Clinical studies only way to end polemics
IS Ivermectin really a wonder drug capable of saving the lives of severely ill (category five) Covid-19 patients?
Armed with the findings of a few small-scale studies done overseas, Malaysian pro-Ivermectin groups, including some opposition members of Parliament, are pressing the authorities to approve the use of this medication to treat Covid-19.
The polemics surrounding Ivermectin — an anti-parasitic drug most commonly used in veterinary medicine — gathered steam after a medical practitioner, in an interview with a local television station recently, supported the use of the drug in the treatment of Covid-19 as it is said to reduce the risk of death.
However, a large number of medical practitioners in this country beg to differ, saying that the efficacy of the drug in treating Covid-19 has not been clinically proven. In fact, the Ministry of Health’s (MOH) National Pharmaceutical Regulatory Agency has also announced that so far, no products containing active Ivermectin have been registered for human consumption.
Nevertheless, the differences in opinion among medical experts on the use of Ivermectin to treat Covid-19, as well as the risk of taking it without a doctor’s guidance, have not stopped some people from buying the drug from the black market.
A tweet posted recently by Hospital Putrajaya consultant physician and nephrologist Dr Rafidah Abdullah more or less sums up the danger that awaits those who consume Ivermectin purportedly to prevent or treat Covid-19. In her tweet, she said she always comes across (patients with) complications involving Ivermectin and that she has resigned herself to it.
“A patient who recovered fully from Covid also wanted to take Ivermectin, now (the patient’s) liver functions have become problematic. Yellow — jaundice,” read her tweet.
Meanwhile, Malaysian Pharmaceutical Society president Amrahi Buang said a report by the United Kingdom-based Cochrane Reviews published on July 28 this year may shed light on the debate concerning the Ivermectin issue.
He said the gold-standard medical study cited by the report concluded that Ivermectin was ineffective in preventing and treating Covid-19.
“This drug cannot replace the vaccine (to prevent Covid-19 infection). Although some countries are using Ivermectin for humans, it’s not necessarily effective.
“India and Indonesia, for example, have withdrawn the use of Ivermectin for treating Covid-19,” he told Bernama recently.
Amrahi, formerly head pharmacist at Universiti Malaya Medical Centre, said large-scale and comprehensive studies would have to be carried out before experts can draw conclusions on the safety and efficacy of Ivermectin to treat Covid-19.
Studies done overseas in the past only involved small sample sizes with the researchers studying the use of Ivermectin only as an additional treatment, he pointed out.
According to Amrahi, the promising findings from previous case studies and clinical trials have resulted in the off-label use of this drug. Off-label use refers to the use of pharmaceutical drugs for an indication not approved by the authorities concerned.
“Whatever it is, the use of this drug specifically to treat Covid-19 still needs to be supported by stronger evidence,” he added.
Amrahi also lauded MOH’s proactive step of embarking on a clinical trial to study the efficacy of Ivermectin in the treatment of Covid-19.
The Ivermectin Treatment Efficacy in Covid-19 High-Risk Patients (I-TECH Study) trial, which was approved by MOH’s Medical Research and Ethics Committee on May 25, would involve 500 subjects from high-risk groups aged 50 and above admitted to MOH hospitals with moderate Covid-19 symptoms (stage two to three).
The study is aimed at determining the efficacy of Ivermectin in preventing the progression of Covid-19 to the more severe stage four and five in the subjects concerned.
“The study will also determine (Ivermectin’s efficacy) in terms of reducing the risk of death,” Amrahi said, adding that the trial is expected to be completed in September.
Ivermectin is approved by the US Food and Drug Agency to treat people with intestinal strongyloidiasis, onchocerciasis and helminthiases caused by parasitic worms but the drug has to be taken under the guidance of a medical professional.
Among the risks posed by Ivermectin are dizziness, allergic reactions and seizure. It can also lead to coma and even death.
Meanwhile, a medical assistant at a private hospital in Petaling Jaya who only wanted to be identified as Yas said she is apprehensive about taking Ivermectin without a doctor’s prescription.
She said she knows of Covid-19 patients who have purchased the drug from online vendors without referring to a doctor.
“I myself have come across a patient who experienced haemoptysis (coughing out blood) and haematuria (blood in the urine) after taking Ivermectin,” she said, adding that taking a drug not backed by clinical data nor approved by the authorities is highly risky and would complicate a Covid-19 patient’s treatment process. – Bernama
