Healthy Skepticism Library item: 16731
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Publication type: Journal Article
Lurie P, Wolfe SM.
Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries.
N Engl J Med 1997 Sep 18; 337:(12):853-6
http://www.ncbi.nlm.nih.gov/pubmed/9295246
Abstract:
PIP: It was published almost 3 years ago that zidovudine administered orally to HIV-infected pregnant women, intravenously during labor, and later administered to newborn infants reduces the incidence of HIV infection in infants by two-thirds. This regimen, known as the ACTG 076 regimen and capable of saving the life of one of every seven infants born to HIV-infected women, subsequently became the standard of care in the US. However, the high cost of zidovudine and the ACTG 076 regimen impedes their use in developing countries. A regimen as effective but less expensive than ACTG 076 is therefore highly desirable in countries worldwide, but especially in developing countries. The authors oppose the use of placebo-controlled trials as unethical in the search for alternative antiretroviral drug regimens to prevent the perinatal transmission of HIV. 15 trials in developing countries are identified in which some or all of the participants are not being provided with antiretroviral drugs. Those studies violate recent guidelines designed specifically to address ethical issues regarding studies in developing countries. An urgent need exists to develop and adhere to a universally recognized code of ethics for medical research upon human subjects.
Keywords:
* Anti-HIV Agents/therapeutic use * Clinical Trials as Topic*/methods * Clinical Trials as Topic*/standards * Control Groups * Developing Countries* * Ethical Relativism* * Ethics, Medical* * Federal Government * Female * HIV Infections/prevention & control* * HIV Infections/therapy * HIV Infections/transmission * Humans * Infectious Disease Transmission, Vertical/prevention & control*n * Placebos*n * Pregnancyn * Pregnancy Complications, Infectious/drug therapyn * Pregnancy Complications, Infectious/therapy*n * Pregnant Women*n * Therapeutic Human Experimentationn * United Statesn * United States Public Health Servicen * Zidovudine/therapeutic use
