Regulators Under Pressure As Illegal Use of Ivermectin to Treat COVID-19 Soars Medicines & Vaccines 05/02/2021 • Kerry Cullinan Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to print (Opens in new window) Police seize bags of ivermectin illegally smuggled into South Africa CAPE TOWN – The South African police have arrested six people in the past two weeks for trying to smuggle large quantities of the anti-parasitic medicine, ivermectin, into the country from India as demand for the drug as a treatment for COVID-19 surges internationally. Ivermectin is only registered to treat parasitic infections in animals in the country, although it is used throughout Africa to treat people with river blindness and scabies. However, under pressure from doctors and patients, the South African Health Products Regulatory Authority (SAHPRA) announced late last week that it would allow doctors to apply to use it for COVID-19 patients on “compassionate grounds” via a complicated process. On Tuesday, following a court challenge by an organisation, Afriforum, a doctor and two patients, SAHPRA also agreed to allow doctors to use the medicine without waiting to be given permission. So far, over 500 doctors and health professionals have petitioned SAHPRA and President Cyril Ramaphosa to fast-track clinical trials and consideration of Ivermectin’s use on humans. There is already widespread use of ivermectin as a COVID-19 treatment – not only in South Africa, but throughout Latin America. Both Peru and Bolivia have already granted doctors permission to use it as a COVID-19 treatment. But the head of the South African health minister’s advisory committee on COVID-19, Professor Salim Abdool Karim, said in a weekend media interview that there was “no compelling case” to use ivermectin to treat COVID-19, available studies were “of really poor quality” and that “the amount of drug needed to kill the virus is toxic to humans”. Last month, the US National Institutes for Health (NIH) held a special meeting to review data on the role of ivermectin in the prevention and treatment of COVID-19, and is considering the available data. Dr Andrew Hill from the University of Liverpool, who has been researching ivermectin for UNITAID and the World Health Organization (WHO), and representatives from the Front Line COVID-19 Critical Care Alliance (FLCCC) presented the NIH with data from 18 randomized controlled trials involving over 2,100 patients, ranging from a 400-person, 5-day Egyptian study to 24-person one day study in Spain. Small Studies Show Faster Viral Clearance, But Still Insufficient Evidence Combined, these “demonstrated that ivermectin produces faster viral clearance, faster time to hospital discharge, faster time to clinical recovery, and a 75% reduction in mortality rates”, according to a press release from the FLCCC. But Hill was cautious: “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.” After the meeting, the NIH released a statement saying that there was “insufficient data to recommend either for or against the use of ivermectin for the treatment of COVID-19”. “Results from adequately powered, well-designed, and well-conducted clinical trials are needed to provide more specific, evidence-based guidance on the role of ivermectin for the treatment of COVID-19,” said the NIH. Piero Olliaro, Professor of Infectious Diseases of Poverty at Oxford University’s Centre for Tropical Medicine and Global Health, said: “There is experimental evidence from in-vitro studies that ivermectin has antiviral action against the SARS-CoV-2, but this requires giving humans doses which are much higher than those normally used for the current indications for ivermectin. So, the question is: will it be safe?”. “A dose-escalating study of healthy adults given increasingly higher doses of ivermectin assessed for adverse events and the levels reached in blood with the different doses, concluded that it would be safe to give 10 times the highest FDA-approved dose of 200 micrograms per kilogram,” said Olliaro. “We need well-conducted, sufficiently-powered trials treating patients with increasing doses of ivermectin to see if a satisfactory compromise between efficacy and safety can be found” So far, there are very few therapeutic options to treat COVID-19. Two drugs that were touted to be re-purposed as COVID-19 treatments – hydroxychloroquine and remdesivir – turned out not to be effective, despite hype from various health professionals. There are currently over 50 trials on ivermectin at present involving over 7000 people, but it is hard to know whether any of these will provide the evidence needed to license ivermectin as a treatment for COVID-19. Image Credits: SA Police Service. Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to print (Opens in new window) Combat the infodemic in health information and support health policy reporting from the global South. Our growing network of journalists in Africa, Asia, Geneva and New York connect the dots between regional realities and the big global debates, with evidence-based, open access news and analysis. To make a personal or organisational contribution click here on PayPal.