19 May 2013

Magic Salves and Consumer Protection

Posts in this blog have noted concerns - eg here and here - regarding the NSW AntiVaccination Network (AVN), a small group of people whose enthusiasm seems to be inversely proportional to their grasp of hard science and who  - in my opinion - are somewhat indifferent to the harm potentially caused by their hostility to vaccination.

The AVN site is full of treats. It features a statement by controversial vitamin entrepreneur Matthias Rath and what a skeptic might consider to be other absurdities. Apparently the 1939-45 War was attributable to drug and oil cartels, Mr Hitler being much less important than the evil vendors of conventional medicine. (One of Rath's sites helpfully explains that "Wikipedia is a modern day propaganda tool for the status quo, namely the Oil and Drug Cartel" and that Jimmy Wales & Co are simply front men for the forces of darkness. Oh dear!)

Presumably it is an advance that in 2013 we are apparently relying on Big Pharma for causation rather than relying on the Illuminati, the Jesuits, the Bogomils, the Templars, women who take black cats for joyrides on broomsticks, the Rothschilds and other folk devils who have been blamed for revolutions, droughts, floods, earthquakes, financial panics, sour milk and toast falling butter-side down over the past 2,000 years!

The site has also featured an advertisement for a "safe, effective, natural" 'black salve' that supposedly has useful properties regarding the treatment of cancer and has been "used for over 2,000 years".

Given the irreverence of this post I will confine myself to noting that 'natural' is not the therapeutic be all and end all. Arsenic, lead, thallium, cobra venom and the toxins of the red back spider or blue-ringed octopus are all definitely quite 'natural' but generally less beneficial than the 'unnatural' vaccines that have saved millions of lives over the past century. Deadly nightshade, water hemlock, aconite and oleander are oh so very natural but perhaps not what you'd want mixed in with your muesli or forming part of the salad. These days we have a better way of ending an unhappy relationship: reach for the Family Law Act 1975 (Cth) rather than the poisoner's handbook or old wives' pharmacopeia!

The salve advertisement has attracted the attention of health advocates and resulted in action by the TGA, which has now issued a mandatory take-down notice under the Therapeutic Goods Regulations 1990 and associated Therapeutics Goods Advertising Code. That action is of interest for Australian competition/consumer law and health law students.

The notice includes the statement that
The Advertiser was not able to produce valid supporting evidence in relation to their claims, nor was there any referenced or highlighted medical evidence in the advertisement to support the representations. The advertisement promoted 'black salve' as a 'safe, effective, natural remedy ... used for over 2,000 years to treat skin cancers and other cancerous conditions, leading to a total remission of the disease.' The Delegate considered that, based on these statements, consumers would be entitled to expect that 'black salve' will cure them of cancer when, in fact, there is no credible, reliable clinical or scientific evidence to demonstrate that the product is effective in the treatment of any cancer. The Delegate found the advertisement was unverified, was not correct and raised unrealistic and unwarranted expectations of product effectiveness therefore in breach of sections 4(1)(b) and 4(2)(a) of the Code.
Breach of sections 4(2)(b) and 4(2)(c) of the Code
The 'black salve' product was advertised both as a cure for cancer and as a legitimate alternative to 'Aldara' a conventional medicine. It was the Delegate's view that this comparison could mislead consumers into incorrectly believing that 'black salve' was a natural safe alternative which was more effective than conventional medicines and that the advertisement sought to give credibility to 'black salve' over clinically proven alternatives. The Delegate considered that statements made in the advertisement could lead to consumers inappropriately relying on 'black salve' to treat skin cancer to the exclusion of clinically proven conventional medicine and that the suggestion that 'black salve' will 'help people cure their own cancers' may lead to self-diagnosis and a failure to seek out proper medical attention for a potentially fatal disease. The Delegate found the advertisement was likely to lead to inappropriate treatment of a potentially serious disease and was misleading, therefore in breach of sections 4(2)(b) and 4(2)(c) of the Code.
Breach of sections 4(2)(d) and 4(2)(e) of the Code
It was the Delegate's view that the advertisement portrayed 'black salve' as a cure for cancer which would exploit a person's vulnerability when seeking an alternative to conventional cancer treatments, especially without diagnosis. The advertisement used language that, in the Delegate's view, would bring about fear or distress by making people fearful of the consequences if they did not use 'black salve' or, alternatively, if they relied on conventional medicine for treatment. The Delegate also found that promoting 'black salve' as a guaranteed safe alternative exploited the lack of knowledge that consumers have about the treatment of cancer and the different treatment modalities that may be required depending on the type of cancer diagnosis. For these reasons the Delegate considered that the advertisement breached sections 4(2)(d) and 4(2)(e) of the Code.
Breach of section 4(2)(f) of the Code
It was the Delegate's opinion that it would be inappropriate for consumers to rely on 'black salve' as a treatment for cancer (diagnosed or not) in preference to, or to the exclusion of, other conventional treatments. As there were no instructions surrounding the use of 'black salve' in the advertisement it was the Delegate's view that misdiagnosis by a consumer would cause greater harm to themselves and that by not seeking appropriate medical help, incorrect application of "black salve" could cause extensive, irreparable damage to their skin. The Delegate found the advertisement was likely to encourage inappropriate or excessive use of the product and therefore was in breach of section 4(2)(f) of the Code.
Breach of sections 4(2)(g) and 4(2)(h) of the Code
The Delegate found that the advertisement encouraged those consumers who may have eschewed conventional medical practice and who were seeking alternative curative measures to use the 'black salve' product. In the absence of any information to the contrary the use of the phrase 'total remission' was in the Delegate's view representing this product as a guaranteed treatment for cancer and that it would be effective in all cases, and was therefore in breach of sections 4(2)(g) and 4(2)(h) of the Code.
Breach of section 4(2)(i) of the Code
The advertisement promoted 'black salve' as a 'safe, effective, natural remedy' and that it was 'time-tested'. The advertisement does not mention that 'black salve' can cause harm or has any side effects, nor did it advise the consumer that 'black salve' can burn the skin (which may require medical attention) and can cause permanent scarring. The Delegate found therefore the advertisement to be in breach of section 4(2)(i) of the Code because it promoted the product as safe, without side effects and that no harm could come from its use.
Breach of section 4(5) of the Code
The advertisement compared 'black salve' with an 'S4' 'Prescription Only' medicine Aldara, stating that Aldara was 'dangerous and ineffective', that it caused 'serious systemic and fatal reactions' and was 'known to CAUSE cancer'. The advertisement stated that the author of the DVD entitled 'One Answer to Cancer' was 'almost killed by Aldara' which is a 'dreadful poison' that has 'ruined or cut (lives) short'. This promotion of 'black salve' was in the Delegate's view, misleading in comparison with the recognised conventional medicine Aldara because it stated that it was both harmful and ineffective in comparison with "black salve" and the advertisement therefore was in breach of section 4(5) of the Code.
The AVN site is accordingly to prominently feature the following 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 (Code).
The full text of the Panel's determination can be found at: www.tgacrp.com.au/complaints
The delegate of the Secretary for the purposes of regulation 9 of the Therapeutic Goods Regulations 1990 also found that the claims and representation in the advertisement were unlawful, inaccurate and misleading in breach of the Code.
The attention of consumers is directed to the safety information from the Therapeutic Goods Administration at: Black salve, red salve and cansema on the TGA website.