Not enough data about Ivermectin’s efficacy and dosing
Professor Terrence Kommal
OPNION - The Covid-19 pandemic has put all of us under pressure, and the uncertainty is unnerving.
Even though I'm a medical doctor and involved in multiple healthcare discussions in South Africa, the continent and internationally, there is uncertainty even in the medical world.
All of us, both patients and healthcare professionals, are looking for solutions fast. Some attribute the spread of infection to the mutations. Others attribute it to public health concerns like the festive periods and other social gatherings.
However, one thing is certain: people are getting sick and many are dying, and they're dying quickly. Solutions need to be found.
I'm not unaffected as a professional or personally by the pandemic. In the last six months, we have suffered significantly as a family and the distress has been unbearable. We have lost no less than four close family members, due to various healthcare concerns during the pandemic. This included my father, his sister and my only sister-in-law.
Last week, we lost my grandmother. She was admitted to a hospital for a simple medical condition with a fractured bone, but she eventually, and regrettably, died from Covid-19 complications.
I am also looking for solutions to save my own and other patients across Africa, and that includes exploring the options of Ivermectin.
The use of Ivermectin among South Africans is topical, and there are many controversies regarding conflicting views on its potential use and benefits.
There are also discussions in South Africa on whether there is a perception of purposeful denial of its use or the molecules, as some call it, for the treatment of Covid-19.
When my grandmother was critically ill, the options were limited. Everyone was desperately trying to save her. Did her immediate family use Ivermectin? Yes, they did. Ultimately, it made no difference to her outcome.
Let us look at some of the facts when it comes to Ivermectin. We know that Ivermectin internationally has been used for various conditions relating to parasitic infections.
We also have information that it has been used for various conditions, even in South Africa with special permission for various parasitic infections.
This includes scabies and others, in which a Section 21 authorisation was provided.
There are discussions taking place on social media between healthcare and non-healthcare professionals about the potential use of Ivermectin. As of Monday morning, according to clinicaltrials.gov there are 51 specific and dedicated trials related to Ivermectin and its potential use for Covid-19 and the treatment of patients.
Due to the fact that Ivermectin has been used in combination with other treatments, like Hydroxychloroquine and Betamethasone Doxycycline, and other medication, there have been no specific findings or dedicated findings for 100% support for its use.
To date, there has also been no specific consensus on the potential dosage for the treatment of Covid-19, and the risk of overdose is high, with its related complications.
What is optimistic from these trials is a positive impetus and move to find the potential use of Ivermectin for potential patients and, in some cases, prophylactic and or preventative use, to reduce the potential transmissibility of the virus.
What has contributed to a lot of the positive urgency in the community is a singular trial in-vitro, or simply put in a test tube, which has found that Ivermectin had reduced the replication of the virus outside of the human body by a factor of more than 5 000. However, that is not enough to find that it is clinically safe in South Africa.
We don't have enough dedicated data to say Ivermectin will work 100% or at least enough positive data yet that is scientifically acceptable.
Do I want it to be positive data? Yes, 100%. Will I use it at this stage? Not yet. There is not enough safe data about its efficacy, its dosing and potential value for treatments right now.
Many have opined that there are other factors that may be influencing the South African Health Products Regulatory Authority (SAHPRA) outside of science.
The current lack of conclusive scientific data to recommend Ivermectin’s use in South Africa, as well as the lack of proven efficacy from the more than 51 trials internationally, has led to SAHPRA's reluctance to authorise its use.
There is a movement on the continent for the drug. But as of Sunday, and based on the international databases of clinical trials, there appears to be no current registered clinical trial in South Africa to explore the potential use and/or to document the outcomes of ivermectin to treat Covid-19 patients.
However, there are also serious dangers in buying the illegal ivermectin on the black market. In any environment in which there is significant demand, there is the risk of illegal products being packaged as Ivermectin.
When one buys medication through the reputable established legal routes, there is a chain of control for the safety of the product. This is to ensure that the medicine has been manufactured according to good manufacturing practices.
In the case of illegal products that I've already seen that come from India and Pakistan, there is always the risk of somebody manufacturing fake products. Toxic substances could be used and it could result in unknown complications and the risk of death.
So until and unless valid products are brought into South Africa, through reputable sources that are verifiable and confirmed safe, there are risks. There is the risk of poisoning our loved ones and allowing them to be harmed by conscious decisions using illegal products.
According to the UN, at least 30% of the healthcare products, including medicines, in Africa are fake. Can we afford to take the chance to use such products?
Do we have conclusive scientific evidence yet, except small pockets of limited studies that prove that Ivermectin alone is useful and proven against Covid-19? At this stage, I don't believe we have. Do we have positive indicators moving in that direction? Yes, we do.
But many of the 51 trials are not finalised and patients are still being recruited to participate or the results are being studied or are still being peer-reviewed. Therefore, I'm optimistic that the scientific community and my peers will soon provide clinical data to advise on the potential use of Ivermectin.
Until and unless that becomes available, there are always critical risks when using illegal products.
Professor Terrence Kommal is a medical doctor and former member of the South African Presidential Medical Team. He is chairperson of the Medical Expert Consulting Group and FDA Medical, a SAHPRA-licensed medical devices company. Kommal is the first Professor of Practice at North West University. He has completed specialist training in pandemic influenzas, biological weapons and other infectious national security threats by the US Defence Institute of Military Operations.