The controversial anti-malaria drug will be given to Australian Covid-19 patients in hospitals outside of clinical trials, the federal government confirms, after Requirements for registration of therapeutic goods for two drugs were revoked to enable them to be imported to and stockpiled in Australia.
Medications, hydroxychloroquine and chloroquine, are being explored in clinical trials around the world for their potential as coronavirus treatments to reduce symptoms, or as preventative drugs to stop people who are treated with infections. Trials are exploring the use of drugs themselves and in combination with others.
But doctor has warned of the hydroxychloroquine can cause severe and even life-threatening side effects, and has been warned against using it for conditions that have not been tested. This is a proven treatment for malaria and for several autoimmune conditions.
Studies of its efficacy as a Covid-19 preventive or mixed treatment. Most of the focus on medicine came after a small study in France, which has since been done a lot denied and found to have deleted data contains fake results. A small study from China found no benefit for chloroquine given to Covid-19 patients.
Hydroxychloroquine has also caused divisions within the White House, Axios reported, after the US president, Donald Trump, considered it a “Game changer” in treating viruses. White House infectious disease experts warned Trump for that evidence the drug is just an anecdote and far from proven.
A spokesman for the health ministry said the inclusion of drugs in national medical supplies was not only based on proven clinical use, but also on the potential clinical utility in the absence of well-documented treatment.
While “clinical trials are very important to ensure the safety and effectiveness of potential treatments, before they are available through the health system”, said the spokeswoman, the drug will be available not only for clinical trials but “for hospital use for the sick”. patient “.
The government says under emergency exemptions for registration requirements the drug therapeutic goods will be sourced from abroad and imported, including intermediate materials and other raw materials so local manufacturing can occur.
The department confirmed that former federal politician Clive Palmer, who said he would produce a drug of 1 million doses, had a prior written arrangement with the Commonwealth and his plan was in line with emergency relief.
“It is estimated that drugs containing hydroxychloroquine sulfate will be available for national medical supplies 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 it will give a dose. And the government invested $ 1.5 million to support guidelines for doctors to ensure they were given the best advice for treating Covid-19 patients.
An infectious disease expert and former World Health The organization’s adviser, Prof. Peter Collignon, said he feared the hoarding was driven by sensation and panic.
“The very bad idea of having panic triggers that we will give to people and chloroquine is just an example of panic,” Collignon said.
“It is very important to see and evaluate this drug throughout the world but only to release this drug after that evaluation. Or we risk killing people.
“I would worry about it being available in the absence of strong trials and doctors making panic decisions. Panic can obscure good knowledge and do things safely. “
He said Australia was not overwhelmed by patients in hospitals such as New York and London, so Australia had time to make careful and considered clinical decisions.
Dr Sacha Stelzer-Braid, a senior scientist at the virological research laboratory at the University of New South Wales and the Prince of Wales hospital, said while the laboratory studies used hydroxychloroquine to disable the promising appearance of the virus, we still need to be careful about the possibility of using drugs to shorten the duration of infection or even prevent infection, if used as prophylaxis in healthcare workers, for example.
“We need to wait for the results of appropriate clinical trials to see whether in vitro laboratory results are translated to have an effect on humans,” he said.
“It looks like part of the inventory will be used for this clinical trial in the first example, which is a wise move. At the moment we don’t have any antivirus that we can use against viruses, so I can understand the steps to getting drugs that have preliminary evidence that might be effective. However, I think we still need to be careful and observe our usual clinical trial protocols, even at a faster rate than usual. ”
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