The Challenges of Ebola Vaccination and Treatment

                Following the infection of several western aid workers in late July of this year^[1], progress towards production of viable vaccines and treatments for Ebola Virus Disease (EVD) has progressed rapidly.  This in and of itself is indicative of the human rights inequities surrounding this particular public health intervention.  Up until that point, the disease, though just as virulent and deadly, had affected only the indigenous populations of Liberia, Sierra Leone, and Guinea. So why has it taken 38 years for substantial progress to be made in treating and vaccinating against Ebola Virus Disease?

                The cost of bringing new pharmaceutical interventions to market can be upwards of $1 Billion (USD).^[2]  It is the prospect of future profits from a treatment for a disease that drives a pharmaceutical company to invest time and money into development of that treatment.  Until recently the population affected by the disease has been both very small and very poor^[3], making it impossible for a company to recover their investment, let alone profit from it.  In Public Health, we constantly find that groups that are relatively lacking in power are those most prone to negative health outcomes, the same is clearly true here.

                From a Bioethics perspective, there are several additional challenges that factor into the difficulty of developing a new medication.  The case fatality rate (CFR) of Ebola is hard to quantify, but the measurements we have suggest a rate at or around 50%^[4], though we suspect it to be much higher.  Because survival without a treatment is already a coin toss, it makes it extraordinarily difficult to determine whether or not a treatment actually had any effect on patient recovery and survival.

                To have any kind of power under such chaotic circumstances, studies will require large amounts of untested medications to be approved by the Food and Drug Administration (FDA) or European Medicines Agency (EMA) on an investigational basis and distributed to a population with low literacy levels^[3] and distrustful of any outsiders, especially in light of recent history^[5].  Geographic isolation, poor roads, and lack of telecommunication infrastructure all contribute further to the logistical difficulties of distribution and monitoring of clinical trials.

                There are mechanisms for producing and distributing medications on an investigational basis in emergency conditions such as currently exist in West Africa.  But it is difficult to know whether we would truly be providing a benefit to the population, since the situation on the ground makes any clinical research data suspect if not outright fraudulent^[6].  The historical legacy of public health is ripe with well-meaning research interventions that were morally untenable due to their failure to observe standards of ethical research^[7], no matter how inconvenient those standards may be. 

                We must be cautious as we seek to provide untested interventions in West Africa, and keep in mind the principles of non-malfeasance that should always be at the core of any medical or health intervention.^[8]  Even though we have the power to act, we must not make the situation worse.  The people of West Africa already have far too many other problems to deal with a rushed or poorly implemented public health intervention.

References:

1.  “Two Americans infected with deadly Ebola virus in West Africa.” CBS/AP. July 27, 2014, 10:30 AM. http://www.cbsnews.com/news/american-doctor-in-west-africa-contracts-deadly-ebola-virus/ Retrieved: October 31, 2014, 12:36 PM.

2. Herper, Matthew.  “The Truly Staggering Cost Of Inventing New Drugs.” Forbes Magazine: Pharma & Healthcare. February 10, 2012. http://www.forbes.com/sites/matthewherper/2012/02/10/the-truly-staggering-cost-of-inventing-new-drugs/ Retrieved: October 31, 2014, 1:12 PM.

3. The World Factbook 2013-14. Washington, DC: Central Intelligence Agency, 2013. https://www.cia.gov/library/publications/the-world-factbook/index.html

4. WHO Media Centre. “Ebola Virus Disease Fact Sheet.” UN World Health Organization. Updated September 2014. http://www.who.int/mediacentre/factsheets/fs103/en/ Retrieved: October 31, 2014, 2:02 PM.

5. Simons, Marlise and Goodman, J. David. “Ex-Liberian Leader Gets 50 Years for War Crimes” New York Times.  May 30, 2012. http://www.nytimes.com/2012/05/31/world/africa/charles-taylor-sentenced-to-50-years-for-war-crimes.html?pagewanted=all  Retrieved: October 31, 2014, 2:16PM.

6. Santelli, John S.  “Research Ethics Session #1: Protection from vs. Inclusion in Research” Mailman School of Public Health. September 17, 2014.

7. Rothman DJ. (1987). “Ethics and Human Experimentation: Henry Beecher Revisited”  NEJM   317(19): 1195-1199.

8. Hippocrates. “The Hippocratic Oath” translated by Michael North, National Library of Medicine, 2002. http://www.nlm.nih.gov/hmd/greek/greek_oath.html. Retrieved: October 31, 2014, 2:06PM.