Dear Department of Defence,

In 2000 the Army Malaria Institute (AMI) conducted a trial of the antimalarial drug tafenoquine on solders from the 3rd Battalion, Royal Australian Regiment (3 RAR), who were returning to Australia from operational service in Timor Leste:

"The deployment of the ADF to Timor Leste ... commencing in September 1999, provided a further opportunity to assess the value of tafenoquine in another area with falciparum and vivax malaria. Volunteers from the Third Battalion, Royal Australian Regiment preparing to return to Australia following InterFET service in February 2000, were randomly allocated to receive a 3-day tafenoquine course (either 400mg or 200mg daily) or the standard 14-day primaquine course. As observed in Bougainville, comparable episodes of vivax malaria were documented over the ensuing 12 months in the 3 groups of volunteers."[1]

The results of other AMI tafenoquine studies in Bougainville and Timor Leste have been published in academic journals.[2-3] However the results of this study involving 3 RAR personnel appear not to have been published.

I hereby request to be provided with the following documents relating to the AMI study of tafenoquine in 3 RAR personnel returning from Timor Leste in 2000:

a. Correspondence between Defence and the Therapeutic Goods Administration (TGA) relating to approvals for the use of tafenoquine, an unregistered drug.

b. The AMI study protocol.

c. Minutes of Australian Defence Mrdical Ethics Committee (ADMEC)/Australian Defence Human Research Ethics Committee (ADHREC) meetings relating to the approval, conduct and results of the study.

d. Reports of the study results.

e. Correspondence with academic journals relating to reports of the study results, including submissions, reviews or rejections.

Yours faithfully,

Stuart McCarthy

1. K. Rieckmann et al., "Army Malaria Institute - its Evolution and Achievements. Fourth Decade (1st Half):1995-2000", Journal of Military and Veterans’ Health, vol. 22, no. 1, 2014. http://jmvh.org/article/army-malaria-ins...

2. P.E. Nasveld et al., "Comparison of tafenpquine (WR238605) and primaquine in the post-exposure (terminal) prophylaxis of vivax malaria in Australian Defence Force personnel", Transactions of the Royal Society of Tropical Medicine and Hygiene, vol. 96, no. 6, 2002. http://m.trstmh.oxfordjournals.org/conte...

3. P.E. Nasveld et al., "Randomized, double-blind study of the safety, tolerability, and efficacy of
tafenoquine versus mefloquine for malaria prophylaxis in nonimmune subjects", Antimicrobial Agents and Chemotherapy, vol. 54, no. 2,pp. 792–798, 2010. http://aac.asm.org/content/54/2/792.long

Dear Mrs Stinson,

Thankyou for replying to my FOI request 004/16/17, advising me of your estimate of charges.

I request that your charges be waived on the grounds that releasing these documents is in the general public interest, given that:

a. Senior Defence officials including the ADF Surgeon General have stated publicly that they are committed to full transparency in relation to this matter.[1]

b. Senior Defence officials including the Vice Chief of the Defence Force have publicly criticised what they claim are "exaggerated" figures of the number of ADF personnel administered tafenoquine reported in recent media coverage.[2] However the total figures provided in Defence media releases[2] and the Defence tafenoquine trials webpage[3] are less than one third of the number of personnel known to have been administered tafenoquine during AMI drug trials.[4]

c. Senior Defence officials including the Vice Chief of the Defence Force have advised affected individuals to "raise their concerns with a medical practitioner so they may receive a proper diagnosis and treatment."[2] The requested documents will assist those individuals to seek this medical assistance.

d. Defence has refused to provide proactive follow up care to the personnel affected by the adverse neurotoxic health effects of tafenoquine. This task is instead being undertaken by volunteers, many of whom are experiencing severe financial hardship.

Yours sincerely,

Stuart McCarthy

References:

1. Lydia Kellner, "Top medic says ADF has ‘nothing to hide’ over controversial drug trials", Townsville Bulletin, 12 March 2016. http://www.townsvillebulletin.com.au/new...

2. R.J. Griggs, "Response to reporting on mefloquine in the Townsville Bulletin", Department of Defence, Canberra, 19 February 2016. http://news.defence.gov.au/2016/02/19/re...

3. Department of Defence, Tafenoquine/mefloquine trials, retrieved 14 July 2016. http://www.defence.gov.au/Health/HealthP...

4. IMVA, Scientific Misconduct in the Australian Army Malaria Institute’s Clinical Trials of Tafenoquine – Part 2, 9 July 2016. https://imvalliance.org/2016/07/09/scien...