Ivermectin: Silver bullet or snake oil?

As the country is struggling to curb the surge in Covid-19 cases, the cheap antiparasitic drug ivermectin has emerged as a “mysterious drug” that could end the transmission.

Although advertised as a “silver bullet,” it may not yet be the magical solution everyone is looking for, as evidence of its effectiveness against deadly viruses is still weak, according to regulators.

That evidence may be supported by the results of regional clinical trials scheduled for this month. But until then, the verdict hasn’t come out yet, even though word-of-mouth continues to spread the good news about ivermectin.

The House of Representatives held a hearing to encourage government regulators to “open their minds” about ivermectin, a drug used in many countries to prevent and treat deadly viruses. It was.

From the collective testimony of experts, Anacarsgan Party list Rep. Mike Defenza and Sagipp Rep. Rodante Marcoleta have said that ivermectin has been widely used in the treatment of various human parasites since its introduction in 1981. , Said to be taken with Vitamin C, D, melatonin, zinc, including steroids for the elderly and asthma patients in particular.

They also said that ivermectin has undergone in vitro studies that effectively kill the Covid-19 virus and has been found to treat bacterial infections in pneumonia.

Discussion on effectiveness

A scientific and medical treatise on the effectiveness of ivermectin by Dr. Pierre Collie, president of the Covid-19 Critical Care Alliance at the forefront of citation. American Journal of Therapeutics, Marcoleta argued that ivermectin was effective in treating Covid-19.

“This study found a meta-analysis of 18 randomized controlled trials of ivermectin in Covid-19 found a significant statistically significant reduction in mortality, time to clinical recovery, and time to viral clearance. And the results of various preventative control trials have shown that regular use of ivermectin significantly reduces the risk of getting infected with Covid-19, “Marcoleta said. I added.

Defensor said he is promoting ivermectin as a treatment because poor people need to use cheaper remedies to fight Covid-19. For the rich. “

His Exhibit A: “For example, remdesivir costs 12,000 to 48,000 pesos per vial and requires two vials per day, while ivermectin costs only 35 pesos per tablet per day. Only one tablet is needed. The DOH and FDA are cracking down on ivermectin while allowing the use of remdesivir. Their prejudice is for the rich and against the poor, “the defender claimed. ..

Nevertheless, DOH and the FDA reiterated that the authorities did not recommend the use of ivermectin for the treatment of Covid-19 due to insufficient scientific evidence.

FDA Executive Director Eric Domingo told lawmakers that the use of ivermectin for the prevention or treatment of Covid 19 should be avoided as the benefits and safety for this purpose have not yet been established.

“I’ve said it many times, but again. I don’t recommend using ivermectin for the prevention and treatment of Covid-19, because the benefits of this antiparasitic drug for this purpose have not been established. . President Rodrigo Duterte also ordered DOST [Department of Science and Technology] Conduct clinical trials to test the efficacy of ivermectin against Covid-19. Let’s wait for the results, “Domingo said in a news statement.

At a briefing on April 15, Domingo told President Duterte that high doses of ivermectin could cause lung problems, neurological and brain damage.

Citing a study conducted in Australia, Domingo added: “It’s a safe drug and has been used primarily in animals and humans for the past 40 years, but it also has side effects if the dose is too high and the patient may have a fever. Liver pain. . “”

Currently, the Philippine FDA states that domestically registered ivermectin products for humans are topical preparations of prescription drugs only, saying that they are used for the treatment of ectoparasites such as head lice and skin conditions such as rosacea. I have.

The FDA also states that registered oral and intravenous formulations of ivermectin are veterinary products approved for use in animals for the prevention of filariasis and the treatment of internal and ectoparasites of certain animal species. Said.

As of April 27, the FDA said five hospitals had already secured a Compassionate Special Permit (CSP) for the use of ivermectin in Covid-19 patients.

Among the more notable individuals reportedly using it as a preventative are former Senate President Juan Ponce Enrile and incumbent Senate President Vicente Sotto III.

The defender also said: “The cabinet, doctors, police and military personnel are all taking ivermectin. I know that sympathetic people do not deny access to ivermectin drugs.”

Clinical trial

Having AMIDed a discussion of the reported efficacy for the prevention and treatment of Covid-19, President Duterte ordered DOST to conduct its own clinical trials on the use of ivermectin.

Dr. Jaimemontoya, Head of the DOST-Philippines Health Research and Development Council, will target 1,200 mild to moderate Covid-19 patients in Metro Manila by the end of May or the first week of June. The goal is to start clinical trials in the Philippines.

According to DOST, clinical trial projects can take at least six months and can last for years.

Because there are nearly 20 completed clinical trials and 40 ongoing clinical trials worldwide, as previously reported on Clinicaltrials.gov, investigating the use of ivermectin preparations for Covid-19. , Authorities said there was no need to conduct another clinical trial in the Philippines.

However, until the results of clinical trials were available, MPs Defender and Marcoleta recently launched “ivermectin pansley” and distributed free capsules of antiparasitic drugs in Quezon City.

Defensor said that on-site practitioners must first fill out a form and sign an exemption before prescribing a drug. Residents of the Barangay Matandan Barara in Quezon City received approximately 2,000 tablets of ivermectin.

According to Defensor, the distribution complies with FDA regulations and does not violate the law. Human grade ivermectin capsules are approved by a doctor’s prescription.

Defensor claimed that the FDA had told them that licensed dispensing pharmacies were allowed to dispense Ibermectin as long as they were manufactured by a licensed dispensing laboratory using a doctor’s prescription. ..

However, DOH revealed that it had been reported that an individual was given an invalid prescription during ivermectin pansley.

This ensures that DOH officially approves the report to the Professional Regulatory Commission (PRC) to investigate the authenticity of the report and impose sanctions as necessary under existing legislation.

The DOH and FDA also repeated statements from various medical and pharmacist associations on distributed prescriptions and strongly advised the public on what constitutes a valid prescription.

Advocates admitted that the ivermectin prescription distributed during the drug distribution did not include the doctor’s name and license number.

As a result, the Philippine Medical Association (PMA) cautioned physicians not to prescribe the use of ivermectin outside hospitals that have obtained CSP.

Meanwhile, the Alliance of Medical Experts on Covid-19 has requested authorities to investigate possible violations of Republic law 10918 or the Philippine Pharmacopoeia. Under the law, it is illegal to formulate well over a single therapeutic dose without the presence and supervision of a formal registered and licensed pharmacist.

Online consultation

Dr. Benny Agbayani, head of the Philippine Concerned Doctor and Citizen (CDC-PH), who was present during the distribution of ivermectin, said he would continue online consultations for those who would like to take ivermectin.

“Our role as a doctor is to make sure everything is possible to help the patient … and a rational scientific method that this drug is dangerous or ineffective. Unless you can prove it in, I think it’s the best way to treat it, not fear, not threat, “he added.

Dr. Alan Landrito of the CDC-PH also advocated the use of ivermectin, saying that the Philippines should see what other countries have achieved after using ivermectin.

Ivermectin allows the outbreak of natural infections, but prevents the onset of the disease, Randrit said.

“Ivermectin is a natural product discovered in 1975. It has properties against dengue fever, chikungunya fever, and even SARS covid,” he said.

He emphasized that the safety and efficacy of ivermectin for human use has been established and has been described as not affecting human biochemistry.

Ivermectin has been reported to be widely used as a Covid-19 drug in India, South Africa, and many Latin American countries.

Don’t spare the doctor

Meanwhile, DEFENSOR and Marcoleta sought to protect the doctors who prescribed the drug to the poor who needed it most.

“I rarely seek help or support for my claims and beliefs. As a civil servant, I accepted the fact that it was a” fair game “and people could attack me. I hope I can punch and clarify my argument, “the defender said on social media.

The defender said it was they who explained any irregularities in his and Marcoleta’s projects.

“If you have any problems with the distribution of this Covid-19 mysterious drug ivermectin, we can answer, volunteer doctors and others who wanted to help our poor people. I’m not a practitioner, “said the defender.

Marcoleta also explained that the ivermectin event delivered a clear message that the aforementioned agencies could not grasp it.

According to Marcoleta, Section 2 of Executive Order 121 allowed the FDA Director to issue an emergency use authorization for ivermectin in the following situations: In the trial, it is reasonable to assume that the drug or vaccine may be effective in preventing, diagnosing, or treating Covid-19. (B) The known and potential benefits of a drug or vaccine when used to diagnose, prevent, or treat Covid-19 outweigh the known and potential risks of the drug or vaccine. (C) There are no suitable, approved and available alternatives to drugs or vaccines for diagnosing, preventing, or treating Covid-19.

Image courtesy of Alexeynovikov | Dreamstime.com and Bernard Testa