US drug firms get WHO backing for Ebola drug trials in West Africa
13 August 2014
The World Health Organisation (WHO) on Tuesday gave the green light for experimental use of untested drugs on people infected with Ebola virus in the West African countries, even as the scarcity of supplies raised questions about who gets priority access to treatment.
''Over the past decade, research efforts have been invested into developing drugs and vaccines for Ebola virus disease. Some of these have shown promising results in the laboratory, but they have not yet been evaluated for safety and efficacy in human beings. The large number of people affected by the 2014 West Africa outbreak, and the high case-fatality rate, has prompted calls to use investigational medical interventions to try to save the lives of patients and to curb the epidemic.
On 11 August 2014, WHO convened a consultation to consider and assess "the ethical implications for clinical decision-making on the potential use of unregistered interventions,'' WHO said in a statement released on Tuesday.
The statement coincides the US authorisation of supplies of experimental Ebola drugs to Liberia.
The Liberian government said the experimental drug on the Ebola virus from the US will arrive in the West African country on Wednesday.
Liberia said it planned to treat two infected doctors with an unproven Ebola medicine called Zmapp, a drug under development that the US FDA said needs further improvements before human trails.
The two Liberian doctors would become the first Africans to receive the drug, which had been administered to a Spanish priest who later died, and two US aid workers.
Health minister Walter Gwenigale said the arrangement was concluded purely with the manufacturer after Liberia waived all claims for use of the drug.
The outbreak is the world's largest and deadliest and the UN agency last week declared it an international health emergency. The WHO has appealed for funds and medical staff to supplement health care in one of the poorest regions in the world.
Meanwhile, Mapp Biopharmaceutical Inc, the maker of Zmapp, said the supply of the experimental drug for treatment of people with the Ebola virus has been exhausted.
San Diego-based Mapp that makes the medication said on Monday it could be many months until more supplies is available.
"We have complied with every request for ZMapp that had the necessary legal/regulatory authorisation," Mapp Biopharmaceuticals said in a statement. The company declined to say where the drug has been sent, but said in all cases it was provided at no cost.
The WHO panel said it explored how the use of these interventions can be evaluated scientifically to ensure timely and accurate information about the safety and efficacy of these investigational interventions.
''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 utilisation,'' the release said.
Ongoing evaluation should guide future interventions, the panel said. Besides it identified areas that need more detailed analysis and discussion, such as:
- Ethical ways to gather data while striving to provide optimal care under the prevailing circumstances;
- Ethical criteria to prioritise the use of unregistered experimental therapies and vaccines; and
- Ethical criteria for achieving fair distribution in communities and among countries, in the face of a growing number of possible new interventions, none of which is likely to meet demand in the short term.
So far, 1,013 people have died, the vast majority in Guinea, Liberia and Sierra Leone. Two have died in Nigeria.
In Liberia, the problem has been complicated by lack of proper health services and the authorities struggling to cope with little or no medical care facilities.
The WHO's panel of medical ethicists said several experimental drugs had passed the laboratory and animal study phases of development and should be fast-tracked into clinical trials and made available for compassionate use.