Diluted Thinking

in Australian healthcare

AVSN: Black Salve - TGA

Black Salve

image: One Answer to Cancer
DVD
One Answer to Cancer DVD
Black salve (also known as Cansema) is an increasingly popular alternative cancer treatment which is applied topically. Proponents believe black salve draws all the cancer cells to the primary cancer site where it then destroys the cancerous cells, leaving normal tissue unharmed. Unfortunately, black salve can make no such distinction between normal and cancerous tissue and application of black salve has resulted in significant scarring and disfigurement, not to mention the associated risks for those patients who also rejected science-based treatments.

One of the most ardent supporters of black salve is Elaine Hollingsworth, who produced a DVD entitled One Answer to Cancer. This DVD looks at the alleged dangers of a drug called Aldara and promotes the use of black salve as a safe and effective cancer treatment. It also contains instructions on how to make your own black salve.

A Warning from the Therapeutic Goods Administration

On 19 March 2012, the Therapeutic Goods Administration (TGA) issued the following safety alert Black and red salves in treating cancer. Here are some excerpts:
"The TGA is advising consumers not to purchase or use unproven products that claim to cure or treat cancer, including certain types of skin cancer.

The recent use of products marketed as containing 'Black salve' in Australia has resulted in serious harm to the skin of three Australian consumers who used the black salves for various skin conditions including the treatment of a skin cancer.

The TGA is not aware of any credible, scientific evidence which shows that any black or red salve preparation is effective in treating cancer.

These types of salves have not been formally assessed by the TGA and are not included in the Australian Register of Therapeutic Goods or exempted from inclusion. All therapeutic goods, including those used for treating cancer, must be included in the Register unless exempted. Penalties of up to $5.5m apply to the illegal importation or supply of therapeutic goods.

Patients and consumers are urged to discuss with their doctor or clinical specialist the use of appropriate medicines that are included on the Register for the treatment of cancer."

"The TGA strongly advises consumers and patients against purchasing or using black or red salves.

Both black and red salves are corrosive and essentially burn off layers of the skin and surrounding normal tissue. They can destroy large parts of the skin and underlying tissue, and leave significant scarring.

In addition to the TGA warning about the purchase and use of black and red salves, the TGA is also investigating the supply in Australia of products containing black and red salves.

Further, a complaint about the advertising of 'Black Salve' on certain Australian Internet sites is currently under consideration by the Complaints Resolution Panel."

The TGA has a committee called the Complaints Resolution Panel (CRP) which can receive and consider complaints about therapeutic goods advertisements directed to consumers.

AVSN: Complaints Resolution Panel 2012/04/022

In May 2012, an anonymous complaint was submitted to the CRP about the AVSN selling Hollingsworth's DVD One Answer to Cancer in their online shop.

The CRP considered the complaint and their determination, dated 3 December 2012, may be viewed online at CRP 2012/04/022.

The following is an excerpt of the advertisement investigated by the CRP:

image: excerpt of AVN shop
advertisement for black salve DVD
One Answer to Cancer DVD - AVN online shop
  • Why 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!
  • How 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.

"This DVD should be viewed by ALL Australians. Statistically speaking 50% of us will face cancer in our own lives at one time or another. That means that 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. I feel that Elaine's work will be life-changing and indeed life-saving for many. If you or someone you know is facing this issue or if you just want to be prepared for any future cancer diagnoses, this will be the best $25 you have ever spent!" Meryl Dorey, Australian Vaccination Network


The CRP found that 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.

On 15 May, as per an order from the TGA, the AVSN withdrew the DVD from sale in their online shop. However, the DVD's page, complete with the advertisement and a rant about the TGA, remained online. Meryl Dorey made the following statement to the AVSN Facebook page on 15 May 2012:

"If anyone would like to buy one of the last copies of the DVD, One Answer to Cancer that the AVN has in stock, please call us on 02 6687 1699 during business hours. The TGA can stop us from listing it on our website, but they haven't yet stopped us from carrying or selling it full stop. Book burning, anyone?"
MD

By June 2012, the AVSN had removed the "advertising" quoted earlier from the DVD's page in their online shop. As of 15 February 2013, the AVSN shop still carries a listing for the One Answer to Cancer DVD.

The Panel applied the following sanctions:

The Panel requests the Australian Vaccination Network, in accordance with subregulation 42ZCAI(1) of the Therapeutic Goods Regulations 1990:
  1. to withdraw the advertisement from further publication;
  2. 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;
  3. not to use the representations in (b) above in any other advertisement*;
  4. 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;
  5. 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,
  6. 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\u2019s 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.

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

The following is the retraction that the AVSN is required to publish on the front page of the AVSN website, in a position that could be viewed without scrolling, for a period of 365 days. Tthis retraction has never been published.

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

Meryl Dorey: Complaints Resolution Panel 2012/05/013

In an interview conducted on 5 May 2012 by Leon Pittard that aired on Fairdinkum Radio, Meryl Dorey said the following about black salve:
"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."

In May 2012, an anonymous complainant submitted a complaint to the CRP. The Panel's determination, dated 29 January 2013, may be viewed online at CRP 2012/05/013.

According to the published determination, the advertisers' responded to the complaint as follows:

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.

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.

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".

If you would like to see part of Meryl Dorey's submission to the TGA, please read Meryl Dorey goes all Freeman-On-The Land-Ish by the wonderful Shellity.

The Panel applied the following sanctions:

The Panel requests Meryl Dorey and Leon Pittard, in accordance with subregulation 42ZCAI(1) of the Therapeutic Goods Regulations 1990:
  1. to withdraw the advertisement from further publication;
  2. 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;
  3. not to use the representations in (b) above in any other advertisement*;
  4. 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;
  5. 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,
  6. 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\u2019s 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.
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

The CRP ordered that the following retraction is to appear on the front page of the website www.fairdinkumradio.com so that it can be viewed without scrolling the page, at the earliest opportunity. As of 16 February 2013, it has not been published.

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