UZKN medical Professor Colleen Aldous and public health care specialist Dr Warren Parker collaborate on this insightful and eye-opening article on the fraught conflicts and wrongdoings during the Covid-19 era. From the get go, we’ve put our faith in medical professionals and big pharma to seek help and guidance through this pandemic. That was the first mistake, say Aldous and Parker, who imply a more open-minded and pragmatic approach would’ve served the world better. This more pragmatic approach would’ve included receiving guidance from various professions in order to gain a more holistic understanding of the challenge at hand. – Justin Rowe-Roberts
Why large scale double-blinded randomised controlled studies are completely inappropriate for use in a pandemic
By Colleen Aldous and Warren Parker*
In early 2020 a deadly disease was unleashed upon all of humanity and we looked to doctors, pharma and medical regulatory authorities to help us out of it. That was our first mistake – putting our unquestioning trust in a few people on our planet who all have the same thought cages imposed on them by their almost identical educations and backgrounds. A thought cage, that in the last half a century, has blinded them to the breadth and scope of science, to a narrow view that includes the notion that only double blinded randomised controlled trials provide adequate evidence of drug efficacy.
In disaster management one would never consider only one group of specialists in a response team. Disaster management approaches involve bringing people together with different skills to collectively resolve the disruption of a disaster. Different disasters require different team members. For example and earthquake disaster management team would require a different team to a disease outbreak disaster.
There are four defined phases in general disaster management: mitigation, preparedness, response and recovery. For disasters that can be foreseen such as earthquakes or floods, plans have been drawn up with protocols to follow in order to decrease loss of life. Mitigation and preparedness are phases that occur before the disaster occurs.
Covid-19 is a global disaster. In this global pandemic, the disaster struck quickly and mitigation and preparedness involved blunt instruments such as lockdowns. Globally, there was an immediate reliance on the health fraternity, especially international and country authorities, following the belief that they alone would deliver us from this disaster. Yet global and national health authorities have consistently been behind the curve. Vital evidence has been overlooked.
It took a vital three weeks to move from denial to concede that human to human transmission of Covid-19 was occurring. It took months to concede that asymptomatic transmission was possible and was a key driver of the pandemic. For more than half a year, the possibility of airborne transmission of SARS-COV-2 was dismissed in favour or droplet spread. All of these concerns were addressed later than they should have been. These delays increased the scale of this pandemic and cost countless lives. And they occurred as a result of a failure to move beyond narrow approaches to science and inadequate review of the body of knowledge in conjunction with new and readily observable data.
And because we have put our trust only in a single discipline for a disaster response, these omissions continue. They continue because global and national health bodies are slow to review and accept evidence. They continue because of dominant medical paradigms that are ill suited to pandemics. Views that are so narrow and so rigid that they hold us back. Yet these narrow views are presented as absolute truths. Novel ideas are disparaged, and any views that fall outside the dominant paradigm are dismissed as disinformation.
This approach is deeply cynical. It fundamentally hold back an effective response to this pandemic and has cost many lives.
One example of the damaging effects of this cynical dominance, is the disparaging of effective therapeutic options for treatment of Covid-19, including repurposed drugs that show promise in reducing Covid-19 morbidity and mortality. There are numerous drugs that have been vociferously dismissed, and we discuss ivermectin here, by way of example. Ivermectin is one of the safest drugs available in the world today. Its mechanism of action against Covid-19 is well documented and has been outlined in numerous peer reviewed articles. The use of Ivermectin in the real world has been well documented through many studies. Over 160 papers have been published on the use of Ivermectin in all phases of Covid-19. The vast majority of these studies indicate positive effects, and overwhelmingly recommend that ivermectin be considered for further study or immediate implementation. Yet this evidence is somehow not enough. It is not enough because the narrow grouping of regulators and policy-makers believe that only one study type will provide definitive proof of the efficacy of Ivermectin – a large scale double blinded randomised controlled study. Such studies are costly and complex to implement and are typically funded by big pharma for novel drug development. Safety and efficacy are the main considerations. But the big pharma model is not practical in the pandemic context.
Drug repurposing represents an efficient short-cut to treatment as safety is already well established. And while most drugs that treat one condition or disease are not relevant for wider use, there are some that demonstrate new – and often unexpected – potential. Ivermectin falls into this category. A drug with an impeccable safety record derived from more than 3.7 billion doses administered. A drug that has demonstrated effects in all stages of Covid-19 and is even effective for prevention. A drug that has a demonstrable mechanism of action against Covid-19 that has been well explained in numerous scientific papers.
A drug that has demonstrable effects at mitigating Covid-19 at population level, and that has reduced disease severity and death at individual level.
More often than not, global guidance for preventing and treating Covid-19 has not involved new science. Rather, it has involved revisiting the evidence, and overcoming dogma. For example, it took a letter from 239 of the world’s top scientists to the World Health Organisation (WHO) to shift the guidance on airborne transmission, following extensive existing evidence for respiratory viral transmission. Many country authorities either defer to this guidance, or follow similar rationale to shape their strategic policies. Acceptance of evidence is a slow process – intolerably and dangerously slow in the context of a rapidly moving pandemic.
This is particularly a concern in the context of the widespread dismissal of Ivermectin. The science is there. It is more than sufficient. It is supported by legitimate peer reviewed evidence that is as best as can be achieved in a pandemic context. Yet it is dismissed as a result of attachment to overly narrow understanding of science that is improper when lives are at stake. How many lives do we still need to lose before we realise that we should broaden the scope of decision-making in epidemic and pandemic response teams? There is no benefit to tediously restating the evidence when all that stands in the way is dogma. We are dealing with human lives, and we are dealing with the right to health and life of everyone on this planet.
I ask if a human rights lawyer, or a child whose parent is ill, or a doctor who has successfully treated Covid-19 patients already using ivermectin would also conclude that the data already available is insufficient to allow the use of ivermectin in Covid-19. It is imperative that we broaden the disaster management team to include other specialists from civil society; doctors from the front lines (not only from academia and regulatory authorities), human rights lawyers, health economists, civil rights movements amongst others. People who will look at the evidence with humane conscience. A team of specialists with different thought cages, all offering equally important thought to decision making.
The pandemic is accelerating and in many places is not being brought under control. It requires that we use every resource at our disposal. Vaccines cannot be relied upon to be the only solution; they are still under development and their efficacy needs improving against new variants. The global rollout is slow. We need to apply our minds more broadly to solving the problem of people getting sick and dying of Covid-19.
The Covid-19 pandemic is fast moving, and it is unpredictable. We have to be nimble and work past the blockages. imposed by single minded dogmatic authorities. The current global guidance on ivermectin cannot be justified. Already many countries are working past these recommendations and are moving ahead with Ivermectin as part of their armoury to deal with Covid-19. As they do so, the benefits of their clearer vision are plain to see.
We need to move ahead and this effort requires support from all quarters of society, across disciplines, across sectors and across communities. We need to be courageous and stand up against narrow and rigid guidance from those who impose scientific rationale that are unjustifiable in ethical and human terms. We need a new disaster response team.
We need to be courageous and create a paradigm shift in thinking about evidence-based medicine. We must look at the totality of evidence, weigh up the bias presented in some forms of research design with an open mind, seeking out the truth in the data, and take cognisance of the context within which the research was carried out. Science moves forward though healthy skepticism and critical thinking, not through cynicism and text book dogma. We need a new evidence-based paradigm, one drawn up by a multidisciplinary team that focusses on the good for all.
Globally, there are clinicians and scientists speaking with a common voice. Their research has shown that ivermectin is safe and effective. It is readily manufactured at low cost and easily distributed. Ivermectin has a vital role to play in bringing Covid-19 under control. Ivermectin brings hope and it needs our support.
- Professor Colleen Aldous has a PHD and is a full Health Care professor at UKZN’s medical school where she runs the doctoral academy at the College of Health Sciences. She has published 130 peer-reviewed articles in rated journals. Dr Warren Parker is a public health care specialist.
- Natural immunity vs Covid-19 vaccine-induced immunity – Marc Girardot of PANDA
- Alec Hogg: Ivermectin gets big US research thumbs up
- The lawyer who won the Ivermectin battle for South Africans