Letter in the Lancet Detailing Unethical Nevirapine (Viramune) Trials

This letter, by Health Research Group Deputy Director Peter Lurie, M.D., MPH and Director Sidney Wolfe, M.D., appeared in the Lancet on November 20, 1999.

Sir--Although Laura Guay and colleagues' (Sept 4, p 795) [1] study on the effectiveness of nevirapine in reducing perinatal HIV-1 transmission offers hope for reducing the enormous global toll of HIV-1 infection, their work remains deeply unethical. For 14 months after an antepartum and intrapartum regimen of zidovudine was shown in Thailand to reduce HIV-1 transmission by 51%, [2] Guay and colleagues continued to enrol participants without providing antepartum antiretroviral drugs. This practice continued for 6 months after WHO had recommended antepartum and intrapartum zidovudine therapy in less developed countries "where adequate infrastructure is in place", [3] a condition certainly met in this study. Because the mothers were enrolled as early as 32 weeks' gestation, there was ample opportunity to provide this life-saving medication.

[1] Guay LA, Musoke P, Fleming T, et al. Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: HIVNET 012 randomised trial. Lancet 1999; 354: 795-802.

[2] CDC. Administration of zidovudine during late pregnancy and delivery to prevent perinatal HIV transmission: Thailand 1996-1998. MMWR Morb Mortal Wkly Rep 1998; 47: 151-54. [PubMed]

[3] WHO. Recommendations on the safe and effective use of short-course ZDV for prevention of mother-to-child transmission of HIV. Wkly Epidemiol Rec 1998; 73: 313-20. [PubMed]