Did the ivermectin ban cost lives?

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.