Since the onset of the Covid-19 pandemic, one of the common criticisms amongst those that have taken umbrage at the manner in which governments and institutions across the world have dictated the management of the disease is the failure to recognise and recommend early treatment options. The overarching advice that most people received was to isolate upon the first onset of any symptoms and to do so until the symptoms became severe enough to warrant going to the hospital for treatment. This article by a general practitioner who has been on the front lines of treating Covid-19 addresses the very real question as to whether we are doing enough to save Covid-19 patients. Dr Erika Drewes – a specialist Family Physician – argues that; ‘Successful early treatment options, which should be the bedrock of any medical intervention in the treatment of Covid 19, are being ignored by our current public health messaging.’ – Nadya Swart
Covid 19 – Successful early treatment options ignored by health authorities
Are we doing enough to save Covid-19 patients asks a general practitioner on the front lines of early Covid-19 patient care.
It is absolutely unacceptable that eighteen months into the pandemic we still haven’t come up with an early treatment approach. Instead there is a heavy reliance on a drive towards vaccinating as many people as possible which plays an important part in reducing hospital admissions, but it should not be the only strategy.
Starting treatment at first symptom onset is the best opportunity to stop Covid-19 in its tracks and should play a central role in the management of Covid-19.
Successful early treatment options, which should be the bedrock of any medical intervention in the treatment of Covid 19, are being ignored by our current public health messaging. Most concerning is that Real World Evidence (RWE) seems to play no part in reviewers’ decisions which according to an article by twelve FDA authors, is perfectly applicable sources of data.1 On their website, the FDA says: “RWE can be generated by different study designs or analyses, including but not limited to, randomised trials, including large simple trials, pragmatic trials, and observational studies (prospective and/or retrospective).” The US even passed a law in 2016 ratifying this use of RWE. RWE is not only appropriate to consider, it also brings in evidence that wouldn’t be seen in RCT trials as these are often conducted in protected clinical settings.
Considering this, there is more than enough evidence to produce an early treatment guideline for Covid-19.
This is not the first time this scenario has played out in South Africa. Not too long ago, many patients died of AIDS because the government was slow to give patients early access to the life-saving drugs they needed. Activists had to take the government to court on several occasions to access anti-retroviral treatment. Thousands of people perished while waiting for antiretroviral approval.2
Early treatment should focus on a combination of medicines introduced at various clinical moments in the illness. For example, corticosteroids are best introduced during the inflammatory phase according to most recommendations.
It is concerning that to date, the official Covid-19 early treatment guideline for mild to moderate Covid-19 does not include anything but supportive management with paracetamol and non-steroidal anti-inflammatory drugs (NSAIDS). While hospital medical staff are using expensive and labour-intensive treatments for patients in advanced stages of disease, a whole team of community health medics are left high and dry on the sidelines.
In a recent BizNews article, Prof Colleen Aldous and Dr Nathi Mdladla alluded to the fact that the National Executive Committee is failing to promote early treatment approaches, for fear that this might harm the vaccine roll-out. This is not based on science.
Studies estimating the damage done by not using early treatment
A recent pre-print paper examining mortality across countries in 2020 reported on the effects of several public health interventions between December 8, 2019 and April 1, 2021.3 (Since remdesivir and ivermectin were only adopted at the end of 2020, these were not included in the analyses.) A 16% reduction in fatalities was associated with countries that used hydroxychloroquine. In fact, the coefficient analysis in this study estimated that had the US made hydroxychloroquine widely available, deaths could have been reduced from 515,000 to 427,000.
The time has come to look more critically at early treatment approaches of mild and moderate Covid-19.
The treatments reviewed by South Africa’s National Institute for Communicable Diseases (NICD) and the South African Health Products Regulatory Authority (SAHPRA), while referring to some late-stage treatments such as corticosteroids, only instruct doctors to treat “supportively” as for any viral infection while officially acknowledged rapid reviews on ivermectin, hydroxychloroquine and colchisine advise that “more evidence is needed.”
The guideline even discourages the use of some nutrients such as vitamin D, Zinc and vitamin C. The rapid reviews that inform the guideline lean heavily on randomised double-blind placebo-controlled trials (RCT). Reviewers argue the required RCT trials are lacking to give conclusive guidance.
If it is true that enough quality RCT trials aren’t available in order for reviewers to draw conclusions, then logically the next level of evidence, namely “Real World Evidence” (RWE), must be used.
Most early treatment discussions these days center around the use of ivermectin (although the list is rapidly expanding).
In a crisis it makes sense to turn to drugs that are already on the dispensary shelf, are proven to be safe and show promise in studies.
Worldwide efforts are underway to establish whether known and registered medications would be valuable to use. Many of these drugs are off-patent and therefore cheap. Several living databases are tracking studies on interventions like ivermectin, colchicine, hydroxychloroquine and many others. Some examples for such databases are https://c19early.com, https://c19hcq.com and https://covid-nma.com.
Having no early treatment strategy leads to adverse, unintended consequences:
- The first is that most patients will source their own drugs, sometimes not through trusted channels and use it of their own accord. This could be a disaster for underdose, overdose and abuse.
- Secondly doctors are afraid of acting outside of what is regarded as the norm and, with no adequate guidelines in place, are disempowered in their treatment approaches of early and mild to moderate Covid-19. This sets the stage for missed early intervention and hospital admission surges with subsequent fatalities.
- And lastly, by not sanctioning and tracking the use of medications of interest, we will never understand if they have any real-world impact in our South African context or not. This constitutes a scientific missed opportunity.
Early treatment for Covid-19 – Success stories
It is presently clear that public health measures (vaccines, social distancing and lockdowns) alone are not sufficient in saving those who need hospital admission. Despite this obstacle, many clinicians (who are now clinical experts, having treated thousands of patients), have been able to report their approaches and outcomes regardless. Surely their evidence should also be considered.
One such clinician is Dr S. Chetty from Port Edward who treated patients with his own early treatment approach during the second wave in Kwa-Zulu Natal in December 2020. His efforts are nothing short of remarkable. Committed to supporting his community, he moved out of his house into a tent on the front lawn of his building and started examining and treating his patients there. He serves an under-privileged community and could not order the many medical tests that form part of the Covid-19 work-up as his patients simply didn’t have the insurance to pay for it. His nearest referral hospital is several kilometers away.
He realised early-on that the Covid-19 infection course followed distinct phases of viral infection followed by the inflammatory and thrombotic (clotting) phases about 8-10 days later. It is this second phase of the infection that proves to be the determining factor for which patients recover and which patients get worse and need hospitalisation. He decided to not leave anything up to chance and took measures to treat early and aggressively. He treated more than 4,000 patients without needing to prescribe oxygen nor referring any for hospitalisation. He also reports no mortalities. His protocol includes promethazine, hydroxychloroquine, corticosteroids and other supportive nutrients.
Dr Peter McCullough and colleagues have published a very successful early treatment protocol in Reviews in Cardiovascular Medicine in 2020. (4,5) Dr McCullough is a highly published and regarded academic and clinician associated with Baylor University in Texas. His article has become one of the most downloaded articles in the history of that publication. Early on in the pandemic, McCullough led groups of physicians via a network of telemedicine locations utilising this approach to great success. A recent study that applied the approach to nursing home residents was since associated with a statistically significant (60%) reduction in mortality. 6
Dr Jackie Stone, a Zimbabwean family physician, has reported tremendous reductions in hospitalisations and deaths since starting early treatment and prevention using ivermectin in combination with other treatments in her community.
Another early treatment success story has been documented in Mexico where treatment is started on Covid-19 diagnostic confirmation. Drs Lima-Morales et al associated their early intervention protocol (termed “TNR4”) with 85% recovery within 14 days and 75% to 81% reduction of hospitalisation or death.7 The protocol is based on ivermectin, azithromycin, monteleuklast and acetylsalicyclic acid.
The Frontline Covid Critical Care (FLCCC) workers is an organisation that took the lead in the development of early treatment protocols. Their work has filled a void that should have been filled by public health and academic institutions. They have also recently produced a protocol focused on treating symptoms of Long-haul Covid-19. They were the first group to identify corticosteroids as efficacious as a treatment modality (since confirmed by an Oxford study) and are now advocating for other additional medications such as ivermectin, fluvoxamine. The latest early treatment protocol suggests the additions of Nitazoxanide, Antiviral mouth wash (e.g. Iodine), Dual anti-androgen therapy, Fluvoxamine and Monoclonal antibody therapy amongst other things.
- Sherman RE, Anderson SA, Dal Pan GJ, et al. Real-World Evidence — What Is It and What Can It Tell Us? New England Journal of Medicine. 2016;375(23): 2293-2297. doi: 10.1056/NEJMsb1609216
- Chigwedere P, Seage GR, Gruskin SJ, Lee T-H, Essex M. Estimating the Lost Benfits of Antiretroviral Drug Use in South Africa. J Acquir Immune Defic Syndr. 2008;49: 410-415.
- Toya H, Skidmore M. A Cross-Country Analysis of the Determinants of Covid-19 Fatalities. Published online April 2021. www.RePEc.org
- Multifaceted highly targeted sequential multidrug treatment of early ambulatory high-risk SARS-CoV-2 infection (COVID-19). Reviews in Cardiovascular Medicine. 2020;21(4): 517. doi: 10.31083/j.rcm.2020.04.264
- McCullough PA, Kelly RJ, Ruocco G, et al. Pathophysiological Basis and Rationale for Early Outpatient Treatment of SARS-CoV-2 (COVID-19) Infection. The American Journal of Medicine. 2021;134(1): 16-22. doi: 10.1016/j.amjmed.2020.07.003
- Alexander PE, Armstrong R, Fareed G, et al. Early multidrug treatment of SARS-CoV-2 infection (COID-19) aqnd reduced mortality among nursing home (or outpatient/ambulatory) residents . Medical Hypotheses. 2021;153(110622).
- Lima-Morales R, Méndez-Hernández P, Flores YN, et al. Effectiveness of a multidrug therapy consisting of Ivermectin, Azithromycin, Montelukast, and Acetylsalicylic acid to prevent hospitalisation and death among ambulatory COVID-19 cases in Tlaxcala, Mexico. International Journal of Infectious Diseases. 2021;105: 598-605. doi: 10.1016/j.ijid.2021.02.014
- Dr Erika Drewes is a specialist Family Physician from Cape Town. Her special interest is health optimisation and preventive medicine.
- SA health regulator gives Ivermectin the red light … again! – Professor Aldous and Dr Mdladla interrogate
- Covid-19 vaccines: Has science been ignored for political expediency?
- Why the ‘gold standard’ of proof demanded to green light Ivermectin is inappropriate – Prof Colleen Aldous
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