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

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

This request has been withdrawn by the person who made it. There may be an explanation in the correspondence below.

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."[1-3]

Tafenoquine was found in 2009 by scientists from the U.S. Walter Reed Army Institute of Research to be "more neurotoxic than mefloquine",[4] which is a similar synthetic quinoline drug able to cause a chronic central nervous system toxicity syndrome in a sizeable minority of users.[5] 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.[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 toxicity of mefloquine and tafenoquine, admitting that the initial cases "could be the tip of the iceberg."[7] 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.[8]

I hereby request to be provided with any applications, dossiers, submissions or related documents submitted to the TGA by 60P, 60P sub-contractors, U.S. Department of Defense officials, Australian Department of Defence officials or 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. 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...

5. 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...

6. 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...

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

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

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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: Stuart McCarthy

Delivered

Dear Therapeutic Goods Administration,

I hereby withdraw this request, to be resubmitted on or after 3 January 2017.

Yours faithfully,

Stuart McCarthy

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Locutus Sum left an annotation ()

It might have been easier if the applicant had just said that he was willing to give the agency an extension of 14 days to process the application. Then he would not have to resubmit it and the agency would have the time it needed.

For the applicant, may I suggest that you use this same request page to resubmit your application. It will keep all the correspondence together.

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