Growing demands for the use of ivermectin in the Philippines as a low cost treatment for COVID-19 continues to drive a wedge in society between those that believe there isn’t sufficient data, necessitating more research, and individuals that suspect the pharmaceutical sector are actively thwarting the movement to use the anti-parasitic drug. Just recently, the Philippines Senate President Vicente Sotto III apparently showed his point of view following in the latter camp as he openly pondered what’s behind the growing resistance not to use the drug, aligning with a movement associated with the positive results of over 50 clinical trials, as well as the declarations by the health regulators of a number of countries that have actually approved its use for COVID-19, including Slovakia, Macedonia, and even the Czech Republic on a limited compassionate basis along with South Africa. While six hospitals have now been given access to the drug via a compassionate use process in this southeastern Asian nation, a majority of the medical establishment appears concerned about use of the drug following a World Health Organization (WHO) declaration that existing data is “inconclusive” and thus should only be used in a research context. Consequently, president Rodrigo Duterte himself ordered a large ivermectin clinical trial to start next month. Sponsored by the Philippines Department of Science and Technology, the president expressed his opinion that he hopes the trial proves its worth against the pandemic. Nearly a half-million dollars were allocated for the 1,200-patient study to be led by Dr. Aileen David Wang at the University of Philippines, Philippines General Hospital.
TrialSite recently reported that the economic divide of this developing nation naturally accentuated the growing divisions around ivermectin. While remdesivir is promoted as the preferred treatment, few can afford access. But reports out of this country that not just the poor but other segments, including apparently the President of the Senate, increasingly promote ivermectin but in most cases are denied access. The country’s Food and Drug Administration (FDA) went on the record via Director General Eric Domingo, declaring that the agency was neither for nor against the drug and that the public should listen to the experts and await clinical trials.
Philippines FDA Warning
In a recent interview captured in a Philippines Senate interview, Senate President Sotto has a more paranoid view of the FDA here, not certain of the regulator’s neutrality in the matter, declaring, “There are countries that have approved this. There are countries that use it, there are doctors who recommend it. It used to be on the FDA formulary; I don’t know why it was removed.” He continued, “There is an ivermectin for human consumption and yet they insist that it is for animals.”
Sotto refers to a Philippines FDA declaration, similar to the U.S. FDA warning: the recently issued Advisory No. 2021-0526 perhaps as a way to dissuade the population from considering.
The Philippines FDA cautionary note seems straight forward, an apparent attempt to warn people there against the use of humans using ivermectin products approved for animals.
But in Sotto’s interview, a conspiratorial tone emerged when he noted in Tagalog, “Is it possible that there are some who are trying to block its use because big pharmaceutical companies have different possible COVID-19 treatments which are very expensive if you compare it with ivermectin which is very affordable.”
As it turns out, Sotto himself is taking ivermectin as a prophylaxis and suggested that the southeast Asian island nation regulatory body consider testimonies of the people taking the drug, such as himself. He reports that he has been using the drug for several weeks with no issues and openly wonders why the regulators seem to single its use out.
The Big Ivermectin Trial
President Duterte sought to use research to determine for certain whether there is efficacy and safety associated with the drug. Ordering the DOST to launch the study, Science Secretary Fortunato De La Pena shared in a report to the President just on Wednesday that the DOH allocated just under a half million U.S. dollars for the large clinical trial, which commences in June and will last from six to eight months.
Led by Dr. Aileen Wang of the University of the Philippines-Philippine General Hospital, the study will involve 1,200 volunteers who are at least 18 and up—those that are asymptomatic and non-severe, that is, mild-to-moderate early onset COVID-19 cases, reported the Manila Times.
Lead Research/Investigator for National Ivermectin trial
Dr. Aileen David Wang, University of the Philippines-Philippine General Hospital
Call to Action: TrialSite will monitor this site with a keen interest on protocol, dosage, and whether this compares with some of the other studies.