MALACAÑANG has given the go signal to the Department of Science and Technology (DOST) to commence clinical trials to determine the potential of the controversial animal deworming drug to cure COVID-19 infections.
According to Food and Drug Administration (FDA) director-general Eric Domingo, no less than President Rodrigo Duterte personally issued the order to the DOST, which has the mandate to undertake the procedure.
Previously, the DOST and the Department of Health (DOH) stood firm on their position — that a local trial is no longer needed, citing over 40 global studies on the drug’s efficacy and safety for COVID-infected patients.
“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. He has heard that many people support it, while several other scientists say available evidence remains insufficient to back their claims,” Domingo said.
He also warded off claims that the government’s decision to hold Ivermectin clinical trials was out of 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, DOST 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.”
A doctor from the Philippine General Hospital (PGH) was also given the marching order 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.
Interestingly, the FDA has granted two hospitals a special permit to use Ivermectin for select COVID-19 patients, but reiterated that the permit is neither a license for commercial use and large-scale distribution nor an endorsement by the FDA on the drug’s safety and efficacy.
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.