Footnotes

Executive Summary

[1]        An umbrella term covering any damage to the brain that occurs after birth.

[2]        IGADF, Inquiry report into issues concerning anti-malarial trials of the drug mefloquine between 2000 and 2002 involving Australian Defence members deploying to East Timor, 2016, pp. ii–iii. 

[3]        IGADF, Inquiry report, 2016, pp. iv, vi–vii.  

[4]        Defence, Letter from AVM Tracy Smart AM to Mr Ian Tindall, Chair DDVA HREC, 4 October 2018, [p. 1] (tabled 11 October 2018).

Chapter 1 - Introduction

[1]        Journals of the Senate, No. 99 —19 June 2018, p. 3187.

[2]        Journals of the Senate, No. 110 —20 August 2018, p. 3534.

[3]        Journals of the Senate, No. 133 —29 November 2018, p. 4325.

[4]        TGA Product and Consumer Medicine Information, Malarone; Defence, Submission 1, p. 11.

[5]        Adjunct Professor John Skerritt, Deputy Secretary, Health Products Regulation, Department of Health, Committee Hansard, 11 October 2018, p. 42.

[6]        Defence, Submission 1, p. 11.

[7]        WHO Model List of Essential Medicines, 20th edition, March 2017.

[8]        Department of Health, Submission 3, pp. 1–2. Note: Roche Products Pty Ltd advised that mefloquine was approved in Australia on 3 September 1986. See additional information from Roche Products Pty Ltd, received 19 November 2018.

[9]        Submission 12, p. 2.

[10]      Submission 12, p. 2. Mr Svend Peterson, Managing Director, Roche Products Pty Ltd, Proof Committee Hansard, 8 November 2018, p. 1.

[11]      WHO Model List of Essential Medicines, 20th edition, March 2017.  The RMA notes that the WHO Model List of Essential Medicines is an expert assessment of the minimum medicine needs for a basic health-care system, listing the most efficacious, safe and cost-effective medicines for priority conditions. RMA, Submission 4, p. 9; Mr Svend Peterson, Managing Director, Roche Products Pty Ltd, Proof Committee Hansard, 8 November 2018, p. 1.

[12]      CDC, Yellow Book, Chapter 3, Infectious Diseases Related to Travel, Malaria: https://wwwnc.cdc.gov/travel/yellowbook/2018/infectious-diseases-related-to-travel/malaria, accessed 15 October 2018.

[13]      Defence, Submission 1, p. 2.

[14]      Defence, Submission 1, p. 15.

[15]      On 26 July 2018 Sixty Degrees Pharmaceuticals announced that the Antimicrobial Drugs Advisory Committee of the US Food and Drug Administration voted to support tafenoquine for the prevention of malaria in adults which will be marketed under the brand name Arakoda. See Sixty Degrees Pharma, 'US FDA Advisory Committee votes in favour of Tafenoquine for the prevention of malaria', Media release, 26 July 2018.

[16]      GlaxoSmithKline (GSK) R&D in partnership with Medicines for Malaria Venture announced that on 20 July 2018 the FDA approved single dose tafenoquine (tradename Krintafel) for the radical cure (prevention of relapse) of P. vivax malaria in patients aged 16 years and older. See GSK, Submission 8, p. 2.

[17]      To be marketed as Kodatef, sponsor Biocelect Pty Ltd.

[18]      To be marketed as Kozenis, sponsor GlaxoSmithKline Australia Pty Ltd.

[19]      See Professor Geoffrey Quail, President, Australian College of Tropical Medicine, Committee Hansard, 30 August 2018, p. 44; Adjunct Professor Skerritt, Committee Hansard, 11 October 2018, p. 40.

[20]      GSK, Submission 8, p. 2.

[21]      GSK, Submission 8, p. 2.

[22]      Defence, Submission 1, p. 2.

[23]      Proof Committee Hansard, 8 November 2018, pp. 11–12. See also Adjunct Professor Skerritt, Committee Hansard, 11 October 2018, p. 40.

[24]      Proof Committee Hansard, 8 November 2018, p. 1.

[25]      In the African region most cases are due to P. falciparum. See WHO World Malaria Report 2018, p. 15.  

[26]      Australian Government, Indo-Pacific Centre for Health Security, Submission 57, p.1.

[27]      WHO, World Malaria Report 2018, p. xiii.

[28]      WHO, Malaria Fact Sheet, 11 June 2018.

[29]      UN Report of the Secretary-General, Progress towards the Sustainable Development Goals, 10 May 2018, p. 5.

[30]      Australasian Society for Infectious Diseases, Submission 6, p. 1.

[31]      Submission 10, [p. 2].

[32]      WHO, World Malaria Report 2018, p. 36.

[33]      WHO, World Malaria Report 2017, pp. 33, 34, 41.

[34]      Defence, Submission 1, p. 3. Defence, Supplementary submission 1.1, pp. 6–7.

[35]      Defence, Submission 1, p. 1.

[36]      Located at Gallipoli Barracks in Brisbane.

[37]      Defence, Submission 1, p. 8.

[38]      Senate Foreign Affairs, Defence and Trade References Committee, Mental health of ADF serving personnel, 17 March 2016. See recommendations 5 and 6.

[39]      Available: https://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Foreign_Affairs_Defence_and_Trade/ADF_Mental_Health/Government_Response

[40]      See Defence, Submission 1, pp. 49–53 for more detail.

[41]      Defence, Submission 1, pp. 50–51.

[42]      Gloria Galloway, 'Canadian Forces curb use of mefloquine, but study findings anger vets', The Globe and Mail, 2 June 2017.

[43]      Defence, Submission 1, p. 13.

[44]      House of Commons, Defence Committee, An acceptable risk? The use of Lariam for military personnel, Fourth Report of Session 2015-16, 24 May 2016, p. 29.

[45]      Ministry of Defence, Mefloquine Prescribing in the UK Armed Forces, 12 September 2016 to 31 March 2018, published 17 May 2018.

[46]      Lydia Williams, 'Ministry of Defence will only hand out Lariam after face-to-face risk assessment', The Telegraph, 13 September 2016.

[47]      VADM Ray Griggs, VCDF, Senate Foreign Affairs, Defence and Trade Legislation Committee, Estimates Hansard, 10 February 2016, p. 173.

[48]      House of Commons Defence Committee, Mental Health and the Armed Forces, Part One: The Scale of mental health issues, 25 July 2018, p. 8.

[49]      Submission 1, p. 51.

[50]      Submission 1, p. 51.

[51]      Greg Miller, 'A gruesome war crime renews concerns about a malaria drug's psychiatric side effects', Wired, 15 August 2013.

[52]      See https://www.wusa9.com/article/news/investigations/investigation-vets-say-anti-malaria-drugs-they-were-ordered-to-take-caused-devastating-side-effects/65-560790227, accessed 25 July 2018.

[53]      Sheila Pratt, 'Germany bans drug linked to brain damage, ramps up pressure on Canada', iPolitics, 9 December 2016.

[54]      An FDA boxed warning, also known as a ‘black box’ warning appears on a prescription drug’s label. It is the strictest warning used by the FDA and is designed to call attention to serious or life-threatening risks. See Defence, Submission 1, p. 53.

[55]      Defence, Submission 1, pp. 52–53.

[56]      Media in January 2018 reports 58 claims. Caroline O'Doherty, 'More soldiers to sue over malaria drug', Irish Examiner, 1 January 2018.

[57]      Defence, Submission 1, p. 52.

[58]      Defence, Submission 1, p. 53.

[59]      Submission 1, pp. 49–53.

Chapter 2 - The causes of symptoms

[1]        Dr Remington Nevin, Committee Hansard, 11 October 2018, p. 2.

[2]        AQVFA, Submission 16, pp. 8, 41.

[3]        AQVFA, Submission 16, p. 8.

[4]        AQVFA, Submission 16, p. 44. Mr Stuart McCarthy, Submission 94, p. 5.

[5]        RMA, Submission 4, Attachment 4, p. 53.

[6]        Submission 15, p. 5.

[7]        Submission 16, pp. 8-9.

[8]        Submission 16, p. 9.

[9]        Submission 94, p. 1. See also Submission 16, p. 42. Submission 16.1, p. 6; The Quinism Foundation, Submission 17, p. 5; Defence Force Welfare Association, Submission 95, p. 2.

[10]      Submission 94, p. 5.

[11]      According to his website, remingtonnevin.com, Dr Nevin 'was the first to publish clinical descriptions of the permanent toxic syndrome of brain and brainstem dysfunction caused by the use of mefloquine'.

[12]      Submission 17, p. 2. See also Dr Remington Nevin, Committee Hansard, 11 October 2018, p. 2.

[13]      Dr Remington Nevin, Committee Hansard, 11 October 2018, p. 2.

[14]      Submission 17, p. 3. See Dr Remington Nevin, Committee Hansard, 11 October 2018, pp. 2-3 for further discussion of the theory being put forward.

[15]      Committee Hansard, 11 October 2018, p. 5. See also Associate Professor Jane Quinn, Proof Committee Hansard, 5 November 2018, p. 40.

[16]      Committee Hansard, 11 October 2018, pp. 4-5. See also Associate Professor Jane Quinn, Proof Committee Hansard, 5 November 2018, p. 41. 

[17]      Committee Hansard, 11 October 2018, p. 5.

[18]      Submission 15, p. 4.

[19]      Submission 15, p. 4.

[20]      Submission 15, p. 6.

[21]      Committee Hansard, 30 August 2018, p. 42.

[22]      Submission 13, p. 1.

[23]      RMA, Submission 4, Attachment 4, p. 58.

[24]      RMA, Submission 4, p. 8.

[25]      Committee Hansard, 15 October 2018, pp. 2-3.

[26]      Committee Hansard, 11 October 2018, p. 22.

[27]      Committee Hansard, 11 October 2018, p. 26.

[28]      Committee Hansard, 11 October 2018, p. 58.

[29]      Committee Hansard, 11 October 2018, p. 29.

[30]      Primaquine is an antimalarial medication used to prevent and treat relapses of malaria. It is given to people as they leave a malarious area to kill any parasites that may be in the body. Defence, Submission 1, p. 15. See also Adjunct Professor John Skerritt, Department of Health, Committee Hansard, 11 October 2018, p. 40.

[31]      It is chemically closely related to primaquine. See 60P, Submission 9, p. 2; GSK, Supplementary submission 8.1, p. 1. See also Defence Submission 1, p. 15.

[32]      Roche, Submission 12, p. 2; Mr Svend Peterson, Managing Director, Roche Products Pty Ltd, Proof Committee Hansard, 8 November 2018, p. 1.

[33]      Department of Health, Submission 3, p. 2.

[34]      Roche, Submission 12, p. 2.

[35]      Roche, Additional information, received 19 November 2018.

[36]      Submission 3, p. 2.

[37]      Submission 12, p. 3.

[38]      Submission 12, p. 3. Roche noted over the time that mefloquine has been registered with the TGA the product information has been updated 15 times to provide more information to prescribers and consumers about the risks and benefits. Five of these related to information around neuropsychiatric adverse events. Ms Natalie Touzell, Director, Regulatory Affairs Australia-New Zealand, Roche Products Pty Ltd, Proof Committee Hansard, 8 November 2018, p. 7.

[39]      Department of Health, Submission 3, p. 2. See also Professor James McCarthy, Committee Hansard, 11 October 2018, p. 24.

[40]      The use of drugs to prevent disease.

[41]      Persistence in the bloodstream.

[42]      Department of Health, Submission 3, p. 3.

[43]      Department of Health, Submission 3, p. 3.

[44]      Submission 12, p. 4.

[45]      Mr Peterson, Proof Committee Hansard, 8 November 2018, p. 1.

[46]      Submission 4, p. 9.

[47]      Professor Nick Saunders, Committee Hansard, 15 October 2018, p. 2.

[48]      Professor Nick Saunders, Committee Hansard, 15 October 2018, p. 2.

[49]      Committee Hansard, 11 October 2018, p. 40.

[50]      Committee Hansard, 30 August 2018, p. 42.

[51]      Committee Hansard, 11 October 2018, p. 40.

[52]      Committee Hansard, 11 October 2018, pp. 33-34.

[53]      Submission 1, p. 2. See also Defence, Supplementary submission 1.1, pp. 22-23.

[54]      Submission 1, p. 12

[55]      Submission 1, p. 12.

[56]      See for example, Name withheld, Submission 53, p. 1; Mr Benjamin Fleming, Submission 72, p. 2; Name Withheld, Submission 76, p. 3; Name withheld, Submission 97, p. 1; Name Withheld, Submission 101, p. 1.

[57]      Committee Hansard, 11 October 2018, pp. 24-25. See also Associate Professor Harin Karunajeewa, Committee Hansard, 11 October 2018, p. 32; Defence, Supplementary submission 1.1, p. 22.

[58]      Defence, Submission 1, p. 45; Defence, Supplementary submission 1.1, p. 25.

[59]      Submission 1, p. 12.

[60]      Dr Peter Stewart, Roche, Proof Committee Hansard, 8 November 2018, p. 4.

[61]      Submission 15, p. 4. See also Professor Geoffrey Quail, President, Australian College of Tropical Medicine, Committee Hansard, 30 August 2018, pp. 44-45.

[62]      Submission 15, p. 4.

[63]      Submission 15, p. 8.

[64]      Committee Hansard, 11 October 2018, pp. 32-33.

[65]      Committee Hansard, 11 October 2018, p. 33. See also The Australasian Society for Infectious Diseases, Submission 6, p. 2.

[66]      Eick-Cost et al, Neuropsychiatric outcomes after Mefloquine exposure among U.S. military service members, American Journal of Tropical Medicine and Hygiene 2017; 96: 159-166. See also Professor James McCarthy, Committee Hansard, 11 October 2018, p. 25.

[67]      Atovaquone-proguanil.

[68]      Submission 15, p. 9.

[69]      Submission 15, p. 8; Committee Hansard, 11 October 2018, p. 29. See also Professor James McCarthy, Committee Hansard, 11 October 2018, p. 27.

[70]      Submission 15, p. 9.

[71]      Submission 15, p. 9. See also Defence, Supplementary submission 1.1, p. 21.

[72]      Committee Hansard, 11 October 2018, p. 22.

[73]      Submission 15, pp. 9-10.

[74]      Committee Hansard, 11 October 2018, p. 23.

[75]      Wells TS, Smith TC, Smith B, Wang LZ, Hansen CJ, Reed RJ, et al. Mefloquine use and hospitlaizations among US service members, 2002-2004, American Journal of Tropical Medicine and Hygiene 2006; 74(5): 744-9.

[76]      Submission 1, p. 47.

[77]      Committee Hansard, 11 October 2018, p. 8.

[78]      Associate Professor Harin Karunajeewa, Committee Hansard, 11 October 2018, p. 33; Professor James McCarthy, Committee Hansard, 11 October 2018, p. 26.

[79]      Committee Hansard, 11 October 2018, p. 44.

[80]      Proof Committee Hansard, 8 November 2018, p. 3.

[81]      See https://cidg.cochrane.org/news/cochrane-review-update-mefloquine-preventing-malaria-during-travel-endemic-areas, accessed 19 November 2018. Tickell-Painter M et al, Melfoquine for preventing malaria during travel to endemic areas, Cochrane database of Systemic Reviews, 2017, Issue 10:CD006491; See also, Roche Products Pty Ltd, Answers to questions on notice from 8 November 2018 hearing, received 19 November 2018.

[82]      Proof Committee Hansard, 8 November 2018, p. 3.

[83]      Dr Stewart, Proof Committee Hansard, 8 November 2018, p. 8.

[84]      Proof Committee Hansard, 8 November 2018, p. 4.

[85]      Proof Committee Hansard, 8 November 2018, pp. 8-9.

[86]      Proof Committee Hansard, 8 November 2018, p. 9.

[87]      Submission 16, pp. 51-52.

[88]      Proof Committee Hansard, 8 November 2018, pp. 8-9.

[89]      Proof Committee Hansard, 8 November 2018, p. 6.

[90]      Submission 58, p. 2.

[91]      Supplementary Submission 9.1, p. 5.

[92]      Defence, Submission 1, p. 2.

[93]      See http://www.defence.gov.au/Health/HealthPortal/Malaria/Anti-malarial_medications/Mefloquine/, accessed 4 July 2018.

[94]      Submission 12, p. 10.

[95]      Submission 12, p. 6. Mr Svend Peterson, Managing Director Roche Products Pty Ltd, Proof Committee Hansard, 8 November 2018, p. 1.

[96]      Dr Stewart, Medical Director, Roche Products Pty Ltd, Proof Committee Hansard, 8 November 2018, p. 3.

[97]      Australian Government, Repatriation Medical Authority, Statement of Reasons Re: Decision not to make Statements of Principles for chemically-acquired brain injury caused by mefloquine, tafenoquine or primaquine, pp. 10-11.

[98]      Committee Hansard, 11 October 2018, p. 15.

[99]      Committee Hansard, 11 October 2018, p. 15.

[100]    See Medicines for Malaria Venture, 'GSK submits US regulatory application for single-dose tafenoquine for Plasmodium vivax malaria', Media Release, 28 November 2017. Note: For radical cure, primaquine needs to be administered daily over 2 weeks but there can be poor compliance which can lead to a 3 to 4 fold reduction in efficacy. See MMV, Submission 10, p. 3. See also GSK, Supplementary submission 8.1, p.1; Australasian Society for Infectious Diseases, Submission 6, p. 1. See also Geoffrey S. Dow et al, Tafenoquine is not neurotoxic following supertherapeutic dosing in rates, Travel Medicine and Infectious Disease, 17 (2017) 28-34, see Introduction.

[101]    See for example Mr Karl Herz, Managing Director, Biocelect Pty Ltd, Proof Committee Hansard, 8 November 2018, p. 17.

[102]    Submission 5, p. 1.

[103]    Submission 5, p. 1.

[104]    Committee Hansard. 11 October 2018, p. 26.

[105]    Prevention of relapse, or eradication.

[106]    Proof Committee Hansard, 8 November 2018, pp. 10, 15.

[107]    MMV works closely with the World Health Organization, and is funded by donors including the governments of Australia, Ireland, Japan, the Netherlands, Norway, Switzerland, the UK and the USA; the Bill and Melinda Gates Foundation and the Wellcome Trust. MMV, Submission 10, p. 2.

[108]    Dr Webster, Proof Committee Hansard, 8 November 2018, p. 12.

[109]    See Committee Hansard, 11 October 2018, p. 9.

[110]    Committee Hansard, 11 October 2018, pp. 27-28.

[111]    For a more detailed explanation of radical cure see Mr David Herd, Director, Market Access and Communications and Government Affairs, GlaxoSmithKline Australia Pty Ltd, Proof Committee Hansard, 8 November 2018, p. 10.

[112]    US FDA approved single-dose 300mg tafenoquine for the radical sure of P. vivax malaria. This was sponsored by GSK and MMV.

[113]    It provides effective protection against both the major types of malaria (P. vivax and P. falciparum) killing the parasites in the blood and the liver. This was sponsored by 60 Degrees Pharmaceuticals. Dr Geoff Dow, Chief Executive Officer and Chief Scientific Officer, 60 Degrees Pharmaceuticals, Proof Committee Hansard, 8 November 2018, p. 17. See Also Mr Mark Reid, Submission 71, p. 9.

[114]    Sponsor Biocelect. Dr Dow, 60 Degrees Pharmaceuticals, Proof Committee Hansard, 8 November 2018, p. 17

[115]    Sponsor, GSK. See Defence, Supplementary Submission 1.1, pp. 4-5.

[116]    See Proof Committee Hansard, 8 November 2018, p. 20. Note: Biocelect have been helping 60 Degrees Pharmaceuticals with the commercialisation of tafenoquine since 2013. This assistance was provided by the consulting company Biointelect Pty Ltd of which Mr Herz, Managing Director of Biocelect, is a director, employee and one of the owners. Biocelect Pty Ltd licenced tafenoquine from 60 Degrees Pharmaceuticals under a Supply and Distribution Agreement executed 22 September 2016 for Australia, NZ, PNG and various Pacific Islands. See Biocelect, additional information, received 19 November 2018.

[117]    Submission 9, p. 2. See also Biocelect, Submission 11, p. 2; Jonathan Berman et al, Tafenoquine and primaquine do not exhibit clinical neurologic signs associated with central nervous system lesions in the same manner as earlier 8-animoquinolines, Malaria Journal, (2018) 17:407. 

[118]    Submission 11, p. 2.

[119]    Dr Webster, GSK, Proof Committee Hansard, 8 November 2018, p. 14.

[120]    Dr Webster, GSK, Proof Committee Hansard, 8 November 2018, p. 15.

[121]    Supplementary submission 8.1, p. 1.

[122]    Submission 8, p. 3.

[123]    Supplementary submission 8.1, p. 3.

[124]    Committee Hansard, 11 October 2018, p. 4.

[125]    Submission 10, pp. 4-5.

[126]    Submission 6, pp. 2-3. See also 60P, Submission 9, p. 2; Dr Webster, GSK, Proof Committee Hansard, 8 November 2018, p. 12. 

[127]    60 Degrees Pharmaceuticals, Supplementary Submission 9.1, p. 4.

[128]    Submission 10, p. 4.

[129]    Submission 10, p. 4.

[130]    Committee Hansard, 11 October 2018, p. 23.

[131]    Proof Committee Hansard, 8 November 2018, p. 19.  See Also Mr Mark Reid, Supplementary Submission 71.3, p. 3.

[132]    Proof Committee Hansard, 8 November 2018, p. 21. GSK also outlined the steps they have taken to address concerns, see Answers to questions taken on notice at 8 November 2018 hearing in Canberra, received 21 November 2018.

[133]    Adjunct Professor John Skerritt, Deputy Secretary, Health Products Regulation, Department of Health, Committee Hansard, 11 October 2018, pp. 35, 37.

[134]    Committee Hansard, 11 October 2018, p. 37. Dr Dow also spoke of the wide range of specialists accumulating and analysing medical data, Proof Committee Hansard, 8 November 2018, p. 19.

[135]    Providing independent medical and scientific advice to the Minister for Health and the TGA.

[136]    Committee Hansard, 11 October 2018, p. 37; Adjunct Professor Skerritt, Committee Hansard, 11 October 2018, p. 42.

[137]    Mr Mark Reid, Submission 71, p. 11.  See also 60 Degrees Pharmaceuticals, Submission 9.1, pp. 3-4; Defence, Supplementary Submission 1.1, p. 5.

[138]    Submission 9, p. 1.

[139]    See Committee Hansard, 11 October 2018, p. 3.

[140]    Committee Hansard, 11 October 2018, p. 27. See also GSK, Supplementary submission 8.1, p. 2.

[141]    Committee Hansard, 11 October 2018, p. 27.

[142]    Supplementary Submission 9.2, p. 1.

[143]    Submission 1, pp. 2-3.

[144]    Submission 1, p. 17.

[145]    Supplementary submission 16.1, p. 2.

[146]    GSK, Submission 8, p. 2; Defence, Submission 1, p. 15. See also Australasian Society for Infectious Diseases, Submission 6, p. 2; Dr Webster, GSK, Proof Committee Hansard, 8 November 2018, p. 12; Dr Dow and Mr Herz, Proof Committee Hansard, 8 November 2018, p. 22.

[147]    Defence, 'Response to Fairfax reporting on the use of tafenoquine in the ADF', Media release, 2 May 2016.

[148]    Proof Committee Hansard, 8 November 2018, p. 23.

[149]    Defence, Submission 1, pp. 2-3; Defence, Supplementary submission 1.1, pp. 10, 14.

[150]    Submission 16, pp. 6, 52-54. See also Mr Stuart McCarthy, Submission 94, p. 4. Note: Cytochrome P450 enzymes are essential for the metabolism of many medications. CYP2D6 is one of the CYP450 enzymes.

[151]    Submission 1, p. 21. See also Professor Dennis Shanks, Director, ADF MIDI, Committee Hansard, 11 October 2018, p. 57.

[152]    AQVFA.

[153]    Supplementary Submission 8.1, p. 2. See also 60 Degrees Pharmaceuticals, Submission 9.2, Presentation of Clinical Safety, p. 81.

[154]    Committee Hansard, 11 October 2018, p. 57.

[155]    See www.tga.gov.au, accessed 13 November 2018.

[156]    A legal requirement.

[157]    Submission 12, p. 3.

[158]    Adjunct Professor Skerritt, Proof Committee Hansard, 11 October 2018, p. 36. Note: the submission from the Department of Health refers to the database containing 242 adverse reports for mefloquine submitted from 1993 to 2018. See Submission 3, p. 4. The committee understands the reference to 1993 in the submission is incorrect.

[159]    Submission 3, p. 4.

[160]    Submission 3, p. 4. See also Adjunct Professor Skerritt and Adjunct Professor Greenaway, Committee Hansard, 11 October 2018, p. 39.

[161]    Committee Hansard, 11 October 2018, pp. 41, 44.

[162]    Dr Stewart, Proof Committee Hansard, 8 November 2018, p. 7.

[163]    Submission 1, pp. 17-18. See also Annex C.

[164]    Submission 1, p. 18. See also Defence, Supplementary submission 1.1, p. 23.

[165]    Submission 9, pp. 3-4.

[166]    Submission 11, p. 3. See also 60 Degrees Pharmaceuticals, Submission 9, p. 3. Note: the 60P submission reference to 2007 refers to the adverse events made to the TGA in 2017 or later which were reported to have occurred many years after the drugs were taken with the earliest such onset being 2007 (see case 2 in Appendix A to Briefing Document for the Antimicrobial Drugs Advisory Committee, p. 139, available in Submission 9, Attachment 1)

[167]    Mr Herd, Proof Committee Hansard, 8 November 2018, pp. 10, 13.

[168]    Mr Herz, Proof Committee Hansard 8 November 2018, p. 17.

[169]    Committee Hansard, 11 October 2018, pp. 41, 42; Dr Carolyn Tucek-Szabo, Head, Regulatory Affairs, Australasia, GSK Australia, Proof Committee Hansard, 8 November 2018, p. 15. See also: https://www.tga.gov.au/black-triangle-scheme, accessed 29 October 2018.

[170]    Submission 16, pp. 40-42.

[171]    Submission 16, pp. 41- 42. Associate Professor Quinn, Proof Committee Hansard, 5 November 2018, p. 42.

[172]    DVA Information Paper: Mefloquine, p. 3. Note: SOPs are legal instruments, based on sound medical-scientific evidence (SMSE) which state the factors that must exist for a particular disease, injury or death to the linked causally to prior service. See RMA, Submission 4, Attachment 1, p. 4.

[173]    See http://www.rma.gov.au/sops/, accessed 27 June 2018. Note: the RMA determines SOPs at two standards of proof: reasonable hypothesis, where the SMSE has to indicate or point to a reasonable hypothesis of a causal association between the factor and the disease; and balance of probability, where the SMSE has to show that it is more probable than not that the factor is causally related to the disease. RMA, Submission 4, Attachment 1, p. 5.

[174]    Professor Saunders, Chairperson, RMA, Committee Hansard, 15 October 2018, p. 1.

[175]    RMA, Submission 4, Attachment 1, p. 4.

[176]    Committee Hansard, 15 October 2018, p. 8.

[177]    Australian Government, Repatriation Medical Authority, Statement of Reasons Re: Decision not to make Statements of Principles for chemically-acquired brain injury caused by mefloquine, tafenoquine or primaquine, p. 3.

[178]    Australian Government, Repatriation Medical Authority, Declaration under subsection 196B(6) of the Veterans' Entitlements Act 1986, 18 August 2017.

[179]    Australian Government, Repatriation Medical Authority, Statement of Reasons Re: Decision not to make Statements of Principles for chemically-acquired brain injury caused by mefloquine, tafenoquine or primaquine, p. 3. See also Defence, Supplementary submission 1.1, pp. 24-25.

[180]    Submission 4, p. 8. See also Professor Nick Saunders, Committee Hansard, 15 October 2018, p. 2.

[181]    Committee Hansard, 15 October 2018, p. 2.

[182]    Submission 4, p. 9.

[183]    Committee Hansard, 15 October 2018, p. 3.

[184]    Committee Hansard, 15 October 2018, p. 5.

[185]    Committee Hansard, 15 October 2018, p. 2.

[186]    Committee Hansard, 15 October 2018, p. 5.

[187]    Submission 16, p. 42.

[188]    An independent statutory body, established by the VEA, responsible to the Minister for Veterans' Affairs.

[189]    DVA, Submission 2, p. 8.

[190]    Mr Paul Murdoch, Registrar, RMA, Committee Hansard, 15 October 2018, p. 3.

[191]    Commonwealth of Australia Gaszette, Specialist Medical Review Council Declarations, Request for Review Declaration no. 34, 17 September 2018.  See also Professor Nick Saunders, Committee Hansard, 15 October 2018, p. 2.

[192]    Committee Hansard, 15 October 2018, p. 3.

[193]    See Dr Remington Nevin, Committee Hansard, 11 October 2018, pp. 7-9.

[194]    Committee Hansard, 15 October 2018, p. 7.

[195]    DVA Submission 2, p. 7. See also RMA, Submission 4, Attachment 2.

[196]    RMA, Submission 4, p. 6.

[197]    Committee Hansard, 15 October 2018, pp. 1-2.

[198]    See Statement of Principles concerning chronic multisymptom illness No. 55 of 2014.

[199]    Professor Saunders, Committee Hansard, 15 October 2018, p. 5.

[200]    Committee Hansard, 15 October 2018, p. 8.

[201]    Committee Hansard, 15 October 2018, p. 5.

[202]    Professor Saunders, Committee Hansard, 15 October 2018, p. 1.

[203]    Professor Saunders, Committee Hansard, 15 October 2018, p. 1.

[204]    Professor Saunders, Committee Hansard, 15 October 2018, p. 3.

[205]    Professor Saunders, Committee Hansard, 15 October 2018, p. 4.

[206]    Professor Saunders, Committee Hansard, 15 October 2018, p. 4; Mr Murdoch, Committee Hansard, 15 October 2018, p. 4.

[207]    Mr Murdoch, Committee Hansard, 15 October 2018, p. 3.

[208]    See http://www.rma.gov.au/consultation/, (accessed 30 November 2018).

[209]    Australian Government, Joint Health Command, Annual Review 2016–17, 2017, p. 4.

[210]    Australian Government, Defence, 'Directorate of Military Medicine', http://www.defence.gov.au/Health/SHC/militaryMedicine.asp, (accessed 29 November 2018).

[211]    Australian Government, Defence, 'Mental Health Research and Evaluation (MHR&E)', http://www.defence.gov.au/Health/DMH/ResearchSurveillancePlan.asp, (accessed 29 November 2018).

[212]    Submission 71, p. 5.

[213]    Committee Hansard, 30 August 2018, p. 44.

[214]    Professor Shanks, Submission 13, p. 2.

[215]    Committee Hansard, 11 October 2018, p. 58.

[216]    Committee Hansard, 11 October 2018, p. 30.

[217]    Committee Hansard, 11 October 2018, p. 46. See also Defence, Supplementary submission 1.1, p. 27.

[218]    Committee Hansard, 11 October 2018, p. 54.

[219]    Committee Hansard, 11 October 2018, pp. 54-55. See also Defence, Supplementary submission 1.1, pp. 23-24.

[220]    Loss of sight/visual disturbances; Encephalitis; Swelling of the brain; Demyelination; Chronic diarrhoea, Irritable Bowel Syndrome (IBS); Body Rashes; Migraines; Photosensitivity; Chronic infections caused by Low Immunity; Allergies; Suicidal; PTSD; Chronic fatigue; Major Depression/Withdrawal; Fibromyalgia; Chemical sensitivities; Low immunity; Weight gain (BMI over 30); Memory loss; Chronic reflux; Aggressive Explosive Anger; Impatient; Overwhelmed; Psoriasis; Hearing loss (not noise related); Auto-immune (blood); Herpes simplex (Compromised Immunity); Vertigo; Daily Nausea; Light headedness; Tinnitus. Name withheld, Submission 67, pp. 2-3.

[221]    Name withheld, Submission 67, p. 3.

[222]    Mr Colin Brock, Submission 69, p. 2.

[223]    Mr Syd Carter, Submission 108, p. 3.

[224]    Name withheld, Submission 75, p. 3.

[225]    Name withheld, Submission 61, p. 6.

[226]    Mr David Madsen, Submission 91, p. 1.

[227]    Mr David Madsen, Submission 91, p. 2.

Chapter 3 - Antimalarial drug trials involving the ADF

[1]        NHMRC, Australian Research Council (ARC) and Universities Australia, National Statement, 2007 (updated 2018), Chapter 4.3: People in dependent or unequal relationships, p. 68. 

[2]        National Statement, p. 16.

[3]        National Statement, p. 68.

[4]        Inspector-General of the ADF (IGADF), Inquiry report into issues concerning anti-malarial trials of the drug mefloquine between 2000 and 2002 involving Australian Defence members deploying to East Timor, 2016, p. 23; Australian Government Therapeutic Goods Administration, Note for Guidance on Good Clinical Practice, 2000, p. 13.

[5]        National Statement, p. 68.

[6]        Ms Jillian Barr, Ethics and Integrity, Research Quality and Priorities Branch, NHMRC, Committee Hansard, 11 October 2018, p. 13.

[7]        Mr Greg Jose, Committee Hansard, 31 August 2018, p. 2.

[8]        See Mr Stuart McCarthy, Submission 94, p. 11; Name withheld, Submission 59, [p. 5].

[9]        Submission 96, [p. 1]; Mrs Susan Armstrong, Committee Hansard, 30 August 2018, p. 15.

[10]      Submission 92, [p. 4].

[11]      Committee Hansard, 30 August 2018, p. 32.

[12]      Submission 16, p. 6.

[13]      Committee Hansard, 11 October 2018, p. 45.

[14]      For other examples see: Professor James McCarthy, Professor of Tropical Medicine and Infectious Diseases, Royal Brisbane Hospital and QIMR Berghofer Medical Research Institute, Submission 15, [p. 12]; Professor Geoffrey Quail, President of the Australian College of Tropical Medicine; Committee Hansard, 30 August 2018, p. 44.

[15]      Submission 15, [pp. 12–13].

[16]      Committee Hansard, 30 August 2018, p. 21. This trial compared tafenoquine and mefloquine use in 1 RAR in Timor-Leste in 2000 to 2001.

[17]      Submission 1, p. 27.

[18]      Supplementary submission 1.1, pp. 15–16.

[19]      NHMRC, ARC and Universities Australia, National Statement, p. 68.

[20]      National Statement, p. 68.

[21]      IGADF, Inquiry report, 2016, p. vi.

[22]      Defence, Submission 1, p. 33. When the research is deemed to be of low- or negligible-risk, reviews are undertaken by the Joint Health Command Low Risk Ethics Panel, People Research Low Risk Ethics Panel or Defence Science and Technology Low Risk Ethics Panel. Defence and Department of Veterans' Affairs, The Departments of Defence and Veterans’ Affairs Human Research Ethics Committee Terms of Reference, p. 2, http://www.defence.gov.au/health/hrec/ (accessed 11 October 2018).

[23]      Defence, Supplementary submission 1.1, p. 15.

[24]      Defence, Supplementary submission 1.1, p. 15.

[25]      DDVA HREC Terms of Reference, pp. 2–4,

[26]      NHMRC, ARC and Universities Australia, National Statement, p. 68.

[27]      Ms Barr, Committee Hansard, 11 October 2018, pp. 13–14.

[28]      Defence, Letter form AVM Tracy Smart AM to Mr Ian Tindall, Chair DDVA HREC,  4 October 2018, [p. 1] (tabled 11 October 2018).

[29]      Letter form AVM Tracy Smart AM to Mr Ian Tindall, [pp. 1–2].

[30]      Defence, Submission 1, Annex R, [pp. 229–233].

[31]      For example, see Mr Brian McCarthy, Submission 73, pp. 3–5.

[32]      Submission 1, p. 36.

[33]      Submission 1, pp. 10, 36. See Defence, Submission 1, Annex S, [pp. 234–249].

[34]      Defence, Submission 1, Annex S, [p. 239].

[35]      Defence, Submission 1, p. 39.

[36]      Defence, Submission 1, p. 39.

[37]      Committee Hansard, 11 October 2018, p. 45.

[38]      Defence, Submission 1, p. 37.

[39]      The new product information for the use of tafenoquine for the prevention of malaria also recommends a loading dose. Submission 1.1, pp. 11–12.

[40]      Dr Peter Stewart, Medical Director, Roche Products Pty Ltd, Proof Committee Hansard, 8 November 2018, p. 3.

[41]      Boudreau. E. et al., Tolerability of Prophylactic Lariam® Regimes; Trop. Med. Parasitol. 44(1993) 257-265.

[42]      Dr Stewart, Proof Committee Hansard, 8 November 2018, p. 3.

[43]      For example, see Ms Anne-Maree Baker, Proof Committee Hansard, 5 November 2018, p. 36; Associate Professor Jane Quinn, Proof Committee Hansard, 5 November 2018, p. 41.

[44]      Defence, Supplementary submission 1.1, p. 12.

[45]      Defence, Submission 1, pp. 36–37.

[46]      Professor Dennis Shanks, Director, ADFMIDI, Committee Hansard, 11 October 2018, p. 55. See also Defence, Supplementary submission 1.1, p. 12.

[47]      Professor Shanks, Committee Hansard, 11 October 2018, p. 55; Defence, Supplementary submission 1.1, p. 12.

[48]      Committee Hansard, 11 October 2018, p. 55.

[49]      See Proof Committee Hansard, 5 November 2018, p. 36.

[50]      Defence, Submission 1, pp. 36–37.

[51]      Defence, Supplementary submission 1.1, p. 21.

[52]      Committee Hansard, 11 October 2018, p. 22.

[53]      Committee Hansard, 11 October 2018, p. 22.

[54]      See, for example, Name withheld, Submission 48, p. 1.

[55]      Defence noted that this was 'to simplify health surveillance activities by aligning dosage requirements with the rest of the group', and Mr Reid also noted that it was to prevent 'an inducement for the soldiers to go into the trial unnecessarily'. Defence, Supplementary submission 1.1, p. 9; Committee Hansard, 30 August 2018, p. 21.

[56]      Supplementary submission 1.1, p. 9.

[57]      Defence, Submission 1, pp. 14, 20.

[58]      Defence, Submission 1, p. 14.

[59]      Submission 1, p. 36, Annex T.

[60]      Submission 1, pp. 2, 36.

[61]      Submission 1, p. 20.

[62]      Defence, Submission 1, Annex E, [p. 149].

[63]      Defence, Supplementary submission 1.1, p. 8.

[64]      See N Elmes, P Nasveld, S Kitchener, D Kocisko, M Edstein, 'The efficacy and tolerability of three different regimens of tafenoquine versus primaquine for post-exposure prophylaxis of Plasmodium vivax malaria in the Southwest Pacific', Transactions of the Royal Society of Tropical Medicine and Hygiene, vol. 102, no. 11, November 2008, pp. 1095–101.

[65]      See P Nasveld, M Edstein, M Reid, L Brennan, I Harris, S Kitchener, P Leggat, P Pickford, C Kerr, C Ohrt, W Prescott 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, 2010, pp. 792–8.

[66]      See S Kitchener, P Nasveld, R Gregory, M Edstein, 'Mefloquine and doxycycline malaria prophylaxis in Australian soldiers in East Timor',  Medical Journal of Australia, vol. 182, no. 4, 2005, pp. 168–171.

[67]      See S Kitchener, P Nasveld, M Edstein, 'Tafenoquine for the treatment of recurrent Plasmodium vivax malaria', American Journal of Tropical Medicine and Hygiene, vol. 76, no. 3, 2007, pp. 494–6.

[68]      Supplementary submission 1.1, p. 6. 

[69]      Defence, Supplementary submission 1.1, p. 6. 

[70]      Defence, Supplementary submission 1.1, p. 6. 

[71]      Supplementary submission 1.1, p. 6. 

[72]      The Quinism Foundation, Submission 17, p. 9.

[73]      Vice Admiral David Johnston AO, Committee Hansard, 11 October 2018, p. 45.

[74]      AQVFA, Submission 16.3, Annex 1, [p. 15].

[75]      Proof Committee Hansard, 5 November 2018, p. 40.

[76]      The Australian Malaria Institute has been renamed the ADF Malaria and Infectious Disease Institute. AQVFA, Submission 16, pp. 19, 45–47.

[77]      Proof Committee Hansard, 5 November 2018, p. 11.

[78]      The Australian Defence Human Research Ethics Committee (ADHREC), Annual Report 2015, Department of Defence, 2016, p. 7.

[79]      ADHREC, Annual Report 2015, Department of Defence, 2016, p. 7.

[80]      IGADF, Inquiry report, 2016, pp. ii–iii. 

[81]      Defence, Supplementary submission 1.1, p. 5.

[82]      The FDA considered 'study 033' (the tafenoquine prevention trial) and 'study 049' (the tafenoquine eradication trial). Proof Committee Hansard, 8 November 2018, p. 18.

[83]      Supplementary submission 1.1, p. 5.

[84]      Submission 1, p. 17.

[85]      Submission 15, [p. 12].

[86]      Submission 1, p. 16.

[87]      Mr Svend Peterson, Managing Director, Roche Products Pty Ltd, Proof Committee Hansard, 8 November 2018, p. 5.

[88]      Dr Alison Webster, Head, Global Health Clinical Research and Development, GSK, Proof Committee Hansard, 8 November 2018, p. 12.

[89]      Supplementary submission 1.1, p. 18.

[90]      Defence, Supplementary submission 1.1, p. 18.

[91]      Proof Committee Hansard, 11 October 2018, p. 37.

[92]      Dr Webster, Proof Committee Hansard, 8 November 2018, p. 14.

[93]      60P is also referred to as 60 Degrees Pharmaceuticals LLC. AQVFA, Submission 16.1, p. 3.

[94]      60P, Supplementary submission 9.1, p. 2.

[95]      Submission 58, [p. 5].

[96]      The forms are for the mefloquine prevention, tafenoquine prevention and tafenoquine eradication trials. See Submission 1, Annexes F to H.

[97]      Supplementary submission 1.1, Annex C, [p. 78].

[98]      Supplementary submission 16.3, Annexes 1 and 2.

[99]      IGADF, Inquiry report, p. i.

[100]    IGADF, Inquiry report, p. 7.

[101]    Ms Barr, Committee Hansard, 11 October 2018, p. 13. 

[102]    Defence, Submission 1, pp. 22, 25.

[103]    NHMRC, ARC and Universities Australia, National Statement, p. 16.

[104]    Committee Hansard, 31 August 2018, p. 25.

[105]    Name withheld, Submission 67, p. 1.

[106]    Mr Warren Goodchild, Committee Hansard, 31 August 2018, p. 31.

[107]    Defence, Military Justice: Organisations, http://www.defence.gov.au/mjs/organisations.asp#1 (accessed 2 October 2018).

[108]    IGADF, Inquiry report, pp. 1–2.

[109]    IGADF, Inquiry report, 2.

[110]    IGADF, Inquiry report, p. 24, [original emphasis removed].

[111]    Mr Stuart McCarthy, Submission 94; AQVFA, Submission 16.3; Quinism Foundation, Submission 17, pp. 5–10.

[112]    IGADF, Inquiry report, p. 49.

[113]    IGADF, Inquiry report, 2016, pp. ii–iii. 

[114]    Submission 17, p. 9.

[115]    Defence, Submission 1, Annex G, [p. 159].

[116]    IGADF, Inquiry report, p. iii.

[117]    IGADF, Inquiry report, p. iii.

[118]    IGADF, Inquiry report, p. 49.

[119]    Committee Hansard, 31 August 2018, pp. 21, 23.

[120]    IGADF, Inquiry report, 2016, p. vi.

[121]    The protocol appears to have been amended during 2001. AQVFA, Submission 16.3, pp. 4, 121–122.

[122]    This was more detailed than the 1998 Lariam consumer medicine information normally provided to patients on prescription. IGADF, Inquiry report, 2016, p. vi.

[123]    IGADF, Inquiry report, 2016, p. vi.

[124]    IGADF, Inquiry report, 2016, p. vi.

[125]    See, for example, name withheld, Submission 76, p. 3.

[126]    Mr Stuart McCarthy, Committee Hansard, 30 August 2018, p. 6.

[127]    Mr Brian McCarthy, Supplementary submission 73.2, pp. 7–8; Mr Stuart McCarthy, Submission 94, pp. 9–10.

[128]    Submission 1, p. 25.

[129]    Annex G of the Defence submission includes four versions of the information sheet and consent form. Defence, 'Tafenoquine Eradication and Treatment Trials', http://www.defence.gov.au/Health/HealthPortal/Malaria/AMI_research/tafenoquine-trials/eradication-treatment-trials.asp (accessed 8 October 2018).

[130]    Name withheld, Submission 59, [p. 1].

[131]    Defence, Supplementary submission 1.1, p. 12.

[132]    Defence, Supplementary submission 1.1, p. 29.

[133]    Submission 1, p. 24.

[134]    IGADF, Inquiry report, p. 9; Defence, Submission 1, p. 25. The TGA manages the Special Access Scheme in recognition that there are circumstances where patients need access to unregistered therapeutic goods. See TGA, 'Special Access Scheme' https://www.tga.gov.au/form/special-access-scheme (accessed 24 July 2018).

[135]    Kitchener et al, 'Tafenoquine for the treatment of recurrent Plasmodium vivax malaria', p. 494.

[136]    Defence, Submission 1, p. 25.

[137]    NHMRC, ARC and Universities Australia, National Statement, p. 18.

[138]    National Statement, p. 69.

[139]    Confidential, Submission 103, p. 1.

[140]    Committee Hansard, 30 August 2018, p. 15.

[141]    Committee Hansard, 30 August 2018, p. 29.

[142]    Committee Hansard, 30 August 2018, p. 11. See also Mr Eveille, Returned and Services League of Australia, Committee Hansard, 11 October 2018, p. 20.

[143]    Committee Hansard, 31 August 2018, p. 20.

[144]    Committee Hansard, 11 October 2018, p. 47.

[145]    Committee Hansard, 11 October 2018, p. 47.

[146]    IGADF, Inquiry report, 2016, p. iii.

[147]    Committee Hansard, 11 October 2018, p. 48.

[148]    Committee Hansard, 11 October 2018, p. 48. See also Mr Reid, Submission 71, p. 12.

[149]    Committee Hansard, 11 October 2018, p. 49.

[150]    Committee Hansard, 11 October 2018, p. 49.

[151]    Committee Hansard, 11 October 2018, p. 50.

[152]    Defence, Supplementary submission 1.1, p. 16.

[153]    Committee Hansard, 11 October 2018, p. 50.

[154]    IGADF, Inquiry report, 2016, p. iii.

[155]    See, for example, Mr Brock, Committee Hansard, 31 August 2018, p. 9; Mr Chris Ellicott, Submission 105, p. 1; Mr Todd Connors, Submission 99, [p. 1]; Mr Glen Norton, Submission 80, [p. 1].

[156]    IGADF, Inquiry report, p. 50; LTGEN Caligari, Committee Hansard, 31 August 2018, p. 25.

[157]    IGADF, Inquiry report, p. 50.

[158]    IGADF, Inquiry report, p. 56.

[159]    Committee Hansard, 11 October 2018, p. 49. See also Mr Reid, Committee Hansard, 30 August 2018, p. 21.

[160]    IGADF, Inquiry report, pp. 37–38, 51. See also Defence, Submission 1, p. 23.

[161]    IGADF, Inquiry report, p. 51.

[162]    AQVFA, Supplementary submission 16.6, pp. 3–4.

[163]    Committee Hansard, 11 October 2018, p. 50.

[164]    Defence, Supplementary submission 1.1, p. 11.

[165]    Supplementary submission 1.1, p. 11.

[166]    For example, Mr Brian McCarthy, Submission 73, pp. 6–8, Mr Stuart McCarthy, Committee Hansard, 30 August 2018, pp. 3–4; Associate Professor Jane Quinn, Proof Committee Hansard, 5 November 2018, pp. 39–40.

[167]    IGADF, Inquiry report, pp. 70–71.

[168]    IGADF, Inquiry report, pp. 71, 73.

[169]    Submission 72, [p. 1].

[170]    IGADF, Inquiry report, 2016, p. viii.

[171]    See Defence, Submission 1, Annex H, [pp. 161–179]; Kitchener et al, 'Tafenoquine for the treatment of recurrent Plasmodium vivax malaria', p. 494.

[172]    Submission 87, [p. 1].

[173]    Committee Hansard, 11 October 2018, p. 53.

[174]    See the information and consent forms for details on specific trials. Defence, Submission 1, Submission 1, Annexes F to H.

[175]    Proof Committee Hansard, 5 November 2018, p. 36.

[176]    Defence, Submission 1, p. 40.

[177]    Committee Hansard, 11 October 2018, p. 53.

[178]    Defence, Supplementary submission 1.1, p. 29; Committee Hansard, 11 October 2018, p. 53.

[179]    Committee Hansard, 11 October 2018, p. 53.

[180]    Submission 72, [p. 2].

[181]    Submission 1, p. 23.

[182]    Submission 1, Annex V, Adverse Event Reporting in AMI Studies 1999–2002.

[183]    Submission 1, p. 38.

[184]    Defence, Submission 1, p. 38.

[185]    Committee Hansard, 11 October 2018, p. 56.

[186]    Defence, Supplementary submission 1.1, p. 13.

[187]    Defence, Supplementary submission 1.1, p. 13.

[188]    Proof Committee Hansard, 5 November 2018, p. 37.

[189]    Proof Committee Hansard, 5 November 2018, p. 37.

[190]    Committee Hansard, 30 August 2018, p. 32.

[191]    Proof Committee Hansard, 5 November 2018, p. 5.

[192]    Committee Hansard, 11 October 2018, p. 5.

[193]    Proof Committee Hansard, 5 November 2018, p. 5.

[194]    The Quinism Foundation, Submission 17, p. 10. Dr Nevin identified the following meta-analysis: M  Tickell-Painter, N Maayan, R Saunders, C Pace, D Sinclair, 'Mefloquine for preventing malaria during travel to endemic areas', Cochrane Database of Systematic Reviews, 2017(10):CD006491.

[195]    The Quinism Foundation, Submission 17, p. 10.

[196]    Submission 16, pp. 18–24; Supplementary submission 16.1, pp. 5–10.

[197]    Submission 16, p. 21.

[198]    Mr Reid, Supplementary submission 71.3, p. 3.

[199]    Committee Hansard, 11 October 2018, p. 58. As noted above, the FDA audited the tafenoquine prevention and eradication trials.

[200]    Committee Hansard, 30 August 2018, p. 19.

[201]    Mr Reid, Supplementary submission 71.3, pp. 5–6.

[202]    LTGEN Caligari, Committee Hansard, 31 August 2018, p. 22.

[203]    Mr Reid, Committee Hansard, 30 August 2018, p. 20.

[204]    Submission 1, p. 41.

[205]    Defence, Submission 1, p. 17; Supplementary submission 1.1, p. 10. See also GSK Submission 8, p. 4; GSK, Supplementary submission 8.1, p. 2.

[206]    Defence, Supplementary submission 1.1, p. 10.

[207]    AQVFA, Submission 16, p. 21; Mr Todd Connors, Proof Committee Hansard, 5 November 2018, p. 18.

[208]    Mr Reid, Supplementary submission 71.5, p. 3, (emphasis added).

[209]    Supplementary submission 71.3, p. 2.

[210]    Supplementary submission 71.3, p. 3. See also GSK, Supplementary submission 8.1, p. 2.

[211]    Defence, Submission 1, p. 38; Mr Reid, Supplementary submission 71.3, p. 3.

[212]    Mr Reid, Supplementary submission 71.3, p. 3.

[213]    Defence, Supplementary submission 1.1, p. 10.

[214]    A draft copy of the letter sent to participants with information on vortex keratopathy was included in the following submissions: Defence, Submission 1, Annex I, [pp. 180–181]; Name withheld, Submission 47, Annex B.

[215]    Defence, Submission 1, pp. 26, 38.

[216]    Defence, Submission 1, p. 26.

[217]    Defence, Submission 1, p. 23.

[218]    Defence, Submission 1, p. 23.

[219]    Submission 1, p. 23.

[220]    Defence, Submission 1, p. 41.

[221]    Submission 1, p. 41.

[222]    IGADF, Inquiry report, p. ii.

[223]    Supplementary submission 16.3, p. 5.

[224]    Committee Hansard, 11 October 2018, p. 54.

[225]    Name withheld, Submission 76, pp. 4, 7–8.

[226]    Committee Hansard, 11 October 2018, p. 54.

[227]    Submission 1, pp. 27–28.

[228]    Defence, Submission 1, p. 28.

[229]    Committee Hansard, 31 August 2018, pp. 16–17.

[230]    Committee Hansard, 31 August 2018, p. 10.

[231]    Committee Hansard, 31 August 2018, pp. 10–11.

[232]    Submission 1, p. 25.

[233]    Committee Hansard, 11 October 2018, p. 54.

[234]    Defence, Supplementary submission 1.1, p. 5.

[235]    Defence, Supplementary submission 1.1, p. 14.

[236]    A draft copy of the letter sent to participants with information on vortex keratopathy was included in the following submissions: Defence, Submission 1, Annex I, [pp. 180–181]; Name withheld, Submission 47, Annex B.

[237]    Committee Hansard, 11 October 2018, p. 54.

[238]    Defence, Supplementary submission 1.1, p. 9.

[239]    Defence, Supplementary submission 1.1, p. 9. The submission provided additional details on the testing.

[240]    Proof Committee Hansard, 5 November 2018, p. 34.

[241]    Name withheld, Submission 56, [p. 1].

[242]    Committee Hansard, 31 August 2018, pp. 8, 16–17.

[243]    Submission 1, p. 24.

[244]    Proof Committee Hansard, 30 August 2018, p. 32; Submission 72, [p. 3].

[245]    Proof Committee Hansard, 5 November 2018, p. 27. 

[246]    Submission 1, p. 25.

[247]    Name Withheld, Submission 47, p. 4.

[248]    Submission 1, pp. 28–29.

[249]    Defence, Submission 1, p. 29.

Chapter 4 - Assistance and support for veterans

[1]        Senate Foreign Affairs, Defence and Trade References Committee, Mental health of ADF serving personnel, 17 March 2016.  See Recommendations 5 and 6.

[2]        The Hon Dan Tehan MP, Minister for Veterans Affairs, 'Addressing mefloquine concerns', Media Release, 15 September 2016.

[3]        Mr Greg Jose, Committee Hansard, 31 August 2018, p. 3; Mr Colin Brock, Committee Hansard, 31 August 2018, p. 8; Mr Wayne Karakyriacos, Committee Hansard, 31 August 2018, p. 8.

[4]        Correspondence from Minister for Veterans' Affairs, The Hon Darren Chester MP, response to Committee Chair, received 18 September 2018.

[5]        Submission 1, p. 30.

[6]        Department of Defence, Submission 1, p. 3.

[7]        See https://news.defence.gov.au/media/media-releases/statement-use-mefloquine-adf, accessed 27 June 2018.

[8]        VADM Ray Griggs, VCDF, Senate Foreign Affairs, Defence and Trade Legislation Committee, Estimates Hansard, 10 February 2016, pp. 173-174.

[9]        See http://www.defence.gov.au/health/healthportal/malaria/default.asp, accessed 16 July 2018. See also http://www.defence.gov.au/Health/HealthPortal/Malaria/Documents/160402%20-%20Townsville%20forum.pdf, accessed 16 July 2018.

[10]      Submission 1, p. 43.

[11]      Submission 1, p. 44. VVCS is now called Open Arms—Veterans and Families Counselling.

[12]      Defence, Submission 1, p.42.

[13]      http://www.defence.gov.au/Health/HealthPortal/Malaria/Documents/160822-Mefloquine-and-suicide.pdf, accessed 16 July 2018.

[14]      DVA, Submission 2, p. 6.

[15]      Ms Cosson, Committee Hansard, 11 October 2018, p. 63.

[16]      DVA, Submission 2, p. 5.

[17]      Defence, response to journalist, 6 December 2016, http://www.defence.gov.au/Health/HealthPortal/Malaria/Resources/media-statements.asp, accessed 16 July 2018.

[18]      Note: Veterans were very clear with the committee that they did not see this event as fitting their definition of 'outreach'. Detailed later in this chapter the committee heard about the next series of consultation forums being held by DVA.

[19]      Submission 1, pp. 31, 35.

[20]      See https://www.dva.gov.au/about-dva/publications/vetaffairs/vol-33-no1-autumn-2017/townsville-mefloquine-outreach-program, accessed 19 July 2018.

[21]      Submission 2, pp. 4­5.

[22]      Submission 2, p. 5.

[23]      Submission 2, p. 5.

[24]      Committee Hansard, 11 October 2018, p. 64.

[25]      DVA, Submission 2, p. 2.

[26]      DVA, Submission 2, pp. 2–3.

[27]      DVA, Submission 2, p. 3.

[28]      DVA, Submission 2, p. 4.

[29]      RMA, Submission 4, p. 4. 

[30]      Committee Hansard, 30 August 2018, p. 12.

[31]      Name withheld, Submission 61, p. 1.

[32]      See for example Mrs Mary Bush, Proof Committee Hansard, 5 November 2018, p. 15.

[33]      See for example Mrs Susan Armstrong, Committee Hansard, 30 August 2018, p. 17.

[34]      Committee Hansard, 30 August 2018, p. 16.

[35]      Mr Chris Ellicott, Proof Committee Hansard, 5 November 2018, p. 49; Mr Aaron King, Proof Committee Hansard, 5 November 2018, p. 29; Mr Michael Bush, Proof Committee Hansard, 5 November 2018, p. 15.

[36]      Committee Hansard, 30 August 2018, p. 8.

[37]      Proof Committee Hansard, 5 November 2018, p. 29.

[38]      Proof Committee Hansard, 5 November 2018, p. 1.

[39]      Proof Committee Hansard, 5 November 2018, p. 28.

[40]      Committee Hansard, 30 August 2018, p. 8.

[41]      Committee Hansard, 31 August 2018, p. 13.

[42]      Committee Hansard, 31 August 2018, p. 13.

[43]      Proof Committee Hansard, 5 November 2018, p. 24.

[44]      Committee Hansard, 31 August 2018, p. 37.

[45]      Committee Hansard, 31 August 2018, p. 17.

[46]      Proof Committee Hansard, 5 November 2018, p. 5.

[47]      Committee Hansard, 31 August 2018, p. 13.

[48]      Mrs Raelene King, Proof Committee Hansard, 5 November 2018, pp. 30–­31; Mr Mark Freer, Proof Committee Hansard, 5 November 2018, p. 48.

[49]      Committee Hansard, 30 August 2018, p. 15.

[50]      Submission 16.4, p. 3.

[51]      Ms Cosson, Committee Hansard, 11 October 2018, p. 63.

[52]      See for example Mr Wayne Karakyriacos, Committee Hansard, 31 August 2018, p. 11.

[53]      Mr Michael Bush, Proof Committee Hansard, 5 November 2018, p. 15; Mr Brian Carlon, Proof Committee Hansard, 5 November 2018, p. 22.

[54]      Ms Cosson, Committee Hansard, 11 October 2018, p. 62.

[55]      Committee Hansard, 15 October 2018, p. 5.

[56]      Ms Cosson, Committee Hansard, 11 October 2018, p. 60.

[57]      Proof Committee Hansard, 5 November 2018, p. 8.

[58]      Proof Committee Hansard, 5 November 2018, p. 8.

[59]      RMA, Submission 4, p. 4.

[60]      RMA, Submission 4, p. 4.

[61]      Committee Hansard, 15 October 2018, p. 1.

[62]      Submission 2, p. 7.

[63]      The list of relevant SOPs was provided in the RMA submission: RMA, Submission 4, Attachment 2. DVA, Submission 2, p. 7.

[64]      Committee Hansard, 15 October 2018, pp. 1­2.

[65]      RMA, Submission 4, p. 6.

[66]      Committee Hansard, 11 October 2018, p. 62.

[67]      Committee Hansard, 15 October 2018, p. 8.

[68]      Committee Hansard, 15 October 2018, p. 5.

[69]      Professor Saunders, Committee Hansard, 15 October 2018, p. 5. See Statement of Principles concerning chronic multisymptom illness No. 55 of 2014.

[70]      DVA, Response to questions on notice from 11 October 2018 public hearing (received 1 November 2018), [p. 1].

[71]      DVA noted that a single claim may represent one or more conditions per veteran, and a veteran may have more than one claim for the same condition to reflect they may have entitlements to test the same claim under multiple Acts. Response to questions on notice from 11 October 2018 public hearing (received 1 November 2018), [p. 1].

[72]      Response to questions on notice from 11 October 2018 public hearing (received 1 November 2018), [p. 1].

[73]      Response to questions on notice from 11 October 2018 public hearing (received 1 November 2018), [p. 3]. Note: the six withdrawn conditions relate to one veteran.

[74]      Response to questions on notice from 11 October 2018 public hearing (received 1 November 2018), [p. 2].

[75]      Response to questions on notice from 11 October 2018 public hearing (received 1 November 2018), [p. 6].

[76]      Committee Hansard, 11 October 2018, p. 61.

[77]      DVA, Response to questions on notice from 11 October 2018 public hearing (received 1 November 2018), [p. 7]. See also Ms Cosson, Committee Hansard, 11 October 2018, p. 62.

[78]      DVA, responses to questions taken on notice at a public hearing on 11 October 2018 (received 1 November 2018), p. 7.

[79]      Proof Committee Hansard, 5 November 2018, p. 8.

[80]      Submission 16, p. 6.

[81]      Proof Committee Hansard, 31 August 2018, p. 20. The tafenoquine prevention trial compared tafenoquine and mefloquine use in 1 RAR in Timor-Leste from October 2000 to April 2001.

[82]      Committee Hansard, 11 October 2018, p. 7.

[83]      Proof Committee Hansard, 5 November 2018, p. 46.

[84]      Committee Hansard, 30 August 2018, p. 15.

[85]      Proof Committee Hansard, 5 November 2018, p. 31.

[86]      Committee Hansard, 30 August 2018, pp. 32–33.

[87]      Proof Committee Hansard, 30 August 2018, p. 27.

[88]      Submission 90, p. 2.

[89]      Proof Committee Hansard, 5 November 2018, p. 4.

[90]      Proof Committee Hansard, 5 November 2018, p. 4.

[91]      Proof Committee Hansard, 5 November 2018, p. 28.

[92]      See for example, Name withheld, Submission 48, p. 2; Mr Karakyriacos, Committee Hansard, 31 August 2018, p. 14.

[93]      Committee Hansard, 30 August 2018, p. 33.

[94]      Committee Hansard, 30 August 2018, p. 32.

[95]      Committee Hansard, 30 August 2018, p. 32.

[96]      Submission 16, pp. 54–55.

[97]      Submission 16, pp. 54–55.

[98]      See Mr Stuart McCarthy, Submission 94, pp. 6–7.

[99]      Mrs Raelene King, Proof Committee Hansard, 5 November 2018, p. 28.

[100]    Proof Committee Hansard, 5 November 2018, p. 4.

[101]    Proof Committee Hansard, 5 November 2018, p. 42.

[102]    Quinism Foundation, Submission 17, p. 11.  

[103]    Proof Committee Hansard, 5 November 2018, p. 8.

[104]    Submission 95, p. 2.

[105]    Proof Committee Hansard, 5 November 2018, p. 43.

[106]    Submission 94, p. 1. See also Submission 16, p. 42. Submission 16.1, p. 6; The Quinism Foundation, Submission 17, p. 5; Defence Force Welfare Association, Submission 95, p. 2.

[107]    Committee Hansard, 11 October 2018, p. 6.

[108]    See for example, Ms Anne-Maree Baker, Proof Committee Hansard, 5 November 2018, p. 31.

[109]    Proof Committee Hansard, 5 November 2018, p. 42.

[110]    Proof Committee Hansard, 5 November 2018, p. 42.

[111]    Associate Professor Harin Karunajeewa, Submission 15, [pp. 10–11].

[112]    Submission 15, [pp. 10–­11].

[113]    Committee Hansard, 11 October 2018, p. 46.

[114]    Submission 1, pp. 31–­32.

[115]    Proof Committee Hansard, 5 November 2018, p. 28.

[116]    Committee Hansard, 30 August 2018, p. 8.

[117]    Committee Hansard, 11 October 2018, p. 64.

[118]    Committee Hansard, 11 October 2018, p. 60.

[119]    DVA, responses to questions taken on notice at a public hearing on 11 October 2018 (received 1 November 2018), [p. 9].

[120]    DVA, responses to questions taken on notice at a public hearing on 11 October 2018 (received 1 November 2018), [p. 10].

[121]    Proof Committee Hansard, 5 November 2018, p. 44.

[122]    Proof Committee Hansard, 5 November 2018, p. 44.

[123]    Committee Hansard, 11 October 2018, p. 15.

[124]    Committee Hansard, 11 October 2018, p. 15.

[125]    See for example, Mr Benjamin Fleming, Committee Hansard, 30 August 2018, p. 33.

[126]    Dr Hodson, Committee Hansard, 11 October 2018, p. 65.

[127]    Committee Hansard, 11 October 2018, p. 16.

[128]    Committee Hansard, 11 October 2018, p. 16.

[129]    Proof Committee Hansard, 8 November 2018, p. 22.

[130]    Committee Hansard, 11 October 2018, p. 16.

[131]    Committee Hansard, 11 October 2018, p. 16.

[132]    See DVA, Health Providers Partnership Forum, Terms of Reference, p. 1.

[133]    RACGP, responses to questions taken on notice from a public hearing on 11 October 2018 (received 31 October 2018).

[134]    Submission 58, p. 4.

[135]    Department of Defence, Submission 1, p. 42.

[136]    Department of Defence, Submission 1, p. 42; DVA, Submission 2, p. 6.

[137]    Submission 2, p. 7.

[138]    Department of Defence, Submission 1, p. 42.

[139]    Ms Veronica Hancock, Acting First Assistant Secretary, Veterans' Services Design, Committee Hansard, 11 October 2018, p. 68.

[140]    Mr Whiley, Committee Hansard, 30 August 2018, p. 35.

[141]    RACGP, The RACGP Curriculum for Australian General Practice 2011, p. 453. See also GK Mitchell, JJ Tieman and TM Shelby-James, 'Multidisciplinary care planning and teamwork in primary care', Medical Journal of Australia, 2008, vol. 188, no. 8, S61–4.

[142]    RACGP, The RACGP Curriculum for Australian General Practice 2011, p. 454.

[143]    Proof Committee Hansard, 5 November 2018, p. 42.

[144]    Committee Hansard, 11 October 2018, p. 66.

[145]    Committee Hansard, 11 October 2018, p. 65.

[146]    Committee Hansard, 11 October 2018, p. 65.

[147]    Committee Hansard, 11 October 2018, p. 65.

[148]    Committee Hansard, 11 October 2018, p. 65.

[149]    Submission 2, p. 6.

[150]    Committee Hansard, 11 October 2018, p. 65.

[151]    Submission 2, p. 6.

[152]    Mr Stuart McCarthy, Committee Hansard, 30 August 2018, p. 2.

[153]    Proof Committee Hansard, 5 November 2018, p. 46.

Chapter 5 - Conclusions and Recommendations

[1]        Vice Admiral David Johnston AO, Vice Chief of the Defence Force, Department of Defence, Committee Hansard, 11 October 2018, p. 45.

[2]        For example, primaquine has been used for more than 60 years in the USA and Australia. See 60P, Submission 9, p. 2.

[3]        Dr Nevin, Committee Hansard, 11 October 2018, p. 7.

[4]        Defence, Supplementary submission 1.1, p. 5.

[5]        IGADF, Inquiry report into issues concerning anti-malarial trials of the drug mefloquine between 2000 and 2002 involving Australian Defence members deploying to East Timor, 2016, pp. ii–iii. 

[6]        Defence, Submission 1.1, p. 15.

[7]        Defence and Department of Veterans' Affairs, The DDVA HREC Terms of Reference, pp. 2–4, http://www.defence.gov.au/health/hrec/ (accessed 11 October 2018).

[8]        Defence, Letter form AVM Tracy Smart Am to Mr Ian Tindall, Chair DDVA HREC,  4 October 2018, [p. 1] (tabled 11 October 2018).

[9]        Defence, Submission 1, p. 33.

[10]      The DDVA HREC Terms of Reference, p. 1; NHMRC, Australian Research Council and Universities Australia, National Statement on Ethical Conduct in Human Research, p. 68.

[11]      National Statement, p. 68.

[12]      IGADF, Inquiry report, 2016, p. iii.

[13]      Defence, Submission 1, p. 28.

[14]      DVA was in attendance at public hearings to provide assistance to veterans if required.

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