Antagolin – Still no robust evidence II

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Posted 07 August 2014

The ASA has previously ruled against the claims for Antagolin. The company submitted new evidence in support of their claims. The ASA requested the two previous complainants to comment on the submission. Based on the ASA’s assessment of the complaint, and the comments, they ruled against the claims for Antagolin.

Importantly, Dr Conrad Smith and pharmacist, Mariaan du Plessis, may have opened themselves to being struck of the professional register for conducting a study without ethical approval or informed consent.

Ruling 2

Antagolin / SJ Goldstein / 22891
Ruling of the : ASA Directorate
In the matter between:
Dr SJ Goldstein Complainant(s)/Appellant(s)
Medical Nutritional Institute (Pty) Ltd Respondent

25 Jul 2014

http://www.asasa.org.za/ResultDetail.aspx?Ruling=6920

BACKGROUND

In a ruling dated 28 February 2014, in accepting the respondent’s undertaking to withdraw its commercial containing claims that were complained against, the ASA Directorate, stated:

“ …the claim that “Antagolin combats insulin resistance, and will help you to lose weight effectively” is currently unsubstantiated and in contravention of Clause 4.1 of Section II of the Code.” and “The claim “Antagolin combats insulin resistance, and will help you to lose weight effectively” may not be used again in its current format in future unless new substantiation has been submitted and accepted in accordance with the provisions of Clause 4.1.7 of Section II of the Code.”

SUBSEQUENT TO THE RULING

Attorneys Erasmus De Klerk Inc., acting on behalf of the respondent, attached copies of the following documents as substantiation:

Professor A L van Gelder’s verification and validation report of the SANLAM and Samancor study groups.

Professor Karen du Toit’s verification and validation report.
RELEVANT CLAUSES OF THE CODE OF ADVERTISING PRACTICE

In light of the complaint the following clauses of the Code were considered relevant:

Clause 4.1 of Section II – Substantiation

Clause 4.2.1 of Section II – Misleading
RESPONSE

The ASA Directorate forwarded the documents submitted by the respondents to the complainant for comment, who submitted, inter alia, that:

The analysed studies (and then the conclusions) are deeply flawed. They were analysed as if they are a randomised control trial, however the number of controls is woefully small, and the controls are people who refused to take Antagolin (which puts them in a specific probably biased group).

The studies were not blinded studies and the effect of the Antagolin was not measured against a placebo which would then really show us whether there is a real effect or not. Unblinded studies, funded by the manufacturers with very poor design and almost no control group, without using a placebo are not acceptable.

All medicines that are approved by the various pharmacological boards have to have had clinical trials (no matter that they are complex and expensive). Ideally these should be done by independent scientists and the results published (no matter the outcome). To say that enough is known about the separate ingredients thus one does not need to do a test of the final composition is not correct.
ASA DIRECTORATE RULING

The ASA Directorate considered all the relevant documentation submitted by the respective parties.

Professor Karen du Toit’s verification and validation report.

Clause 4.1 of Section II of the Code requires advertisers to hold satisfactory documentary evidence of any direct or implied claims made. It stipulates that such evidence must emanate from, or be evaluated by an independent and credible expert in the field to which the claims relate.

It is also trite that the Directorate requires product-specific substantiation which unequivocally states that taking the advertised product, as is bought in-store and at the recommended dose, will deliver on the advertised claims.

It should also be noted that Clause 4.1.2 of Section II states, inter alia, that documentary evidence “shall have market relevance”. Clearly the respondent is not promoting or selling individual nutrients and extracts in isolation, but rather its own combination of such ingredients and extracts as contained in its product. For its evidence to have “market relevance” it would have to apply to the actual product available on the market under current conditions.

In light of the above, and in keeping with the long-standing approach, the Directorate requires that the respondent ought to submit adequate, independent substantiation that unequivocally verifies that its product as is available on the market, when used at the recommended dose, will deliver on its efficacy claims. Professor Karen du Toit’s verification and validation report is however not product-specific and is therefore not acceptable in terms Clause 4.1 of the Code.

Professor A L van Gelder’s verification and validation report of the SANLAM and Samancor study groups.

Clause 4.1.3 of Section II states in relation to survey data, inter alia, that “The accuracy of the claims based on the survey shall be confirmed by an entity approved by, or acceptable to, the South African Market Research Association. The Directorate notes that the respondent relies on Professor A L Gelder’s verification of its research data without submitting his curriculum vitae to enable the Directorate to assess whether he is suitable to act as an independent evaluator of its substantiation documents in terms of the Code. The Directorate is therefore unable to accept the said documentation as it not in line with the requirements of the Code.

Accordingly the claim that “Antagolin combats insulin resistance, and will help you to lose weight effectively” is still unsubstantiated and in contravention of Clause 4.1 of Section II of the Code.”

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