August 6, 2014

expert reaction to WHO convening ethical review of experimental treatment for Ebola

The World Health Organization (WHO) announced they will convene a panel of medical ethicists to explore the use of experimental treatment in the ongoing Ebola outbreak in West Africa. 

Prof Tom Solomon, Director of the NIHR Health Protection Research Unit in Emerging and Zoonotic Infections, and Director of the Institute of Infection and Global Health, University of Liverpool, said:

“Doctors often use drugs on a compassionate basis, to treat medical conditions for which the drugs have not been evaluated. However the difference here is that some of these new treatments have not been evaluated at all. For all new drugs there is always a “first in man” study, where the drug is given to a human for the first time. The difference here is the desire for this “first in man” experiment to be for a patient with the disease. What is key is that if these new experimental drugs are going to be used, then this should only be done in the context of a clinical trial. Otherwise the worry is that we will have tried these drugs, including putting people through the potential risk of experimental treatments, and still be none the wiser about which are effective. Within our Health Protection Research Unit we have teams experienced in setting up drug trials in challenging settings overseas, including using antiviral drugs, and treating haemorrhagic fevers. We look to those who have developed the drugs to make them available, and to the international funders to support such research so we can work with our African partner organisations to assess these new drugs, and try to save lives.”

Dr Jeremy Farrar, Director of the Wellcome Trust, said:

“This announcement from the WHO is a very welcome step in the right direction. The ethical considerations involved are critical and it is right they are addressed in a responsible and transparent way. It is also essential that rigorous protocols for the study of experimental interventions are developed quickly so that African countries have the same opportunities to consider them that western ones would, and that there is equitable access to any that prove effective. We must also remember that while we can likely provide safety data from anywhere in the world, we can only assess whether a vaccine or drug works for Ebola by using it in affected countries with the consent of individuals and communities concerned.”

Prof Jonathan Ball, Professor of Molecular Virology, University of Nottingham, said:

“Giving unlicensed and untested (at least in humans) treatments and vaccines is a very thorny ethical issue.

“The infected US healthcare workers are receiving a type of treatment (antibodies that specifically target the virus) that has a reasonably long safety track record, so it isn’t surprising – given the high fatality rate in the current outbreak – that they are happy to receive the therapy.

“But not all drugs are safe – that’s why we have very stringent clinical trials. One could argue that the current outbreak provides a perfect arena in which to test new drugs, but that isn’t without risk. We don’t know their safety, we don’t know if they are likely to work – sure they have been tested in animals but these studies don’t always tell us what will happen in humans.

“Also, who do you give the drugs to – infected people from the general populace, or healthcare workers battling in the frontline? Restricting treatment only to healthcare workers and volunteers could be seen as unethical, but treating the larger number of local infected people isn’t easy; the supply isn’t large enough and trying untested treatments that may or may not work and may or may not be safe might reverse all the efforts made building trust and goodwill.

“At the end of the day, good infection control is what is going to beat this virus.”

Prof David Heymann, Professor of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, said:

“The ethics of research must be a national decision, and countries that require support in making that decision need guidance from international organisations such as the WHO. The decision will be based on several factors that countries deem important such as risk/benefit and usual human subjects research standards. These discussions must be held in full transparency with all the evidence known from previous or current R and D.”

Declared interests

None declared