Following the latest remarks from the President of the United States regarding hydroxychloroquine, the RACGP has urged Australians not to seek it out to try and cure or prevent COVID-19
The medicine shot to prominence in March 2020 after President Donald Trump announced that it would be fast-tracked by the US Food and Drug Administration as a treatment for COVID-19 infection.
In response to this, the Pharmaceutical Society of Australia asked pharmacists not to dispense it outside its existing approved indications, and asked prescribers not to write scripts for it as a “just in case” measure.
Reports soon came in that increased off-label prescribing could cause a shortage, and Australia’s Department of Health introduced new restrictions on who could initiate therapy.
Now, stakeholders have expressed alarm after Mr Trump said he was taking hydroxychloroquine as a preventive strategy against COVID-19.
US House Speaker Nancy Pelosi told CNN that she would prefer that “he not be taking something that has not been approved by the scientists, especially in his age group and his, shall we say, weight group”.
“I would rather he not be taking something that has not been approved by the scientists, especially in his age group, and in his, shall we say, weight group: ‘Morbidly obese,’ they say,” says House Speaker Nancy Pelosi on Pres. Trump’s revelation he is taking hydroxychloroquine. pic.twitter.com/0ImjpEjg9q
— Anderson Cooper 360° (@AC360) May 19, 2020
The RACGP’s president, Dr Harry Nespolon, said that hydroxychloroquine, as well as chloroquine, should not be used in an attempt to prevent or cure COVID-19.
A trial is currently underway in Australia, aiming to find out whether hydroxychloroquine does in fact have a preventive effect, focusing on health workers who are at significant risk of contracting the disease.
However the RACGP highlighted that as it stands, the evidence is not sufficient to use the medicine in this manner.
“It is positive news that this new Australian clinical trial featuring 2,000 frontline healthcare workers is now open for volunteers,” he said.
“It’s one of several trials underway but the evidence base is simply not there to say that this drug can be used to prevent the COVID-19 virus.
“The results of trials so far have proven inconclusive so let’s just wait to see what emerges from this trial and whether regulatory bodies will eventually give the all clear.
“The COVID-19 pandemic has presented many challenges for public health advocates and health professionals across the world. I can’t believe I have to say this but please do not follow the lead of the President of the United States and immediately source hydroxychloroquine to ‘cure’ or ‘prevent’ the COVID-19 virus.
“The drugs should not be provided to patients outside of a formal randomised clinical trial and I also strongly advise against acquiring these drugs on the dark web or anywhere else.
“When prescribing and using any drug we need to rely on sound, scientific evidence and make careful determinations of whether these drugs or any other can help combat the COVID-19 pandemic.
“We need to exercise extreme caution here. That is one of the reasons why the RACGP supported the Therapeutic Goods Administration’s recent move to place tight new restrictions on who can write prescriptions for these drugs.
“Some studies have also indicated an elevated risk of serious adverse effects like cardiac arrest.”
Dr Nespolon noted that attempts to have the drug prescribed and dispensed for COVID-19 would cause shortages for those who are normally prescribed it.
Meanwhile the President said in a Cabinet meeting that he would continue to take hydroxychloroquine.
“I think it’s worth it as a line of defense,” Mr Trump said. “And I’ll stay on it for a little while longer. I’m just very curious myself. But it seems to be very safe.”
He referred to a “false study” in which hydroxychloroquine was given to “very sick people — extremely sick people, people that were ready to die”.
This was likely the Outcomes of Hydroxychloroquine usage in United States Veterans Hospitalized with COVID-19” study, which has not yet been peer reviewed and which according to its authors “found no evidence that use of hydroxychloroquine, either with or without azithromycin, reduced the risk of mechanical ventilation in patients hospitalized with Covid-19”.
The study, which evaluated 368 patients, found an association of increased overall mortality in patients treated with hydroxychloroquine alone.
“These findings highlight the importance of awaiting the results of ongoing prospective, randomized, controlled studies before widespread adoption of these drugs,” the authors wrote.
“It was given by, obviously, not friends of the administration,” Mr Trump said. “And the study came out. The people were ready to die. Everybody was old, had bad problems with hearts, diabetes, and everything else you can imagine. So they gave it.
“So, immediately, when it came out, they gave a lot of false information, just so you understand.”
The RACGP urged Australians to listen to medical experts rather than “prominent and outspoken advocates of an unproven drug.”