From Dr Musa Mohd Nordin & Dr Husna Musa
No one is discrediting the “godsend” medicine Ivermectin, as alleged by a quartet of three organisations and an individual. But its advocates need to look themselves in the mirror and pose the same benchmarks they mandated upon other competing drugs and vaccines.
Ivermectin must be scrutinised by the scientific discipline of placebo controlled, randomised controlled trial as much as all the new Covid-19 vaccines were thoroughly examined.
The six candidate vaccines from Pfizer, Moderna, AstraZeneca, 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 and the Lancet. Vaccine manufacturers have committed to continue the trial for a total of 30 months.
The same claim of a “godsend” was made of hydroxychloroquine.
The World Health Organization’s Solidarity trials, enrolling almost 12,000 patients in 500 hospital sites in over 30 countries, and most recently the New England Journal study showed unequivocally that hydroxychloroquine did not prevent Covid-19 infection or symptomatic Covid-19 in healthy persons exposed to a PCR-positive case patient.
Hydroxychloroquine had little or no effect on hospitalised patients with Covid-19, as indicated by overall mortality, initiation of ventilation, and duration of hospital stay.
The issue of Ivermectin has similarly been brought to the attention of the scientific fraternity. The US National Institutes of Health issued the following recommendations:
“The Covid-19 Treatment Guidelines Panel has determined that currently there is 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.”
Meta-analysis of randomised controlled trials of Ivermectin to treat Covid-19 infection revealed that many of the studies included were not peer reviewed, and that Ivermectin should be validated in larger, appropriately controlled randomised trials before the results are sufficient for review by regulatory authorities.
New South Wales’ health ministry’s rapid evidence checks commented that the evidence on Ivermectin is still emerging and most of the available evidence is of low quality. Currently, there is insufficient data to support the use of Ivermectin for prophylaxis or treatment of Covid-19.
The Dec, 17 update of the WHO guideline on drugs for Covid-19 did not include Ivermectin.
The Pan American Health Organization, the WHO 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.
Advocates of 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 Food and Drugs Administration 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.”
The rules should apply similarly to the “magic drug” Ivermectin as it has been applied to the Covid-19 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 is 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 hydroxychloroquine which has now been debunked by good science.
Dr Musa Mohd Nordin & Dr Husna Musa are FMT readers.
The views expressed are those of the writers and do not necessarily reflect those of FMT.
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