MANILA, Philippines — The Department of Health (DOH) on Wednesday reiterated that only hospitals that had been granted special permits could use the veterinary antiparasitic drug ivermectin on COVID-19 patients.
The DOH issued the public reminder following reports that two Quezon City congressmen who had been promoting ivermectin as a COVID-19 treatment were intent on distributing the drug for free among their constituents on Thursday.
One of the lawmakers, Anakalusugan Rep. Mike Defensor, even threatened to hale the Food and Drug Administration (FDA) to court if it stops him and his colleague, Deputy Speaker Rodante Marcoleta, from giving away the unregistered drug to the residents.
Health Undersecretary Maria Rosario Vergeire stressed that only hospitals that had been granted a compassionate special permit (CSP) could use human-grade ivermectin as a form of treatment for COVID-19.
So far, only five hospitals had been granted a CSP for the drug. FDA Director General Eric Domingo earlier explained that these hospitals could use it only on “specific patients for a set time.’’
“Aside from these hospitals that were given CSPs, no one else can distribute the drug since, as we have said, it is not registered,” Vergeire said in an online briefing.
Low quality of evidence
The quality of available evidence on the effectiveness of ivermectin for such use remained “very low,’’ Vergeire added, citing a paper — Living Clinical Practice Guidelines (in treating COVID-19) — prepared by experts around the country.
“There is also a suggestion against the use of ivermectin for the treatment of patients with severe COVID-19. This is a conditional recommendation from [the experts] because of the very low quality of evidence found across the globe,” she said.
Another health undersecretary, Leopoldo Vega, echoed Vergeire’s concerns, saying ivermectin was still considered an “investigational and experimental drug” for Covid-19 treatment. He said the public should wait for the results of clinical trials being conducted around the world.
“Not unless we see the final scientific data… can we clearly say that it is safe and effective or it can also be harmful,” Vega said in a television interview.
Unfit for human use
The permit issued by the FDA was “coursed through hospitals,’’ he said, therefore the drug should be administered only in an “institution’’ or hospital setting.
“In other words, it is not fit for any kind of human consumption, not unless the drug suppliers submit the [certificate of product registration or CPR] to the FDA so it can be cleared and specified whether this is for human use or animal use,” Vega said.
“That’s the only way that this can be marketed to the different constituents,” he added. According to Domingo, the FDA chief, at least two companies have applied for a CPR for human-grade or human-edible ivermectin.
Defensor and Marcoleta on Wednesday announced plans to distribute what they maintain to be human-grade ivermectin—at three tablets per person—at Matandang Balara Barangay Hall Park inside Villa Beatriz Subdivision, Quezon City, this morning.
“I will fight them (FDA) in court. If they will again stop this initiative, I will fight them in court,” Defensor said in an online briefing when asked about the possibility of the drug regulator stopping the distribution.
The party list lawmaker earlier said “those who are in dire need” of ivermectin would be given a doctor’s prescription from the group Concerned Doctors and Citizens of the Philippines.
He insisted that the distribution of the drug was “legally compliant.”
“I know I would not be violating any law, unless they tell me otherwise,’’ said Defensor, who tried to make his case during an inquiry on the issue conducted last month by the House committee on health.
‘’As far as I’m concerned, based on the two committee hearings … a licensed compounding laboratory is allowed to produce with a doctor’s prescription,” he said.
Invited to the House hearing, Dr. Rabindra Abeyasinghe, the World Health Organization representative to the country, said advocates of ivermectin were giving “false confidence” to the public.
There is still no strong evidence that the drug can treat COVID-19, the WHO official said.