President Rodrigo Duterte has personally ordered the government to hold clinical trials for the use of controversial drug Ivermectin to treat coronavirus patients, the Food and Drug Administration (FDA) said Tuesday.
FDA director general Eric Domingo disclosed the President’s order in a televised briefing, a day after the Department of Science and Technology (DOST) announced that it was preparing to conduct trials for the anti-parasitic drug.
Duterte’s order overturned the previous stance of the DOST — along with the Department of Health — that a local trial was not needed since over 40 global studies on the drug’s efficacy and safety for Covid-19 patients were being conducted so far.
“In our meeting last Thursday, the President himself ordered us to do such. The DOST will start clinical trials and they are preparing its design,” Domingo told reporters.
“He has heard that many people support it, while several other scientists say available evidence remains insufficient to back their claims,” the official added.
Domingo’s disclosure came as he denied that the government’s decision to hold Ivermectin clinical trials was driven by pressure from some doctors and private groups advocating its use.
“The President probably wants to try it for Filipinos so he asked the DOST to look into it,” he said.
During the President’s weekly public address aired Monday night, Science and Technology Secretary Fortunato Dela Peña said local trials would give a “reliable estimate” on Ivermectin’s effect as an antiviral agent to “reduce virus shedding of mild and moderate patients.”
He also announced that a doctor from the Philippine General Hospital (PGH) has been chosen to lead the clinical trials, which may run for up to eight months in at least six quarantine centers near the state-run hospital.
The clinical trials would note how Ivermectin reduces symptoms or length of hospital admission among trial participants compared to other treatments being used.
The FDA has so far granted two hospitals a special permit to use Ivermectin for select Covid-19 patients, acknowledging there was some “pressure” to approve it.
The permit was not a license for commercial use and large-scale distribution nor an FDA’s endorsement on the drug’s safety and efficacy.
Ivermectin products commercially available in the country are limited to treating parasitic ailment of animals and are in the form of a topical cream for skin application.
The World Health Organization, the United States FDA, the European Medicine Agency, and even Ivermectin manufacturer, Merck, all said there is lack of data and evidence on its efficacy and benefits for Covid-19 prevention and treatment.
Health experts have also expressed concern over the drug’s risks and potential side effects such as hypotension or low blood pressure, allergic reactions, seizures, coma, and even death.