Document Release Exposes Meryl Dorey's Tenuous Grip On Reality

- TGA DOCUMENT RELEASE -
EXPOSING MERYL DOREY’S TENUOUS GRIP ON REALITY
We have seen Meryl Dorey adopt some loony ideas in the past, but this one takes the cake.
But first some background. “Black Salve” is an alternative- medicine concoction containing
sanguinarine, which comes from Bloodroot (Sanguinaria canadensis), and sometimes zinc
chloride. It has been sold in Australia as an alternative treatment for cancer, including skin
cancer.
Black Salve is highly corrosive, highly dangerous, does not discriminate between cancerous
tissue and healthy tissue, and relies on the user to self-diagnose, self-prescribe, self-
administer and self-monitor. Read more about it at Quackwatch.
The Therapeutic Goods Administration has issued a warning advising consumers against
purchasing or using black salve. The pharmaceutical industry has developed far more
effective treatments, to be prescribed and administered by real doctors.
For all these reasons, Black Salve has found favour in the alternative medicine milieu, so of
course Meryl Dorey and the Australian Vaccination Network have recommended and
publicised it. Some of that publicising involved selling a DVD from the AVN shop and
spruiking it on radio.
Once the TGA were informed that Meryl Dorey and the AVN were on the Black Salve
bandwagon, they issued a recommendation to them to stop such irresponsible behaviour.
Of course Meryl Dorey contested that, as she is wont to do, and the following
correspondence outlines the discourse between them.
All very normal until you get to page 24. At this point Meryl Dorey stops using rational
argument and invokes the “Freeman Of The Land” defence. For those of you who have led
rational lives, this lunacy is the theory that a person can declare themselves to be, in effect,
a sovereign nation and not subject to law.
Of course it is rubbish, but Meryl Dorey’s use of it shows how tenuous her grip on reality is.
What follows is the correspondence between the TGA and Ms Dorey. Enjoy.
Further reading: See Reasonable Hank’s perspective.
Ken McLeod
19 May 2013.
Australian Government
Department of Health and Ageing
Therapeutic Goods Administration
Mr Ken McLeod
PO Box 51
Moruya NSW 2537
Dear Mr McLeod
FREEDOM OF INFORMATION REQUEST FOI 181-1213
Notice of Decision
I refer to your request of 19 February 2013 under the Freedom ofInformation Act 1982 (the FOI
Act) for access to the following documents:
"... all correspondence between the TGA and the AVN [Australian Vaccination Network] and
Ms Meryl Dorey from 19 April 2012 until today [18 February 2013]."
Decision Maker
I am the Therapeutic Goods Administration (TGA) officer authorised to make this decision under
the FOI Act. What follows is my decision under the FOI Act.
Scope of the FOI request

The TGA has identified thirteen (13) documents falling within the scope of your request.
Background
On 19 February 2013 the TGA received a request from you, under the FOI Act.
On 27 February 2013 you were advised that the cost of processing your request amounted to
$168.05 and you were asked to pay a deposit of$42.01. You were also advised at this time ofthe
need to conduct a third party consultation in relation to your request.
On 12 March 2013 the TGA received a deposit in the amount of$42.01 for the processing of your
request. Along with your deposit you applied for a waiver of further charges on both public interest
and financial hardship grounds.
On 26 March 2013 third party consultation was initiated.
On 10 Apri12013 you were advised of my decision to waive any further charges (in excess ofthe
deposit paid) associated with the processing of your request.
Material Considered in Decision-Making

In coming to my decision I had regard to the following:
• the correspondence from you of 19 February 2013 including the terms of your FOT
request;
• the documents falling within the scope ofthe FOI request;
PO Box 100 Woden ACT 2606 ABN 40 939 406 804 l1GAHealth Safety
Pho Ill': 02 6232 9444 Fdx: 0262329605 1111,111 info@tga.gov.au VVWW. tga,goV.d II Regulation
PAGE 1 (This page numbering sequence was added by Ken McLeod)

• all relevant papers in the TGA FOI processing file;
• the provisions of the FOI Act;
• the guidelines issued by the Australian Information Commissioner under section 93A of
the Freedom oflriformation Act 1982;
• consultations with the third parties whose documents are involved.
Decision
My decision in relation to the documents falling within the scope ofthe FOI request is to release
thirteen (13) documents in full. A schedule listing these documents along with the documents
themselves is at Attachment A.
In accordance with the Freedom oflriformation (Charges) Regulations 1982 (the Charges
Regulations) I have calculated the actual costs associated with processing your request. In this case,
the actual costs exceed the estimate of charges notified to you previously. However, as noted above,
on 10 April 2013, you were advised of my decision to waive the remaining charges associated with
the processing of your request, thus you are not required to pay any further charges and the
documents can be released to you immediately.
Review and Complaint Rights

If you are not satisfied with this decision, you can either seek internal review or apply to the Office
ofthe Australian Information Commissioner for review ofthe decision. A statement of your review
rights and your rights to make a complaint to the Information Commissioner is at Attachment B.
If you have any queries regarding this matter, please contact Elizabeth Santolin on (02) 62328664.
Head, Office of Product Review

Therapeutic Goods Administration
2- May2013

A
FOI Request 181-1213 in relation Complaints about Black Salve Advertisements
The request is for the following:
" ... all correspondence between the TGA and the Au..<;tralian Vaccination Network (AVN) and Ms Meryl Dorey from 19 April 2012 until today. "
By way of background information, this request relates to two complaints that have been lodged concerning the promotion of "Black Salve"
1. The first complaint was submitted on April 19th 2012, has the Code 2012/04/022, and the respondent was the AVN.
2. The second complaint was submitted on 13 th May 2012, has the Code 2012105/013, and the respondents were Ms Meryl Dorey and Mr
Leon Pittard.
The request is for documents dated between 19 April 2012 and 18 February 2013. It is for correspondence from AVN and Ms Dorey only in
relation to the named complaints.
Schedule of Relevant Documents

Doc. FileNo. Folio No. Author Addressee Date Description Pages Decision Relevant sections
No. of the FOI Act
1 2013/002066 20-21 Complaints Australian Vaccination 30 April 2012 Email advising advertiser 2 Release in full
Resolution Network of complaint
Panel
Release in full
2 2013/002066 22 James Fuggle Complaints Resolution 5 June 2012 Advertisers Response 1
Rummery Panel Form
Solicitors
Release in full
3 2013/002066 24 James Fuggle Complaints Resolution 9 May2012 Letter- Advertisers I
Rummery Panel response, request for
Solicitors extension
Release in full
4 2013/002066 26 James Fuggle Complaints Resolution 28 May 2012 Letter- Advertisers initial 1
Rummery
F6
o="
113

Solicitors Panel response to complaint
Release in full
5 2013/002066 27 Complaints James Fuggle 29 May 2012 Email - Complaints 1
Resolution Rummery Solicitors Resolution Panel reply to
Panel first response
Release in full
6 2013/002066 30-31 James Fuggle Complaints Resolution 5 June 2012 Letter - Advertisers full 2
Rummery Panel response to complaint
Solicitors
Release in full
7 20131002066 41 Complaints Australian Vaccination 4 December Email - Complaints 1
Resolution Network 2012 Resolution Panel
Panel notification of
determination - advertiser
Release in full
8 2013/002066 42 Complaints James Fuggle 4 December Email - Complaints 1
Resolution Rummery Solicitors 2012 Resolution Panel
Panel notification of
determination advertisers
representative
Release in full
9 2013/002066 43 James Fuggle Complaints Resolution 5 December Email - Read confirmation 1
Rummery Panel 2012 -advertisers representative
Solicitors
Release in full
10 2013/002066 49-52 Complaints James Fuggle 18 February Email - Complaints 4
Resolution Rummery Solicitors 2013 Resolution Panel
Panel notification of referral to
TGA
Release in full
11 2013/002066 88-90 Complaints Australian Vaccination 2 July 2012 Email - Complaints 3
Resolution Network Resolution Panel
Panel notification of complaint
Release in full
12 2013/002066 109 Meryl Dorey Complaints Resolution 16 July 2012 Letter to CRP - Offer to 1
Australian Panel settle in private
Vaccination
Network
FOI 181-1213

tJ;~13/0()2066
112 Complaints
Resolution
Australian Vaccination
Network
30 January
2013
Email - Complaints
Resolution Panel
1
Release in full
Panel notification of referral to

TGA
FOI 181-1213

Ernie Waldstein
From: Ernie Waldstein

Sent: Monday, 30 April 2012 2:25 PM 1
To: 'meryl@avn.org.au'
Subject: Complaint 2012/04/022 Black Salve
Attachments: Advertising Complaint Procedures.pdf; Commonwealth Legislation.pdf; Guidelines
for respondents.pdf; Response Form 2012.doc; TGACC Advertising Code.pdf; TGACC
Seminar Brochure 2012.pdf; 2012-04-02 Balk Salve.pdf
Ms Meryl Dorey
Australian Vacinnation Network, Inc
Dear Ms Dorey
Complaint 2012/041022 Black Salve
The Complaints Resolution Panel" has been established under the Regulations (Regulation 42R) to consider
tdvertisements and generic information about designated therapeutic goods, medical devices and other therapeutic
goods, published in mainstream print, broadcast media including TV, radio and the internet, cinema and outdoor
media (Regulation 424CAB). Complaints must be made in writing.
The Complaints Resolution Panel (CRP) has received a complaint about an advertisement for Black Salve in
www.avn.org.au on 19 April 2012.
Please find attached a copy of the advertisement and the complaint.
You should respond to the complaint. If you do not provide a response, the Panel may determine the
complaint on the basis of the material before It.
We interpretthe complaint as alleging brea~hes of section 42DL(1)(g) of the Act and sections 4(1 )(a), 4(1)(b), 4(2)(a),
4(2)b, 4(2)(c), 4(2)(d), 4(2)(e)(il), 4(2)(f), 4(2)(g), 4(2)(h), 4(2)(1), 4(4), 4(5), 4(7), 5(2) and 6(3) of the Code. You should
provide a response to each allegation.
Pursuant to regulation 42ZCAH, following a preliminary review of the complaint, please respond as well to each of the
following possible breaches or the Code, Regulations and/or Act:
• Section 42DL(1)(g) of the Act, because the advertisement promotes Black Salve for therapeutic use, when
these productls may not be included in the Register
• Section 5(1) of the Code because of representations about cancer
Pursuant to regulation 42ZCAE, the Panel requires you to produce evidence in support of claims made in the
advertisement. Please take this into account when preparing your response. Should you wish to provide supporting
material for any claims challenged, you must provide an explanation as to how the material supports the complaint
and identify relevant parts in the material. Please provide pivotal evidence to support the efficacy of the product with
r~~~:~t to the?l~i~~~~~j:ct to compl~i~t:"!he attached documents assist Y?LJiQPr.~p_~riI19l()urTf?~PQI1~f?,
You should also provide the following additional Information:
In addition to responding to the particulars of the complaint as noted abQve, the Panel also requests that you provide
the following:
• The completed Response Form (attached)

• A statement as to whether the subject matter of the complaint is also the subject of legal proceedings that
have not been finally disposed of (regulation 42ZCAJ)
• If the advertised products are incfuded in the Register, the ARTG number and a copy of ARTG entries for
each advertised product
• Any approval that was required for the publication of the advertisement and/or representations within it
You should also be aware ofthe following matters:

1

The Panel must consider a complaint and decide whether the complaint is justified having regard to written
submission and documents given to the Panel, the results of its inquiries and information obtained about the
complaint (regulation 42ZCAO).
After the parties have received a copy of the final written determination of the Panel concerning this complaint, that
determination will be made available to the public on request and will be included on the website www.tgacrp.com.au
under "Complaint Register". Before making the determination public in these ways, the identity of the complainant will
be omitted if the complainant has so requested. Also, any information accepted by the Panel as confidential will be
omitted.
The TGA observer to the Panel appointed by the TGA may be entitled to use any information provided to the Panel
(whether confidential or not) pursuant to section 61 (8) of the Therapeutic Goods Act.
When the Panel considers the complaint, it may decide to raise other matters. If it does so, you will be notified in
writing and asked to provide a further response.
If the complaint is found to be justified, you may be asked to withdraw the advertisement, withdraw certain
representations and not use them in future advertisements, publish corrective information or publish
retraction/s. Where the Panel requests withdrawal of representations, the validity of the representations will not
generally be reconsidered (per Regulation 42ZCAI(1)(d)) unle.ss:
• at least 12 months have elapsed since the Panel made its request or
• genuinely new evidence has become available that was not available at the time of the complaint.
Your response must b~ provided to the Panel no later than 14 May 2012. Should no response be received,
the Panel may, nevertheless, consider the complaint at its next meeting.
If you do not understand the complaint or are unsure as to how to respond, you may need to seek legal advice or the
advice of a regulatory consultant.
Attached for your information please find a copy of each of the Therapeutic Goods Advertising Code 2007, the
Complaints Resolution Panel procedures and some relevant clauses from the therapeutic goods legislation. The
Code and procedures document also can be found on the website at www.tgacrp.com.au.
Should you require any further information, please let me know.
Please acknowledge receipt of this email.
"In this correspondence, references to the Code, Regulations, and Act are references to the Therapeutic Goods
Advertising Code 2007, the ThElrapeutic Goods Regulations 1990 and the Therapeutic Goods Act 1989. References
to the Register are references to the Australian Register of Therapeutic Goods. References to the Panel or the CRP
are references to the Complaints Resolution Panel. References to theTGA are references to the Therapeutic Goods
,dministration.
Yours Sincerely
Ernest Waldstein
for Judith Brimer, Executive Officer
Complaints Resolution Panel
PO Box 764, North Sydney 2059
(02)94602796· ... -.. . . . . .... - - . .
Enrol at www.tgacc.com.au/events for the 2012 TGACC Advertising Seminar courses:
Fundamentals
Sydney Wed 20 June; Wed 24 October
Melbourne Fri 11 May; Thurs 22 November
~erth Fri 27 July
~delaide Wed 25 July
:srisbane Fri 25 May; Fri 9 November
\dvanced
;ydney Wed 19 September
2

05-06-12;14:42 ; ;61 2 66221402 # 1
C nplaints Resolution Panel

Response Form for Advertisers
Uu this kJrm to submit oompJaltttslJiboul advertisl'lmfHIls lar therapeutic good&
Contact Information
Fletlse provide wrrent conlad Jnforfllatkm. For lndlvIduBlsl p/fAa$e $f(tte yOUI' namfllJndf;r "oompany name». {(you alii inlding undM a b/J$lnes8
I2
n81'M Q/l!Jase show both your indillJdoo/ name omd the ~slrleBIf name. I
Company name: AlASffeF\LI A' N vA Cc.. fl\)fT TI ~ (\) t£..TvJ~121C

ABN/ACN:
30077 00 ~9 2.~
Address: C/- 0-A-M~S f4A CiG. L e: RV.(VltYl f:R ~ ,5£) L.\;C' T QR S
Po COx.. 1~
k\SvY1b1ZE:" NSIr-J aLt~0 I
eontam person (name and title) for this oomplalnt: fY\ S £.lLE~ 6PrR..~ JtJ GTOr0
Phone: (0.2.)(0 G:, ~ \ f),. 475 Fax: (0 c2,) ~b ~a IltO,Q
Email ~ddress; e..\\'\ e. • bo.cnV"\~+f:>ne Jt V- \€()G\,.\. COM. QL-\
The products promoted In the advertisement

identifY BitCh advtIrtlled IXOrioot. If tho tmduet i$ on the ARm. IncllJdB 1M ARM l;JenriMna nt.IrtIIW.
Product: 6\a.c.k. 'Sa.lve.. ARTG 10; N IPwt

Produot: ARTGID:
Product:
ARTG 10:
Product: i ARTGID:
Product ARTG 10:
Product
ARTG 10:
Product:
ARTG ID:
Produot: .... --_."..
.........-,.
.............
"
. ART(lIO~. . . . .
Product: ARTG ID:
Product: ARTG ID:
Complaint Number: 2012/ 0'+ 10;2:2.

3
James Fuggle Rummery
SOLICITORS and BARRISTERS

Level I, 73 Magellan Street, Lismore NSW 2480
PO Box 95, DX 77IlE-mail: enquiries@jfrlegaLcom.au
PH: (02) 6621 2475 FAX: (02) 6622 1402
Anita Barbara Pty Limited ABN:26101460 833 an incorporated legal practice
Our Ref: EB:8073

Yom: Ref:
9 May, 2012
Judith Brimer
IlJ)
Executive Officer
Complaints Resolution panel
POBox 764
NORTH SYDNEY NSW 2059
Also by facsimile: (02) 9460 2798
Dear Madam
RE: MERYL DOREY, AUSTRALIAN VACCINATION NETWORK INC

COMPLAINT 2012/04/022
We act for Meryl Dorey of Austtalian Vaccination Network regarding complaint

2012/04/022.
Ms Dorey has recendy made contact with OUI office and engaged counsel, however, we
note that you requite a response to the complaint no later than 14 May 2012.
We ate seeking an extension of a further 14 days to respond to the complaint to allow

advice to be obtained
\Ve look forward to hearing from you.
ellie. barrington@jfrlegal.com.au
Liability limited by a Scheme approved under Professional Standards legislation rmi',,

)
4
. SOLICITORS and BARRISTERS

Levell, 73 Magellan Street, Lismore NSW 2480
PO Box 95, DX 7711 E-mail: enquiries@jfrlegal.com.au
PH: (02)66212475 FAX:'(02) 6622 1402
Anita Barbara Pty Limited ABN:26101460 833 an incorporated legal practice
Our Ref: EB:8073

Your Ref:
28 May, 2012
Judith Brimet
Executive Officer
PO Box 764
Dear Madarn
RE: MERYL DOREY, AUSTRALlAN VACCINATION NETWORK INC

We refer to the abovementioned matter.
We are instructed that-oU! client has 'Withdtawn the advertisements for the DVD entitled
'One Answer to Cancer', being the subject of the complaint, from their website.
Please advise whether it remains necessary for a fulsome response to the complaint,
which would very likely consume resources and time of the AVN, Ms Dorey and the
'-'U'L.u.~J.l4J.llU) Resolution Panel
We look forward to hearing from you.
Yours faithfully
JAMES FUGGLE RUMMERY
tJrj ~,
Liability limited by a Scheme approved under Professional Standards legislation ~"-

Judith Brimer
From: Judith Brimer
Sent: Tuesday, 29 May 2012 11 :35 AM 5
To: 'ellie.barrinton@jfrlegal.com.au'
Subject: Complaint 2012104/022 Black Salve
Attachments: Complaint 2012/04/022 Black Salve
Dear Ms Barrington,
Your fax dated 28 May has been received.
Please provide a full response to the complaint as requested in the letter sent to Ms Dorey on 30 April 2012 (copy
attached).
I note a request for an extension of time to respond to this complaint from 14 May to 28 May 2102 was requested by
you on 9 May 2012 and granted by telephone on 15 May 2012.
I'fease provide any further response you may wish to make no later than close of business on Tuesday 5 June 2012 as
the complaint will be considered by the Complaints Resolution Panel on Thursday 7 June.
Please confirm receipt of this email by return .
Yours faithfully,
Judith Brimer
Executive Officer
Therapeutic Goods Advertising Code Council and
Tel: 0294602796
Fax: 02 9460 2798
The 2012 TGACC Advertising Seminars:

Enrol at www.tgacc.com.au/events

6
SOLICITORS and BARRISTERS

Levell, 73 Magellan Street, Lismore NSW 2480
PO Box 95, DX 7711 E-mail: enquiries@jfrlegaLcom.au
PH: (02) 66212475 FAX: (02) 6622 )402
Anita. Barbara pry Limited ABN:16 101 460833 an incorporated legal practice
Our Ref: EB:8073

Your Ref:
5 June, 2012
Judith Brimer
Executive Officer
POBox: 764
Dear Madam
RE: MERYL DOREY, AUSTRALIAN VACCINATION NETWORK INC
We refer to the abovementioned matter.
Australian Vaccination Network
In relation to the AVN, it is conceded that there are breaches of section 42DL(g) of the
Therapeutic Goods Act (fGA) and sections 4(1)(a), 4(2)(d), 4(2)00, 4(2)(i) and 4(5) of
the Therapeutic Goods Advertising Code (the Code).
. . Bteathesare not· adtbittedfor sections 4(1 )(b);"4(2)(a);4(2)(b) and4(2)(c)ufthe Code; .

These are a matter for scientific and medical opinion, however, the AVN are not
cuttendy in a position to furnish such evidence.
It is denied that there is a breach of section 4(2)(e)(ii) of the Code as the advertisement
never made any suggestion that a person with cancer would be worse off if they chose
not to take Black Salve.
Uability limited by a Scheme approved under Professional Standards legislation 1'-.. .

A breach of section 4(2)(f) of the Code is denied as the advertisement made no reference
to consumption or quantity of consumption of Black Salve.
A breach of section 42(2)(h) is denied as the advertisement does not claitn to be effective
in all cases ..
It is denied that there is any breach of section 4(4) of the Code as there was no scientific
information presented in the advertisement.
A breach of section 4(7) of the Code is denied as the advertisement did not contain any
testimonials.
There is no breach of section 5(1) of the Code as the adve:rtiscment does not fall within
the definition of a prohibited representation in Part 1 of Appendix 6, as it does not make
any representations regarding the diseases listed and neithe:r is it a sunscreen. Similarly,
there is no breach of section 5(2) of the Code as Black Salve is not a sunscreen by any
definition, neither is it obvious that cancer falls within Table 1 to Part 2 of Appendix 6.
Finally, a breach of section 6(3) of the Code is denied as the advertisement was for a
DVD not for the good itself.
MetylDorey
In relation to Ms Dotey, breaches of sections 4(2)(e)(ii), 4(2)(f), 42(2)(h), 4(4),4(7), 5(1),

5(2) and 6(3) of the Code are denied for the reasons outlined above.
In relation to section 42DL(g) of the TGA and sections 4(1)(a), 4(1)(b), 4(2)(a), 4(2)(b)
4(2)(c), 4(2)(d), 4(2)(g), 4(2)(i) and 4(5) of the Code, no breaches are admitted.
The Complaint
We are instructed that the subject matter of the complaint is not the subject of any legal
proceedings that have not been fulally disposed of and neither was any approval required
for the publication of the advertisement and/or representations within it.
We enclose a completed Response Form for your attention.
We look forward to hearing from you.
Yours faithfully
JAMESFUGGLERUMMERY
liability limited by as.cheme approved under Professional Standards legislation ~"-

tl
Josie Barisic
From:
Sent:
Josie Barisic
Tuesday, 4 December 2012 2:03 PM
7
To: 'meryl@avn.org.au' 7
Attachments: CRP 2012-04-022 Black Salve.pdf
Ms Meryl Dor~y
Australian Vaccination Network Inc
PO Box 177
BANGALOW NSW 2479
4 December 2012
Dear Ms Dorey
'-::omplaint 2012/04/022 Black Salve
Please find attached a copy of the determination reached by the Complaints Resolution Panel after its
consideration of the above complaint at the meeting of the Panel held on 16 August 2012.
Please note that sub-regulations 42ZCAI(3) and (4) of the Therapeutic Goods Regulations 1990 permit the
Panel to make recommendations to the Secretary of the Department of Health and Ageing in the event of non
compliance with this determination.
Where a retractionhas been requested, please provide a copy of the proposed retraction for the Panel's
approval, before its publication or broadcast. Also subsequently provide a copy of the published or broadcast
retraction.
In practice, determinations that have not been complied with are referred to the Therapeutic Goods
Administration (TGA) for follow-up action. Referral to the TGA may result in an order being made under
Regulation 9 ofthe Therapeutic Goods Regulations to enforce compliance with the Panel's
determination. Non-compliance with this order could also result in suspension or cancellation of the product
'ntry from the Australian Register of Therapeutic Goods.
Regulation 9 Orders issued by TGA for advertising complaint determinations finalised by the Panel after 1
November 2010 will be publicised on the TGA's website at http://www.tga.gov.au/advert/complaint
investigations. htm
Yours Sincerely
Josie Barisic
on behalf of Judith Brimer, Executive Officer
The rap utit Goods Advertising Code Council and

Ph: 02 9460 2796
Fax: 02 9460 2798
The dates for the 2013 TGACC Fundamentals and Advanced Seminars will be available soon
For information and enrolments go to www.tgacc.com.au/events

Josie Barisic
From: Josie Barisic
Sent: Tuesday, 4 December 20122:25 PM

8
To: 'ellie.barrington@jfrlegal.com.au'
Ms Ellen Barrington
James Fuggle Rummery Solicitors
PO Box 95
Lismore NSW 2480
4 December 2012
Dear Ms Barrington
':omplaint 2012/04/022 Black Salve
I write to you in your capacity as acting for Australian Vaccination Network Inc.
Please find attached a copy ofthe determination reached by the Complaints Resolution Panel after its
consideration of the above complaint at the meeting of the Panel held on 16 August 2012.
Please note that sub-regulations 42ZCAI(3) and (4) of the Therapeutic Goods Regulations 1990 permit the
Panel to make recommendations to the Secretary of the Department of Health and Ageing in the event of non~
Where a retraction has been requested, please provide a copy of the proposed retraction for the Panel's
approval, before its publication or broadcast. Also subsequently provide a copy of the published or broadcast
retraction.
"'egulation 9 of the Therapeutic Goods Regulations to enforce compliance with the Panel's
entry from the Australian Register of Therapeutic Goods.
investigations.htm
Yours sincerely
Josie Barisic
Theraputic Goods Advertising Code Council and

Ph: 02 9460 2796
Fax: 02 9460 2798
The dates for the 2013 iGACC Fundamentafs and Advanced Seminars win be avallabie soon
For information and enrolments go to www.tgacc.com.aulevents
1

Josie Barisic
From: Ellie Barrington <ellie.barrington@jfrlegal.com.au>

To: Josie Barisic
Sent: Wednesday,S December 2012 11:48 AM
Subject: Read: Complaint 2012/04/022 Black Salve
9
Your message
To:
Sent: Wednesday, December 05,201211:48:26 AM (UTC+10:00) Canberra, Melbourne, Sydney
was read on Wednesday, December 05,201211:48:15 AM (UTC+10:00) Canberra, Melbourne, Sydney.

Judith Brimer
From: Judith Brimer 10
Sent: Monday, 18 February 20131:40 PM
To: 'Ellie Barrington'
Subject: RE: Complaint 2012/04/022 Black Salve
Attachments: 2012-04-022 Black Salve Letter JFR 180213.pdf
Dear Ms Barrington,
The letter of recommendation from the Complaints Resolution Panel (and the annexures) were addressed to the
Secretary of the Department of Health & Ageing. A copy of the letter was provided to you as a courtesy so that you
would be aware of the recommendation.
Please now find attached, formal notice of the recommendation, pursuant to Regulation 42ZCAI.
Yours sincerely,
Judith Brimer
Executive Officer
Therapeutrc Goods Advertising Code Council and
Tel: 02 94602796
Fax: 02 9460 2798
From: Ellie Barrington [mailto:ellie.barrington@jfrlegal.com.au]

Sent: Thursday, 14 February 2013 2:24PM
To: Judith Brimer
Subject: RE: Complaint 2012/04/022 Black Salve
Dear Ms Brimer
Thank you for your email.
fortunately the annexures to the letter, being a copy ofthe determination and the material which you considered
when you made the determination about the complaint, were not attached to the letter. Would you please forward
these documents. .
Regards,
Yours faithfully,
Ellen Barrington
~
JAMES FUGGLE RUMMERY SOLICITORS
Level 1, 73 Magellan Street, Lismore NSW 2480
PO Box 95, DX 7711
- - - Email: ellie.barrington@ifrlegal.com.au
Ph: (02) 6621 2475, Fax: (02) 6622 1402
Liability Limited by a scheme approved under Professional Standards Legislation.

The information transmitted is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. ;"'.1
review, retransmission, dissemination or other use of, or taking of any action in reliance upon, by persons or entities other than the intended recipient is
prohibited. If you received this in error, please contact the sender and delete the material from any computer.
From: Judith Brimer [mailto:jbrimer@tgacc.com.au]
Sent: Thursday, 14 February 2013 12:16 PM
To; Ellie Barrington
14 February 2013
Dear Sirs}
Complaint 2012/04/022 Black Salve
'I rite to you in your capacity as acting on behalf of Meryl Dorey and the Australian Vaccination Network.
This note is to inform you that, in relation to the above complaint, the Complaints Resolution Panel has made
a recommendation to the Secretary per subregulations 42ZCAI(3) and (4) ofthe Therapeutic Goods
Regulations 1990.
A copy of the recommendation is attached.
Yours sincerely
Judith Brimer
Executive Officer
Therapeutic Goods Advertising Code Council and
Tel: 02 9460 2796
Fax; 02 9460 2798
• rle 2013 TGACC Advertising Seminars:
Fundamentals
Sydney: Wed 20 March, Wed 19 June, Wed 16 October
Brisbane: Fri 24 May
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Sydney: Wed 17 April, Wed 18 September
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COMPLJ\INTS
RESOLUTION PANEL
[ntegrity in Healthcare Advertising
Ellie Barrington
James Fuggle Rummery Solicitors
Levell, 73 Magellan Street
Lismore NSW 2480
18 February 2013
Dear Ms Barrington,
Pursuant to sub-regulation 42ZCAI(5) of the Therapeutic Goods Regulations 1990

("Regulations"), you are hereby given written notice. of a decision made by the
Complaints Resolution Panel ("Panel") under sub-regulation 42ZCAI(3) of the
Regulations.
By letter dated 4 December 2012, the Panel Secretary sent to James Fuggle Rummery
Solicitors, acting on behalf of Australian Vaccination Network Inc, the person
responsible for the advertisement, a copy of the Panel's determination for the above
complaint, requesting the withdrawal of the advertisement subject of the complaints,
withdrawal of representations that are outlined in the determination, and the
publication of a retraction.
The Panel requested that evidence of compliance be provided within 14 days. The
determination drew the sponsor's attention to the provisions of sub-regulations
42ZCAI(3) and (4) which permit a recommendation to be made to the Secretary in the
event of non-compliance with a request of the Panel.
At its meeting of 17 January 2013, the Panel noted that no response to the
determination had been received. The Panel was satisfied that its determination for the
complaint had made findings of breaches of the Therapeutic Goods Advertising Code
C1Code"), the Regulations, and/or the Therapeutic Goods Act 1989 ("Act'·)~ and that the
sanctions requested in the determination were appropriate and necessary to address
those breaches.
For the reasons that:
the determination identified breaches of the Code, Regulations, and/or Act

the sanctions requested in the determination were appropriate and necessary to
address those breaches
The Australian Vaccination Network provided no evidence or indication to the
Panel that it would comply with the requested sanctions
Complaints Resolution Pane!

Suite 2202, Leve! 22,141 Walker Street North Sydney NSW 2060 Postal Address CRP, C/O PO Box 764 North Sydney NSW 2059
Phone: 61 2 9460 2796 Fax: 61294602798 Website: www.tgacrp.com.au Email; jbrimer@tgacc.com,au

2
the Pane] decided to recommend pursuant to sub-regu]ations 42ZCAI(3) and 42ZCAI[4)

that the Secretary make orders that Australian Vaccination Network Inc comply with
the requests made in the determination.
Yours sincerely,
Judith Brimer
Executive Officer

Q.il-S~t- \$ f\JSt
Co /7 J12
Ern .Waldstein
From: Ernie Waldstein 11

Sent: Monday, 2 July 2012 4:28 PM
To: meryl@avn.org.au
Attachments: 20120702l71958589.pdf; Advertising Complaint Procedures.pdf; Commonwealth
Legislation.pdf; Guidelines for respondents.pdf; Response Form 20l2.doc; TGACC
Advertising Code. pdf; TGACC Seminar Brochure 20l2.pdf
Ms Meryl Dorey
Australian Vaccination l\Ietwork Inc
2 July 2012
Dear Ms Dorey
mplaint 2012/05/013 Black Salve
The Complaints Resolution Panel* has been established under the Regulations (Regulation 42R) to consider
advertisements and generic information about designated therapeutic goods, medical devices and other therapeutic
goods, published in mainstream print, broadcast media including TV, radio and the internet, cinema and outdoor
media (Regulation 42ZCAB). Complaints must be made in writing.
The Complaints Resolution Panel (CRP) has received a complaint about an advertisement for Black Salve on
fairdinkumradio.com, the AVN "facebook invitation" and the AVN "twitter invitation" both linking to the Fairdinkum
Radio material on 5 May 2012.
Please find attached a copy of the advertisement and the complaint.
You should respond to the complaint. If you do not provide a response, the Panel may determine the complaint
on the basis of the material before it.
We interpret the complaint as alleging breaches of sections 42C, 42DP and 42DM of the Act and sections 4(1)(b),
.1)(a), 4(2)(b), 4(2)(c), 4(2)(d), 4(2)(e), 4(7),5(2) and 6(3) of the Code. You should provide a response to eaCh
allegation.
Pursuant to regulation 42ZCAH, following a preliminary review of the complaint, please respond as well to each of
the following possible breaches of the Code and Act:
• Section 42Dl(1)(g) of the Act, because the advertisement promotes Black Salve for therapeutic use, when
these product/s may not be included in the Register
• Sections 4(1)(b), 4(2)(a), 4(2)(c) and 4(5) of the Code because of representations about the effects and
properties of Black Salve and comparisons with other goods and treatments
• Sections 4(2)(b) and 5 of the Code because of representations concerning serious or potentially serious
conditions and diseases
• Section 4(2)(d) of the Code because the material may abuse the trust or exploit the lack of knowledge of
consumers or contain language which could bring about fear or distress because of representations about
cancer treatments other than Black Salve, about medicines regulation and about the TGA
• Section 4(1)(b) and 4(2)(c) of the Code because of representations about cancer treatments other than Black
Salve, about medicines regulation and about the TGA

Pursuant to regulation 42ZCAE, the Panel requires you to produce evidence in support of claims made in the
advertisement. Please take this into account when preparing your response. Should you wish to provide suppng
material for any claims challenged, you must provide an explanation as to how the material supports the complaint
,and identify relevant parts in the material. Please provide pivotal evidence to support the efficacy of the product
with respect to the claims subject to complaint. The attached documents may assist you in preparing your response.
You should also provide the following additional information:
As well as responding to the particulars of the complaint as noted above, the Panel requests that you provide the
following:
• The completed Response Form (attached)

• A statement as to whether the subject matter of the complaint is also the subject of legal proceedings that
have not been finally disposed of (regulation 42ZCAJ)
• Ifthe advertised products are included in the Register, the ARTG number and a copy of ARTG entries for
each advertised product
• Any approval that was required for the publication of the advertisement and/or representations within it
You should also be aware of the following matters:
,e Panel must consider a complaint and decide whether the complaint is justified having regard to written
submission and documents given to the Panel, the results of its inquiries and information obtained about the
complaint (regulation 42ZCAD).
After the parties have received a copy of the final written determination of the Panel concerning this complaint, that
determination will be made available to the public on request and will be included on the website
www.tgacrp.com.au under "Complaint Register". Before making the determination public in these ways, the identity
of the complainant will be omitted if the complainant has so requested. Also, any information accepted by the Panel
as confidential will be omitted.
The TGA observer to the Panel apPOinted by the TGA may be entitled to use any information provided to the Panel
(whether confidential or not) pursuant to section 61(8) of the Therapeutic Goods Act.
When the Panel considers the complaint, it may decide to raise other matters. If it does so, you will be notified in
writing and'asked to provide a further response.
101' the complaint is found to be justified, you may be asked to withdraw the advertisement, withdraw certain
. _,:)resentations and not use them in future advertisements, publish corrective information or publish
retraction/so Where the Panel req uests withdrawal of representations, the validity of the representations will not
generally be reconsidered (per Regulation 42ZCAI(1){d)) unless:
• at least 12 months have elapsed since the Panel made its request or
• genuinely new evidence has become available that was not available at the time of the complaint.
Your response must be provided to the Panel no.later than 16 July 2012. Should no response be received, the
Panel may, nevertheless, consider the complaint at its next meeting.
If you do not understand the complaint or are unsure as to how to respond, you may need to seek legal advice or
the advice of a regulatory consultant.
Attached for your information please find a copy of each of the Therapeutic Goods Advertising Code 2007, the
Complaints Resolution Panel procedures and some relevant clauses from the therapeutic goods legislation. The
Code and procedures document also can be found on the website at www.tgacrp.com.au.
Should you require any further information, please let me know.

Yours sincerely
Erne!>( Waldstein
for Judith Brimer, Executive Officer
PO Box 764, North Sydney 2059
(02) 94602796
Enrol at www.tgacc.com.au/eventsforthe 2012 TGACC Advertising Seminar courses:
Fundamentals
Sydney Wed 24 October
Melbourne Thurs 22 November
Perth Fri 27 July
Adelaide Wed 25 July
Brisbane Fri 9 November
Advanced
Sydney Wed 19 September
Melbourne Fri 23 November

)o~.
o J j2
PRIVATE
Person's Personal Representative
For MERYL DOREY
Ernie Waldstein 12
In his Private capacity
Australia
16th July 2012
In Regards: OFFER TO SETTLE IN PRIVATE
Dear Ernie Waldstein
The Person's Personal Representative, after seeking wise council, writes to Ernie Waldstein, today in his
Private capacity and humbly and sincerely apologises for any dishonour he may have caused.
~'he Person's Person&! Representative, in his Inherent Jurisdiction de jure solum ei naturale, conditionally
a~cepts that Ernie Waldstein has made a well pled claim that, Meryl Dorey has advertised and promoted
'Black Salve' and that Leon Pittard has further promoted and advertised 'Black Salve' by publishing the
interview, and offers to settle this matter in private upon Ernie Waldstein in his own private capacity
providing true, correct and complete proof; that .
o Relating a personal condition to anyone constitutes advertising; and that .
o The person making the claim has full knowledge of any fees paid fot any alleged advertising; and
that .
o The right to free speech is not an inherent right; and that

o Any Corporation has the right to sue any individual in their private capacity; and
o The Persons Personal Representative in his Inherent Jurisdiction is not able to settle this matter in
private.
NOTICE
Ernie Waldstein, in his own private capacity, shall have twenty one days (21) from being served to
respond by rebutting all of the above - point for point - or it shall be declared that free speech is still an
inherent right, and the Person's Personal Representative has the proprietary right to settle all outstanding
issues in the private. .
Sincerely
M.D.
Person's Personal Representative

By Accommodation

.I ie Barisic
From: Josie Barisic

Sent: Wednesday, 30 January 2013 2:03 PM I~
To: meryl@avn.org.au
13
Ms Meryl Dorey
Australian Vaccination Network Inc
PO Box 171
BANGALOW NSW 2479
30 January 2013
Dear Ms Dorey
Please find attached a copy of the determination reached by the Complaints Resolution Panel after its
consideration of the above complaint at the meeting of the Panel held on 20 September 2012.
Please note that sub-regulations 42ZCAI(3) and (4) ofthe Therapeutic Goods Regulations 1990 permit the
Panel to make recommendations to the Secretary ofthe Department of Health and Ageing in the event of non
Where a retraction has been requested, please provide a copy of the proposed retraction for the Panel's
approval, before its publication or broadcast. Also subsequently provide a copy ofthe published or broadcast
retraction.
Regulation 9 of the Therapeutic Goods Regulations to enforce compliance with the Panel's
~ntry from the Australian Register of Therapeutic Goods.
investigations.htm
Yours sincerely
Josie Barisic
Theraputic Goods Advertising Code Council and

Ph: 02 9460 2796
Fax: 02 9460 2798
The 2013 TGACC Advertising Seminars:

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- TGA DOCUMENT RELEASE -

EXPOSING MERYL DOREY’S TENUOUS GRIP ON REALITY

Further reading: See Reasonable Hank’s perspective.

Department of Health and Ageing

Therapeutic Goods Administration

FREEDOM OF INFORMATION REQUEST FOI 181-1213

Scope of the FOI request

Material Considered in Decision-Making

PAGE 1 (This page numbering sequence was added by Ken McLeod)

Review and Complaint Rights

Head, Office of Product Review

PAGE 2 (This page numbering sequence was added by Ken McLeod)

The request is for the following:

Schedule of Relevant Documents

PAGE 3 (This page numbering sequence was added by Ken McLeod)

PAGE 4 (This page numbering sequence was added by Ken McLeod)

Panel notification of referral to

PAGE 5 (This page numbering sequence was added by Ken McLeod)

From: Ernie Waldstein

Australian Vacinnation Network, Inc

Complaint 2012/041022 Black Salve

media (Regulation 424CAB). Complaints must be made in writing.

Please find attached a copy of the advertisement and the complaint.

complaint on the basis of the material before It.

You should also provide the following additional Information:

• The completed Response Form (attached)

You should also be aware ofthe following matters:

PAGE 6 (This page numbering sequence was added by Ken McLeod)

Should you require any further information, please let me know.

Please acknowledge receipt of this email.

Enrol at www.tgacc.com.au/events for the 2012 TGACC Advertising Seminar courses:

PAGE 7 (This page numbering sequence was added by Ken McLeod)

C nplaints Resolution Panel

Company name: AlASffeF\LI A' N vA Cc.. fl\)fT TI ~ (\) t£..TvJ~121C

Phone: (0.2.)(0 G:, ~ \ f),. 475 Fax: (0 c2,) ~b ~a IltO,Q

Email ~ddress; e..\\'\ e. • bo.cnV"\~+f:>ne Jt V- \€()G\,.\. COM. QL-\

The products promoted In the advertisement

Product: 6\a.c.k. 'Sa.lve.. ARTG 10; N IPwt

Product ARTG 10:

Produot: .... --_."..

Product: ARTG ID:

Product: ARTG ID:

Complaint Number: 2012/ 0'+ 10;2:2.

PAGE 8 (This page numbering sequence was added by Ken McLeod)

James Fuggle Rummery

SOLICITORS and BARRISTERS

PO Box 95, DX 77IlE-mail: enquiries@jfrlegaLcom.au

PH: (02) 6621 2475 FAX: (02) 6622 1402

Anita Barbara Pty Limited ABN:26101460 833 an incorporated legal practice

Our Ref: EB:8073

Also by facsimile: (02) 9460 2798

RE: MERYL DOREY, AUSTRALIAN VACCINATION NETWORK INC

We act for Meryl Dorey of Austtalian Vaccination Network regarding complaint

We ate seeking an extension of a further 14 days to respond to the complaint to allow

\Ve look forward to hearing from you.

Liability limited by a Scheme approved under Professional Standards legislation rmi',,­

. SOLICITORS and BARRISTERS

PO Box 95, DX 7711 E-mail: enquiries@jfrlegal.com.au

PH: (02)66212475 FAX:'(02) 6622 1402

Anita Barbara Pty Limited ABN:26101460 833 an incorporated legal practice

Our Ref: EB:8073

Also by facsimile: (02) 9460 2798

RE: MERYL DOREY, AUSTRALlAN VACCINATION NETWORK INC

Liability limited by a Scheme approved under Professional Standards legislation rmi',,