South Africans might be desperate to stop Covid-19 in its tracks, but this does not mean scientific rigour will be forfeited.
This is the clear message from some of the country’s top vaccinologists, scientists and infectious diseases experts who have warned against the “irresponsible social media hype around the use of Ivermectin” to treat Covid-19 until such time as it is officially approved for use in humans in the country.
Ivermectin is an anti-parasitic medicine that is being studied across the globe as a possible agent against Covid-19, and in SA is currently registered for veterinary use only, with a few exceptions of external use on humans.
On a webinar hosted by Project ECHO and the National Health Laboratory Service, a member of the public posed the question, “Why is our government saying Ivermectin can’t be rolled out as it is not registered, when people are dying?”
On Tuesday this week, a preprint study (a study not yet peer-reviewed) was published.
It focused on meta-analysis of Ivermectin and considered some promising results of many different studies across the globe, but the study also stated severe limitations by those who had done the research.
Prof Ian Sanne, the director of Right to Care, said, “I don’t understand how Ivermectin would work because it would require doses a hundredfold the dose in the studies. Also, where does it fit in the cascade of treatment?”
He added, “I would struggle to prescribe it and the social media and hype is irresponsible and inappropriate at this stage. We need to see more data. Much more evidence is required and the regulatory hurdles we face are that we don’t know the correct dose, we do not know its safety profile, and we are concerned about the random prescription that occurs.”
He said a major concern was its potential to cause blindness.
A study published this week in The Lancet stated that, while Ivermectin does “inhibit the replication of SARS-CoV-2 in vitro”, it only does so at “concentrations not readily achievable with currently approved doses”.
It concluded: “There is limited evidence to support its clinical use in Covid-19 patients”.
Prof Koleka Mlisana, an executive manager at NHLS, said a large meeting had been organised by UKZN on Tuesday this week, and that Ivermectin was under the spotlight.
She said that regardless of positive signs from studies, “At the end of the day we are a country with regulatory bodies so the answer is that we need to make sure data is presented to those authorities and that no delay ensues.”
Prof Doug Wassenaar, a bioethics expert at UKZN, said that while the public and scientists alike might get frustrated, “we should be thankful for the rigour we have in SA before products are approved by regulating authorities”.
He said, “The work that is done behind the scenes before products appear on the market is hidden from the public. To reach the public as a product, it has to go through various regulatory systems. SA has an extremely well regulated ethics research system that is approved independently.”
He said that even scientists get frustrated with the delays, but that the ethical component has to be “extremely vigorous”.
The South African Health Products Regulatory Authority, on whose shoulders it falls to rubber-stamp Ivermectin, has emphasised that in SA, Ivermectin is used to treat animals and not humans.
It said in a statement, “Preliminary findings suggest that standard doses of Ivermectin would not result in efficacious concentrations, and that extraordinary doses to achieve efficacious concentrations may result in unacceptable toxicity in Covid-19 patients.”
It said that at present there is insufficient “clinical trial evidence to justify its use” for the treatment of Covid-19 and that it remains unapproved for internal use in humans.