By Dr Musa Mohd Nordin
Dr Husna Musa
No-one is discrediting this “godsend medicine” as alleged by the quartet of NGOs and an individual (1)
But they need to look at themselves in the mirror and pose the same benchmarks they mandated upon other competing drugs and vaccines.
Ivermectin must be scrutinized by the scientific discipline of placebo controlled, randomized controlled trial (RCT) as much as all the new COVID-19 vaccines were thoroughly examined
The 6 candidate vaccines from Pfizer, Moderna, AstraZenea, SputnikV, Johnson & Johnson and Novavax recruited approximately 180,000 volunteers between them, with interim analysis published in peer reviewed journals, namely in the New England Journal of Medicine (NEJM) and the Lancet). And they vaccine manufacturer have committed to continue the trial for a total of 30 months.
The same “godsend medicine” claim was made of chloroquine. The WHO Solidarity enrolling almost 12 000 patients in 500 hospital sites in over 30 countries and most recently the NEJM showed unequivocally that hydroxychloroquine did not prevent SARS-CoV-2 infection or symptomatic Covid-19 in healthy persons exposed to a PCR-positive case patient. Hydroxychloroquine had little or no effect on hospitalized patients with Covid-19, as indicated by overall mortality, initiation of ventilation, and duration of hospital stay. (2,3)
The issue of ivermectin has similarly been brought to the attention of the scientific fraternity. The National Institute of Health issued the following recommendations:
“The COVID-19 Treatment Guidelines Panel (the Panel) has determined that currently there are 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” (4)
Meta-analysis of randomized controlled trials of ivermectin to treat SARS-Cov-2 infection revealed that many of the studies included were not peer reviewed. And that ivermectin should be validated in larger, appropriately controlled randomized trials before the results are sufficient for review by regulatory authorities. (5)
NSW Health rapid evidence checks commented that the evidence on ivermectin is still emerging and most of the available evidence is of low quality. Currently, there was insufficient data to support the use of ivermectin for prophylaxis or treatment of COVID-19. (6)
The17 December 2020 update for the World Health Organization guideline on drugs for COVID-19 did not include ivermectin. (7)
The Pan American Health Organisation, the World Health Organization regional office for the Americas, published a report in June 2020 that stated studies on ivermectin were found to have a high risk of bias, very low certainty of the evidence, and that the existing evidence is insufficient to draw a conclusion on benefits and harm. (8)
Advocates for ivermectin have described it as a “wonder drug” with immensely powerful anti-viral and anti-inflammatory properties during a US Senate hearing. However, the US FDA and the NIH have not approved ivermectin for the prevention or the treatment of COVID-19.
The advocates in Malaysia have demanded the quick approval of “… ivermectin to provide a safe, cheap and effective “weapon” against Covid-19. (1)
The rules should apply similarly to the “magic drug” ivermectin as it has been applied to the covid vaccines. Large, strongly powered, RCT must be undertaken by the advocates of this miracle drug, if they believe so strongly in its effectiveness and safe track record. The trial may even be stopped early on the basis of interim analysis if the drug was overwhelmingly effective as they so claim.
Meanwhile patient safety must be protected and we should not be lowering the standards of evidence and research or cutting corners just because we are in a pandemic.
We must learn from the lessons of the much touted miracle drug hydrocycholoquine which has now been debunked by good science.
(The views expressed are those of the contributor and do not necessarily reflect the views of Rebuilding Malaysia.)
Dr Musa Mohd Nordin is a Consultant Paediatrician & Neonatologist
Dr Husna Musa is a paediatrician and lecturer in University Putra Malaysia
8 February 2021
7. Siemieniuk R, Rochwerg B, Agoritsas T, Lamontagne F, LeoY-S, Macdonald H, et al. A living WHO guideline on drugs for covid-19. BMJ. 2020;370:m3379
8. Pan American Health Organization. Recommendation Regarding the Use of Ivermectin as a Treatment for COVID-19, 22 June 2020. PAHO IRIS; 2020 June 22.