Human trials begin despite warnings about Monash' COVID-19 head lice study

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Human trials begin despite warnings about Monash' COVID-19 head lice study

By Liam Mannix

A Monash University study showing that a head lice drug kills the COVID-19 virus has prompted warnings from other researchers the level of drug needed was up to 100 times higher than approved human doses.

The publication of the study led to a surge in demand for ivermectin around the world, forcing the US Food and Drug Administration to issue an extraordinary warning urging people not to take the drug, cautioning it “can cause serious harm in people.”

A microscope image of the virus that causes COVID-19.

A microscope image of the virus that causes COVID-19.Credit: AP

The study, published on April 3, shows certain concentrations of ivermectin can kill the virus that causes COVID-19 in cells in a test tube.

Ivermectin is a commonly used and inexpensive treatment for parasites, including head lice. It can be taken as a tablet or applied as a cream, and is used as a heartworm medicine for dogs.

But the amount of the drug a person would need to take to reach those levels is up to about 100 times the approved dose of the medicine, and about 10 times higher than levels ever studied in humans, two independent scientists say.

The Sunday Age has seen emails indicating those scientists, Professor Mark Sullivan and Dr Craig Rayner, were asked to informally review the ivermectin data before publication.

They said they raised major concerns about the extremely high levels of the drug used in the study and suggested more research was needed.

A spokesman for Monash's School of Biomedical Sciences said the paper was peer-reviewed, and it was normal to publish early results and then build on them.

"This is just how research works," he said. “I think it’s perfectly reasonable to publish that positive response, and then look at what the next steps are, so we can get progress moving as quickly as possible.

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“In this sort of environment, what you don’t want to do is keep data back that could be beneficial."

Monash said the rush to clinical trials was an unintended consequence when "it’s been clear in everything in relation to their paper, in relation to the information that’s gone out in the press release, that it’s not ready for human trials".

But Professor Sullivan said he was shocked to discover the study had been published despite his concerns.

“Using the highest possible dose that’s been studied in a human, it’s 10 to 30 times short of where it needs to be,” said Professor Sullivan, managing director at vaccine development company Medicines Development for Global Health.

“You will hit safety problems far sooner than you will hit efficacy.”

Dr Rayner, president of integrated drug development at Certara and adjunct associate professor at Monash, said he urged the scientists to make a “pretty simple” calculation on how much ivermectin a person would need to take to potentially kill COVID-19 before publication.

“What was disappointing was there were some very easy things that could have been done to contextualise the relevance to the clinic that weren’t made."

“We cannot give false hope.”

Professor Sullivan is so concerned he is contacting anyone doing an ivermectin clinical trial to tell them about the dosages required.

At least three clinical trials giving the drug to patients have been registered, two in Egypt and one in Iraq. One Florida medical clinic is now using the drug to treat patients, according to a report from NBC, and a network of hospitals there plans to start rolling out the treatment to patients.

The journal that carried the original study has now published two letters from scientists raising concerns about it.

The American Journal of Tropical Medicine and Hygiene carried an editorial saying the drug should be tested in clinical trials, but warned levels needed to kill the virus could be toxic to the brain.

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