document release exposes meryl dorey's tenuous grip on reality

- TGA DOCUMENT RELEASE -

EXPOSING MERYL DOREYS 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 Doreys 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 Hanks 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 ofyour 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 ofprocessing 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 ofmy decision to waive any further charges (in excess ofthe deposit paid) associated with the processing ofyour 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 ofyour 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 [email protected] VVWW. tga,goV.d II Regulation

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 ofcharges 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 ofyour request, thus you are not required to pay any further charges and the documents can be released to you immediately.

Review and Complaint Rights Ifyou 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 ofyour 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 ofProduct Review Therapeutic Goods Administration

2- May2013

2

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..

Solicitors Panel response to complaint

5 2013/002066 27 Complaints Resolution Panel

James Fuggle Rummery Solicitors

29 May 2012 Email - Complaints Resolution Panel reply to first response

1 Release in full

6

7

2013/002066

20131002066

30-31

41


Complaints Resolution Panel


Australian Vaccination Network

5 June 2012

4 December 2012

Letter - Advertisers full response to complaint

Email - Complaints Resolution Panel notification of determination - advertiser

2

1

Release in full

Release in full

8 2013/002066 42 Complaints Resolution Panel


4 December 2012

Email - Complaints Resolution Panel notification of determination advertisers representative

1 Release in full

9 2013/002066 43 James Fuggle Rummery Solicitors


5 December 2012

Email - Read confirmation -advertisers representative

1 Release in full

10 2013/002066 49-52 Complaints Resolution Panel


18 February 2013

Email - Complaints Resolution Panel notification of referral to TGA

4 Release in full

11 2013/002066 88-90 Complaints Resolution Panel


2 July 2012 Email - Complaints Resolution Panel notification of complaint

3 Release in full

12 2013/002066 109 Meryl Dorey Australian Vaccination Network


16 July 2012 Letter to CRP - Offer to settle in private

1 Release in full

FOI 181-1213

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

TGA

FOI 181-1213

Ernie Waldstein

From: Ernie Waldstein Sent: Monday, 30 April 2012 2:25 PM To: '[email protected]' 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

KenText Box1

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

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;61 2 66221402 # 105-06-12;14:42 ;

C nplaints Resolution Panel Response Form for Advertisers Uu this kJrm to submit oompJaltttslJiboul advertisl'lmfHIls lar therapeutic good&

I

I

.........-,.

Contact Information Fletlse provide wrrent conlad Jnforfllatkm. For lndlvIduBlsl p/fAa$e $f(tte yOUI' namfllJndf;r "oompany name. {(you alii inlding undM ab/J$lnes8 n81'M Q/l!Jase show both your indillJdoo/ name omd the ~slrleBIf name. I

Company name: AlASffeF\LI A' N vACc.. fl\)fTTI ~ (\) t..TvJ~121C ABN/ACN: 3007700 ~9 2.~ Address: C/- 0-A-M~S f4A CiG.Le: RV.(VltYl f:R ~ ,5) L.\;C' T QR S

Po COx.. 1~ k\SvY1b1ZE:" NSIr-J aLt~0

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. Iftho tmduet i$ on the ARm. IncllJdB 1M ARMl;JenriMna nt.IrtIIW.

ARTG 10; N IPwtProduct: 6\a.c.k. 'Sa.lve.. ARTGID:

Product:

Produot:

ARTG 10:

Product: ARTGID:i

Product ARTG 10:

Product ARTG 10:

Product: ARTG ID:

.. ART(lIO~..........Produot: " ............. .... --_."..

ARTG ID:

Product:

Product:

ARTG ID:

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

KenText Box2

James Fuggle Rummery

SOLICITORS and BARRISTERS

Level I, 73 Magellan Street, Lismore NSW 2480

PO Box 95, DX 77IlE-mail: [email protected]

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

IlJ)Judith Brimer Executive Officer Complaints Resolution panel POBox 764 NORTH SYDNEY NSW 2059

Also by facsimile: (02) 9460 2798

Dear Madam

RE: MERYL DOREY, AUSTRALIAN VACCINATION NETWORKINC 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.

[email protected]

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

KenText Box3

JAMES FUGGLE RUMMERY tJrj ~,

)


. SOLICITORS and BARRISTERS

Levell, 73 Magellan Street, Lismore NSW 2480

PO Box 95, DX 7711 E-mail: [email protected]

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 Complaints Resolution panel PO Box 764 NORTH SYDNEY NSW 2059


Dear Madarn

RE: MERYL DOREY, AUSTRALlAN VACCINATION NETWORK INC COMPLAINT 2012/04/022

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 A VN, Ms Dorey and the

'-'U'L.u.~J.l4J.llU) Resolution Panel

We look forward to hearing from you.

Yours faithfully

Liability limited by a Scheme approved under Professional Standards legislation ~"-

KenText Box4

Judith Brimer

From: Judith Brimer Sent: Tuesday, 29 May 2012 11 :35 AM To: '[email protected]' 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 Complaints Resolution Panel Tel: 0294602796 Fax: 02 9460 2798

The 2012 TGACC Advertising Seminars:

Enrol at www.tgacc.com.au/events

1

KenText Box5


SOLICITORS and BARRISTERS

Levell, 73 Magellan Street, Lismore NSW 2480

PO Box 95, DX 7711 E-mail: [email protected]

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

Complaints Resolution panel

POBox: 764

NORTH SYDNEY NSW 2059


Dear Madam

RE: MERYL DOREY, AUSTRALIAN VACCINATION NETWORK INC

COMPLAINT 2012/04/022

We refer to the abovementioned matter.


In relation to the A VN, 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 A VN 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'-.....

KenText Box6

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 ~"-

7

tl Josie Barisic

From: Josie Barisic Sent: Tuesday, 4 December 2012 2:03 PM To: '[email protected]' Subject: Complaint 2012/04/042 Black Salve 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 noncompliance 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/complaintinvestigations.htm

Yours Sincerely

Josie Barisic on behalf of Judith Brimer, Executive Officer

The rap utit Goods Advertising Code Council and Complaints Resolution Panel 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

1

KenText Box7

Josie Barisic

From: Josie Barisic

Sent: Tuesday, 4 December 20122:25 PM

To: '[email protected]'

Subject: Complaint 2012/04/022 Black Salve

Attachments: CRP 2012-04-022 Black Salve.pdf

Ms Ellen Barrington


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~ compliance with this determination.

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.

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

"'egulation 9 of the 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

entry from the Australian Register of Therapeutic Goods.


Yours sincerely


Theraputic Goods Advertising Code Council and Complaints Resolution Panel 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

KenText Box8

Josie Barisic

From: To: Sent: Subject:

Ellie Barrington Josie Barisic Wednesday,S December 2012 11:48 AM Read: Complaint 2012/04/022 Black Salve

Your message

To: Subject: Complaint 2012/04/022 Black Salve 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.

1

KenText Box9

Judith Brimer

From: Judith Brimer 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 Complaints Resolution Panel Tel: 02 94602796 Fax: 02 9460 2798

From: Ellie Barrington [mailto:[email protected]] 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: [email protected] Ph: (02) 6621 2475, Fax: (02) 6622 1402

Liability Limited by a scheme approved under Professional Standards Legislation.

1

KenText Box10

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:[email protected]]

Sent: Thursday, 14 February 2013 12:16 PM

To; Ellie Barrington

Subject: Complaint 2012/04/022 Black Salve

14 February 2013

Dear Sirs}

Complaint 2012/04/022 Black Salve

'Irite 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 Complaints Resolution Panel 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 Melbourne: Fri 10 May, Thurs 28 November Adelaide: Mon 8 July Perth: Fri 2 August Advanced Sydney: Wed 17 April, Wed 18 September Brisbane: Fri 8 November Melbourne: Fri 29 November

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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; [email protected],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\JStCo /7 J12

Ern .Waldstein

Ernie WaldsteinFrom: Monday, 2 July 2012 4:28 PMSent: [email protected]:

Subject: Complaint 2012/05/013 Black Salve 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

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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.

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Yours sincerely

Erne!>( Waldstein for Judith Brimer, Executive Officer Complaints Resolution Panel 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

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PRIVATE Person's Personal Representative

For MERYL DOREY

Ernie Waldstein 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 ofany 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

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.I ie Barisic

From: Josie Barisic Sent: Wednesday, 30 January 2013 2:03 PM I~

To: [email protected] Subject: Complaint 2012/05/013 Black Salve Attachments: CRP 2012-05-013 Black Salve.pdf

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 noncompliance with this determination.

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.

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 of the 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.


Yours sincerely


Theraputic Goods Advertising Code Council and Complaints Resolution Panel Ph: 02 9460 2796 Fax: 02 9460 2798

The 2013 TGACC Advertising Seminars:


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