Ebola 2014: lessons for global healthcare
The current Ebola outbreak has brought to the fore the importance of culture in healthcare, particularly in relation to gaining multilingual informed consent for clinical trials and building trust in the established Western drug development model.
The ongoing Ebola outbreak in West Africa has centred attention on those diseases for which the world is unprepared, and for which no approved prophylactic or therapeutic vaccine exists. In spite of the burgeoning drug development industry, pathogens such as Ebola are paid insufficient attention.
In comparison with malaria, Tuberculosis or HIV/AIDS, Ebola Virus Disease has not claimed a shockingly large number of victims, but there are several reasons why health professionals are becoming increasingly concerned.
This recent outbreak claimed its first fatality in Guinea, has spread to Liberia, Sierra Leone and Nigeria already and is present in both rural and urban settings, each of which poses different challenges.
The statistics themselves are also sobering; with over 2,615 reported cases (WHO estimates) and over 1,427 deaths to date in 2014, this outbreak has claimed more lives than all previous instances combined.
There is also the virulence of the disease; it is not an airborne disease and is less contagious than influenza, but in the context of weak health infrastructure and strong cultural norms this is genuine cause for concern. Ebola is readily transmitted through contact with the bodily fluids of infected people, including through sweat. This means that something as day-to-day as a handshake can kill; a legitimate concern in the generally more tactile African cultures.
This draws attention to the wider cultural issues around drug development process in Africa. Chief among these is obtaining individual informed consent to test experimental treatments. As the medical ethicist Daniel Sokol, among others, has pointed out, the concept of individual informed consent is challenging in rural Africa, and the idea differs in important ways compared to the US or Europe.
In many rural communities, for example, consent must be obtained not only from the individual subject but through an approach to the community elders, who must make a judgment on the benefit/risk of the trial to the community and approve it. As study managers are well aware, it is impossible to conduct a successful study without local buy-in at the site, and in many parts of Africa this extends beyond the investigator to the wider community. Thus in high-context cultures such as those found in Africa, the work of feasibility and patient engagement professionals takes on a new dimension.
The concept of obtaining informed consent in writing, recommended as preferable by the Declaration of Helsinki, can be problematic in some cultures, either because of low literacy rates or due to a belief that a verbal agreement is sufficient. However, as demonstrated below in an example of a trial that went wrong in the 1990s, a full and clear record of approvals and agreements is indispensable.
The translation of informed consent forms and patient information sheets into local languages is critical, and should be undertaken with expertise and great care. To take Liberia as an example, there are four groups of local languages and over 30 languages spoken in total: informed consent information must be provided in the correct local language in order to ensure that the patients have the chance to read, understand and question the study in which they are invited to participate. The scarcity of resources to perform these translations and regulatory requirements governing the quality and readability of the translated documents presents a challenge for drug developers.
Culture can create an epidemic
The social structures of African countries are completely different from the individualist, subjective culture of the West. We should not generalise on this point as this would be to underappreciate the complexities of the African continent; there are clearly differences between urban and rural populations, between southern, northern, eastern and western Africa, for example. In fact, Ijsselmuiden and Faden1 suggested that there may be 900 different distinct cultures in Africa. While this figure is disputed, it gives some sense of the complexity of the situation.
In addition to the generally more tactile nature of many of Africa’s cultures, the consumption of infected bush meat and fruit bats has probably played a role in the spread of the disease. More fundamentally, burial rites in western Africa involve touching the corpse of the deceased and, if someone has died from Ebola, this can significantly increase the risk, as their viral load is likely to be very high after death. Unfortunately it is extremely difficult to alter cultural rites of this nature, especially at times of grief. The question then becomes more fundamental: should cultural sensitivity supersede the public interest?
The trust deficit
Contract research organisations, pharmaceutical companies and other healthcare bodies are well aware that there is a lack of confidence on the part of many Africans with regard to the drug development model of the Western pharmaceutical industry.
Many will remember the Trovan trial in 1996 in which Pfizer ran a study in the midst of a meningitis outbreak using trovafloxacin as a comparator drug with an existing treatment.
Five per cent of the children treated died, many were left blind or handicapped and there were questions around the documentation of informed consent and regulatory authority approvals. Whatever the facts in this situation, the reputational damage to the pharmaceutical industry and Western medicine that resulted from this episode was immense.
In light of this kind of history – not to mention the folk-memory of the Colonial Era – it is not surprising that reports have emerged from Liberia of locals in the West Point township claiming “There is no Ebola!” as they released very sick and contagious people from a facility there. Public awareness campaigns are now underway in Liberia to increase awareness of how to contain the virus and to counteract the notion of a hoax.
The generally poor health infrastructure in rural Africa, and the inability of hospitals to cope with such outbreaks, has also led to hospitals and doctors being viewed as the source of Ebola. This gave rise to rumours that doctors were murdering diamond-smugglers from nearby mines in Democratic Republic of Congo during a 1995 incidence.
Nigeria is now showing promise in containing the virus; the US ambassador has praised the Nigerian Health Minister, Onyebuchi Chukwu, for his work in contact tracing and, so far, only four deaths have resulted from the 15 infections there. As the most populous country in Africa, Nigeria will be very keen to quash the outbreak, particularly as it has affected Lagos, the country’s business capital.
But this will not be at any cost: the Nigerian Health Ministry has also shown robust good sense in rejecting the Nano-Silver drug, developed locally, which does not meet the requirements of the National Health Research Ethics Code. This rejection is particularly impressive given that the most promising experimental treatment, the monoclonal antibody ZMapp, is not being supplied to Nigeria currently and is in very short supply globally.
The role of local culture must always be borne in mind during outbreaks of new pathogens. However the objective involvement of international bodies like the World Health Organization, an increase in foreign aid to fill the shortfall in funding (estimated at $79m) and, above all, robust science which will cater for expanded access without exposing populations to unnecessary risk, are the measures which will bring Ebola under control and make us all more aware of areas in which we are underprepared, from a public healthcare perspective.
1. Ijsselmuiden, C and Faden, R. (1992). Research and Informed Consent in Africa – Another Look. New England Journal of Medicine 326, no. 16: 830-33.
About the author:
Chris McCourt is a Global Consultant in SDL’s Life Sciences Solutions division.
SDL is a top three provider of language, technology and business intelligence solutions to international pharmaceutical and medical device companies and contract research organisations.
Chris can be reached on firstname.lastname@example.org or +44 (0)7715 798981
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