It’s the drug everyone’s talking about and ivermectin will now make its way, legitimately, into the hands of doctors countrywide as they try to save patients from a Covid-19 death.
The South African Health Products Regulatory Authority (Sahpra) has stood firm in its conviction that there isn’t sufficient data to authorise the drug in general or put it on the protocol for treating Covid-19, but on Wednesday it announced that it has authorised a limited “compassionate and controlled-access programme” for ivermectin.
Detailed guidelines for what this controlled access will entail will be revealed later in the week and “evolve” as data emerges, but in general a controlled-access programme is limited acquisition of a product for people with serious or life-threatening conditions while clinical trials are still taking place.
Prof Helen Rees, chairperson of Sahpra, said this interim measure “will give respite while we wait for better data” and will at least ensure that the quality of the product being used is of a high standard, which isn’t the case for products imported on the black market.
Boitumelo Semete-Makokotlela, CEO of Sahpra, said: “We are very cognisant of the second wave and some of us within the regulator itself have been affected and lost family members, so we understand the position the healthcare practitioners are coming from.”
Unlike in other countries, ivermectin is not registered for human use in SA, so in other states it is being used “off label”, she explained.
Sahpra has, according to Rees and Semete-Makokotlela, engaged with the World Health Organisation (WHO) and regulators in other countries, such as the US Food and Drug Administration (FDA) and European Medicines Agency, and “they have indicated a very similar position to ourselves — that there is not yet sufficient and robust data for a regulator to make a decision and that the current studies that are ongoing need to continue”.
While detailed guidelines are to follow, it has been stated that “there won’t be priority recipients” and that Sahpra “will look at every application”.
In the meantime, “larger, better, randomised trials are needed” to boost the data.
The announcement comes in the wake of heated debate among scientists, with some crying foul about the authority’s failure to authorise it sooner, and others cautioning strongly against a drug that is used for humans, but at much lower doses for other conditions.
For one group, however, the real gap is preparation — and that is what the focus should be while the trials continue.
On Wednesday, medical doctor and activist Dr Arne von Delft, who co-founded TB Proof, said he was part of a lobby group that had sent a letter to the authorities on January 18.
It was signed by six organisations, about 45 healthcare professionals and approximately 30 “interested and affected individuals”, including four professors.
In the document submitted to government, the signatories called for ivermectin, primarily used as a veterinary antiparasitic in SA, to be registered for human use, for a quality supply to be assured, for systems to be set up for equitable access and distribution, and proper guidelines prepared on dosage and indications for use.
It also calls for effective communication with the public, free of misinformation and hype, and the setting up of systems to monitor and evaluate the use of the drug in real time.
“Ivermectin is well-known, safe and without intellectual property restrictions, so there is very little risk and very much to gain in pre-emptively preparing for its rollout,” said Von Delft and the others supporting the call to government.
You don’t know if people are getting the right medicine and if they’re taking the right dose. We need it to be legalised so we can give it at the correct dose to the right people.
— GP Dr Naseeba Kathrada
According to Dr Naseeba Kathrada, a GP working in Durban, ivermectin has been sought on the black market, resulting in safety issues.
“You don’t know if people are getting the right medicine and if they’re taking the right dose. We need it to be legalised so we can give it at the correct dose to the right people. So many products have flooded the black market, but they have to be tested you can’t tell just by looking at it”.
Prof Ian Sanne, head of Right to Care, said: “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.”
According to the Institute for Global Health, ivermectin is authorised in the US, Europe and Australia.
In all three regions it is only authorised for specific diseases at specific doses.
The ivermectin debate heated up in the wake of a recent study by Andrew Hill from the UK’s University of Liverpool, in which several trials were comprehensively reviewed.
It was found in a third of the 18 trials under review that the drug has the potential to reduce the risk of death in those with Covid-19 by 75%.
But Hill also cautioned that further studies were needed and that has been the contention of Sahpra as it probes the call for authorisation.
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