‘Unethical’: crowdfunded online clinical trial giving ivermectin to treat COVID-19

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.

Trial’s investigators say it’s not about ivermectin

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. 

Oversight of clinical trials ‘fundamentally flawed’

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.

Online communities are promoting trial

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.”