Complaints Resolution Panel
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  Tuesday 16 September 2014
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Date of Meeting: 16/08/12
Code: 2012/04/022
Product: Black Salve
Complainant: Requested anonymity
Respondent: Australian Vaccination Network
Finding: Justified
Sections Found Justified: Act section 42DL(1)(g); Code sections 4(1)(a), 4(1)(b), 4(2)(a), 4(2)(b), 4(2)(c), 4(2)(d), 4(2)(e)(ii), 4(2)(f), 4(2)(g), 4(2)(h), 4(2)(i), 4(5), 4(7), 5(1), 6(3)
Sections Found Not Justified: Act section 42C; Code sections 4(4), 5(2)
Action: Withdrawal of representations, Withdrawal of advertisement, Publication of a retraction
Panel Determination:
COMPLAINTS RESOLUTION PANEL DETERMINATION

Complaint 2012-04-022 Black Salve

Meeting held 16 August 2012

 




































Complaint summary^


Complainant


Requested anonymity


Advertiser


Australian Vaccination Network


Subject matter of complaint


Website advertisement


Type of determination


Final


Sections of the Code, Regulations or Act found to have been breached*


Act section 42DL(1)(g)

Code sections 4(1)(a), 4(1)(b), 4(2)(a), 4(2)(b), 4(2)(c), 4(2)(d), 4(2)(e)(ii), 4(2)(f), 4(2)(g), 4(2)(h), 4(2)(i), 4(5), 4(7), 5(1), 6(3)


Sections of the Code, Regulations or Act found not to have been breached*


Act section 42C

Code sections 4(4), 5(2)


Sanctions

 


Withdrawal of representations

Withdrawal of advertisement

Publication of a retraction


 

 

 

 

 

 

 

 


* only sections of the Code, Act, or Regulations that were part of the complaint or were raised by the Panel are listed
The advertisement(s)^


1.      The complaint concerned internet advertising published at the website avn.org.au.

2.      The advertisement included representations such as “a dangerous and ineffective drug called Aldara has continued to be used in Australia and overseas despite serious systemic and fatal reactions. In fact, this drug is known to CAUSE cancer!”, “a safe, effective and natural remedy called Black Salve (amongst other names) or ‘nature’s scalpel’ has been used for over 2,000 years to treat skin cancers and other cancerous conditions, leading to a total remission of the disease”, “personal stories of people who have been told they had only months to live, being completely cured by black salve without surgery, chemotherapy, radiation or drugs”, “Elaine’s tale of how she was almost killed by Aldara. Her search to discover the truth about this dreadful poison has brought her into contact with thousands of people from around the world whose lives have been ruined or cut short by Aldara while doctors, government watchdogs and those who were supposed to protect us have put personal profit ahead of morality or their duty of care”, “witness first-hand the reactions to Aldara and the subsequent success stories of Black Salve”, “meet the doctors and natural therapists who brave the wrath of Big Pharma, Big Government and Big Medicine to help people cure their own cancers – sometimes at the cost of their own careers”, “either we or someone we love will have to face the choice of how to treat our illness - using toxic drugs or safe, effective, time-tested natural remedies”, and other claims.

3.      An excerpt of the advertisement can be viewed in the relevant Appendix to this determination.


The product(s)


4.      The advertisement promoted the product Black Salve, and a DVD entitled “One Answer to Cancer”.


The advertiser(s)


5.      The advertiser was the Australian Vaccination Network.


The complaint^


6.      The complainant requested anonymity.

7.      The complainant alleged that the advertisement breached sections 42DL(1)(g) and 42C 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)(ii), 4(2)(f), 4(2)(g), 4(2)(h), 4(2)(i), 4(4), 4(5), 4(7), 5(2), and 6(3) of the Code.


Additional matters raised by the Panel


8.      Under sub-regulation 42ZCAH(1), the Panel is empowered to raise matters other than those specified in the complaint, where the Panel is satisfied that the advertisement to which the complaint relates contains matter that is not mentioned in the complaint, which may contravene the Act, Regulations, or the Code in other ways. The Panel was so satisfied and raised the following additional matters:

 

a)      A possible breach of section 42DL(1)(g) of the Act, because the advertised product may not be included in the Australian Register of Therapeutic Goods;

 

b)      A possible breach of section 5(1) of the Code because of representations about cancer.


The advertiser’s response to the complaint^


9.      Through legal counsel, the advertiser stated that they had withdrawn the DVD from sale.

10. The advertiser conceded that the advertisement breached section 42DL(1)(g) of the Act and sections 4(1)(a), 4(2)(d), 4(2)(g), 4(2)(i), and 4(5) of the Code. The advertiser stated that the alleged breaches of section 4(1)(b), 4(2)(a), 4(2)(b) and 4(2)(c) had not been breached, and were “a matter for scientific and medical opinion, however, the AVN are not currently in a position to furnish such evidence”.

11. The advertiser denied that any of the other alleged or possible breaches had occurred.


Findings of the Panel


12. An advertisement for therapeutic goods is defined in the Act to include “any statement, pictorial representation or design, however made, that is intended, whether directly or indirectly, to promote the use or supply of the goods.”

13. The Panel was satisfied that the advertisement promoted both the “One Answer to Cancer” DVD, and the medicine “Black Salve”.

14. Therapeutic goods are defined in the Act to include goods that are represented in any way to be for therapeutic use. Therapeutic use is defined to include use in or in connection with preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons, or influencing, inhibiting, or modifying a physiological process in persons.

15. The Black Salve product was clearly represented to be for therapeutic use and the advertisement was therefore an advertisement for therapeutic goods as defined in the Act.

16. Section 42DL(1)(g) of the Act prohibits the publication of advertisements for therapeutic goods that are not included in the Register. The advertised Black Salve product is not included in the Register, and the advertisement, therefore, breached section 42DL(1)(g) of the Act. The Panel found this aspect of the complaint justified.

17. Section 42C of the Act outlines the preapproval requirements for certain advertisements in ‘specified media’. Section 5BA of the Regulations allows for the exclusion of internet advertisements from the requirement of approval. Therefore the Panel found that this aspect of the complaint was not justified.

18. Section 4(1)(b) of the Code requires that advertisements for therapeutic goods “contain correct and balanced statements only and claims which the sponsor has already verified.” Section 4(2)(a) of the Code prohibits representations that are “likely to arouse unwarranted and unrealistic expectations of product effectiveness”. Section 4(2)(c) of the Code prohibits representations that “mislead directly or by implication or through emphasis, comparisons, contrasts or omissions”.

19. The Panel noted that the representations about Black Salve contained in the advertisement were strong, and ought to have been supported by a robust and extensive range of evidence material. The advertiser provided no evidence at all in relation to the advertisement.

20. In the absence of any evidence from the advertiser, the Panel was satisfied that the advertisement contained many representations that had not been verified, were not correct and balanced, were likely to arouse unwarranted expectations, and were misleading in breach of sections 4(1)(b), 4(2)(a), and 4(2)(c) of the Code. These included the representations that the advertised Black Salve product was “a safe, effective and natural remedy”, could be regarded as “‘nature’s scalpel’”, has benefits in relation to “skin cancers and other cancerous conditions”, can cause a total remission of cancer, offers a complete cure to cancer. These aspects of the complaint were therefore justified.

21. Section 4(2)(b) of the Code prohibits advertisements that are “likely to lead to consumers self-diagnosing or inappropriately treating potentially serious diseases”. Section 5(1) of the Code prohibits advertisements that “contain, expressly or by implication, a representation specified in Part 1 of Appendix 6.” The representations specified in Part 1 of Appendix 6 of the Code include representations regarding the treatment, cure, or prevention of neoplastic diseases. Section 5(2) of the Code prohibits advertisements that “refer, expressly or by implication, to serious forms of diseases, conditions, ailments or defects specified in Part 2 of Appendix 6, unless prior approval is given under the Therapeutic Goods Act 1989.” The diseases and conditions specified in Part 2 of Appendix 6 of the Code include “serious forms of” a wide range of health concerns.

22. The advertisement clearly represented the advertised Black Salve product to be for use in the treatment of cancer, and to enable people to “cure their own cancers”. The Panel was satisfied that the advertisement was therefore likely to lead to consumers self-diagnosing or inappropriately treating potentially serious diseases, and that contained representations about treating and curing neoplastic diseases (including skin cancer, a serious form of a skin disease), in breach of sections 4(2)(b) and 5(1) [not section 5(2) as alleged by the complainant] of the Code. These aspects of the complaint were therefore justified.

23. Section 4(2)(d) of the Code prohibits advertisements which “abuse the trust or exploit the lack of knowledge of consumers or contain language which could bring about fear or distress.” The Panel was satisfied that the advertisement was very likely to cause fear or distress in consumers, because of representations that cancer treatment Aldara is likely to cause cancer and is likely to cut short or ruin lives and that “doctors, government watchdogs, and those who [are] supposed to protect us have put personal profit ahead of morality or their duty of care”. Moreover, the Panel was satisfied that the advertisement abused the trust and exploited the lack of knowledge of consumers because of the misleading and unverified representations already noted. This aspect of the complaint was therefore justified.

24. Section 4(2)(e)(ii) of the Code prohibits representations that are likely to lead persons to believe that harmful consequences may result from advertised products not being used. The Panel was satisfied that the advertisement implied that consumers who did not use the advertised Black Salve product would suffer very harmful consequences, if they chose instead to undergo conventional cancer treatment. This aspect of the complaint was therefore justified.

25. Section 4(2)(f) of the Code prohibits representations that “encourage inappropriate or excessive use” of therapeutic goods. The Panel was satisfied that use of the Black Salve product in the treatment of cancer as promoted in the advertisement would constitute inappropriate use. This aspect of the complaint was therefore justified.

26. Section 4(2)(g) of the Code prohibits representations that therapeutic goods are “infallible, unfailing, magical, miraculous”, or that they are “a certain, guaranteed or sure cure”. The Panel was satisfied that the advertisement represented the advertised Black Salve product to be invariably effective and to constitute a sure cure for cancer. The Panel therefore found that this aspect of the complaint was justified.

27. Section 4(2)(h) of the Code prohibits advertisements for therapeutic goods that “contain any claim, statement or implication that it is effective in all cases of a condition”. The Panel was satisfied that the advertisement represented the advertised Black Salve product to be effective in all cases of skin cancer and other cancerous conditions. This aspect of the complaint was therefore justified

28. Section 4(2)(i) of the Code prohibits representations that the goods advertised are safe, harmless, or free of side-effects. The advertisement clearly represented the advertised Black Salve product to be “safe” without qualification. This aspect of the complaint was therefore justified.

29. Section 4(4) of the Code requires scientific information to be “presented in a manner that is accurate, balanced and not misleading”, and requires that publication of scientific research results should “identify the researcher and financial sponsor of the research.” The Panel did not find the advertisement to contain scientific information. The Panel therefore found that this aspect of the complaint was not justified.

30. Section 4(5) of the Code requires that comparisons made in advertisements must be balanced and must not be misleading or likely to be misleading, and prohibits the inclusion in advertisements of comparisons that “imply that the therapeutic goods, or classes of therapeutic goods, with which comparison is made, are harmful or ineffectual.” The advertisement clearly stated that medicines with which the advertised Black Salve product was compared were harmful and ineffectual. Moreover, the advertiser provided no evidence that the advertised Black Salve product was comparatively effective in the way that the advertisement implied. The Panel therefore found this aspect of the complaint justified.

31. Section 4(7) of the Code requires that testimonials included in advertisements for therapeutic goods “must be documented, genuine, not misleading and illustrate typical cases only.” The Panel noted the argument of the advertiser that the advertisement did not contain any testimonials. However, the Panel was satisfied that the words “Elaine’s tale of how she was almost killed by Aldara. Her search to discover the truth about this dreadful poison has brought her into contact with thousands of people from around the world whose lives have been ruined or cut short by Aldara while doctors, government watchdogs and those who were supposed to protect us have put personal profit ahead of morality or their duty of care” constituted a testimonial, albeit one that was expressed in the grammatical third person. The Panel was satisfied that this testimonial was misleading, and was not satisfied that it was documented, genuine, and illustrative of typical cases only. This aspect of the complaint was therefore justified.

32. The advertisement ought to have included the words “always read the label” (section 6(3)(c) of the Code), and the words “use only as directed” and “if symptoms persist see your doctor/healthcare professional” (section 6(3)(d) of the Code). The advertisement did not include these mandatory statements. These aspects of the complaint were therefore justified.

33. Section 4(1)(a) of the Code requires advertisements for therapeutic goods to comply with the statute and common law of the Commonwealth, States and Territories. Because of the breaches already noted, this aspect of the complaint was justified.


Sanctions


34. The Panel requests the Australian Vaccination Network, in accordance with subregulation 42ZCAI(1) of the Therapeutic Goods Regulations 1990:

a)      to withdraw the advertisement from further publication;

b)      to withdraw any representations that the advertised Black Salve product is for any therapeutic use, is safe or free of side effects, or offers any benefits in relation to cancer (including skin cancer), together with any representations that compare Black Salve with cancer medicines or imply that cancer medicines are harmful or ineffective;

c)      not to use the representations in (b) above in any other advertisement*;

d)      where the representation has been provided to other parties such as retailers or website publishers, and where there is a reasonable likelihood that the representation has been published or is intended to be published by such parties, to advise those parties that the representation(s) should be withdrawn;

e)      to arrange for publication on the website www.avn.org.au of a retraction in the form of, and in accordance with, the conditions set out in the attachment to this determination; and,

f)        within 14 days of being notified of this request, to provide evidence to the Panel of its compliance, including a response in writing that they will comply with the Panel’s sanctions, and where appropriate, supporting material such as copies of instructions to advertising agents or publishers, or correspondence with retailers and other third party advertisers.

35. The advertiser’s attention is drawn to the provisions of sub-regulations 42ZCAI(3) and (4) which permit the Panel to make recommendations to the Secretary in the event of non-compliance with this request.

 

Dated 3 December 2012

For the Panel

 

Jason Korke

Chairman




Appendix A:       Definitions and footnotes


In this determination, unless otherwise specified:

a)      “the Act” means the Therapeutic Goods Act 1989;

b)      “the Regulations” means the Therapeutic Goods Regulations 1990;

c)      “the Code” means the Therapeutic Goods Advertising Code;

d)      “the Register” means the Australian Register of Therapeutic Goods;

e)      “any other advertisement” appearing in sub-regulation 42ZCA1(1)(d) is not confined to advertisements in specified or broadcast media (in relation to which complaints may be made to the Panel under Regulation 42ZCAB). It should be noted that HTML metatags and other information which can be retrieved by internet search engines, whether or not it is ordinarily viewed directly by consumers, constitutes advertisement material.

 

^Readers of the determination should note that the sections “complaint summary”, “the advertisement(s)”, “the complaint”, and “[a party]’s response to the complaint”, are summaries that are intended to aid readers of this document. In reaching its decision, the Panel considered all of the material before it, including material that may not be mentioned specifically in the summaries. The summaries do not form part of the Panel’s reasoning.

*Under regulation 42ZCAI of the Regulations, the Panel may request that a representation not be used in any other advertisement unless the advertiser satisfies the Panel that the use of the representation would not result in a contravention of the Therapeutic Goods Act 1989, the Therapeutic Goods Regulations 1990 or the Therapeutic Goods Advertising Code. Under the Panel’s procedures, the Panel will not ordinarily give additional consideration to such a matter unless significant new material that was not available at the time of the Panel’s determination has become available, or until at least 12 months have passed since the Panel’s request was made.




Appendix B:       Retraction


 

An advertisement is to appear on the website www.avn.org.au at the earliest booking opportunity.

 

A copy of the retraction advertisement, and the page on which it will be published, is to be provided to the Complaints Resolution Panel for approval before publication.

 








 

RETRACTION

 

An advertisement promoting illegal therapeutic goods under the name “Black Salve”, which we published on this website, should not have been published. In publishing the advertisement, we misled and abused the trust of consumers.

 

In the advertisement we unlawfully made claims that Black Salve is safe, and that it can be used as an effective treatment for cancers including skin cancer. We also claimed that cancer medicines are harmful and cause cancer, and are ineffectual.

 

A complaint about the advertisement was recently upheld by the Complaints Resolution Panel. We provided no evidence whatsoever to support the claims we made, and the Panel found that the claims were unlawful, misleading, and unverified and breached the Therapeutic Goods Advertising Code.

 

The Panel therefore requested that Australian Vaccination Network publish this retraction.

 

The attention of consumers is directed to this information from the Therapeutic Goods Administration: http://www.tga.gov.au/consumers/information-salve-cansema.htm

 

The full text of the Panel’s determination can be found at: www.tgacrp.com.au/complaints

 


 

No other copy should be included in the advertisement.

 

































Location:


website front page, so that it can be viewed without scrolling the page


Size:


No less than 500 pixels wide and 200 pixels high


Heading:

 


Arial or Helvetica

Red on a white background

The letters should be no less than 20 pixels in height, and should be no smaller than any other body text on the page

Bold


Text:


Arial or Helvetica

Red on a white background

The letters should be no less than 14 pixels in height, and should be no smaller than any other body text on the page

Bold


Text Box:


Red on a white background


Duration:


365 days


HTML


In the case of website retractions, the retraction is to be presented in ordinary and valid HTML 4 in the body of the page. Pop-ups, Flash objects, or images are not acceptable formats for website retractions.



Appendix C:       Excerpt of the Advertisement


 

 

 
Advertisement Copy: Download

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