A controversial anti-malaria drug will be given to Australian Covid-19 patients in hospitals outside of clinical trials, the federal government confirmed, after the therapeutic goods registration requirements for two drugs were waived to allow them to be imported to and stockpiled in Australia.
The drugs, hydroxychloroquine and chloroquine, are being explored in clinical trials around the world for their potential as a coronavirus treatment to ease symptoms, or as a preventative drug to stop people being overcome with the infection. Trials are exploring use of the drugs on their own as well as in combination with others.
But clinicians have warned that hydroxychloroquine can cause severe and even life-threatening side-effects, and have cautioned against using it for conditions for which it has not been tested. It is a proven treatment for malaria and for some autoimmune conditions.
Studies on its efficacy as a Covid-19 preventative or treatment are mixed. Much of the focus on the drug came after a small French study, which has since been widely disputed and been found to have omitted data contain spurious results. A small study from China found no benefit to chloroquine being given to Covid-19 patients.
Hydroxychloroquine has also caused division within the White House, Axios reported, after the US president, Donald Trump, hyped it as a “game changer” in treating the virus. The White House infectious disease expert warned Trump that evidence for the drug was only anecdotal and far from proven.
A health department spokesman said the inclusion of the medicine in the national medical stockpile was based on not only its proven clinical uses, but on its potential clinical utility in the absence of a well-documented treatment.
While “clinical trials are critical for ensuring the safety and effectiveness of potential treatments, before they are made available through the health system”, the spokesman said, the drug would be made available not only for clinical trials but “for use in hospitals for ill patients”.
The government said under an emergency exemption to therapeutic goods registration requirements the drug would be sourced from overseas and imported, including intermediates and other raw materials so that local manufacturing could occur.
The department confirmed that the former federal politician Clive Palmer, who has said he will produce 1m doses of the drug, has a prior written arrangement with the commonwealth and so his plan aligned with the emergency exemption.
“It is anticipated that medicines containing hydroxychloroquine sulfate will be made available to the national medical stockpile from a number of pharmaceutical companies,” the spokesman said. “Some of these include generous donations funded by Mr Clive Palmer.”
Novartis Pharmaceuticals Australia has also confirmed that it will provide doses. And the government is investing $1.5m to support guidance for clinicians to ensure they are given the best possible advice on managing Covid-19 patients.
An infectious diseases expert and former World Health Organization adviser, Prof Peter Collignon, said he was concerned the stockpiling was being driven by hype and panic.
“It a very bad idea to have panic driving drugs we are going to give to people and chloroquine is just an example of panic,” Collignon said.
“It is very important to look at and evaluate these drugs around the world but to only issue these drugs after that evaluation. Or we run the risk of killing people.
“I would be worried about it being made available in the absence of strong trials and doctors make panicked decisions. Panic can blur good science and doing things safely.”
He said Australia was not overwhelmed with patients in hospitals like New York and London were, so Australia had time to make careful and considered clinical decisions.
Dr Sacha Stelzer-Braid, a senior scientist in the virology research lab at the University of New South Wales and the Prince of Wales hospital, said while laboratory studies using hydroxychloroquine to inactivate the virus look promising, we still needed to be cautious about the possible use of the drug to shorten the duration of infection or even possibly prevent infection, if used prophylactically in healthcare workers, for example.
“We do need to wait for the results of proper clinical trials to see whether the in vitro laboratory results translate to having any effects in humans,” she said.
“It sounds like part of the stockpile will be used for these clinical trials in the first instance, which is a wise move. At the moment we don’t have any antivirals that we can use against the virus, so I can understand the move to acquire a drug that has preliminary evidence as possibly effective. However, I think we still need to be careful and observe our usual protocols of clinical trials, albeit at a more accelerated rate than usual.”