An unpublished government report on an anti-malarial drug given to thousands of Australian soldiers has been criticised by a decorated war veteran for downplaying the drug’s side-effects.
Mefloquine, also known as Lariam, was given to soldiers deployed to Bougainville and Timor-Leste more than 15 years ago as part of clinical trials comparing its efficacy to doxycycline, an antibiotic and the first-line medication for malaria prevention in the Australian defence force.
Since then there have been well-documented questions raised about the consent process for the soldiers involved in the trials, and veterans have said they were not properly informed of mefloquine’s potential side-effects. Veterans have also spoken of symptoms including suicidal thoughts, hallucinations and nightmares which they attribute to being on the drug, sometimes emerging years later. They have accused researchers of downplaying the extent of severe side-effects such as neurological issues.
Last year an inter-departmental Department of Veterans’ Affairs and Department of Defence steering committee was formed to examine some of these concerns and was ordered to report back to the government with recommendations by November.
Those recommendations have not been made public but were given to Guardian Australia by the Department of Defence.
“The vast majority of Australian defence force members have never been prescribed mefloquine,” the report states.
“Centralised medicines dispensing information has only been available in the ADF since 2000 and records show that, between July 2000 and June 2015, approximately 1,979 ADF personnel have been prescribed mefloquine. Most of these prescriptions were as part of the Army Malaria Institute studies in Timor-Leste from 2000-2002 (a total of 1,319 soldiers).
“These figures are contentious and advocates in this area claim that the real numbers – including those prescribed tafenoquine – are closer to 5,000.”
The report goes on to say that “a small number of current and former serving members of the ADF” attributed mefloquine as the cause of their acquired brain injury and/or post-traumatic stress disorder.
But the committee was “not aware of any globally accepted evidence that supports the suggestion that acquired brain injury can be caused by mefloquine”.
The report also said: “There is no evidence that mefloquine causes or triggers PTSD.”
While veterans and their families have called for a widespread outreach campaign targeting all defence personnel given or prescribed mefloquine to alert them to potential symptoms, the report recommends against this, saying “the vast majority are no longer serving and are unlikely to have any adverse health effects from its use”.
A difficulty for researchers has always been untangling which symptoms may be due to the drug and which may be due to other illnesses or mental health conditions brought on by servingg.
Major Stuart McCarthy said the committee’s report was based on “poor and misleading advice” from senior veterans’ affairs and defence staff to the minister for veterans’ affairs, Dan Tehan. He said evidence had emerged since the trials that known serious side-effects of mefloquine were more prevalent than soldiers were told.
McCarthy joined the army in 1998 and was part of another controversial anti-malarial drug trial, for the unregistered drug tafenoquine, after being deployed to Bougainville in 1999. In 2001, during six months deployed to Ethiopia and Eritrea, he was prescribed mefloquine and experienced adverse side-effects including depression.
He continued to suffer neurological symptoms that he believes are due to a neurotoxic brain injury caused by the drug. In January 2016 McCarthy was diagnosed with an acquired brain injury. He was medically discharged from the army in March.
He said the steering committee report downplayed the seriousness of the side-effects by emphasising the small numbers of ADF personnel prescribed mefloquine between 2010 to 2015. But the drug had used by several thousand personnel since its introduction in early 1990s, he said.
“The main issue of concern is the chronic health effects experienced by the 5,000 personnel given mefloquine and tafenoquine since the early 1990s,” McCarthy said. “Drug regulators including the US Food and Drug Administration warn that mefloquine is able to cause neuropsychiatric side effects that may persist or become permanent.
“Extensive research dating as far back as the 1940s found that several drugs from this class are able to cause lasting or permanent brain damage. Many ADF veterans who were given mefloquine or tafenoquine have since suffered serious health problems including bipolar disorder, schizophrenia, major depression and anxiety, seizures, hallucinations and psychosis, suicide attempts and suicide.
“Minister Tehan has rejected repeated requests to fund independent follow-up health studies involving these veterans.”
Tehan told Guardian Australia that this year’s budget provided $33.5m to extend the non-liability healthcare program to cover the treatment of all mental health conditions for full-time ADF staff.
“So if someone has served one day in the full-time ADF, the government will pay for their mental health treatment, for any condition, without having to prove it was linked to their service,” he said.
“Over the past year defence has had direct contact with more than 250 concerned individuals about the use of melfoquine and has provided information on the trials, how to request individual medical records, and the mechanisms in place through which to seek help.”
Veterans’ affairs has received 21,125 claims since September 2016, 14 mefloquine-related.
McCarthy believes side-effects from mefloquine could confound the diagnosis and management of post-traumatic stress disorder, citing a US military study which found that personnel given mefloquine were almost twice as likely to be diagnosed with the disorder compared with those given other antimalarial drugs. That’s why he wants the outreach program to target anyone involved in the trials.
“ADF veterans are not screened for exposure to mefloquine or tafenoquine prior to being diagnosed with post-traumatic stress disorder,” he said. “Only in rare cases have they been referred to health professionals specialising in brain injury. The vast majority have been unable to access appropriate medical care as a direct result if this mismanagement.”
The Townsville outreach event failed to address these concerns, he said.
But Assoc Prof Harin Karunajeewa, a research fellow at the Walter and Eliza Hall Institute of Medical Research and a specialist infectious diseases physician, described the steering committee’s report as balanced. The drug was safely used by millions of people worldwide each year, he added.
“The bone of contention is how frequently those long-term serious neurological side effects are occurring,” he said.
He added that a serious conversation about informed consent when taking part in clinical trials needed to be ongoing, and that he believed poorly obtained consent during the Timor-Leste and Bougainville trials had led to much of the anxiety around the drug that existed today.
“Those people are suffering and I’m sure their symptoms are real,” Karunajeewa said. “There are real ambiguities around consent when you’re part of an organisation where the basis of its structure is obedience and commands.”
Assoc Prof Jane Quinn, a pharmaceuticals researcher at Charles Sturt University’s school of veterinary sciences, disagreed with Karunajeewa’s assessment that the steering committee report was balanced.
Quinn works with military veterans exposed to quinolone antimalarials, including mefloquine, to study neuropsychiatric conditions that arise from taking the drugs. Originally from the UK, Quinn’s husband, Major Cameron Quinn, was an officer in the British army and was given mefloquine during a training exercise in Kenya in 2001.
He suffered depression and nightmares immediately after taking the drug, Quinn said, and eventually took his own life in 2006.
“The report is disappointing but not at all surprising, because it uses the same rhetoric we have heard from defence and the government all along,” Quinn said. “I think there is still a fundamental disregard for this group of veterans, and shows there is an attitude that has permeates the upper levels of defence and veterans’ affairs that neurological conditions are not bonafide conditions related to this drug.”
All defence personnel deployed to malaria-prone areas are required to take antimalarials. In the ADF mefloquine is a third-line agent, meaning it is only used when one of the other two medications is not appropriate, for example because of adverse reactions. While the number of personnel given mefloquine today is therefore minimal, Quinn said this was not historically the case, particularly for those involved in clinical trials.
She was yet to gain approval from defence to access data from all of those personnel involved in the clinical trials so that she could do a thorough retrospective analysis to ascertain the prevalence and severity of side-effects.
But the steering committee report appeared to have used the same data she had been long requesting to make its recommendations, Quinn said.
“The study myself and another researcher have asked to do would try to evaluate and untangle all of the different things that might be causing these symptoms and ascertain what is being caused by the drug and what is being caused by multiple other factors that can impact an individual over their lifetime,” she said.
The opposition spokeswoman for defence personnel, Amanda Rishworth, said she couldn’t understand why the steering committee report had not been made public.
“When you talk to veterans concerned about mefloquine, they are really concerned about what they consider to be a lack of transparency around the issue,” she said. “Whenever there is new information or research they should have access to it.”
Rishworth said veterans were also concerned about a lack of consultation, and described the Townsville sessions in December as inadequate.
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