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Date of Meeting: 20/09/12
Code: 2012/05/013
Product: Black Salve
Complainant: Requested anonymity
Respondent: Meryl Dorey; Leon Pittard
Finding: Justified
Sections Found Justified: Act sections 42DL(1)(g), 42DM; Code sections 4(1)(b), 4(2)(a), 4(2)(b), 4(2)(c), 4(2)(d), 4(2)(e), 4(2)(g), 4(2)(h), 4(2)(i), 4(5), 4(7), 5, 6(3)
Sections Found Not Justified: None
Action: Publication of a retraction, Withdrawal of representations, Withdrawal of advertisement
Panel Determination:
COMPLAINTS RESOLUTION PANEL DETERMINATION

Complaint 2012-05-013 Black Salve

Meeting held 20 September 2012

 




































Complaint summary^


Complainant


Requested anonymity


Advertisers


Meryl Dorey

Leon Pittard


Subject matter of complaint


Internet advertisement


Type of determination


Final


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


Act sections 42DL(1)(g), 42DM

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


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


None


Sanctions

 


Publication of a retraction

Withdrawal of representations

Withdrawal of advertisement


 

 

 

 

 

 

 

 


* 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 audio material published at the website www.fairdinkumradio.com and viewed by the complainant in May 2012.

2.      It was a matter of dispute whether the material constituted an advertisement. However, the Panel was satisfied that it was an advertisement (see below). The material consisted of spoken words, and appeared in the context of an interview between Leon Pittard and Meryl Dorey.

3.      It included words such as “one of the DVDs that we sell is by Elaine Hollingsworth and it's called One Answer to Cancer. Now Elaine runs a um, a health retreat up on the Gold Coast called Hippocrates Health, and she was almost killed by um, a mainstream cancer treatment called ... um ... I think it’s called Altara (sic), I could have the name wrong, ah it’s been banned in many countries and um, she had skin cancer, was given this treatment, and it almost killed her. And as a result of that experience she found a treatment that's been used for at least two thousand years, called Black Salve. And it's a combination of herbs and um, and minerals that is applied topically to cancer and it... it's called Nature's Scalpel. Now, I've used it myself um, on a cancer that I had on my shoulder and I've gotta tell you it is like a scalpel, it cut it out in a perfect circle. Um, and it got rid of it completely.”

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


The product(s)


5.      The advertisement promoted Black Salve.


The advertiser(s)


6.      The advertisers were Leon Pittard and Meryl Dorey.


The complaint^


7.      The complainant requested anonymity.

8.      The complainant alleged that the material was misleading and that it was “intended to evoke distrust and fear of the Australian therapeutic goods regulator process, and by extension support a latter contention that Aldara is a dangerous medication”, and stated that “the presented notion that the TGA is financially dependent upon drug companies is presented to convey a financial conflict of interest that leads into false comparative advertising. Namely that Aldara as a licenced drug has not been ‘safety tested’ and that TGA regulation of Black Salve and advertising of Black Salve is void.”

9.      The complainant alleged that the material breached sections 4(2)(a), 4(2)(b), 4(2)(c), 4(2)(d), 4(2)(e)(ii), 4(2)(g), 4(2)(h), 4(2)(i), 4(5), 4(7), 5(2), and 6(3) of the Code, and sections 42C, 42DM, 42DO, 42DL and 42DP of the Act.


Additional matters raised by the Panel


10. 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)      Possible breaches of section 42DL(1)(g) of the Act, because the advertisement promotes Black Salve for therapeutic use, when Black Salve may not be included in the Register;

 

b)      Possible breaches of 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;

 

c)      Possible breaches of sections 4(2)(b) and 5 of the Code because of representations concerning serious or potentially serious conditions and diseases;

 

d)      Possible breaches of 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;

 

e)      Possible breaches of 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.


The advertisers’ response to the complaint^


11. The advertisers each responded with a letter purporting to respond to an employee of the Panel’s office “in his private capacity”, using words such as “offer to settle in private”, “the Persons Personal Representative after seeking wise counsel writes to [the employee], today in his Private capacity and humbly and sincerely apologises for any dishonour he may cause”, “the Persons Personal Representative in his Inherent Jurisdiction de jure solum et naturale conditionally accepts that [the employee] 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 [the employee] in his own private capacity providing true, correct and complete proof; that: Relating a personal condition to anyone constitutes advertising; and that the person making the claim has full knowledge of any fees paid for any alleged advertising; and that the right to free speech is not an inherent right; and that any Corporation has the right to sue any individual in their private capacity; and the Persons Personal Representative in his Inherent Jurisdiction is not able to settle this matter in private.”

12. The letters also stated that the employee “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.”

13. The advertisers did not respond to the substance of the complaint.


Findings of the Panel


14. Section 1(3) of the Code states that the Code should be interpreted with an emphasis on the object and the principles of the Code, and the total presentation and context of the advertisement. Section 3(2) of the Code states that the conformity of an advertisement with this Code should be assessed in terms of its probable impact upon the reasonable person to whom the advertisement is directed. In assessing the complaint and the material that was the subject of the complaint, the Panel was mindful not only of the particular words cited by the complainant, but of the entire context of the advertisement and its likely impact on a reasonable consumer.

15. 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.”

16. The Panel was satisfied that at least some of the material in the interview constituted an advertisement as defined in the Act, and that it was an advertisement directed to consumers. This was the material, spoken by Meryl Dorey, in which she stated:

one of the DVDs that we sell is by Elaine Hollingsworth and it's called One Answer to Cancer. Now Elaine runs a um, a health retreat up on the Gold Coast called Hippocrates Health, and she was almost killed by um, a mainstream cancer treatment called ... um ... I think it’s called Altara (sic), I could have the name wrong, ah it’s been banned in many countries and um, she had skin cancer, was given this treatment, and it almost killed her. And as a result of that experience she found a treatment that's been used for at least two thousand years, called Black Salve. And it's a combination of herbs and um, and minerals that is applied topically to cancer and it... it's called Nature's Scalpel. Now, I've used it myself um, on a cancer that I had on my shoulder and I've gotta tell you it is like a scalpel, it cut it out in a perfect circle. Um, and it got rid of it completely.

17. The Panel was satisfied that an ordinary and reasonable consumer hearing this material would regard it as a “statement… intended… directly or indirectly, to promote the use or supply” of “Black Salve”.

18. Moreover, the Panel was satisfied that an ordinary and reasonable consumer hearing this material would regard it as promoting the use or supply of “Black Salve” in preference to the medicine Aldara, as comparing Black Salve with Aldara, as implying that Aldara may be harmful and ineffectual, and as implying the Black Salve is comparable with and superior to Aldara.

19. The Panel was also satisfied that, in this context, the interview material implied that medicines other than Black Salve were permitted to be used in Australia only because Australian regulatory authorities are “totally dependent on the multi-national corporations that they are meant to oversee” and “if they stop licencing the drugs or the vaccines they won't have money to operate”, and that, by implication, medicines other than Black Salve were likely to be harmful or ineffectual.

20. 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.

21. The Panel was satisfied that the advertisement represented Black Salve to be for therapeutic use, including use in the treatment or cure of cancer. The advertisement was therefore an advertisement for therapeutic goods as defined in the Act.

22. 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. The advertisement therefore breached section 42DL(1)(g) of the Act, and the Panel found this aspect of the complaint justified.

23. Section 42C of the Act makes it an offence to publish certain advertisements for therapeutic goods in specified media that do not have an approval number, or to publish an advertisement without its approval number, and through reference to the Regulations, applies to “advertisements for designated therapeutic goods published or inserted, or intended to be published or inserted, for valuable consideration, in specified media.” This provision did not appear to apply to the present complaint because it was published only on the internet. This aspect of the complaint was therefore given no further consideration by the Panel.

24. Sections 42DO and 42DP of the Act relate to generic information about therapeutic goods. Generic information is defined as information “about the composition, properties or other characteristics of therapeutic goods”, but is defined to exclude advertisements about therapeutic goods. The Panel was satisfied that the material that was the subject of the complaint was an advertisement for Black Salve, and was not generic information as defined in the Act. The Panel therefore gave no further consideration to this aspect of the complaint.

25. 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”.

26. The Panel noted that the representations about Black Salve, as well as the representations about other medicines, were of a kind that ought to be supported by a robust and extensive body of evidence if they were to be included in advertisements directed to consumers. The advertisers provided no evidence at all about the representations made in the advertisement.

27. The Panel was satisfied that the advertisement contained representations that had not been verified, were not correct and balanced, were likely to arouse unwarranted and unrealistic 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 Black Salve is a cure or treatment for cancer, that it acts like a scalpel or is comparable to the surgical removal of a cancer, or that it can “get rid of” cancer “completely”, together with the implied representations that other medicines are likely to be ineffectual or harmful.

28. These aspects of the complaint were therefore justified.

29. The Panel did not consider whether more general statements about the TGA or regulatory policy were, or were not, misleading as alleged in the complaint.

30. Section 4(2)(b) of the Code prohibits advertisements that are “likely to lead to consumers self-diagnosing or inappropriately treating potentially serious diseases”. The Panel was satisfied that the advertisement was very likely to lead consumers into self-diagnosing or inappropriately treating potentially serious diseases, namely cancer, both because it encouraged the use of Black Salve for cancer, and because it discouraged the use of other medicines for cancer. This aspect of the complaint was therefore justified.

31. 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, by implying that medicines permitted to be used in Australia were likely to be unsafe, harmful, or ineffectual, the advertisement abused the trust and exploited the lack of knowledge of consumers, and was likely to cause fear or distress. This aspect of the complaint was therefore justified.

32. 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 harmful results could result from a failure to use Black Salve, at least in a context where another medicine was used in the treatment of cancer. This aspect of the complaint was therefore justified.

33. 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”. 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 a certain or sure cure for cancer, and that it implied that Black Salve would be effective in all cases of cancer. In reaching this conclusion the Panel noted the use of words such as “it's called Nature's Scalpel. Now, I've used it myself um, on a cancer that I had on my shoulder and I've gotta tell you it is like a scalpel, it cut it out in a perfect circle. Um, and it got rid of it completely”. These aspects of the complaint were therefore justified.

34. Section 4(2)(i) of the Code prohibits representations that the goods advertised are safe, harmless, or free of side-effects. The Panel was satisfied that the advertisement implied that the advertised Black Salve product was safe and free of side-effects, particularly when compared with other therapeutic goods. This aspect of the complaint was therefore justified.

35. 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.” For reasons similar to those already noted, the Panel was satisfied that the advertisement compared Black Salve with medicines that are permitted to be used in Australia, and implied that those medicines were harmful and ineffectual. The Panel therefore found this aspect of the complaint justified.

36. 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 advertiser provided no evidence that the testimonial material in the advertisement was documented, genuine, illustrative of typical cases only, and not misleading. This aspect of the complaint was therefore found to be justified.

37. 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. The advertisement clearly represented Black Salve to be a treatment or cure for cancer. This aspect of the complaint was therefore justified.

38. 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.

39. Section 42DM(1) of the Act requires advertisements for therapeutic goods to comply with the Code. Because of the breaches already noted, this aspect of the complaint was justified.


Sanctions


40. The Panel requests Meryl Dorey and Leon Pittard, 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, including use in the treatment or cure of cancer, that it can act as “nature’s scalpel” or in a manner comparable to surgical treatment of cancer, or that it is safe or free of side effects, together with the representations conveyed by the testimonials in the advertisement;

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.fairdinkumradio.com 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.

41. 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 29 January 2013

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 homepage of the website www.fairdinkumradio.com at the earliest 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 for Black Salve, which we published on this website, was misleading and abused the trust of consumers, and should not have been published.

 

The advertisement appeared in the context of an interview between Leon Pittard and Meryl Dorey. In the advertisement, we unlawfully made claims that Black Salve is a treatment or cure for cancer, and that it is safe and free of side effects.

 

A complaint about the advertisement was recently upheld by the Complaints Resolution Panel. We provided no evidence 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.

 

Black Salve is corrosive and can destroy large parts of the skin and underlying tissue and leave significant scarring. The attention of consumers is directed to http://www.tga.gov.au/consumers/information-salve-cansema.htm

 

The Panel therefore requested that we publish this retraction.

 

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, black and blue on a white background, per above

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:


180 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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