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2. Crimp D, Ed. AIDS: Cultural Analysis, Cultural Activism. Cambridge, Massachusetts: MIT Press, 1988.
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4. Torres G. ACTG 175 and delta. Treatment Issues 1995;9(10):2–3.
5. Fischl MA, Richman DD, Grieco MH et al. , The efficacy of azidothymidine (AZT) in the treatment of patients with AIDS and AIDS-related complex. New England Journal of Medicine 1987;317:185–91; Richman DD, Fischl MA. Grieco MH et al. , The toxicity of azidothymidine (AZT) in the treatment of patients with AIDS and AIDS-related complex. New England Journal of Medicine 1987;314:192–7.
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8. Sande MA, Arpener CCJ, Obiss CG et al. , Antiretroviral therapy for adult HIV-infected patients recommendations from a state-of-the-art conference. Journal of the American Medical Association 1993;270:2583–9.
9. The estimate is conservative, based on TAG's Summary of US Research Budget. When one adds the costs of the many industry trials, the effort of the MRC in Britain, INSERM in France, the Australian European Cooperative Group, etc., the amount is probably double this figure.
10. [Anonymous]. On stopping a trial before its time. The Lancet 1993;342:1311–2.
11. AOL PWA mailing list [privileged communication].
12. As defined by Freedman B. Equipoise and the ethics of clinical research. New England Journal of Medicine 1987;317:141–5.
13. Pneumocystis carinii pneumonia is a common opportunistic infection in PWAs and the cause of most AIDS-related deaths.
14. Nussbaum B. Good Intentions. How Big Business and the Medical Establishment Are Corrupting the Fight Against AIDS, Alzheimer's, Cancer and More. New York: Penguin, 1991.
15. Hogan C, Hodges J, Abrams DI et al. , MAPS: a proposal for more clinically relevant research in AIDS [In press].
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17. Rothman KJ, Michels KB. The continuing unethical use of placebo controls. New England Journal of Medicine 1994;331:394–8.
18. Hellman S, Hellman DS. Of mice but not men: problems of the randomized clinical trial. New England Journal of Medicine 1991;324:1585–9.
19. Hogan C. Test treatment strategies under real conditions. Treatment Issues 1995;9(4):7–9.
20. See note 15. Hogan [In press].
21. Levine C, Neveloff Dubler N, Levine RJ. Building a new consensus: ethical principles and policies for clinical research on HIV/AIDS. IRB: A Review of Human Subjects Research 1991;31(1–2):1–17.
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23. CDC. Update: mortality attributable to HIV infection and AIDS (25–44 years). Morbidity and Mortality Weekly Report 1993;42:481–6.
24. See note 22. Mirken . 1995;217:1–4.
25. Cameron ME. Living With AIDS -Experiencing Ethical Problems. Newbury Park, California: Sage, 1993:114–27.
26. TRT-5. Concerning a clinical phase III trial on saquinavir-balancing research and health care. science.medicine.aids article 11418, posted February 22, 1995. This text was taken from an internet newsgroup devoted to scientific aspects of the AIDS problem.
27. Novick A. Reflections on a term of public service with the FDA anti-virals advisory committee AIDS and Public Policy Journal 1993;8:5–61.
28. Annas GJ. Faith (healing), hope, and charity at the FDA: the politics of AIDS drug trials. In: Gostin LO, Ed. AIDS and the Health Care System. New Haven, Connecticut: Yale University Press, 1990:183–94.
29. We tend to agree by and large with liberal and libertarian arguments in this regard as they have been put forward by Illingworth P. AIDS and the Good Society. London: Routledge, 1990; and Mohr RD. AIDS, gays and state coercion. Bioethics 1987;1:35–50.
30. For example, Armington K. Evaluating new or “alternative treatments,” GMHC Treatment Issues 1993;7(ll/12):28–9; [Anonymous]. Evaluating alternative treatments. PWAC-NY Newsline 1994;03 27;Hogan C. A professional patient's survival guide. PWALive 1994;5(3): 19–21.
31. See note 28. Annas. 1990:183–94.
32. Young R. Personal Autonomy: Beyond Negative and Positive Liberty. Kent, United Kingdom: Groom Helm, 1986.
33. Mill JS. Utilitarianism Liberty. Representative Government. London: Dent, 1960.
34. Shorr AF. AIDS and the FDA: an ethical case for limiting patient access to new medical therapies. IRB: A Review of Human Subjects Research 1992; 14(4): 1–5.
35. Beauchamp TL. Childress JF. Principles of Biomedical Ethics. New York: Oxford University Press 1994.
36. See note 34. Shorr . 1992; 14(4): 1–5; and note 28. Annas. 1990:183–94.
37. Birnbacher D. Verantwortung für zukunftige Generationen. Stuttgart: Reclam, 1988.
38. Singer P. Practical Ethics. Cambridge, United Kingdom: Cambridge University Press, 1993.
39. Minogue B, Palmer-Fernandez G, Udell L, Waller BN. Individual autonomy and the double-blind controlled experiment. Journal of Medicine and Philosophy 1995;20:43–55.
40. Fleming TR. Surrogate markers in AIDS and cancer trials. Statistics in Medicine 1994;13:1423–35.
41. Ellenberg S. Discussion of “surrogate markers in AIDS and cancer trials.” Statistics in Medicine 1994;13:1437–40.
42. Concorde Coordinating Committee. Concorde: MRC/ANRS randomized, double blind controlled trial of immediate and deferred zidovudine in symptom free HIV infection. Lancet 1994;348:871–80.
43. [Editorial]. On stopping a trial before its time. Lancet 1993;342:1311.
44. Rowlands C, Powderly WG. The use of alternative therapies by HIV-positive patients attending the St. Louis AIDS Clinical Trials Unit. Missouri Medicine 1991;88:807–10; Greenblatt RM, Hollander A, MacMaster JR, Henke GJ. Polypharmacy among patients attending an AIDS clinic: utilization of prescribed, unorthodox, and investigational treatments. Journal of the Acquired Immune Deficiency Syndrome 1991;4:136–43.
45. Ellenberg SS, Finkelstein D, Schoenfeld DA. Statistical issues arising in AIDS clinical trials. Journal of the American Statistical Association 1992;87:573–6.
46. Byar DP, Choenfeld DA, Reen SB et al. , Design considerations for AIDS trials. New England Journal of Medicine 1990;323:1343–8.
47. Green SB et al. Issues in the design of drug trials for AIDS. Controlled Clinical Trials 1990;11:80–7.
48. Cooper E. A prospective, randomized master antiretroviral trial: a proposal for improving the quality of information on the clinical usefulness of AIDS drugs. Second National Conference on Human Retroviruses and Related Infections[USA, Abstract 278].1994.
49. See note 15. Hogan [In press].
50. Schwarz D, Lellouch J. Explanatory and pragmatic attitudes in therapeutical trials. Journal of Chronic Disease 1967;20:637–48.
51. Buyse M. Regulatory vs public health requirements in clinical trials. Drug Information Journal 1993;27:977–84.
52. See note 15. Hogan [In press].
53. Larntz K. Individually guided design. Second CPCRA Statistical Center Clinician's Seminar. 1992.