No Evidence Required? What About Ivermectin?


I know I’ve touched on this topic in a previous post, but as Winston Churchill said:

“If you have an important point to make, don’t try to be subtle or clever. Use a pile driver. Hit the point once. Then come back and hit it again. Then hit it a third time – a tremendous whack.”

This is a direct cut and paste from the Therapeutic Goods Regulations:

Source: Therapeutic Goods Regulations 1990 – Part 2D – Provisional determinations for medicine

Part (2) is a new addition to the latest version of the Regulations. Inserted specifically to cater to the new ‘vaccines’…obviously!

You’ll notice that it has removed, amongst other things, the requirement to provide “preliminary clinical data demonstrating that the medicine is likely to provide a major therapeutic advance”, as long as the medicine is designed to treat or prevent COVID-19.

That leaves us with pretty much only one requirement to get Provisional Registration for a COVID vaccine…a plan to collect and provide safety and efficacy data at some point in the next 6 years, after it’s been unleashed on the public.

Unbelievable that such a low bar can be set for something now being effectively made mandatory, but wait…

If there is no longer a need to demonstrate “that the medicine is likely to provide a major therapeutic advance”, why has Ivermectin been banned for treating COVID based on the claim that:

The head of Australia’s pharmaceutical regulator said there is no credible evidence ivermectin works to prevent or treat COVID-19.

ABC Morning Show

Surely someone can provide Professor Skerritt with a plan to collect data over the next 6 years?


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Greg
Greg
September 27, 2021 12:00 pm

We are being lied to!

Mark M
Mark M
September 27, 2021 12:06 pm

Disturbing if true … detection of cancer after getting the jab, video of doctor via Twitter …

https://mobile.twitter.com/Kukicat7/status/1441526348309278724

duncanm
duncanm
September 27, 2021 12:40 pm

Exactly Mater,

the hypocrisy stuns me.

They’ll be pushing remdesivir at $3000 a course way before Ivermectin gets a look-in.

duncanm
duncanm
September 27, 2021 12:41 pm

Oh wait. they already did

The Therapeutic Goods Administration (TGA) has granted provisional approval to remdesivir (“Veklury”, Gilead Sciences Pty Ltd) as the first treatment option for COVID-19. It has received provisional approval for use in adults and adolescent patients with severe COVID-19 symptoms who have been hospitalised.

duncanm
duncanm
September 27, 2021 12:42 pm

(apologies for the multiple posts.. anger is getting the better of my submit finger).

From that TGA announcement..

The sponsor, Gilead Sciences Pty Ltd may apply for full registration when additional clinical data required by the TGA to confirm the safety and efficacy of the medicine are available.

Again – why not Ivermectin?

Crossie
Crossie
September 27, 2021 12:54 pm

We are being ruled by intellectual and moral pygmies who are demanding that we not notice they are intellectual and moral pygmies.

OldOzzie
OldOzzie
September 27, 2021 12:54 pm
OldOzzie
OldOzzie
September 27, 2021 1:36 pm

Australians who participated in the Novavax Covid vaccine clinical trial are currently said not to be vaccinated in the Australian Immunology Register.

Hundreds of Australians attended Clinical trial At last year’s Novavax Jab, we hope to help the world get out of the pandemic.

However, participants have faced significant uncertainties regarding their vaccination status since then and are uncertain whether their doses will be recognized by Australia.

As a result, Novavax study participants may wait several months for the TGA to give its own approval and the vaccine to be recognized in the immune registry.

this is That’s not the only problem Experienced by people who want to get their vaccine approved in Australia prior to the Moted Vaccine Passport System and conditional relaxation.

Guardian has Continued to receive reports Percentage of Australians vaccinated but not reflected in AIR, often due to inadequate data entry by vaccine providers.

Who has Also the mixed dose of Pfizer and AstraZeneca Currently, it cannot be recognized that Covid-19 has been fully vaccinated. Even if you switch the vaccine between the first and second doses and act on medical advice.

The Australian Immunology Registry (AIR) is currently unaware of the vaccine given to Novavax study participants. This is because only vaccines approved by the Therapeutic Goods Department and available in Australia can be added to the enrollment.

“At the moment, this is AstraZeneca Vaxzevria, Pfizer Cominarty, Moderna Spikevax vaccine, “said a spokeswoman.

The Ministry of Health states that if Novavax is approved for use in Australia, vaccinated individuals will “record details in AIR.” Asked if it included test participants, the spokesperson confirmed that it would eventually be included.

The Australian Government has ordered 51 million Novavax vaccines Repeated delay Average delivery is not expected until next year.

Miss Anthropist
Miss Anthropist
September 27, 2021 3:51 pm

Lying sneaking low rent bastards.
That’s what you get with the left in charge.

Bruce of Newcastle
Bruce of Newcastle
September 27, 2021 3:59 pm

The head of Australia’s pharmaceutical regulator said there is no credible evidence ivermectin works to prevent or treat COVID-19.

There’s so much evidence (like Uttar Pradesh vs Kerala) that this is clearly a lie.
Therefore we can’t believe anything Skerritt says.
He should be immediately fired.

Lee
Lee
September 27, 2021 4:13 pm

The head of Australia’s pharmaceutical regulator said there is no credible evidence ivermectin works to prevent or treat COVID-19.

There are none so blind as those who refuse to see.

Judge Dredd
Judge Dredd
September 27, 2021 4:27 pm

You will know them by their fruits.
We can now all see how many lying and wicked people are in charge.
Which is actually a great thing to know, as they have always been there, they are now just exposing themselves to the light.
Make sure though that you never forget, that you will fight the urge to be lulled into a false sense that “good” people are now ruling.
It has never was, and it will not be as long as they follow the god of this world rather than the God of creation.

Fat Tony
Fat Tony
September 27, 2021 5:42 pm

They really want everyone to get “jabbed” – while they loot the Treasury

Indolent
Indolent
September 28, 2021 6:59 am

They’ll be pushing remdesivir at $3000 a course way before Ivermectin gets a look-in.

Of course they will. It’s both expensive AND toxic. Absolutely perfect, from their point of view. The add should read – if you want (short) lifetime of dialysis use Remdesivir.

Indolent
Indolent
September 28, 2021 7:11 am

We are being ruled by intellectual and moral pygmies who are demanding that we not notice they are intellectual and moral pygmies.

We are way beyond the point of accidental damage through ignorance. We have to accept that they are knowingly and deliberately harming us in every way possible – up to and including outright murder in hospitals through the mandated use of a deadly protocol (Remdesivir and ventilators).

A whistleblower nurse in America said that senior administration in the hospital where she worked insisted on the use of a sedative on the elderly at a dose she knew to be fatal. This was at the beginning of the “pandemic” probably to get the death numbers up but who knows how long it went on for and even whether it occurred here as well.

We must let go of the idea that the bad things happening are the result well meaning blunders and accept the fact that we are facing deliberate evil.

Perfidious Albino
Perfidious Albino
September 28, 2021 7:32 am

New 2(a) also seems to cater for ‘new’ (expensive) applications only, perhaps intended to preclude existing treatments (cheap) such as Ivermectin?

However, if Remdesivir can be approved as a Covid treatment under this changed regulation, does it just need someone to have the temerity to make a new application to the TGA for Ivermectin or a treatment protocol including it? If nothing else it would shine a light on any double standard at play.

‘Aussiemectin’ – Where’s Dick Smith when you really need him!

OldOzzie
OldOzzie
September 28, 2021 12:36 pm

Summary of the Evidence for Ivermectin in COVID-19

Ivermectin is an anti-parasite medicine whose discovery won the Nobel Prize in 2015 for its impacts in ridding large parts of the globe of parasitic diseases via the distribution of over 3.7 billion doses within public health campaigns since 1987.

Since 2012, numerous in-vitro and in-vivo studies began to report highly potent anti-viral effects of ivermectin against a diverse array of viruses including SARS-CoV-2. Further, increasing antiinflammatory and immuno-modulating effects are being identified

Our comprehensive narrative review of the “totality of the evidence” supporting ivermectin was published in The American Journal of Therapeutics in April, 2021 where we reviewed data on efficacy from a diverse array of scientific sources beyond just the randomized controlled trial evidence as illustrated in the diagram below.

Currently, as of September 19, 2021, the totality of the evidence is as follows

CONCLUSION

Based on the totality of the existing evidence above, the FLCCC strongly recommends ivermectin be used in both the prevention and treatment of all phases of COVID-19 in both vaccinated and unvaccinated populations.

Retracted Research

The totality of evidence for ivermectin is large enough that removal of any single data set, trial or study has minimal impacts. The integrity of one study in Egypt (Elgazzar et al) out of the then 28 RCT results available, was recently called into question. While we share the concerns about this study, the removal of its data from the most comprehensive meta-analyses did not change the conclusion that ivermectin is highly effective in both prevention and treatment

John H.
John H.
September 29, 2021 3:44 pm

There is the sarcasm that ivermectin is horse juice. The irony is that the popular street drug ketamine, colloquially referred to as horse tranquilliser, is FDA approved for the treatment of depression. I know how ketamine works and have serious concerns about long term use.

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