LIES

Rod Hamblin (Account suspended) made this Freedom of Information request to Therapeutic Goods Administration

Waiting for an internal review by Therapeutic Goods Administration of their handling of this request.

From: Rod Hamblin (Account suspended)

Delivered

Dear Therapeutic Goods Administration,

Why are you back dating the Warnings on Champix. How much is Pfizer paying you?

Yours faithfully,

Rod Hamblin

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From: TGA FOI


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Dear Mr Hamblin,

 

We refer to your email dated 8 November 2016 to the Therapeutic Goods
Administration seeking information about Champix.

 

It appears you would like to make a request for access under the Freedom
of Information Act 1982 (the Act). Your email, in its current form, does
not constitute a valid request.

 

Section 15 of the Act requires that a request for documents meets certain
requirements. A Freedom of Information (FOI) request must:

 

• state that the request is an application for purposes of the FOI Act;

• provide sufficient information about the document(s) to allow us to
process the request; and

• provide an address for reply.

 

Further information about how to apply for your FOI is available on the
TGA website: [1]http://www.tga.gov.au/about/foi.htm

 

Please note that the Act provides for access to documents and not to
'information'.  In order for the TGA to be able to process a request under
the provisions of the FOI Act, you will need to provide us with further
information to enable us to identify the document or documents you are
seeking.

 

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

 

Kind regards,

 

Freedom of Information

Reporting and Collaborative Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [2][email address]

 

[3]cid:image004.png@01D10B4F.695253A0

 

 

 

 

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References

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1. http://www.tga.gov.au/about/foi.htm
2. mailto:[email address]

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Locutus Sum left an annotation ()

This is not an FOI request; it is only a rhetorical question and an implied insult. If Mr Hamblin wants to write to the Therapeutic Goods Administration there are many ways to do it; private email is one method, the slow mail is another. But it is not appropriate to use Right to Know for this kind of email. Right to Know is designed to facilitate requests under the Freedom of Information Act.

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From: Rod Hamblin (Account suspended)

Delivered

Dear TGA FOI,

Why did you BACK DATE the warnings on CHAMPIX?
How much is Pfizer paying you and your staff

Yours sincerely,

Rod Hamblin

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Luke Bacon left an annotation ()

Hi Robin,

If you are genuinely interested in answers, you could word a proper FOI request with something like:

> I would like to request the latest documents that refer to the back dating of ... . I would also like any invoices issued by ... to the TGA.

There are lots of examples of well-worded FOI requests on this site that you can use as a template starting point.

I hope that helps,

Luke

the Right To Know Team.

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Locutus Sum left an annotation ()

Mr Hamblin: Luke Bacon has shamed me (https://www.righttoknow.org.au/request/l... ) for my quick criticism (https://www.righttoknow.org.au/request/l... ) of your application. He is absolutely correct; if you want to get answers to your questions, the secret might be in how you ask. Also, I am sure that you have already done your own research but maybe I have some ideas that will help also.

Because I knew nothing about the Therapeutic Goods Administration, I first looked at http://www.tga.gov.au and discovered that there is a committee called the "Advisory Committee on Prescription Medicines (ACPM)" and another committee called the "Advisory Committee on the Safety of Medicines (ACSOM)". I found the committee names first on this page, https://www.tga.gov.au/tga-statutory-adv... .

The next thing I discovered is that the committees have regular meetings and the topics for discussion at the meetings, and the decisions of the meetings are published on the TGA web-site.

The next thing that I did was a specific search of the TGA for the drug that interests you, Champix. The generic name for the drug is "varenicline" . I did two Google searches, looking only at the TGA. I searched
site:tga.gov.au varenicline
and then
site:tga.gov.au champix

As a result, I found many copies of a publication called "Australian Adverse Drug Reactions Bulletin" with many dates from more than 8 years ago. For example, this page https://www.tga.gov.au/publication-issue...

I could not find any evidence that the TGA back-date warnings. They change their warnings when they get new information and they report that they have updated their advice and warnings, but I cannot see evidence that the TGA has tried to hide an early mild warning by deleting it and replacing it with a more heavy warning. The evidence is there of a committee that has listened to the reports of adverse events, and tried to update the warnings as necessary. Also, of course, many reported side-effects and adverse effects of drugs turn out to be coincidental; they are of the kind, "I took the very expensive miracle drug called Kostakashload to cure my impotence but after two weeks I discovered I had prostate cancer". Maybe the cancer is because of Kotaskashload but maybe it is just unlucky timing.

If you want to remake your FOI request, I would like to make three suggestions. The first suggestion is to use Right to Know but to say that you would like to make this request using "administrative arrangements if possible" rather than FOI. This will save you money because you will not need to limit the search for information in the same way that would be necessary if you use FOI. The second suggestion is to assume at first that the TGA has tried to do the right thing, and only get out the big ammunition if this is obviously not true. To stay with the second suggestion, I suggest that you keep your sights on the reports from the committees. The third suggestion is to ask specifically about events that might be of interest, e.g., neuropsychological events and neurovascular events. (Note, I was able to find many reports, also in the United States, of neuropsychological events but not of neurovascular events). Then you will have a FOI request like this:

Dear FOI Coordinator, ... (I got this from the FOI page of the site)

Please treat this as a request under administrative arrangements. If it is not possible to do this, please let me know and then I will have to think about an FOI request.

I am interested to obtain some information about the changing status of warnings on the safety of the drug Champix (varenicline). I would very much want to get copies of the different warnings/advisories since Champix was first available in Australia. This is maybe around 2006. Also, I would like to know the dates (and decisions) of committee meetings of ACSOM or ACPM where there was consideration of adverse events relating to Champix (varenicline). I am also specifically interested in neuropsychological and neurovascular adverse events.

I know that an FOI request that covers this information would be very big but I think that much of the information is already published by TGA, but I cannot find it. Please let me know how much you can help, possibly by explaining to me how I could find copies of all this information on the TGA web-site if it is there. If this is not possible, maybe it is possible for you to tell me what information I can find through the website, what information you can give me that is not on the website, and what information would need for me to use FOI.

Yours faithfully, etc.

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From: Rod Hamblin (Account suspended)

Delivered

Dear Locutus Sum

READ my web page http://champixclassaction.com/

Yours sincerely,

Rod Hamblin

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Locutus Sum left an annotation ()

I understand the frustration of the applicant, But what will it cost to send the letter that I have already written? I think the expression in English is "Money for Marmelade."

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From: Rod Hamblin (Account suspended)

Delivered

Dear TGA FOI,

You are a total waist of time & money. It's easy what I want & that is the contact details of those who have died or been hurt from Champix.

You are liars from hiding the warnings on Champix

http://champixclassaction.com/

Yours sincerely,

Rod Hamblin

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Locutus Sum left an annotation ()

I add this annotation to explain why I am about to ask an administrator to block further requests on this page.

The applicant is aggrieved and wants answers to questions. In this respect he is the same as many other users of Right to Know and he is entitled to use Right to Know to obtain documents that contain useful information. But he is NOT entitled to use Right to Know in a way that endangers the usefulness of the site itself.

We have already seen the Australian Taxation Office refuse to answer requests from Right to Know because somebody once wrote abusive comments in response to a reply from the agency. If the applicant on this page continues to abuse the staff of the Therapeutic Goods Administration (TGA), there is a risk that the TGA will also refuse to process requests from Right to Know. If this happens, it will diminsh to usefulness of the site for all users and lessen the value of the site for the greater Australian society. So, in my opinion, the rights of the applicant to use Right to Know as an email method are overtaken by the rights of all the other users of Right to Know. It is not as if Right to Know is the only way that the applicant can contact the TGA.

I understand that it is difficult for any person to write a letter when they are feeling angry and frustrated and not to let this emotion enter into the letter in some way. Many emails on Right to Know show the emotion of the user and it is probably not so bad and maybe even a good thing that it happens. But the "requests" on this page are not normal FOI requests with some emotion added as an ingredient in the recipe. They are invalid requests that are not consistent in what they ask for and the main part of the so-called request is insulting, abusive and libelous.

The first so-called request was:
"Why are you back dating the Warnings on Champix. How much is Pfizer paying you?"
The second was a repetition and increase in the first request:
"Why did you BACK DATE the warnings on CHAMPIX? How much is Pfizer paying you and your staff"
Now in the latest request, the applicant explains that it should be obvious what he wants --- even though it is completely different from what he asked for in the first email. He wants the contact details (!?) of people who are dead or who have suffered an injury. It is difficult to imagine that any reasonable response from the TGA will satisfy the applicant.

Although I was quick to criticize the original request of this applicant and retracted my criticism, things have changed since then. The applicant has by had two lots of assistance to suggest how he could write a valid FOI request to the agency but has not done this and continues his tirade of abuse. In my opinion (and I am only an ordinary user of Right to Know who wants the site to continue to be useful and effective), it is time to put a stop the the request chain.

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Kristof Wing left an annotation ()

Having followed this case and conversed with Mr. Hamblin over email I would whole-heartedly support a move to bar Mr. Hamblin from continuing this request at the very least.

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Luke Bacon left an annotation ()

Luke here (I'm an admin of Right To Know). Following the suggestion of these two helpful annotations (thank you for your input!) I've altered this request so that only the authority can send responses. I'm not sure if they will, but in case they want to.

I agree that this request is becoming unhelpful to the site, and plainly isn't intended to be a valid FOI request.

Thanks for everyone’s contributions. I think these annotations are a great record for us all to use :)

All the best,

Luke

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From: Rod Hamblin (Account suspended)

Delivered

Dear TGA FOI,

GET STUFFED

Yours sincerely,

Rod Hamblin

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Things to do with this request

Therapeutic Goods Administration only: