Ebola death toll tops 1,000 in West Africa; WHO says use of test treatments is ethical
Health workers load Ebola patient, Spanish priest Miguel Pajares, into an ambulance on the tarmac of Torrejon airbase in Madrid, after he was repatriated from Liberia for treatment in Spain, August 7, 2014. CREDIT: REUTERS/MINISTRY OF DEFENCE/HANDOUT VIA REUTERS
As the death toll from the Ebola outbreak in four West African nations officially climbed above 1,000, the World Health Organization on Tuesday said the use of unproven, experimental treatments and vaccines is ethical given the magnitude of the crisis.
Marie-Paule Kieny, assistant WHO director general, said she hopes that efforts to produce more of an Ebola treatment developed by a small San Diego biopharmaceutical company, as well as other drugs under development, could result in wider availability late this year or early in 2015. There currently is no vaccine or cure for Ebola, but several treatments are in various stages of clinical development.
The San Diego company, Mapp Pharmaceutical, has said that the remaining supply of its ZMapp treatment, which was used on two U.S. missionaries who contracted the Ebola virus, have been exhausted after it sent its several doses to Liberia. The Liberian government said Tuesday it would give ZMapp to two doctors, Zukunis Ireland and Abraham Borbor, who had fallen ill with the virus while treating other patients.
A panel of experts convened by the WHO this week agreed that the use of experimental treatments for the disease is ethical, but the agency’s declaration Tuesday did not address the difficult questions about who should receive the limited amount of drugs available.
The shortage of medications amounts to “a market failure,” Kieny said. “It’s a market failure because this is typically a disease of poor people in poor countries, and so there is no market.” As a result, she said, “there are no clinical stockpiles” and the best authorities can do is “accelerate development and scale up” as quickly as possible. Kieny said the WHO will convene another panel at the end of August to discuss prioritizing distribution of scarce medications.
The use of an experimental drug to treat two Americans and a Spaniard diagnosed with Ebola is raising questions about who gets access to new therapies. Associated Press medical writer Lauran Neergaard takes a closer look. (AP)
The two American patients who were sickened while treating the outbreak in Liberia both received ZMapp, which had never been tested in humans. Both are improving after being flown to the United States for treatment in an Atlanta hospital. But a Spanish priest who reportedly was also given access to the drug died Tuesday, according to media reports.
The WHO said Tuesday that the death toll from Ebola in Guinea, Sierra Leone, Liberia and Nigeria had reached 1,013. A total of 1,848 cases have been reported.
Several other African nations are closely monitoring ill patients who are suspected to have contracted the disease. Aside from Guinea, Liberia and Sierra Leone — the three countries where the outbreak initially spread —only Nigeria, Africa’s most populous country, has confirmed cases of Ebola. Nigeria has confirmed 10 cases, and two of the patients have died.
Still, fear over the spread of the virus has continued to cripple West Africa.
In Liberia, aid workers fear that they are losing the battle with the virus as the country’s frail medical system is stretched beyond its limits. The situation is “catastrophic,” Lindis Hurum, Doctors Without Borders’ emergency coordinator in Liberia, said in a recent statement. The organization has more than 600 doctors working in the region but says that more are desperately needed.
As the outbreak worsens, U.S. officials have said they intend to fast-track development of an Ebola vaccine and could begin human trials next month. The potential vaccine has shown encouraging results in non-human primates, and if human testing goes well it could be available in limited amounts next year.
At the same time, the Food and Drug Administration has said it continues to work with numerous other federal agencies, such as the National Institutes of Health, to fund the development of Ebola drugs and to speed up treatments already in the pipeline. Last week, the FDA said it had removed one regulatory hurdle for an Ebola drug under development by a Canadian company, Tekmira. The move would allow the potential use of the drug for Ebola victims in the near term.
Ethical considerations for use of unregistered interventions for Ebola virus disease (EVD)
Summary of the panel discussion
West Africa is experiencing the largest, most severe and most complex outbreak of Ebola virus disease in history. Ebola outbreaks can be contained using available interventions like early detection and isolation, contact tracing and monitoring, and adherence to rigorous procedures of infection control. However, a specific treatment or vaccine would be a potent asset to counter the virus.
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, have prompted calls to use investigational medical interventions to try to save the lives of patients and to curb the epidemic.
Therefore, on 11 August 2014, WHO convened a consultation to consider and assess the ethical implications for clinical decision-making of the potential use of unregistered interventions.
In the particular circumstances of this outbreak, and provided certain conditions are met, the panel reached consensus that it is ethical to offer unproven interventions with as yet unknown efficacy and adverse effects, as potential treatment or prevention.
Ethical criteria must guide the provision of such interventions. These include transparency about all aspects of care, informed consent, freedom of choice, confidentiality, respect for the person, preservation of dignity and involvement of the community.
In order to understand the safety and efficacy of these interventions, the group advised that, if and when they are used to treat patients, there is a moral obligation to collect and share all data generated, including from treatments provided for ‘compassionate use’ (access to an unapproved drug outside of a clinical trial).
The group 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 utilization. Ongoing evaluation should guide future interventions.
In addition to this advice, the panel 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 prioritize the use of unregistered experimental therapies and vaccines;
- 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.
A report of the meeting proceedings will be available to the public by 17 August 2014.
