Claims by war veterans of serious mental health damage caused by antimalarial drug trials have been supported by Defence’s own medical ethics committee, which said it had not been made aware of dangerous side-effects and that the risk of “depression and psychosis caused considerable concern”.
More than 2500 ADF members were used in trials of two antimalarial drugs about 15 years ago even though one drug, tafenoquine, has never been approved for public use in Australia and a second, mefloquine, can cause permanent brain damage among other mental health impacts.
The minutes show that Australian Defence Medical Ethics Committee approved the trials despite having serious concerns, and that some adverse reactions were not recorded.
“This protocol caused considerable debate when it became apparent that mefloquine had potentially serious side effects of which ADMEC had been previously unaware. In particular, CNS [central nervous system] side effects of depression and psychosis caused considerable concern to Committee, especially were they to occur in deployed troops,” the February 2001 minutes reveal.
A senior medical officer told the committee that the trial was “scientifically necessary” and that adverse reactions normally occur after four doses of mefloquine, which are taken prior to deploying overseas.
Mefloquine, which is branded as Lariam and is still available in Australia, was given to about 1300 troops deployed to East Timor in 2001 and 2002. Numerous troops have told The Australian that they were compelled by their commanding officer to take it, but Defence strongly denies this.
ADMEC said in August 2002 that the “apparent high incidence of adverse events was of concern to the committee”.
The ADF has consistently claimed that ADMEC approved all the trials, but the minutes show that the committee was also alarmed by them.
East Timor veteran Scott McCormick was sent back to Australia after he had a psychotic reaction to mefloquine, but his records show that he was not given a medical assessment upon arriving home.
Mr McCormick believes he is one of the 16 per cent participants recorded as having withdrawn from the trial, rather than showing an adverse reaction to the drug mefloquine. A very substantial 6.5 per cent are recorded as having been adversely affected.
Mr McCormick, 34, started suffering from anxiety and sleep disturbances after receiving the first three doses over nine days — more than double the recommended dose. He now suffers from depression and has been awarded a Totally and Permanently Incapacitated (TPI) pension by the Department of Veterans Affairs.
During the trial in 2001, he scrawled on a survey form that he was suffering from anxiety, tiredness and sleep disorders, including bad dreams.
“I was 20, I barely knew what anxiety was but I knew I was feeling it. For me to indicate I was suffering anxiety it must have been something pretty serious and I couldn’t find the column for basket case,’ he said.
He has now been diagnosed with depression and has taken five different antidepressants which have not worked. He says that his mental health problems make it difficult to work.
“I struggle to concentrate. I have learning difficulties and get extremely fatigued. I am concerned about the neuro toxic nature of this drug. I believe it may have done permanent damage,” he says.
Mr McCormick recently pressed the Army Malaria Institute, which was responsible for the trials, to give him his records.
The file has a page that is blank except for the words “RTA Questionnaire Missing”, which refers to his return to Australia assessment.
Another Timor veteran who took part in the trial says he suffers from vertigo and has bowel problems linked to a series of digestive disorders.
A decade ago, up to 400 veterans had planned to mount a class action against the Defence Department but this was dropped after the government changed the law to limit its liability.
Major Stuart McCarthy, whose mental health has been affected by mefloquine, said the minutes “reinforce the need for an urgent judicial inquiry into what appears to be extensive criminal conduct on the part of numerous senior ADF officials over many years”.
Dr Remington Nevin, a former US army medical officer, said he found it troubling that by the time ADMEC had reviewed the tafenoquine and mefloquine trials, some had in fact already been completed.
Dr Nevin, who now lectures at Johns Hopkins University, says the information on the consent forms downplayed the risks of mefloquine and was misleading.
The Defence Minister Senator Marise Payne declined to answer The Australian’s questions and instead referred them to Defence media.
Labor’s veterans affairs spokesman David Feeney said there should be a review of the way the ADF prescribes drugs and treatment to members so that practices are “both clear and ethical”.
“It is unacceptable for there to be the perception, let alone the reality, that ADF personnel are being prescribed drugs that have not been adequately tested and are not yet available to the general public for the purposes of testing them,” he added.
This article first appeared on ‘The Australian’ on 23 December 2015.