Responding to Ebola
How can medical research keep up with disease outbreaks?
In 2014, faced with the most serious outbreak of Ebola virus to date, governments, drug companies, researchers and the World Health Organization (WHO) had some tough decisions to make. Should experimental vaccines and drugs be given? If so, who should get them first? And what would be the most ethical way of carrying out clinical trials?
The conventional process for drug approval ensures that drugs and vaccines have been subjected to thorough safety tests before they reach the market, first in animals and then in human volunteers. But on 12 August 2014, a WHO consultation panel announced its decision that it would be ethical to give unproven medical interventions to those affected by Ebola. It also highlighted the need for further discussion of the criteria for fair distribution of drugs and vaccines among countries.
By September a fast-track scheme for clinical trials of experimental Ebola drugs had been established. But within the scientific community, arguments soon broke out about how the trials should proceed – how to ensure high-quality data would be collected to inform the containment of future epidemics while saving as many lives as possible.
Randomised controlled trials (RCTs), which compare treatments to standard care or placebos, are usually considered the ‘gold standard’ in medical trials. However, because Ebola was killing at least every second person it infected, many scientists felt that it would be unethical to ask participants to sign up to a study in which they might receive no treatment.
A WHO-led initiative later laid out plans for Africa-based trials of two experimental drugs (and a blood transfusion treatment) that would not include control groups. Meanwhile, some experts continued to argue that since the drugs were untested there should be no reason to expect them to be safer than standard care – and therefore that RCTs remained an ethical option that would provide the most useful information in the long term.
Some commentators claim that more time and money should have been devoted to developing experimental drugs before the outbreak. But could research on treatments for a virus that killed far fewer people than, for instance, malaria or flu really have been justified before the outbreak?Lead image:
Global Panorama/Flickr CC BY NC
- WHO: Ethical considerations for use of unregistered interventions for Ebola virus disease (EVD)
- National Geographic: Long quest for Ebola vaccine slowed by science, ethics, politics
- Science: Issues continue to dog the testing of Ebola drugs and vaccines
- Randomised controlled trials for Ebola: practical and ethical issues (2014)
- Evaluating novel therapies during the Ebola epidemic (2014)
- Guardian: Ebola vaccine trials with placebo group would be unethical, scientists say
- The ethics of fighting Ebola
- New York Times: Researchers to test new treatments in countries hit hardest by Ebola
- Nature: Ethical dilemma for Ebola drug trials