When the implications of the unfolding COVID-19 pandemic dawned, the race for effective vaccines and/or treatments began. However, as Dinis-Oliveira (2020) notes, the scientific approach ranged ‘from robust studies to dishonest studies being conducted, posted, and shared at an unprecedented rate’, and he asks for balance ‘between the benefits of the rapid access to new scientific data and the threat of causing panic or erroneous clinical decisions based on mistakes or misconduct.’
When Johnson et al (2020) debated the question of whether doctors should recommend treatments and vaccines against COVID-19 and its causative agent SARS-CoV-2, one contributor argued that ‘unpublished trial results, even with limited data transparency and peer review, can deliver crucial interventions without sacrificing integrity’, whereas others contended that ‘doctors and professional societies should publicly state that, without complete data transparency, they will refuse to endorse COVID-19 products as being based on science’ (Johnson et al, 2020). Further, while Doshi (2021) acknowledged that global vaccination against COVID-19 was underway, he cautioned that although it might be seen as nit-picking, the fact remained that ‘none of the COVID-19 vaccines in use are [sic] actually “approved.” Through an emergency access mechanism known as Emergency Use Authorisation (EUA), the products being rolled out still technically remain “investigational”’ (Doshi, 2021).
Vaccination influences the epidemiology of COVID-19 by conferring immunity – although how long-lasting it might be remains to be determined – but to what extent might non-vaccine treatments have a role in prevention and/or resolution of infections?
According to Molento (2020), ivermectin, which was introduced in 1981 and used worldwide as an anti-parasitic agent in veterinary and human medicine, has anti-viral effects against, for example, dengue. Caly et al (2020) demonstrated in vitro that when ivermectin was added to cultured cells ‘2 hours post-infection with SARS-CoV-2 [it was] able to effect ~5000-fold reduction in viral RNA at 48 hours. Ivermectin, therefore, warrants further investigation for possible benefits in humans'.
Further investigation has been underway. For example, Rajter et al (2021) report that ‘Ivermectin was associated with lower mortality during treatment of COVID-19 patients, especially in patients who required higher inspired oxygen or ventilatory support’. When Bryant et al (2021) conducted a meta-analysis of 24 randomised controlled trials (RCTs) involving 3406 participants, they found that in 15 trials assessing 2438 participants, ivermectin reduced the risk of death by an average of 62% compared with no ivermectin treatment. They concluded that ‘using ivermectin early in the clinical course may reduce numbers progressing to severe disease. The apparent safety and low cost suggest that ivermectin is likely to have a significant impact on the SARS-CoV-2 pandemic globally.’
Then – to use a non-scientific word – something of a ‘stushie’ followed. Shortly after Bryant et al (2021) published their encouraging findings, Roman et al (2021) reported on their analysis of 10 RCTs involving 1173 participants, observing that their systematic review ‘showed that ivermectin did not reduce all-cause mortality, length of stay or viral clearance vs controls in COVID-19 patients with mostly mild disease. Ivermectin is not a viable option to treat COVID-19 patients.’ This prompted Fordham et al (2021) to write to the Editor of Clinical Infectious Diseases demanding a retraction and claiming that since the analysis of Roman et al (2021) had arrived at conclusions that ‘are not defensible on the evidence presented, it makes no contribution to science or medicine’ (Fordham et al, 2021).
Bryant et al (2021) endorse the aims of the British Ivermectin Recommendation Development (BIRD) Group, who met in Bath, UK, in February 2021 to develop recommendations, health policies and protocols to promote the use of ivermectin in addressing the COVID-19 pandemic. Their report (BIRD Group, 2021) cites a statement from the World Health Organization that was made on ‘global norms for sharing data and results during public health emergencies’ following the 2015 Ebola emergency: ‘The onus is on the researcher, and the funder supporting the work, to disseminate information through pre-publication mechanisms, unless publication can occur immediately using post-publication peer review processes.’ Meanwhile, Wadvalla (2021) reports that the ivermectin ‘debate has reached fever pitch in South Africa, which has the worst infection rate in Africa.’
It appears that the interface between a medical need for apparently successful treatment that ivermectin may provide and the demands of scientific rigour can be a messy one.