THE Food and Drug Administration and the Department of Health yesterday vowed to hold accountable individuals or groups behind the controversial distribution of the anti-parasitic drug ivermectin as COVID-19) medication, in Quezon City last week.
In separate briefings, Health Undersecretary Maria Rosario Vergeire and FDA Director General Eric Domingo assured the public that all those who violated laws and regulations will be held liable.
“We will act accordingly, according to existing laws that we have, according to identified violations, according to accountable persons. That is what we will do. We are on to that position and direction to uphold what is provided for by the law,” Vergeire said.
“We treat each report we receive as a complaint that we have to investigate. Our regulatory enforcement unit is already investigating these complaints. There is due process that we have to follow and we will act accordingly based on the findings,” said Domingo.
The FDA has given only five hospitals compassionate special permits (CSPs) to use human-grade ivermectin for the treatment of COVID-19 patients.
Vergeire said the DOH is prepared to include in the investigation everyone involved in the controversial event organized by Anakalusugan party-list Rep. Mike Defensor and deputy speaker Rodante Marcoleta (PL, Sagip).
As of the moment, she said, the DOH has coordinated with the Professional Regulation Commission to look into the actions of physicians who supposedly provided questionable prescriptions to the public during the distribution held last Thursday.
“We gave them (PRC) anecdotes and reports we have received regarding these invalid prescriptions. We would like to know their opinion on the practice of profession by those healthcare workers who joined the event,” said Vergeire.
Domingo said the FDA investigation will focus on the process involving the drug products distributed during the event.
In particular, he said, the agency’s regulatory enforcement unit will look into the process of manufacturing and dispensing of the ivermectin products by the partner compounding pharmacy of the event.
“We will look into their process during the said event, if they followed the regulations, if they are licensed manufacturers and distributors, were there violations. If so, there will be appropriate sanctions and penalties,” said Domingo.
Last week, Defensor and Marcoleta launched the “Ivermectin Pan-three” in Quezon City through which they provided ivermectin capsules to several individuals who went to the event.
The project was launched despite numerous statements from the DOH, FDA, the World Health Organization, and other medical organizations on the lack of adequate scientific evidence to prove the efficacy and safety of ivermectin against COVID-19.
During the event, the beneficiaries were issued prescriptions that had no name, office address, professional regulation number, and professional tax receipt number of the prescribing physicians.
Still, the QC residents were able to get 10 capsules of ivermectin during the event from Lifecore Bio-Integrative Inc.
Marcoleta said the FDA’s stubbornness as what led to their ivermectin distribution.
“The FDA and DOH are free to do anything they want. That is what they do best. But before they could pass judgment on the `Ivermectin Pan-Three’ in QC, they should have first asked themselves this basic and simple question: Why did that event in Matandang Balara, Quezon City happen in the first place?” Marcoleta said.
Defensor said his group is still distributing free ivermectin in Quezon City even amid the FDA probe: “Style tulak kami ngayon (We’re like illegal drug pushers now).”
Marcoleta said the FDA and the DOH had “failed to grasp” the event’s message which is “helping people at the time when the very people tasked to do it are hesitating and dillydallying.”
Marcoleta said the time to act fast and decisively is wasted by the government agencies’ “complacency and indecision,” refusing to “improvise and be flexible and chose to stick to peacetime guidelines that do not apply in a war-like pandemic that we are all in.”
A veteran lawyer, Marcoleta stressed it is still the state’s policy to “protect and promote the right to health of the people and instill health consciousness among them” including the mandate to “adopt an integrated and comprehensive approach to health development which shall endeavor to make essential goods, health services available to all the people at affordable cost”.
“Don’t you think the FDA and DOH officials should have been the first to show up at the Ivermectin Pan-Three in Matandang Balara the other day instead of myself and Cong. Mike Defensor? In fact, instead of raising a howl to probe the event, they should have been behind that symbolic act, or could have done it way ahead in time before our group managed to do it, is it not,” he said.
Marcoleta challenged the FDA and DOH to explain the “medical justification” for allowing the “wide use” of remdesivir, an expensive anti-viral drug which costs a patient P16,000 to P48,000 per shot, “despite WHO’s advisory against its use.”
“Why can’t they allow Ivermectin–the poor man’s drug that only costs P35 per capsule?” he said.
The Department of Science and Technology-Philippine Council for Health Research and Development (DOST-PCHRD) expects results of clinical trial and analysis on ivermectin to be completed by the first quarter of 2022 or as early as January next year.
Speaking at the public briefing “Laging Handa,” DOST-PCHRD executive director Jaime Montoya said barring unforeseen last-minute hitches, the collection of information on a controlled group of volunteers should be done before 2021 ends.
That would leave only the analysis of the collected data, which he said can be released early the following year.
Montoya said the research team will be headed by a panel of experts from the University of the Philippines-Manila whose first job is to come up with a research protocol for submission to the DOST-PCHRD and the Food and Drugs Administration.
He said the research protocol defines the parameters of the study — the methods, the venue, the scope, and which segment of the population will be covered.
There is a chance that the clinical trials can be fast tracked to get the result earlier than projected but Montoya said this would depend on how many will be willing to participate.
He said the DOST-PCHRD is eyeing the quarantine facilities of the Philippine Red Cross as an ideal venue provided the NGO agrees to take part.
Montoya stressed the importance of full disclosure to potential volunteers as to what their participation in the clinical trials will entail. — With Wendell Vigilia and Peter Tabingo
