"Ethical” to offer experimental drugs to curb Ebola outbreak: WHO
Xinhua, August 12, 2014 Adjust font size:
The World Health Organization (WHO) on Tuesday said it is ethical to offer unproven interventions with as yet unknown efficacy and adverse effects, as potential treatment or prevention in particular circumstances of Ebola outbreak.
On Monday, WHO convened a panel of medical ethicists, scientific experts, and lay people from affected countries to assess the role of experimental therapies in the Ebola outbreak.
WHO said 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.
It added the large number of people affected by the 2014 west Africa outbreak, and the high fatality rate, have prompted calls to use experimental medical interventions to try to save the lives of patients and to curb the epidemic.
The panel agreed that ethical criteria must guide the provision of such interventions, which including 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 panel 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 panel decided that there is a moral duty to 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.
In addition, the panel identified areas that need more detailed analysis and discussion, such as ethical ways to gather data, prioritize the use of unregistered experimental therapies and vaccines, as well as fair distribute in communities and among countries.
As of Aug. 9, the cumulative number of cases attributed to Ebola virus disease in Guinea, Liberia, Nigeria, and Sierra Leone stands at 1,848, including 1,013 deaths.