This post was recently written by Loren Ries, the proud and accomplished wife of an Australian Army mefloquine & tafenoquine veteran, re-published with kind permission from her blog Loren Land.
When you think of human trials and the military, what images pop into your mind? If you are like me and have probably watched too many youtube clips you may conjure images of “Russian sleep experiments”, “The Philedelphia Experiment” or “Manchurian Candidates”. Human trials can be a legitimate way to advance research and product development.
There has to be questions about the ethics surrounding such trials.
Who can access Australian defence personnel for drug trials?
Should a Human Guineapig have to give clear and informed consent to the testing being conducted on them before they become part of a human trial?
Should the human test subject have a choice about whether they wish to ta take part in the testing?
Exactly how thorough do researchers have to be when following up side effects?
I would have presumed this was a no-brainer. I imagined human trials was something a University student might consent to take part in for a few extra bucks. The idea that a group of researchers could just conduct human trials without giving the test subject an informed choice to take part or not seems like a movie plot. Perhaps at the stretch of your mind you might think maybe prisoners are treated in such a way. According to the Australian Government National Health and Medical Research Council informed consent MUST be gained under no duress before a test subject can take part in a clinical trial. What if you were a soldier serving in the Australian Army, do you waive your rights to be able to give informed consent to take part in human trials?
I am particularly speaking of the recent ethical debacle created by the Army Malaria Institute (AMI) when conducting human trials on serving ADF members. I can only really imagine how it feels to a; be included in a human drug trial whether you wanted to be or not and b; to find out later that those drugs being tested had a risk of dangerous side effects.
I spoke recently to someone who can do more than imagine what this feels like, they were in fact part of these controversial trials. The individual in question contracted Malaria while serving a tour of duty overseas. This individual was not given an informed choice to take part in these trials but instead was told that this experimental drug would cure them and it was promptly administered. This soldier was given the course of Tafenoquine and a weird handout stating the results of the tests conducted on cows and beagles and only one follow up check with a doctor. This veteran was not checked on ever again in regards to this pharmaceutical trial there was ZERO, ZILCH, NADA NONE and NOTHING done to check at any point to see if he had in fact developed any side effects. I asked this veteran if he had been warned of any risks? His response was that he was told “this will cure you, like it’s some kind of wonder drug” It seems the Tafenoquine did in fact cure this digger of Malaria but at what cost … ? This soldiers life just coincidentally started to fall apart within 6 months of being part of these drug trials. Many soldiers who took part in this trial did so without being given a free and informed choice to take part.
How do you not sign a consent form when you are under duress. That’s entire point of legal protections against duress!
How do you give informed consent when you are told this is the medication we are treating you with? I wonder if he would have had it recorded that he refused treatment if he didn’t want to take part in the drug trial. Because as far as he was concerned that’s what he was receiving simply treatment for his malaria, it’s not like there was great deal of informed choice.
Some say they were pressured by their commanding officer and told if they did not take part in the trial they would not deploy. These soldiers must have been under terrible duress to risk their bodies in such a careless manner.
Regardless of whether or not these anti-malarial drugs worked Australian soldiers were put at unnecessary risk and treated with a frightening lack of care and consideration.
How many of these soldiers are now living with the side effects? How many are even still living? We don’t know, why don’t we know? Because the drug trial was so shoddy in it’s processes, because until recently this has been a rather dirty little secret and as far as I can tell these soldiers have been left supporting themselves through the confusion and are finding their efforts to even get a hold of their trial records very difficult.
Some veterans I spoke with only found out that these drugs may have serious side effects when it was recently broadcast on ABC radio.
Some are suggesting they are being met with a frustrating lack of sympathy. The most heart wrenching statement to come out of my conversation with a soldier who was part of these trials was “I presumed the army wanted me in good health, I presumed they wouldn’t do anything that might harm me. I presumed I was valuable. Tafenoquine was presented to me as a safe wonder drug, Given an educated choice I would never have taken part”
Like most civilians I am really mortified that this has happened even once to our soldiers. We presume a lot about the care given to our diggers. We might be wrong.
There are a lot of things the ADF should learn from this mess, first and foremost the citizens of Australia expect a higher level of ethics when conducting human drug trials on soldiers, we expect they will be given an informed choice under no duress to participate or not, we expect that if something goes wrong like in this case that those veterans will not be left to help each other navigate justice and confusion. We expect that these veterans will be given assistance to gain their relevant paperwork and that someone would answer their questions.
We expect that study protocols relating to the use of Australian Defence personnel and drug companies conducting human trials will be thoroughly reviewed and problems will be fixed, corrections will be made and appropriate help and access to records will be given to the satisfaction of all affected veterans and their families.
These veterans and their loved ones are not asking for too much and what they are asking for is logical and would not be hard to implement. First and foremost they want to be heard and understood. I am just left to wonder why these soldiers had to find out through the media.
I was offered personal assurance that an online resource centre for affected veterans has been made top priority by Vice Admiral Ray Griggs and should be up and running shortly. I would like a timeline for the implementation of this resource and I think perhaps some consultation with the veterans community as to what they need out of the resource would be wise. I for one have about a million questions buzzing about in my mind so it’s going to want to be comprehensive to allay my concerns. I am very pleased though that Vice Admiral Ray Griggs was prompt to respond, now I pray that he comes good on his assurances and does so swiftly.