Why are SA authorities blocking cheap drug that shows promise against Covid-19?

Why are South Africa’s health authorities still refusing to allow doctors to use Ivermectin when so much medical evidence shows the drug is highly beneficial against Covid-19?

Specialist physicians and scientists from the US, UK, and Australia are loudly advocating this 50-year-old, Nobel Prize-winning and very cheap drug for use against Covid-19.

In Zimbabwe (ZIMBABWE!!!) doctors who are treating seriously ill patients say that their Ivermectin intervention has made their work “fun”.

F-U-N. This is not a word you’re likely to hear in SA hospitals.

Four countries have already adopted the drug as part of their Covid-19 treatment protocols.

Ivermectin has been through at least 50 trials since the pandemic began, 18 of them clinically controlled and randomised as per World Health Organisation requirements. The results indicate that the drug:

• Ramps up viral clearance in both moderately and severely ill patients;
• Cuts the mortality rate by at least an average of 73%;
• Massively improves the prospects of ventilated patients;
• Slices down hospital time; and
• Works as prophylactic.

In Zimbabwe patients with low oxygen saturation levels are discharged within a day of admission, off oxygen.

Also included in the compelling evidence coming out virtually daily, are three case studies from Argentina, Paraguay and Mexico, in which entire cities or regions were dosed. Ivermectin’s positive effect — as a prophylactic and to crush outbreaks — is breathtakingly clear. Argentina is now one of the four countries officially using Ivermectin to counter Covid-19.

Yet the SA Health Products Regulatory Authority (Sahpra), which banned Ivermectin in December, continues to cling like a barnacle to narrow and outdated data to uphold its opposition to Ivermectin for human use.

And, in a carefully-worded statement last week, the head of the Ministerial Advice Committee made it clear that he agreed. Professor Saliem Karim also issued a warning: “The Ivermectin available in SA is for animal use only. It would be professional misconduct for any doctor to prescribe it and any pharmacist to dispense it.”

In the days that followed at least 500 doctors stepped to the fore to implore President Cyril Ramaphosa to urgently review the ban against human use.

The response of the Minister of Health, Zweli Mkhize, was to tell the doctors to ask Sahpra to run clinical trials.

How does this even begin to equate to leadership? At least 21 countries have already been running trials. Why should it be the task of overwhelmed frontline doctors to invite our health authorities to come to the party?

Sahpra meanwhile, has zealously opposed Ivermectin “for human use” against Covid-19”.

It has threatened to rain hellfire onto anyone caught bringing tablets into the country. It has pressed criminal charges against medical practitioners who have dispensed the medication. It has, together with Professor Karim, in the middle of a killer pandemic, insisted that peer review be a criterion for accepting the drug. And it deemed inadequate the findings of Dr Andrew Hill of Liverpool University, who analysed a number of trials from around the world and who announced some of the favourable outcomes listed earlier in this article.

This Tuesday the drug regulator reiterated its January 6 statement in which it said it would reconsider Dr Hill’s analysis once his database had been sufficiently expanded.

Fair enough, but the number of trials has now more than quadrupled. New data has been coming out almost daily. Why does Sahpra still harp on about there being “no evidence from randomised, controlled trials of any reduction in mortality?”

And why does it continue to claim that Ivermectin is not “fit for human use” against Covid-19? This, frankly, is nonsensical doublespeak, possibly intended to gloss over the fact that South Africans, have for decades, been denied access to this highly effective anti-parasitic/anti-inflammatory medication with anti-viral properties that has been around for 45 years.

It has been used, including throughout Africa, to treat a multitude of parasitic diseases, including scabies, rosacea (acne), lice infestations, elephantiasis, river blindness and onchocerciasis — a worm that gets under the skin. It has also been used to mass dose entire communities against malaria.

In the US the drug is approved by the Federal Drug Agency and in 2019, it was listed as America’s cheapest option for delousing children.

Ivermectin is also on the WHO’s list of essential medicines.

So, why is it not part of every South African householder’s medicine kit?

I really would like to know why, in this country, it has been confined to treating livestock?

This brings me to another rapidly developing feature of our coronavirus crisis — the now predictably booming black market.

Now that the balloon has gone up about the benefits being associated with Ivermectin, people everywhere are lunging for anything resembling the drug. I know of folk who are consulting the internet for advice on how to dose themselves. “Middlemen” have apparently also popped up.

This might have been okay since the drug is considered relatively safe — that is to say, by the rest of the world and the WHO, which indicates that it is probably safe enough for use by breastfeeding mothers. The only side effects for the correct doses seem to be a possible headache, itchy skin or diarrhoea and it is contra-indicated for children under five-years-old who weigh less than 15kg, and people who have kidney disease.

Dr Nathi Ndladla, who works at a hospital north of Pretoria, also writes that Ivermectin has been dosed more than 3,5-billion times with minimal side-effects.

Trouble is, in SA, we are confined to animal grade Ivermectin which comes in different formulations. Some of these contain other ingredients. It is surely not remotely conceivable that the average urban South African knows how to pick his or her way through the different brands of animal grade Ivermectin, let alone knows how to dose themselves.

Does Sahpra not understand that its blockade against this drug is feeding a dicey blackmarket?

Presently, that all that seems to be in the way of this train smash is an undertaking by Afriforum’s legal team to look into going to court — as the Treatment Action Campaign has done twice before, to force the state to make life-saving medicines available.

So here we are, in the middle of the most pulverising medical crisis in living memory, with a surge accelerated by a mutated virus that is now killing healthy 40-year-olds. Our bureaucrats appear to be at war against our doctors. A court action is potentially on the horizon. And there is the stark and haunting possibility that people might die unnecessarily.

In this unchartered territory there is one more significant element – the different price-tags on some of the drugs involved.

Remdesivir, for instance, costs about R10 000 per dose – for the generic. Tocilizumab reportedly costs around R55 000 per dose. Both drugs, say doctors, appear to be effective only within window periods.

Ivermectin, meanwhile is the only drug, out of the arsenal in use, that is indicated as beneficial during all three phases of the disease. And, in a sane world, this cheap, old drug costs only a few rand per tablet.

This price disparity is possibly the cause of big pharma’s apparent lack of interest in repurposing Ivermectin for use against Covid-19.

But it is mindboggling that our leadership is not more attuned to those doctors who have been steamrollered by death for nearly a year and who are now standing up and shouting, at the top of their lungs, that there might be hope.

The Health Department’s Dr Aqunia Thulare is on record saying that they will consider enabling human access to Ivermectin, but no greenlight has yet been given for its use against Covid-19 by a regulatory authority such as the WHO.

Nor have any applications to run clinical trials been submitted to Sahpra, she said.

But why is our leadership not at the forefront of initiating clinical trials for this country? 

And why are SA doctors not, at the very least, allowed to use Ivermectin on the simple and immediate basis of patient consent. Currently they are required to apply to Sahpra for section 21 authorisation for any case. And this involves filling in a complicated form and submitting it to the regulator at R300 a pop.

Yes, I understand the need for caution. I understand too, that the state must protect the population while simultaneously covering its back against litigation. But when, finally, there looks to be a safe chance for life at the end of a terrifyingly dark tunnel, surely people who are frightened and dying have a right to take it?

This week our nation lost its beloved Minister in the Presidency, Jackson Mthembu, just 10 days after he announced that he had tested positive for Covid 19. A day earlier the continent lost the evangelist Stephen Lungu, the retired leader of African Enterprise and a man described as “the Billy Graham of Africa’’.

SA’s official death toll is now approaching 40 000. The continent’s is nearing 82 000, says the Africa Centre for Disease Control and Prevention.

Surely our leaders cannot, in all good conscience, stand back and ponder while the bodies pile up and South Africans are either strangled by red tape or bled dry by grotesque profiteering?