With clinical trials of experimental Ebola treatments set to begin in December, public-health officials face a major ethical quandary: should some participants be placed in a control group that receives only standard symptomatic treatment, despite a mortality rate of around 70% for Ebola in West Africa?
Two groups planning trials in Guinea and Liberia are diverging on this point, and key decisions for both are likely to come this week. US researchers meet on 11 November at the National Institutes of Health (NIH) in Bethesda, Maryland, to discuss US-government sponsored trials. A separate group is gathering at the World Health Organization (WHO) in Geneva, Switzerland, on 11 and 12 November to confer on both the US effort and trials organized by the WHO with help from African and European researchers and funded by the Wellcome Trust and the European Union.
Experts convened by the WHO in August gave ethics approval to test experimental treatments amid the Ebola epidemic in West Africa. But the WHO trial organizers are not including control arms because most African patients treated with ‘standard of care’ — which includes fluid-replacement therapy, pain relief and drugs to ward off secondary infections — die. A trial in Guinea of ‘convalescent serum’, a blood product thought to include protective antibodies, will only assign a patient to a control group if there is no available serum matched to that person’s blood type.
“These trials will be conducted in a context of fear, distrust, a lack of effective care options, the admission of multiple family members to the same centre, and sometimes violence against health-care workers,” says Peter Horby, an epidemiologist at the University of Oxford, UK. “Scientific arguments cannot tell us what will work in these conditions.”
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