Experimental Ebola drugs should not be withheld, WHO says

World Health Organisation doubts feasibility of placebo-controlled trials in west Africa, but FDA favours ‘gold standard’

THE GUARDIAN                                                                                                           Nov. 6, 2014
By Sarah Bosley

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 that it is the only way to be sure they work.

Vials of the experimental VSE-EBOV vaccine for Ebola. Photograph: Mathilde Missioneiro/AP

The Food and Drug Administration, which licences medicines in the US, believes the 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 in the two groups can be compared.

Other scientists, including those at the University of Oxford who are currently preparing for trials in the epidemic region, say that with a death rate of 70% 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....

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.

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http://www.theguardian.com/world/2014/nov/06/ebola-experimental-drugs-patients-west-africa-world-health-organisation-placebo-trials-fda