Lawmakers on Monday, May 17, questioned how health experts in the Philippines came up with their recommendation on the use of anti-parasitic drug ivermectin for COVID-19 treatment, after the experts said that there was no sufficient evidence for its efficacy.

In the House committee on good government hearing on alleged red tape in the process of the Food and Drug Administration (FDA) and the Department of Health (DOH) on experimental drugs, Deputy House Speaker Bernadatte Herrera-Dy asked the members of the Philippine COVID-19 Living Clinical Practice Guideline (CPG) Reviewers what criteria the group used in choosing which studies to include in assessing ivermectin for COVID-19 treatment.

“Sino ba ang nag de-decide ng titingnan na foreign clinical trials (Who decides on which foreign clinical trials to look into)? Who decides? Paano po ba ang treatment natin sa (How do you treat the) clinical trials?” Herrera-Dy asked.

Dr. Leonila Dans of Living CPG, composed of 20 medical societies in the Philippines, replied that the group based its recommendations on 18 carefully reviewed randomized clinical trials, as well as published meta-analyses. They had reported that there was “no sufficient evidence to use ivermectin for mild to moderate COVID-19 [cases] except in the context of clinical trials.”

Dans said that while there have been a lot of studies on the use of ivermectin as a COVID-19 treatment, some of them were “just Powerpoint presentations.”

“They are not really published. We appraise the quality of the evidence. We don’t just include all available studies. We have to choose. [We] have a very strict eligibility criteria,” she said.

But Herrera-Dy seemed unconvinced and asked why the health experts were, in that case, also not against the use of remdesivir, another experimental drug for treating COVID-19.

“Doon nga po ako nagtataka; same level sila ng ivermectin. Pero sa ivermectin, lahat ng societies nagsabi na bawal ireseta ‘yan. Pero sa remdesivir, halos lahat ng hospital ginagamit yan,” she said. (READ: DOH: Remdesivir in PH used under hospitals’ limited permits)

(That’s what I’m wondering; remdesivir is on the same level as ivermectin. But while all societies ban ivermectin from being prescribed, virtually all hospitals use remdesivir.)

Dr. Marissa Alejandria, also from Living CPG, replied that remdesivir is being used for hospitalized patients alongside other drugs, and that there has been evidence to prove this reduces the hospital stay of COVID-19 patients.

“There have been four big clinical trials done. There were trials that showed benefits in terms of clinical improvement, that it reduces hospital stay,” she said.

Alejandria also told lawmakers that evidence is evolving, so their recommendations on experimental drugs are also constantly updated as new studies come in. “That’s the concept of a living CPG. We update as the evidence evolves.”

Prescribing ivermectin as off-label

In the same hearing, Anakalusagan Representative Mike Defensor also questioned the Philippine Medical Association’s (PMA) statement on ivermectin, which recommends its member doctors against prescribing the drug for COVID-19 treatment outside of hospitals with compassionate special permits.

Defensor, who is not a health professional, asked why the PMA made this recommendation, even though the drug has now been registered in the country as a human-grade anti-nematode. Nematodes are parasitic roundworms that could infect humans.

“Kung ang gamot, halimbawa ivermectin, ay registered for parasite at sinabi ‘nyo po na ang gamot ay bibigay niyo for another disease, hindi po maganda ‘yan,” Dr. Leo Olarte of PMA said. (If a drug, for instance ivermectin, is registered for parasitic use, but you say you want to prescribe it for another disease, that’s not good.)

“If a doctor doesn’t follow the labeling of the medicine – ivermectin, for instance, which is labeled for parasites – and prescribe it for off-label use for COVID-19, that is unethical,” he added in a mix of English and Filipino.

Defensor, together with SAGIP Representative Rodante Marcoleta, led a distribution of ivermectin in Quezon City in April, which was met with criticism due to “invalid prescriptions.” Both have been advocating for the use of ivermectin as COVID-19 treatment despite warnings from experts here and abroad.

As experimental treatment for COVID-19, oral ivermectin is allowed by the FDA only in two instances: if the medical facility dispensing the drug has secured a compassionate special permit, or if a doctor has prescribed it and the drug is compounded by a pharmacist according to the prescription.

There is an ongoing public debate over the use of ivermectin to treat COVID-19. Some doctors recommend it, and some patients share how it had been beneficial to them. Other medical experts, meanwhile, issue stern warnings against its use in treating the deadly disease.

Amid the debates, President Rodrigo Duterte ordered the Department of Science and Technology (DOST) and DOH to study the use of ivermectin as a possible treatment against COVID-19. He gave the order a week after the DOST itself said there was no need for local studies, as there were ongoing trials abroad whose results could inform decisions in the Philippines.

Other things discussed

The hearing, which ran for over 5 hours, also discussed the alleged red tape within the DOH and FDA. Anti-Red Tape Authority (ARTA) Director General Jeremiah Belgica said that FDA has not acted on 413 renewals of product registrations, and added that ARTA has issued a show cause order to the regulatory agency. FDA chief Eric Domingo was not present in the hearing as he is on leave for a month.

Meanwhile, the House panel also warned DOH Secretary Francisco Duque III that he would be cited in contempt if he continues to skip its probe into the government’s response to the pandemic. (READ: House panel warns Duque of contempt over ‘continued absence’)

Lawmakers also approved a motion to write a letter to the Professional Regulation Commission (PRC) and the Office of the President (OP) to stop the probe into Defensor and Marcoleta’s alleged illegal distribution of ivermectin in Quezon City. – Rappler.com