Kara Thomas and Andrew McIntyre
It appears that we live in a reality where doctors are censored and early treatments such as ivermectin are banned, apparently to ensure public confidence in the government’s vaccine rollout is not undermined.
AHPRA and National Boards threatened doctors with regulatory action on March 9, 2021 if they made any statements that ‘undermined public confidence in the vaccination rollout’. The TGA also banned ivermectin’s use for the prevention or treatment of Covid in September 2021 because, according to the TGA, if people had access to it they may not get vaccinated. Are we seeing a trend?
From the TGA website.
In whose interests are decisions really being made? Ivermectin is safe, cheap, fully approved, and has been shown effective in the prevention and treatment of Covid, as will be demonstrated. As repeatedly outlined in Senate estimates by Martin Fletcher, CEO of AHPRA, doctors can use their clinical judgment and the best available evidence to treat their patients – except they can’t in this country because of excessive government overreach. These decisions do not seem to make any medical sense, let alone resemble public protection. Is it possible that the TGA, being 96 per cent funded by the pharmaceutical industry, is influencing restrictions and approvals? Some in the medical industry have asked the question now, and in the past, including a ‘scathing review’ from the BMJ in July of 2022. The TGA has always maintained that their decisions are made independent of financial attachment. Even so, a Goldman Sachs analyst suggested in a 2018 report, ‘Is curing patients a sustainable business model? These questions arise when trying to explain the banning of ivermectin as a safe, Nobel prize-winning, WHO essential medicine which showed a strong signal of benefit, under the banner of sudden safety concerns.
What the TGA does is to cite safety and a lack of evidence against ivermectin, and then instead it goes in favour of vaccines only provisionally-approved, novel, poorly tested, and lacking in safety data. These are vaccines that in reality don’t work well and at the same time have the highest rate of adverse events of any therapeutic ever prescribed, according to government information outlets, both in Australia and overseas.
On September 10, 2021, a delegate of the Secretary of the Department of Health considered the advice provided by the Advisory Committee on Medicines Scheduling (ACMS) and made the decision to amend the Poisons Standard by creating a new Appendix D listing for ivermectin, and thus eliminated its use as an off-label treatment option for Covid. This occurred with reference to subsection 52E(1) of the Therapeutic Goods Act 1989, in particular paragraph (f), which empowers the Secretary to act on any other matters that the Secretary considers necessary to protect public health.
The Australian Medical Professionals’ Society made a public submission to the TGA Consultation on September 29, 2022 arguing that the Poison Scheduling for ivermectin was inappropriate, not evidence-based, and not in the best interests of medicine in Australia. Our submission reviewed extensive evidence showing ivermectin use was associated with statistically significant reductions in mortality, time to clinical recovery, and time to viral clearance for Covid. It can be argued and indeed it is, in fact, being argued here that denying Australians access to ivermectin poses a threat to public health and the secretary’s other matters were not used appropriately to protect the public.
The TGA on February 3, 2023 following a review of multiple extensively-referenced submissions decided not to amend the current Poisons Standard in relation to ivermectin, ‘for your safety’, of course. This decision continues the ban on doctors’ ability to prescribe ivermectin either in isolation or as part of a multi-drug protocol for the prevention or treatment of Covid.
In our opinion, from a scientific and medical perspective the TGA approval decisions surrounding ivermectin make no sense. The TGA banned a cheap, safe fully approved repurposed medicine that showed great promise for the prevention and treatment of Covid with 95 clinical trials worldwide. It was banned in favour of promoting a provisionally-approved (experimental) novel genetic lipid nanoparticle synthetic mRNA vaccine that was never tested for transmission, and had poor efficacy of unknown duration with what amounts to limited reliable safety data, according to the TGA’s own reports. Ivermectin efficacy has been tested in more than 90 clinical trials including more than 100,000 patients while the Advisory Committee on Vaccines (ACV) recommended Pfizer be approved on data from one study with the FDA issuing the EUA on efficacy data of 170 patients.
The risk versus benefit analysis by the TGA claims first that ivermectin safety is an issue, and secondly that the efficacy evidence base for use in Covid is not well established. Our AMPS submission addressed these two reasons for denying Australians access to ivermectin for the treatment of Covid.
AMPS showed ivermectin has a well-established safety record – ‘more than 3.7 billion doses of ivermectin have been administered to humans worldwide since the 1980s’. The TGA’s 2013 AusPar Report for ivermectin stated, ‘No significant safety concerns were found with the use of ivermectin.’ Very importantly, the report found no safety concerns even at 10 times the (then) current approved dose of 200ug/kg. The U.S. National Institute of Health (NIH) has recognised that ‘ivermectin has been widely used and is generally well tolerated’. A recent systematic review stated ‘ivermectin at the usual doses is considered extremely safe for use in humans’. In 2018, ivermectin was added to the WHO list of Essential Medicines, and in supporting the submission for inclusion in the list, the WHO concluded that the adverse events associated with ivermectin are ‘primarily minor and transient’. The clinical evaluator in the WHO Report found that there were no significant safety concerns or serious adverse events reported with the use of ivermectin.
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:
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:
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.
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?
Kara Thomas – is the Secretary of the Australian Medical Professionals’ Society.
Andrew McIntyre – Gastroenterologist on Queensland’s Sunshine Coast and Coordinator of the Doctors Against Mandates legal action.