FORMER health minister Datuk Seri Dr S. Subramaniam today expressed his hopes that the Government will continue conducting Ivermectin trials to provide clarity on the usage of the anti-parasitic drug Ivermectin to treat COVID-19.
He is responding to recent news that numerous health groups are pushing for Ivermectin to be used to help stem the increasing number of COVID-19 cases in the country.
“Medical decisions and treatment protocols are guided to a great extent by the information gathered by clinical trials,” he told FocusM. “In most instances the global medical fraternity reaches consensus on the treatment.
“There are, however, some instances where different countries interpret data differently and make different decisions.”
In the case of Ivermectin, Subramaniam opined that the global medical community is unfortunately “badly divided”, adding that this particular issue has somewhat become political with strong lobby groups emerging on both sides.
“Over the years agencies like FDA (the Food and Drug Administration), WHO (World Health Organisation) and CDC (Centres for Disease Control and Prevention) have moulded global decisions,” he said.
It was comfortable to fall back on their decisions, and unfortunately the ‘big three’ have not endorsed the regular usage of Ivermectin in COVID-19 quoting the lack of evidence, Subramaniam explained.
“The Health Ministry has hence taken a cautious stand in this and allowed ‘off-label usage’. As such, a medical practitioner in Malaysia is at liberty to use (the drug) if he feels it would be useful, being responsible however for any side effects that might arise from it,” he added.
Ivermectin off-label use sensible and fair
On a separate note, Malaysian Alliance for Effective Covid Control (MAECC) told FocusM that the call for Ivermectin off-label use by the Pakatan Harapan MPs is most sensible and fair and conforms to the principle of patient-centred care in the practice of medicine.
“There can be no logical reason not to allow off-label use of Ivermectin by qualified doctors who abide by their Hippocratic Oath and have informed consent from their patients,” said MAECC Secretariat member Capt Dr Wong Ang Peng (Rtd).
“Numerous doctors throughout the world have declared publicly that they have used Ivermectin to save the lives of COVID-19 patients.
“These are world-famous and highly-published physicians who have developed and used the FLCCC (Front Line COVID-19 Critical Care) protocols.
“Playing deaf to such declaration is ridiculous, especially in a COVID-19 health emergency that has claimed so many lives,” he opined.
Commenting on the MOH-sponsored Ivermectin Treatment Efficacy in COVID-19 High Risk Patients (I-TECH) study which compares Ivermectin to standard care, Wong said that the low dosage of Ivermectin prescribed – a single dose of 12 mg a day for five days for Category 3 patients – is unlikely to show much difference for both groups.
“Most randomised controlled rials (RCTs) on Ivermectin that produced positive results used 12mg to 14mg, two doses a day,” Wong elaborated.
Rather than seeing if patients get worse during the trial, Wong noted that the study design should instead be for how fast a patient recovers, duration of hospital stay, viral loads; and not whether a patient advances from Category 3 to 4 and 5.
Meanwhile, on the study’s secondary outcome – mortality – Wong opined that both groups are not likely to have high mortality numbers and the margin is likely to be narrow.
“An underpowered study is not going to show statistical significance in the mortality outcome.
“Due to the expected small effect size, this small-scaled study using 200 or 500 subjects has little potential to show a significant difference in both the primary and secondary outcomes, and therefore not likely to show statistical significance,” Wong explained.
Simply put, he added, the study is poorly designed or has been designed to show negative results.
However, Wong denied that MAECC is trying to cast aspersions on the I-TECH study.
“The plea for doctors to be allowed off-label use of Ivermectin for early outpatient treatment is justified and there cannot be any reason to prevent that in the light of the current surging infection and death rates,” Wong concluded. – July 28, 2021
