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Health professionals and Army veterans fear military personnel may be "used as guinea pigs" in a drug trial conducted by the Australian Defence Force (ADF) to find a medicine that will help fight COVID-19.
Key points
- The ADF surgeon general has sent an email indicating a COVID-19 drug trial will draw volunteers from the ADF and frontline healthcare services
- International guidelines for good clinical practice say members of the armed forces are vulnerable subjects for medical research
- The CSIRO's health and biosecurity health director says he has confidence the trials will be conducted ethically
Ethical approval to carry out a clinical trial of the anti-malaria drug chloroquine was granted to the ADF's Malaria and Infectious Diseases Institute on Wednesday last week.
It will test whether chloroquine is effective in stopping people from contracting coronavirus.
An email sent by ADF surgeon general Sarah Sharkey and obtained by the ABC's PM program said the trial would involve military personnel and frontline civilian healthcare workers who volunteered to take part.
"Well controlled trials are urgently needed given the profound global impacts of this disease," the email states.
Veterans involved in previous drug trials speak out
Major Stuart McCarthy, who was given the anti-malarial drug tafenoquine during a different trial conducted in the early 2000s, said he had serious concerns about the COVID-19 research.
"One of my primary concerns with these proposed trials is that there will be a degree of coercion placed on exactly the people who will be at the front line of our response to the COVID-19 pandemic," Major McCarthy said.
He said participants in past trials were pressured into taking part and felt unable to report side effects.
"That then has a flow-on effect when those reports are published, that then distorts the safety of those drugs as they enter the civilian market," he said
International guidelines for good clinical practice identify members of the armed forces as vulnerable subjects for medical research because they may feel an expectation to participate.
Steven Scally, a former Australian Army medical officer and practising GP with an interest in veteran health, said the ADF had a "poor track record" of conducting medical research.
"I wouldn't even be confident seeing them conduct trials on Panadol to be quite honest," Dr Scally said.
"We are nowhere near getting to the bottom of what's happened with trials that were conducted many years ago, so I just don't think the Australian Defence Force has an established reputation at all for conducting any sort of medical research at all."
Recommendations on using Defence personnel in drug trials
In 2018, a Senate inquiry handed down its report into the mefloquine and tafenoquine trials conducted by the ADF in the late 1990s and early 2000s.
Veterans involved in the trials told the inquiry they continued to experience long-term side effects linked to the anti-malaria drugs, including psychosis, anxiety, depression and memory loss.
"Many of those individuals continue to beg to charity for medical care, some of them are homeless and sadly many of them have suicided," Major McCarthy said.
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The Department responded to the inquiry by announcing a $2.1 million to provide comprehensive health assessments for those involved in the trials over four years.
It also agreed to the recommendation that the Defence and Veterans' Affairs Human Research Ethics Committee change its terms of reference to consider that research participants may be vulnerable to perceived coercion to participate in trials.
The same committee approved the COVID-19 trial on Wednesday.
An ADF spokesperson said it was part of the whole-of-Government response to the COVID-19 pandemic, and the trial would be subject to rules provided by the Therapeutic Goods Administration, including obtaining informed consent.
But Dr Scally said he did not believe that was possible.
"Consent and volunteerism is a redundant concept in the military," he said.
"Pretty much at the time of enlistment, upon taking the oath, you exchange free will for obedience and that is a culture that really has to exist for the purpose of carrying out your role as a soldier or a sailor or an airman to defend the country."
He said serving members of the defence force should not be subjected to further potential harm by participating in medical research.
"I don't think it's the role of the ADF to offer up its personnel and human resources to be used as guinea pigs for a drug trial," he said.
Some in favour of urgently needed trials
The ADF did not responded to a series of questions from the ABC about suggestions of ongoing health issues in time for publication.
In the email obtained by the ABC, the ADF surgeon general said the safety profile of chloroquine as an anti-malaria drug was well understood from its use in over a billion people.
She said despite the similar sounding name, it did not share the same adverse events as mefloquine.
Others have also spoken in favour of the COVID-19 trial, saying medical research into coronavirus prevention is urgently needed.
The CSIRO's health and biosecurity health director Rob Grenfell said he was confident the study would be well designed.
"Australia has very tight and stringent and some of the highest order of trial-conducted studies," Dr Grenfell said.
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The University of Sydney's head of pharmacy Andrew McLachlan said chloroquine trails were still in the very early stages.
"It is a medicine we have a lot of experience with over really decades of treatment, but like any medicine it does carry some risks, particularly at higher doses," he said.
"Finding the right dose will be absolutely critical, and that's why trials at the moment will be starting with the recommended current doses but potentially exploring a range of doses to see how effective this treatment might be."
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He said testing the drug on people at higher risk from exposure to COVID-19 such as the health workforce would "make sense".
"Of course we're always weighing that against the possible harmful effects of chloroquine and that would have to be monitored," Professor McLachlan said.
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Topics: covid-19, defence-forces, army, medical-research, doctors-and-medical-professionals, australia
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