Dear Mr McCarthy,

 

I refer to your freedom of information request for adverse event reports
relating to tafenoquine.

 

The Database of Adverse Event Notifications (DAEN) only publically
displays adverse events information of medicines that are available for
general marketing in Australia i.e., medicines that have been entered on
the Australian Register of Therapeutic Goods after having been assessed
for quality, safety and effectiveness. Although TGA collects information
on adverse events for unapproved medicines such as tafenoquine that may be
accessed through clinical trials and other available unapproved medicine
access pathways, these are not published on the DAEN.

 

The TGA routinely conducts quality assurance activities on adverse events
entered into the DAEN. This allows TGA to identify and rectify any
administrative errors to ensure that the accuracy of the information
published on the DAEN is maintained. In the case of tafenoquine, a number
of adverse events were entered into the database at various times which
incorrectly indicated that the medicine was approved for general marketing
when in fact it has only been accessed through the unapproved medicine
access pathways. When the TGA identified these administrative errors they
were quickly rectified to reflect the correct marketing status of
tafenoquine. Consequently, all adverse events relating to tafenoquine no
longer appear in the DAEN.

 

The TGA is able to release information on adverse events arising from the
use of tafenoquine in clinical trials and other unapproved medicine access
pathways through requests made under the Freedom of Information Act
(1989). For example, adverse event reports (redacted to remove personal
information) involving the use of the tafenoquine accessed by Australian
Defence Force personnel between 1999 and 2001 have previously been
provided to you through this mechanism and are also available publically
on the [1]TGA’s disclosure log (FOI 222-1516).

 

Given the above please advise whether you wish to revise the scope of your
request. Specifically could you please indicate whether you are happy to
remove part two of your request so that the request would become:

“I hereby request to be provided with a summary of all tafenoquine related
AEs submitted to the TGA, to include the information normally available
for all drugs via the DAEN.”

 

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: [2][email address]

 

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

-----Original Message-----
From: Stuart McCarthy
[mailto:[FOI #3484 email]]
Sent: Thursday, 11 May 2017 4:54 PM
To: FOI
Subject: Freedom of Information request - Tafenoquine Adverse Event
Notifications [SEC=No Protective Marking]

 

Dear Therapeutic Goods Administration staff,

 

Tafenoquine is a synthetic quinoline drug that is being developed by
GlaxoSmithKline (GSK) and 60 Degrees Pharmaceuticals (60P) for prevention
and treatment of P. vivax malaria.[1,2] The drug was administered to more
than 1,500 Australian Defence Force personnel in a series of clinical
trials conducted by the Army Malaria Institute (AMI) in Australia,
Bougainville and Timor Leste from 1999 to 2001.[3-4]

 

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.[5,6] Some
of these severe adverse events have previously been listed publicly on the
TGA Database of Adverse Event Notifications (DAEN), including at least one
reported suicide.[7]

 

Tafenoquine has inexplicably been removed from the publicly accessible
DAEN, some time between 18 February 2017 and 9 May 2017.[8]

 

I hereby request to be provided with a summary of all tafenoquine related
AERs submitted to the TGA, to include the information normally available
for all drugs via the DAEN.

 

I also request to be provided with any documents relating to decisions by
TGA staff to remove tafenoquine from the publicly accessible DAEN,
including but not limited to emails, memos, meeting summaries, file notes
and/or correspondence between TGA officials and third parties.

 

I request that fees for this FOI request be waived given that this is a
matter of public interest, the information was previously available to the
public and would normally be available to the public.

 

Yours faithfully,

 

Stuart McCarthy

 

References:

 

1. GlaxoSmithKline, Media release: GSK and MMV announce start of phase III
programme of tafenoquine for Plasmodium vivax malaria, London, 28 April
2014.
[4]http://us.gsk.com/en-us/media/press-rele...

 

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

 

3. P. Nasveld, Tafenoquine in the prophylaxis and treatment of malaria in
Australian Defence Force personnel, PhD thesis, James Cook University,
2011. [6]https://researchonline.jcu.edu.au/29749/

 

4.  S. McCarthy, "The ADF's drug trial outrage", The Spectator Australia,
28 December 2016. [7]https://spectator.com.au/2016/12/adfs-dr...

 

5. S. McCarthy, "PM must support Diggers used as drug guinea pigs", Herald
Sun, 6 December 2016.
[8]http://www.heraldsun.com.au/news/opinion...

 

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

 

7. TGA, Tafenoquine report 20170218, Database of Adverse Event
Notifications, 18 February 2017.

 

8. TGA, Database of Adverse Event Notifications, accessed 11 May 2017.
[10]http://apps.tga.gov.au/PROD/DAEN/daen-en...

 

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This request has been made by an individual using Right to Know. This
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More information on how Right to Know works can be found at:

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Dear Mr McCarthy

 

Please find attached correspondence in relation to your FOI request.

 

Kind regards

Heather

 

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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"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."

References

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