WHO advocates use of experimental drugs for all Ebola sufferers

Scientists involved in trials of experimental drug treatments for the Ebola epidemic in west Africa should not be compelled to withhold them from some patients, says the World Health Organisation, despite objections from the US

The Food and Drug Administration, which licenses medicines in the US, says Ebola drug trials should be set up in west Africa on the “gold standard” model designed to provide a conclusive answer as to whether they have an effect.

The FDA says the trials should be randomised and controlled, which means giving experimental drugs to one group of patients selected at random but not to others so death rates and other outcomes can be compared.

Fear and suspicion

Other scientists, including those at the University of Oxford who are preparing for trials in the epidemic region, say that with a death rate of 70 per cent, and fear and suspicion of hospitals running high in the three worst-affected countries in west Africa, it is not possible to run the sort of trial that would be standard in the UK or US.

Instead, they are designing alternatives that will reach an answer but without depriving some patients of a drug that might possibly help them survive. The virus has claimed more than 4,800 lives since the outbreak began in December.

A meeting of the WHO’s ethics working group has supported that view, concluding that an alternative approach may be preferable in the very difficult circumstances of Sierra Leone, Liberia and Guinea.

Random trials

In west Africa where the disease has a high fatality rate, and there are tensions between local communities, governments and healthcare workers, it may not be acceptable or feasible to conduct randomised placebo-controlled trials.

Some members of the working group said that in certain situations, it may also be unethical to do so, say the formal minutes of the meeting.

A trial without a control group that fails to show clearly whether a drug is helping or harming patients could also be considered unethical, the group acknowledged. But, it goes on, representatives at the ethics meeting from Guinea and Liberia, “expressed their view that individually randomised placebo-controlled trials would not be acceptable to local communities because such trials would deny a new experimental treatment to some participants”.

Trudie Lang, professor of global health research at the University of Oxford and part of a team working to get drug trials started in west Africa quickly using funding from the Wellcome Trust, said she did not believe the traditional gold-standard randomised controlled model was possible in the Ebola epidemic. “We have had health workers murdered. There is very fragile trust in the health systems,” she said.

At the meeting, a doctor in charge of treatment centres said she would not put her staff at risk by denying drugs to some of the patients but not others. It could be particularly difficult if some members of a family were randomly selected to receive the experimental treatment while others were not.

Ms Lang and colleagues are designing trials that will still come up with the answers, for instance by comparing survival rates now at a specific treatment centre with survival rates once all patients are given a certain drug. As there are several potential Ebola drugs being rushed into production, it may also be possible to compare one against another.

There are several drugs in the pipeline that scientists hope to trial in west Africa, all of them in early stages of development and some of which have not yet been tested in humans. – (Guardian service)