This has been a complex and challenging inquiry for the
committee. The committee wishes to thank the individuals who appeared before it
to share their personal stories. During the course of the inquiry the committee
read and heard many moving personal accounts of individuals suffering from
debilitating symptoms. The committee is deeply concerned to hear their distress
as well as the frustration and dismay experienced by these individuals when
The committee recognises that for these individuals to
appear before a parliamentary committee is not easy. It showed their
determination to contribute in a positive way to ensure that they and their
mates and families receive the support they need. The committee also thanks the
family members who spoke with the committee about the challenges of getting
their loved ones and themselves access to assistance and support.
The disagreement over the cause of symptoms
A common theme was presenting to a medical practitioner with
various symptoms, being referred to multiple specialists and eventually being
diagnosed with Posttraumatic stress disorder (PTSD). However, individuals and
advocates claim it is their exposure, in most cases, over 18 years ago, to the
antimalarial drugs mefloquine and/or tafenoquine, which has resulted in their
current symptoms and some of them are being misdiagnosed with PTSD.
It is important to note that although individuals presenting
evidence to the committee appeared to group them together, mefloquine and
tafenoquine are different drugs that act differently in the body.
The first issue from the evidence is whether the symptoms
being experienced now by individuals can be causally related to prior
antimalarial drug use. The Australian Quinoline Veterans and Families Association
claim there is a condition which they call 'mefloquine poisoning' or an acquired
brain injury (ABI).
The Quinism Foundation in the USA calls it 'chronic quinoline encephalopathy' or
The committee needs to state that it is not comprised of
medical professionals or health experts and so cannot make any findings or
rulings in relation to the medical causes for health issues. However, it notes
that the weight of prevailing medical evidence provided to the committee in
response to these claims is that long term problems as a result of taking mefloquine
are rare and there is no compelling evidence that tafenoquine causes long term
effects. To be clear, there has always been recognition by Defence that
mefloquine, like any drug, has side effects and this has been taken into
consideration in the development of its health policy.
The committee takes confidence that Australia's independent
medical bodies have looked at the claim of ABI from the use of mefloquine. The
committee was informed that the claim that mefloquine and tafenoquine results
in ABI is not backed by definitive evidence. In August 2017, the Repatriation
Medical Authority (RMA) found there was insufficient sound medical evidence to
support this claim. This decision was reviewed by the Specialist Medication
Review Council which in September 2018 supported the decision of the RMA.
The medical evidence provided to the committee shows that
the incidence of long term or persistent neuropsychiatric adverse reactions to
mefloquine is very rare. If the committee looks at the 40 million doses of
mefloquine worldwide, the committee was provided with no evidence that the same
symptoms are manifesting in the Australian population or across the world in
the civilian population. To the committee this is a critical point. The
committee heard there is no evidence of an emerging global public health issue.
The medical evidence is presented in Chapter 2 (covering ToR a(ii), b and d).
The committee was reassured that, should any sound
medical-scientific evidence pertinent to this inquiry arise in the future, it
would be identified through existing channels and responded to by Defence and
The committee notes that tafenoquine, which was not an
approved drug at the time of the Australian Defence Force (ADF) trials, was
approved in 2018 by the US Food and Drug Administration (US FDA) and the
Australian Therapeutic Goods Administration (TGA). Tafenoquine has undergone a rigorous
safety evaluation by these regulatory bodies. TGA's Advisory Committee on
Medicines and the US FDA's Antimicrobial Drug Advisory Committee (AMDAC) have
all had input for both indications, prevention and radical cure, and the
findings are consistent. The processes of the US FDA and TGA included an audit
of the relevant Defence studies.
This issue appears to be manifested in military populations
where it seems to the committee trying to assign a single cause to veterans'
illnesses does not reflect the many potential contributors to their physical
and mental health at the time and in the years since the medications were
The symptoms are real
However, the committee does not doubt that the symptoms
being experienced by individuals are real and regardless of the cause or causes,
these veterans are unwell and should receive the assistance to which they are
entitled. The committee notes that this is not a different view to that
stressed by the Department of Defence (Defence) and the Department of Veterans'
Affairs (DVA), i.e. that regardless of the cause of the symptoms, help is
available. It will therefore be the committee's focus in Chapter 4 to review
and improve processes to ensure that any current and past ADF members receive appropriate
treatment and support they need.
Regarding treatment, the committee notes that an independent
review of the published literature by Professor Sandy McFarlane concluded that
there is no specific way to diagnose chronic mefloquine effects as many
symptoms are shared with other conditions such as PTSD and there is no specific
treatment except to cease the drug and treat the symptoms.
As there is no specific treatment and there is help
available for symptoms being experienced, in Chapter 4, the committee will look
at the barriers to people accessing appropriate treatment. Some individuals
were calling for there to be more treatment available for neurocognitive issues
and the committee was pleased to hear that a neurocognitive program is being
developed by DVA which the committee commends and supports.
The committee notes with concern that for some individuals
having their symptoms recognised as resulting from mefloquine or tafenoquine
appears to be of overriding importance which may keep some of them from seeking
and receiving available treatment.
The committee's inquiry into veterans' suicide highlighted
to the committee how challenging it can be to deal with DVA, which is
exacerbated when someone is unwell. The committee made a number of
recommendations the government agreed to which the committee trusts are leading
to improvements in service delivery over time. The committee has been
monitoring actions being taken by DVA to improve services through the estimates
process. However, the individual stories indicate to the committee that there
is still work to be done and that some individuals and their families are not
in a position to wait until improvements flow through the system from reforms.
The committee has made more targeted recommendations which it believes will improve
processes for those needing assistance.
Conduct of the studies
The second area of contention is the conduct of the
antimalarial drug trials undertaken in the late 1990s and early 2000s. Individuals
who blame mefloquine or tafenoquine for their current symptoms believe that the
trials should not have taken place, were unethical and used them as 'guinea
pigs'. These allegations have been investigated in an independent investigation
outside the military chain of command by the Inspector-General of the ADF
(IGADF). The investigation of some of the trials undertaken by the Army Malaria
Institute (AMI) from 2000 to 2002 in Timor-Leste involving mefloquine and
tafenoquine found that they 'were conducted ethically and lawfully' and 'in
accordance with the National Guidelines issued by the NHMRC [National Health
and Medical Research Council] and the TGA'. The IGADF also found trial
participants voluntarily consented to participate in the trials, and were adequately
informed of the potential side effects known at the time.
The committee acknowledges that these findings have not been accepted by some
veterans, but it is not the role of the committee to repeat or reopen the IGADF
investigation. The Australian Defence Human Research Ethics Committee, TGA and
US FDA have also examined the conduct of some of the trials and found no
indication that good clinical practice was not followed.
However, the committee shares the IGADF and witnesses' concerns
about how to ensure ADF members are able to provide informed consent in the military
environment. The Departments of Defence and Veterans' Affairs Human Research
Ethics Committee (DDVA HREC) already reviews research protocols in accordance
with the NHMRC National Statement on Ethical Conduct in Human Research
(National Statement). This identifies defence force personnel as a potentially
vulnerable group due to the unequal relationships within the military
hierarchy. However, there are opportunities to improve the consent process, as outlined
in the recent correspondence asking DDVA HREC to consider additional measures
to ensure participants 'are fully informed of all aspects of the studies and
that there is no belief created that Command is endorsing or actively
encouraging the study'.
The committee also suggests that the appointment of independent participant
advocates should be considered.
The committee does not believe that all medical research
with members of the ADF should be prohibited, provided it does not disrupt the
work of the ADF and has been approved in accordance with the National
Statement. This is because research is essential for advancing medical care and
force protection measures, and the ADF has a duty of care to protect and
maintain the health of its personnel. For example, in relation to the trials, the
committee is aware that during the INTERFET deployment, 64 ADF members became
infected with malaria and over 200 more developed malaria on return to
Australia. These cases of malaria were of concern to Defence as potentially
indicating resistance to the preferred antimalarial medication doxycycline, or
non-compliance in taking the medication, and were the catalyst for approved
clinical studies to be undertaken to assess whether policy changes were
necessary to ensure adequate protection against malaria in the ADF.
The committee commends the work of the ADF Malaria and
Infectious Disease Institute (formerly AMI), and recognises the importance of
its research in protecting ADF members and the international community more
broadly. The conduct of the trials and the issue of informed consent is
discussed in Chapter 3 (covering ToR a, a(i), a(ii) and b).
The committee recognises that for some individuals, the
outcomes of this inquiry will be insufficient unless the committee supports
their view of the medical evidence and the trials and supports calls for a
Royal Commission. As the committee does not have the role or expertise to make
any medical findings and the conduct of the trials has been reviewed by the
IGADF and some of the trials audited by the US FDA and TGA, the committee
believes the focus of the recommendations for this inquiry should be on the
common ground of making sure that individuals are able to access the assistance
and support they need and are entitled to receive.
While the committee recognises that both Defence and DVA
have taken actions to respond to the concerns raised by veterans, reports from veterans
indicated that they were either unaware of many of the current initiatives, believed
that they were inappropriate or did not go far enough. It was of concern to the
committee that, despite the efforts made to date, the message that assistance
is available is not being received by many veterans. Veterans are reporting
that they are still facing a number of practical barriers when trying to access
assistance including: ADF cultural issues, the provision of information and
trying to access and navigate the DVA claims process.
This suggests that improvements can be made to ensure that
veterans have access to support and assistance. The committee heard a number of
suggestions from veterans about the assistance and support they would like.
While there have been concerns raised about some of the suggestions put forward
by veterans, the committee emphasises that there is unanimous agreement that their
symptoms are real and the veterans and their families who participated in this
inquiry need help.
With this in mind, the committee's focus has been to explore
how best to address the health concerns identified by veterans and their
families and how to connect them with the help available. It is positive that DVA
is actively taking steps to address concerns and it is important that this is
continued. In particular, DVA has acknowledged that individuals need tailored,
wrap around assistance and that this needs to include support from a range of
specialists to address their complex needs.
The committee heard how the role of GPs is central to
ensuring veterans have access to a range of health services and ongoing
support. Actions have been taken to make GPs aware of the issues raised with
the committee and suggestions were made to ensure this flow of information is
continued and enhanced.
Noting the need for research to be independent so veterans
can have confidence in the outcomes, the committee was pleased to hear that
Defence and DVA have jointly commissioned the University of Queensland to
undertake a research study looking at the self-reported health of ADF personnel
using antimalarials on deployment. This research is due to be completed in late
2018. The committee anticipates that the findings of this research may be used
by DVA in the context of developing services and support that address the
challenges reported by this cohort of the veteran community.
The committee commends the recent consultation forums being
undertaken by DVA and notes that preliminary feedback from the first forum is
that some veterans who attended found it beneficial. These forums provide an
opportunity to enhance trust in the system by facilitating greater collaboration
and fostering connections.
Another important initiative being
developed by DVA is a Neurocognitive Health Program to assist veterans who may
have symptoms of a neurocognitive disorder. Further details about initiatives
to improve veterans' access to assistance and to enhance collaboration between
DVA and the veteran community are outlined in Chapter 4 (covering ToR c). ToR e
is covered in Chapter 1.
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