BY PHYLLIS MBANJE
AS most parts of the country report increased cases of COVID-19, which are largely fuelled by the Delta variant, desperate measures on possible treatment and cures are once again being dragged into the limelight.
These include drugs like Ivermectin which has attracted a fair share of controversy over its efficacy, as both a preventive and treatment option for COVID-19.
Its existence is shrouded in hotly debated scientific discussions with proponents claiming that it has worked in their patients and could be the game changer in COVID-19 management.
The cynics, however, maintain that more research and plausible evidence is required before the drug can be rolled out for use.
University of Oxford scientists are placing the drug on trial by giving Ivermectin to people with COVID-19 symptoms to see if it can keep them out of hospital.
The drug has become controversial after being promoted for use across Latin America and in South Africa, despite being unproven.
Previous studies of Ivermectin have generally been either small or of low quality.
The Oxford team said they had selected Ivermectin to be included in the trial because it was “readily available globally” and known to be relatively safe, although, like most things, it can be toxic at very high doses.
About the drug …
Ivermectin is a broad spectrum anti-parasitic agent.
It is included in the World Health Organisation (WHO) essential medicines list for several parasitic diseases and is used in the treatment of onchocerciasis (river blindness), strongyloidiasis and other diseases caused by soil transmitted helminthiasis. It is also used to treat scabies.
Ivermectin was developed during the 1970s as a partnership between the Kitasato Institute in Japan and Merck and Co. It was popular in the veterinary field but during the 1970s, river blindness, also known as onchocerciasis afflicted many countries.
This led to accelerated efforts to test Ivermectin in humans that ended with the approval by the French regulatory authorities in the early 1980s.
But is it safe? …
According to scientists, when used for the current indications, at the currently approved doses, Ivermectin is a very safe drug.
Most adverse reactions are mild. But there have been reports of a series of cases with severe neurological adverse reactions after Ivermectin treatment outside onchocerciasis endemic areas.
In individuals infected with a high burden of the parasite known as Loa loa, Ivermectin treatment can lead to severe encephalopathy and death.
This has prevented the administration of Ivermectin in several countries of central Africa. There is no evidence to support the use of Ivermectin during pregnancy.
Ivermectin links to COVID-19 …
Ivermectin has been proven to inhibit the replication of several RNA viruses such as, dengue, Zika, Yellow fever, Porcine reproductive and respiratory syndrome virus , and recently SARS-CoV-2
The proponents …
Local family medicine physician Jackie Stone last year ran a series of video lectures, alleging that a combination of nebulised nano silver, Ivermectin and doxycycline could treat COVID-19 and can even be given at home.
In an interview on Medical Update online, Stone said at her own clinic, two critical patients also survived and were discharged with oxygen for use at home.
“One of them I really sent home for palliative care, with a very good nurse. From August 8 (2020) until December 24, I didn’t lose a patient,” she said.
Well-respected Australian researcher and gastroenterologist Thomas Borody populated the triple therapy for COVID-19 consisting of Ivermectin, Zinc and Doxycycline.
“An Ivermectin tablet can cost as little as US$2, which could make it by far the cheapest, safest, and fastest cure,” he said.
Borody said Stone should be lauded for advocating for use of Ivermectin.
The cautious …
One of the most vocal people agitating against Ivermectin is medicinal chemist Derek Lowe, who has worked for multiple pharmaceutical companies and writes a drug development blog for Science Magazine called In the Pipeline.
In his widely circulated and quoted commentary, he says his opinion is pretty much exactly that of the WHO guidance.
“I do not think that the current evidence is strong enough to say that Ivermectin is a useful therapy for coronavirus patients,” Lowe said.
He said the few studies done suffer from various combinations of small sample size, poor trial design, not enough data reported, and in many cases, inconclusive statistics.
“I think that WHO page does a solid job of evaluating the literature to that point, and overall, the better the quality of the evidence, the more it tends to show little or no effect of Ivermectin,” he said.
WHO which is yet to give the nod has said the current evidence on the use of Ivermectin to treat COVID-19 patients is inconclusive. Until more data is available, WHO recommends that the drug only be used within clinical trials?
The local regulatory body Medicines Control Authority of Zimbabwe (MCAZ) has sternly warned against “blanket use of the drug”.
Although it gave the green light, practitioners can only do it within a prescribed framework and are required to give feedback.
However, the cautionary stance taken by MCAZ has drawn the ire of certain pockets of the community including proponents of Ivermectin, who are now accusing the regulatory body of dragging its feet.
Responding to the allegations, the authority said it acknowledged the various clinical studies being conducted globally and the peer reviewed literature around Ivermectin suggesting its beneficial effect in the management (prophylaxis and treatment) of COVID-19.
“The authority has systematic review and assessment processes for such developments of public health importance. This is to ensure that informed regulatory decisions are made that would ultimately protect the public and promote access to potentially lifesaving COVID-19 therapeutics,” said the projects and public relations officer Shingai Gwatidzo.
He, however, said despite the suggested beneficial effects of Ivermectin, there is still no conclusive scientific evidence as yet to support unrestricted use of Ivermectin in the management of COVID-19 within the Zimbabwe context.
“Furthermore, the available literature raises some methodological limitations which ought to be carefully scrutinised in view of the conclusions that can be drawn regarding the efficacy and safety of Ivermectin in the management of COVID-19.”
Gwatidzo explained that against this backdrop, the authority developed the operational research framework which guides practitioners and other healthcare personnel who wish to use Ivermectin human oral formulations for the treatment and/or prevention of COVID-19.
He also said the authority was aware of some healthcare practitioners who are using Ivermectin without seeking approval and sternly warned against this practice.
“The public is strongly urged to desist from self-prescribing and sourcing unapproved medication from unapproved sources,” he said.
Meanwhile, in wide searching interviews with medical personnel and health stakeholders, mixed feelings were drawn.
Rashida Ferrand, a specialist physician and professor of international health, said she still stood by her previous stance.
Early this year, she was part of specialist doctors who wrote a complaint letter to Josephine Mwakutuya, the registrar for Medical and Dental Practitioners Council of Zimbabwe (MDPCZ), saying Stone’s actions needed urgent review.
“We strongly believe she has transgressed the strong code of conduct that the medical profession is bound to and is potentially putting her patients at risk of harm,” read the letter in part.
They accused Stone of taking advantage of her patients’ anxiety and vulnerable situations to promote panic and utilisation of a non-evidence-based treatment regime.
Ferrand this week said after reviewing the latest evidence, her stance had not changed.
“The available evidence does not support the use of Ivermectin and WHO has recommended that it should not be used. I have made the same recommendation to the MCAZ. The practitioners who use this should not be doing so as they contravene national and international guidelines,” she said.
Other medical practitioners who refused to be named said the much-touted Ivermectin was not making significant impact on those taking it, especially with the newer variants.
Follow Phyllis on Twitter @pmbanje