Saturday, August 09, 2014

WHO Statement On The Ethics Panel Meeting On Experimental Ebola Drugs




# 8934


Last week, in WHO To Convene Panel On Ethical Use Of Experimental Ebola Treatments, we learned that a meeting would be held on Monday, August 11th to discuss the ethical dilemmas surrounding the use of experimental, or untested Ebola drugs, on human subjects in West Africa.


Two Americans have already received treatment using the experimental monoclonal antibody cocktail ZMapp (see CDC FAQ On Experimental Ebola Treatments & Vaccine Development), although its safety and effectiveness has yet to be determined.


Although media reports suggest that both recipients of ZMapp are doing better, it isn’t clear how much of their improvement can be linked to the drug. Today the World Health Organization has released the following statement regarding the meeting to be held early next week.



Panel discussion on ethical considerations for use of unregistered interventions for Ebola viral disease

8 August 2014

The recent treatment of two health and workers infected with the Ebola virus with experimental medicine has raised questions about whether medicine that has never been tested and shown to be safe in people should be used in the outbreak, and, given the extremely limited amount of medicine available, if it is used, who should receive it.

A number of interventions have been through the laboratory and animal study phases of development. It is likely that ‘first in man’ studies will be conducted over the next 2-4 months. It is also likely that the number of doses available for further study and/or deployment from end 2014 onwards will remain insufficient to meet demand.

On Monday, August 11, WHO is convening a panel discussion of medical ethicists, scientific experts and lay people from affected countries to assess the role of experimental therapies in the Ebola outbreak response.

Issues to be considered include:

• Whether it is ethical to use unregistered interventions with unknown adverse effects for possible treatment or prophylaxis. If it is, what criteria and conditions need to be satisfied before they can be used?

• If it is ethical to use these unregistered interventions in the circumstances mentioned above, then what criteria should guide the choice of the intervention and who should receive priority for treatment or prevention?

Names of those attending will be added shortly.

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