Malaysian officials respond to claims of ‘miracle drug’ ivermectin

By NewsDesk @infectiousdiseasenews

Ivermectin is an anti-parasitic drug that is widely used in veterinary medicine, especially treating worm infestations. In April 2020, researchers using laboratory methods demonstrated that Ivermectin can also inhibit the replication of SARS-CoV-2, the new virus that causes the disease COVID-19. Since then, many authors relying on findings from small studies and case series have suggested the potential use of Ivermectin against COVID-19. But the recommendation for ‘off-label’ use of Ivermectin in COVID-19 has been controversial from the start.

Image by Gerd Altmann from Pixabay

First, many studies of Ivermectin have limitations including small sample sizes, uncontrolled study designs or that the drug is used as an adjunct treatment. Therefore, this has confounded the effects of Ivermectin, if any. In January 2021, a randomized placebo-controlled trial involving 24 non-severe COVID-19 patients failed to show a reduction in the proportion of PCR-positive patients on day 7 following a single dose of 400 mcg/kg Ivermectin treatment. The authors of the pilot study, published in EClinical Medicine (Lancet), argue that larger trials may be needed to understand the effects of Ivermectin. In March this year, the Journal of the American Medical Association (JAMA) published a randomized controlled trial involving 476 adults with mild COVID-19 disease who were given Ivermectin for 5 days. The results showed that there was no significant increase in the resolution time of COVID-19 symptoms. While Ivermectin may have some anti-viral and anti-inflammatory effects, the evidence remains inconclusive.

Regulatory bodies including the US FDA and European EMA, after evaluating these studies, have concluded that there is insufficient evidence to support the use of Ivermectin as a COVID-19 treatment. WHO also issued guidelines against the routine use of Ivermectin in the treatment of COVID-19 except in clinical trial settings.

Despite this decision, support for Ivermectin as a “miracle drug” is being circulated by some NGOs and by those who want the drug to be reused against COVID-19. Recently, the Coalition on Integrity of Vaccines & Drugs Against COVID-19 (CIVDAC) Malaysia, suspected that no one would die from COVID-19 if only given Ivermectin early in the illness. In particular, CIVDAC cites scientific evidence on the usefulness of Ivermectin as recommended by several experts from the US-based Front Line COVID-19 Critical Care (FLCCC). However, the evidence synthesis only included conclusions from preliminary reports of the work without peer review, and the lack of clarity on the risk of assessment bias of the studies included in the evidence.

The Malaysian Ministry of Health has started a randomized clinical trial to reuse Ivermectin and evaluate its efficacy and safety in high-risk COVID-19 patients (NMRR-21-155-58433). The trial will register 500 COVID-19 patients being treated at 12 MOH hospitals. Through this research, the MOH hopes to have the correct perspective on the clinical effectiveness of Ivermectin. Although Malaysia’s risk for COVID-19 may be increasing at this time, we must remember that under all circumstances, we need to take the necessary steps to find out what actually works. Without the evidence benefit from well-designed clinical trials, the Malaysian Ministry of Health has not been able to support Ivermectin to prevent or treat COVID-19 disease. Science remains the best weapon against the SARS-Cov-2 virus, no indirect hype.

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