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November 21, 2018

Ethics of developing the cure for Ebola

Health workers in Hazmat suits tend to an Ebola patient. Photo/COURTESY
Health workers in Hazmat suits tend to an Ebola patient. Photo/COURTESY

It may, in the end, turn out to be fortunate that a handful of people in developed countries – four in the US and one in Spain – have contracted Ebola. Tragic as this was for Thomas Duncan, the only one of these patients who has died, if all of the more than 13,000 cases and nearly 5,000 deaths had occurred in Africa, Ebola would never have aroused nearly as much attention in rich countries.

Ebola is – or, rather, was – an example of what is sometimes referred to as the 90/10 rule: 90 per cent of medical research is directed toward illnesses that comprise only 10 per cent of the global burden of disease. The world has known about Ebola since 1976; but, because its victims were poor, pharmaceutical companies had no incentive to develop a vaccine. The firms could expect to earn more from a cure for baldness.

State research funds in affluent countries are disproportionately targeted toward diseases that kill these countries’ citizens, rather than diseases like malaria and diarrhoea that are responsible for much greater loss of life.

But the tiny number of Ebola cases in rich countries – and the ensuing panic-inducing headlines and quarantine measures – have brought home the global nature of infectious disease today. Mass travel has made effective containment of epidemics extremely difficult.

The best defence against an infectious disease is to fight it where it originates.

Scientists are rushing to find both a vaccine and an effective treatment for Ebola. What ethical considerations should guide them?

The standard way to judge the efficacy of a vaccine is to conduct a trial in which those who could benefit are randomly assigned to two groups, one of which receives the potentially beneficial vaccine, while the other receives a substance with no active ingredients, known as a placebo. To avoid greater risk-taking by those who know they have been vaccinated, or the desire of those conducting the trial to show that the vaccine works, the study is “double blind”: Neither the subjects nor those administering the trial and collecting the data know who got the vaccine or the placebo. Only an independent group examining the data has that information.

Without such a trial, the appearance of efficacy may be an illusion, because other factors would have led to a lower rate of infection anyway. Yet if a promising vaccine is available – and if safety trials in healthy human volunteers who are not at risk of infection demonstrate that it does no harm – to deny it to those who are tending to the sick, at great risk to their own health, seems unethical.

That question will soon need to be answered, because GlaxoSmithKline (in conjunction with the US National Institute of Allergy and Infectious Diseases) and the Public Health Agency of Canada have candidate vaccines in development.

At a recent World Health Organisation meeting in Geneva, Ripley Ballou, the head of GlaxoSmithKline’s programme to develop a vaccine, argued that a randomised controlled trial comparing a potential Ebola vaccine with a vaccine that protects against another virus would be the most ethical way to assess efficacy. Depending on the outcome, results could be available within three months, allowing production to go ahead with greater confidence.

Representatives of Médecins Sans Frontières (Doctors without Borders), which has more than 3,000 staff combating Ebola in the most affected countries, strongly opposed giving placebos to anyone at high risk of contracting the disease. But Ballou appears to have persuaded many of the participants at the meeting that his proposal will save more lives in the long run. If that is true, a randomised controlled trial could be the most ethical option.

When it comes to treatment, the situation is different. In a letter published last month in The Lancet, doctors, scientists, and bioethicists from a wide range of countries – including Guinea, Ghana, Nigeria, and Senegal, as well as Britain, France, Hong Kong, and the United States – argued that a randomised trial is justified only when there is balance between the two options offered. This can happen when doctors do not know whether a proposed treatment will do more harm than good, or when they are in doubt about which of two treatments is more likely to cure the patient.

But, when facing a disease that kills up to 70 per cent of those who are infected, and no accepted treatment exists, patients could reasonably refuse consent to a trial in which they might receive a placebo, rather than an experimental treatment that offers hope of recovery. In such cases, it might be more ethical to monitor the outcomes of different treatment centres before experimental treatments become available, and then compare these outcomes with those achieved by the same centres after experimental treatments are introduced.

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