MANILA - The WHO representative to the Philippines has warned against the use of Ivermectin on humans against COVID-19, saying it lacks stringent clinical trials to prove its efficacy.

Speaking before the House Committee on Health on Tuesday, Dr. Rabindra Abeyasinghe, WHO representative to the Philippines, said extra caution should be made as several doctors in the country have prescribed the use of the veterinary anti-parasitic drug to COVID-19 patients, including several congressmen who contracted the virus.

Abeyasinghe pointed out there has been a number of small-scale studies following a study in Australia using almost a thousand times dosage normally used in humans. But all these trials, including those done in several countries, were statistically insignificant.

“The issue with Ivermectin is that based on that initial study and the currently available data it is not strong enough for us to advocate the use of Ivermectin for treatment or prevention of COVID,” he said.

This also happened when the WHO did solidarity trials on the anti-malarial drug hydroxychloroquine, according to Abeyasinghe.

“We had a similar situation in the hydroxychloroquine a few months ago, if you remember, and then when WHO did the details in the solidarity trials, it was conclusively shown that hydroxychloroquine not of them had any efficacy in reducing the severity or in protecting COVID-19 infection,” he said.

He cited the conclusion by the European Medical Association and the US FDA, which both recommended that Ivermectin does not and cannot be used for treatment against COVID, based on existing data.

“What they are recommending is that we look at carefully planned controlled clinical trials to have a proof whether Ivermectin works that is the global evidence that we have not only from WHO but also from very stringent regulatory authority and medicines authority both in Europe and in North America," Abeyasinghe said.

The continued use and prescription of Ivermectin in the Philippines maybe counter-intuitive and could do more harm than good.

“What we are actually creating is a false confidence in people that if they take Ivermectin they are going to be protected and that could actually be harmful,” he said.

Dr. Allan Landrito, an advocate on the use of Ivermectin in the Philippines against the coronavirus, claimed he “dispensed to more than 8,000 individuals from July 2020 up to present time”.

He also claimed that there were no reports of drug to drug interactions and adverse reactions were reported aside from side effects such as soft and water stools in 50 to 100 patients, abdominal cramping in 10 patients, and 10-15 patients who experienced rashes or allergy.

American doctor Pierre Kory also gave his support for the use of the anti-parasitic drug vs COVID-19, claiming there is enough data to support their claims on its efficacy.

Some lawmakers believe the FDA is not acting fast enough to use Ivermectin in helping manage COVID-19 symptoms.

But the DOH does not approve of its use to combat COVID-19.

“I am not here to debate because I am not really an expert on this. I just like to read the statement on the use of Ivermectin in the treatment for COVID-19, based on the evaluation done by these experts,” said DOH spokesperson Usec. Rosette Singh-Vergeire.

Vergeire read the statement from Living CPH, a group of various experts from all medical societies in the Philippines including UP-NIH ICE and Consensus Panel Representative of FDA-DOH, PMA, PCP, PAFP, POGS, PCEM, PSGIM, PCCP, PSPHP, and PSMID.

Vergeire said the DOH has adopted the statement because they are part of the group.

“A systematic review of 6 randomized control trials of good methodological quality shows that first the use of ivermectin for the treatment of COVID-19 does not reduce mortality risk. It is also not associated with a definite benefit in terms of other clinically important outcomes such as clinical improvement at day 6 to 10 clinical deterioration nor need for a mechanical ventilation," said Vergeire.

"Furthermore it does not significantly reduce the duration of hospitalization and the time to resolution of symptoms. The rate of hospital discharge at day 10 to 14 does not differ significantly between those given ivermectin and those who received standards of care or placebo.

“Based on the current evidence from the randomized controlled trials, we do not recommend the use of ivermectin for the treatment of COVID-19 as it has not been proven to significantly reduce mortality or improve other clinical outcomes this recommendation will be updated as more evidence will be generated from our on-going trials,” she added.

Landrito called out the Philippine FDA for not acting on his application to register his Ivermectin product which he said was submitted in February this year.

Anakalusugan Party-list Rep. Mike Defensor, who admitted during the briefing that he received Ivermectin when he was diagnosed with COVID-19, hit the FDA for failing to attend to Landrito’s application.

But FDA Director General Eric Domingo said they are simply doing their job.

“Kasi po kami ang mandate talaga namin is to assure that all products that are available out there are authorized by the FDA. Kami naman po gumagawa lang po kami ng trabaho namin at kapag nag-apply naman po ang isang produkto eh aaralin naman po namin lahat ng isusumite sa amin na data, ng product quality atsaka all of the scientific data,” said Domingo.

Health Sec. Francisco said he will look into how to make the process faster, reiterating the DOH's response on the pandemic is based on science.

“Ang DOH po kasi, ang proseso namin, meron po kaming mga experts 'yung technical advisory group of experts na iyan po idinudulog namin sa kanila itong mga issues na ito. Kasi from the start, we want the response to the pandemic to be science and evidence based,” he said.

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