Australian military doctors were warned about the dangers of using an experimental antimalarial drug on soldiers while in the midst of a coordinated trial under investigation by the ADF watchdog.
Documents obtained by Fairfax Media reveal the Therapeutic Goods Administration wrote to senior doctors at the Balmoral Naval Hospital in Sydney to warn they had no authority to acquire or use the drug under existing arrangements.
Six months later, the hospital received 13 capsules of tafenoquine from pharmaceutical giant GlaxoSmithKline to use on a 26-year-old on the condition it would not be held responsible for side-effects.
The company urged the doctors to contact US Army Medical Research and Materiel Command within 24 hours of serious or unexpected reactions by soldiers. It also told doctors to supply detailed records of patient history and health outcomes.
Tafenoquine remains banned in Australia and has been linked to blood cell damage and anaemia. Common side effects include nausea, vomiting, diarrhoea, headaches and eye disease. It was trialled on 461 ADF personnel as part of a clinical trial in East Timor during 2000-01.
Also trialled was the approved drug mefloquine, or Lariam, which remains the ADF's third choice antimalarial despite being banned by US Special Forces. The ADF Inspector-General continues to investigate whether any failures of military justice occurred during the trial.
A Department of Defence spokesman said the TGA warning related to the treatment of soldiers with recurrent malaria rather than the clinical trials. But correspondence reveals Australia's drug regulator did not shy from expressing concern about the drug.
Military doctors were initially granted full access to tafenoquine although this was overruled once the TGA realised the doctors would not comply with relevant safety regulations.
The letter, sent by the TGA's director of drug safety Dr Leonie Hunt, told doctors they were not authorised to use the drug outside a controlled clinical environment and without the approval of a hospital ethics committee.
"It has been brought to my attention that you do not satisfy these requirements and therefore the authorisation should not have been issued," Dr Hunt said.
"Accordingly you are no longer authorised to supply or prescribe tafenoquine for use in defence personnel for the treatment of recurrent vivax malaria."
According to the Department of Defence, the warning was the result of "an administrative error" caused when military doctors applied for the drug under the wrong subsection of the relevant act.
The doctors were eventually granted the drug for "compassionate use" under a special access scheme that judged patient needs on a case-by-case basis. Another 30 ADF personnel were treated under the scheme after a spike in malaria cases during 2001-02.
A TGA spokeswoman said the only way to acquire the dug remained the special access scheme.
"Were the TGA to become aware that unregistered products were being supplied without obtaining appropriate exemption, the matter would be investigated," she said.
GlaxoSmithKline told the military doctors all patients needed to be provided with information about the drug including alternative options. Written consent forms were also required.
"An integral component and condition of approval for supply of an experimental drug is the documentation of safety and efficacy data," the letter said.
"It is extremely important that we, as the manufacturers of tafenoquine, obtain detailed information regarding treatment and we ask for your co-operation to document details of patient history and therapeutic outcome."
Patient outcomes were recorded by military doctors at the Australian Army Malaria Institute and published in the American Journal of Tropical Medicine and Hygiene in 2007.
According to the journal article, the authors were full-time ADF employees and received funding from GlaxoSmithKline to present their findings. They insist no other potential conflicts of interest existed.
Andrew George, a former infantry soldier and public relations officer with the Army Reserve, was treated with tafenoquine in Sydney and claims it left him with damaging side effects.
Mr George, who features in promotional material for the reserves, said he was given the drug after being diagnosed with malaria but does not recall giving informed consent after a detailed explanation of the drug.
He is one of many veterans seeking answers about the drugs with many believing it complicated their diagnosis and management of post-traumatic stress-disorder.
"I am still proud of my service," he said. "I am proud to have done what my dad did - a Vietnam veteran," Mr George said.
Australian Defence Medical Ethics Committee documents, released late last year under freedom of information laws, showed the ADF was concerned about whether the trials were properly explained to soldiers.
"It would be preferable to have all information conveyed openly and honestly to every member involved in current and previous tafenoquine trials," the document said. "This will markedly reduce the risk of a perceived cover-up"
Since the release of the document, the Department of Defence has made a catalogue of information about the trials and the drug available for veterans online.
Surgeon General of the ADF, Air Vice-Marshal Tracy Smart, has also met with veterans at a community event in Townsville and insisted the military was being transparent as possible.
Last month, a senate committee called on the Australian Defence Force to explain all potentially damaging side effects of the antimalarial drugs to every veteran or soldier who has taken them since 2001.