Documents Relating to U.S. Department of Defense Research into Neurotoxicity and/or Adverse Neuropsychiatric Effects of the Anti-malarial Drug Mefloquine

Stuart McCarthy made this Freedom of Information request to Department of Defence

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Dear Department of Defence,

Mefloquine (trade name Lariam) is an anti-malarial drug that has been used by the Australian Defence Force (ADF) since 1990. The Australian Army Malaria Institute (AMI) has undertaken research on mefloquine since at least the 1980s, in close cooperation with the U.S. Walter Reed Army Institute of Research (WRAIR).[1] The drug is now known to be neurotoxic, able to cause a chronic central nervous system toxicity syndrome in a sizeable minority of users.[2] In mid-2014 the U.S. Defense Health Agency completed a study on neuropsychiatric adverse events following mefloquine exposure in U.S. military personnel,[3] and on 3 December 2014 a presentation on mefloquine use in the U.S. military was delivered to the Association of Military Surgeons United States (AMSUS) annual meeting.[4]

I hereby request to be provided with documents held by the Australian Department of Defence (Aus DoD) relating to U.S. Department of Defense (U.S. DoD) research into the neurotoxicity and/or neuropsychiatric adverse effects of mefloquine, dating from 1 January 2013 to the present, including:

a. Emails, minutes, letters, memos, briefings, presentations, or summaries relating to proposals, conduct, findings, outcomes or recommendations of the above research, including correspondence between U.S. DoD and Aus DoD officials, or internal Aus DoD correspondence.

b. Documents relating to the involvement of Aus DoD officials in the above research, as sponsors, researchers, reviewers or subjects.

c. Documents relating to the attendance of Aus DoD officials at meetings, visits or conferences on the subject of mefloquine use in the military, including notes, briefings or similar correspondence on the observations, findings or outcomes of those activities.

d. Documents relating to the implications of the above research for the use of mefloquine in the ADF, or possible adverse health effects on ADF personnel.

Yours faithfully,

Stuart McCarthy

References:

1. 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. http://www.ncbi.nlm.nih.gov/pubmed/26793...

2. 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. http://www.ncbi.nlm.nih.gov/pubmed/25057...

3. A. Cost, Neuropsychiatric Adverse Events following Mefloquine Exposure, U.S. Armed Forces Health Surveillance Center, Silver Spring MD, 28 July 2014. https://t.co/4kcR2sE5Fc

4. R. L. Nevin and E. C. Ritchie, "Mefloquine and the US Military", in E. Altman Milhiser (Ed), Synopsis: AMSUS Meeting, Gray & Associates, Arlington VA, pp. 13-14, 3 December 2014. http://www.amsus.org/wp-content/uploads/...

UNCLASSIFIED

Good morning

Thank you for your email. Your email has been forwarded for consideration/action.

Kind regards

FOI Operations
[email address]
(02) 6266 2200
http://www.defence.gov.au/foi/

-----Original Message-----
From: Stuart McCarthy [mailto:[FOI #2004 email]]
Sent: Friday, 17 June 2016 06:11
To: FOI requests at Defence
Subject: Freedom of Information request - Documents Relating to U.S. Department of Defense Research into Neurotoxicity and/or Adverse Neuropsychiatric Effects of the Anti-malarial Drug Mefloquine

Dear Department of Defence,

b. Documents relating to the involvement of Aus DoD officials in the above research, as sponsors, researchers, reviewers or subjects.

d. Documents relating to the implications of the above research for the use of mefloquine in the ADF, or possible adverse health effects on ADF personnel.

Yours faithfully,

Stuart McCarthy

References:

3. A. Cost, Neuropsychiatric Adverse Events following Mefloquine Exposure, U.S. Armed Forces Health Surveillance Center, Silver Spring MD, 28 July 2014. https://t.co/4kcR2sE5Fc

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160701 389 1516 PA letter.pdf

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UNCLASSIFIED

Good afternoon Mr McCarthy

Please find attached the preliminary assessment of FOI Charges relating to
FOI 389/15/16.

Kind regards

Theresa Stinson

Assistant Director - Media Case Management

Freedom of Information

Governance and Reform Division

Building F065

Level 2 - 057

Gallipoli Barracks

ENOGGERA QLD 4051

Ph: (07) 3332 6359

Alternative email: [1][email address]

____________________________________________________________________

Website:[2]http://www.defence.gov.au/foi/index.htm

Privacy Statement: [3]http://www.defence.gov.au/FOI/privacy.asp

FOI Act: [4]https://www.comlaw.gov.au/Details/C2014C...

FOI Guidelines:
[5]http://www.oaic.gov.au/freedom-of-inform...

IMPORTANT: This email remains the property of the Department of Defence
and is subject to the jurisdiction of section 70 of the Crimes Act 1914.
If you have received this email in error, you are requested to contact the
sender and delete the email.

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Dear Mrs Stinson,

Thankyou for replying to my FOI request 389/15/16, 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. Since c.1990 mefloquine has been administered to several thousand ADF personnel, the majority of whom are no longer serving.[1]

b. Mefloquine is known to be neurotoxic, able to cause lasting or permanent brain injury and chronic neuropsychiatric symptoms in a sizeable minority of those given the drug.[1,2]

c. Senior Defence officials including the ADF Surgeon General have stated publicly that they are committed to full transparency in relation to this matter.[3]

d. 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."[4] The requested documents will assist those individuals to seek this medical assistance.

e. The Department of Defence has thus far refused to contact the affected individuals, contrary to the recommendations of the recent Senate inquiry into ADF mental health.[5] This task is instead being undertaken by volunteers, many of whom are experiencing severe financial hardship.

Yours sincerely,

Stuart McCarthy

References:

1. 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. http://dx.doi.org/10.1155/2015/287651

2. 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. 118-125, 2014. http://www.sciencedirect.com/science/art...

3. 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...

4. R.J. Griggs, "Response to reporting on mefloquine in the Townsville Bulletin", Department of Defence, Canberra, 19 February 2016. http://news.defence.gov.au/2016/01/15/re...

5. Senate Foreign Affairs, Defence and Trade Committee, "Mental health of Australian Defence Force members and veterans", Parliament House, Canberra, 17 March 2016. http://www.aph.gov.au/Parliamentary_Busi...

UNCLASSIFIED

Good morning Mr McCarthy,

Thank you for your email below. Defence has 30 days to consider your request for waiver of FOI processing charges. Accordingly a response will be provided by no later than 1 August 2016.

In the meantime should you have any queries about your request, please do not hesitate to contact me.

Kind regards

Theresa Stinson

Assistant Director - Media Case Management

Freedom of Information

Governance and Reform Division

Building F065

Level 2 - 057

Gallipoli Barracks

ENOGGERA QLD 4051

Ph: (07) 3332 6359

Alternative email: [email address]

____________________________________________________________________

Website:http://www.defence.gov.au/foi/index.htm

Privacy Statement: http://www.defence.gov.au/FOI/privacy.asp

FOI Act: https://www.comlaw.gov.au/Details/C2014C...

FOI Guidelines: http://www.oaic.gov.au/freedom-of-inform...

-----Original Message-----
From: Stuart McCarthy [mailto:[FOI #2004 email]]
Sent: Saturday, 2 July 2016 14:01
To: Stinson, Theresa MRS
Subject: Re: FOI 389/15/16 [SEC=UNCLASSIFIED]

Dear Mrs Stinson,

Thankyou for replying to my FOI request 389/15/16, 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. Since c.1990 mefloquine has been administered to several thousand ADF personnel, the majority of whom are no longer serving.[1]

b. Mefloquine is known to be neurotoxic, able to cause lasting or permanent brain injury and chronic neuropsychiatric symptoms in a sizeable minority of those given the drug.[1,2]

c. Senior Defence officials including the ADF Surgeon General have stated publicly that they are committed to full transparency in relation to this matter.[3]

Yours sincerely,

Stuart McCarthy

References:

3. 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...

4. R.J. Griggs, "Response to reporting on mefloquine in the Townsville Bulletin", Department of Defence, Canberra, 19 February 2016. http://news.defence.gov.au/2016/01/15/re...

-----Original Message-----

UNCLASSIFIED

Good afternoon Mr McCarthy

Please find attached the preliminary assessment of FOI Charges relating to FOI 389/15/16.

Kind regards

Theresa Stinson

Assistant Director - Media Case Management

Freedom of Information

Governance and Reform Division

Building F065

Level 2 - 057

Gallipoli Barracks

ENOGGERA QLD 4051

Ph: (07) 3332 6359

Alternative email: [1][email address]

____________________________________________________________________

Website:[2]http://www.defence.gov.au/foi/index.htm

Privacy Statement: [3]http://www.defence.gov.au/FOI/privacy.asp

FOI Act: [4]https://www.comlaw.gov.au/Details/C2014C...

FOI Guidelines:
[5]http://www.oaic.gov.au/freedom-of-inform...

IMPORTANT: This email remains the property of the Department of Defence and is subject to the jurisdiction of section 70 of the Crimes Act 1914.
If you have received this email in error, you are requested to contact the sender and delete the email.

References

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Please use this email address for all replies to this request:
[FOI #2004 email]

If you find this service useful as an FOI officer, please ask your web manager to link to us from your organisation's FOI page.

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160801 389 1516 Charges decision letter.pdf

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UNCLASSIFIED

Good afternoon Mr McCarthy,

Please find attached the charges decision letter relating to FOI 389/15/16.

Should you have any queries about this matter, please contact me.

Kind regards

Theresa Stinson

Assistant Director - Media Case Management

Freedom of Information

Governance and Reform Division

Building F065

Level 2 - 057

Gallipoli Barracks

ENOGGERA QLD 4051

Ph: (07) 3332 6359

Alternative email: [email address]

____________________________________________________________________

Website:http://www.defence.gov.au/foi/index.htm

Privacy Statement: http://www.defence.gov.au/FOI/privacy.asp

FOI Act: https://www.comlaw.gov.au/Details/C2014C...

FOI Guidelines: http://www.oaic.gov.au/freedom-of-inform...

-----Original Message-----
From: Stuart McCarthy [mailto:[FOI #2004 email]]
Sent: Saturday, 2 July 2016 14:01
To: Stinson, Theresa MRS
Subject: Re: FOI 389/15/16 [SEC=UNCLASSIFIED]

Dear Mrs Stinson,

Thankyou for replying to my FOI request 389/15/16, 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. Since c.1990 mefloquine has been administered to several thousand ADF personnel, the majority of whom are no longer serving.[1]

b. Mefloquine is known to be neurotoxic, able to cause lasting or permanent brain injury and chronic neuropsychiatric symptoms in a sizeable minority of those given the drug.[1,2]

c. Senior Defence officials including the ADF Surgeon General have stated publicly that they are committed to full transparency in relation to this matter.[3]

Yours sincerely,

Stuart McCarthy

References:

3. 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...

4. R.J. Griggs, "Response to reporting on mefloquine in the Townsville Bulletin", Department of Defence, Canberra, 19 February 2016. http://news.defence.gov.au/2016/01/15/re...

-----Original Message-----

UNCLASSIFIED

Good afternoon Mr McCarthy

Please find attached the preliminary assessment of FOI Charges relating to FOI 389/15/16.

Kind regards

Theresa Stinson

Assistant Director - Media Case Management

Freedom of Information

Governance and Reform Division

Building F065

Level 2 - 057

Gallipoli Barracks

ENOGGERA QLD 4051

Ph: (07) 3332 6359

Alternative email: [1][email address]

____________________________________________________________________

Website:[2]http://www.defence.gov.au/foi/index.htm

Privacy Statement: [3]http://www.defence.gov.au/FOI/privacy.asp

FOI Act: [4]https://www.comlaw.gov.au/Details/C2014C...

FOI Guidelines:
[5]http://www.oaic.gov.au/freedom-of-inform...

IMPORTANT: This email remains the property of the Department of Defence and is subject to the jurisdiction of section 70 of the Crimes Act 1914.
If you have received this email in error, you are requested to contact the sender and delete the email.

References

-------------------------------------------------------------------
Please use this email address for all replies to this request:
[FOI #2004 email]

If you find this service useful as an FOI officer, please ask your web manager to link to us from your organisation's FOI page.

-------------------------------------------------------------------

hide quoted sections

Verity Pane left an annotation (June 15, 2017)

While it is positive that this agency has reduced its the charges estimate by 50% to $83.50, it is worth saying that the agency really wasn't interested in considering any public benefit claims (being a bit intentionally obtuse by my read).

This is an issue that has received notable media coverage over the last couple of years, including an Inspector-General's report, public interest statements by members in Parliament, and various Defence hot issues briefs, a special Defence 1800 number, etc.

That sort of public debate should have been considered. Especially given media statements by Air Vice Marshal Tracy Smart, Commander Joint Health and Surgeon General, stating “From the beginning what we’ve tried to do is provide the facts, provide transparency and answer people’s concerns". This FOI could be reasonably considered as assisting in providing the facts, and providing transparency, to help answer concerns evident in public debate that this media coverage demonstrates.

Sometimes agencies use charge assessments to stall access (given the clock on the statutory processing deadline stops, while such charge assessment remain in dispute), and to unlawfully deter access. One can only hope that is not the intent of the agency here.

It should also be noted that charge estimates are exactly that. An applicant, if they agree to the charges estimate, may be up for a larger bill later (and there is almost no right to dispute). So just something to be aware of, although continuing to dispute the charges will just continue to delay an FOI decision being given, so no easy answers unfortunately.

Verity Pane left an annotation (June 24, 2017)

It would be worth reminding this agency that where charges sought are typically less $100, the Information Commissioner has generally been of the view that the costs of collection (including calculation) generally exceed the charges to be applied, and therefore charges should not be sought by the agency [see Australian Associated Press Pty Ltd and Department of Immigration and Border Protection [2015] AICmr 65 (2 October 2015) for example]

The s 93A Guidelines give specifics here

Guiding principles

4.3 An agency or minister has a discretion to impose or not impose a charge, or impose a charge that is lower than the applicable charge, under reg 3 of the Charges Regulations. In exercising that discretion, the agency or minister should take account of the ‘lowest reasonable cost’ objective, stated in the objects of the FOI Act (s 3(4)):

… functions and powers given by this Act are to be performed and exercised, as far as possible, to facilitate and promote public access to information, promptly and at the lowest reasonable cost.

4.4 Agencies and ministers should interpret the ‘lowest reasonable cost’ objective broadly in imposing any charges under the FOI Act. That is, an agency or minister should have regard to the lowest reasonable cost to the applicant, to the agency or minister, and the Commonwealth as a whole. Where the cost of calculating and collecting a charge might exceed the cost to the agency to process the request, it would generally be more appropriate not to impose a charge. In assessing the costs of calculating and collecting a charge, agencies should also take into account the likely costs that may be incurred by the agency, as well as other review bodies, if the applicant decides to seek further review.

4.5 The objects of the FOI Act guide the following principles relevant to charges under the FOI Act:

A charge must not be used to unnecessarily delay access or discourage an applicant from exercising the right of access conferred by the FOI Act.

Charges should fairly reflect the work involved in providing access to documents on request.

Charges are discretionary and should be justified on a case by case basis.
Agencies should encourage administrative access at no charge, where appropriate.

Agencies should assist applicants to frame FOI requests.

Agencies should draw an applicant’s attention to opportunities available to the applicant outside the FOI Act to obtain free access to a document or information (s 3A(2)(b)).

A decision to impose a charge should be transparent.

4.6 An agency should ensure that the notice to an applicant of a charge fully explains and justifies that charge. Implicit in the lowest reasonable cost objective is a requirement for sound record keeping so that an agency’s documents can be readily identified and found when an FOI request is received.

You can access the s 93A FOI Guidelines here https://www.oaic.gov.au/freedom-of-infor...

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Documents Relating to U.S. Department of Defense Research into Neurotoxicity and/or Adverse Neuropsychiatric Effects of the Anti-malarial Drug Mefloquine

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Verity Pane left an annotation (June 15, 2017)

Verity Pane left an annotation (June 24, 2017)

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