Ivermectin for Covid-19: Not enough evidence, warn WHO and doctors

A debate has broken out over the safety and efficacy of the drug Ivermectin after Goa’s Health Minister Vishwajit Rane announced that all adults (18 and above) be given the medicine as prophylaxis to bring down mortality amid a surge in Covid cases. 

Scientists and doctors, including the World Health Organisation (WHO), have advised against the use of Ivermectin for Covid. Soumya Swaminathan, chief scientist, WHO, said, “Safety and efficacy are important when using any drug for a new indication. WHO recommends against the use of ivermectin for Covid-19 except within clinical trials.”

Rane had said that expert panels from the UK, Italy, Spain and Japan found a large, statistically significant reduction in mortality, time to recovery and viral clearance in Covid-19 patients treated with Ivermectin. “This does not prevent Covid-19 infection but helps in reducing the severity of the disease and at the same time one should not have a false sense of security and complacency but strictly take all the precautionary measures,” he said.

The Front Line Covid Critical Care Alliance, a US-based non-profit organisation, has also recommended that Ivermec­tin be used by adults as Covid-19 prophylaxis on a large scale thro­ugh mass distribution to decrease transmission amongst the population in the current crisis. “We believe this will save thousands of lives and reduce the suffering of millions,” it said in a statement. 

However, a study by Merck, a manufacturer of Ivermectin, found that there is no scientific basis for a potential therapeutic effect against Covid-19 from pre-clinical studies. 

Merck also said there was “no meaningful evidence for a clinical activity or clinical efficacy in patients with Covid-19 disease”. The company flagged a “concerning lack of safety data in the majority of studies”. 

“We do not believe that the data available support the safety and efficacy of ivermectin beyond the doses and populations indicated in the regulatory agency-approved prescribing information,” Merck said in a statement published as early as February 4, 2021.

Despite this, doctors in India have been prescribing the drug for Covid treatment. The medical fraternity, however, agreed that the drug is used only in mild cases and does not prevent deaths. Firms like Cipla, Sun Pharmaceuticals and Zuventus have popular Ivermectin brands in the market. 

Ivermectin, a Food and Drug Administra­tion (FDA)-approved drug used to treat parasitic infections, rose to prominence in 2020 as a treatment for Covid-19, pushing its sales up by more than 25 times and prompting more drug firms to launch the product.

The FDA, too, has warned against its use for Covid prevention or treatment.

Doctors treating Covid patients also pointed out that even as a prophylaxis, it is not certain how much and for how long should this medicine be prescribed.

“Clinical studies have not shown any conclusive evidence of any robust efficacy or reduced hospitalisation in patients due to the use of Ivermectin. It is being used in hope that something will work,” said Praveen Gupta, director, Neurology, Fortis Memorial Research Institute, Gurugram. 

According to Merck, the drug is not recommended during pregnancy and its safety and efficacy is not established in paediatric patients weighing less than 15 kg.  

Meanwhile, in Goa, the government has decided to make available 12 mg tablets of the drug as a prophylaxis in all districts, sub-districts and primary health care centres. Goa has seen a big surge in cases during the second wave with a positivity rate touching almost 50 per cent, the highest in the country.

A study published in the British Medical Journal by researchers from the Interdisciplinary Centre for Health Studies (Chile) and Instituto Universitario del Hospital Italiano de Buenos Aires (Argentina) also concluded: “Research related to ivermectin in Covid-19 has serious methodological limitations resulting in very low certainty of the evidence.”