Those who have reported Adverse Effects to CHAMPIX
Dear Therapeutic Goods Administration,
I made a request for 24 names & contact details of those who made an adverse reaction report to the ADR.
I still haven't received an answer to my request
Yours faithfully,
Rod Hamblin
Dear Mr Hamblin
I attach the correspondence sent to you in September 2015 in relation to your invalid FOI request.
Please don't hesitate to contact me should you wish to discuss further.
Kind regards
Liz
Elizabeth Santolin
Freedom of Information Team
Reporting and Collaborative Services Section
Regulatory Engagement and Planning Branch
Phone: (02) 6232 8664
Email: [email address]
Therapeutic Goods Administration
Department of Health
PO Box 100
Woden ACT 2606
www.tga.gov.au
-----Original Message-----
From: Rod Hamblin [mailto:[FOI #1789 email]]
Sent: Friday, 1 April 2016 11:20 AM
To: FOI
Subject: Freedom of Information request - Those who have reported Adverse Effects to CHAMPIX [SEC=No Protective Marking]
Dear Therapeutic Goods Administration,
I made a request for 24 names & contact details of those who made an adverse reaction report to the ADR.
I still haven't received an answer to my request
Yours faithfully,
Rod Hamblin
-------------------------------------------------------------------
Please use this email address for all replies to this request:
[FOI #1789 email]
Is [TGA request email] the wrong address for Freedom of Information requests to Therapeutic Goods Administration? If so, please contact us using this form:
https://www.righttoknow.org.au/change_re...
This request has been made by an individual using Right to Know. This message and any reply that you make will be published on the internet. More information on how Right to Know works can be found at:
https://www.righttoknow.org.au/help/offi...
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.
-------------------------------------------------------------------
*******************************************************************************
"Important: This transmission is intended only for the use of the addressee and may contain confidential or legally privileged information and has been sent in accordance with the TGA security policy.
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."
********************************************************************************
Kristof Wing left an annotation ()
Hey Rod,
I appreciate what you are trying to do here are would like help you!
It looks like you're after information relating to adverse events related to varenicline.
The best you're going to do in this case is get the de-identified information about adverse events.
The people at the FOI office of the TGA are really great to work with and generally they will fulfil all reasonable requests.
It might be worthwhile to start broad and then narrow you request accordingly, if it is deemed to be too much work or you find it too expensive.
I would recommend that you start by asking for summary data relating to all adverse events for varenicline (if available), when it was prescribed under the indication of smoking cessation. This will give you a good idea of where the events lie.
Then, you could request further information about specific event categories (i.e. deaths and suicides), and see if case reports (de-identified) would be made available.
What specific purpose do you have for this request? Maybe I can be of more help then.
Feel free to email me privately, too.
Alternatively you can Direct Message me on Twitter.
Best wishes,
Kristof
--
Kristof Wing
Email: kristof.wing@gmail.com
Twitter: @Yunadal