By Theo Schall

 

Everyone agrees that it’s tremendously important to stop the West African Ebola outbreak, but controversy has arisen over how to do it. With no cure for the disease, researchers and public health officials are determined to begin testing the best available treatment and vaccine prospects as quickly as possible. Yet the history of clinical trials in Africa is a challenging one and researchers, aware of intense international scrutiny, feel pressed to ensure that they proceed ethically.

 

While a number of potentially effective interventions have been identified, Ebola research has had little funding for the past decade, and progress has been slow. Limited supplies of experimental drugs have forced officials to make hard decisions about how to allocate their scarce, unproven resources, and critics have voiced concern over how those decisions have been made. Satirical online newspaper The Onion parodied public perception of research priorities with its July headline Experts: Ebola Vaccine At Least 50 White People Away. Moving forward, it’s important that research on the safety and efficacy of new interventions be carefully designed to both be and appear socially just.

 

In September, World Health Organization (WHO) delegates met to choose which potential interventions to prioritize in coming clinical trials. There remain many unanswered questions about how those interventions will be tested. Who will receive investigational therapies? Will some people be given placebos? Is it more ethical to use the gold standard – randomized clinical trials – or to give more people early access to unproven therapies that might themselves be harmful? Disagreement is ongoing between those who think the Ebola crisis merits exceptional trial design, without a placebo arm, and those who think the severity of the circumstances requires that studies be as scientifically valid as possible. Others have suggested intermediate designs intended to minimize safety concerns while preserving a control.

 

In late October, the WHO convened a meeting of its Ethics Working Group on Ebola Interventions to review the ethics of designing clinical studies on new therapeutic interventions for Ebola. The group was also tasked with providing advice on the ethics of particular study designs. Attendees included regulators, researchers, ethics committee chairs and administrators, and pharmaceutical company representatives. Our own Paulina Onvumaha Tindana, a 2002 trainee of the Johns Hopkins-Fogarty African Bioethics Training Program and a member of the Ethics Working Group, was present. The group’s recommendations on the advantages and disadvantages of various study designs are forthcoming.

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