The "best proven therapeutic method" standard in clinical trials in technologically developing countries

Journal of Clinical Ethics

Volumn 9, Issue 2, 1998, Pages 167-172

  Levine, Robert J ^a  

^a YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT; ZIDOVUDINE;

ARTICLE; DEVELOPING COUNTRY; DISEASE TRANSMISSION; DOSE RESPONSE; FEMALE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; LEGAL ASPECT; MEDICAL ETHICS; PREGNANCY; PREGNANCY COMPLICATION; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME;

ANTI-HIV AGENTS; DEVELOPING COUNTRIES; DISEASE TRANSMISSION, VERTICAL; DOSE-RESPONSE RELATIONSHIP, DRUG; ETHICS, MEDICAL; FEMALE; HIV INFECTIONS; HUMANS; PREGNANCY; PREGNANCY COMPLICATIONS, INFECTIOUS; RANDOMIZED CONTROLLED TRIALS; TREATMENT OUTCOME; ZIDOVUDINE;

EID: 0032087564     PISSN: 10467890     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (10)

1. P. Lurie and S.M. Wolfe, "Unethical Trials of Interventions to Reduce Perinatal Transmission of the . Human Immunodeficiency Virus in Developing Countries," New England Journal of Medicine 337 (1997): 853-56.
2. M. Angell, "The Ethics of Clinical Research in the Third World," New England Journal of Medicine 337 (1997): 847-49.
3. For rebuttals to the critiques by Lurie and Wolfe and Angell see H. Varmus and D. Satcher, "Ethical Complexities of Conducting Research in Developing Countries," New England Journal of Medicine 337 (1997): 1003-05
4. and B.R. Bloom, "The Highest Attainable Standard: Ethical Issues in AIDS Vaccines," Science 279 (1998): 186-88.
5. The antiretroviral drug, originally known as azidothymindine (AZT), and subsequently renamed zidovudine (ZDV) and Retrovir (R).
6. The passage of the human immunodeficiency virus (HTV), the causative agent of AIDS, from infected pregnant women to their fetuses during pregnancy or delivery is known as perinatal transmission.
7. The Declaration of Helsinki, the code of research ethics of the World Medical Association, was first promulgated in Helsinki in 1964. Quoted above is the fourth and most recent amended version adopted in 1996 in the Republic of South Africa. The second (and last) sentence of Article II.3 is "This does not exclude the use of inert placebo in studies where no proven diagnostic or therapeutic method exists." This final sentence was added because the WMA was distressed that its Helsinki Declaration was being misinterpreted as proscribing all placebo controls.
8. E. M. Connor et al., "Reduction of Maternal-Infant Transmission of Human Immunodeficiency Virus Type I with Zidovudine Treatment," New England Journal of Medicine 331 (1994): 1173-80;
9. R.S. Sperling et al., "Maternal Viral Load, Zidovudine Treatment, and the Risk of Transmission of Human Immunode-ficiency Virus Type I from Mother to Infant," New England Journal of Medicine 335 (1996): 1621-29.
10. The daily dose of AZT is the same as that of the 076 regimen. The total dose is lower owing to the shorter duration of administration.