CLINICAL TRIALS In Cali, Colombia, in July 2020, a health worker shows a bottle of ivermectin that is being used to treat mild or asymptomatic COVID-19 patients in clinical trials to determine safety and efficacy. —AFP
In what appeared as a turnaround on its previous stance, the Food and Drug Administration (FDA) on Thursday granted a compassionate special permit for a hospital’s use of the drug ivermectin for COVID-19 patients.
FDA Director General Eric Domingo said the drug is now the subject of clinical trials to check its efficacy. “Ivermectin is an investigational product and we know that there are ongoing clinical trials on its use for COVID-19,” he said at Malacanang’s Laging Handa briefing.
Domingo cited patient privacy in refusing to disclose the name of the hospital that had applied for the compassionate use permit.
“The attending physician takes full responsibility for the use of the product,” he said in a Viber message.
A number of physicians have been advocating the use of pharmaceutical-grade (or USP-grade) ivermectin for the prevention and treatment of COVID-19 that is seeing an unprecedented spike in the country.
But the Department of Health (DOH) and the FDA had been quick to shut down this option, saying there was lack of studies to prove that its use cut mortality rates or improved “other clinically important outcomes.”
Still, heads of business groups and other organizations recently issued an open letter to President Duterte and the leaders of Congress, calling for “serious, urgent and immediate attention to ivermectin as an inexpensive drug to prevent and treat COVID-19 during this public health crisis.”
For unregistered drugs
A compassionate special permit is granted for the use of drugs that are not registered or are still in the process of registration in the country.
Domingo said that the FDA had also received two applications for a certificate of product registration for ivermectin, and that it had given the applicants a list of requirements to support their application.
“The FDA has always said it is not against ivermectin,” he said. “But the product has to be registered and undergo the proper process to ensure the quality of the drug that would be given to the public.”
At present, the ivermectin products registered in the Philippines are for veterinary use.
Dr. Jacinto Blas Mantaring, chair of the Department of Clinical Epidemiology of the University of the Philippines’ College of Medicine, said in a forum that there is a need for a clinical trial on the use of ivermectin on COVID-19 patients.
Speaking at the online forum hosted by the Philippine-American Academy of Science and Engineering (PAASE), Mantaring said he studied the results of 11 trials and saw no evidence to suggest the drug’s effectiveness in treatment and prevention.
‘Wait for trial results’
At the same PAASE forum conducted online on March 31, Dr. Benigno Agbayani, president of the Concerned Doctors and Citizens of the Philippines, said that with the emergency situation gripping the country, ivermectin should be given due consideration.
Agbayani said the drug fills the “void” resulting from the slow rollout of the Philippines’ COVID-19 vaccination drive.
But in a radio interview on Thursday, the Philippine Council for Health Research and Development (PCHRD) of the Department of Science and Technology said it would be prudent to wait for results of clinical studies being conducted in other countries on ivermectin’s efficacy and safety.
“We are open to any possible drugs that could be used for COVID-19. We know that we need drugs that will help ease the suffering of our COVID-19 patients,” said Dr. Jaime Montoya, PCHRD executive director.
The council is the lead agency for health research and development in the country. It is tasked to oversee all clinical trials, including those for vaccines and drugs against COVID-19 and its complications.
“We believe that we must wait for the results of the studies being conducted by different countries on ivermectin … and we can determine if it is useful,” Montoya said, adding:
“If it is useful, I’m sure the FDA will look into this with a favorable outcome so that it can be approved [either for emergency or for general use].”
According to the Philippine Health Research Registry, there is an ongoing clinical trial of Unilab Laboratories Inc. in Mandaluyong City on the use of topical ivermectin for treatment of head lice infestation among Filipino children.
The trial started in 2017 and is currently in Phase 2.
Clinical trials on USP-grade ivermectin are being conducted in Japan, the United States and Europe.
Fighting chance
In the Philippines, Dr. Allan Landrito told a hearing conducted by the House of Representatives’ committee on health on March 30 that he “compounded” ivermectin and sold it to his patients. He stopped doing so after the FDA and DOH warned against the practice.
“We are in the middle of a pandemic. … My patients are begging me to treat them. I am just giving prophylaxis to patients, early treatment,” said Landrito, who practices integrative medicine.
“If they want to put me [behind] bars for this, it doesn’t matter,” he said.
Dr. Rafael Castillo, a specialist in cardiology and internal medicine, also advocates the use of ivermectin as treatment and prophylaxis for COVID-19, particularly during this pandemic when patients are unable to gain admission to hospitals.
According to Castillo, who writes a weekly health column for the Inquirer, ivermectin is reported to be one of the safest drugs, with some 3.5 billion doses administered worldwide.
“When you’re under attack by ruthless killers, you’ll use anything that can help you ward off the killers, and give you a fighting chance to survive,” he wrote.