronic Pain – United States, 2016, 65 Recommendations & Rep. 1, https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm [https://perma.cc/9CU5-UGMY].

67 For a brief discussion of other possible forms of influence, see Marks, supra note 1, at 153.

68 I offer a more detailed critique of dyad and triad-based accounts of corporate influence in Marks, supra note 1, at 7–9.

69 Id. at 65.

70 42 U.S.C. § 1320a-7h (2018).

71 See Int'l Comm. Med. Journal Editors, Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly work in Medical Journals 3-4 (2019), http://www.icmje.org/icmje-recommendations.pdf [https://perma.cc/WGF4-KSRN] (last accessed May 31, 2020).

72 See, e.g., ICMJE Form for Disclosure of Potential Conflicts of Interest, http://www.icmje.org/conflicts-of-interest/ [https://perma.cc/8DUY-ZRBF] (last accessed May 31, 2020) (requiring authors to disclose “all sources of revenue paid (or promised to be paid) directly to you or your institution on your behalf over the 36 months prior to submission of the work.”)

73 For research suggesting that disclosure can have the opposite effect, see e.g., Daylian M. Cain et al., The Dirt on Coming Clean: Perverse Effects of Disclosing Conflicts of Interest, 34 J. Legal Stud. 1 (2005); George Loewenstein et al., The Unintended Consequences of Conflict of Interest Disclosure, 307 JAMA 669 (2012).

74 Cain et al., supra note 73, at 6-8; Loewenstein et al., supra note 73, at 669.

75 Loewenstein, George et al., The Limits of Transparency: Pitfalls and Potential of Disclosing Conflicts of Interest, 101 Am. Econ. Rev. 423, 424-25 (2011)CrossRefGoogle Scholar.

76 See Cain et al., supra note 73, at 7.

77 Sunita Sah, Conflict of Interest Disclosure as a Reminder of Professional Norms: Clients First!, 154 Org. Behav. Hum. Decision Processes 62 (2019). Making professional norms more salient is, of course, not inherently good. The ethics of promoting norm salience will depend on the nature and content of those norms. For example, norms that promote self-interest among advisors are clearly far more problematic than norms that promote the interests of fiduciaries whose interests the advisors have an obligation to protect.

78 See id. at 75-77.

79 Id. at 66-75.

80 42 U.S.C. § 1320a-7h (2018).

81 Matthew Chao & Ian Larkin, Regulating Conflicts of Interest Through Public Disclosure: Evidence from a Physician Payments Sunshine Law 9 (Oct. 1, 2017) (unpublished manuscript); see also Tong Guo et al., Let the Sun Shine in: The Impact of Physician Payment Disclosure on Physician Prescribing Behavior 2 (2017, rev. Feb. 25, 2019) (unpublished manuscript).

82 See Rodwin, supra note 19, at 1406.

83 Andreas Lundh et al., Industry Sponsorship and Research Outcome, 2 Cochrane Database of Systematic Reviews, no. MR000033, 2017, at 22. For another example of a study finding evidence of what I call the “interpretation gap,” see also Barnard et al., supra note 15, at 7.

84 Sunita Sah & Daniel Feiler, Conflict of Interest Disclosure with High-Quality Advice: The Disclosure Penalty and the Altruistic Signal, 26 Psychol., Pub. Pol'y, L. 88, 102 (2020).

85 See Sah, Sunita & Loewenstein, George, Nothing to Declare: Mandatory and Voluntary Disclosure Leads Advisors to Avoid Conflicts of Interest, 25 Psychol. Sci. 575, 576 (2014)CrossRefGoogle ScholarPubMed. The authors made this claim in earlier work too. See also Loewenstein et al., supra note 73, at 670.

86 See Sah & Lowenstein, supra note 85, at 576-82.

87 See Sinha, Michael & Kesselheim, Aaron, The Effects of the Sunshine Act: What Can and What Should We Expect?, 17 Am. J. Bioethics 22, 22-23 (2017)CrossRefGoogle ScholarPubMed.

88 See, e.g., Lisa Cosgrove & Sheldon Krimsky, A Comparison of DSM-IV and DSM-5 Panel Members' Financial Associations with Industry: A Pernicious Problem Persists, PLoS Med. 9(3): e1001190, at 1 (2012); see also Cosgrove, Lisa et al., Developing unbiased diagnostic and treatment guidelines in psychiatry, 360 N Eng. J Med. 2035, 2036 (2009)CrossRefGoogle Scholar.

89 See, e.g., Sah, Sunita & Fugh-Berman, Adriane, Physicians under the Influence: Social Psychology and Industry Marketing Strategies, 41 J. L. Med. & Ethics 665, 669 (2013)Google ScholarPubMed (drawing on the work of Robert Cialdini).

90 For a focus group study (conducted in 2015) exploring physicians' views of the PPSA, see Susan Chimonas et al., Bringing Transparency to Medicine: Exploring Physicians' Views and Experiences of the Sunshine Act, 17 Am. J. Bioethics 4 (2017).

91 The Facts About Open Payments Data, CMS.Gov, https://openpaymentsdata.cms.gov/summary [https://perma.cc/UF2Q-B6BA] (last accessed Apr. 21, 2020).

92 Id.

93 Tong Guo et al., The Effect of Information Disclosure on Industry Payments to Physicians (2017, rev. Aug. 6, 2019) (unpublished manuscript).

94 Id. at 5.

95 Id.

96 On the impact of disclosure on physicians, see Kesselheim et al., supra note 65 (finding that disclosure of funding in research studies undermined the trust of health professionals—they were less willing to rely on those studies).

97 Genevieve P. Kanter et al., Effect of the Public Disclosure of Industry Payments Information on Patients: Results from a Population-Based Natural Experiment, 9 BMJ Open, no. 024020, 2019, at 3.

98 Id.

99 Susannah L. Rose et al., Patient Responses to Physician Disclosures of Industry Conflicts of Interest: A Randomized Field Experiment, Org. Behav. & Hum. Decision Processes, at 9 (2019), https://doi.org/10.1016/j.obhdp.2019.03.005 [https://perma.cc/BA84-UR95] (last accessed May 31, 2020). This assumes, as the authors note, that the patients received and opened the letter.

100 Id. The study found that uncertainty about the existence of conflicts of interest created more distrust than knowing about the conflict. Cf. Sah & Feiler, supra note 84 (finding that disclosure of conflicts of interest may result in a disclosure penalty, but that the effect of the penalty may be muted if the presence of the advisor's conflict is perceived as systemic or beyond the advisor's control, and not reflective of the advisor's character).

101 Genevieve P. Kanter et al., US Nationwide Disclosure of Industry Payments and Public Trust in Physicians, 2 JAMA Network Open, no. 2, Apr. 2019, at 1.

102 See Sah, Sunita et al., Conflict of Interest Disclosure as an Expertise Cue: Differential Effects of Automatic and Deliberative Processing, 147 Org. Behav. & Hum. Decision Processes 127, 128, 143-45 (2018)Google Scholar.

103 For an early articulation and exploration of this concern, see Loewenstein, George et al., The Limits of Transparency: Pitfalls and Potential of Disclosing Conflicts of Interest, 101 Am. Econ. Rev. 423, 424 (2011)CrossRefGoogle Scholar. For more recent empirical work on this question, see Rose et al., supra note 99.

104 Sah, Sunita et al., Insinuation Anxiety: Concern that Advice Rejection Will Signal Distrust After Conflict of Interest Disclosures, 45 Personality & Social Psych. Bull. 1099, 1100 (2019)CrossRefGoogle ScholarPubMed (also finding that insinuation anxiety may be diminished when disclosure is made by an external sources rather than by the advisor directly.) See also Sunita Sah, Why Humans Find it so Hard to Resist Taking Bad Advice, L.A. Times (Oct. 22, 2019, 6:50 AM), https://www.latimes.com/opinion/story/2019-10-29/advice-neuroscience-psychology-social-pressure-research [https://perma.cc/XT8U-TGYX]. This work builds on Loewenstein et al., supra note 75, at 424-26; and Loewenstein et al., supra note 73, at 670.

105 Rose et al., supra note 99, at 607.

106 See Kanter, Genevieve P. & Loewenstein, George, Evaluating Open Payments, 322 JAMA 401, 401-02 (2019)CrossRefGoogle ScholarPubMed.

107 Marks, Lessons from Corporate Influence, supra note 40 (examining the role of corporate influence in the opioid epidemic, and reviewing evidence that physicians' interactions with opioid sales “reps” are associated with increased opioid prescribing and higher rates of overdose deaths). While patients are clearly ill-equipped, even professionals and public health agencies may have difficulty knowing how to respond to conflicts disclosures, an issue I address in the next paragraph.

108 John et al., supra note 57.

109 Id. at 6.

110 Id. at 9.

111 Id.

112 Kanter & Loewenstein, supra note 106, at 402.

113 Marks, Lessons from Corporate Influence, supra note 40.

114 See The Triumph of Doubt, supra note 7, at 261-62.

115 See generally McCoy et al., supra note 31; Rose et al., supra note 30; Aaron & Siegel, supra note 32.

116 See The Facts About Open Payments Data, supra note 91.

117 See discussion supra Section I and notes 33-35.

118 See Marks, supra note 1, at 121-39.

119 See Sah & Fugh-Berman, supra note 89, at 666-67.

120 See id. at 669-70. The term “key opinion leader” (KOL) is designed to make physicians believe that these are not only financially lucrative positions but also scarce resources, and that being hired as a KOL is a signifier of status.

121 In addition to the scholarship discussed in this paragraph, see also Tracy E. Miller & William M. Sage, Disclosing Physician Financial Incentives, 28 JAMA 1424 (1999), in which proponents of disclosure of physician financial incentives recognize that disclosure laws “exemplify regulatory restraint,” and that they should support not substitute for substantive regulation that would protect patients from “unreasonable risk.” Id. at 1429.

122 DeJong, Colette & Steinbrook, Robert, Shining a Light on Industry Payments to Health Care Professionals Who Are Not Physicians, 179 JAMA Internal Med. 1430, 1433 (2019)CrossRefGoogle Scholar.

123 Loewenstein et al., supra note 73, at 670.

124 Koch, Cora et al., Transparency of Conflicts of Interest: A Mixed Blessing? The Patient Perspective, 17 Am. J. Bioethics 27, 27 (2017)CrossRefGoogle Scholar.

125 Bachynski, Kathleen E. & Goldberg, Daniel S., Time out: NFL Conflicts of Interest with Public Health Efforts to Prevent TBI, 24 Inj. Prev. 180, 182 (2018)CrossRefGoogle ScholarPubMed.

126 Cain et al., supra note 73, at 20.

127 Loewenstein et al., supra note 73, at 670.

128 Loewenstein et al., supra note 75, at 427.

129 Sah, supra note 77, at 77.

130 Sah & Feiler, supra note 100, at 101.

131 Kanter & Loewenstein, supra note 106, at 402.

132 See Chambers, Tod, The Illusion of Transparency, 17 Am. J. Bioethics 32, 32-33 (2017)CrossRefGoogle ScholarPubMed.

133 See, e.g., Marks, supra note 1; Bachynski & Goldberg, supra note 125; Krimsky, supra note 41, at 116; Schafer, supra note 21, at 23.

134 In this paragraph, I summarize some of the key claims in Marks, supra note 1.

135 See Freudenberg, supra note 3, at 96; Marks, supra note 1; Gornall, supra note 3.

136 Michaels, supra note 28, at 17; William H. Wiist, The Corporate Play Book, Health, and Democracy: The Snack Food and Beverage Industry's Tactics in Context, in Sick Societies: Responding to the Global Challenge of Chronic Disease 205 (David Stuckler & Karen Siegel eds., 2011); Brownell & Warner, supra note 16, at 259; and The Disinformation Playbook, Union of Concerned Scientists (Oct. 10, 2017), https://www.ucsusa.org/resources/disinformation-playbook [https://perma.cc/H726-D8HX]. For the use of “playbook” in a narrower sense, see Sismondo, supra note 6, at 144.

137 See Kickbusch et al., supra note 4.

138 See Joana M. Lima & Sandro Galea, Corporate Practices and Health: A Framework and Mechanisms, 14 Globalization & Health, no. 21, 2018, at 1-9; Martin McKee & David Stuckler, Revisiting the Corporate and Commercial Determinants of Health, 108 Am. J. Pub. Health 1167 (2018).

139 On status quo bias, see, e.g., Daniel Kahneman, Thinking Fast and Slow 292 (2011).

140 The “wave” metaphor has a precedent in public health. See, e.g., Peter Hanlon, et al., Making the Case for a ‘Fifth Wave’ in Public Health, 125 Pub. Health 30 (2011). My characterization of corporate influence in waves is broad in a number of ways. First, the timeline for each wave may vary according to the industry sector and the entities affected. Second, given that the processes involved tend to be gradual, we should not expect to find clear delineations between the waves. Third, underlying any wave there may be counter-currents—that is, incidents or events that run counter to or are in tension with the prevailing wave.

141 See sources cited supra note 14.

142 See Marks, supra note 1, at 89-90.

143 See McCoy et al., supra note 31.

144 We should also be deeply concerned about the influence of these patient advocacy organizations on others, including policymakers. See section III supra for a discussion of “co-influencers.”

145 For example, corporate influence among clinical practice guideline committees may become exhaustive, even though only a minority of the members on any one committee has a financial conflict of interest. See, e.g., Lisa Cosgrove et al., Conflicts of Interest Policies and Industry Relationships of Guideline Development Group Members: A Cross-Sectional Study of Clinical Practice Guidelines for Depression, 24 Accountability Res. 99 (2017) (expressing concern about financial conflicts of interest when only one member of a committee has a conflict—a concern exacerbated when that member is the committee chair).

146 I discuss this further in Marks, Lessons from Corporate Influence, supra note 40.

147 See id.

148 Id.

149 Id.

150 See, e.g., Lima & Galea, supra note 138, at 1-3.

151 See Louis D. Brandeis, What Publicity Can Do, Harper's Wkly, Dec. 20, 1913, at 10.

152 Id. at 11.

153 See James Bryce, The American Commonwealth: Two Volumes 1012 (Liberty Fund Inc. 1995).

154 Id.