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Experimental Ebola drugs must be fairly distributed, tested ethically in clinical trials

Date:
August 21, 2014
Source:
The Lancet

Summary:
Critical ethical principles need to be adhered to if experimental drugs are to be deployed in the Ebola outbreak, bioethicists say, stating that the patients selected to receive such drugs must not be limited to well-off or well-connected patients -- including health care professionals. These experts also point out that, given the limited supply of experimental drugs and their low probability of success, containment of the epidemic and strengthening health systems in affected regions should be a priority.

Leading bioethicists Professor Ezekiel Emanuel, of the University of Pennsylvania, Philadelphia, USA, and Dr Annette Rid, of King's College London, UK, outline critical ethical principles which need to be adhered to if experimental drugs are to be deployed in the Ebola outbreak, stating that the patients selected to receive such drugs must not be limited to well-off or well-connected patients -- including health care professionals. They also point out that, given the limited supply of experimental drugs and their low probability of success, containment of the epidemic and strengthening health systems in affected regions should be a priority.

Moreover, it is vitally important that experimental drugs are provided to patients as part of randomized-controlled trials, in collaboration with local communities and other stakeholders, say the authors, and any communities who participate in research trials must receive fair benefits, such as access to any successful treatments.

According to Dr Rid, "Less than less than 10% of candidate drugs make it from pre-clinical selection to commercial launch. Although promising in non-human primates, there is no reason to believe that the experimental Ebola interventions will be more successful. In other words, it is more likely than not that the interventions will not improve symptoms for patients, and might even weaken them as they battle a life-threatening disease. Experimental Ebola treatments or vaccines should only be deployed in clinical trials, and if trials are done, they must meet ethical principles for research."

Professor Emanuel adds that, "Now that the global response to the Ebola outbreak is picking up, the international community needs more focus on strengthening of health systems and infrastructure and less on experimental treatments. Adoption of infection containment measures with a view to strengthening health systems and infrastructure is the most effective way to curb this epidemic and prevent future ones, and the international community now needs to show that it can meet the challenge of this public health emergency,while learning the lessons for future Ebola and other epidemics."

The Viewpoint is published at the same time as the Ebola resource centre goes live. This new online resource, hosted by The Lancet, brings together existing Ebola content from The Lancet journals and Cell Press, and will host the latest Ebola research as it is published. The resource centre is intended to be a comprehensive Ebola resource for clinicians, public health professionals, and anybody else who needs access to existing Ebola research and latest developments; all content on the site is free to access.

Story Source:
The above story is based on materials provided by The Lancet. Note: Materials may be edited for content and length.

Journal Reference:
Annette Rid, Ezekiel J Emanuel. Ethical considerations of experimental interventions in the Ebola outbreak. The Lancet, August 2014

http://www.sciencedaily.com/releases/2014/08/140821102113.htm

Planning for future Ebola outbreaks

Even if clinical trials happen during this Ebola outbreak,
additional research will probably be needed in a future
epidemic. To better anticipate the surrounding ethical
dilemmas, and to build consensus about potential
solutions with representatives from affected regions,
future trials should be carefully planned and reviewed in
advance.19 One model for this is offered by Médecins Sans
Frontières, an international network providing emergency
medical aid. The research ethics committee of Médecins
Sans Frontières has a practice of pre-approving some
generic research protocols.27–30

Furthermore, plans should be made to make any
proven Ebola interventions available in affected regions,
as part of providing fair benefits from research and
promoting global justice regarding access to essential
medicines.6,23 Ebola vaccines should be fairly cheap to
produce and implement, and could be covered by existing
health partnerships such as the GAVI Alliance. By
contrast, it is difficult to see how complex treatments like
Zmapp—which is expensive to produce and requires
intravenous administration—can be implemented in
resource-poor settings in the near future. Together with
the low odds of success for all experimental Ebola
interventions, this issue underscores the importance of
providing fair benefits to communities who participate in
research in this outbreak.

Conclusions
The global response to the current Ebola outbreak has
initially been slow and inadequate. Now that the
response is picking up, the international community
needs more focus on strengthening of health systems
and infrastructure and less on experimental treatments.
Adoption of containment measures with a view to
strengthen health systems and infrastructure is the
most effective way to curb this epidemic and prevent
future ones; it has positive externalities for health
promotion and offers fair benefits to communities who
engage in research in this outbreak. Experimental Ebola
treatments or vaccines should only be deployed in
clinical trials. If trials are done, they must meet the
eight ethical principles for research. The international
community needs to show that it can meet the challenge
of this public health emergency, while learning the
lessons for future Ebola and other epidemics.

http://download.thelancet.com/flatcontentassets/pdfs/S0140673614613155.pdf