Chapter 8 Dilemmas and Divisions in Science and Politics
1. See, for example, Samuel Broder, "Controlled Trial Methodology and Progress in Treatment of the Acquired Immunodeficiency Syndrome (AIDS): A Quid Pro Quo," Annals of Internal Medicine 110 (15 March 1989): 417-418. [BACK]
2. See the published report of the study in Tze-Chiang Meng et al., "Combination Therapy with Zidovudine and Dideoxycytidine in Patients with Advanced Human Immunodeficiency Virus Infection: A Phase I/II Study," Annals of Internal Medicine 116 (1 January 1992): 13-20. [BACK]
3. John S. James, "ddC Background," AIDS Treatment News, 21 February 1992. [BACK]
4. Meng et al., "Combination Therapy with Zidovudine and Dideoxycytidine," 18-19. [BACK]
5. G'dali Braverman, interview by author, tape recording, San Francisco, 17 December 1993. [BACK]
6. James, "ddC Background." [BACK]
7. Warren J. Blumenfeld, "FDA, Buyers Clubs Negotiate New Relationship," Advocate, 19 November 1991, 62-63. [BACK]
8. Gina Kolata, "Patients Going Underground to Buy Experimental Drugs," New York Times, 4 November 1991, A-1. [BACK]
9. Ibid. [BACK]
10. Rachel Nowak, "Conditional Approval Touted," Nature 352 (8 August 1991): 464. [BACK]
11. Blumenfeld, "FDA, Buyers Clubs Negotiate New Relationship." [BACK]
12. Jonathan Kwitny, Acceptable Risks (New York: Poseidon Press, 1992), 97. [BACK]
13. Blumenfeld, "FDA, Buyers Clubs Negotiate New Relationship." [BACK]
14. Deborah R. Gordon, "Clinical Science and Clinical Expertise: Changing Boundaries between Art and Science in Medicine," in Biomedicine Examined, ed. M. Lock and D. R. Gordon (Dordrecht, Holland: Kluwer Academic Publishing, 1988), 257-295, quote from 257; Harry Milton Marks, "Ideas as Reforms: Therapeutic Experiments and Medical Practice, 1900-1980" (Ph.D. diss., Massachusetts Institute of Technology, 1987). [BACK]
15. John S. James, "ddC: AZT Combination Approval Recommended," AIDS Treatment News, 1 May 1992. [BACK]
16. Mark Harrington, "Gina Kolata Sings the ddI Blues (Again)," Outweek, 28 March 1990, 34-35, quote from 35. [BACK]
17. John S. James, "ddI and ddC: The Call for Early Approval," AIDS Treatment News, 5 October 1990. [BACK]
18. John S. James, "Montreal Conference: Overview and Comment," AIDS Treatment News, 29 June 1989. [BACK]
19. John S. James, "Why No Antivirals: A Case History of Failed Trial Design," AIDS Treatment News, 29 June 1989. [BACK]
20. Andrew R. Moss, "Laboratory Markers as Potential Surrogates for Clinical Outcomes in AIDS Trials," Journal of Acquired Immune Deficiency Syndromes 3, suppl. 2 (1990), S69-S71; David Amato and Stephen W. Lagakos, "Considerations in the Selection of End Points for AIDS Clinical Trials," Journal of Acquired Immune Deficiency Syndromes 3, suppl. 2 (1990), S64-S68. [BACK]
21. "Surrogate Endpoints in Evaluating the Effectiveness of Drugs against HIV Infection and AIDS" (transcript of conference of the National Academy of Sciences, Washington, D.C., 11-12 September 1989, photocopy). [BACK]
22. This account is from Moss, "Laboratory Markers as Potential Surrogates." [BACK]
23. See the discussion in Kwitny, Acceptable Risks, 225, 297, 331. [BACK]
24. Amato and Lagakos, "Considerations in the Selection of Endpoints," S66. [BACK]
25. "Design of Clinical Trials—End Points: Open Discussion," Journal of Acquired Immune Deficiency Syndromes 3, suppl. 2 (1990): S75. [BACK]
26. "Surrogate Endpoints in Evaluating the Effectiveness of Drugs," 100-101. [BACK]
27. "A Barrier Falls at the FDA," PI Perspectives, April 1991. [BACK]
28. Paul Cotton, "HIV Surrogate Markers Weighed," Journal of the American Medical Association 265 (20 March 1991): 1357, 1361, 1362. [BACK]
29. See Bruce Nussbaum, Good Intentions: How Big Business and the Medical Establishment Are Corrupting the Fight against AIDS (New York: Atlantic Monthly Press, 1990); Kwitny, Acceptable Risks. [BACK]
30. John S. James, "Drug Development: What's Needed Now?" AIDS Treatment News, 8 March 1990. [BACK]
31. On the role of "standing-for" (or "metonymical") relationships in the construction of scientific credibility, see Steven Shapin, "Cordelia's Love: Credibility and the Social Studies of Studies," Perspectives on Science 3, no. 3 (1995): 255-275. [BACK]
32. James, "Drug Development: What's Needed Now?" [BACK]
33. John S. James, "The Wrong Nightmare: The Worst Delay of Clinical Trials," AIDS Treatment News, 21 December 1989. [BACK]
34. Tim Kingston, "The Coming Storm over Expedited Drug Approval," San Francisco Bay Times, June 1991, 10-12. [BACK]
35. John S. James, "Expanded Access to Experimental Drugs: Interview with David Feigal, M.D., of the FDA," AIDS Treatment News, 30 May 1993. [BACK]
36. Paul Houston, "Administration Revamps Drug-Approval Policies," Los Angeles Times, 10 April 1992, A-1. [BACK]
37. Kingston, "Coming Storm," 12. [BACK]
38. Henry A. Waxman, letter to Dr. David Kessler, Washington, D.C., 10 April 1991. [BACK]
39. Martin Delaney, letter to Congressman Henry Waxman, San Francisco, 2 May 1991. [BACK]
40. Paul Cotton, "Surrogate Markers of Disease Studied as Means of Determining AIDS Drugs' Effectiveness," Journal of the American Medical Association 264 (14 November 1990): 2362, 2365. [BACK]
41. John S. James, "ddI and ddC Approval Effort—Interview with Martin Delaney," AIDS Treatment News, 7 December 1990. [BACK]
42. See Kwitny, Acceptable Risks, 383; Victor F. Zonana, "Top AIDS Drug Regulator to Step Down," Los Angeles Times, 22 December 1990, A-6. [BACK]
43. "Barrier Falls at the FDA." [BACK]
44. Antiviral Advisory Committee, meeting transcript (Food and Drug Administration, Bethesda, Md., 13-14 February 1991, photocopy), 162-163. [BACK]
45. Cotton, "HIV Surrogate Markers Weighed," 1362. [BACK]
46. Kwitny, Acceptable Risks, 391. [BACK]
47. "ddI Approval: Today and Tomorrow," PI Perspectives, October 1991. [BACK]
48. Ibid. [BACK]
49. Paul Cotton, "FDA 'Pushing Envelope' on AIDS Drug," Journal of the American Medical Association 266 (14 August 1991): 757-758, quotes from 757. [BACK]
50. Donald Abrams, interview by author, tape recording, San Francisco, 16 December 1993. [BACK]
51. Sheila Jasanoff, The Fifth Branch: Science Advisers as Policymakers (Cambridge, Mass.: Harvard Univ. Press, 1990), 178, 229. [BACK]
52. Cotton, "FDA 'Pushing Envelope,'" 757. [BACK]
53. Ibid. [BACK]
54. Gina Kolata, "U.S. Panel Backs Sale of Experimental AIDS Drug," New York Times, 20 July 1991, A-1. [BACK]
55. Gina Kolata, "Speeded Approval of AIDS Drug Is Termed Justified by Test Data," New York Times, 20 April 1992, C-3. [BACK]
56. See James, "ddC: AZT Combination Approval Recommended." [BACK]
57. David Feigal, interview by author, tape recording, Rockville, Md., 1 November 1994. [BACK]
58. Michael C. Botkin, "ddC's Bumpy Road," Bay Area Reporter, 7 May 1992, 20, 23. [BACK]
59. Liz Hunt, "Panel Recommends Conditional Approval for New AIDS Drug," Washington Post, 20 July 1991, A-9. [BACK]
60. Botkin, "ddC's Bumpy Road," 23. [BACK]
61. Marlene Cimons, "FDA Approves AIDS Drug for Use with AZT," Los Angeles Times, 23 June 1992, A-1. [BACK]
62. Botkin, "ddC's Bumpy Road," 20. [BACK]
63. Ibid. [BACK]
64. Jon Cohen, "Searching for Markers on the AIDS Trail," Science 258 (16 October 1992): 388-390, quote from 388 (brackets are Cohen's). [BACK]
65. Deborah Cotton, interview by author, tape recording, Boston, Mass., 25 October 1994. [BACK]
66. Cohen, "Searching for Markers," 389-390. [BACK]
67. Ibid., 390. [BACK]
68. "AIDS Treatment Research Agenda" (ACT UP/New York Treatment & Data Committee, New York, 1990, photocopy), 2. [BACK]
69. Larry Kramer, "Second-Rated to Death," Outweek, 24 October 1990, 48-50. [BACK]
70. "AIDS Treatment Research Agenda," 9, 11-13. [BACK]
71. Gina Kolata, "AIDS Research Finds 13 Vulnerable Spots in Virus Life Cycle," New York Times, 2 October 1990, C-3; see also Hiroaki Mitsuya, Robert Yarchoan, and Samuel Broder, "Molecular Targets for AIDS Therapy," Science 249 (28 September 1990): 1533-1544. [BACK]
72. John S. James, "AIDS Antivirals: A New Generation," AIDS Treatment News, 19 April 1991. [BACK]
73. John S. James, "1992: Treatments to Watch," AIDS Treatment News, 23 December 1991. [BACK]
74. David Baltimore and Mark B. Feinberg, "HIV Revealed: Toward a Natural History of the Infection," New England Journal of Medicine 321 (14 December 1989): 1673 (editorial). [BACK]
75. See "Therapeutic Vaccines," PI Perspectives, April 1992. [BACK]
76. Veronica T. Jennings and Malcolm Gladwell, "1,000 Rally for More Vigorous AIDS Effort," Washington Post, 22 May 1990, B-1. [BACK]
77. John S. James, "ACT UP Calls for NIH Demonstration May 21," AIDS Treatment News, 28 April 1990. [BACK]
78. Mark Harrington, "Eating Where They ...," Outweek, 18 February 1990, 34; Mark Harrington, "Anatomy of a Disaster: Why Is Federal AIDS Research at a Standstill?" Village Voice, 13 March 1990, 40-41. [BACK]
79. See David Concar, "Protests Oust Science at AIDS Conference," Nature 345 (28 June 1990): 753. [BACK]
80. Victor F. Zonana, "Did AIDS Protest Go Too Far?" Los Angeles Times, 2 July 1990, A-3. [BACK]
81. Anthony Fauci, interview by author, tape recording, Bethesda, Md., 31 October 1994. [BACK]
82. Nussbaum, Good Intentions, 306-307. [BACK]
83. Arno and Feiden, Against the Odds, 227-229; David Barr, interview by author, tape recording, New York City, 28 April 1994. [BACK]
84. Arno and Feiden, Against the Odds, 234-235. [BACK]
85. Philip J. Hilts, "82 Held in Protest on Pace of AIDS Research," New York Times, 22 May 1990, C-2; Arno and Feiden, Against the Odds, 232. [BACK]
86. Mark Harrington, interview by author, tape recording, New York City, 29 April 1994. [BACK]
87. See the arguments in the introduction and chapter 1. [BACK]
88. Gena Corea, The Invisible Epidemic: The Story of Women and AIDS (New York: HarperCollins, 1992), 265. [BACK]
89. See Cindy Patton, "Resistance and the Erotic: Reclaiming History, Setting Strategy as We Face AIDS," Radical America 20 (November-December 1986): 68-78. [BACK]
90. Maxine Wolfe, "The AIDS Coalition to Unleash Power, New York (ACT UP NY): A Direct Action Political Model of Community Research for AIDS Prevention," in AIDS Prevention and Services: Community Based Research, ed. J. Van Vugt (Westport, Conn.: Bergin Garvey, forthcoming). On the varieties of AIDS activism by women, see also Beth E. Schneider and Nancy E. Stoller, eds., Women Resisting AIDS: Feminist Strategies of Empowerment (Philadelphia: Temple Univ. Press, 1995). [BACK]
91. Cathy Jean Cohen, "Power, Resistance and the Construction of Crisis: Marginalized Communities Respond to AIDS" (Ph.D. diss., University of Michigan, 1993), 325. [BACK]
92. Moisés Agosto, interview by author, tape recording, New York City, 26 April 1994. [BACK]
93. Jonathan Wadleigh, interview by author, tape recording, Brookline, Mass., 25 October 1994. [BACK]
94. Ibid. [BACK]
95. Anne-Christine d'Adesky, "Empowerment or Co-Optation?" The Nation, 11 February 1991, 158-160. [BACK]
96. See Carrie Wofford, "Sitting at the Table," Outweek, 3 April 1991, 22-23; Cohen, "Power, Resistance, and the Construction of Crisis," 320-324. [BACK]
97. For a range of perspectives on the causes and significance of the ACT UP/San Francisco split, see: Tim Vollmer, "ACT-UP/SF Splits in Two over Consensus, Focus," San Francisco Sentinel, 20 September 1990, 1; Jesse Dobson, "Why ACT-UP Split in Two" (same issue), 4; Kate Raphael, "ACT-UP: Growing Apart" (same issue), 5; Michele DeRanleau, "How the 'Conscience of an Epidemic' Unraveled," San Francisco Examiner, 1 October 1990, A-15. [BACK]
98. Risa Dennenberg, "Women, AIDS, Lesbians and Politics," Outweek, 20 March 1991, 27. [BACK]
99. Harrington, interview. [BACK]
100. Barr, interview. [BACK]
101. Gilbert Elbaz, "The Sociology of AIDS Activism, the Case of ACT UP/New York, 1987-1992" (Ph.D. diss., City University of New York, 1992), 488. [BACK]
102. Michelle Roland, interview by author, tape recording, Davis, Calif., 18 December 1993. [BACK]
103. Barr, interview. [BACK]
104. Theo Smart, "This Side of Despair," QW, 13 September 1992, 43-44, 69. [BACK]
105. Mark Golden, "ACT UP Redux," QW, 11 October 1992, 22-25. [BACK]
106. Jason Heyman, interview by author, tape recording, San Francisco, 12 July 1994. [BACK]
107. On boundary work in science, see Thomas F. Gieryn, "Boundary Work and the Demarcation of Science from Non-Science: Strains and Interests in Professional Ideologies of Scientists," American Sociological Review 48 (December 1983): 781-795; Thomas F. Gieryn, "Boundaries of Science," in Handbook of Science and Technology Studies, ed. Sheila Jasanoff et al. (Thousand Oaks, Calif.: Sage, 1995), 393-443. [BACK]
108. Heyman, interview. [BACK]