Ivermectin issue sparks debate in HP medical community

MANILA, Philippines – There is intense debate among Filipino doctors about the use of ivermectin, an antiparasitic drug commercially available only in veterinary grade in the country, as a treatment and as a prophylactic (preventive medicine) for COVID-19.

Pharmaceutical grade (USP grade) ivermectin that is safe for humans used to be available here until the manufacturer’s certificate for product registration expired.

Several doctors are confident in the efficacy of ivermectin and say the government should make it available to give COVID-19 patients who cannot enter crowded hospitals “a fighting chance to survive.”

On March 30, the Director General of the Food and Drug Administration (FDA), Eric Domingo, told the House of Representatives health committee in a hearing that only topical creams containing ivermectin used to treat lice and rosacea were commercially available here.

He said the FDA had already met with doctors to urge the agency to allow the use of ivermectin for the treatment of COVID-19. Domingo cited procedures to be followed, including clinical trials and applications for these trials, before they could be allowed for distribution.

At the same hearing, the representative of the World Health Organization in the Philippines, Rabindra Abeyasinghe, said that the available data “is not strong enough” to defend the use of ivermectin for the treatment and prevention of COVID-19.

The Philippine Medical Association (PMA), in a memorandum dated March 27, reminded all members and constituent societies of the PMA code of ethics, adding that “prescribing unregistered drugs to patients will constitute an unethical act. “.

Opposite position

Around that time, Undersecretary of Health Maria Rosario Vergeire read a joint statement signed by representatives of the FDA, the University of the Philippines-National Institutes of Health, and several private medical groups that drew attention to a “systematic review of six randomized scientific studies. ”. showing that the use of ivermectin to treat COVID-19 did not reduce the risk of mortality or improve “other clinically important outcomes.”

Still, there are doctors in the country who have taken a contrary position.

Dr. Rafael Castillo, a specialist in cardiology and internal medicine, said in an interview that he recommends ivermectin to patients as preventive medicine and prescribes it in variable doses to patients with COVID-19 depending on the severity of the case.

Castillo, who writes a weekly health column for the Inquirer, noted that ivermectin remains listed on the Philippine National Drug Formulary as an “essential drug,” albeit for another indication.

“The government, through the Department of Health (DOH), is obligated to make essential drugs available … We are not asking the DOH or the FDA … to endorse the use of ivermectin. We are just asking them to make the drug available, to give countless COVID-19 patients who can no longer be housed in hospitals a chance to fight to survive, “he said.

Castillo also cited records showing that ivermectin has been “considered safe for humans for more than 40 years, … with around 3.5 million doses administered.”

Dr. Benigno Agbayani, president of Physicians and Concerned Citizens of the Philippines, said ivermectin fills a “gap” resulting from the slow launch of the COVID-19 vaccine nationwide.

In an online forum organized by the Philippine-American Academy of Sciences and Engineering (Paase) on March 31, Agbayani said that the country faces an emergency situation that should consider the use of ivermectin.

The inclusion of ivermectin on the essential drugs list of the national formulary would also support the effort to reuse it as an anti-COVID treatment, he said.

In the United States, Japan

“Early treatment is more successful,” Agbayani said. “I am not in the recommendation business. I look at these things, I perceive the data. I guess it’s my right as a doctor. I show my patients the studies I have read. The patient may or may not want to take the medication that I offer him ”.

Given the lack of clinical trials in the country, Filipino doctors with reservations about ivermectin refer to a March 5 USFDA statement warning against its use in the treatment of COVID-19.

The USFDA said that ivermectin is not an antiviral drug and that it has not approved the use of ivermectin to treat or prevent COVID-19 in humans. But he noted, without elaborating, that “some initial research is underway” for the use of ivermectin to treat COVID-19.

The official website of the US National Institutes of Health took note of the USFDA’s warning. In a statement issued Feb. 11, it said there is “insufficient data” that can be used as a basis “to recommend either for or against” the use of ivermectin.

He added: “Results from adequately powered, well-designed, and well-conducted clinical trials are needed to provide more specific and evidence-based guidance on the role of ivermectin in the treatment of COVID-19.”

It is not a novel idea

Reusing ivermectin to treat COVID-19 is not a new idea. Microbiologist Dr. Satoshi Omura, the 2015 Nobel Prize in Medicine who discovered the use of bacterial ivermectin for river blindness and elephantiasis, told Nikkei Asia in an April 2020 interview that ivermectin “appears effective. in the treatment of patients with COVID-19 “.

In January, Nikkei Asia said that the Tokyo Metropolitan Government “plans to conduct clinical trials of … ivermectin” in metropolitan and public hospitals in the city.

Kitasato University Hospital began clinical trials for ivermectin in September 2020. The hospital said it will administer the drug to 240 patients by the end of March 2021 “to see if it shortens the time it takes for patients to test negative for reaction to polymerase, “Nikkei Asia reported.

Drawing conclusions

The lack of clinical trials required by the Philippine FDA was discussed in the Paase forum. Jacinto Blas Mantaring III, president of the Department of Clinical Epidemiology at the UP School of Medicine, said doctors and researchers cannot draw conclusions about the efficacy of a drug based on the experience of a patient who received ivermectin.

“Describing the outcome of a single person is called a case report,” he said. “You cannot make a conclusion for a population based on the results of a single person. But it encourages other researchers to report on their experience, perhaps to contribute to the body of knowledge on [its] effects “.

Several factors must also be considered, such as the patient’s immunology, general health, genetics, administered dose, and virulence of the virus, “especially now that there are multiple strains,” Mantaring said.

Castillo said in a recent column that “certainly, the studies [on ivermectin] they are of low to moderate quality, because practically all were self-financed; no big pharma or international agencies would fund these studies before. “

“But it also cannot simply be ruled out that there is a strong suggestion of benefit to the tune of about 70-83 percent reduction in deaths, and a vaccine-like efficacy of about 90 percent in preventing transmission. disease, ”he wrote.

‘Fear symptom’

Dr. Dominga “Minguita” Padilla, founder of COVID Project ARK’s private testing initiative, warned that the use of “unproven remedies can drive mutations and lead to more variants that are more infectious. We now have P.3, or the Philippine variant, in addition to the Brazilian, British, and South African variants. “

But more than the ivermectin firestorm, Padilla said the health sector should not lose sight of the urgent issue of the launch of vaccines nationwide and a more immediate government response to the pandemic.

“I think the publicity is being orchestrated so that we forget about corruption and incompetence in government… This din is a symptom of fear, confusion and frustration. If we had the right vaccines sooner, people would not have to hold on to other things, “he said.

For more news on the new coronavirus, click here.

What you need to know about the coronavirus.

For more information on COVID-19, call the DOH hotline: (02) 86517800 local 1149/1150.

The Inquirer Foundation supports our leaders in healthcare and still accepts cash donations to be deposited into the Banco de Oro (BDO) checking account # 007960018860 or donate through PayMaya using this Link .

Read next