Controversial Ebola Vaccine Trials in Ghana: A Thematic Analysis of Critiques and Rebuttals in Digital News

"The rumours identified in this dataset highlight the vital importance of understanding the emotional context of public concerns: a story of secret vaccine trials in Ghana, or scientists intentionally infecting Ghanaians with Ebola, is only credible in the context of deep mistrust."

Recognising that communication is crucial in responding to health crises, researchers studied the media messages put forth by different stakeholders in two Ebola vaccine trials that became controversial in Ghana. Through an analysis of online media, they analyse stakeholder concerns and incentives throughout the dispute, to understand how the situation evolved to the point of the trials being suspended and to outline what steps might have been taken to avert this outcome. They contend that these interactions between health authorities, political actors, and public citizens - and the media monitoring and analysis system they developed to understand the complex interactions - can offer key lessons for future research.

As part of the communication and community engagement mandate of the project EBODAC (EBOla Vaccine Deployment, Acceptance and Compliance), thousands of digital news articles from West Africa were tracked to identify any potential communication risk within the Ebola vaccination trials. EBODAC addressed the risk of misinformation and controversies undermining the trial of a prime-boost Ebola vaccine regimen, developed by Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen). Rumours were already hindering the Ebola response in the affected countries, and the early detection and analysis of emerging rumours around the vaccine trials was considered a priority for EBODAC.

In brief, in late May 2015, a controversy was reported in Ghanaian newspapers and became inflamed into a public debate, finally resulting in the suspension of both the planned Phase 1 trial for the Janssen Ebola vaccine at the University of Health and Allied Sciences (UHAS) in Hohoe, Volta region, and a planned Phase 2 trial for the GlaxoSmithKline (GSK) Ebola vaccine in Hohoe and in Kintampo. This controversy was exacerbated by the fact that, when these critical articles first became public, both the Minister of Health and the trial lead investigator were travelling outside Ghana.

The paper provides context by reviewing historical research controversies and their implications. For example, in Nigeria in 2003, Northern states boycotted polio vaccination campaigns because of a complex set of factors, including the memory of a controversial trial of the antibiotic Trovan in 1996, in which 11 children died. A resulting perception that the government responds more to international interests than to its own people was reinforced by the fact that polio vaccines were being provided free by the Global Polio Eradication Initiative (GPEI), while services for other pressing health needs were lacking. The polio boycott, which allowed polio cases to quadruple between 2002 and 2006, re-seeded the disease in multiple countries that had already eliminated it - hampering the effort at global polio eradication. "This case illustrates how important it is to recognize and address stakeholder concerns early, as they can influence public trust, with serious public health consequences in the long term."

For the present study, the researchers developed at Norut (with the help of the London School of Hygiene and Tropical Medicine) a web-based system to download and analyse news reports relevant to Ebola vaccine trials. To monitor news in each country with planned vaccine trials - Sierra Leone, Ghana, Uganda, and Kenya - the project team selected online newspapers in each country. The selection was based on a qualitative assessment of expected impact and maximum variation to ensure detection of any news regarding the planned trials. All news articles were downloaded, selecting out those containing variants of the words "Ebola" and "vaccine", which were analysed thematically by a team of three coders. Two types of themes were defined: critiques of the trials and rebuttals in favour of the trials. After reconciling differences between coders' results, the data were visualised and reviewed to describe and interpret the debate. With this system, a total of 27,460 articles, published between May 1 and July 30 2015, were collected from nine different newspapers in Ghana, of which 139 articles contained the keywords and met the inclusion criteria. The final codebook included 27 themes, comprising 16 critiques and 11 rebuttals.

After coding and reconciliation, the main critiques (and their associated rebuttals) were selected for in-depth analysis, including statements about:

• The trials being secret (mentioned in 21% of articles) - For example, the initial Starr FM Online article of May 21 included the passage, "Investigations by Starr FM under-cover team have made public a clandestine attempt by authorities to use midwifery students at Hohoe in the Volta region for human experiment on the Ebola vaccine in a country with no Ebola case." Perceptions about secrecy arose from a combination of premature news reporting and the fact that the trials were prohibited from conducting any publicity before being approved at the time that the story came out. Even as public education efforts were permitted to get underway (once ethics approval was received), the secrecy claim continued to reappear. (The researchers point out that this exposes a vulnerability inherent in the established protocol for conducting research, which may need to be revised.)
• Claims that the vaccine trials would cause an Ebola outbreak in Ghana (33%) - The claim was first mentioned in Starr FM Online (30.05), and is a direct quote from a press release issued by the Coalition for Ghana's Independence Now (CGIN): "Ebola outbreak, which is 100% sure to happen in Ghana should this human trials be allowed to go on, will be the greatest national security threat our country will ever face....". In general, fears appeared in two forms, the first alleging that scientists would intentionally infect Ghanaians with Ebola in order to test the vaccine, and the second suggesting that the vaccine might give trial participants Ebola as a side effect - over the course of the debate, the latter became the more prominent of the two variants.
• The alleged impropriety of the incentives offered to participants (35%) - The incentives were sometimes criticised for being coercively large, but were much more often criticised for being too small, which may have been related to a misperception that the incentives were meant as compensation for the trials' risks, which were themselves exaggerated. In general, the allegations made no distinction between the GSK trial (which was to offer participants money (200 Ghanaian Cedis, or GH?)and a mobile phone) and the Janssen trial (which was not). For example, in an opinion piece in Modern Ghana, Michael Bokor issued this strong condemnation: "Clearly, using Ghanaians as guinea pigs for this Ebola vaccine experiment is insulting and misguided. It is unethical, immoral, and despicable, especially if we consider what is being used as an inducement for participants."

A chronological overview of the major events can be found in Appendix 1. To give a visual summary of the coded data, a timeline of theme density is shown in Figure 6. At the time the controversy broke out, the Ghana Food and Drugs Authority (FDA) was considering both vaccine trials for approval. Five months after the suspension, both vaccine trials were finally approved by Parliament. To date, however, neither trial has proceeded since receiving this approval.

An excerpt from the conclusion section follows (emphasis added):
"...[T]he trials debate is marked, from beginning to end, by the overwhelming fear engendered by the Ebola outbreak, as well as a pervasive anxiety to distance Ghana from the disease, even at the expense of research that could help protect against it. Since the trials themselves were partly sponsored by Western pharmaceutical companies, opposing them could be portrayed as a show of independence from the influence of former colonial powers. In this way, critics tapped into long-running historical themes, as well as the visceral fear of the Ebola epidemic.

...As shown in this analysis, even marginal critics can mobilize a widespread and sophisticated opposition movement to derail important public health programmes, if they are taken up by high-profile opinion leaders. The situation in Ghana demonstrates the importance of early and constant engagement with both supporters and critics of trials, bringing them into conversations and ensuring that their fears, concerns and perspectives are heard and considered from the very beginning of the process. We recommend early engagement as a way to minimise the risk of individuals and communities feeling excluded, or their concerns dismissed, provoking perceptions of secrecy and potentially leading high-profile opinion leaders to take up their arguments on a wider scale.

It is noteworthy that although some of the initial critiques remained major themes throughout the debate, others, such as the conspiratorial allegation that 'Ebola is a business,' did not last as long....New arguments and angles also emerged as more people joined the debate. For example, the controversy clearly resonated with racial and colonial themes, as evidenced by the repeated references to historical instances of unethical experimentation on African bodies. This should serve as a stark reminder that past injustices can still undermine trust in the present. In addition, researchers should work to build trusting relationships within the communities where they are working by being consistently open and transparent as early as possible. This is particularly vital when considering sensitive issues or protocol requirements such as taking blood or the use of incentives that may be particularly sensitive given histories of extraction in the region.

Although regulations sometimes prevent trials from sharing public information about a specific trial prior to receiving ethical approval, this doesn't necessarily preclude the possibility of a more general, government-led national discussion on the need for an Ebola vaccine, the strong value that such a vaccine would have for Ghana's national security, and the long-term economic and diplomatic benefits of taking part in the international effort....We also recommend the involvement of community representatives in the development of clinical trial protocols, in order to ensure that trial designs are both scientifically valid and also acceptable to the communities within which they are occurring.

One of the other major challenges is making the collected information comprehensible and useable to decision makers. To achieve this, effective visualisation techniques are vital. Some of these techniques are demonstrated in this article, and many of these can be generated on-demand in real time. For stakeholders involved in a major health crisis, real-time insights can be vital, given the limited amount of time available for decision-making. It is our hope that these techniques can be incorporated into a reliable tool for assessing public information needs in future epidemics and similarly emotive national crises."