Dr Nathi Mdladla and Dr Warren Parker respond to the statement issued by the Critical Care Society of Southern Africa (CCSSA) and the South African Society of Anaesthesiologists (SASA) on 23 July 2021: Vaccinations and Ivermectin use in critically ill patients with COVID-19 infection, that Ivermectin should not be used until the results of further randomised controlled trials (RCTs) are available.
Scientific evidence for any therapeutic drug is not limited to randomised control trials (RCTs). Many repurposed drugs are routinely used without RCTs.
For example, in the field of anaesthesia, pulse oximetry has never been proven to conclusively improve peri-operative outcomes, yet intuitively it is the recommendation that is made in many closed-claims reports, as it makes sense. The same applies to the use of epidural anaesthesia for various types of surgery.
There is a clear and measurable benefit of the intervention for pain management, which makes the use of the modality, but there have never been conclusive randomised double-blind clinical trials (RDBCT) to say the intervention impacts outcomes.
There is clear evidence of the benefit of Ivermectin in limiting COVID-19 progression, hospitalisation and death. All studies providing evidence on drug repurposing in a pandemic context, where time is of the essence and complex studies cannot be carried out, and where ethical concerns and frontline clinical experiences are relevant, should be used and recognised in decision-making to save lives.
The jurisdiction of both the CCSSA and SASA is limited to inpatient treatment, yet their statement over-reaches into the early outpatient setting where Ivermectin is possibly most beneficial. The current approach to treating COVID-19 has been shown to be ineffective. By instructing symptomatic patients with a positive SARS-CoV 2 swab to go home with vitamins and supplements but no “disease course- altering" agent, to return to hospital when short of breath and needing ventilation, is obviously flawed, both ethically and pragmatically.
While giving the impression that their argument is scientific, the CCSSA and SASA support it with a series of anecdotal statements and biased assertions that do not advance our response to the COVID-19 epidemic in South Africa.
We examine the assertions made:
Assertion 1: Low numbers of patients have been vaccinated while many have been treated with Ivermectin and many may choose Ivermectin instead of vaccination.
Response: The CCSSA and SASA make anecdotal statements and use subjective quantities that show an absence of rigorous scientific process. They irresponsibly introduce the impression that many people are choosing Ivermectin over vaccination. There is no scientific basis to support this in the absence of objective data. No clarity is provided regarding the history of the patient being “treated with Ivermectin”. Several questions such as source of Ivermectin, purpose of prescription and dose all need to be interrogated before conclusions about effect can be made.
Assertion 2: Vaccines are the only effective response to COVID-19.
Response: By 22 July 2021, only 3.7% of South Africans had been fully vaccinated. Vaccination does not help those who are already infected and hospitalised. The vaccine rollout cannot prevent disease in those who have not yet been vaccinated. No prioritisation is given to therapeutic measures in the CCSSA and SASA statement—yet therapeutic measures are the primary means to support people who are ill and hospitalised with COVID-19.
Assertion 3: Ivermectin should not currently be supported as a COVID-19 intervention.
Response: The choice of language exhibits prejudice. No acknowledgement is made of the extensive and accumulating scientific studies focused on Ivermectin, peer-reviewed studies and reviews published in reputable scientific journals. The scientific efforts of many groups of doctors, scientists, health and allied workers, to ensure that Ivermectin is available as part of the COVID-19 response in South Africa, is ignored. Selecting a single sensationalised withdrawal of one unpublished study is disingenuous where this is an exceptional case compared with the body of reputable evidence available.
Assertion 4: Only “sufficiently powered randomised RCTs” as the singular type of evidence necessary for therapeutics such as Ivermectin are acceptable.
Response: The body of evidence for Ivermectin exists across a spectrum of scientific studies including:
• Peer-reviewed studies demonstrating the safety of the drug.
• Peer-reviewed studies clarifying the mechanism of action of Ivermectin against SARS-COV-2.
• Studies on drug repurposing.
• Experiences of frontline doctors—in South Africa and elsewhere.
• Ethical principles that balance saving lives and reducing morbidity with possible harms.
• Integrating multidisciplinary approaches.
CCSSA and SASA are reputable bodies with a large constituency. While we appreciate the concerns that may have motivated the issuing of this statement, it will be beneficial to reappraise the approach taken, and commit to focusing on the scientifically-grounded solutions that this pandemic demands of all of us to ensure health for all and save lives.
Dr Nathi Mdladla and Dr Warren Parker
*Dr Nathi Mdladla is the Associate Professor and HOD of ICU at the Dr George Mukhari Academic Hospital (DGMAH) and Sefako Makgatho University. He is involved in both outpatient and inpatient treatment of patients with COVID-19. The ICU at DGMAH is the only academic hospital currently treating COVID-19 with a protocol that includes Ivermectin.
• Dr Warren Parker is a public health specialist who has worked in more than 20 countries with a focus on translating on-the-ground experiences and research into strategic policy. He has a track record in the contextual strategies used to direct research to inform strategies in the fight against HIV and Aids in South Africa
See more from MedicalBrief archives:
Warning from CCSSA and SASA on vaccinations and Ivermectin
UKZN professor challenges Ivermectin expose
Ivermectin: Studies come thick and fast; Regulators remain unmoved