AS the country struggles mightily to tame a surge in Covid-19 cases, the cheap anti-parasitic drug Ivermectin has emerged as the “wonder drug” that may potentially end the contagion.
Though touted by some as the “silver bullet,” it may not be yet, however, the magical solution everyone is looking for, as evidence for its efficacy against the deadly virus remains thin, according to regulators.
That evidence may be bolstered by the outcome of local clinical trials scheduled this month. But till then, the verdict is still out, though the word of mouth continues to spread the good news about Ivermectin.
In the House of Representatives, hearings have been conducted to urge government regulators to “keep an open mind” on Ivermectin, a drug being used in many countries to prevent and treat the deadly virus.
From the experts’ collective testimony, Anakalusugan Party-list Rep. Mike Defensor and Sagip Rep. Rodante Marcoleta said Ivermectin had been widely used to treat a variety of human parasites since its introduction in 1981, and since then is being taken along with vitamins C and D, melatonin, zinc, among others, including steroids for elderly and asthmatic patients.
They also said Ivermectin has undergone in vitro studies effectively killing the Covid-19 virus and was found to cure bacterial infection for pneumonia.
Debates on efficacy
CITING Frontline Covid-19 Critical Care Alliance President Dr. Pierre Kory, et al.’s scientific medical paper on the efficacy of Ivermectin, which is now published in the American Journal of Therapeutics, Marcoleta asserted that Ivermectin is effective in treating Covid-19.
“This study concludes that meta-analyses based on 18 randomized controlled treatments of Ivermectin in Covid-19 have found large, statistically significant reduction in mortality, time to clinical recovery and time to viral clearance. Also, results from various controlled prophylaxis trials showed significantly reduced risks of contracting Covid-19 with regular use of Ivermectin,” Marcoleta added.
Defensor said they are pushing for Ivermectin as a cure because the poor needed to gain access to an inexpensive therapeutic to fight Covid-19 “because the drugs the Department of Health (DOH) and the Philippine Food and Drug Administration (FDA) are promoting are for the rich.”
His exhibit A: “Remdesivir, for instance, costs from P12,000 to P48,000 per vial, and you need two vials a day. On the other hand, Ivermectin costs only P35 per tablet, and only one tablet is needed daily. The DOH and FDA are allowing the use of Remdesivir, while cracking down on Ivermectin. Their bias is for the rich and against the poor,” Defensor alleged.
Nonetheless, the DOH and the FDA reiterated that the agencies do not recommend the use of Ivermectin for the treatment of Covid-19 due to insufficient scientific evidence.
FDA Director General Eric Domingo told lawmakers that any use of Ivermectin for the prevention or treatment of Covid 19 should be avoided as the benefits and safety for this purpose has not yet been established.
“We have said this many times before and we will say it again. We do not recommend the use of Ivermectin for the prevention and treatment of Covid-19 as the benefits of this anti-parasitic drug for this purpose have not been established. President Rodrigo Duterte has also ordered DOST [Department of Science and Technology] to conduct a clinical trial to test the efficacy of Ivermectin against Covid-19. Let’s wait for the results,” Domingo said in a news statement.
In a briefing on April 15, Domingo told President Duterte that high doses of Ivermectin may cause pulmonary problems, neurologic and brain damage.
Citing studies done in Australia, Domingo added that, “Although it is a safe medicine and has been used largely for the past 40 years for animals and humans, there are also side effects when the doses are too high and patients may get a fever and liver damage.”
Currently, the Philippines FDA said the registered Ivermectin products in the country for human use are in topical formulations under prescription use only, saying this is used for the treatment of external parasites such as head lice and skin conditions such as rosacea.
start in May.
The FDA also said the registered oral and intravenous preparations of Ivermectin are veterinary products which are approved for use in animals for the prevention of heartworm disease and treatment of internal and external parasites in certain animal species.
As of April 27, the FDA said, five hospitals have already secured compassionate special permits (CSP) to use Ivermectin on Covid-19 patients.
Among the more notable personalities reported to be using it as prophylactic are former Senate President Juan Ponce Enrile and the incumbent Senate President Vicente Sotto III.
Also, Defensor said, “everyone from the Cabinet, doctors, police and military officials are drinking Ivermectin. I know those who sympathize will not deny the poor access to the Ivermectin drug.”
Clinical trial
AMID the debates over the reported efficacy to prevent and to treat Covid-19, President Duterte has ordered the DOST to conduct its own clinical trial on the use of Ivermectin.
DOST-Philippine Council for Health Research and Development head Dr. Jaime Montoya said the agency is targeting to start the clinical trial for Ivermectin by the end of May or first week of June among 1,200 mild to moderate Covid-19 patients in Metro Manila.
The DOST said clinical trial projects will require a minimum of six months and may extend to years.
Earlier, the agency said there is no need to conduct another clinical trial in the Philippines as there are almost 20 completed and 40 ongoing clinical trials around the world, as reported in Clinicaltrials.gov, exploring the use of Ivermectin formulations against Covid-19.
But pending the results of the clinical trial, Congressmen Defensor and Marcoleta recently launched “Ivermectin Pan-Three,” and distributed free capsules of the anti-parasitic drug in Quezon City.
Defensor said people were required first to fill up a form and sign a waiver before medical practitioners onsite prescribed them with the drug. Around 2,000 Ivermectin tablets have been given to the residents of Barangay Matandang Balara in Quezon City.
According to Defensor, they are not violating any law because the distribution complies with the regulations of the FDA; and human-grade Ivermectin capsules are allowed with a doctor’s prescription.
Defensor claimed that the FDA told them that licensed compounding pharmacies are allowed to compound Ivermectin, as long as such is made by a licensed compounding laboratory with a doctor’s prescription.
The DOH disclosed, however, that it has received reports of alleged invalid prescriptions being given to individuals during the Ivermectin Pan-Three.
With this, the DOH gave assurances that it would officially endorse the reports to the Professional Regulation Commission (PRC) to investigate the veracity of the reports and impose sanctions as deemed necessary, based on existing laws.
The DOH and the FDA also echoed the statements of various medical and pharmacist associations on the distributed prescriptions and strongly advised the public on what constitutes a valid prescription.
Defensor admitted that a prescription for Ivermectin handed out during the drug distribution did not contain a physician’s name and a license number.
With this, the Philippine Medical Association (PMA) reminded doctors not to prescribe the use of Ivermectin outside the hospitals that got the CSPs.
The Healthcare Professionals Alliance Against Covid-19, meanwhile, asked authorities to look into possible violations of Republic Act 10918, or the Philippine Pharmacy Act. Under the law, compounding in quantities greatly in excess of single therapeutic doses, without the presence and supervision of a duly registered and licensed pharmacist, is illegal.
Online consultations
For his part, Dr. Benigno Agbayani, head of Concerned Doctors and Citizens of the Philippines (CDC-PH), who was also present during the Ivermectin distribution, said they will continue to conduct online consultations for those who want to take Ivermectin.
“As doctors, our role is to make sure everything is possible to help our patients…and unless they can prove to me through a rational scientific way that this drug is a dangerous drug or it doesn’t work, I guess that’s the best way to treat it, not by fear, not by threats,” he added.
Dr. Allan Landrito, also of CDC-PH, and an advocate for the use of Ivermectin, said the Philippines should look at what other countries have achieved after using Ivermectin.
Landrito said Ivermectin allows natural infection to occur but prevents the disease from developing.
“Ivermectin is a natural product discovered in 1975. It has properties against dengue, chikungunya, even SARS Covid,” he said.
He stressed that the safety and efficacy of Ivermectin for human use has been established and it has been described as having zero impact on human biochemistry.
Ivermectin is reportedly widely used as a Covid-19 drug in India, South Africa and many Latin American countries.
Spare the doctors
DEFENSOR and Marcoleta, meanwhile, sought to protect the doctors who prescribed the experimental drug to poor people who need it most.
“It is seldom that I ask for help and support for my advocacies and beliefs. As a public official, I have accepted the fact that I am ‘fair game’ and people may attack me and I just I have to roll with the punches and hope that my arguments will come to light,” Defensor said in a social-media post.
Defensor said if there was any irregularity in his and Marcoleta’s project, it is they who are accountable for it.
“If there was anything wrong with our distribution of this Covid-19 wonder drug Ivermectin, we are the ones answerable, not our volunteer doctors and other medical practitioners who just wanted to help our poor people,” Defensor said.
Marcoleta also explained that the Ivermectin event conveyed a clear message that the said agencies failed to grasp.
Marcoleta said Section 2 of Executive Order 121 authorizes the FDA director general to issue emergency use authorization for Ivermectin when the following circumstances are present, namely: (a) based on the totality of evidence available, including data available from adequate and well-known controlled trials, it is reasonable to believe that the drug or vaccine may be effective to prevent, diagnose or treat Covid-19; (b) the known and potential benefits of the drug or vaccine when used to diagnose, prevent or treat Covid-19 outweigh the known and potential risks of the drug or vaccine, if any; and (c) there is no adequate, approved and available alternative to the drug or vaccine for diagnosing, preventing or treating Covid-19.
Images courtesy of Alexeynovikov | Dreamstime.com and Bernard Testa
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