The case against ivermectin

This is the transcript of the reply by Noor Hisham bin Abdullah, Director-General of Health, Malaysia, to a burning question why ivermectin has not been approved for use in the country to treat people affected by Covid-19. This question came at the end of Noor Hisham's public lecture which was organised by The Dr Wu Lien-Teh Society in Penang last Saturday. 

When we look into the data, there is conflicting evidence and there is no consistency among the available data to suggest ivermectin. And remember when this started, we also used hydroxychloroquine, a malarial drug, and we had a clinical trial by WHO, they call it a Solidarity trial, and it was proven that hydroxychloroquine had no effect at all and likewise we used [Note: several names were mentioned very quickly which I was unable to catch] HIV drugs, and they also had no impact to manage Covid-19. Last year even in Parliament this ivermectin issue also was raised. The public raised ivermectin and I actually was also a board member of the DNDi. In fact, two or three years ago when we explored a new compound in the DNDi to treat dengue, ivermectin was raised again in terms of using it to manage and treat dengue. 

Ivermectin is an old drug used for parasitic infection but there is actually an antiviral effect. We know that. The question is the consistency. To use the antiviral effect, you need to have a very high dose of ivermectin and we did a clinical trial for dengue… ivermectin for dengue in Thailand. They did a study. But you need a very high dose and you need close monitoring of ivermectin dosage because otherwise complication of diarrhea, renal toxicity, etc, will be there. They did the trial but halfway through the trial they had to abandon because of the high side effect. This is from Thailand. 

Dr PP Shah asking the "tough" question on ivermectin

What we did last year, and then when the pressure for the Ministry of Health to use ivermectin, we approved ivermectin for clinical trial, exactly what WHO had highlighted. You can use ivermectin but on a clinical trial basis. We started to do the ITEC trial, recruiting patients from both sides on a randomised control study of Covid-19. We had about 500 patients recruited, and then we monitored their progress. They were given ivermectin and whether they deteriorated to Category 4 or 5, more severe forms of Covid-19 and initially there was a lot of pressure on us. We said that we give (approval) in terms of clinical trial. Those enrolled in the clinical trial can use ivermectin. 

We have now completed our clinical trial. In fact, that paper has been published in the Journal of American Medical Association. JAMA journal, one of the peer review journals, a global peer review journal, accepted and it was actually one of the top references for ivermectin study, and that study showed that there was no improvement, no whatsoever benefit in terms of to stop the progression to a severe form. That was the conclusion of the paper. We have another clinical trial ongoing under the Institute of Clinical Research looking into ivermectin as prophylaxis, whether we can use it as a prophylaxis. Again, this trial has not been concluded yet so we cannot comment on that. 

Likewise last year when in Parliament they were asking us to register ivermectin but we needed evidence. Like I said, we follow science, facts and data. This evidence today, when we published the paper in JAMA in America, not only the issues of ivermectin but it shows that our clinical trial in Malaysia is able to penetrate (an) international journal which means the quality and standard of our trial is very high. The data has shown clearly that there is no benefit whatsoever. If you recover with ivermectin, if you don’t take ivermectin you also will recover. This is the thing that we have shown and proved in our clinical trial. We go on that and today this paper, we call it the ITEC paper, is the centre of referral for the global community using ivermectin in Covid-19.