Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials

Notes

221 Chapter 1 — Clinical Trials: Coming Soon to a Physician Near You 1. CenterWatch, 2005 State of the Clinical Trials Industry (Boston: Thomson CenterWatch , 2005). 2. CenterWatch, An Industry in Evolution (Boston: Thomson CenterWatch, 2003). 3. CenterWatch, 2005 State. 4. Contract research is often contrasted with “investigator-initiated” research. The latter implies that investigators conceive of all elements of the research and conduct (or directly supervise) the protocols themselves. Investigator-initiated research continues to be more typical of academic physicians who are often rewarded more by their universities for successful grant proposals to government agencies such as the National Institutes of Health than they are for their contracts with the pharmaceutical industry. 5. Gina Kolata and Kurt Eichenwald, “Stopgap Medicine: For the Uninsured, Experiments May Provide the Only Treatment,” New York Times, 22 June 1999; Christine Pace, Franklin G. Miller, and Marion Danis, “Enrolling the Uninsured in Clinical Trials: An Ethical Perspective,” Critical Care Medicine 31, no. 3 (2003): S121–25. 6. Larry Gorkin et al., “Clinical Trial Enrollers vs. Nonenrollers: The Cardiac Arrhythmia Suppression Trial (CAST) Recruitment and Enrollment Assessment in Clinical Trials (REACT) Project,” Controlled Clinical Trials 17, no. 1 (1996): 46–59. 7. Vanessa B. Sheppard et al., “If You Build It, They Will Come: Methods for Recruiting Latinos into Cancer Research,” Journal of General Internal Medicine 20, no. 5 (2005): 444–47. 8. G. Marie Swanson and Amy J. Ward, “Recruiting Minorities into Clinical Trials: Toward a Participant-Friendly System,” Journal of the National Cancer Institute 87, no. 23 (1995): 1747–59. 9. This research is part of the growing social science literature engaging the field of bioethics. The earliest examples of this approach to medical ethics can be traced to the following works: Renée C. Fox, Experiment Perilous: Physicians and Patients Facing the Unknown (New Brunswick, NJ: Transaction Publishers, 1959); Renée C. Fox, “Advanced Medical Technology—Social and Ethical Implications,” Annual Review of Sociology 2 (1976): 231–68; Bernard Barber et al., Research on Human Subjects: Problems of Social Control in Medical Experimentation (New York: Russell Sage Foundation, 1973); Bernard Barber, Informed Consent in Medical Therapy and Research (New Brunswick: Rutgers University Press, 1980); Bradford H. Gray, Human Subjects in Medical Experimentation: A Sociological Study of the Conduct and Regulation of Clinical Research (Huntington, NY: R. E. Krieger, 1975); and Charles Bosk, Forgive and Remember: Managing Medical Failure (Chicago: University of Chicago Press, 1979). More recent examples include Charles Bosk, All God’s Mistakes: Genetic Counseling in a Pediatric Hospital (Chicago: University of Chicago Press, 1995); Oonagh P. Corrigan, “Empty Ethics: The Problem with Informed Consent,” Sociology of Health Notes and Illness 25 (2003): 768–92; Raymond G. DeVries, “How Can We Help? From ‘Sociology in’ to ‘Sociology of’ Bioethics,” Journal of Law, Medicine, and Ethics 32 (2004): 279–92; Sydney A. Halpern, Lesser Harms: The Morality of Risk in Medical Research (Chicago: University of Chicago Press, 2004); Adam Hedgecoe, The Politics of Personalized Medicine: Pharmacogenetics in the Clinic (New York: Cambridge University Press, 2004); Sergio Sismondo, “Pharmaceutical Maneuvers,” Social Studies of Science 34, no. 3 (2004): 149–59; and Robert Zussman, Intensive Care: Medical Ethics and the Medical Profession (Chicago: University of Chicago Press, 1992). 10. See the appendix for more detailed information about my methods and about the organizations included and informants interviewed. 11. CenterWatch, 2006 State of the Clinical Trials Industry (Boston: Thomson CenterWatch , 2006); Thomas Bodenheimer, “Uneasy Alliance: Clinical Investigators and the Pharmaceutical Industry,” New England Journal of Medicine 342, no. 20 (2000): 1539–44. 12. Pharmaceutical Research and Manufacturers of America, “Biopharmaceutical Industry Research and Development Tops $49 Billion in 2004,” in Pharmaceutical Industry Profile 2005 (Washington, DC: PhRMA, March 2005). 13. CenterWatch, An Industry. 14. “Trials and Tribulations: More Effective Clinical Trials May Be Just Around the Corner,” Economist, Feb. 21, 1998, 13–15. 15. CenterWatch, An Industry. 16. B. Rainville, “Strategic Outsourcing with Contract Research Organizations: Targeting Corporate Goals,” Drug Information Journal 36, no. 1 (2002): 77–81. 17. For a more nuanced analysis of the framing of populations as “ready-to-recruit,” see Jill A. Fisher, “‘Ready-to-Recruit’ or ‘Ready-to-Consent’ Populations?: Informed Consent and the Limits of Subject Autonomy,” Qualitative Inquiry 13, no. 6 (2007): 875–94. 18. CenterWatch, An Industry. 19. ACRO (Association of Clinical Research Organizations), “Clinical Research Participation : Today’s Challenges, Tomorrow’s Possibilities” (paper read at ACRO Webcast, 2004). 20. There is considerable (long-standing) debate about how much it costs to bring a drug to market...