MANILA — The Department of Science and Technology-Philippine Council for Health Research and Development (DOST-PCHRD) did not see a need for clinical trial on Ivermectin against COVID-19 in the Philippines.
DOST Sec. Fortunato de la Peña posted on Facebook that clinical trials require a minimum of six months and could extend to years.
De la Peña said there are almost 20 completed and 40 ongoing clinical trials exposing the use of Ivermectin formulations against COVID-19 worldwide according to clinicaltrials.gov, noting “PCHRD is of the position that there is no need to conduct another clinical trial in the Philippines.”
“It would be appropriate to await the results of these studies that are already significantly advanced in terms of data collection and conducting interim analyses,” de la Peña said.
Following the Food and Drug Administration’s (FDA) granting of one hospital’s compassionate use of Ivermectin on April 8, medical experts echoed the statements of Philippine regulatory officials and the World Health Organization (WHO) that scientific processes must be followed to ensure the safety and quality of drugs to be used against COVID-19 during a webinar organized by the Philippine-American Academy of Science and Engineering (PAASE) on April 9.
In a report by Rappler, University of the Philippines (UP) and Department of Health’s (DOH) research ethics board chairman Dr. Jacinto Mantaring said it would be better to wait for the results of ongoing clinical trials before assessing if Ivermectin could be used to treat COVID-19.
The US FDA, European Medicines Agency (EMA) and Ivermection manufacturer Merck have also cited the lack of data and evidence of the drug’s efficacy in COVID-19 prevention and treatment.
Infectious diseases and clinical pharmacology specialist Dr Benjamin Co told Rappler that a lot of questions on Ivermectin’s treatment efficacy and prophylaxis (action taken to prevent disease) remain unanswered, so there’s a need for well-planned and controlled trials.
“There is this promotion of Ivermectin for prophylaxis and then there is this promotion of the drug for treatment. I would like to see the difference between (them) because for infectious disease, you should have basis for prophylaxis and basis for treatment regimen,” Dr. Co said, noting the lack of data on how the drug should be administered to patients “makes it hard for medical experts to review its safety and efficacy.”
“The question is, how long would you give it to patients during the pandemic? You must meet a certain endpoint for certain treatment,” he added.
In another report by the Philippine News Agency (PNA), FDA said that the registered Ivermectin products in the country for human use are in topical forms under prescription use only for the treatment of external parasites such as head lice and skin conditions such as rosacea.
“Any use of Ivermectin veterinary products for the prevention or treatment of Covid-19 should be avoided as the benefits and safety for this purpose has not been established,” FDA said, noting “data from clinical trials are necessary to determine whether Ivermectin is safe and effective in treating or preventing Covid-19,”
FDA Director-General Eric Domingo insists Ivermectin is an “investigational product” and its distribution remains illegal, adding only the hospital given compassionate use permit will be allowed to import the drug through a licensed importer.
Domingo also noted that the compassionate use permit “is different from the pending application of two local manufacturers seeking for certificate of product registration for Ivermectin.”
In another report by GMA News, former Health secretary and Iloilo Rep. Janette Garin criticized the FDA’s granting of a hospital’s compassionate use of Ivermectin, a veterinary drug used to prevent parasites and heartworm illness in certain animals and hailed by “some” as a treatment against COVID-19.
In a press statement, Garin labelled the FDA’s move as ”a political decision rather than a medical one” and “one big joke.”
“This should not have a place in an institution which is primarily responsible for safety and efficacy of drugs and vaccines prior to allowing Filipinos to access such,” Garin said.
“Issuing a compassionate use permit for just one hospital but saying it cannot be distributed and used for COVID-19 treatment in general seems to be more of a political accommodation than a medical decision,” she added.
Garin noted that “compassionate use means access is a potential pathway for a patient with an immediate and urgent life-threatening condition or serious disease when no other option is available.”
“Therefore, you give it to dying patients where risks of an experimental drug are outweighed by current situation of the patient. Kumbaga, no choice na. Last resort,” Garin said.
In a separate interview, Garin said a compassionate special permit (CSP) “is being granted to a specialized institution or a specialty society. She added that there must be an ongoing Phase 3A trial in other countries or the country of origin before a CSP is granted.”
“It should also be clear if the CSP is for a clinical trial, who is the principal investigator, who are the subjects and what are the scientific basis of such and what does the trial intend to achieve/answer,” she said, mentioning Administrative Order number 4, issued by the late DOH secretary Juan Flavier, stating the guidelines on issuing CSP for restricted use of unregistered drug and device product or preparation, and amended by current DOH Sec. Francisco Duque III last year.
“FDA is allowing itself to be bullied and that’s a very scary thing because the very institution that should be independent, the very institution that should take care and be transparent on the safety and efficacy of all the medicines that is coming to our country is now submitting to the outside pressures of the world,” she added.
Wait for experts’ evaluation
In another report by ABS-CBN News, the DOH has urged the public on April 12, to wait for experts’ evaluation on the use of Ivermectin to treat COVID-19.
DOH spokesperson and Undersec. Maria Rosario Vergeire said they are finalizing their report before informing the public of their evaluation.
“Let’s just wait for the advice of experts. It’s not going to be long…so government will be able to monitor and be accountable if ever you take that drug,” Vergeire said, noting the government can’t guarantee the safety and quality of the drug currently unregistered for human intake.
Previously, lawmakers including Anakalusugan party-list Rep. Mike Defensor were pushing for the use of Ivermectin as a potential treatment for COVID-19.
Defensor has even announced his intention to distribute Ivermectin for COVID-19 patients in Quezon City, prioritizing senior citizens and those with comorbidities.