No placebo in vaccine studies

Phillip Hayes made this Freedom of Information request to Therapeutic Goods Administration

Therapeutic Goods Administration did not have the information requested.

From: Phillip Hayes

Delivered

Dear Therapeutic Goods Administration,

We constantly hear from health officials that “vaccines are safe and effective”. But few people are aware of the fact that no vaccine has ever been tested against a true placebo for safety or effectiveness. So the claim that vaccines are safe and effective is based on complete pseudoscience, not science as falsely claimed.

The double-blind placebo-controlled randomised clinical study is the gold standard of medicine. Every drug must undergo these extensive long-term studies before been granted approval (even supposed life-saving medication). Every drug that is EXCEPT vaccines!

Vaccine safety trials use placebo-controlled groups that are either injected with another vaccine or an “active comparator” solution containing the same minor ingredients as the vaccine (eg. aluminium – a proven neurotoxin when injected – and a host of other toxic additives), less only the antigen, so that the vaccine ‘appears’ safe – but only in comparison to the equally toxic placebo. This is not a genuine placebo. Placebos in real scientific studies are inert. Otherwise the placebo is a waste of time (or a fraud).

Yet such scientific fraud and systematic deception of the public is not only endorsed by medical regulators and health authorities, it is deliberately covered up and censored from the public by powerful vested interests including the pharmaceutical companies who manufacture vaccines, the medical establishment who approve, endorse and administer vaccines, the medical universities and journals reliant on funding from pharma, the media who profit from pharma advertising and governments whose vaccination policies they feel obligated to protect - at all costs!

Few people, even fewer doctors, know that vaccines have NEVER been properly safety tested. As per the article below, this makes a mockery of the claims of vested interests that “vaccines are safe”.

So it's actually health authorities - including Australia's Health Department, medical regulator the Therapeutic Goods Administration (TGA) and the Advisory Committee on the Safety of Vaccines (ACSV) - that is deceiving the public with misleading information by falsely claiming that “vaccines are safe”.

No Placebo in Vaccine Safety Tests

They found that none of the current vaccines on the schedule have any meaningful pre-marketing safety data. And worse, there’s never been a trial of a vaccine against a genuine placebo…the toxic vaccines were only ever compared with an equally toxic comparator (ie. another vaccine or the vaccine less the antigen only), rather than against an inert saline solution. Shockingly, such deliberate and blatant scientific fraud was not only permitted by medical regulators but fully endorsed as part of the licensure and mandating of vaccines on the schedule.

..”Contrary to commonly accepted dogma, vaccines are dangerous. Vaccine researchers — fully aware of this fact — design “safety” studies to hide vaccine injury and death. Rather than compare new vaccines to an inert placebo, researchers compare them to another vaccine, vaccines, or toxic vaccine ingredients, such as aluminum, which scientists routinely use to induce autoimmunity in laboratory rats. The result of these experiments is known beforehand: at least 2% of vaccine recipients in both the test group and the “placebo” group will experience serious adverse events. Researchers write off the injuries as “New Medical Events” unrelated to the test vaccine or to the toxic “placebo.”

I repeat for emphasis: Researchers intentionally injure, and sometimes kill, healthy children who would not have been injured or killed, had they been given a legitimate placebo. The FDA licenses new vaccines fully aware that industry “safety” tests are nothing more than scientific treachery.”..

Learn more here about the hidden fraudulent practices and endemic corruption within the pharma-medical industrial complex;

https://www.ageofautism.com/2019/01/no-u...

I request that the TGA confirm whether they are aware of this suppressed fact or, if not aware, that the TGA will investigate this crucial public health issue forthwith and issue a public statement accordingly.

Yours faithfully,

Phillip Hayes.

Link to this

From: TGA FOI
Therapeutic Goods Administration


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Dear Mr Hayes

 

Thank you for your correspondence of 26 November 2019 addressed to the
Therapeutic Goods Administration and the Advisory Committee on the Safety
of Vaccines, (as below).

 

Section 15 of the FOI Act requires that a request for access meets certain
requirements. Your request, in its current form, does not constitute a
valid request as it is a request for information rather than documents.
The FOI Act provides for access to documents and not to 'information'.

 

In order for your request to be processed under the provisions of the FOI
Act we require further information to enable us to identify the document
or documents you are seeking.

 

For example, you may wish to consider constructing the scope of your
request as follows:

 

“For the purposes of the Freedom of Information Act, I seek access to a
document/s confirming whether the Therapeutic Goods Administration
(including the Advisory Committee on the Safety of Vaccines) is aware
that… and if not aware, that the TGA (including the Advisory Committee on
the Safety of Vaccines) has or will be investigating…”

 

Please note that this scope suggestion is a sample only. At this early
stage, a search and retrieval has not been conducted and the TGA is unable
to advise on whether it may be too voluminous to process or if any
documents will be returned.

 

Please also note until your request meets the requirements of Section 15
of the FOI Act, your request is not being processed, and no further action
will be taken in relation to this matter.

 

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

 

Kind regards

 

Freedom of Information

[1]cid:image001.png@01D54DDB.C1CF42E0

Therapeutic Goods Administration

Australian Government Department of Health

T: 02 6289 4630 | E: [2][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [3]www.tga.gov.au

 

[4]cid:image002.png@01D55CBC.5655D390[5]cid:image003.gif@01D55CBC.5655D390[6]cid:image004.png@01D55CBC.5655D390

 

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.

 

The Department of Health acknowledges the Traditional Custodians of
Australia and their continued connection to land, sea and community. We
pay our respects to all Elders past and present. 

 

______________________________________

 

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From: Phillip Hayes

Delivered

Dear TGA FOI,

Thank you for your prompt reply and clarification of the FOI process.

I therefore wish to request that the TGA provide any and all scientific literature of safety studies for any vaccine currently on the Australian Immunisation Schedule having undergone a genuine double-blind placebo-controlled randomised clinical safety study as is required by every other medication prior to approval for public use in Australia.

Yours sincerely,

Phillip Hayes

Link to this

From: TGA FOI
Therapeutic Goods Administration


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Dear Mr Hayes

FREEDOM OF INFORMATION REQUEST – NOTIFICATION OF RECEIPT

I am writing to notify you that the Department of Health (Department) has
received your request for access to documents under the Freedom of
Information Act 1982 (FOI Act), the scope of the request is as follows:

“…Any and all scientific literature of safety studies for any vaccine
currently on the Australian Immunisation Schedule having undergone a
genuine double-blind placebo-controlled randomised clinical safety study
as is required by every other medication prior to approval for public use
in Australia.”

Under section 15(5)(b) of the FOI Act, the agency has 30 calendar days
after the date your request was received in which to provide a decision in
response to your request for access. A decision is currently due on or
before 29 December 2019.

However, where there is requirement to undertake consultation with
affected third parties, this timeframe is extended by a further 30 days.
It may also be extended in certain circumstances, including with your
agreement or where the Department applies to the Office of the Australian
Information Commissioner for an extension.

 

In addition, please note that if the decision maker decides that you are
liable to pay a charge in relation to your request then this timeframe is
extended pending payment of a deposit. You will be notified by the
Department if you are liable to pay a charge and/or if third party
consultation is required.

 

PROCESSING YOUR REQUEST

To assist us to streamline the processing of your request we ask you to
consider and respond to the following questions.

 

1.       Personal Information

Documents containing personal information, (e.g. the names and contact
details of any individuals, or any information that could reasonably
identify an individual) may require the Department to consult with the
identified individuals or parties. This consultation is likely to add to
the time taken to process your request, and potentially increase the
charge imposed on you.

 

We would therefore be grateful if you could confirm if you are seeking
access to personal information in the documents (e.g. names, contact
details, addresses) relating to:

·         third parties; and

·         Commonwealth staff (please note that unless you advise
otherwise, we will assume that you do not seek access to personal
information of Commonwealth employees below Senior Executive Service
level).

 

If you are not seeking access to any personal information, you can simply
reply: 'no personal information requested'.

 

If you are seeking access to specific types of personal information,
please specify the type of personal information you require.

 

2.       Duplicate Documents

Under section 4(1) of the FOI Act, the definition of a document includes
‘any copy, including an part of any copy, of a reproduction or duplicate’.
Confirmation that you are not seeking duplicate documents may enable more
timely and less costly processing of your request.

 

Can you please clarify if you are seeking duplicate copies, either in part
or in full, as part of your request?

 

If you are not seeking access to duplicate documents, you can simply
respond: ‘no duplicates requested’.

 

We look forward to hearing from you by COB Friday 6 December 2019.

If you have any queries, please contact the FOI team on (02) 6289 4630, or
via email at [1][email address].

Kind regards

Karen

 

Freedom of Information

Kyla | Karen | Tara | Cindy

[2]cid:image001.png@01D54DDB.C1CF42E0

Therapeutic Goods Administration

Australian Government Department of Health

T: 02 6289 4630 | E: [3][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [4]www.tga.gov.au

 

[5]cid:image002.png@01D55CBC.5655D390[6]cid:image003.gif@01D55CBC.5655D390[7]cid:image004.png@01D55CBC.5655D390

 

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.

 

The Department of Health acknowledges the Traditional Custodians of
Australia and their continued connection to land, sea and community. We
pay our respects to all Elders past and present. 

 

 

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From: Phillip Hayes

Delivered

Dear TGA FOI,

Thank you for clarifying my FOI request for “…Any and all scientific literature of safety studies for any vaccine currently on the Australian Immunisation Schedule having undergone a genuine double-blind placebo-controlled randomised clinical safety study as is required by every other medication prior to approval for public use in Australia.”

To help speed this request no personal information is requested and no duplicate documents are requested.

Yours sincerely,

Phillip Hayes

Link to this

From: TGA FOI
Therapeutic Goods Administration


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Dear Mr Hayes

 

Initial searches conducted by the relevant line area suggest that the
scope of your request in its current form, appears to be too voluminous
for the TGA to process.

 

For your information, the amount of clinical trial data associated with
just one vaccine can be very extensive, especially if (like in this case)
a product has been on the market in Australia for many years. In order to
identify which trials (if any) were carried out with double blind placebo
controls it would be necessary for TGA to conduct a manual search of a
large quantity of paper dossiers. The volume of documents associated with
just one MMR vaccine is in excess of 1200 pages of material.

 

In order to narrow our search field, we would be grateful if you could you
please clarify the scope of your request by:

·              Confirming a vaccine of interest (brand name) and/or

·              Identifying a specific time period of interest (e.g. at the
time of registration, or post-market for a particular year) and/or

·              Seeking clinical evaluation reports and/or delegate
overviews.

 Please note that at this early stage, these are suggestions only, and the
TGA is unable to advise on how many documents (if any) would be returned
if a search and retrieval was conducted.

 We would be grateful for your response by COB Friday 13 December 2019.

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

Kind regards

Karen

Freedom of Information

[1]cid:image001.png@01D54DDB.C1CF42E0

Therapeutic Goods Administration

Australian Government Department of Health

T: 02 6289 4630 | E: [2][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [3]www.tga.gov.au

 

[4]cid:image002.png@01D55CBC.5655D390[5]cid:image003.gif@01D55CBC.5655D390[6]cid:image004.png@01D55CBC.5655D390

 

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.

 

The Department of Health acknowledges the Traditional Custodians of
Australia and their continued connection to land, sea and community. We
pay our respects to all Elders past and present. 

 

 

show quoted sections

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From: Phillip Hayes

Delivered

Dear TGA FOI,

The TGA cannot claim that a vaccine is classified as safe if it has not undergone clinical safety studies using a genuine inert placebo (as per the the gold-standard double blind randomised control group studies required prior to approval of all medications in Australia).

To do so would provide false and/or misleading information about the safety of vaccines on the Immunisation Schedule to the Australian public.

Considering that the TGA cannot quickly and easily provide such fundamental safety information, or requested documents, on any vaccine currently on the Australian Immunisation Schedule is both deeply disturbing, highly unethical and neglectfully unprofessional.

If such documentation is not forthcoming within 30 days then the Australian people have the right to know, and indeed the TGA have the obligation to disclose, that such studies do not exists and that until they are undertaken on each vaccine currently on the schedule then they should be withdrawn from public use in Australia.

Yours sincerely,

Phillip Hayes

Link to this

From: TGA FOI
Therapeutic Goods Administration


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Attachment D19 6548346 FOI 1432 Request consultation.PDF.pdf
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Attachment D18 10395235 ATTACHMENT A Request Consultation Process.PDF.pdf
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Dear Mr Hayes

 

Please find attached correspondence in relation to your Freedom of
Information request.

 

As set out in the attached correspondence, we seek your response within 14
days, being 30 December 2019.

 

Pursuant to section 24AB(8) of the Freedom of Information Act 1982, the
statutory timeframe for processing your request is set aside during this
consultation process.

 

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

 

Kind regards

 

Freedom of Information

[1]cid:image001.png@01D54DDB.C1CF42E0

Therapeutic Goods Administration

Australian Government Department of Health

T: 02 6289 4630 | E: [2][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [3]www.tga.gov.au

 

[4]cid:image002.png@01D55CBC.5655D390[5]cid:image003.gif@01D55CBC.5655D390[6]cid:image004.png@01D55CBC.5655D390

 

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.

 

The Department of Health acknowledges the Traditional Custodians of
Australia and their continued connection to land, sea and community. We
pay our respects to all Elders past and present. 

 

show quoted sections

Link to this

From: TGA FOI
Therapeutic Goods Administration


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Dear Mr Hayes

 

Thank you for your email.

 

On 11 December 2019 you were advised by email that initial searches
indicated that your Freedom of Information request appeared to be too
voluminous for TGA to process. In that email we provided guidance and
advice to assist you to reduce the scope and size of your request. We
sought your response and clarification of a number of points.

 

As you did not provide advice or revise the scope of your request, you
were subsequently issued a request consultation notice on 16 December 2019
stating that a practical refusal reason existed in relation to your
request (that the request was too voluminous to process).  You were
afforded 14 days to make contact with the FOI Team to do one of the
following:

·         Withdraw the request;

·         Make a revised request; or

·         Indicate that you do not wish to the revise the request.

 

As you did not consult with the FOI Team within the required consultation
period, your request was taken to have been withdrawn in accordance with
subsection 24AB(6) of the Freedom of Information Act 1982.

 

You are welcome to submit another FOI request to this email address.

 

Kind regards

 

Freedom of Information

[1]cid:image001.png@01D54DDB.C1CF42E0

Therapeutic Goods Administration

Australian Government Department of Health

T: 02 6289 4630 | E: [2][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [3]www.tga.gov.au

 

[4]cid:image002.png@01D55CBC.5655D390[5]cid:image003.gif@01D55CBC.5655D390[6]cid:image004.png@01D55CBC.5655D390

 

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.

 

The Department of Health acknowledges the Traditional Custodians of
Australia and their continued connection to land, sea and community. We
pay our respects to all Elders past and present. 

 

show quoted sections

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Things to do with this request

Anyone:
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