Documents Relating to Tafenoquine Neurotoxicity Testing on Monkeys by the Australian Army Malaria Institute
Dear Department of Defence,
Tafenoquine is an experimental 8-aminoquinoline antimalarial drug which was tested on more than 1,500 Australian Defence Force personnel during the period 1998 to 2001.[1] The drug is currently under consideration for regulatory approval by the Australian Therapeutic Goods Administration[2] and the U.S. Food and Drug Administration.[3]
Several historically used 8-aminoquinoline drugs, including pamaquine and plasmocid, were found to be neurotoxic following laboratory testing on monkeys.[4-9] The Army Malaria Institute (AMI) maintains a colony of monkeys for the study of malaria and other tropical diseases including drug development,[10] however a recent integrated safety analysis of tafenoquine makes no reference to neurotoxicity testing on monkeys.[11]
I hereby request to be provided with documents relating to tafenoquine neurotoxicity testing on monkeys by AMI or affiliated organisations, from 1999 to 2017, including:
a. proposals for tafenoquine neurotoxicity testing on monkeys, including requests to relevant ethics committees;
b. approvals or rejections of such proposals, including memos, emails or minutes of meetings discussing or considering the proposals; and/or
c. results of any such neurotoxicity testing.
Please note the very specific nature of this request, i.e. tafenoquine neurotoxicity testing on monkeys. Such testing would involve administering tafenoquine to the monkeys then examining the adverse effects of the drug on the monkeys' nervous systems. I am not requesting documents relating to:
a. efficacy of tafenoquine or other antimalarial drugs,
b. testing on humans or animal models other than monkeys, or
c. safety testing other than neurotoxicity testing.
I request that administrative charges for this request be waived given that this is a matter of significant public interest. Tafenoquine is being considered for registration by drug regulators in Australia, the U.S. and elsewhere. There are substantial public safety risks should this drug be approved for the market in the absence of appropriate neurotoxicity testing.
Yours faithfully,
Stuart McCarthy
References:
1. Nasveld PE. Tafenoquine in the prophylaxis and treatment of malaria in Australian Defence Force personnel. PhD thesis, James Cook University. 2011. https://researchonline.jcu.edu.au/29749/
2. Therapeutic Goods Administration. Reason for scheduling delegate's final decisions, January 2018. 2018. https://www.tga.gov.au/book-page/119-taf...
3. 60 Degrees Pharmaceuticals. 60° Pharmaceuticals submits new drug application to US FDA for antimalarial drug tafenoquine. 2017. https://www.prnewswire.com/news-releases...
4. Schmidt LH et al. Studies on the 8-aminoquinolines; the toxicities of pamaquine and plasmocid in different animal species. Fed Proc. 1947;6(1):369. https://www.ncbi.nlm.nih.gov/pubmed/2024...
5. Schmidt IG. Effects of pamaquine on the central nervous system. Anat Rec. 1947 Mar;97(3):367. https://www.ncbi.nlm.nih.gov/pubmed/2034...
6. Schmidt IG, Schmidt LH. Neurotoxicity of the 8-aminoquinolines. III. The effects of pentaquine, isopentaquine, primaquine, and pamaquine on the central nervous system of the rhesus monkey. J Neuropathol Exp Neurol. 1951 Jul;10(3):231-56. https://www.ncbi.nlm.nih.gov/pubmed/1486...
7. Lyle DJ, Schmidt IG. The selective effect of drugs upon nuclei of the oculogyric system. Am J Ophthalmol. 1962 Oct;54:706-16. https://www.ncbi.nlm.nih.gov/pubmed/1393...
8. Schmidt IG, Schmidt LH. Neurotoxicity of the 8-aminoquinolines; lesions in the central nervous system of the rhesus monkey induced by administration of plasmocid. J Neuropathol Exp Neurol. 1948 Oct;7(4):368-98. https://www.ncbi.nlm.nih.gov/pubmed/1888...
9. Side JC et al. Plasmocid encephalopathy in the rhesus monkey: a study of selective vulnerability. J Neuropathol Exp Neurol. 1973 Jul;32(3):446-57. https://www.ncbi.nlm.nih.gov/pubmed/4198...
10. McGregor K. Defence Force supports monkey tests. 2012. http://www.news.com.au/tablet/defence-fo...
11. Novitt-Moreno A et al. Tafenoquine for malaria prophylaxis in adults: An integrated safety analysis. Travel Med Infect Dis. 2017 May - Jun;17:19-27. https://www.ncbi.nlm.nih.gov/pubmed/2849...
UNCLASSIFIED
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-----Original Message-----
From: Stuart McCarthy [mailto:[FOI #4414 email]]
Sent: Sunday, 4 March 2018 10:05 PM
To: FOI requests at Defence
Subject: Freedom of Information request - Documents Relating to Tafenoquine Neurotoxicity Testing on Monkeys by the Australian Army Malaria Institute
Dear Department of Defence,
Tafenoquine is an experimental 8-aminoquinoline antimalarial drug which was tested on more than 1,500 Australian Defence Force personnel during the period 1998 to 2001.[1] The drug is currently under consideration for regulatory approval by the Australian Therapeutic Goods Administration[2] and the U.S. Food and Drug Administration.[3]
Several historically used 8-aminoquinoline drugs, including pamaquine and plasmocid, were found to be neurotoxic following laboratory testing on monkeys.[4-9] The Army Malaria Institute (AMI) maintains a colony of monkeys for the study of malaria and other tropical diseases including drug development,[10] however a recent integrated safety analysis of tafenoquine makes no reference to neurotoxicity testing on monkeys.[11]
I hereby request to be provided with documents relating to tafenoquine neurotoxicity testing on monkeys by AMI or affiliated organisations, from 1999 to 2017, including:
a. proposals for tafenoquine neurotoxicity testing on monkeys, including requests to relevant ethics committees;
b. approvals or rejections of such proposals, including memos, emails or minutes of meetings discussing or considering the proposals; and/or
c. results of any such neurotoxicity testing.
Please note the very specific nature of this request, i.e. tafenoquine neurotoxicity testing on monkeys. Such testing would involve administering tafenoquine to the monkeys then examining the adverse effects of the drug on the monkeys' nervous systems. I am not requesting documents relating to:
a. efficacy of tafenoquine or other antimalarial drugs,
b. testing on humans or animal models other than monkeys, or
c. safety testing other than neurotoxicity testing.
I request that administrative charges for this request be waived given that this is a matter of significant public interest. Tafenoquine is being considered for registration by drug regulators in Australia, the U.S. and elsewhere. There are substantial public safety risks should this drug be approved for the market in the absence of appropriate neurotoxicity testing.
Yours faithfully,
Stuart McCarthy
References:
1. Nasveld PE. Tafenoquine in the prophylaxis and treatment of malaria in Australian Defence Force personnel. PhD thesis, James Cook University. 2011. https://researchonline.jcu.edu.au/29749/
2. Therapeutic Goods Administration. Reason for scheduling delegate's final decisions, January 2018. 2018. https://www.tga.gov.au/book-page/119-taf...
3. 60 Degrees Pharmaceuticals. 60° Pharmaceuticals submits new drug application to US FDA for antimalarial drug tafenoquine. 2017. https://www.prnewswire.com/news-releases...
4. Schmidt LH et al. Studies on the 8-aminoquinolines; the toxicities of pamaquine and plasmocid in different animal species. Fed Proc. 1947;6(1):369. https://www.ncbi.nlm.nih.gov/pubmed/2024...
5. Schmidt IG. Effects of pamaquine on the central nervous system. Anat Rec. 1947 Mar;97(3):367. https://www.ncbi.nlm.nih.gov/pubmed/2034...
6. Schmidt IG, Schmidt LH. Neurotoxicity of the 8-aminoquinolines. III. The effects of pentaquine, isopentaquine, primaquine, and pamaquine on the central nervous system of the rhesus monkey. J Neuropathol Exp Neurol. 1951 Jul;10(3):231-56. https://www.ncbi.nlm.nih.gov/pubmed/1486...
7. Lyle DJ, Schmidt IG. The selective effect of drugs upon nuclei of the oculogyric system. Am J Ophthalmol. 1962 Oct;54:706-16. https://www.ncbi.nlm.nih.gov/pubmed/1393...
8. Schmidt IG, Schmidt LH. Neurotoxicity of the 8-aminoquinolines; lesions in the central nervous system of the rhesus monkey induced by administration of plasmocid. J Neuropathol Exp Neurol. 1948 Oct;7(4):368-98. https://www.ncbi.nlm.nih.gov/pubmed/1888...
9. Side JC et al. Plasmocid encephalopathy in the rhesus monkey: a study of selective vulnerability. J Neuropathol Exp Neurol. 1973 Jul;32(3):446-57. https://www.ncbi.nlm.nih.gov/pubmed/4198...
10. McGregor K. Defence Force supports monkey tests. 2012. http://www.news.com.au/tablet/defence-fo...
11. Novitt-Moreno A et al. Tafenoquine for malaria prophylaxis in adults: An integrated safety analysis. Travel Med Infect Dis. 2017 May - Jun;17:19-27. https://www.ncbi.nlm.nih.gov/pubmed/2849...
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Please find attached the Statement of Reasons relating to FOI 329/17/18.
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Freedom of Information
Governance and Reform Division
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email: [1][email address]
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Cos Cameron
Assistant Director Case Management
Information Management and Access
Governance and Reform Division
Department of Defence CP1-06-007
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Fax: 02 626 62112
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