TWO party-list lawmakers yesterday pushed through with the distribution of the antiparasitic drug ivermectin in Quezon City despite legal and medical questions surrounding its use supposedly for the prevention and treatment of COVID-19.
The “Ivermectin Pan-three” project was launched by Reps. Michael Defensor (Anakalusugan) and Rodante Marcoleta (Sagip) together with the firm Lifecore Bio-Integrative Inc. and the groups Concerned Doctors and Citizens-PH and Malayang Quezon City.
Several physicians issued prescriptions to about 35 individuals who showed up up at the distribution area at the barangay hall of Barangay Matandang Balara, one of the areas with the most COVID-19 infections.
A photo showed one the supposed prescriptions written on a piece of paper which did not have the doctor’s license and PTR (professional tax receipt) numbers.
Marcoleta said Defensor feared they would be arrested.
“Kagabi tumawag si Mike (Defensor) ang sabi baka bukas ng umaga dakpin tayo dahil wala raw tayong lisensiya. E ano naman kako diprensiya nun, dalawa naman tayo makukulong?
Palagay ko si Cong. Bingbong sasama naman sa amin sa kulungan; sanay naman na yan e (Last night, Mike called saying we could be arrested because we don’t have a license. I said, what’s wrong with that when both of us will be jailed. I think, Cong. Bingbong will also join us in jail because he’s used to it),” Marcoleta said in jest, referring to former Rep. Vincent Crisologo who attended the event with his son, Rep. Anthony Peter “Onyx” Crisologo.
The launching came amid repeated warnings from the Department of Health and the Food and Drug Administration on the lack of evidence that the anti-parasitic drug can be used against COVID-19. The World Health Organization last month recommended against using the drug for COVID-19 patients except in clinical trials, because of a lack of data to show its benefits.
The Philippine Society for Microbiology and Infectious Diseases (PSMID) yesterday said there is still no sufficient evidence to show ivermectin is effective against COVID.
“Among high-quality studies, there are no benefits in terms of reduction of mortality, clinical improvements. The lower-quality studies are the ones showing potential benefits.
However, the trials are small, and the quality of implementation of trials have some risk of bias,” said PSMID president Dr. Marissa Alejandria.
Justice Secretary Menardo Guevarra said the Department of Justice will look into the legal basis of the exemptions made by the FDA on the on the use of the controversial drug.
The Department of Health and FDA are split on whether the distribution is legal. On Wednesday, Health Undersecretary Maria Rosario Vergeire said only hospitals which have been issued a compassionate special permit by the FDA can use and distribute the drug, while FDA Director General Eric Domingo said physicians who will be present at the event can prescribe the drug to patients, “and they can get the drug from compounding pharmacies that are licensed by the FDA.”
Also on Wednesday, Defensor said the project is “legally compliant” and vowed to legally challenge the FDA if it will stop the distribution.
Defensor, at the event, said the drug will help individuals recover from COVID-19 or prevent them from getting the disease.
“Preventive, it’s 90 percent, for treatment almost 80 percent,” he said.
The prescriptions were issued by physicians Allan Landrito, Iggy Agbayani, Noel Castillo and Sham Quinto who also gave free consultations to those who showed up and were asked to sign forms by barangay officials before attending the event.
Marcoleta said he and Defensor and the other organizers of the event pushed through with the distribution even if they are being accused of promoting the drug.
Since the country is at war against COVID-19, he said, the people should be allowed to choose and take the medicine of their choice.
Agbayani, president of the Concerned Doctors and Citizens of the Philippines, said humans can take ivermectin because humans are also animals by specie.
Most of the ivermectin drugs registered with the FDA are for veterinary use.
“Sabi nila (FDA) para sa hayop, e di ba hayop naman talaga tayo (They say it’s for animals but we, too, are really animals),” he said. “Ang gamot ay gamot… san ka pa makakakita ng gamot na napakamura, napakabisa? (A medicine is a medicine… where will you find a drug that is cheap and effective?).”
Agbayani also said that in Peru, COVID cases significantly went down in September last year after the government distributed ivermectin, and rose again by November when the its president stopped it.
PSMID’s Alejandria reminded the public that there is no one “magic pill” that can trump COVID-19.
“Ivermectin is just one drug. There are other drugs that are already tried in big trials. The management of COVID-19 is not like one drug will heal the COVID-19 virus,” she said.
Guevarra said while the FDA law punishes the importation, sale, distribution or administration of unregistered drugs or vaccines, and that Ivermectin is not registered as a drug against COVID-19 and as such its distribution would appear to violate the FDA law, Domingo also cited two exemptions for its use on humans.
These exemptions, according to Guevarra as earlier announced by Domingo, are when its use is covered by a compassionate special permit, which are issued to specific hospitals, doctors or other entities, and when ivermectin is compounded by duly-licensed pharmacies and supported by doctor’s prescription.
“If Representative Defensor and Representative Marcoleta’s act of distributing ivermectin would fall under any of these two situations, it would appear that they can put these up as defense just in case a complaint is filed against them,” he said.
But Guevarra said he is not sure about the legal basis of the FDA ruling.
“Personally, I am not too sure whether these two exemptions cited by the FDA director general have a sound legal basis so that is something for future study,” Guevarra said. — With Noel Talacay, Gerard Naval and Ashzel Hachero
