Ivermectin and Covid: no time to lose and lives to save

By Prof. Saroj Jayasinghe,

MBBS, MD (Colombo), FRCP (London), MD (Bristol) PhD (Colombo), FCCP, FNASSL

Consultant to the Faculty of Medicine

Sabaragamuwa University of Sri Lanka.

Former Professor of Medicine, University of Colombo

It is with a degree of reluctance that I am stepping into the controversy relating to Ivermectin use in COVID. Unknown to many, the pros and cons of Ivermectin in COVID have been discussed in private forums of physicians, academia and doctors from 2020. It has been in the international media ever since laboratory studies in Australia showed that the drug inhibits the growth of the virus. However, the public in Sri Lanka became more aware of the controversy recently, when a confidential letter sent to an official of the Ministry of Health appeared in the social media. I had written this in June 2021 as an individual professional after several months of raging controversy among professionals. It was about treatment of COVID, and I firmly believe vaccination is the best option to prevent the illness. One reason for the very cautious approach of not approving the use of Ivermectin in the West could be because anti-vaccine groups are promoting it as an alternative. Sri Lanka has no such problems, and our population is willingly getting vaccinated.

Proposals to use Sri Lanka as a large study area as a clinical trial or as an observational study were made as far back as early 2021. I understand a clinical trial has begun in patients admitted with COVID, after considerable delays due to procedures related to clinical trials. Such studies are scrutinised by independent ethics committees, the drug must be approved by the National Medicinal Drugs Authority, and the study must be registered in an entity that makes is publicly available for anyone to read about it. This study will at least take another few weeks to months to yield results.

Most discussions in Sri Lanka Centre around the question whether the evidence to prescribe Ivermectin in COVID-19 is strong or inconclusive. One group says there is inconclusive evidence to use Ivermectin while another group says there IS sufficient evidence. As with many issues, this is not black or white but shades of grey, i.e. there are grades on the ‘strength of evidence’ from the field of Evidence Based Medicine (EBM). A parallel in the legal field is when we say that the evidence is ‘beyond reasonable doubt’ or there is ‘proof of the crime’, vs. circumstantial evidence.

Let us assume that using the principles of EBM we find that the evidence to use Ivermectin in COVID is ‘inconclusive’. Such a dilemma is very relevant to a situation where a decision is needed immediately, but the stakes are high. In other words, how would doctors decide to treat in a situation when the evidence for efficacy of a drug is inconclusive, but the stakes are high? Let me share an example.

Imagine a doctor who sees a very ill-looking patient with features of a serious infection (e.g. high fever, vomiting and body aches). She or he requests tests to identify the cause of the illness and the bacteria that may be causing the illness. In such an instance, should the doctor wait till the reports of the tests (e.g. culture reports) are available before treating? If a decision is made to treat immediately, the doctor does not have the ‘strength of evidence’ on the cause of the illness. However, if treatment is delayed until the reports arrive in two days the patient may be dead. This hypothetical example highlights a common dilemma: How do doctors balance between reliance on strength of evidence vs. taking an immediate decision when the evidence is inconclusive. This is best addressed by theories of decision-making and is a question very familiar to practicing doctors.

Now I will demonstrate the parallel with Ivermectin. In the case of ivermectin let us assume that the current evidence for its efficacy in COVID is inconclusive. However, the stakes are very high because COVID is currently raging, hundreds are dying, and there are no alternative drugs to treat early disease. Furthermore, Sri Lanka needs to bridge only a short vulnerable period of 4-6 weeks during which time our vaccination programme would become effective.

Let us assume that doctors begin to prescribe Ivermectin for treatment and prevention of COVID, for the next 4 to 6 weeks, despite the inconclusive evidence. There are two possible key outcomes:

Outcome 1: Future research confirms that it is effective, and it would contribute to saving many lives.

Outcome 2: Future research shows that it is ineffective, and we would have wasted money on the drug. Therefore, Ivermectin could either save lives or waste money. Even the money wasted is miniscule because the cost of a course of Ivermectin is less than Rs 200.00 (i.e. less than one US dollar)! Is it safe to use over the next 4 to 6 weeks? We know it is a very safe drug that has been used for almost 40 years. It is used in mass scale by the WHO to eliminate ‘River Blindness’ and is in their Essential Drug List.

A combination of other factors add support to the decision to prescribe Ivermectin.

1. Evidence is evolving, and studies are in progress. Therefore, conclusive evidence may emerge to confirm its efficacy.

2. There is laboratory (in vitro) evidence that Ivermectin is active against the COVID-19 virus.

3. It’s easy to give (tablets and not injections).

4. Currently there are no effective drugs in Sri Lanka to treat early COVID or prevent it.

5. Certain regions in India and South American countries are using Ivermectin to treat and prevent COVID-19

Summary

Therefore, my humble question is, should doctors in Sri Lanka consider whether to use Ivermectin to treat or prevent COVID-19? We need this only for 4-6 weeks. During this period, rates of COVID are likely to increase due to the very rapid transmission of Delta variant. We have no time to lose, nothing to lose, and lives to save. There is no time for clinical trials. Those who wish to embark on trials to wet their thirst for more evidence are welcome to do so. By the time the results of a new trial are available the horse would have bolted, and hundreds would have died.

My suggestion is for patients to ask your doctors about Ivermectin. You have a right to do so. Doctors are divided on the issue because of their sincerity to the views they have about science, scientific evidence, and decision-making. Please do not assume that there is a conspiracy against the drug in Sri Lanka! I can vouch for the honesty of all the doctors who are having different views on the topic. This is a disagreement between professionals who have diverse views, and we seem to have dug into our lines of defence!

The Ministry of Health has allowed the use of Ivermectin under the direction of a doctor. A range of doses for treatment and prevention is available at BIRD-group.org a group working in the UK. The opinions I have stated here are my own independent views and not in any way linked to the institutions I am affiliated to.