Philippines, Manila-There is intense debate among Philippine healthcare professionals about the use of ivermectin, an anthelmintic drug marketed only in veterinary grade in the country, for the treatment and prevention (preventive medicine) of COVID-19.
Human-safe pharmaceutical grade (USP grade) ivermectin was available here until the manufacturer’s certificate of product registration expired.
Many doctors have pledged the effectiveness of ivermectin and say the government should make it available to give COVID-19 patients who are unable to enter overcrowded hospitals a “fighting chance to survive.”
On March 30, the FDA’s Executive Director Eric Domingo said in a hearing that only topical creams containing ivermectin, which is used to treat head lice and rosacea, are on the market here. I told the meeting.
He said the FDA had already met with a practitioner asking authorities to allow the use of ivermectin for the treatment of COVID-19. Domingo cited the steps to be taken before distribution is approved, including clinical trials and applications for these trials.
At the same hearing, Rabindra Abeyasinghe, head of the World Health Organization in the Philippines, said the data available to advocate the use of ivermectin for the treatment and prevention of COVID-19 are “not strong enough.” I did.
In a memorandum of understanding dated March 27, the Philippine Medical Association (PMA) reminded all members and constituents of the PMA Code of Ethics: “Prescribing unregistered medicines to patients is unethical. I added.
Around that time, Under Secretary of Health Maria Rosario Vergueile of the FDA, the University of the Philippines-National Institute of Health, and several private medical groups calling attention to a systematic review of “six randomized” scientific studies. Read a joint statement signed by representatives, showing that the use of ivermectin to treat COVID-19 did not reduce the risk of death and did not improve “other clinically significant outcomes” I am.
Still, there are doctors in the country who are in the opposite position.
In an interview, cardiology and internal medicine expert Dr. Rafael Castillo said he would recommend ivermectin to patients as preventive medicine and prescribe ivermectin to patients with COVID-19 in different doses, depending on the severity of the case.
Castillo, who writes a weekly health column for the inquirer, said that ivermectin is another indication, but remains listed in the Philippine National Drug Formulations as an “essential medicine.”
“The government is obliged to make essential medicines available through the Ministry of Health (DOH) … DOH or the FDA … does not require approval for the use of ivermectin. We’re just asking them to make medicines available to give COVID-19 patients a chance to fight to survive, “he said.
Castillo also cited records showing that ivermectin “has been considered safe for humans with approximately 3.5 million doses over 40 years.”
Dr. Benny Agbayani, Ph.D. doctor and citizen president of the Philippines, said ivermectin fills the “blank” caused by the slow deployment of the COVID-19 vaccine nationwide.
Agbayani said in an online forum hosted by the Filipino American Academy of Sciences and Engineering (Paase) on March 31 that he was facing an emergency to consider the use of ivermectin.
He said that the inclusion of ivermectin in the list of essential medicines in the national prescription book would also support efforts to reuse ivermectin as an anti-COVID treatment.
In America, Japan
“Early treatment is more successful,” Agbayani said. “I’m not doing a nomination job. I see these things and recognize the data. I think it’s my right as a doctor. Show the research I read to the patient. Patient May want to take the medicine I offer. “
Given that no clinical trials have been conducted in the country, a Filipino doctor who reserves for ivermectin refers to a March 5 USFDA statement warning about the therapeutic use of COVID-19.
The USFDA stated that ivermectin is not an antiviral drug and does not approve the use of ivermectin in the treatment or prevention of human COVID-19. However, he did not elaborate on “some initial studies are underway” for the use of ivermectin to treat COVID-19.
The official website of the National Institutes of Health has noted the USFDA warning. A statement released on February 11 stated that there was “insufficient data” that could be used as a basis for “agreeing or disagreeing” with the use of ivermectin.
In addition, “Providing more specific and evidence-based guidance on the role of ivermectin in the treatment of COVID-19 requires the results of well-functioning, well-designed and well-conducted clinical trials. is.”
Not a novel idea
The diversion of ivermectin to treat COVID-19 is not a novel idea. Microbiologist Satoshi Omura was a 2015 Nobel Prize winner in medicine for discovering the use of bacterial ivermectin for river blindness and elephantiasis. In an interview in April 2020, ivermectin was used to treat patients with COVID-19. It seems to be effective, “he told Nikkei Asia.
In January, Nikkei Asia announced that the Tokyo Metropolitan Government will conduct clinical trials of ivermectin at metropolitan hospitals and public hospitals in the city.
Kitasato University Hospital began clinical trials of ivermectin in September 2020. By the end of March 2021, the hospital would administer the drug to 240 patients and “see if they could reduce the time it takes for patients to test negative for the polymerase reaction test.” Asia reported.
Reaching a conclusion
The lack of clinical trials required by the FDA in the Philippines was discussed at the Paase forum. Jacinto Blas Mantaring III, chair of the Department of Clinical Epidemiology at UP Medical University, said doctors and researchers cannot draw conclusions about the efficacy of the drug based on the experience of a single patient receiving ivermectin. It was.
“Explaining the results of one person is called a case report,” he said. “We cannot draw conclusions about the population based on the results of just one person, but it encourages other researchers to report their experiences and probably [its] effect. “
According to Mantaling, a variety of factors need to be considered, including the patient’s immunology, general health, genetics, dosage, and viral toxicity.
In a recent column, Castillo said: [on ivermectin] Quality is low to medium as virtually everything was done on its own. To date, no major pharmaceutical company or international organization has funded these studies. “
“But we can’t simply deny that the vaccine-like effect of reducing deaths by about 70-83% and preventing the transmission of the disease is strongly suggested,” he wrote. I am.
“Symptoms of fear”
Dr. Dominga “Minguita” Padilla, founder of the private sector COVID test initiative project ARK, said: “Unproven therapies can cause mutations and increase more infectious variants. I warned. Currently, there are P.3, or Filipino variants, with the exception of the Brazilian, British, and South African variants. “
But more than the ivermectin fire, Padilla said the health sector should not lose sight of the urgent issue of nationwide vaccine deployment and the faster government response to the pandemic.
“I think hype is tuned to forget about government corruption and incompetence … This turmoil is a sign of fear, confusion, and frustration. If enough vaccines are available sooner, people will find others. You don’t have to cling to things, “she said.
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