FDA chief says DOH has commissioned experts’ group to study Ivermectin clinical trials on COVID; group finds 11 “good” clinical trials abroad
(Eagle News) – President Rodrigo Duterte expressed interest about the drug Ivermectin as a possible treatment against COVID-19.
In his latest Talk to the Nation address Thursday night, April 15, the President asked Food and Drug Administration (FDA) Director General Eric Domingo about the anti-parasitic drug used in animals, but which has recently been reported to be undergoing clinical trials for use in humans against coronavirus.
“Pag-usapan nga natin ito, gusto ko lang malaman na what is really the primary purpose for the manufacture of the drug sa baboy?” Duterte said at the last part of his public address Thursday night, April 15.
Domingo said that Ivermectin was an anti-parasitic drug mostly used treat parasites inside and outside of the body, and is mostly for veterinary use.
“Pero mayroon din pong pantao nito kasi mayroon din pong parasite sa mga tao na puwedeng gamutin nito pero sa ngayon po kasi madalang lang pong ginagamit sa tao ito. Mostly po veterinary, sa mga hayop po,” the FDA chief said.
-PHL experts studying possible use of Ivermectin to defeat COVID virus-
Domingo said that a group commissioned by the Department of Health (DOH) in the Philippines, the Living Clinical Practice Guidelines Group — composed of experts from the Department of Science and Technology, members of the vaccine expert panel, infectious disease specialists, clinical epidemiologists, and the Philippine General Hospital – is already studying Ivermectin.
“So dito po sa Pilipinas, ang DOH mayroon po siyang kinomisyon, yong Living Clinical Practice Guidelines Group. Ito po ay kino-compose ng DOST, ‘yong mga vaccine expert panel po natin, ‘yong mga espesyalista po natin sa Infectious Disease, mga clinical epidemiologist, at saka UP-PGH. Sila po sir ‘yong gumagawa noong clinical guidelines natin kung ano ‘yong mga gamot na gagamutin sa mga pasyenteng may COVID-19 kaya naman po ngayon napakababa ng mortality rate natin ‘no, less than two percent kasi sinusunod po ‘yong mga guidelines nitong mga espesyalista po natin na ito,” he said.
-“Passionate testimonials” on alleged “wonder drug” being assessed vs clinical trial evidence-
The FDA chief said that this group of experts is closely monitoring and studying clinical trials all over the world about Ivermectin use to treat COVID-19 in humans, amid claims that it “works wonders” and other “passionate testimonials” on its effectiveness against the COVID-19 virus.
“So lahat po ng gamot na under investigation tinitingnan po nila lahat ng mga clinical trials all over the world tapos magbibigay po sila ng rekomendasyon. So ito po ‘yong rekomendasyon nila sa pag-aaral nila sa Ivermectin kasi po marami talagang maliliit na mga trials at marami pong nagke-claim na talagang it really works wonders ‘no at saka na talaga pong may mga testimonial and very passionate po ang mga tao,” he said.
-Experts’ group meeting weekly since February-
Domingo said that the Philippine investigation is being done in a “very scientific” manner.
“Pero ito po very ano po ito very scientific. Tsinetsek po nila lahat ng mga studies nitong ating Living Clinical Practice Guidelines Group. ‘Pag hindi po maganda ‘yong design ng isang study, hindi isasama ‘yon; kapag maganda naman ay titingnan ang resulta nito.” he said.
He said that from February, this group of experts have been meeting weekly and studying the clinical trials outside the country about Ivermectin. He said so far, the group found 11 good clinical trials.
“So from February unti now, tuloy-tuloy po ‘yan every week nagmi-meeting po sila. Ang tinitingnan po nila ‘yong magagandang clinical trial about Ivermectin; and in this case, nakahanap po sila ng magandang 11 clinical trials.”
-Drug of choice for parasites-
Domingo explained that Ivermectin is a “drug of choice for parasites” and has been in use for the past 40 years both for animals and humans.
“So iyong Ivermectin po, isang antiparasitic, it’s a drug of choice for parasites, ito po ‘yong mga Strongyloidiasis, Onchocerciasis, sa mga bulate katulad po ng Ascaris, Trichuris, at saka sa ano pati po sa kuto ganyan po,” he said.
Domingo also explained its side-effects if used in large doses and for long periods, including fever, liver damage, pulmonary damage, and neurologic and brain damage. He said that this is why they are very careful in assessing the drug.
“So bagamat safe naman po siya na gamot at marami na pong ginagamit nito for the past 40 years for animals and humans pero may mga side effect din po siya ‘no katulad po ng ‘pag sobrang taas po ‘yong mga dose ay mayroong nilalagnat, mayroong tinatamaan ang atay, mayroon pong magkaka-pulmonary problem including neurologic and brain damage kaya medyo maingat lang po tayo dahil mayroon din pong side effects,” he told the President.
-First Ivermectin study in relation to COVID in April 2020-
He also explained to President Duterte how studies on the use of Ivermectin to treat COVID-19 came about. He said that this was way back April 2020 when a group of scientists from Australia tried to use Ivermectin, injecting it in cells taken from monkeys that had the COVID-19 virus. He said the scientists there observed that the virus died “within 24 to 48 hours.”
“Now, what does it have to do with COVID-19? Paano po ba nag-umpisa ito? Noon po kasing April 2020, noon pong nagsa-start ang COVID-19 at na-isolate ‘yong virus, may isang mga grupo po ng mga scientist sa Australia, kumuha sila ng cells galing sa unggoy, nilagyan nila ng virus ng COVID-19, pagkatapos nilagyan po nila nang mataas na mataas na dose nito pong Ivermectin ‘no, higher than the usual dose na ginagamit na kontra bulate. Pagkatapos po nakita nila na within 24 to 48 hours namatay po ‘yong mga COVID virus,” Domingo explained to President Duterte.
He said that this eventually led to human clinical trials of Ivermectin in relation to COVID-19.
“Of course ang ano naman po nila, ang kanilang naging conclusion doon is that we need to study in humans and to check kung paano po ang magiging effect nito kaya nagkaroon po nang maraming pag-aaral. Pero hanggang ngayon po sa Australia, hindi pa rin po ito approved na gamot para sa COVID-19 ‘no. Inaaral pa po talaga kung mayroon siyang effect sa COVID-19 kasi hindi naman nga po siya antiviral drug,” he said.
(Eagle News Service)
