Why does the ADF need to field test medical interventions?
Medications that work well in the laboratory may not do so in a clinical setting. Insect repellents that fail after two hours are not useful products when soldiers are exposed to harsh environments. The only way to be certain that medical interventions such as drugs, vaccines and insecticides will perform to requirements during a war or emergency is to test them under rigorous field conditions that closely resemble how the product would be used by the ADF.
Does the ADF conduct drug trials ethically?
The ADF conducts drug trials in accordance with national guidelines issued by the National Health and Medical Research Council (NHMRC) and the Therapeutic Goods Administration (TGA). The mefloquine study protocols were given ethical approval by the Australian Defence Human Research Ethics Committee (ADHREC).
ADHREC was a properly constituted human research ethics committee registered with the NHMRC. It was replaced by the joint Departments of Defence and Veterans Affairs Human Research Ethics Committee (DDVA HREC) on 1 July 2017. More information about DDVA HREC is available from the DDVA HREC website.
Information about ADHREC is available from the Joint Health Command Health Research Cocordination website.
Were ADF members forced to participate in clinical trials of mefloquine?
Participation in the anti-malarial studies involving mefloquine was voluntary. At the time of these studies, mefloquine had already been registered and used in Australia for over a decade: it was not an experimental drug. ADF members were provided with comprehensive information packs, were fully briefed and given the opportunity to ask questions. A point of emphasis was that whatever their decision, whether they chose to participate or not, there would be not negative impact on them, their career or future health care. Once fully informed, those who wanted to participate in the studies signed a consent form. The participants were also made aware that they could withdraw from the study at any time without detriment.
Some ADF members chose not to participate in the study. These members still needed to take an anti-malarial medication for their protection during the deployment in accordance with extant health policy. Some of these personnel would have taken mefloquine if other anti-malarials were not suitable for them.
Defence is aware of allegations from some personnel who feel that their participation was not voluntary. These allegations were investigated by the Inspector General of the Australian Defence Force (IGADF). The IGADF found that the mefloquine studies were conducted ethically and lawfully in accordance with national clinical and regulatory guidelines. The IGADF report is available here.
Was mefloquine ever trialled in ADF members deployed to Somalia?
No, mefloquine was never trialled in ADF personnel in Somalia.
A retrospective review of the use of doxycycline as an anti-malarial in Australian soldiers deployed to Somalia and Cambodia was undertaken which noted that a small number of soldiers in Somalia (1.7% or 15 individuals) had their medication changed from doxycycline to mefloquine due to the adverse effects they experienced on doxycycline.
Those members who ceased taking doxycycline were prescribed mefloquine in accordance with extant health policy.
Can former soldiers and ADF members involved in the trials request and access their medical records from the Department of Defence?
Serving and former ADF members who participated in the anti-malarial trials can access both their case records from the trial and their Defence health records.
Participants seeking their trial case records can make a request in writing to Joint Health Command at ADF.Malaria@defence.gov.au. They will need to provide their full name, date of birth, service/PMKEYS number and contact details (telephone, email and postal address). It may take several weeks to provide the documents as they have to be located and retrieved from the AMI* archives and checked for completeness. These documents will be released by the Commander Joint Health.
Serving ADF members who want to access their health records can make a request through their supporting Defence Health Centre.
Ex-serving members who want to access their personnel and health records need to submit a request to the Defence Archives Centre on ADF.Records@defence.gov.au. More information is available from the Defence Service Records site.
Can the Department of Defence confirm that the medical records of those involved in drug trials conducted by the ADF will not be deleted
Health records of ADF members are managed in accordance with the Archives Act 1983 and Defence records management policy. Health records of ADF members are retained for at least 100 years after their date of birth. Case records for trial participants are held at AMI* and will not be destroyed. Records related to significant medical research activities conducted in the ADF are retained permanently.
Did ADF members involved in the anti-malarial trials receive any follow-up?
ADF members who participated in the trials were specifically monitored in accordance with the applicable trial protocol, as approved by the human research ethics committee.
In addition to the examinations required by the approved protocols, ADF members had post deployment medical and mental health examinations prior to return to Australian and again three-six months after deployment. These examinations are designed to identify any significant health conditions.
Further to this, all ADF members receive periodic health assessments throughout their service. These were conducted annually until 2010 and since then all members receive a comprehensive health assessment every two to five years (depending on age) and before they separate from the ADF. More information on health monitoring in the ADF is available here.
* In 2017 the Army Malaria Institute was renamed the Australian Defence Force Malaria and Infectious Diseases Institute