Clinical trials on use of Ivermectin ‘welcome development’: solon

MANILA – Deputy Speaker Bernadette Herrera on Tuesday lauded the government’s decision to hold clinical trials on the use of the anti-parasitic drug Ivermectin to find treatments for the coronavirus disease (Covid-19).

During the Laging Handa public briefing, Herrera said while the conduct of clinical trials to evaluate the use of Ivermectin as Covid-19 remedy is a welcome development, she emphasized the need to make the drug available in the market as soon as possible.

“Of course, it’s a welcome development but how long will a clinical trial be? There are local or foreign clinical trials and there are foreign clinical trials that can be taken a look. At marami naman tayong foreign clinical trials na puwede nating gamiting basis (We have a lot of foreign clinical trials that can be used as basis),” she said. “Iba kasi iyong available na siya sa market (It would be different if it is already available in the market).”

Herrera said she is pushing for a congressional inquiry into the policies and guidelines of the Department of Health (DOH) and the Food and Drug Administration (FDA) for the registration, utilization, manufacture, distribution or sale of drug products for Covid-19.

“While there is no actual cure for Covid-19, health, drug and medical experts have come up with a treatment protocol including the administration of certain drugs and therapeutics currently allowed for use and treatment of Covid-19,” Herrera said in filing House Resolution 1711 together with Speaker Lord Allan Velasco.

Herrera and Velasco particularly cited DOH Department Memorandum No. 2020-0138, which adopts clinical practice guidelines on Covid-19; and FDA Circular No. 2020-12, which provides for the guidelines for the registration of drug products under emergency use for Covid-19.

They said the FDA Circular and other related guidelines have been questioned for being “arbitrary, bureaucratic, and inhumane for causing unnecessary delays in the approval and clearance of drugs and therapeutics for emergency use authorization or for use of drugs under compassionate special permit against the dreaded Covid-19 disease.”

Herrera suggested the possibility of applying the drug for authorization related to Covid-19 treatment in FDA, considering that it has already granted compassionate special permit for a hospital’s use of Ivermectin.

“Ang sa akin (For me), if you allow prescription, why not make it available in the market?” Herrera said.

In a taped meeting with President Rodrigo Duterte aired late Monday, Department of Science and Technology (DOST) Secretary Fortunato de la Peña said the clinical trial may take around six months but this could be shorter if there would be many volunteers.

De la Peña said he and Health Secretary Francisco Duque III decided to hold the clinical trials and are eyeing the quarantine centers near the Philippine General Hospital (PGH) as a venue.

Earlier, the DOST issued a statement saying there is no need to do a clinical trial on the use of Ivermectin for Covid-19 in the country since there are completed and ongoing clinical trials exploring the use of Ivermectin formulations against Covid-19 globally.

The Department of Health (DOH) has allocated a fund for the clinical trials to be led by Dr. Aileen Wang of the University of the Philippines-Manila.

“At hopefully po ay ‘pag natapos ‘yong trial na ‘yan ay magkaroon tayo ng mas reliable estimates ng epekto ng Ivermectin bilang isang anti-viral agent at na makapag reduce po nung virus shedding sa mga mild at moderate patients. At makikita natin ang epekto ng Ivermectin doon sa haba ng hospitalization nung iba (Hopefully after the clinical trial, we would have reliable estimates of the effects of Ivermectin as an anti-viral agent that could reduce virus shedding among mild to moderate patients. We hope to see the influence of Ivermectin on the hospital stay of patients),” de la Peña said.