Fifteen Eighty Four

Many governments claim that the way out of the COVID-19 pandemic is through vaccines. But this can only be partly true because of two inherently complicated and confounding factors: (i) the endless ingenuity of nature to adapt itself to changing circumstances, and (ii) the behaviours and beliefs of people themselves. Before COVID-19, the fastest that a vaccine came to market after testing – for mumps – was four years. Today, a mere 18-months after the first reported cases of SARS-Cov-2 infection, rich countries are awash with vaccines. The pandemic rages on, however, because stubborn global injustices deny vaccine and health access to millions of people, while millions more are highly sceptical about the vaccines themselves. Science has delivered but our social structures continue to fail us. What, then, are the lessons that we can learn to improve human health research and how it can benefit humanity in the future?

1. The watchwords ‘safety’ and ‘efficacy’ have always driven drug and vaccine development. Highly complicated regulatory systems worldwide have ensured that a cautious risk-based approach prevailed, but this took time. Not anymore. If scepticism about the speed of COVID-19 vaccines coming to fruition (through ‘temporary authorisation’ or ‘emergency use authorisation’, i.e. pre-market approval/authorisation) is to be challenged, then we must have full transparency and accountability of the fast-track processes that have been deployed. By the same token, difficult questions must be answered about failures to address other conditions, such as HIV/AIDS, as we pass the 40th anniversary of the first reported cases. The death toll worldwide has surpassed 35 million since 1981 and it is estimated that 37.6 million are living with HIV, of which only 27.4 million are accessing antiretroviral treatment (UNAIDS 2021). The current pandemic must lead us to ask: What are we prepared to do to secure the things that we value most, such as human health?
3. The COVID-19 pandemic has shown that, in many ways, we are all vulnerable. Our lives prior to 2020 were far more fragile than we realised. A cautious approach to human health research – one that is largely risk-averse – can lead to the labelling of individuals or groups as vulnerable in an effort to protect them from risks, but this can also result in stigmatisation, discrimination and exclusion from potentially valuable health research. By the same token, we are not all equally vulnerable – our personal circumstances and particular social settings make our capacity to be harmed very context-specific. An appreciation of this can help to improve the future of human health research. For those who are responsible for conducting health research, researchers and regulators alike, the question becomes this: How can we design health research in the future that is alert to the multiple potential sources of vulnerability that require particular protections and which, at the same time, promotes inclusion to the largest possible extent?
4. The development of COVID-19 vaccines, or new drugs, or new medical interventions to treat a range of conditions from infertility to genetic disorders, or even the use of artificial intelligence algorithms in medical devices to diagnose medical conditions, are all dependent on one thing – the trust of citizens. Human health research is simply not possible without a high level of public trust that this endeavour is ultimately worth the risks to benefit humanity as a whole. But trust is a fickle beast. People need to be given reasons to trust. It is a big mistake for anyone seeking trust to talk about ‘building trust’ because trust is given, it is not constructed. The fragility of human trust has been exposed very extensively by the pandemic. At the time of writing, a Bill has been proposed before the US Congress by Republicans to fire Dr Anthony Fauci – the face of the pandemic response in America. Vaccine scepticism is extremely high among supporters of this group, and it reflects long-standing distrust about modern medicine’s response to disease through vaccines. But vaccines – like all biomedical interventions – are the product of human health research. Of course, biomedicine alone cannot address these wider social issues, but biomedical scientists, regulators and regulatory systems can take important steps in doing so by asking: What must be done in the design and delivery of human health research that demonstrates trustworthiness in our work?

Human health research is not an arms-length endeavour. It is not an example of Them vs Us. Human health research – when done well – involves us because, ultimately, it is about all of us. The pandemic has touched all of us, and if biomedicine’s response is indeed to be the way through and out of this crisis, then the ultimate lesson is that biomedicine cannot do it alone.

Featured image by Daniel Schludi on Unsplash