The Practice Of Medicine Should Not Be Pressurised By Popular Vote — Prof Dr Moy Foong Ming

Regulatory bodies including the US FDA and the European EMA, as well as MOH, concluded that there is insufficient evidence to support the use of ivermectin as treatment of Covid-19.

Calls to have the Ministry of Health (MOH) endorse ivermectin as a routine drug for prophylaxis and treatment for Covid-19 are getting stronger. There are also efforts to collect signatures from the public on this aspect.

I feel something is very wrong when we have ordinary citizens pushing for this. The practice of medicine should be evidence-based.  

Evidence based medicine (EBM) is the conscious, specific, and reasonable use of modern, best evidence in making decisions about treatment of patients.

The doctor chooses the best possible solution for his patients by using the best possible evidence, to provide the optimum health care in every aspect.

It is also used to avoid major mistakes in the course of treatment, by providing better quality health care for the patients. Ultimately, it aims to save the lives of patients.

The MOH is right in not giving in to pressure when there is inadequate evidence in endorsing ivermectin in the prophylaxis and treatment of Covid-19.  

Ivermectin is a broad-spectrum antiparasitic agent approved by the Food and Drug Administration (FDA) and has been proven to be safe at the conventional dose of ≤200 µg/kg, although severe adverse effects ranging from ataxia to seizures were occasionally reported.

Due to its in vitro antiviral activity against a broad range of viruses, it has been used off-label for the treatment of some viral diseases.  

However, regulatory bodies including the FDA and the European Medicines Agency, as well as MOH, concluded that there is insufficient evidence to support the use of ivermectin for the treatment of Covid-19.

The WHO also issued guidelines against the routine use of ivermectin in the treatment of Covid-19, except within clinical trial settings.  

What is the basis of these regulatory bodies coming to this conclusion, when there are many groups both globally and locally pushing for it?  

Most of the justification in proposing ivermectin as a prophylaxis for the treatment of Covid-19 presented were from randomised controlled trials (RCTs) or systematic reviews of low quality. The results were taken at face value without considering the methodological issues.  

Among the RCTs, there are considerable differences in the population receiving ivermectin, who were family contacts of confirmed Covid-19 cases as a prophylactic measure, mildly to moderately infected, or severe, hospitalised patients using ivermectin for treatment.

Applied doses and outcomes of interest were also highly variable. Additionally, patients in the control groups received different kinds of comparators, ranging from the application of placebos, or no intervention, to standard care, etc.

The sample sizes of these RCTs were also small.  Most of the RCTs were not registered with the Trial Registration Platform and were in the form of preprints, not peer reviewed nor published in journals.

Registering clinical trials before they begin and making results peer reviewed can overcome selective outcome reporting biases.

The highest level of evidence comes from systematic reviews with meta-analysis from RCTs. However, the quality of the evidence generated depends greatly on the quality of the included RCTs.

Therefore, more RCTs which are well planned and peer reviewed, without conflict of interest and are ethically approved are required. 

If the results are proven to be positive, ivermectin may be endorsed as a routine drug for the prophylaxis and treatment of Covid-19 in the future.

This decision should not be pushed by the public. Polls for getting this endorsed should not be encouraged as medicine should be evidence based, and not by popular vote. 

Prof Dr Moy Foong Ming is from the Centre of Epidemiology and Evidence Based Practice, Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya.

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