Posted 08 November 2013
AllergoStop is a product that claims to be an effective replacement for corticosteroids, anti-histamines and antibiotics, in that it is effective treatment “with immunoglobulins that play a dominant role at the time of the allergic reaction”. If you are going to claim that your product will reduce your need for among other, steroids, you better have good proof of this.
AllergoStop did not have. Dr Liezl Voshol-Botha of The Tygerberg Multicare Centre argued that this product is homeopathic and “the principles and practice followed at this practice are based on homeopathy, which is why one would not find any articles on conventional searches such as PubMed.” In other words, because Dr Voshol-Botha claims the product is “homeopathic”, that one does not need any proof that it works. The ASA agreed with the complainant’s argument that proof is required, (and in particular if you are going to compare yourself against a proven treatment). Furthermore, one does not become allergic to lactose as Dr Voshol-Botha claims! She also utilises “thermography (infrared imaging) for the early detection of signs of breast cancer” which is a dangerous and fairly useless form of detecting breast cancer – read more about this here.
04 Nov 2013
Doctor Steinman lodged a consumer complaint against a print advertisement that was published in “Cape Town Get It” during September 2013. The advertisement is headed “Tired of cortisone, anti-histamines and antibiotics? Recurrent throat and ear infections? Asthma, sinus, eczema, hay fever and allergies?”
Directly below this, a large, bold banner reads “Allergostop is the answer!”
It then carries a body-copy explaining that the treatment protocol is based on a “German method” and that the product “… consists of treatment with immunoglobulins that play a dominant role at the time of the allergic reaction”.
It further states the following:
“The patient-specific reaction products such as allergic antibodies, auto-antibodies and enzymes responsible for the allergic reaction are changed by the serum activator and then returned to the patient’s body where these reactions products will be recognised as foreign, and specific counter-actions can therefore take place (anti-antibody reactions)”,
“Allergostop is recommended to both exogenous allergies (such as gluten, lactose, house dust mites, pollens, dairy and animal hairs, etc.) as well as endogenous anti-immune anti-bodies. There are two methods of administration of Allergostop i.e. sub-cutaneous injections or oral drops”.
The complainant submitted that the claims made are false and unsubstantiated. He has searched PubMed, which comprises more than 23 million citations for biomedical literature, and was unable to find any evidence to support the advertising claims.
The complainant added that another website (www.allergyclinic.co.za) states “Allergostop is a new and as yet unproven allergy treatment which has taken off in South Africa but has never been proven to be of benefit and the explanation of how it works makes no physiological sense (Personal communication Prof P Potter)”. He explained that the “Prof Potter” referred to in this quotation is the head of allergy at Groote Schuur hospital and the University of Cape Town Medical School.
RELEVANT CLAUSE OF THE CODE OF ADVERTISING PRACTICE
In light of the complaint Clause 4.1 of Section II (Substantiation) of the Code was taken into account.
The respondent submitted that there was a typing error, and that the bold claim should have read “Allergo may be the answer” as oppose to “is the answer.” The article merely explains how allergies are treated at her practice and most of the information is taken from the manufacturer’s website.
The principles and practice followed at this practice are based on homeopathy, which is why one would not find any articles on conventional searches such as PubMed.
During consultation, the procedure is explained to patients according to the scope of practice and it remains the patient’s choice whether they want to use it. It tendered a list of contact details of some patients that were treated successfully with the product if the ASA were interested.
ASA DIRECTORATE RULING
The ASA Directorate considered all the relevant documentation submitted by the respective parties.
While the Directorate notes the respondent’s undertaking to change the bold statement from “Allergostop is the answer!” to “Allergostop may be the answer!”, it is not convinced that this would address the concerns raised, as it does little (if anything) to change the overall tone and message of the advertisement.
The overwhelming impression is that this product would be beneficial in instances where cortisone, anti-histamines and antibiotics are not, or are not desired by the patient. The advertisement lists specific conditions such as “Asthma, sinus, eczema, hay fever and allergies” and explains how using the product would produce an “anti-antibody reaction”. In addition, it pertinently states that this product is “recommended to both exogenous … as well as endogenous anti-immune anti-bodies …”
It is therefore clear that the overall message is that this product will work. The respondent is correct in stating that not all medicine is effective 100% of the time in all patients, but this is not the point currently. The question still arises whether the respondent has any evidence to support the notion that this product is beneficial (or even that it “may” be beneficial).
The proposed undertaking to change “is the answer!” to “may be the answer!” is therefore rejected, as it will not address the concerns raised. The Directorate is therefore obliged to consider the advertising and determine whether or not it contravenes the provisions of Clause 4.1 of Section II of the Code.
Clause 4.1 of Section II states, inter alia, that an advertiser must hold documentary evidence to support all claims that are capable of objective substantiation. In addition, it clarifies that such documentary evidence shall emanate from or be evaluated by an independent and credible expert in the particular field to which the claims relate.
The respondent’s claims are clearly capable of objective verification as outlined in the provisions of Clause 4.1 of Section II of the Code.
However, aside from submitting a brief explanation on the theory of countersensitisation, the respondent has submitted nothing to show that this product has ever even been tested.
It is specifically noted that the Code places the onus of proof at the respondent’s door. Accordingly, the respondent bears the responsibility of proving that its claims are valid and true. The Directorate requires unequivocal confirmation from an independent and credible expert in the relevant field (allergies and related treatments) to support the exact claims made in the advertising. Such unequivocal verification should apply specifically to the respondent’s product as sold to customers.
There is currently nothing before the Directorate to show that the product is able to (or even that it “may” be able to) deliver on the efficacy claims made.
As a result, the advertising is currently unsubstantiated and in contravention of Clause 4.1 of Section II of the Code.
As a result of the above finding:
The advertising and relevant claims must be withdrawn in its current format;
The process of withdrawing the advertising and relevant claims must be actioned with immediate effect;
The process of withdrawing the advertising and relevant claims must be completed within the deadlines stipulated by Clause 15.3 of the Procedural Guide, and
The advertising and relevant claims may not be used again in its current format in future until the respondent has submitted adequate substantiation in accordance with Clause 4.1 of Section II of the Code, which is accepted by means of a new Directorate ruling.
The complaint is upheld.