Fears Australian military personnel will be harmed by coronavirus drug trials
Labor, the crossbench senator Jacqui Lambie and experts have urged Defence to avoid exposing military personnel to harm while using them to test potential Covid-19 drugs.
The Australian defence force is using its members for a clinical trial of chloroquine, an anti-malarial drug, as a potential “preventative measure against Covid-19”.
Chloroquine and a similar compound, hydroxychloroquine, have been hailed as miracle drugs by the US president, Donald Trump, despite the lack of any comprehensive study backing their efficacy for Covid-19 prevention or treatment.
Both have known side-effects and experts say more research is needed to determine whether they are safe and effective in humans.
The Doherty Institute is currently leading a separate randomised trial of hydroxychloroquine – and a separate drug used in Aids treatment – that involves 2,500 patients at more than 70 hospitals, covering every state and territory of Australia, and 12 hospitals in New Zealand.
“While the World Health Organization considers both drugs used in this trial to be promising treatments for Covid-19, more research is needed to ensure they are safe and effective in humans,” said associate professor Steven Tong, the co-lead of the Doherty research.
Defence, though, has faced sustained criticism for its handling of such trials in the past.
The trial of a separate anti-malarial, mefloquine, on soldiers serving in Bougainville and Timor-Leste in the 1990s and 2000s prompted widespread complaints of serious side-effects and unethical conduct.
Veterans said they were used as “guinea pigs” and their complaints sparked multiple inquiries, which largely delivered favourable findings to Defence.
A key concern is that ADF personnel, who operate in a rigid and hierarchical command structure, do not have the ability to freely consent to taking part in medical trials. That concern was raised in the findings of a Senate inquiry in 2018, which urged Defence to “improve the consent process”.
Defence says it has since implemented the recommendations of previous inquiries and taken steps to ensure that the new chloroquine trial is voluntary. The department said the safety of its personnel “is our highest priority”.
The shadow defence personnel minister, Shayne Neumann, agreed that there was a need for Australia to do everything it could to tackle Covid-19, including conducting clinical trials.
But he also warned it was critical that the trial program was truly voluntary, saying the safety and health of ADF members was “paramount”.
“It is important that those defence personnel who participate in any drug trial are properly informed of the nature of the trial and do so voluntarily,” Neumann told Guardian Australia. “Any trials must be conducted safely and ethically, and be completely voluntary.”
Lambie said the trials had to be conducted with more stringent oversight and accountability than the mefloquine tests. She said she didn’t “want to see this as another cover-up, like the mefloquine – it’s as simple as that”.
“They’re going to have to go in a lot harder and watch what’s going on than what they did with the mefloquine,” Lambie told Guardian Australia. “What safety are they putting in? What reporting procedures? What checks?”
“If they haven’t learnt from the first time they did this, without having all that appropriately put in place … who’s policing all this?”
Defence said the current trial was not an anti-malarial trial like that conducted with mefloquine. Instead, it involved the testing of a “well-known drug for a new purpose”.
The trial would involve civilian and ADF healthcare workers. It would also be entirely voluntary and require a “deliberate action” by potential volunteers wanting to take part.
“This requires taking action to access and read all online information, watch a video explaining the trial and to make an appointment to attend in-person for evaluation,” Defence said. “They are then carefully screened against a set of inclusion and exclusion criteria.”
Participants would be required to fill out daily questionnaires detailing the state of their health and wellbeing, Defence said. Close monitoring would take place and participants could quit at any time.
“Well conducted clinical trials are needed in the global fight against Covid-19,” Defence said.
The US Centres for Disease Control has described chloroquine as “a relatively well-tolerated medicine”, which has some side-effects, including most commonly stomach pain, nausea, vomiting and headaches.
Australia’s drug regulator, the Therapeutic Goods Administration, also says the side-effects of chloroquine can include headaches, skin eruptions, gastrointestinal disturbance, psoriarsis and, in rare cases, psychotic episodes, anxiety, personality change, seizures and blood disorders.
The actor and singer Rita Wilson was given chloroquine when she and her husband, Tom Hanks, tested positive for Covid-19 this year in Australia. Wilson claimed to have suffered side-effects including nausea and vertigo.
Research out of the US tested the similar compound of hydroxychloroquine in veterans’ hospitals. The Associated Press reported that the study – which was not rigorous or peer-reviewed – showed no benefit for Covid-19 patients. More deaths were recorded for those given hydroxychloroquine compared to those who received standard care, the study said.
Assoc Prof Jane Quinn, a pharmaceuticals researcher at Charles Sturt University’s school of veterinary sciences, has worked with veterans to study neuropsychiatric conditions arising from quinolone anti-malarials like mefloquine.
Quinn said she was concerned that Defence’s “management of past trials of these sorts of drugs” was problematic. She said the military had traditionally been poor at obtaining informed consent for clinical trials. The drug itself, she said, was completely unproven.
“I think it’s an unsubstantiated use at the present in that there has been no suggestion that you can prevent somebody from contracting Covid-19 by giving them hydroxychloroquine,” Quinn said. “There’s been no proof of that at all.”
“So why we would be saying that we will undertake a first trial to look into that with Defence members, I don’t know. I don’t think that’s the right population to even be trying to attempt that.”
The Senate inquiry into the mefloquine and tafenoquine trials said serious side-effects were rare and noted that the Defence inspector general had found some were “conducted ethically and lawfully”.
Defence, acting on the recommendations of that inquiry, appointed an advocate for trial participants. The advocate role is designed to give ADF personnel a confidential mechanism to seek advice and support about clinical trials.
This latest trial is being conducted through the ADF’s malaria and infectious diseases institute, in conjunction with the national medical countermeasures initiative at DMTC Ltd. It has received ethics approval and will be subject to the rules and regulations of the TGA, including rules around informed consent.
Prof Peter Collignon, an infectious diseases physician, has previously said he would be reluctant to have anti-malarials tested on him. “If I got Covid-19 tomorrow, I wouldn’t want any of those drugs being tested [on me],” he said.
“It could help with treatment, it could do nothing, or it could be very harmful, and at at the moment we don’t know which of those statements are true.”
“Hydroxychloroquine is quite a worry for two reasons, including that people are already using it when there are marginal benefits for it, and people can take too high a dose and experience toxicity. So often, clinical trials give preliminary results that look promising but in doing the proper larger studies you realise not only that it doesn’t work, but it does more harm than good.”