World Health Organisation allow unlicensed Ebola drugs in west Africa
Experimental, unlicensed drugs and vaccines can ethically be used in the Ebola outbreak in west Africa, the World Health Organisation (WHO) has said following a meeting of experts.
The decision was announced shortly after news of the death of a Spanish missionary, who contracted the disease in Liberia. Miguel Pajares, a 75-year-old priest, was evacuated to Spain and was due to be given the experimental drug ZMapp at Madrid's Carlos III hospital. A spokesman could not confirm whether the treatment had gone ahead or not before Pajares died.
Liberia has become the first African country to announce that it would use the drug. It plans to give it to two doctors who have tested positive for Ebola. There had been growing outrage the drug had only been made available to two Americans and Pajares all westerners who had been repatriated to their home countries for treatment. Only limited quantities exist, however. The California-based manufacturer of ZMapp, Mapp Biopharmaceutical, said it had run out of treatment after responding to a request from an unidentified west African country.
There will be pressure on the company to manufacture more, following the WHO decision that its use, and that of other drugs yet to go through full clinical and human trials, is ethical in the current outbreak.
The group of 12 international experts convened by the WHO concluded it was ethical in the situation in west Africa to offer unproven treatments with as yet unknown efficacy and adverse effects, either as treatment or prevention.
But they made clear high ethical standards must be observed. There must be complete transparency about the implications of the treatment and patients and their families must give informed consent - which means they must understand the risks as well as the possible benefits. There must also be freedom of choice, confidentiality, respect for the person, preservation of dignity and involvement of the community, the WHO said in a statement.
"There was unanimous agreement that there is a moral duty to also evaluate these interventions (for treatment or prevention) in the best possible clinical trials under the circumstances in order to definitively prove their safety and efficacy or provide evidence to stop their utilization," the statement went on.
Any experimental drugs will have to be given effectively as part of a clinical trial, therefore. The group said ethical ways of gathering data from their use in the difficult setting of an Ebola outbreak needed further discussion. There also needs to be further consideration of which experimental drugs and vaccines might be used and a fair way of distributing them given that demand is likely to outstrip supply.
Pajares was one of three missionaries to test positive for the virus at the San José de Monrovia hospital in Liberia. All three had been helping to treat people infected with Ebola as part of their work with the San Juan de Dios hospital order, a Catholic humanitarian organisation that runs hospitals around the world. The two other missionaries, from Ghana and the Democratic Republic of the Congo, who were not evacuated, have also died in recent days from the virus.
Pajares arrived in Spain with Juliana Bohi, a nun born in Equatorial Guinea who holds Spanish nationality, who tested negative for the virus.