1 Courtney Davis, Huseyin Naci, Evrim Gurpinar, Elita Poplavska, Ashlyn Pinto, and Ajay Aggarwal, ‘Availability of Evidence of Benefits on Overall Survival and Quality of Life of Cancer Drugs Approved by European Medicines Agency: Retrospective Cohort Study of Drug Approvals 2009-13’, The British Medical Journal 359 (4 October 2017): j4530. In a similar vein, the majority of the forty-eight new treatments for solid cancers approved by the US Food and Drug Administration (FDA) between 2002 and 2014 did not have meaningful health benefits, increasing survival by a median of only 2.1 months. Peter H. Wise, ‘Cancer Drugs, Survival, and Ethics’, The British Medical Journal 355 (9 November 2016): i5792.

2 On the effectiveness of statins, see, e.g. R. Chou, T. Dana, I. Blazina, M. Daeges, and T.L. Jeanne, ‘Statins for Prevention of Cardiovascular Disease in Adults: Evidence Report and Systematic Review for the US Preventive Services Task Force’, JAMA 316, no. 19 (15 November 2016): 2008–2024. For patients who have not suffered a heart attack, it is statistically unclear that taking statins delays death: Therapeutics Letter 77, ‘Do Statins Have a Role in Primary Prevention? An Update’, Therapeutics Initiative, 18 October 2010 <http://www.ti.ubc.ca/2010/10/18/do-statins-have-a-role-in-primary-prevention-an-update-/>. The 2013 guidelines changed focus from cholesterol targets to risk factors. See Neil J. Stone, Jennifer Robinson, Alice H. Lichtenstein, C. Noel Bairey Merz, Conrad B. Blum, Robert H. Eckel, Anne C. Goldberg, David Gordon, Daniel Levy, Donald M. Lloyd-Jones, Patrick McBride, J. Sanford Schwartz, Susan T. Shero, Sidney C. Smith, Karol Watson, and Peter W.F. Wilson, ‘2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults’, American Heart Association Journal 137, no. 2 (12 November 2013) <https://doi.org/10.1161/01.cir.0000437738.63853.7a>. Indefinitely increasing the number of people taking the drugs would make sense if there were no negative effects or other costs.

3 ‘Prescrire’s Ratings: New Products and Indications over the Last 10 Years’, Prescrire in English, last modified 1 May 2017 <http://english.prescrire.org/en/81/168/53056/0/NewsDetails.aspx>.

4 Nortin Hadler, ‘American Healthcare Rackets: Monopolies, Oligopolies, Cartels and Kindred Plunderbunds’, The Health Care Blog, 25 November 2016 <http://thehealthcareblog.com/blog/2016/11/25/american-healthcare-rackets-monopolies-oligopolies-cartels-and-kindred-plunderbunds/>.

5 Alan Cassels, ‘More Cholesterol Craziness’, Common Ground, 8 July 2017 <http://commonground.ca/category/drug-bust-by-alan-cassels/>.

6 For example, CenterWatch, State of the Clinical Trials Industry: A Sourcebook of Charts and Statistics (Boston, MA: CenterWatch, 2009).

7 Ian Hacking, ‘“Style” for Historians and Philosophers’, Studies in History and Philosophy of Science Part A 23, no. 1 (1992): 1–20; Chunglin Kwa, Styles of Knowing: A New History of Science from Ancient Times to the Present, David McKay, trans. (Pittsburgh: University of Pittsburgh Press, 2011).

8 Arthur A. Daemmrich, Pharmacopolitics: Drug Regulation in the United States and Germany (Chapel Hill: University of North Carolina Press, 2004).

9 Harry M. Marks, The Progress of Experiment: Science and Therapeutic Reform in the United States, 1900–1990 (Cambridge: Cambridge University Press, 1997).

10 Harry M. Marks, ‘Trust and Mistrust in the Marketplace: Statistics and Clinical Research, 1945–1960’, History of Science 38, no. 3 (2000): 343–355.

11 Ariel L. Zimerman, ‘Evidence-Based Medicine: A Short History of a Modern Medical Movement’, AMA Journal of Ethics 15, no. 1 (2013): 71–76.

12 G. Guyatt, J. Cairns, D. Churchill, et al., ‘Evidence-Based Medicine: A New Approach to Teaching the Practice of Medicine’, Journal of the American Medical Association 268, no. 17 (1992): 2420–2425.

13 E.g. John Worrall, ‘Evidence in Medicine and Evidence-Based Medicine’, Philosophy Compass 2, no. 6 (2007): 981–1002.

14 Stefan Timmermans and Marc Berg, The Gold Standard: The Challenge of Evidence-Based Medicine and Standardization in Health Care (Philadelphia: Temple University Press, 2003); David Healy, Pharmageddon (Bekeley: University of California Press, 2012).

15 Robin Bluhm, ‘From Hierarchy to Network: A Richer View of Evidence for Evidence-Based Medicine’, Perspectives in Biology and Medicine 48, no. 4 (2005): 535–547; Jason Grossman and Fiona J. Mackenzie, ‘The Randomized Controlled Trial: Gold Standard, or Merely Standard?’ Perspectives in Biology and Medicine 48, no. 4 (2005): 516–534.

16 Andreas Lundh, Sergio Sismondo, Joel Lexchin, Octavian A. Busuioc and Lisa Bero, ‘Industry Sponsorship and Research Outcome and Quality (Review)’, The Cochrane Library (12 December 2012) <doi 10.1002/14651858.MR000033>.

17 D. A. Tobbell, Pills, Power, and Policy: The Struggle for Drug Reform in Cold War America (Berkeley: University of California Press, 2012).

18 Daniel Carpenter, Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA (Princeton, NJ: Princeton University Press, 2010).

19 Daniel Carpenter, Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA (Princeton, NJ: Princeton University Press, 2010), 272.

20 ‘Obligatory point of passage’ is Bruno Latour’s term of art for an element required in order for others to form a network. In the case of drugs, we can see marketing as the formation of very large networks. See Bruno Latour, Science in Action: How to Follow Scientists and Engineers through Society (Cambridge, MA: Harvard University Press, 1987).

21 There are, nonetheless, complex relationships among in-patent, branded and generic drugs, with the generic often serving as a challenge to in-patent drugs: Jeremy A. Greene, Generic: The Unbranding of Modern Medicine (Baltimore, MD: Johns Hopkins University Press, 2014). Brands of generics sometimes themselves become markers of quality: see Cori Hayden, ‘Generic Medicines and the Question of the Similar’, in Sergio Sismondo and Jeremy A. Greene, eds, The Pharmaceutical Studies Reader (Chichester: John Wiley & Sons, 2015), 261–267; Kris Peterson, Speculative Markets: Drug Circuits and Derivative Life in Nigeria (Durham, NC: Duke University Press, 2014).

22 For example, Edward Nik-Khah, ‘Neoliberal Pharmaceutical Science and the Chicago School of Economics’, Social Studies of Science 44, no .4 (2014): 489–517.

23 For example, in recent years, challenges to a core piece of the 1962 Act have been slowly working their way through the US courts: drawing on the US’s strong protection of freedom of speech, companies have been chipping away at the FDA’s legal authority to regulate off-label marketing. Joshua M. Sharfstein and Alta Charo, ‘The Promotion of Medical Products in the 21st Century: Off-label Marketing and First Amendment Concerns’, Journal of the American Medical Association 314, no. 17 (2015): 1795–1796.

24 Courtney Davis and John Abraham, Unhealthy Pharmaceutical Regulation: Innovation, Politics and Promissory Science (Basingstoke: Palgrave MacMillan, 2013); Govin Permanand, EU Pharmaceutical Regulation: The Politics of Policy-Making (Manchester: Manchester University Press, 2006).

25 John Abraham and Tim Reed, ‘Progress, Innovation and Regulatory Science in Drug Development: The Politics of International Standard-Setting’, Social Studies of Science 32, no. 3 (2002): 337–369. ‘ICH’ now stands for the International Council for Harmonization.

26 Kaushik Sunder Rajan describes this as ‘pharmocracy’, and, like me, finds Gramsci’s idea of hegemony valuable here. See Kaushik Sunder Rajan, Pharmocracy: Value, Politics, and Knowledge in Global Biomedicine (Durham, NC: Duke University Press, 2017)

27 Monique L. Anderson, Karen Chiswell, Eric D. Peterson, Asba Tasneem, James Topping, and Robert M. Califf, ‘Compliance with Results Reporting at ClinicalTrials.gov’, New England Journal of Medicine 372, no. 11 (2015): 1031–1039.

28 P. C. Gøtzsche, A. Hróbjartsson, H. K. Johansen, M. T. Haahr, D. G. Altman, and A. –W. Chan, ‘Ghost Authorship in Industry-Initiated Randomised Trials’, PLoS Medicine 4, no. 1 (2007): 47–52.

29 Kalman Applbaum, ‘Getting to Yes: Corporate Power and the Creation of a Psychopharmaceutical Blockbuster’, in Sergio Sismondo and Jeremy A. Greene, eds, The Pharmaceutical Studies Reader (Chichester: John Wiley & Sons, 2015), 133–149.

30 I am drawing on Edward Nik-Khah, ‘Neoliberal Pharmaceutical Science and the Chicago School of Economics’, Social Studies of Science 44, no. 4 (2014): 489–517.

31 Tufts Center for the Study of Drug Development, ‘Research’ <http://csdd.tufts.edu/research> [accessed 4 January 2018].

32 The CSDD also helped to support the idea that regulation created a ‘drug lag’, reducing the number of new drugs on the market. In addition to Edward Nik-Khah’s work cited above, see Arthur Daemmrich, ‘Invisible Monuments and the Costs of Pharmaceutical Regulation: Twenty-Five Years of Drug Lag Debate’, Pharmacy in History 45, no. 1 (2003): 3–17.

33 Tufts Center for the Study of Drug Development, ‘Cost to Develop and Win Marketing Approval for a New Drug Is $2.6 Billion’, MarketWired, 18 November 2014 <http://www.marketwired.com/press-release/cost-develop-win-marketing-approval-new-drug-is-26-billion-according-tufts-center-study-1969439.htm>.

34 Jerry Avorn, ‘The $2.6 Billion Pill – Methodologic and Policy Considerations’, New England Journal of Medicine 372 (2015): 1877–1899.

35 Donald W. Light and Rebecca Warburton, ‘Demythologizing the High Costs of Pharmaceutical Research’, BioSocieties 6, no. 1 (2011): 34–50; Steve Morgan, Paul Grootendorst, Joel Lexchin, Colleen Cunningham and Devon Greyson, ‘The Cost of Drug Development: A Systematic Review’, Health Policy 100, no. 1 (2011): 4–17.

36 Vinay Prasad and Sham Mailankody, ‘Research and Development Spending to Bring a Single Cancer Drug to Market and Revenues After Approval’, JAMA Internal Medicine 177, no. 11 (2017): 1569–1575.

37 Fran Quigley, ‘Escaping Big Pharma’s Pricing with Patent-Free Drugs’, The New York Times, 18 July 2017.

38 Ben Hirschler, ‘GlaxoSmithKline Boss Says New Drugs Can Be Cheaper’, Reuters, 14 March 2013 <https://www.reuters.com/article/us-glaxosmithkline-prices/glaxosmithkline-boss-says-new-drugs-can-be-cheaper-idUSBRE92D0RM20130314>.

39 Kaushik Sunder Rajan, Biocapital: The Constitution of Postgenomic Life (Durham, NC: Duke University Press, 2006); Stefan Helmreich, ‘Species of Biocapital’, Science as Culture 17, no. 4 (2008): 463–478.

40 Javier Lezaun and Catherine M. Montgomery, ‘The Pharmaceutical Commons: Sharing and Exclusion in Global Health Drug Development’, Science, Technology, & Human Values 40, no. 1 (2015): 3–29.

41 Alberto Cambrosio, Peter Keating, Thomas Schlich, and George Weisz, ‘Regulatory Objectivity and the Generation and Management of Evidence in Medicine’, Social Science & Medicine 63, no. 1 (2006): 189–199; Claes-Fredrik Helgesson, ‘From Dirty Data to Credible Scientific Evidence: Some Practices Used to Clean Data in Large Randomised Clinical Trials’, in Catherine Will and Tiago Moreira, eds, Medical Proofs, Social Experiments: Clinical Trials in Shifting Contexts (New York: Routledge, 2016), 49–64.

42 Andreas Lundh, Sergio Sismondo, Joel Lexchin, Octavian A. Busuioc and Lisa Bero, ‘Industry Sponsorship and Research Outcome and Quality (Review)’, The Cochrane Library (12 December 2012) <doi 10.1002/14651858.MR000033>.

43 Jill Fisher, Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials (New Brunswick, NJ: Rutgers University Press, 2009); Philip Mirowski and Robert Van Horn, ‘The Contract Research Organization and the Commercialization of Scientific Research’, Social Studies of Science 35, no. 3 (2005): 503–534.

44 Anu Gummerus, Marja Airaksinen, Mia Bengtström and Anne Juppo, ‘Outsourcing of Regulatory Affairs Tasks in Pharmaceutical Companies – Why and What?’, Journal of Pharmaceutical Innovation 11, no. 1 (2016): 46–52.

45 Outsourcing of the chemistry and the other laboratory studies is common enough that Pfizer had to employ ‘queue management theory’ and the ‘Six Sigma’ approach to factory production developed by Motorola, to make the work more efficient. See F. Christopher Bi, Heather N. Frost, Xiaolan Ling, David A. Perry, Sylvie K. Sakata, Simon Bailey, Yvette M. Fobian, Leslie Sloan, and Anthony Wood, ‘Driving External Chemistry Optimization Via Operations Management Principles’, Drug Discovery Today 19, no. 3 (2014): 289–294.

46 Adriana Petryna, When Experiments Travel: Clinical Trials and the Global Search for Human Subjects (Princeton, NJ: Princeton University Press, 2009), 17.

47 Melissa Cooper, ‘Experimental Labour – Offshoring Clinical Trials to China’, East Asian Science and Technology Studies Journal 2, no. 1 (2008): 73–79.

Adriana Petryna, ‘Clinical Trials Offshored: On Private Sector Science and Public Health’, in Sergio Sismondo and Jeremy A. Greene, eds, The Pharmaceutical Studies Reader (Chichester: John Wiley & Sons, 2015), 208–221.

48 Ignatio Atal, Ludovic Trinquart, Raphaël Porcher, and Philippe Ravaud, ‘Differential Globalization of Industry- and Non-Industry-Sponsored Clinical Trials’, PLOS On (14 December 2015) <https://doi.org/10.1371/journal.pone.0145122>.

49 Johan P.E. Karlberg, Globalization of Industry-Sponsored Clinical Trials (Clinical Trial Magnifier Limited, 2014) <http://www.clinicaltrialmagnifier.org/Globalization/> [accessed 4 August 2017]; Tamara Lytle, ‘Industry Struggles with Prospect of Trials Leaving U.S.’, CenterWatch Monthly 19, no. 4 (April 2012): 14–20.

50 Johan P. E. Karlberg, ‘Sponsored Clinical Trial Globalization Trends’, Clinical Trial Magnifier 1, no. 2 (2008): 13–19; Adriana Petryna, ‘Globalizing Human Subjects Research’, in A. Petryna, A. Lakoff, and A. Kleinman, eds, Global Pharmaceuticals: Ethics, Markets, Practices (Durham, NC: Duke University Press, 2006), 33–60.

51 Sonia Shah, The Body Hunters: Testing New Drugs on the World’s Poorest Patients (New York: New Press, 2006), 17.

52 Kaushik Sunder Rajan, ‘The Experimental Machinery of Global Clinical Trials: Case Studies from India’, in Sergio Sismondo and Jeremy A. Greene, eds, The Pharmaceutical Studies Reader (Chichester: John Wiley & Sons, 2015), 222–234.

53 Kaushik Sunder Rajan, ‘Experimental Values: Indian Clinical Trials and Surplus Health’, New Left Review 45 (2007): 67–88.

54 Sonia Shah, The Body Hunters: Testing New Drugs on the World’s Poorest Patients (New York: New Press, 2006), 17; Kaushik Sunder Rajan, ‘Experimental Values: Indian Clinical Trials and Surplus Health’, New Left Review 45, (2007): 67–88.

55 C. Foster and A.Y. Malik, ‘The Elephant in the (Board) Room: The Role of Contract Research Organizations in International Clinical Research’, The American Journal of Bioethics 12, no. 11 (2012): 49–50 <doi 10.1080/15265161.2012.719267>.

56 Sonia Shah, The Body Hunters: Testing New Drugs on the World’s Poorest Patients (New York: New Press, 2006), 117.

57 Kaushik Sunder Rajan, ‘Experimental Values: Indian Clinical Trials and Surplus Health’, New Left Review 45 (2007): 67–88.

58 Melissa Cooper, ‘Experimental Labour – Offshoring Clinical Trials to China’, East Asian Science and Technology Studies Journal 2, no. 1 (2007): 73–92.

59 Kaushik Sunder Rajan, ‘The Experimental Machinery of Global Clinical Trials: Case Studies from India’, in Sergio Sismondo and Jeremy A. Greene, eds, The Pharmaceutical Studies Reader (Chichester: John Wiley & Sons, 2015), 222–234.

60 Roberto Abadie, The Professional Guinea Pig: Big Pharma and the Risky World of Human Subjects (Durham, NC: Duke University Press, 2010).

61 Mark Schmukler, Pharma Marketing News, Physician Education Special Supplement (2006), 14–16.

62 Mark Schmukler, Pharma Marketing News, Physician Education Special Supplement (2006), 14–16.

63 John LaMattina, ‘Does Marketing Have Too Much Control In Big Pharma Clinical Trials?’, Forbes, 26 January 2016 <https://www.forbes.com/sites/johnlamattina/2016/01/26/does-marketing-have-too-much-control-in-big-pharma-clinical-trials/#79c744e557c>.

64 John LaMattina, ‘Does Marketing Have Too Much Control In Big Pharma Clinical Trials?’, Forbes, 26 January 2016 <https://www.forbes.com/sites/johnlamattina/2016/01/26/does-marketing-have-too-much-control-in-big-pharma-clinical-trials/#79c744e557c>.

65 M. T. Whitstock, ‘Manufacturing the Truth: From Designing Clinical Trials to Publishing Trial Data’, Indian Journal of Medical Ethics (14 November 2017): 1–11 <doi 10.20529/IJME.2017.096>.

66 Richard Smith, ‘Lapses at the New England Journal of Medicine’, Journal of the Royal Society of Medicine 99, no. 8 (August, 2006): 380–382 <doi 10.1258/jrsm.99.8.380>.

67 Clive Barker, Books of Blood, vol. 1 (Hertford, NC: Crossroad Press, 2017).

68 Here I am drawing on the extensive work of Jill Fisher and Roberto Abadie, who have done excellent studies of Phase I trials and trial participants. See, e.g. Torin Monahan and Jill A. Fisher, ‘“I’m Still a Hustler”: Entrepreneurial Responses to Precarity by Participants in Phase I Clinical Trials’, Economy and Society 44, no. 4 (2015): 545–566; Jill A. Fisher, ‘Feeding and Bleeding: The Institutional Banalization of Risk to Healthy Volunteers in Phase I Pharmaceutical Clinical Trials’, Science, Technology, & Human Values 40, no. 2 (2015): 199–226; Roberto Abadie, The Professional Guinea Pig: Big Pharma and the Risky World of Human Subjects, (Durham, NC: Duke University Press, 2010). Abadie’s study was of a number of frequent trial participants in Philadelphia, including a number of anarchists for whom trial income meant that they didn’t have to maintain more permanent jobs. Fisher has interviewed hundreds of Phase I trial participants and dozens of staff at multiple clinics running the trials. Her work addresses day-to-day routines within the clinics, the attitudes and actions of frequent Phase I trial participants, and structures that shape the system. In addition, I have drawn on the systematic account of Phase I trial participation on the website Just Another Lab Rat!, last modified 26 January 2017 <http://www.jalr.org/about_just_another_lab_rat.html>, as well as a number of anecdotal accounts.

69 Again, I am following the insights of Jill Fisher here. See Jill A. Fisher, ‘Feeding and Bleeding: The Institutional Banalization of Risk to Healthy Volunteers in Phase I Pharmaceutical Clinical Trials’, Science, Technology, & Human Values 40, no. 2 (2015): 199–226.

70 See T.S. Eliot, The Use of Poetry and the Use of Criticism (Cambridge, MA: Harvard University Press, 1933). Bruno Latour and Steve Woolgar introduce the idea of an ‘inscription device’, which also focuses on the transformation of materials into ink. Laboratories are places where materials are manipulated, to be turned into written data. See Bruno Latour and Steve Woolgar, Laboratory Life: The Construction of Scientific Facts, 2^nd edn (Princeton, NJ: Princeton University Press, 1986).

71 Jill A. Fisher, ‘Feeding and Bleeding: The Institutional Banalization of Risk to Healthy Volunteers in Phase I Pharmaceutical Clinical Trials’, Science, Technology, & Human Values 40, no. 2 (2015): 199–226.