Response to Fairfax reporting on the use of tafenoquine in the ADF

It is disappointing that reporting on the use of anti-malarial drugs in the Australian Defence Force (ADF) continues to be sensationalist, inaccurate and highly selective. Henry Belot’s article ‘Military used drug despite warning’ (Canberra Times, 29 April 2016) is a case in point.

The article implies ADF medical staff acted improperly when they did not. Defence’s use of the drug tafenoquine to treat ADF members with recurrent malaria occurred only after standard treatments had failed. This was done in accordance with an established protocol once the appropriate approval was provided by the Therapeutic Goods Administration (TGA).

As advised to the journalist before publication, the documents cited in the article relate to TGA correspondence alerting Defence to an administrative error in paperwork lodged with the TGA. The result of this error was that a Defence medical practitioner was approved to prescribe tafenoquine under the wrong subsection of the TGA Act and as such that approval was withdrawn. This was entirely appropriate, and the letter provided advice about how the approval could be sought to use the medication under the correct subsection.

The letter was part of a larger information pack recently released by Defence, which also included a subsequent application to the TGA under the correct legislative subsection, the ‘Special Access Scheme’, along with documentation that demonstrated this application was successful. Tafenoquine was not provided by the pharmaceutical company or administered to any individual until after this approval was granted. As such it is misleading to suggest that Defence had no authority to acquire or use the drug.

The TGA warning cited in the article was not specific to tafenoquine. It was the standard warning provided by TGA when they approved supply of medications under the Special Access Scheme. Its purpose was to alert providers that the medication in question was investigational and had not been registered by the TGA at that time.

Tafenoquine has never been “banned” – it has simply not been registered by the TGA. It was used by the ADF in a number of studies between 1998 and 2001 and on a case-by-case basis under the Special Access Scheme when other treatments for recurring malaria failed. In all of these circumstances the medication was used in accordance with protocols cleared by the then Australian Defence Medical Ethics Committee (ADMEC) and/or under the auspices of the TGA.

Of particular concern is that the quoted side effects of tafenoquine in the article are misleading. As is the case for other anti-malaria medications, the serious side effects of “blood cell damage and anaemia” are only seen in individuals who have a deficiency in an enzyme called G6PD which all ADF members are checked for before being administered such medications. Importantly, it should also be noted that there is no evidence that tafenoquine causes serious neuropsychiatric effects such as those described in the article.

I continue to be concerned that the nature of this reporting might lead readers to conclude that Defence was using this medication illegally. Based on the specialist advice I have received, I want to reassure those who may be concerned that this is categorically not the case.

Regardless, if any ADF member, past or present, is concerned that they might be suffering side-effects from the use of any medication they should raise their concerns with a medical practitioner so they may receive a proper diagnosis and treatment.

R.J. Griggs, AO, CSC

Vice Admiral, RAN

Vice Chief of the Defence Force