Documents Relating to Applications for the Registration of Tafenoquine for Malaria Chemoprophylaxis

Stuart McCarthy made this Freedom of Information request to Therapeutic Goods Administration

The request was refused by Therapeutic Goods Administration.

From: Stuart McCarthy

Delivered

Dear Therapeutic Goods Administration staff,

In 2014 the U.S. Army awarded a contract to 60 Degrees Pharmaceuticals (60P) to "assist in the development of tafenoquine as a malaria prophylactic drug for FDA-TGA (Food and Drug Administration-Therapeutic Goods Administration) approval first in Australia and then in the United States."[1-4]

60P CEO Mr Geoff Dow stated in a 2015 interview that his motivation in seeking FDA approval for tafenoquine:

"... is really around the [FDA] priority review voucher. That is basically a voucher granted by the FDA if you succeed in getting regulatory approval for a drug for a tropical disease. Those vouchers can be sold to another company that allows fast track review at the FDA of an unrelated therapeutic. They are freely salable on the open market. The most recent sale was for three hundred and fifty million by United Therapeutics to Abbvie. Three out of four of our products are eligible for the PRV and it is a financial incentive independent of your actual development program or the therapeutic you are moving forward. Therefore, that definitely has interest for individual investors, but also big pharma who have an interest in molecules that happen to be in your portfolio."[3]

Tafenoquine was found in 2009 by scientists from the U.S. Walter Reed Army Institute of Research to be "more neurotoxic than mefloquine",[5] which is a similar synthetic quinoline drug able to cause a chronic central nervous system toxicity syndrome in a sizeable minority of users.[6] An Army Malaria Institute (AMI) phase 3 clinical trial in 2000-01 found there was "no statistical difference" between tafenoquine and mefloquine in the type and incidence of neuropsychiatric adverse effects.[7]

In 2014 a leading expert in the neurotoxicity of quinoline anti-malarials emphasised in relation to tafenoquine:

"[Neurohistopathological] testing appears particularly needed for tafenoquine, an 8-aminoquinoline initially developed by the U.S. military ... and associated in pre-licensing trials with a similar risk of vertigo as mefloquine. While tafenoquine has been eagerly anticipated for its utility against vivax malaria and potentially against leishmaniasis, the recent granting by the U.S. FDA of Breakthrough Therapy status, in the absence of any published neurohistopathological testing, risks recreating the sense of urgency that contributed to the approval of mefloquine in the absence of appropriate CNS safety data."[6]

The Department of Veterans Affairs recently commenced a health outreach program for serving and ex serving Australian Defence Force personnel who are adversely affected by the neurotoxicity of mefloquine and tafenoquine, admitting that the initial cases "could be the tip of the iceberg."[8] Many of the AMI tafenoquine clinical trial subjects have since experienced bipolar disorder, schizophrenia, major depression and anxiety, seizures, hallucinations and psychosis, suicide attempts and/or suicide.[9,10]

Previous FOI requests to the TGA have established that the Australian Defence Force did not have TGA approval for some of the tafenoquine clinical trials conducted in Timor Leste from 1999 to 2001.[11]

I hereby request to be provided with any applications, dossiers, submissions or related documents submitted to the TGA by 60P, 60P sub-contractors including Clinical Network Services (CNS), U.S. Department of Defense officials, Australian Department of Defence officials or other third parties for the purpose of registering tafenoquine for malaria prophylaxis.

Yours faithfully,

Stuart McCarthy

References:

1. Staff, "Army seeks services for malaria drug dvancement", Global Biodefense, 3 July 2014, https://globalbiodefense.com/2014/07/03/...

2. U.S. Army Medical Research Acquisition Activity (USAMMDA), Request for information, solicitation number W81XWH-14-RFI-00TQ (tafenoquine), 23 June 2014. https://www.fbo.gov/index?s=opportunity&...

3. L. Fosse, "Therapeutics and travel medicine for tropical diseases such as dengue fever and malaria", CEOCFO Magazine, 21 September 2015. https://www.ceocfointerviews.com/intervi...

4. S. McCarthy, "The ADF's drug trial outrage", The Spectator Australia, 28 December 2016. http://spectator.com.au/2016/12/adfs-dru...

5. R. Agboruche et al., In-itro toxicity assessment of antimalarial drugs on cultured embryonic rat neurons, macrophage (RAW 264.7), and kidney cells (VERO- CCl-81), 2009. https://muckrock.s3.amazonaws.com/foia_f...

6. 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. https://www.ncbi.nlm.nih.gov/pubmed/2505...

7. P. E. Nasveld et al., "Randomized, double-blind study of the safety, tolerability, and efficacy of tafenoquine versus mefloquine for malaria prophylaxis in non-immune subjects", Antimicrobial Agents and Chemotherapy, vol. 54, no. 2, pp. 792–798, 2010. https://www.ncbi.nlm.nih.gov/pubmed/1999...

8. R. Riley, "Malaria drug project starts", Townsville Bulletin, 14 December 2016. http://www.townsvillebulletin.com.au/new...

9. S. McCarthy, "PM must support Diggers used as drug guinea pigs", Herald Sun, 7 December 2016. http://www.heraldsun.com.au/news/opinion...

10. D. Welch, "A bitter pill", ABC 7.30 Report, 22 August 2016. http://www.abc.net.au/7.30/content/2016/...

11. E. Santolin, TGA response to FOI request 222-15/16, TGA email, 21 September 2016. https://www.righttoknow.org.au/request/t...

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From: FOI
Therapeutic Goods Administration

We wish to advise that the Department of Health, including the Freedom of
Information Unit, will be closed from 3pm Friday 23 December 2016 and will
resume operations on Tuesday 3 January 2017.  To assist in processing your
application, please submit your application on or after 3 January 2017.

 

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From: TGA FOI
Therapeutic Goods Administration


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Attachment FOI 159 1617 Estimate of Charges.pdf
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Dear Mc McCarthy

 

Please find attached correspondence in relation to your FOI request.

 

If you have any questions, please do not hesitate to contact the FOI Team.

 

Kind regards

 

Freedom of Information
Liz Santolin 02 6232 8664

Jodie Russell 02 6232 8720
Karen Bedford 02 6232 8772

Heather Davidson 02 6232 8012

 

Reporting and Collaborative Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]

 

[2]cid:image001.png@01D1D5D9.7DDEADA0

 

 

 

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From: FOI
Therapeutic Goods Administration

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.

Unless you advise otherwise, duplicate documents and Commonwealth employee names and contact details below Senior Executive Service level and mobile telephone numbers of all staff will be excluded from the scope of your request under s22(1)(a)(ii) of the FOI Act.

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.

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From: Stuart McCarthy

Delivered

Dear TGA FOI staff,

Thankyou for providing an estimate of charges for my FOI request.

I request that these charges be waived on the grounds that disclosing the documents would be in the public interest, in particular:

a. Clinical trials cited by the proponents of tafenoquine were conducted by public institutions (including the Australian Defence Force), on subjects who were employed by the Commonwealth.[1]

b. Proposals for tafenoquine to be registered by the TGA have been funded by public institutions.[2-5]

c. Published research indicates that tafenoquine poses a serious safety risk to the public in the event that it is registered by the TGA.[6-7]

d. Public scrutiny of the documents prior to registration will assist to mitigate these safety risks.

Yours sincerely,

Stuart McCarthy

References:

1. S. McCarthy, "PM must support Diggers used as drug guinea pigs", Herald Sun, 7 December 2016. http://www.heraldsun.com.au/news/opinion...

2. Staff, "Army seeks services for malaria drug advancement", Global Biodefense, 3 July 2014. https://globalbiodefense.com/2014/07/03/...

3. U.S. Army Medical Research Acquisition Activity (USAMMDA), Request for information, solicitation number W81XWH-14-RFI-00TQ (tafenoquine), 23 June 2014. https://www.fbo.gov/index?s=opportunity&...

4. L. Fosse, "Therapeutics and travel medicine for tropical diseases such as dengue fever and malaria", CEOCFO Magazine, 21 September 2015. https://www.ceocfointerviews.com/intervi...

5. S. McCarthy, "The ADF's drug trial outrage", The Spectator Australia, 28 December 2016. http://spectator.com.au/2016/12/adfs-dru...

6. R. Agboruche et al., In-itro toxicity assessment of antimalarial drugs on cultured embryonic rat neurons, macrophage (RAW 264.7), and kidney cells (VERO- CCl-81), 2009. https://muckrock.s3.amazonaws.com/foia_f...

7. 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. https://www.ncbi.nlm.nih.gov/pubmed/2505...

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From: Stuart McCarthy

Delivered

Dear TGA FOI staff,

could you please provide an update on the progress of this FOI request?

Yours sincerely,

Stuart McCarthy

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From: TGA FOI
Therapeutic Goods Administration


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Attachment D17 192876 FOI159 1617 Notice of decision request for waiver.PDF.pdf
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Dear Mr McCarthy

 

Please find attached the decision relating to your request for a waiver of
charges.

 

Kind regards
Karen

 

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 Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]

 

[2]cid:image001.png@01D1D5D9.7DDEADA0

 

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From: TGA FOI
Therapeutic Goods Administration


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Dear Mr McCarthy

 

A third party that the TGA was required to consult about the documents,
has indicated that they would like to be informed of your identity (as the
applicant for this request).

 

I have advised the third party that all FOI applicants are entitled to
remain anonymous under the FOI Act. However, could you please indicate
whether you would like the third party to be informed of your identity?

 

Kind regards

 

Sasha

 

Freedom of Information
Jacki Joester 02 6232 8612 / 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]

 

[2]cid:image001.png@01D1D5D9.7DDEADA0

 

 

 

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From: Stuart McCarthy

Delivered

Dear Sasha,

Thankyou for your email and continuing assistance with this FOI request.

Please do not disclose my identity to the third party.

Yours sincerely,

Stuart McCarthy

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From: TGA FOI
Therapeutic Goods Administration

Dear Mr McCarthy

Thank you for your reply.

Your identity will not be disclosed.

Kind Regards

Sasha

Freedom of Information
Jacki Joester 02 6232 8612 / 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: [email address]

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From: Stuart McCarthy

Delivered

Dear TGA FOI staff,

I request an internal review into the delays and charging of fees in relation to this FOI request.

The documents I requested were identified by the TGA four and a half months ago. A deposit was paid for the documents more than a month ago.

The TGA's processing of this request is in breach of the FOI Act.

Yours sincerely,

Stuart McCarthy

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From: TGA FOI
Therapeutic Goods Administration

Dear Mr McCarthy,

 

The TGA has been undertaking third party consultation and is in the
process of finalising the decision on your request. The decision is due to
be provided to you by 29 May 2017.

 

Regards,

Jacki

 

Freedom of Information
Jacki Joester 02 6232 8612

Sasha Pesic 02 6232 8795
Karen Bedford 02 6232 8772

Heather Davidson 02 6232 8012

 

 

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Health Products Regulation Group
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]

 

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From: Carl English


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Our reference: RQ17/01111

Agency reference: FOI 159-1617

Mr Stuart McCarthy

By email: [FOI #2897 email]

Dear Mr Mccarthy

Extension of time under s 15AB

On 25 May 2017, the Department of Health (the Department) applied for
further time to make a decision on your FOI request of 3 January 2017.

This request was on the basis that the processing period is insufficient
to deal adequately with your request, because it is complex.

I have decided to grant the Department an extension of time to process
your request to 12 June 2017. This decision has been made under s 15AB(2)
of the Freedom of Information Act 1982 (Cth).

By granting further time it is anticipated that the Department will
provide a well-reasoned and better managed decision.

Contact

If you have any questions regarding this email please contact me on 02
9284 9745 or via email [email address]. Please quote OAIC
reference number RQ17/01111 in all correspondence.

 

Yours sincerely

 

Carl English | Assistant Review and Investigation Officer | Freedom of
Information Dispute Resolution

Office of the Australian Information Commissioner

GPO Box 5218 SYDNEY NSW 2001| [1]www.oaic.gov.au

Phone:  +61 2 9284 9745 | E-mail: [email address]

 

Protecting information rights – advancing information policy

[2]cid:image001.png@01D26682.9CE52410

 

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1. http://www.oaic.gov.au/

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Stuart McCarthy left an annotation ()

“Extensive research dating as far back as the 1940s found that several drugs from this class are able to cause lasting or permanent brain damage. Many ADF veterans who were given mefloquine or tafenoquine have since suffered serious health problems including bipolar disorder, schizophrenia, major depression and anxiety, seizures, hallucinations and psychosis, suicide attempts and suicide.

“Minister Tehan has rejected repeated requests to fund independent follow-up health studies involving these veterans.

“ADF veterans are not screened for exposure to mefloquine or tafenoquine prior to being diagnosed with post-traumatic stress disorder. Only in rare cases have they been referred to health professionals specialising in brain injury. The vast majority have been unable to access appropriate medical care as a direct result if this mismanagement.”

Quoted in M. Davey, "Veterans say report on anti-malaria drug mefloquine downplays side-effects", The Guardian, 3 June 2017. https://www.theguardian.com/australia-ne...

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From: Stuart McCarthy

Delivered

Dear Mr English,

Thankyou for your email of 25 May, informing me of your decision to grant the TGA an extension of time to 12 June.

The TGA has again failed to meet this deadline. I request that the TGA be directed to immediately provide the requested documents and waive the processing fees.

Yours sincerely,

Stuart McCarthy

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From: Carl English


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Our reference: RQ17/01178

Agency reference: FOI 159-1617

Mr Stuart McCarthy

By email:  [FOI #2897 email]

Dear Mr Mccarthy

Extension of time under s 15AB

On 13 June 2017, the Department of Health (the Department) applied for
further time to make a decision on your FOI request of 3 January 2017.

This application was on the basis that the processing period is
insufficient to deal adequately with your request, because it is complex
or voluminous.

I have decided to grant the Department an extension of time to process
your request to 22 June 2017. This decision has been made under s 15AB(2)
of the Freedom of Information Act 1982 (Cth).

By granting further time it is anticipated that the Department will
provide a well-reasoned and better managed decision.

Contact

If you have any questions regarding this email please contact me on 02
9284 9745 or via email [email address]. Please quote OAIC
reference number RQ17/01178 in all correspondence.

Yours sincerely

Carl English | Assistant Review and Investigation Officer | Freedom of
Information Dispute Resolution

Office of the Australian Information Commissioner

GPO Box 5218 SYDNEY NSW 2001| [1]www.oaic.gov.au

Phone:  +61 2 9284 9745 | E-mail: [email address]

 

Protecting information rights – advancing information policy

[2]cid:image001.png@01D26682.9CE52410

 

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1. http://www.oaic.gov.au/

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From: Carl English


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Attachment RQ17 01178 Extension of time decision SEC UNCLASSIFIED.html
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Dear Mr McCarthy

 

Thank you for your email.

 

On 13 June 2017, the Department of Health (the Department) applied for
further time to make a decision on your FOI request of 3 January 2017.

 

On 14 June 2017, the OAIC decided to grant further time, a copy of the
decision was sent to you the same day to you. A copy of the decision is
attached.

 

The Department now has until 22 June 2017, to complete your request.

 

Kind regards

 

Carl English | Assistant Review and Investigation Officer | Freedom of
Information Dispute Resolution

Office of the Australian Information Commissioner

GPO Box 5218 SYDNEY NSW 2001| [1]www.oaic.gov.au

Phone:  +61 2 9284 9745 | E-mail: [email address]

 

Protecting information rights – advancing information policy

 

 

 

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From: JOESTER, Jacki
Therapeutic Goods Administration


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Attachment FOI 159 1617 Notice of decision.pdf
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Dear Mr McCarthy,

 

Please find attached correspondence in relation to your FOI request.

 

Kind regards

Jacki

 

Freedom of Information
(02) 6232 8612

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]

 

[2]cid:image001.png@01D1D5D9.7DDEADA0

 

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Things to do with this request

Anyone:
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