TGA Approvals for Australian Defence Force Use of Mefloquine in Townsville (Queensland) and Somalia, 1992-93
Dear Therapeutic Goods Administration staff,
In 1992-93 the Australian Defence Force (ADF) administered the anti-malarial drug mefloquine to a group of personnel from the 1st Battalion Royal Australian Regiment (1 RAR) during a clinical trial conducted in Townsville (Queensland) and Somalia.[1] This trial commenced before mefloquine was registered by the TGA in January 1993.[2]
Mefloquine is a neurotoxic drug, known to be a cause of permanent brain injury resulting in a range of chronic neuropsychiatric symptoms.[3-5] The Department of Veterans Affairs has recently commenced a pilot outreach program for veterans who were adversely affected by mefloquine.[6]
I hereby request the TGA to provide documents relating to any approvals for the ADF or Department of Defence to administer mefloquine to Australian personnel during this period, including but not limited to:
a. Requests from ADF or Defence officials for TGA approval to use mefloquine.
b. Requests from ADF or Defence officials for TGA approval to import mefloquine to Australia or export mefloquine to Somalia.
b. Minutes of meetings, records of conversations, or other corre Roche, relating to the proposed use, import or export of mefloquine.
e. Written approvals by the TGA for Defence use, import or export of mefloquine.
f. Reports from Defence officials to the TGA relating to adverse events experienced by ADF personnel administered mefloquine during this clinical trial.
Yours faithfully,
Stuart McCarthy
References:
1. G.D. Shanks et al, "Doxycycline for Malaria Prophylaxis in Australian Soldiers Deployed to United Nations Missions in Somalia and Cambodia", Military Medicine, vol. 160, no. 9, 1995. https://www.ncbi.nlm.nih.gov/pubmed/7478...
2. Therapeutic Goods Administration, Summary for Australian Register of Therapeutic Goods Entry 43321: LARIAM Mefloquine 250mg (as Hydrochloride) Tablet Blister Pack, Canberra, 19 November 2014. https://www.tga.gov.au/artg/artg-id-43321
3. E.C. Ritchie, J. Block and R.L. Nevin, "Psychiatric Side Effects of Mefloquine: Applications to Forensic Psychiatry", Journal of the American Academy of Psychiatry and the Law, vol. 41, no. 2, pp. 224-35, 2013. https://www.ncbi.nlm.nih.gov/pubmed/2377...
4. R.L. Nevin, "Idiosyncratic Quinoline Central Nervous System Toxicity: Historical Insights into the Chronic Neurological Sequelae of Mefloquine", International Journal for Parasitology: Drugs and Drug Resistance, vol. 4, no. 2, pp. 118-25, 2014. https://www.ncbi.nlm.nih.gov/pubmed/2505...
5. S. McCarthy, "Malaria Prevention, Mefloquine Neurotoxicity, Neuropsychiatric Illness and Risk-Benefit Analysis in the Australian Defence Force", Journal of Parasitology Research, vol. 2015 , Article ID 368064, 2015. https://www.ncbi.nlm.nih.gov/pubmed/2679...
6. R. Riley, "Pilot outreach program begins in Townsville for mefloquine related health concerns", Townsville Bulletin, 14 December 2016. http://www.townsvillebulletin.com.au/new...
Dear Mr McCarthy
I refer to your Freedom of Information (FOI) request to the Department of
Health below which has been allocated reference number #153-1617.
Pursuant to s15AA of the Freedom of Information Act 1982, I am seeking
your agreement to a 20 day extension of time due to the Department’s
shutdown period, for providing you with a decision on your request.
Your prompt response regarding an agreement to this extension would be
much appreciated.
Kind Regards,
FOI Unit
Ministerial, Parliamentary, Executive Support and Governance Branch
People, Capability and Communication Division
Australian Government Department of Health
T: (02) 6289 1666 | E: [TGA request email]
PO Box 9848, Canberra ACT 2601, Australia
The Department of Health acknowledges the traditional owners of country
throughout Australia, and their continuing connection to land, sea and
community. We pay our respects to them and their cultures, and to elders
both past and present.
-----Original Message-----
From: Stuart McCarthy
[mailto:[FOI #2865 email]]
Sent: Saturday, 17 December 2016 11:53 AM
To: FOI
Subject: Freedom of Information request - TGA Approvals for Australian
Defence Force Use of Mefloquine in Townsville (Queensland) and Somalia,
1992-93 [SEC=No Protective Marking]
Dear Therapeutic Goods Administration staff,
In 1992-93 the Australian Defence Force (ADF) administered the
anti-malarial drug mefloquine to a group of personnel from the 1st
Battalion Royal Australian Regiment (1 RAR) during a clinical trial
conducted in Townsville (Queensland) and Somalia.[1] This trial commenced
before mefloquine was registered by the TGA in January 1993.[2]
Mefloquine is a neurotoxic drug, known to be a cause of permanent brain
injury resulting in a range of chronic neuropsychiatric symptoms.[3-5] The
Department of Veterans Affairs has recently commenced a pilot outreach
program for veterans who were adversely affected by mefloquine.[6]
I hereby request the TGA to provide documents relating to any approvals
for the ADF or Department of Defence to administer mefloquine to
Australian personnel during this period, including but not limited to:
a. Requests from ADF or Defence officials for TGA approval to use
mefloquine.
b. Requests from ADF or Defence officials for TGA approval to import
mefloquine to Australia or export mefloquine to Somalia.
b. Minutes of meetings, records of conversations, or other corre Roche,
relating to the proposed use, import or export of mefloquine.
e. Written approvals by the TGA for Defence use, import or export of
mefloquine.
f. Reports from Defence officials to the TGA relating to adverse events
experienced by ADF personnel administered mefloquine during this clinical
trial.
Yours faithfully,
Stuart McCarthy
References:
1. G.D. Shanks et al, "Doxycycline for Malaria Prophylaxis in Australian
Soldiers Deployed to United Nations Missions in Somalia and Cambodia",
Military Medicine, vol. 160, no. 9, 1995.
[1]https://www.ncbi.nlm.nih.gov/pubmed/7478...
2. Therapeutic Goods Administration, Summary for Australian Register of
Therapeutic Goods Entry 43321: LARIAM Mefloquine 250mg (as Hydrochloride)
Tablet Blister Pack, Canberra, 19 November 2014.
[2]https://www.tga.gov.au/artg/artg-id-43321
3. E.C. Ritchie, J. Block and R.L. Nevin, "Psychiatric Side Effects of
Mefloquine: Applications to Forensic Psychiatry", Journal of the American
Academy of Psychiatry and the Law, vol. 41, no. 2, pp. 224-35, 2013.
[3]https://www.ncbi.nlm.nih.gov/pubmed/2377...
4. R.L. Nevin, "Idiosyncratic Quinoline Central Nervous System Toxicity:
Historical Insights into the Chronic Neurological Sequelae of Mefloquine",
International Journal for Parasitology: Drugs and Drug Resistance, vol. 4,
no. 2, pp. 118-25, 2014. [4]https://www.ncbi.nlm.nih.gov/pubmed/2505...
5. S. McCarthy, "Malaria Prevention, Mefloquine Neurotoxicity,
Neuropsychiatric Illness and Risk-Benefit Analysis in the Australian
Defence Force", Journal of Parasitology Research, vol. 2015 , Article ID
368064, 2015. [5]https://www.ncbi.nlm.nih.gov/pubmed/2679...
6. R. Riley, "Pilot outreach program begins in Townsville for mefloquine
related health concerns", Townsville Bulletin, 14 December 2016.
[6]http://www.townsvillebulletin.com.au/new...
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If you are not the intended recipient, you are notified that any use or
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References
Visible links
1. https://www.ncbi.nlm.nih.gov/pubmed/7478...
2. https://www.tga.gov.au/artg/artg-id-43321
3. https://www.ncbi.nlm.nih.gov/pubmed/2377...
4. https://www.ncbi.nlm.nih.gov/pubmed/2505...
5. https://www.ncbi.nlm.nih.gov/pubmed/2679...
6. http://www.townsvillebulletin.com.au/new...
Dear Mr McCarthy
FREEDOM OF INFORMATION REQUEST – NOTIFICATION OF RECEIPT
I am writing to notify you that the Department of Health (Department) has received your request (in your below email) for access to documents under the Freedom of Information Act 1982 (FOI Act).
The Department will take all reasonable steps to notify you of a decision no later than 30 calendar days after the date your request was received. You will be contacted where a charge is applied for processing your request or if we need to consult a third party.
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You can contact the FOI Unit on (02) 6289 1666, or via email at [email address], should you have any enquiries.
Kind regards
FOI Officer
Ministerial, Parliamentary, Executive Support and Governance Branch
People, Capability and Communication Division
Australian Government Department of Health
T: (02) 6289 1666 | E: [TGA request email]
PO Box 9848, Canberra ACT 2601, Australia
The Department of Health acknowledges the traditional owners of country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to elders both past and present.
-----Original Message-----
From: Stuart McCarthy [mailto:[FOI #2865 email]]
Sent: Saturday, 17 December 2016 11:53 AM
To: FOI
Subject: Freedom of Information request - TGA Approvals for Australian Defence Force Use of Mefloquine in Townsville (Queensland) and Somalia, 1992-93 [SEC=No Protective Marking]
Dear Therapeutic Goods Administration staff,
In 1992-93 the Australian Defence Force (ADF) administered the anti-malarial drug mefloquine to a group of personnel from the 1st Battalion Royal Australian Regiment (1 RAR) during a clinical trial conducted in Townsville (Queensland) and Somalia.[1] This trial commenced before mefloquine was registered by the TGA in January 1993.[2]
Mefloquine is a neurotoxic drug, known to be a cause of permanent brain injury resulting in a range of chronic neuropsychiatric symptoms.[3-5] The Department of Veterans Affairs has recently commenced a pilot outreach program for veterans who were adversely affected by mefloquine.[6]
I hereby request the TGA to provide documents relating to any approvals for the ADF or Department of Defence to administer mefloquine to Australian personnel during this period, including but not limited to:
a. Requests from ADF or Defence officials for TGA approval to use mefloquine.
b. Requests from ADF or Defence officials for TGA approval to import mefloquine to Australia or export mefloquine to Somalia.
b. Minutes of meetings, records of conversations, or other corre Roche, relating to the proposed use, import or export of mefloquine.
e. Written approvals by the TGA for Defence use, import or export of mefloquine.
f. Reports from Defence officials to the TGA relating to adverse events experienced by ADF personnel administered mefloquine during this clinical trial.
Yours faithfully,
Stuart McCarthy
References:
1. G.D. Shanks et al, "Doxycycline for Malaria Prophylaxis in Australian Soldiers Deployed to United Nations Missions in Somalia and Cambodia", Military Medicine, vol. 160, no. 9, 1995. https://www.ncbi.nlm.nih.gov/pubmed/7478...
2. Therapeutic Goods Administration, Summary for Australian Register of Therapeutic Goods Entry 43321: LARIAM Mefloquine 250mg (as Hydrochloride) Tablet Blister Pack, Canberra, 19 November 2014. https://www.tga.gov.au/artg/artg-id-43321
3. E.C. Ritchie, J. Block and R.L. Nevin, "Psychiatric Side Effects of Mefloquine: Applications to Forensic Psychiatry", Journal of the American Academy of Psychiatry and the Law, vol. 41, no. 2, pp. 224-35, 2013. https://www.ncbi.nlm.nih.gov/pubmed/2377...
4. R.L. Nevin, "Idiosyncratic Quinoline Central Nervous System Toxicity: Historical Insights into the Chronic Neurological Sequelae of Mefloquine", International Journal for Parasitology: Drugs and Drug Resistance, vol. 4, no. 2, pp. 118-25, 2014. https://www.ncbi.nlm.nih.gov/pubmed/2505...
5. S. McCarthy, "Malaria Prevention, Mefloquine Neurotoxicity, Neuropsychiatric Illness and Risk-Benefit Analysis in the Australian Defence Force", Journal of Parasitology Research, vol. 2015 , Article ID 368064, 2015. https://www.ncbi.nlm.nih.gov/pubmed/2679...
6. R. Riley, "Pilot outreach program begins in Townsville for mefloquine related health concerns", Townsville Bulletin, 14 December 2016. http://www.townsvillebulletin.com.au/new...
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Dear Mr McCarthy
Please find attached correspondence in relation to your Freedom of
Information request.
If you have any questions, please do not hesitate to contact the FOI Team.
Kind regards
Sasha
Freedom of Information
Liz Santolin 02 6232 8664
Sasha Pesic 02 6232 8795
Karen Bedford 02 6232 8772
Heather Davidson 02 6232 8012
Shreya Thakur 02 6232 8688
Reporting and Collaborative Services Section
Regulatory Engagement and Planning Branch
Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]
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"Important: This transmission is intended only for the use of the
addressee and may contain confidential or legally privileged information.
If you are not the intended recipient, you are notified that any use or
dissemination of this communication is strictly prohibited. If you receive
this transmission in error please notify the author immediately and delete
all copies of this transmission."
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