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The drug Ivermectin, which has been touted by some as an effective treatment for the coronavirus even though it is not clinically proven, is at the center of a legal battle in South Africa as some doctors want it cleared for human use, as reported by Pumza Fihlani.
Many South Africans are in desperate need of something that could ease the impact of a predicted third wave of coronavirus infections.
With a vaccination program that has yet to cover all of the most vulnerable, there are fears that the continent’s worst-affected country will suffer more as the temperature cools as winter approaches.
More than 52,000 people have died from the coronavirus and although new infections are now low, they are not going away.
It is in this context that ivermectin – a drug used to treat parasitic worms – has attracted a lot of attention. Some doctors have prescribed it to coronavirus patients, claiming to have seen anecdotal evidence that it may alleviate some of the worst effects of Covid-19.
However, the South African medical regulator, the drug’s maker and some of the country’s most prominent scientists have all warned against its use to treat the coronavirus.
It has now become popular on the black market – millions of tablets have been intercepted in South Africa since the start of the year, with the illicit network spreading as far as China and India.
Before the link to the coronavirus was made, 10 ivermectin pills would cost around $ 4 (£ 2.90) – the price has now been multiplied by 15 for the same packet.
But the use of ivermectin for the treatment of the coronavirus has divided opinion in the country.
The pill is currently not approved for human use by the South African Health Products Regulatory Authority (Sahpra), it is only registered to treat parasites in animals.
Despite this, some doctors started using the drug at the height of South Africa’s first wave in July last year.
‘People were dying’
Professor Nathi Mdladla, head of the intensive care unit at George Mukhari University Hospital in Durban, is one of the few doctors who have called for the use of ivermectin in desperate cases.
“At the height of the first wave, many public and private hospitals and general practitioners in South Africa were using ivermectin,” Dr Mdladla told the BBC.
“People were dying and doctors were considering many treatment options in an attempt to save lives. Ivermectin has been one of the drugs reused by doctors. “
The idea came from Latin America where doctors in some countries used it. More recently, some studies have suggested that it may be effective, but more research is needed.
But it wasn’t until the second wave at the end of last year that authorities got wind of it and cracked down on its use, forcing the doctors who prescribed it to stop, fearing sanctions from the authorities, Dr Mdladla added.
He believes this answer has not been helpful, especially for families who cannot afford the more expensive treatment options.
Now, advocacy groups, doctors on both sides of the debate and Sahpra will have to argue their case in the Gauteng High Court at a hearing scheduled soon.
“The fight is over the quality of the studies that have been carried out so far. What we’re saying is that in a pandemic you may never be able to actually generate those long, high level studies because that means in the meantime you are watching people die, ”says Dr Mdladla .
Doctors advocating for it to be approved locally in the treatment of coronavirus say the drug does not pose a major safety concern.
Some common side effects include dizziness, nausea, diarrhea, stomach pain, nausea, and rash, according to the United States Food and Drug Administration.
In South Africa it has been used on animals, but it has only been recommended for humans by the World Health Organization for treating river blindness.
Nonetheless, Sahpra is concerned that there isn’t enough research into how it affects patients with coronavirus and therefore wary of approval for its widespread use.
In December, he banned the use of the drug on people unless doctors obtained approval through a special “compassionate use” application – this allows an unauthorized drug to be released. prescribed in dire situations.
If it is used in these cases, doctors should provide information about the patient’s reaction.
One theory as to why it might appear to be effective in coronavirus patients is that it might actually treat all the parasites they carry and thereby make them stronger, without actually tackling the virus that causes Covid-19.
But in any case, the South African drug regulator has warned that: “There is not enough evidence for or against the use of ivermectin in the prevention or treatment of Covid-19.”
Sahpra also expressed concern over the use of ivermectin sourced from the illegal market, saying “quality cannot be guaranteed”.
Its manufacturer, Merck, also cautioned against using the drug to treat coronavirus, saying: “We do not believe the available data supports the safety and effectiveness of ivermectin beyond doses and populations indicated in the prescribing information approved by the regulatory agency. . “
This is something Professor Abdool Karim, one of the medics leading the coronavirus response in South Africa, also pointed out.
He says the doses given to people can even be toxic.
“It must be clearly stated that ivermectin does not kill the virus at doses that humans can tolerate. The amount of medicine needed to kill the virus is toxic to humans. Whatever it does, it doesn’t kill the virus, ”the TimesLive website told the TimesLive website.
“ Ivermectin must be tested ”
Another health expert, intensive care specialist Professor Rietze Rodseth, says more research is needed on ivermectin and that there are more questions than answers at this point.
“I am quite surprised by everyone’s petitions and by the wonders of this drug. The evidence base and the quality of the studies carried out so far are quite low. We just don’t have enough evidence to say, ‘Yes, it works,’ ”he told the BBC.
“Just because you know drugs, [it] doesn’t mean he gets a free pass, he has to be tested, ”he added.
It may now be up to the courts to decide, but as the legal dispute continues, people will likely continue to try to source from the black market, reflecting a level of anxiety among the population.
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