Photo by Michael Longmire on Unsplash
For many the unproven COVID-19 treatment has become a desperate lunge for safety in the ‘third wave’.
The controversial off-label use of the anti-parasitic drug Ivermectin to treat COVID-19 patients has become a flashpoint issue as a devastating ‘third wave’ rolls over Namibia.
According to reports, since the ‘third wave’ started in May 2021, Ivermectin use to treat COVID-19 has escalated, with many people allegedly self-medicating.
In this, Namibia is treading a path that other countries have already traveled in the pandemic – of unproven Ivermectin becoming a go-to medication for many even as questions continue to dog its usefulness and safety as a treatment for COVID-19.
But how did Ivermectin become so controversial?
Here’s how it all came about and what the facts are:
- On 3 April 2020, researchers in Australia published a scientific paper stating that: “Ivermectin is an inhibitor of the COVID-19 causative virus (SARS-CoV-2) in vitro”;
- On 6 April 2020, a group of American researchers also published a paper claiming that Ivermectin “was able to reduce SARS-CoV-2 viral RNA by 5000-fold within 48 hours”;
- The paper and a follow-up version were later retracted by the journal that initially published it following the exposing of flaws in the data used in the study;
- On 16 April 2020, other researchers published a response to the Australian paper, pointing out some issues and concerns with the Australian study and calling for more scientific rigour in studying the potential effects of Ivermectin as a possible COVID-19 treatment option;
- However, by then some South American governments and peoples had apparently already latched onto the medication, using the flawed Australian and American studies as guidance, in a desperate bid to deal with a destructive pandemic tide then sweeping across large parts of the continent in early 2020;
- Since then, from about mid-2020, Ivermectin has been featuring in mis- and disinformation about COVID-19 treatments;
- But it was really with the Indian COVID-19 ‘second wave’ surge from early 2021 that Ivermectin shot to prominence, as some Indian health authorities and a growing chorus of anti-vaccine propagandists in the West started vouching for its effectiveness in taming a raging COVID-19 tide, even as the evidence for their claims was lacking;
- In May 2021 Namibia entered its ‘third wave’, and on 6 June 2021 a group of local doctors petitioned the Ministry of Health and Social Services and the Namibia Medicines Regulatory Council to grant emergency use approval for Ivermectin as a treatment of COVID-19 patients.
Despite Ivermectin drifting around the fringes of the Covid-19 treatment discussion since early 2020 as a claimed, but unproven, potential treatment for COVID-19, health authorities have recommended against its use:
- Already on 25 January 2021, the Namibia Medicines Regulatory Council (NMRC) issued a public notice on the use of Ivermectin as a COVID-19 treatment, stating: “No clear conclusion can be drawn from the currently available data on the clinical efficacy and safety of ivermectin in the treatment of COVID-19 infection”. This NMRC position was reiterated in mid-June 2021 as calls to approve Ivermectin were becoming louder in Namibia;
- In early January 2021, the South African government issued a public notice stating that: “It is dangerous to market Ivermectin as a treatment against COVID-19 as the drug has not been properly tested for humans”;
- On 27 January 2021 the South African Health Products Regulatory Authority (SAHPRA) announced that it had approved “Ivermectin for controlled human use” while it continued to gather data and evidence.
- On 6 April 2021, SAHPRA was ordered by the Pretoria High Court to allow “a registered pharmacist or medical practitioner [to] compound and sell compounded medicine that contained ivermectin as an active ingredient”;
- However, a SAHPRA rapid review of the data, a report of which was published on 18 June 2021, found that: “The current evidence for the use of ivermectin in COVID-19 does not suggest any clear benefits with respect to mortality, clinical improvement, or viral clearance”;
- On 4 February 2021, one of the companies that makes and markets Ivermectin-based products, US-based Merck, issued a statement, saying that its scientists had looked at the data of various studies and had found: “No meaningful evidence for clinical activity or clinical efficacy in patients with COVID-19 disease, and; A concerning lack of safety data in the majority of studies”;
- Following the Merck statement, on 17 February 2021, the Africa Centres for Disease Control and Prevention (Africa CDC) issued a statement, saying of Ivermectin that there was: “No evidence of its clinical efficacy for the management of patients with asymptomatic, mild, moderate or severe COVID-19”;
- On 5 March 2021, the US Food and Drug Administration (FDA) issued a warning, stating: “FDA has not approved ivermectin for use in treating or preventing COVID-19 in humans. Ivermectin is not an anti-viral (a drug for treating viruses)”;
- On 22 March 2021, the European Medicines Agency (EMA) issued its own statement, saying: “EMA has reviewed the latest evidence on the use of ivermectin for the prevention and treatment of COVID-19 and concluded that the available data do not support its use for COVID-19 outside well-designed clinical trials”;
- And on 31 March 2021, the World Health Organization (WHO) issued a statement, saying: “The current evidence on the use of ivermectin to treat COVID-19 patients is inconclusive. Until more data is available, WHO recommends that the drug only be used within clinical trials”.
As it stands, as of 30 June 2021, Ivermectin remains unproven as an effective treatment for COVID-19, but on 23 June 2021 it was announced that Ivermectin would be included in the Platform Randomised Trial of Treatments in the Community for Epidemic and Pandemic Illnesses (PRINCIPLE) at the University of Oxford, UK. The PRINCIPLE trial is one of the largest trial platforms in the world investigating various potential treatments for COVID-19.
For an informative read on the Ivermectin controversy, see this expert article in The Conversation.