The evidence on Ivermectin is flimsy and there is no compelling case for it to be used in the fight against COVID-19. The Times reports that this is according to the co-chairperson of the ministerial advisory committee (MAC) Professor Salim Abdool Karim who said research on whether Ivermectin can cure COVID-19 was currently flawed due to the small sample size and a lack of clear recommended dosages.
The report says the country’s top vaccinologists, scientists and infectious diseases experts also warned against the “irresponsible social media hype around the use of Ivermectin” to treat COVID-19 until it was officially approved for use in humans in the country.
The Times reports that speaking on a webinar hosted by Project ECHO and the National Health Laboratory Service, Professor Ian Sanne, the director of Right to Care, said: “I don't understand how Ivermectin would work because it would require doses a hundredfold the dose in the studies. Also, where does it fit in the cascade of treatment?”
However, the report says, the South African Health Products Regulatory Authority (SAHPRA) has now announced that it has authorised a limited “compassionate and controlled access programme” for Ivermectin to be used to treat COVID-19. The decision came after many doctors called for it, but SAHPRA said better data was needed to establish safety, doses and efficacy.
Professor Helen Rees, chairperson of SAHPRA, said there was not yet sufficient data to indicate a full authorisation of the drug for human use, but that the programme put in place would “give respite while we wait for better data to normalise the situation”.
“We are acutely aware that we don’t have many options for acute treatment, and we are very sensitive to what is at stake,” said Rees.
Nathan Geffen, the editor of GroundUp, writes that the obsessive pressure being put on SAHPRA to approve Ivermectin is extraordinary and dangerous. Geffen, writes that there are circumstances when early – or even illegal – access to drugs is justified.
He writes in Groundup that in the early 2000s he worked with the Treatment Action Campaign (TAC) to import fluconazole, a life-saving anti-fungal drug that was obscenely priced in the country. “A decade ago, we advocated for pre-approval access to a TB drug called bedaquiline. I’ve written extensively on the subject including a peer-reviewed paper: Anything to Stay Alive: The Challenges of a Campaign for an Experimental Drug. So you might think I’d be sympathetic to the push for ivermectin to treat COVID-19."
He writes, however, that the push for Ivermectin is a dubious campaign that is undermining the scientific governance of medicine. “Our campaigns for fluconazole and bedaquiline were well-researched and considered, and we tried to cooperate with the regulatory authority. This is in stark contrast to Ivermectin.
Geffen writes that there is promising evidence that Ivermectin is useful for the treatment of COVID-19. But that evidence falls short of what’s required to approve a drug. There is a system in place with clear standards for medicines to be approved. As with all systems there are edge cases (for example, bedaquiline at the time the TAC pushed for pre-approval access). But Ivermectin is not such an edge case.
“Ivermectin may work. But it may not. Calling for it to be made available before a properly conducted clinical trial has proven its efficacy against COVID-19 is like calling for a vaccine to be rolled out before it has been proven.”
He writes that the results of several clinical trials of Ivermectin have been published, but they’re all either incompletely described, poorly designed or small – The Lancet published a study of ivermectin with only 24 patients, 12 in each group!
Ivermectin advocates point to an analysis of the ivermectin clinical trials led by Andrew Hill, an excellent scientist with the University of Liverpool. Hill has found that if you combine Ivermectin trial results, the drug is associated with 75% reduced mortality. This is very promising.
But Hill concludes: “Many studies included were not peer reviewed and meta-analyses are prone to confounding issues. Ivermectin should be validated in larger, appropriately controlled randomised trials before the results are sufficient for review by regulatory authorities.”
Moreover, there is no consensus yet what dose of Ivermectin to use, what form of ivermectin to use (intravenous, pill or nasal spray), how long to use it, or in which patients to use it. (It is also unclear why an anti-parasitic drug possibly has benefits against a viral disease, though this isn’t a barrier to approval.)
Geffen writes that this is in contrast to colchicine, an anti-inflammatory drug. Scientists at the Montreal Heart Institute (MHI) decided to test if this medicine could be useful against COVID-19. Some patients’ immune systems go into overdrive when they are infected, causing what is called a cytokine storm. This requires hospitalisation and is often fatal. The theory was that colchicine could dampen the cytokine storm.
MHI published the results of their study (it’s not yet peer-reviewed). Geffen writes that assuming the researchers haven’t made any blunders, this study exemplifies high-quality medical research.
Participants with positive COVID-19 tests, who were over 40 and had at least one high-risk criterion, were randomly assigned either to receive a placebo or to receive 0.5mg of colchicine daily for 30 days (twice daily for the first three days). Of the 2,195 people assigned to the colchicine arm, five died and 93 were hospitalised. Nine died on the placebo arm and 123 were hospitalised. The difference between the two arms is small but statistically significant. Colchicine has a modest but proven benefit in the treatment of COVID-19.
Geffen writs that colchicine not a wonder drug – those don’t exist yet for COVID-19, including ivermectin – but it’s readily available and cheap: R5 per tablet. The full one-month course currently costs R165.
He writes there has been very little social media buzz about colchicine, and perhaps it’s just as well.
[link url="https://www.timeslive.co.za/news/south-africa/2021-01-28-the-amount-of-ivermectin-needed-to-kill-covid-19-is-toxic-to-humans-says-prof-salim-abdool-karim/"]Full report in The Times (Open access)[/link]
[link url="https://www.groundup.org.za/article/covid-19-ivermectin-obsession-dangerous/"]Full Groundup report (Open access)[/link]
[link url="https://pubmed.ncbi.nlm.nih.gov/25982452/"]NIH National Library of Medicine study (Restricted access)[/link]
See also MedicalBrief archives:
[link url="https://www.medicalbrief.co.za/archives/colcorona-trial-is-gout-drug-colchicine-set-to-be-the-next-ivermectin/"]COLCORONA trial: Is gout-drug colchicine set to be the next Ivermectin?[/link]
[link url="https://www.medicalbrief.co.za/archives/fact-file-making-sense-of-the-ivermectin-controversy/"]Fact File: Making sense of the Ivermectin controversy[/link]
[link url="https://www.medicalbrief.co.za/archives/exotics-hog-the-headlines-but-its-an-old-workhorse-that-has-done-the-covid-19-job/"]Exotics hog the headlines but it’s an old workhorse that has done the COVID-19 job[/link]