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.
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.
3. John S. James, "ddC Background," AIDS Treatment News, 21 February 1992.
4. Meng et al., "Combination Therapy with Zidovudine and Dideoxycytidine," 18-19.
5. G'dali Braverman, interview by author, tape recording, San Francisco, 17 December 1993.
6. James, "ddC Background."
7. Warren J. Blumenfeld, "FDA, Buyers Clubs Negotiate New Relationship," Advocate, 19 November 1991, 62-63.
8. Gina Kolata, "Patients Going Underground to Buy Experimental Drugs," New York Times, 4 November 1991, A-1.
9. Ibid.
10. Rachel Nowak, "Conditional Approval Touted," Nature 352 (8 August 1991): 464.
11. Blumenfeld, "FDA, Buyers Clubs Negotiate New Relationship."
12. Jonathan Kwitny, Acceptable Risks (New York: Poseidon Press, 1992), 97.
13. Blumenfeld, "FDA, Buyers Clubs Negotiate New Relationship."
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).
15. John S. James, "ddC: AZT Combination Approval Recommended," AIDS Treatment News, 1 May 1992.
16. Mark Harrington, "Gina Kolata Sings the ddI Blues (Again)," Outweek, 28 March 1990, 34-35, quote from 35.
17. John S. James, "ddI and ddC: The Call for Early Approval," AIDS Treatment News, 5 October 1990.
18. John S. James, "Montreal Conference: Overview and Comment," AIDS Treatment News, 29 June 1989.
19. John S. James, "Why No Antivirals: A Case History of Failed Trial Design," AIDS Treatment News, 29 June 1989.
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.
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).
22. This account is from Moss, "Laboratory Markers as Potential Surrogates."
23. See the discussion in Kwitny, Acceptable Risks, 225, 297, 331.
24. Amato and Lagakos, "Considerations in the Selection of Endpoints," S66.
25. "Design of Clinical Trials—End Points: Open Discussion," Journal of Acquired Immune Deficiency Syndromes 3, suppl. 2 (1990): S75.
26. "Surrogate Endpoints in Evaluating the Effectiveness of Drugs," 100-101.
27. "A Barrier Falls at the FDA," PI Perspectives, April 1991.
28. Paul Cotton, "HIV Surrogate Markers Weighed," Journal of the American Medical Association 265 (20 March 1991): 1357, 1361, 1362.
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.
30. John S. James, "Drug Development: What's Needed Now?" AIDS Treatment News, 8 March 1990.
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.
32. James, "Drug Development: What's Needed Now?"
33. John S. James, "The Wrong Nightmare: The Worst Delay of Clinical Trials," AIDS Treatment News, 21 December 1989.
34. Tim Kingston, "The Coming Storm over Expedited Drug Approval," San Francisco Bay Times, June 1991, 10-12.
35. John S. James, "Expanded Access to Experimental Drugs: Interview with David Feigal, M.D., of the FDA," AIDS Treatment News, 30 May 1993.
36. Paul Houston, "Administration Revamps Drug-Approval Policies," Los Angeles Times, 10 April 1992, A-1.
37. Kingston, "Coming Storm," 12.
38. Henry A. Waxman, letter to Dr. David Kessler, Washington, D.C., 10 April 1991.
39. Martin Delaney, letter to Congressman Henry Waxman, San Francisco, 2 May 1991.
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.
41. John S. James, "ddI and ddC Approval Effort—Interview with Martin Delaney," AIDS Treatment News, 7 December 1990.
42. See Kwitny, Acceptable Risks, 383; Victor F. Zonana, "Top AIDS Drug Regulator to Step Down," Los Angeles Times, 22 December 1990, A-6.
43. "Barrier Falls at the FDA."
44. Antiviral Advisory Committee, meeting transcript (Food and Drug Administration, Bethesda, Md., 13-14 February 1991, photocopy), 162-163.
45. Cotton, "HIV Surrogate Markers Weighed," 1362.
46. Kwitny, Acceptable Risks, 391.
47. "ddI Approval: Today and Tomorrow," PI Perspectives, October 1991.
48. Ibid.
49. Paul Cotton, "FDA 'Pushing Envelope' on AIDS Drug," Journal of the American Medical Association 266 (14 August 1991): 757-758, quotes from 757.
50. Donald Abrams, interview by author, tape recording, San Francisco, 16 December 1993.
51. Sheila Jasanoff, The Fifth Branch: Science Advisers as Policymakers (Cambridge, Mass.: Harvard Univ. Press, 1990), 178, 229.
52. Cotton, "FDA 'Pushing Envelope,'" 757.
53. Ibid.
54. Gina Kolata, "U.S. Panel Backs Sale of Experimental AIDS Drug," New York Times, 20 July 1991, A-1.
55. Gina Kolata, "Speeded Approval of AIDS Drug Is Termed Justified by Test Data," New York Times, 20 April 1992, C-3.
56. See James, "ddC: AZT Combination Approval Recommended."
57. David Feigal, interview by author, tape recording, Rockville, Md., 1 November 1994.
58. Michael C. Botkin, "ddC's Bumpy Road," Bay Area Reporter, 7 May 1992, 20, 23.
59. Liz Hunt, "Panel Recommends Conditional Approval for New AIDS Drug," Washington Post, 20 July 1991, A-9.
60. Botkin, "ddC's Bumpy Road," 23.
61. Marlene Cimons, "FDA Approves AIDS Drug for Use with AZT," Los Angeles Times, 23 June 1992, A-1.
62. Botkin, "ddC's Bumpy Road," 20.
63. Ibid.
64. Jon Cohen, "Searching for Markers on the AIDS Trail," Science 258 (16 October 1992): 388-390, quote from 388 (brackets are Cohen's).
65. Deborah Cotton, interview by author, tape recording, Boston, Mass., 25 October 1994.
66. Cohen, "Searching for Markers," 389-390.
67. Ibid., 390.
68. "AIDS Treatment Research Agenda" (ACT UP/New York Treatment & Data Committee, New York, 1990, photocopy), 2.
69. Larry Kramer, "Second-Rated to Death," Outweek, 24 October 1990, 48-50.
70. "AIDS Treatment Research Agenda," 9, 11-13.
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.
72. John S. James, "AIDS Antivirals: A New Generation," AIDS Treatment News, 19 April 1991.
73. John S. James, "1992: Treatments to Watch," AIDS Treatment News, 23 December 1991.
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).
75. See "Therapeutic Vaccines," PI Perspectives, April 1992.
76. Veronica T. Jennings and Malcolm Gladwell, "1,000 Rally for More Vigorous AIDS Effort," Washington Post, 22 May 1990, B-1.
77. John S. James, "ACT UP Calls for NIH Demonstration May 21," AIDS Treatment News, 28 April 1990.
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.
79. See David Concar, "Protests Oust Science at AIDS Conference," Nature 345 (28 June 1990): 753.
80. Victor F. Zonana, "Did AIDS Protest Go Too Far?" Los Angeles Times, 2 July 1990, A-3.
81. Anthony Fauci, interview by author, tape recording, Bethesda, Md., 31 October 1994.
82. Nussbaum, Good Intentions, 306-307.
83. Arno and Feiden, Against the Odds, 227-229; David Barr, interview by author, tape recording, New York City, 28 April 1994.
84. Arno and Feiden, Against the Odds, 234-235.
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.
86. Mark Harrington, interview by author, tape recording, New York City, 29 April 1994.
87. See the arguments in the introduction and chapter 1.
88. Gena Corea, The Invisible Epidemic: The Story of Women and AIDS (New York: HarperCollins, 1992), 265.
89. See Cindy Patton, "Resistance and the Erotic: Reclaiming History, Setting Strategy as We Face AIDS," Radical America 20 (November-December 1986): 68-78.
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).
91. Cathy Jean Cohen, "Power, Resistance and the Construction of Crisis: Marginalized Communities Respond to AIDS" (Ph.D. diss., University of Michigan, 1993), 325.
92. Moisés Agosto, interview by author, tape recording, New York City, 26 April 1994.
93. Jonathan Wadleigh, interview by author, tape recording, Brookline, Mass., 25 October 1994.
94. Ibid.
95. Anne-Christine d'Adesky, "Empowerment or Co-Optation?" The Nation, 11 February 1991, 158-160.
96. See Carrie Wofford, "Sitting at the Table," Outweek, 3 April 1991, 22-23; Cohen, "Power, Resistance, and the Construction of Crisis," 320-324.
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.
98. Risa Dennenberg, "Women, AIDS, Lesbians and Politics," Outweek, 20 March 1991, 27.
99. Harrington, interview.
100. Barr, interview.
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.
102. Michelle Roland, interview by author, tape recording, Davis, Calif., 18 December 1993.
103. Barr, interview.
104. Theo Smart, "This Side of Despair," QW, 13 September 1992, 43-44, 69.
105. Mark Golden, "ACT UP Redux," QW, 11 October 1992, 22-25.
106. Jason Heyman, interview by author, tape recording, San Francisco, 12 July 1994.
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.
108. Heyman, interview.