With WHO and the Democratic Republic of Congo Ministry of Health reaching an agreement on the use of Merc’s experimental Ebola vaccine in the Democratic Republic of Congo’s latest battle with the hemorrhagic disease, the reaction across health and the press is understandably muted.
Ebola in Africa
There was Guinea, Sierra Leone and Liberia before DRC. And other DRC Ebola outbreaks in 2014 and 2017. They have been nine Ebola outbreaks in the DRC so far. So, nothing new here. Besides, knowledge that Ebola is easily transmitted and has an average fatality rate of 50%, makes it a much feared disease. To further understand this response, consider that there is no known treatment effective for Ebola. Therefore, the only hope of protecting populations lies in rigorous outbreak control. With this Ebola outbreak, meeting such demanding expectations appears to lie in adoption of a somewhat novel approach.
The worldwide response to 2018 Ebola outbreak whose foci is DRC’s Equateur province – lead by the World Health Organization, Médecins Sans Frontières and DRC Ministry of Health — would fit nicely into the established 10 steps of controlling a disease outbreak. Were it not that the choice for step 10, outbreak control. With adminstration of the vaccine, the response to this Ebola outbreak in the Congo goes one step beyond traditional ‘harmless’ play. Beyond the usual – the likes of isolation, contact tracing and community engagement.
Given that, as we await imminent deployment of Merc’s experimental Ebola vaccine in the DRC, we cannot fail to ask the hard questions.
Ethical Questions Facing Deployment of Merc’s Experimental Ebola Vaccine in Democratic Republic of Congo’s 2018 Ebola Outbreak
First, the widespread use of the terminology experimental Ebola vaccine masks the implicit consequences of its choice as an outbreak control measure. It is easy to overlook the complexity of the actual activity. This is becuase to the casual eye, the term “experimental” talks to the characteristics of the vaccine. Granted, it correctly flags but at the same time downplaying the process of its deployment. The adjective ‘experimental’ employed by numerous news reports is meant to denote that research will take place. But insufficiently so, we opine.
Experimental
‘Experimental’ is fair enough until you consider that the Democratic Republic of Congo’s fragile health system ranks 188 out of the 191 WHO member countries for overall efficiency. This unfortunate statistic should serve as a harbinger to the scale of ethical challenges. Tough dilemmas that will accompany this effort in collaborative research in low and middle income countries. More so those of the DRC mold.
Nuffield Council of Bioethics’s report on The ethics of research related to healthcare in developing countries identifies challenges facing collaborative research in such settings. Given the emergency nature of the DRC outbreak, issues flagged in the report like social and cultural issues affecting the acquisition of informed consent, standards of care, handling the period after research is over and standard of ethical review are likely to be exacerbated.
Ring Vaccination
Moreover, the likely study design to be employed by WHO and partners in this latest deployment of Merc’s experimental Ebola vaccine forces us to confront another ethical dilemma. In the 70’s and earlier, Small Pox elicited similar reactions to Ebola today. So devastating was Small Pox that it became ingrained in the folklore of indigenous African tribes. This is Maragoli proverb of significance to medical anthropology: Inyundu erondera keheregete. serves as a sufficient reminder.
In the final ebbs of eradication of Small Pox global health players employed ring vaccination as an eradication strategy. In the barest of ways, ring vaccination is an extension of contact tracing. Persons deemed to have had contact with a confirmed case of a disease of interest, get vaccinated. A study on the first deployment of ring vaccination as a control measure in the thick of an Ebola epidemic, the Guinea Ebola ça Suffit ring vaccination trial, made the following observation:
interim results…suggest that the efficacy of a single injection of rVSV-ZEBOV to prevent Ebola virus disease might be high, that protection can be established quickly, and that the vaccine might be effective at the population level when delivered by ring vaccination
Flawed Study Design Yields an Unethical Outcome?
Observers have faulted both this study’s design and reporting of the vaccine’s efficacy rate. This raises important ethical questions on the continued administration of Merc’s experimental Ebola vaccine. More importantly, this article by Dr. Kucharski, a lecturer in infectious disease epidemiology at the London School of Hygiene and Tropical Medicine, London casts doubts. These caveats (in the quote) make ring vaccination effective. We therefore cant help but think of the DRC situation. Given DRC’s fragile health system, there are important considerations to ingest. Dr. Kucharski summaries them as follows:
Ring vaccination enhances standard public health measures of contact tracing, isolation, and community engagement and could be effective when such measures are in place. However, if standard measures are not working because many cases are not in known transmission chains, as in West Africa in early 2014, ring vaccination might be insufficient to contain the outbreak.
Conclusion
Medical research, any research for that matter, is about the future. In conducting research, we seek and test possible future solutions to problems that exists today. Those who bear the burden of this noble task aren’t sacrificial lambs nor are they guinea pigs. Human subjects are important assets in humanity’s quest for survival. Like all assets, human subjects must be protected.
Research ethics is an endeavor that walks these narrow streets. Research ethics seeks to ensure that researchers express their freedom of speech through propriety. Ethical conduct balances that against the duty to protect the autonomy and well being of human subjects. Vulnerable populations like pregnant women, prisoners and children are of particular concern in research ethics. And so is the need to nurture public interest as a stakeholder in the health research.
These tenets of ethical practice when applied to administration of Merc’s experimental Ebola vaccine in the DRC raises important ethical questions.
Ethical questions Surrounding Administration of Merc’s Experimental Ebola Vaccine
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- What measures were/ are to be employed to ensure ethical conduct of ring vaccination with the experimental vaccine? The concerns here are the impact of selective vaccination in a remote part of Africa given the communiterian ethics of Africa. How well will the study objects reintegrate into society in the after study period? Is just one of the many ethical questions.
- Moreover, the emergency situation begets the likelihood of expedited approval of the vaccine’s deployment. How does expedited review hold against consensus on the need to have a participatory process in seeking informed consent in a developing country like the DRC?
- The World Health Organization rubber stamped a go ahead on deployment of the experimental vaccine. From a public health perspective, it is hard to fault that. Still, keeping with this prism, we have to wonder the state of DRC’s health system in the aftermath. The fight against HIV pandemic in Africa has demonstrated it’s applicability as a route for substantial healthcare reform in Africa. Understandably, it is near impossible to solve all the deficiencies of DRC’s health system with this single move. But we have to wonder, will the lessons learned attain system memory and be replaceable through out Africa? We ask not for DRC’s research approval mechanism to handle ethical conundrums in the mold of deployment of CRISPR. But at the very least it should beget personnel, systems and processes on bioethics in emergency situations that the rest of Africa can learn and adopt.