Crowdfunded online clinical trial gives ivermectin to treat COVID-19

2022-07-23 03:16:27 By : Ms. Daisy Lee

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Australians are bragging online that they're able to legally take ivermectin thanks to a study given approval by a controversial institute.

Australians are bragging online about a loophole that allows them to legally obtain ivermectin to treat COVID-19 after a crowdfunded group of doctors launched a clinical trial approved by a controversial medical institute.

The “Primary Care Australian COVID-19 Therapeutics (PAC) Trial” is a clinical study funded by not-for-profit Lumina Medical Research to test “therapies to prevent progression of COVID-19” that has recruited dozens of participants. It is officially registered and received ethics approval from the National Institute of Integrative Medicine in Melbourne. 

The trial is open to anyone who signs up via a website after testing positive for COVID and participants are mailed a treatment of drugs including ivermectin. 

Numerous large, credible international studies have determined that ivermectin is not an effective treatment for COVID. 

Despite this it has been championed by sceptics and conspiracy theorists as an alternative to vaccines. Participants in Australian online conspiracy groups have shared PAC trial’s details as a way to get access to the drugs.

“They will deliver the therapeutics to you and it includes ivermectin,” one user wrote.

Even as the PAC trial is shared by some as a way to legally access ivermectin, the team behind it says it’s not about testing the anti-parasitic drugs.

Instead the study is presented as being about assessing the effectiveness of an over-the-counter medicine to treat heartburn, famotidine, as part of a COVID-19 treatment. The design of this study means that both arms of it — meaning everyone who’s enrolled — are treated with ivermectin, antibiotic doxycycline, vitamin C, vitamin D and zinc. 

University of New South Wales researcher Kyle Sheldrick told Crikey the study would not provide any proof that this cocktail of drugs would help with COVID-19 given the lack of a true random, blind study: “This is not a piece of research that can seriously give us any information about how ivermectin works and whether it treats COVID-19.”

Trial participants can register within the first four days of testing positive if they are over 40. Once they’ve indicated interest, the study says a nurse will contact them, answer any questions, obtain consent and then send out the treatment along with an oximeter. Participants are supposed to keep a diary of their oxygen saturation levels and speak to either a doctor or nurse daily.

The trial is registered with the Australian New Zealand Clinical Trials Registry with a target of 300 participants and claims to have registered 44 patients in a month. No results have yet been published.

PAC trial is the first registered trial of Lumina Medical Research, a registered charity launched in late 2021. Its website claims it was founded by “healthcare professionals, who saw a need for ethical and objective medical research in the COVID-19 landscape”. 

The charity lists three directors: Dr Bruce Wauchope, Dr Lucia Murnane, and Paul Batten. None of them responded to interview requests or specific questions about the study.

Wauchope is the owner and principal at a South Australian general practice clinic, Bedford Medical Clinic, which also promotes PAC trial on its website. Murnane is listed on a LinkedIn account as a GP at a Melbourne practice who also signed an open letter calling on Dan Andrews in September 2020 to “reopen safely”. Both are also contacts for PAC trial along with Dr Lucas McLindon, an obstetrician and gynaecologist who lobbied to oppose the decriminalisation of abortion in South Australia in 2018.

The Lumina Medical Research website claims that each participant costs $501 for insurance, salaries, medicines and other administration. So far, the charity said it has raised enough to cover the first 300 participants — costing more than $150,000 — and is seeking enough to cover 2000.

“Lumina Medical Research, with its community based origins and spirit, has been funded by generous members of the community. We have not received any funding from the pharmaceutical industry or lobby groups,” it said. 

The trial received ethics approval from the National Institute of Integrative Medicine (NIIM). It also lists NIIM’s director of research Assistant Professor Karin Ried as the study’s chief investigator, and NIIM’s Professor Avni Sali and Dr Taufiq Binjemain as investigators assisting.

For clinical trials to go ahead in Australia outside of a public hospital, they must simply be approved by a human research ethics committee registered with the National Health and Medical Research Council (NHMRC). 

Human research ethics committees are responsible for reviewing a study’s design, safety and ethics and for deciding if it can go ahead. Even then, a human research ethics committee’s compliance with the standards — the National Statement on Ethical Conduct in Human Research — is self-reported. 

NIIM has come under scrutiny for approving controversial clinical trials in the past. In August 2021, The Age reported that Victoria’s health minister asked the health complaints commissioner to investigate it after it was revealed a disgraced former doctor had been employed to run blood tests in an unaccredited laboratory.

As part of this investigation, documents showed that NIIM told the NHMRC that it did not have enough members to meet NHMRC requirements. The NHMRC told Crikey that the NIIM human research ethics committee has provided information to show that it now complies with its requirements.

NIIM did not respond to questions about its involvement in the trial.

Dr David Vaux is a medical researcher and member of the Centre for Scientific Integrity who has criticised Australia’s lack of regulatory oversight for clinical studies. He said Australia’s regulatory framework is fundamentally flawed: “There’s no process of oversight. If a human research ethics committee goes rogue, there’s no one to call it out.”  

Speaking generally, he said there was nothing to stop a human research ethics committee from colluding with an organisation to carry out a treatment: “It’s a hole that you can drive a truck through.” 

Dr Ken Harvey is a leading medical campaigner who resigned from the TGA’s advertising committee after criticising its weak treatment of complementary medicines. He told Crikey he believed that it is “unethical” to do a trial involving treating COVID-19 with ivermectin because so many properly done trials have shown no benefit. 

“I can’t see for the life of me how it could be ethical to do a trial on ivermectin at this point of time,” he said.

The trial has been promoted by users across Facebook, Twitter, YouTube and Telegram as a way of accessing ivermectin. Although the trial has had only little attention, some people have claimed to have enrolled. One YouTube user who claims to have worked as a pharmacist for 20 years uploaded a vlog about her experiences in the trial: “It’s an excellent way to assess the effectiveness of these therapies.”

One user told a Telegram channel run by One Nation Senator and ivermectin promoter Malcolm Roberts that she had met one of the doctors behind the trial at a party in May.

“He said to spread the word, as he can’t,” she wrote. “You have to have a positive RAT, ideally PCR too but not necessary (they’re preparing for naysayers who challenge their research).”

Others replied saying they’d signed up: “Thank you, we have registered. Feeling quite poorly but don’t want to go to hospital.”

Cam Wilson is Crikey's associate editor. He previously worked as a reporter at the ABC, BuzzFeed, Business Insider and Gizmodo. He primarily covers internet culture and tech in Australia.

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Can the anti-vax zealots explain why a proven vaccine is evil and unsuitable for injection into humans whilst a veterinary anti-parasitic drug is OK to ingest?

Errr no comment here on efficacy, but checking / knowing your facts would be good. Ivermectin is a well known and much used (prior to covid) HUMAN anti-parasitic drug, that also happens to be efficacious for parasites in animals.

The paper promoting ivermectin as a treatment for Covid-19 has been proven to be faked, not inaccurate but faked.

Which paper are you referring to?

Parasites are very different to viruses .

Ivermectin was developed in 1975 for veterinary use

it is not a veterinary drug – it was developed for human use

It WAS originally developed in 1975 for veterinary use

It’s good to see you sprouting the ‘truths’ about Ivermectin as it demonstrates the effectiveness of the propaganda blitz we are experiencing. A little research on your part would have shown that the Nobel Prize for medicine was awarded to the discoverers of Ivermectin in 2015. It’s my understanding that this prize is NOT for veterinary discoveries. It was such a revelation 30 years previous when first synthesised that there was a plinth erected outside the Geneva headquarters of the WHO celebrating its discovery, one which the WHO at the time equated with the discovery of penicillin.

If you want to hear of alternative and highly successful remedies for the pandemic, I can go no further but to recommend a book by 2 medical doctors practicing in the Napa Valley of California – “Overcoming the Covid Darkness: How two doctors successfully treated 7000 Patients”. One of the authors, Dr George Fareed, has been an Assistant Professor of medicine at Harvard where he studied recombinant DNA before branching out into full time medical research for the next 30 years. He then went into practice with the other author, Dr Brian Tyson who has practiced in the Napa valley all his professional life. Dr Fareed is also in an academic role with UCLA as an Associate Professor. In this book, they detail how all the patients who followed their methodology were cured of Covid, no matter what variant took the collective fantasy and only 3 died because their recommendations were not followed. An impressive cure rate by any definition.

I for one, at 74 and my wife at 70, unvaccinated and intending to remain so, caught the latest variant (Omicron) 2 months ago. Thankfully we were fully prepared with supplies of Ivermectin, HCQ, aspirin and antibiotics as recommended and were both up and about after 2 weeks of a heavy flu. These results were verified by the necessary testing. We did not need nor did not seek any medical help as we knew that the only help we would be offered is a vaccine which from our research has more potential for harm than the virus itself if properly treated.

I also understand that peer reviewed research has shown that those like us who have overcome this virus have now a natural immunity no matter what variant rears its ugly head. Only time will tell if that is false.

Not to rain on your parade, RW, but at least four of my friends and co-workers have caught Covid in the last three months, and none experienced any issues. Most strain or strains have mutated into symptoms resembling little more than a mild cold, and all that was needed was chicken soup and a couple of early nights. Your course of treatment might have been overkill. (Unless you’ve got horse worms). For the record, all were vaccinated.

Time has already told that is false.

The point is that they are both drugs. Why is one evil (but with proven efficacy) and the other acceptable (although the evidence is that it is inefficacious in treating COVID-19)?

This year’s Darwin awards should be well subscribed.

Ahh Cam, more clickbait on a slow week? A whole 44 people have so far signed up for a medical trial that is approved by the organization that is supposed to approve of such things, but it’s a serious conspiracy is it? I just don’t understand your antipathy to other people’s opinions and desires to find out. It will work or it won’t. It will help them or it won’t. Maybe it’ll prove that the whole ivermectin, Vitamin D and zinc thing is a wank. Maybe not. You think not. Most of your readers here will ‘think not’ with you. I sure as heck don’t know the answer and personally wouldn’t be keen to put large amounts of a human anti-parasitic chemical into my body. Either way, why the heck are you so invested against them finding out? Why not let them find out for themselves? What is the freaking big deal here?

An investor wishes to bring into Australia, one hundred thousand boxes of rainbow-coloured candy-snacks made out of mushroom-extract that reportedly protect children from autism.

The investor has already launched a massive global social media campaign spruiking the ‘medical confectionary’, and has formed an investment partnership with at least one media mogul who has asked his star contrarians to lobby for the product using the nanny state v free enterprise/communism v freedom tropes.

Should Australian be ‘free’ to find out for themselves if the product does what it says and if the mushroom extract is likely to actually poison them?

Or should a representative of the Australian people – say, a democratically elected government – be tasked with doing a few background checks first to make sure the product passes all the import requirements?

I think the answer to “What is the freakin big deal here?” is the bigger story. Mass vaccination to reduce hospitalisation and death was the strategy most health and gov bodies agreed was the best approach.

Alternatives like Ivermectin prophylaxis undermined that strategy. The guardians of knowledge – public health authorities and the media become activist in supporting this approach and characterised Ivermectin as a hobby horse of cookers, antivaxers, freedom gronks and right wing grifters (unfortunately Cam you’re kind of on that program with this article) By doing this and being selective with the truth, they undermined their own authority and actually created more resistance.

Just to be clear I support vaccination.

Everyone these days seems to be a professor -the university industry throws the title around the same ways as other industries use shift supervisor , team leader etc around but professor seems more grandiose.

How can research be conducted into a cocktail and then discern what works – it is usually the other way around- something works what ingredient is the one that works. for instance eating purple foxglove flowers helped heart patients then the component of the plant – digitalis is what worked on the heart so we stopped the eating flowers and took the medicine derived from the plant..

Professor is an academic title not any type of qualification.

At this stage, shouldn’t we just let stupidity be appropriately rewarded and work on the best treatments for the rest of us? It’s almost impressive the lengths people are going to taking a drug that demonstrably doesn’t work for what they want to use it for.

It’s not like in 2020 when there were hints it may have had some efficacy (who knows why anyone thought an antiparasitic drug would work against a virus) and there was nothing else really to point to that works. Now we have a good body of evidence around a variety of prevention measures and treatments, all of which are accessible as part of our healthcare system.

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