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Patient Access to Experimental Drugs and AIDS Clinical Trial Designs: Ethical Issues

Published online by Cambridge University Press:  29 July 2009

Udo Schüklenk
Affiliation:
Monash University Centre for Human Bioethics, Australia. is a German philosopher. He has published widely on philosophical aspects of AIDS, environmental issues of animal rights, and ethics of sexual orientation research.
Carlton Hogan
Affiliation:
He is Editor-in-Chief of PWALive magazine and works at the University of Minnesota School of Public Health, Division of Biostatlstics. He publishes on AIDS-related issues in advocate newsletters, magazines, and scientific journals.

Extract

Today's clinical AIDS research is in trouble. Principal investigators are confronted with young and frequently highly knowledgeable patients. Many of these people with AIDS (PWAs) are often unwilling to adhere to the trial protocols. These PWAs believe they are ethically justified in breaching trial protocols because they do not consider themselves true volunteers in such trials. PWAs argue that they do not really volunteer because existing legislation prevents them from buying and using experimental drugs or from testing alternative treatment strategies. Their only access to such agents is participation in clinical trials.

Type
Special Section: Rejuvenating Research Ethics
Copyright
Copyright © Cambridge University Press 1996

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References

Notes

1. US National Research Council. Social Impact of AIDS. Washington, DC: National Academy Press, 1993.Google Scholar

2. Crimp, D, Ed. AIDS: Cultural Analysis, Cultural Activism. Cambridge, Massachusetts: MIT Press, 1988.Google Scholar

3. Delaney, M. The case for patient access to experimental therapies. Journal of Infectious Diseases 1989;159:416–9.CrossRefGoogle Scholar

4. Torres, G. ACTG 175 and delta. Treatment Issues 1995;9(10):23.Google ScholarPubMed

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;317:185–91CrossRefGoogle ScholarPubMed; 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.CrossRefGoogle Scholar

6. Lauritsen, J. The AIDS War. New York: Asklepios Press, 1993.Google Scholar

7. Sonnabend, J. A review of AZT multi center trial-data obtained under the Freedom of Information Act by Project Inform and ACT Up. AIDS Forum 1989; 1(1):915.Google Scholar

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.CrossRefGoogle ScholarPubMed

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.Google Scholar

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.CrossRefGoogle ScholarPubMed

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.Google Scholar

15. Hogan, C, Hodges, J, Abrams, DI et al. , MAPS: a proposal for more clinically relevant research in AIDS [In press].Google Scholar

16. Annas, GJ. The dominance of American law (and market values) over American bioethics. In: Grodin, M, Ed. Meta Medical Ethics: The Philosophical Foundations of Bioethics. Dordrecht: Kluwer Academic Publishers, 1995.Google Scholar

17. Rothman, KJ, Michels, KB. The continuing unethical use of placebo controls. New England Journal of Medicine 1994;331:394–8.CrossRefGoogle ScholarPubMed

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.CrossRefGoogle Scholar

19. Hogan, C. Test treatment strategies under real conditions. Treatment Issues 1995;9(4):79.Google Scholar

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):117.CrossRefGoogle Scholar

22. Mirken, B. AIDS clinical trials: why they have recruiting problems. AIDS Treatment News 1995;217:14.Google Scholar

23. CDC. Update: mortality attributable to HIV infection and AIDS (25–44 years). Morbidity and Mortality Weekly Report 1993;42:481–6.Google Scholar

24. See note 22. Mirken, . 1995;217:14.Google Scholar

25. Cameron, ME. Living With AIDS -Experiencing Ethical Problems. Newbury Park, California: Sage, 1993:114–27.Google Scholar

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;8:561.Google Scholar

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.Google Scholar

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;Google Scholar and Mohr, RD. AIDS, gays and state coercion. Bioethics 1987;1:3550.CrossRefGoogle ScholarPubMed

30. For example, Armington, K. Evaluating new or “alternative treatments,” GMHC Treatment Issues 1993;7(ll/12):28–9Google Scholar; [Anonymous]. Evaluating alternative treatments. PWAC-NY Newsline 1994;03 27;Google ScholarHogan, C. A professional patient's survival guide. PWALive 1994;5(3): 1921.Google Scholar

31. See note 28. Annas. 1990:183–94.

32. Young, R. Personal Autonomy: Beyond Negative and Positive Liberty. Kent, United Kingdom: Groom Helm, 1986.Google Scholar

33. Mill, JS. Utilitarianism Liberty. Representative Government. London: Dent, 1960.Google Scholar

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): 15.CrossRefGoogle ScholarPubMed

35. Beauchamp, TL. Childress, JF. Principles of Biomedical Ethics. New York: Oxford University Press 1994.Google ScholarPubMed

36. See note 34. Shorr, . 1992; 14(4): 15; and note 28. Annas. 1990:183–94.Google Scholar

37. Birnbacher, D. Verantwortung für zukunftige Generationen. Stuttgart: Reclam, 1988.Google Scholar

38. Singer, P. Practical Ethics. Cambridge, United Kingdom: Cambridge University Press, 1993.Google Scholar

39. Minogue, B, Palmer-Fernandez, G, Udell, L, Waller, BN. Individual autonomy and the double-blind controlled experiment. Journal of Medicine and Philosophy 1995;20:4355.CrossRefGoogle ScholarPubMed

40. Fleming, TR. Surrogate markers in AIDS and cancer trials. Statistics in Medicine 1994;13:1423–35.CrossRefGoogle ScholarPubMed

41. Ellenberg, S. Discussion of “surrogate markers in AIDS and cancer trials.” Statistics in Medicine 1994;13:1437–40.CrossRefGoogle Scholar

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.Google Scholar

43. [Editorial]. On stopping a trial before its time. Lancet 1993;342:1311.CrossRefGoogle ScholarPubMed

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;88:807–10Google Scholar; 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.Google ScholarPubMed

45. Ellenberg, SS, Finkelstein, D, Schoenfeld, DA. Statistical issues arising in AIDS clinical trials. Journal of the American Statistical Association 1992;87:573–6.Google Scholar

46. Byar, DP, Choenfeld, DA, Reen, SB et al. , Design considerations for AIDS trials. New England Journal of Medicine 1990;323:1343–8.CrossRefGoogle ScholarPubMed

47. Green, SB et al. Issues in the design of drug trials for AIDS. Controlled Clinical Trials 1990;11:80–7.CrossRefGoogle Scholar

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.Google Scholar

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.CrossRefGoogle Scholar

51. Buyse, M. Regulatory vs public health requirements in clinical trials. Drug Information Journal 1993;27:977–84.CrossRefGoogle Scholar

52. See note 15. Hogan [In press].

53. Larntz, K. Individually guided design. Second CPCRA Statistical Center Clinician's Seminar. 1992.Google Scholar