As the nation awaits the arrival of the first batch of Covid-19 vaccines, South Africans are desperately trying to get access to the antiparasitic drug ivermectin that has now been authorised for “compassionate use”.
Until recently, ivermectin was but a trusted, injectable cattle formulation, widely used by farmers and veterinarians. However, what began as a discussion on farmers’ groups on WhatsApp has now turned into a nationwide outcry over the drug’s ability to treat Covid-19.
Yesterday, after many weeks of pushback which Agri SA described as embarrassing for agriculture, the South African Health Products Regulatory Authority (Sahpra) made a dramatic turn.
It authorised the “controlled compassionate use” of ivermectin to treat Covid-19 after initially insisting that it could be unsafe for humans.
Sahpra has repeatedly warned farmers and later members of the public against the use of the drug used for parasitic infections and infestations due to gastrointestinal roundworms, eyeworms, lungworms, grubs, mites, and horn flies in cattle.
Not only was ivermectin not authorised for use in humans, but scientists also warned that there was no available confirmatory data for its use in the management of Covid-19 infections.
ivermectin still not registered…
Despite Sahpra’s green light, the chief executive of animal health products provider Afrivet, Dr Peter Oberem, stresses that it must not be considered as a “miracle cure” for the novel coronavirus.
“ivermectin is an active ingredient used in animal and human medicines,” says Oberem.
“It has been registered, approved and used in many countries across Africa and Latin America for two or three decades now.”
According to Oberem, ivermectin can be used in different formulations to combat, among others, scabies, headlice, rosacea and river blindness in animals.
The only challenge is that the drug is still not registered for human use in South Africa.
“It is currently only registered as a drug for the treatment of worms and parasites in sheep, cattle and goats under the authority of the department of agriculture. But the use of ivermectin to cure and prevent Covid-19 symptoms has gained traction.”
“Desperate people are orally consuming ivermectin-based products only registered for use in livestock.”
The drug regulator’s announcement of the “compassionate-use programme” indicates that ivermectin medicines are now available to all patients. Applications, however, must be done by healthcare practitioners.
In other words, even farmers who currently might have easy access to ivermectin, can only use it if a doctor, veterinarian, or nurse is available to closely monitor the patient’s progress.
“This does not mean that our position changes around the lack of availability of scientific data, but, as a regulator, we had very in-depth discussions around the context which we find ourselves in with the pandemic with limited options,” said Sahpra chief executive Dr Boitumelo Semete-Makokotlela.
“We hope the controlled access will enable the product to be used properly and limit the black market,” she said.
A guideline for responsible usage will be published shortly, she said.
Meanwhile, as it becomes clear that it will take at least a year for all South Africans to have access to the approved Covid-19 vaccines, people are going to great lengths to gain access to ivermectin in the hope that it will save their lives.
“The issue is the risk-to-benefit ratio. People will not die from taking human-approved ivermectin products. But people are dying from Covid-19,” says Oberem.
Sahpra ‘doing more harm than good’
Desperate people are orally consuming ivermectin-based products only registered for use in livestock through oral, injectable, or pour-on formats.
While, until recently, ivermectin was sold for about R49, Afrivet and Food For Mzansi has established that some retailers are now selling it for as much as R900.
On the black market, people are paying dramatically more, often as a last resort to save the lives of loved ones who are battling severe coronavirus infections.
Oberem says, “We have done everything humanly possible to ensure that the product is used only for animals.
“We have specifically decided not to increase prices, so to see the disgraceful and unscrupulous greed of others is shocking and deplorable. This will continue while Sahpra is so short-sighted.”
Afrivet currently sells ivermectin in its Ecomectin product for agricultural use. Oberem says the company has noticed that Ecomectin is now sold illegally at outrageously marked-up prices for human consumption.
Don’t use stock remedy ivermectin
Meanwhile Dr Gerhard Verdoorn, a toxicologist who heads up the Griffon Poison Information Centre, says he is “concerned that people are dosing themselves with ivermectin-based animal products at rates far exceeding even the officially registered doses for treating parasites in livestock.”
Oberem also repeated his warning to farming communities and members of the public to not consume stock remedy ivermectin.
Earlier this week, Afriforum brought an urgent court application against Sahpra and health minister Dr Zweli Mkhize to ensure that ivermectin was available to doctors who wanted to prescribe it to treat Covid-19.
“Ivermectin is listed by the World Health Organisation as an essential medicine, and it has been proven safe – also in children.
Studies undertaken in, among others, the US, Argentina, India, Egypt and Spain all show that ivermectin has the potential to treat Covid-19 and reduce deaths,” says Afriforum’s research head Barend Uys.