The Department of Health (DoH) is standing firm on its decision to deny the use of ivermectin to treat patients with the coronavirus disease 2019 (Covid-19).
“Based on the current evidence from randomized control trials, we do not recommend the use of ivermectin for the treatment of Covid-19. It has not been proven to significantly reduce mortality or improve other clinical outcomes. This recommendation will be updated as more evidence is generated from ongoing trials,” Health Undersecretary Maria Rosario Clarissa Singh-Vergeire said in a statement.
To recall, the Anti-Red Tape Authority (ARTA) is urged the Food and Drug Administration (FDA) to expedite its processing of applications for the use of Ivermectin, an anti-parasitic drug undergoing trials for possible treatment of Covid-19 symptoms.
This, after the FDA announced earlier Monday that doctors and hospitals may now apply for a Compassionate Special Permit (CSP). The CSP allows for the registration of food and drugs for applicants that will be able to provide a License to Operate, a Certificate of Product Registration, a Letter of Intent with undertaking to take full responsibility, and other requirements.
“With this directive, FDA needs to be clear with their timelines and come up with a fixed list of requirements in accordance with their submitted Citizen’s Charter,” ARTA Director General Jeremiah Belgica said, noting that the regulatory body for food and drugs shall only take three working days to act on requests for CSPs based on its updated Citizen’s Charter.
The FDA is an agency under the DOH.
However, even the World Health Organization (WHO) Representative to the Philippines Dr. Rabindra Abeyasinghe, in a virtual meeting with the House of Representatives’ Committee on Health, said there was the insufficient data on the efficacy and safety of ivermectin against Covid -19.
“The issue with ivermectin is that based on that initial study and the currently available data, it is not strong enough for us to advocate the use of ivermectin for treatment of Covid or prevention of Covid,” Abeyasinghe said.
Vergeire said proponents of ivermectin can apply for a formal clinical trial so that the DoH can evaluate its efficacy and give recommendations.
“We are open to helping these proponents of ivermectin to do a clinical trial so that there is evidence that it will be safe and effective against Covid-19,” Vergeire added.
Meanwhile, Dr. Allan Landrito, said that he has dispensed doses of the ivermectin to more than 8,000 patients with little side effects.