September 10th was a Significant Anniversary

The following article from Spectator Australia

Saturday September 10 marks the anniversary of the banning of prescription of Ivermectin for Covid by our Therapeutic Good Administration (TGA).

The story of Ivermectin is a story of the pandemic that might have been.

There are doctors around the world, including Australia, who believe that, far from Covid being an unusual disease for which expensive new therapies had to be found, there were existing medicines, which could markedly reduce the chance of ending up in hospital or dying from the infection.

They say one of these is Ivermectin and another is Hydroxychloroquine. These are tried-and-tested drugs that have been used to treat illnesses like scabies and rheumatoid arthritis, respectively, for decades. Their safety profiles are well known because millions, or even billions, of people worldwide, have taken them.

It’s important to note that we know a lot more about the safety profiles of these two drugs than we do about the new Covid antivirals, simply because these established drugs have been used in so many people for such a long time.

And what’s more, they are cheap! They have been ‘off patent’ for decades and so can be made by any reputable pharmaceutical company, with competition keeping prices low.

You would think the government would jump at such saviour drugs. But the TGA banned GPs from prescribing these medicines for Covid.

I’m a medical journalist trained in science with over a decade of experience trawling medical literature and writing up important studies for busy doctors and the public.

Ivermectin was first championed by Dr Pierre Kory, a US specialist critical care physician treating Covid patients.

In December 2020, Dr Kory testified to the US senate on behalf of the Front Line Covid-19 Critical Care Alliance (FLCCC), advocating for Ivermectin to be made available for prevention and early treatment of Covid. He showed graphs demonstrating the effect of the use of the drug in eight states in Peru.

In January 2021, Dr Tess Lawrie, an independent medical research consultant in the UK, who counts the World Health Organisation (WHO) among her clients, independently reviewed the studies gathered by the FLCCC. She sent a video message to the then UK Prime Minister, Boris Johnson, telling him the good news that Ivermectin was effective in treating Covid.

Both Dr Kory and Dr Lawrie thought their message of a solution to the pandemic would be welcomed. They were wrong.

Instead, there were a lot of stories in the media last year, telling us that Ivermectin was something that should not be used for early treatment of Covid.

In February 2021, I edited a piece that drew on a Reuters news story which was in turn based on a press release from the pharmaceutical company, Merck, the original developer of Ivermectin.

Merck said it had concerns about the safety of the use of its drug, Ivermectin, for Covid, and that there was ‘no meaningful evidence for clinical activity or clinical efficacy’ in Covid patients.

As I edited the story, I remember saying to myself: ‘Good heavens, that’s the first time I’ve ever seen a press release from a drug company rubbishing its own drug!’ I put it in the ‘surprised’ bucket and thought about it no more.

Merck made another press release in March 2021. Good news! They were re-purposing an antiviral they had been developing and it was doing well in phase 2 trials as an early treatment for Covid. The drug’s name – Molnupiravir.

Merck, and other companies, were hurrying to develop new, patented therapies for early treatment of Covid. They were aiming to get an Emergency Use Authorisation (EUA) that would make their path to regulatory approval faster, easier and cheaper.

But a condition of the US Food and Drug Administration’s EUA is that ‘there are no adequate, approved, and available alternatives’.

I was astounded when, on September 10, 2021, the TGA banned GPs from prescribing Ivermectin for Covid, though perhaps I shouldn’t have been, since similar restrictions on the use of Hydroxychloroquine had been put in place in March 2020.

The ban attacked something doctors and patients hold dear – the doctor-patient relationship.

It is a long-held tradition that a doctor can use their judgment to prescribe a medication for a condition other than the one it has been approved for, as long the doctor believes it to be in the best interests of the patient. This is called prescribing ‘off-label’.

By that stage, the media worldwide were disparaging Ivermectin as a Covid therapy, including in a tweet from the US Food and Drug Administration emphasising its use as a dewormer in horses and cows. Some Australian journalists were busy running an Ivermectin witch hunt, exposing GPs who were breaking the TGA’s ban.

Let’s examine the statement the TGA wrote when they banned our GPs from prescribing Ivermectin for Covid.

They gave three reasons.

First, they were worried that people might choose to use Ivermectin rather than be vaccinated. ‘Individuals who believe that they are protected from infection by taking Ivermectin may choose not to get tested or to seek medical care if they experience symptoms. Doing so has the potential to spread the risk of Covid infection throughout the community,’ they said.

How laughable this seems, especially in the light of what has happened: multiply-vaccinated people everywhere are catching and spreading Covid!

‘Secondly, the doses of Ivermectin that are being advocated for use in unreliable social media posts and other sources for Covid are significantly higher than those approved and found safe for scabies or parasite treatment.’ But remember, Ivermectin was going to be prescribed by qualified GPs, not Facebook!

Finally, they said that the increased use of Ivermectin for Covid might lead to shortages for its TGA-approved uses such as for scabies. ‘Such shortages can disproportionately impact vulnerable people, including those in Aboriginal and Torres Strait Islander communities.’

What a lack of faith this shows in the free market, particularly considering that the drug is off-patent and can be made by many pharmaceutical companies! If demand were to increase, so would production.

Back in September 2021, how could the TGA, have responded rationally and scientifically to the reports of Ivermectin’s effectiveness for Covid? Let’s consider the evidence.

First, the drug had an exemplary safety record. Dr Kory says 3.7 billion doses have been distributed over its 35 years of use. The WHO has Ivermectin on its list of essential medicines and its discoverer, Japanese scientist Dr Satoshi Omura, received the Nobel prize in 2015 for the drug, which has dramatically reduced river blindness and other diseases caused by roundworms.

There was never a question about safety – providing a doctor prescribed the drug properly – there was only a question about whether it worked.

Furthermore, there was no body of evidence showing Ivermectin made Covid worse – instead there were numerous randomised controlled trials showing it made it better. Physicians like Dr Kory were saying it had turned patients around and there were reports that some states in Mexico, Peru, and India had found it to be very effective.

One has to ask – what was to be lost by trying it? And what was to be gained – if it really worked as Drs Kory and Lawrie suggested – was a markedly reduced number of people getting seriously ill and dying from Covid.

Here’s a possible alternative approach. Instead of banning Ivermectin, the TGA could have allowed GPs to prescribe Ivermectin for Covid but require them to report on the outcome. In other words, proactively collect data on its effectiveness.

One year on, we may reflect on what the outcome of such a decision might have been.

And if you are wondering what happened about Mulnupiravir, Merck got its EUA and reports sales of USD 4.4 billion for the first half of 2022. Molnupiravir (sold as Lagevrio) is now being used to treat early Covid in Australia. The other new antiviral being used in Australia, Paxlovid, which also got its EUA last year, has been forecast by its developer, Pfizer, to bring in USD 22 billion in sales in 2022.

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