Antagolin – Still no robust evidence I

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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 1

Antagolin Insulin / H A Steinman / 2014 – 372F
Ruling of the : ASA Directorate
In the matter between:
Dr H A Steinman Complainant(s)/Appellant(s)
Medical Nutritional Institute (Pty) Ltd Respondent

25 Jul 2014

http://www.asasa.org.za/ResultDetail.aspx?Ruling=6919

BACKGROUND

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

“ …the advertising objected to, and more specifically all claims that imply an ability to combat insulin resistance and to assist in weight loss, are not used again in future until such time as adequate substantiation has been submitted and evaluated, and a new Directorate ruling has been issued on the matter.”

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 CLAUSE OF THE CODE OF ADVERTISING PRACTICE

The complainant identified Clause 4.1 of Section II (Substantiation) as relevant to his complaint.

RESPONSE

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

Antagolin is a new formulation, never been tested on humans before. The product’s individual ingredients have been studied and found to be lacking in efficacy, and the dosages do not correlate with the original studies, hence Prof du Toit’s submission should be dismissed in its entirety. In order to claim the product works, she (Prof du Toit’s) has extrapolated evidence from studies done in rats and not humans. There is no evidence that these rat models are equivalent to humans or that the dosages used in the rats are equivalent to that used in this product for humans. She (Prof du Toit’s) acknowledges this by stating “in terms of the amounts of the different ingredients present in Antagolin it must be understood that a direct extrapolation between the doses of drugs used in laboratory and animal studies and those used in human clinical trials is not possible”.

She (Prof du Toit’s) feels that the Samancor and Sanlam studies clinical studies provides “strong evidence” that Antagolin will result in an initial weight loss. However, the rate she mentions has been shown to be possible with placebo responses, and the two studies she refers to, had no controls, i.e., the response may have been purely a placebo response. In fact, the weight-loss, if true, could simply be as a result of the life-style intervention that was also a component of the study.

Prof van Gelder, points out that the small sample size prevents drawing a firm conclusion.

The study had no informed consent and no ethical approval was obtained for it, as Professor van Gelder points. Prof du Toit defines this as a clinical study. If this was the case, then this was an illegal study and contrary to the law, and therefore the study cannot even be considered. Furthermore, it was not published in a peer-reviewed publication, the authors or study leaders are not identified. The Directorate is being asked to assess a “study” without all the relevant aspects being made known.

Professor du Toit, has not pointed out that the amended Medicine Act, makes this product an illegal medicine until registered by the Medicines Control Council. As it does not fit the definition of the Act for a Complementary Medicine, and therefore will require registration as a Category A medicine, which requires, among other robust clinical evidence. These studies fall far short of that. In fact, Prof van Gelder admits this by stating “… should these data and this analysis be presented for registration purposes to the Medicines Control Council (MCC), serious barriers will arise at the regulator in this regard”.

The ASA, under Guidelines 1, Medicines, makes it explicit that Antogolin will therefore be contrary to ASA regulations, for among other, the following is stated: “This Act makes all medicines liable for registration by the Medicines Control Council and contains specific provisions relating to labelling and advertising. Section 18 of the Act determines that no person shall advertise any medicine or scheduled substance for sale unless such advertisement complies with prescribed requirements”.

The ASA also requires independence of substantiators or individuals involved in trials. The studies referred to were conducted by Samancor and Sanlam. Antagolin is a product of MNI and MNI were 2013 Sanlam / Business Partners Entrepreneur of the Year.

Although Professor van Gelder and Prof du Toit attempt a meaningful attempt to suggest that Antagolin’s claims are valid, they themselves couch these with many aspects and arguments that in fact count against the validity of the claims, the most critical of these, that the studies conducted were illegal. Furthermore, as of November 2013, this product is an illegal medicine.

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, all claims that imply the advertised product’s ability to combat insulin resistance and to assist in weight loss are still not substantiated in terms of Clause 4.1 of Section II of the Code and the condition set in the ruling dated 26 March 2014 remain binding in this regard.

[note note_color=”#f8fddd”]CAMCheck posts related to Antagolin

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