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WHO to debate ethical issues surrounding experimental Ebola drugs

The main topics of discussion will be who should be first in line to receive the treatment and whether the drugs are safe for human consumption.

Margaret Chan, Director-General of the World Health Organisation during a press conference on ebola outbreak

Source: Xinhua News Agency / Rex Features

Margaret Chan, Director-General of the World Health Organisation, during a press conference on 8 August 2014 on the Ebola outbreak

The World Health Organization (WHO) is to meet on Monday to discuss ethical issues surrounding experimental treatments being given to people with Ebola, a virus that has claimed the lives of 932 people in West Africa so far in this outbreak.

The 11 August meeting follows a declaration by the WHO on 8 August 2014 that the outbreak is a public health emergency of international concern.

Gregory Hartl, the chief of public relations at the WHO, said there were two ethical issues around this issue. Firstly, whether it is safe to administer treatments that have never been tested on humans before and secondly, who should receive the treatment when there are so few doses available.

There are a number of treatments for Ebola currently in development.

Zmapp is a combination of three “humanised” monoclonal antibodies, manufactured from Nicotiana plants, which binds to the Ebola protein virus. It is being developed by Mapp Biopharmaceutical, LeafBio, Defyrus, the US government and Public Health Agency of Canada (PHAC).  So far, Zmapp has been used in two US patients in Liberia. It was first identified as a drug candidate in January 2014 and has not yet been evaluated for safety in humans. As very little of the drug is available, Mapp and LeafBio are co-operating with appropriate agencies to increase production as quickly as possible.

According to the US Centers for Disease Control and Prevention (CDC), the National Institute of Allergy and Infectious Diseases (NIAID), under the National Institutes of Health (NIH), is working on developing an Ebola vaccine and hopes to launch phase 1 clinical trials in the autumn.

The NIH is also supporting the Crucell biopharmaceutical company in its development of an Ebola/Marburg vaccine and assisting Profectus Biosciences with its development of an Ebola vaccine. Additionally, NIH and the Thomas Jefferson University are collaborating to develop a candidate Ebola vaccine based on the established rabies vaccine.

Two other companies, Tekmira and Biocryst Pharmaceuticals, have received funding from the Department of Defense’s Defense Threat Reduction Agency (DTRA) and have therapeutic candidates for Ebola in early development.

On August 7 2014, Tekmira said that the US Food & Drug Administration (FDA) had changed the clinical research status of its candidate treatment (TKM-Ebola), meaning it could potentially be used in infected individuals.  

The US Department of Defense is working with a company called Newlink to develop an Ebola vaccine candidate.   

At the moment, the standard treatment for Ebola is supportive therapy, which consists of maintaining fluids and electrolytes, oxygen status and blood pressure, and treating infections, adds the CDC. 

 

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.20066125

Readers' comments (3)

  • I commented on this ethical question on my blog: http://stconsultant.blogspot.com/2014/08/thoughts-about-ethics-of-biomedical.html

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  • What does WHO mean by asking "whether it is safe to administer treatments that have never been tested on humans before." The first person to receive any treatment for anything is receiving a treatment that has never been tested in humans.

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  • Emil a package of information about a potential medical product has to be established before permission is granted to commence testing in humans. I would image that the comment is reflection about the current state of knowledge of test treatments. Is there enough known to consider that the risk to volunteers is minimal, balanced with the benefits to patients if effective Tx can be established quickly.

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