SEPTEMBER , 2021 | THE HEALTH

While vaccines play an important role in halting this pandemic , clearly an anti-viral is required alongside as admitted to by vaccine manufacturer Pfizer and the medical fraternity .

Currently , the medical fraternity has nothing to offer those infected with Covid- 19 to prevent its progression . Those infected have to wait fearfully for their fate . That is the stark brutal and cruel truth .

Currently , the only viable anti-viral candidate drug is Ivermectin .

In 2011 , its broad-spectrum anti-viral activity in-vitro ( cell cultures ) against a number of viruses was discovered . The mechanistic evidence shows that it acts at “ host level ” and not on the virus itself . This means that even if the virus mutates , the mode of action of Ivermectin will not be affected unless the virus now uses a different pathway of entry .

Small scale Proof-of-Concept studies on humans have shown that this anti-viral activity is seen in human subjects and a recent study shows that human subjects given Ivermectin become culture-negative faster . This is indeed very strong proof that Ivermectin works as postulated in humans as well .

Unfortunately , the mechanism of action limits the efficacy of Ivermectin to the earliest stages .

However , for some strange reason , this drug has been subjected to a persistent disinformation campaign which the Rakyat just refuses to believe . This has led the Rakyat to take matters into their own hands and buy Ivermectin from dubious sources .

This is extremely dangerous as without a doctor ’ s supervision , they may over-dose themselves or fall prey to fake drugs containing unknown toxic substances .

First , review the safety of Ivermectin

Ivermectin is a drug and is classed as a Class D poison and must be respected as such . However , it has a good safety profile and the UK Oxford PRINCIPLE Trial and the US-Activ-6 Trial dispenses it ( by courier ) without it being necessary to see a doctor , in most patients . Self-monitoring is also done by the participant online . The US Activ-6 Trial gives it at double the FDA recommended dose .

A French pharmaceutical company , Medincell , also commissioned an independent expert safety review prior to starting their own clinical trials and “ confirms the safety of Ivermectin up to a dose of 100 μg / kg / day in continuous administration over one month ”.

Other researchers have used various short high-dose regimes with good safety outcomes .

Hence , any attempt to portray Ivermectin as an unsafe drug in its usual doses and duration is “ fake news ”.

The efficacy issue of Ivermectin

As to the matter of efficacy , the main argument seems to be that the studies done so far that show a positive result are of low quality . As doctors , we acknowledge that these studies do have some shortcomings .

Even the UK-PRINCIPLE Trial is not of high quality since it is an un-blinded study . However , that is merely reflective of the fact that , in general , clinical trials conducted by non-Pharma or non- Industrial sources tend to suffer from a lack

BARE FACTS

BY DR MANIMALAR SELVI NAICKER of funding and lack of Clinical Research Methodological & Statistical expertise .

This has been highlighted for at least 20 years and the medical profession has accepted the status quo until Ivermectin came on the horizon . Suddenly , all the professors from medical universities across the world and all the Medical Ethics committees approving these “ low quality ” studies across the world have suddenly been labelled as incompetent and “ fake news ” peddlars .

Clearly , there is a double standard at play here .

There is even an attempt to portray the recent unfavourable Cochrane Collaboration as an “ independent Gold Standard ” review . This is not correct as the Cochrane Review itself has many shortcomings .

The Ministry of Health ’ s ( MoH ) own I-TECH study will have shortcomings as it was conducted on moderately ill patients ( mid-stage of disease ) when the mechanism of anti-viral effect is clearly in the early stages of the infection .

To prevent the Rakyat from consuming Ivermectin from suspicious sources , it is better for MoH to follow WHO ’ s advice and do a clinical trial . A clinical trial simply means giving a person an experimental drug after full disclosure , informed consent , close monitoring and data collection .

Patients can be given Ivermectin , if they request , by their GPs and details entered into the MySejahtera app . The GP can follow up as usual and any hospitalisation can be recorded in the MySejahtera app for analysis .

This is a win-win situation for all as the drug is given early , it is given to those who want it and KKM can collect the data and analyse it against “ historical controls ” which is an approved method by the US FDA . — The Health

Dr Manimalar Selvi Naicker is a Consultant Histopathologist & Statistician ( GStat ).