7. Sirens of Hope, Trolls of Fury and Other Vocal Creatures

1 Steven Woloshin and Lisa Schwartz, ‘US Food and Drug Administration Approval of Flibanserin: Even the Score Does Not Add Up’, JAMA Internal Medicine 176, no.4 (2016): 439–442.

2 Jennifer Block and Liz Canner, ‘The “Grassroots Campaign” for “Female Viagra” Was Actually Funded by Its Manufacturer’, New York Magazine, 8 September 2016 <https://www.thecut.com/2016/09/how-addyi-the-female-viagra-won-fda-approval.html>.

3 Jacinthe Flore (2017) ‘Intimate Tablets: Digital Advocacy and Post-Feminist Pharmaceuticals. Feminist Media Studies <doi 10.1080/14680777.2017.1393834>.

4 Quoted in Alycia Hogenmiller, Alessandra Hirsch and Adriane Fugh-Berman, ‘The Score is Even’, The Hastings Center Report, 14 June 2017 <https://www.thehastingscenter.org/the-score-is-even/>.

5 John Mack, ‘Introduction’, Pharma Marketing News 16, no. 2 (2017) <http://www.virsci.com/pmn/PMN1602-01patph.pdf>.

6 Judy Z. Segal, ‘Sex, Drugs and Rhetoric: The Case of Flibanserin for “Female Sexual Dysfunction”’, Social Studies of Science, forthcoming (2018).

7 Judy Z. Segal, ‘The Rhetoric of Female Sexual Dysfunction: Faux Feminism and the FDA’ Canadian Medical Association Journal 187, no. 12 (2015): 915–916.

8 Alycia Hogenmiller, Alessandra Hirsch and Adriane Fugh-Berman, ‘The Score is Even’, The Hastings Center Report 14 June 2017 <https://www.thehastingscenter.org/the-score-is-even/>. In late 2017, Valeant gave Sprout, including flibanserin, back to its original shareholders. The smaller company will attempt to restart the marketing of Addyi, paying only small royalties to Valeant if successful. See Jen Wieczner, ‘Valeant Is Paying to Get Rid of Its $1 Billion “Female Viagra” Acquisition, Fortune, 7 November 2017 <http://fortune.com/2017/11/06/valeant-pharmaceuticals-sprout/>.

9 Quoted in Leela Barham, ‘Market Access: How to Engage Emerging Stakeholders’, Eye for Pharma, 6 November 2011 <http://social.eyeforpharma.com/print/58312> [accessed 11 November 2011].

10 For an excellent account of AIDS activism, see Steven Epstein, Impure Science: AIDS, Activism, and the Politics of Knowledge (Berkeley: University of California Press, 1996).

11 There has been an enormous amount of research on patient advocacy organizations, and I cannot canvass it here. For a comprehensive general overview, see: Steven Epstein, ‘Patient Groups and Health Movements’, in Edward J. Hackett, Olga Amsterdamska, Michael Lynch and Judy Wajcman, eds, The Handbook of Science and Technology Studies (Cambridge, MA: The MIT Press, 2008): 499–540. Much of the focus has been on how patient advocates contribute to medical research. For example, see: Pei P. Koay and Richard R. Sharp, ‘The Role of Patient Advocacy Organizations in Shaping Genomic Science’, Annual Review of Genomics and Human Genetics 14 (August 2013): 579-595; Vololona Rabeharisoa, Tiago Moreira, Madeleine Akrich, ‘Evidence-Based Activism: Patients’ Users’ and Activists’ Groups in Knowledge Society’, BioSocieties 9, no. 2 (2014): 111–128.

12 Sarah Jane Tribble, ‘Drugmakers Help Turn Patients With Rare Diseases Into D.C. Lobbyists’, Kaiser Health News, 10 April 2017 <https://khn.org/news/drugmakers-help-turn-patients-with-rare-diseases-into-d-c-lobbyists/>.

13 Sarah Jane Tribble, ‘Drugmakers Help Turn Patients With Rare Diseases Into D.C. Lobbyists’, Kaiser Health News, 10 April 2017 <https://khn.org/news/drugmakers-help-turn-patients-with-rare-diseases-into-d-c-lobbyists/>.

14 DIA Patient Initiatives <http://www.diaglobal.org/en/get-involved/patients> [accessed 4 February 2018].

15 Aaron Fleishman, ‘Part One: Insights Into The DIA’s Patient Advocacy Programme’, BBK Worldwide, 9 September 2013 <http://innovations.bbkworldwide.com/bid/186718/Part-One-Insights-Into-The-DIA-s-Patient-Advocacy-Program>.

16 Among other things, this patient advocate mentions ‘enlightening educational sessions’ and ‘fascinating information about research positioning, study designs and precision medicine’. Colleen Zak, ‘My Experience as a Patient Advocate Fellow’, Global Forum 4, no. 4 <http://www1.diahome.org/en-US/Networking-and-Communities/~/media/News-and-Publications/Global-Forum/Patient_Perspective.ashx> [accessed 4 February 2018].

17 Leela Barham, ‘Market Access: How to Engage Emerging Stakeholders’, eyeforpharma, Nov. 6, 2011 <http://social.eyeforpharma.com/print/58312>.

18 Amber Spier and David Golub, ‘Leveraging the Power of Patient Advocates in Drug Development’, Global Forum 2, no. 5 (2010): 29–31 <http://rs.diaglobal.org/Tools/Content.aspx?type=eopdf&file=%2fproductfiles%2f19794%2fgf_11%2Epdf> [accessed 27 December 2017].

19 Redrawn from Amber Spier and David Golub, ‘Leveraging the Power of Patient Advocates in Drug Development’, Global Forum 2, no. 5 (2010): 29–31 <http://rs.diaglobal.org/Tools/Content.aspx?type=eopdf&file=%2fproductfiles%2f19794%2fgf_11%2Epdf> [accessed 27 December 2017].

20 Sharon Batt, Health Advocacy, Inc.: How Pharmaceutical Funding Changed the Breast Cancer Movement (Vancouver: UBC Press, 2017). The quote is from activist Pat Kelly, on page 194.

21 Sharon Batt, Health Advocacy, Inc.: How Pharmaceutical Funding Changed the Breast Cancer Movement (Vancouver: UBC Press, 2017), 234–235.

22 The phrase is from Janice E. Graham, ‘Harbinger of Hope or Commodity Fetishism: “Re-cognizing” Dementia in an Age of Therapeutic Agents’, International Psychogeriatrics 13, no. 2 (2001): 131–134. Graham observes that patient advocates’ hope can change how scientists understand and evaluate the phenomena, in this case dementia. In another analysis focused on hope, Carlos Novas describes how patient advocacy, especially by groups representing patients with particular genetic conditions, creates medical identities, and facilitates medical research. He argues that patient organizations can shape medical futures by mobilizing hope. Carlos Novas, ‘The Political Economy of Hope: Patients’ Organizations, Science and Biovalue’, BioSocieties 1, no. 3 (2006): 289–305.

23 The phrase ‘magic bullet’ is owed to immunologist Paul Ehrlich. See, e.g. Robert S. Schwartz, ‘Paul Ehrlich’s Magic Bullets’, New England Journal of Medicine 350 (11 March 2004): 1079–1080.

24 For discussions of how patients should be involved in regulatory decisions, see, e.g. Michael K. Gusmano, ‘FDA Decisions and Public Deliberation: Challenges and Opportunities’, Public Administration Review 73, no. S1 (2013): S115-S126; Barbara von Tigerstrom, ‘The Patient’s Voice: Patient Involvement in Medical Product Regulation’, Medical Law International 16, no. 1-2 (2016): 27–57.

25 For the largest PAOs, see Matthew S. McCoy, Michael Carniol, Katherine Chockley, John W. Unwin, Ezekiel J. Emanuel and Harald Schmidt, ‘Conflicts of Interest for Patient-Advocacy Organizations’, The New England Journal of Medicine 376 (2 March 2017): 880–885. The more general statistics can be found in Susannah L. Rose, Janelle Highland, Matthew T. Karafa and Steven Joffe, ‘Patient Advocacy Organizations, Industry Funding, and Conflicts of Interest’, JAMA Internal Medicine 177, no. 3 (2017): 344–350. As this book is going to press, Kaiser Health News is launching a database of US pharmaceutical companies’ payments to PAOs, finding, for example, that companies spend more on PAOs than they do on direct lobbying of governments; see Emily Kopp, Sydney Lupkin and Elizabeth Lucas, ‘Patient Advocacy Groups Take in Millions From Drugmakers. Is There a Payback?’ Kaiser Health News, 6 April 2018 <https://khn.org/news/patient-advocacy-groups-take-in-millions-from-drugmakers-is-there-a-payback/>.

26 Sheila M. Rothman, Victoria H. Raveis, Anne Friedman, and David J. Rothman, ‘Health Advocacy Organizations and the Pharmaceutical Industry: An Analysis of Disclosure Practices’, American Journal of Public Health 101, no. 4 (2011): 602–609.

27 David S. Hilzenrath, ‘In FDA Meetings, “Voice” of the Patient Often Funded by Drug Companies’, Project on Government Oversight, 1 December 2016 <http://www.pogo.org/our-work/reports/2016/in-fda-meetings-voice-of-the-patient-often-funded-by-drug-companies.html>.

28 Ian Sample, ‘Big Pharma Mobilising Patients in Battle Over Drugs Trials Data’, The Guardian, 21 July 2013.

29 For a tremendously insightful account of this conflict, see Stefan Ecks, ‘Global Pharmaceutical Markets and Corporate Citizenship: The Case of Novartis’ Anti-Cancer Drug Glivec’, in Sergio Sismondo and Jeremy A. Greene, eds, The Pharmaceutical Studies Reader (Chichester: John Wiley & Sons, 2015), 247–260.

30 Tom Jefferson, ‘The UK Turns to Witty, Vallance, and Van Tam for Leadership: Revolving Doors?’ The BMJ Opinion, 6 December 2017 <http://blogs.bmj.com/bmj/2017/12/06/tom-jefferson-the-uk-turns-to-witty-vallance-and-van-tam-for-leadership-revolving-doors/>.

31 Corporate Europe Observatory, ‘Ex-Head of Europe’s Drug Regulator Set Up Consultancy While Still in Office’, 19 December 2011 <https://corporateeurope.org/pressreleases/2011/12/ex-head-europe-drug-regulator-set-consultancy-while-still-office>.

32 Sydney Lupkin, ‘Big Pharma Greets Hundreds of Ex-Federal Workers at the “Revolving Door”’, STAT News, 25 January 2018 <https://www.statnews.com/2018/01/25/pharma-federal-workers-revolving-door/>.

33 Robert Yapundich, ‘How Pharma Sales Reps Help Me Be a More Up-to-Date Doctor’, STAT News, 1 September 2017 <https://web.archive.org/web/20170901111434/https://www.statnews.com/2017/09/01/doctor-pharma-sales-reps/>.

34 Kevin Lomangino, ‘Tone Deaf Again on Pharma Conflict of Interest: STAT Piece Praising Drug Reps Fails to Disclose Industry Payments’, HealthNewsReview.org, 5 September 2017 <https://www.healthnewsreview.org/2017/09/tone-deaf-pharma-conflict-interest-stat-piece-praising-drug-reps-fails-disclose-industry-payments/>.

35 Mary Chris Jaklevic, ‘Non-Profit Alliance for Patient Access Uses Journalists and Politicians to Push Big Pharma’s Agenda’, HealthNewsReview.org, 2 October 2017 <https://www.healthnewsreview.org/2017/10/non-profit-alliance-patient-access-uses-journalists-politicians-push-big-pharmas-agenda/>.

36 Kevin Lomangino, ‘“A Blow to [STAT’s] Credibility”: MD Listed as Author of Op-Ed Praising Drug Reps Didn’t Write It. Ghostwriting/PR Influence’, HealthNewsReview.org <https://www.healthnewsreview.org/2017/09/a-blow-to-stats-credibility-public-relations-firm-may-have-ghostwritten-op-ed-praising-drug-reps/> (accessed 4 February 2018).

37 For example, in the midst of a public outcry over steep drug price hikes, the Alliance for Patient Access wrote a blog post on the need for a ‘comprehensive dialogue’, especially focused on how insurers should cover full costs of drugs: Amanda Conschafter, ‘Rx Cost Debate Overlooks Patient Access Issues’, Institute for Patient Access, 3 November 2015 <http://allianceforpatientaccess.org/rx-cost-debate-overlooks-patient-access-issues/>. When discussions at a United Nations panel on access to medications turned to the exorbitant prices allowed by patents, the Alliance wrote a blog post on how patents make access possible: ‘Rx Pricing, Patents & Patient Access’, Institute for Patient Access <http://allianceforpatientaccess.org/rx-pricing-patents-patient-access/> [accessed 24 May 2018].

38 Global Colon Cancer Association (and others), Letter to Secretary of State John F. Kerry, 6 September 2016 <http://docs.wixstatic.com/ugd/21cfdb_658604e96b1040beaf243554d6c6f354.pdf>.

39 For example, see the organization Patients for Affordable Drugs <https://www.patientsforaffordabledrugs.org/> [accessed 4 February 2018] which sees the problem of drug pricing as created primarily by the pharmaceutical industry.

40 The original is Cary P. Gross and Abbe R. Gluck, ‘Soaring Cost of Cancer Treatment: Moving Beyond Sticker Shock’, Journal of Clinical Oncology, published online before print, 13 December 2017 <doi 10.1200/JCO.2017.76.0488>.

41 Robert Goldberg, ‘CMPI Awards Billy Madison Pharma Idiocy Award to Yale University Professors’, DrugWonks.com, 3 January 2018 <http://drugwonks.com/blog/cmpi-awards-billy-madison-pharma-idiocy-award-to-yale-university-professors> [accessed 5 January 2018].

42 Cathy Jones (as told to Wency Leung), ‘What It’s Like to Speak Out About Vaginal Atrophy’, The Globe and Mail, 24 March 2017 <https://www.theglobeandmail.com/life/health-and-fitness/health/what-its-like-to-have-vaginal-atrophy/article31990317/>.

43 This story was brought to my attention when I was contacted by Kelly Crowe of CBC News, asking if I would be interviewed for it. The quotes by Jones and the CGI Group contact are taken from Kelly Crowe, ‘Ads Disguised as News: A Drug Company’s Stealth Marketing Campaign Exposed’, CBC News, 5 October 2016 <http://www.cbc.ca/news/health/vaginal-atrophy-analysis-1.3786547>.