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Unethical research to cut mother-to-child HIV transmission

A history lesson with at least one happy landing

Fortunately this page is mostly a history lesson. Ethical problems in late 1990s research on mother-to-child HIV transmission stand as warnings to beware similar ethical lapses in current HIV research and prevention. As for 1990s debates about research on mother-to-child transmission in Africa, this seems to be one time the good guys won: in recent years, experts and governments promote the same treatment to prevent mother-to-child HIV transmission in Africa as in rich countries, giving antiretroviral treatment (ART) to all HIV-positive pregnant and breastfeeding women.

Placebos: giving useless pills, then watching women infect babies

However, it was not always so. In the late 1990s, when researchers in Africa tested ways to reduce mother-to-child HIV transmission, a double standard got in the way. In Africa, only rarely did researchers compare their proposed interventions to something already known to work, as was required for research in rich countries; instead, most researchers in Africa compared their proposed interventions to nothing.

In other words, researchers in Africa managed trials in which some pregnant women got a proposed intervention to reduce mother-to-child transmission (for example: nevirapine or vitamin A) while others got a placebo (that is, a pill that had no benefit). This violates ethical guidelines as laid out in the Declaration of Helsinki: researchers should test proposed interventions against the best available treatment.[1] At the time, the best available treatment was to give zidovudine to pregnant women and babies – research in the US reported in 1993 that zidovudine reduced the rate of mother-to-child transmission at birth from more than 20% to 8% only.[2]

In 1997, six health and public policy experts US wrote a long letter to the US Secretary of Health and Human Services, calling her attention to “unethical trials which administer placebos to HIV-infected pregnant women.”[3] The letter asks the Secretary to: “immediately order the researchers in these studies to provide effective prophylaxis to all subjects in these studies… We also request that you immediately ask the HHS [Health and Human Services] Office of the Inspector General to launch an investigation into how these U.S.-funded studies received ethical approval and into possible violations of federal law…” For anyone interested to know more, the letter provides not only a wealth of detail but also a long list of references.

The controversy brought in the editor of the prestigious New England Journal of Medicine, Marcia Angell. Her editorial in the Journal in 1997 criticizes “trials in the Third World of regimens to prevent” mother-to-child HIV transmission, most of which “employ placebo-treated control groups, despite the fact that zidovudine has already been clearly shown to cut the rate of vertical transmission greatly and is now recommended in the United States for all HIV-infected women… The fact remains that many studies are done in the Third World that simply could not be done in the countries sponsoring the work.”[4]

References

1. World Medical Association. WHA Declaration of Helsinki – ethical principles for medical research involving human subjects, 2013. Available at: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/ (accessed 6 November 2018).

2. Zidovudine for the prevention of HIV transmission from mother to infant. MMWR 1994; 43: 283-287. Available at: https://www.cdc.gov/mmwr/preview/mmwrhtml/00030635.htm (accessed 6 November 2018).

3. Lurie P, Wolfe SM, Jordan W, et al. Letter concerning funding of unethical trials which administer placebos to HIV-infected pregant women. Letter to Donna Shalala, Secretary, Department of Health an Human Services, 22 April 1997. Available at: https://www.citizen.org/our-work/health-and-safety/letter-concerning-funding-unethical-trials-which-administer (accessed 6 November 2018).

4. Angell M. The ethics of clinical research in the Third World. NEJM 1997; 337: 847-849. Available for purchase at: https://www.nejm.org/doi/full/10.1056/NEJM199709183371209 (accessed 6 November 2018).

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