Nycomed-Dona – does it work?

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Posted 16 August 2012

A consumer laid a complaint against print advertisements promoting Nycomed’s “DONA” range of products formulated to treat osteoarthritis (OA). The advertisements appeared in the Sunday Times during March 2012. The complainant submitted that “… based on current scientific evidence, it is impossible to make such a definitive statement about reduction of pain, inflammation and swelling”. He added that “None of the evidence supplied supports the claim that Glucosamine Sulphate will ‘prevent further progression of OA’.”  

The ASA agreed feeling that the evidence was insufficient. 

Nycomed-Dona / K Charleston / 20066
Ruling of the : ASA Directorate
In the matter between:
Kevin Charleston Complainant(s)/Appellant(s)
Nycomed (Pty) Ltd Respondent

16 Aug 2012

http://www.asasa.org.za/ResultDetail.aspx?Ruling=6213

Mr Charleston lodged a consumer complaint against print advertisements promoting the respondent’s “DONA” range of products formulated to treat osteoarthritis (OA). The advertisements appeared in the Sunday Times during March 2012.

The advertisements feature images of sportsmen, dancers, and business people, and promotes the respondent’s product as “… the original crystalline formulation of glucosamine sulphate (a natural substance). DONA ® has been clinically proven to not only aid in the reduction of pain, inflammation and swelling of affected joints in OA, but also to improve mobility and prevent further progression of OA”. It contains a total of seven citations to references listed in the advertising, and clarifies that “OA” refers to osteoarthritis.

COMPLAINT
The complainant submitted that “… based on current scientific evidence, it is impossible to make such a definitive statement about reduction of pain, inflammation and swelling”. He added that “None of the evidence supplied supports the claim that Glucosamine Sulphate will ‘prevent further progression of OA’.”

In addition, he noted that the references to osteoarthritis are in contravention of Appendix F of the Code, which prevents such claims from being made.

Finally, the complainant noted that Glucosamine Sulphate was a schedule 3 medicine, and may therefore not be advertised to the general public in terms the Medicines and Related Substances Act. The respondent’s advertising is therefore illegal

RELEVANT CLAUSES OF THE CODE OF ADVERTISING PRACTICE
The complainant identified the following clauses of the Code as relevant:

• Section I, Clause 1.1 – Legal, decent, honest and truthful

• Section II, Clause 3.3 – Legality

• Section II, Clause 4.1 – Substantiation

• Appendix F – References to diseases in advertising

RESPONSE
The respondent submitted that this product has been clinically proven to not only aid in the reduction of pain, inflammation and swelling of the affected joints, but also to improve mobility and prevent further progression of osteoarthritis.

It explained the nature of the organic component of this product, and how it interacts with cartilage and inflammation, and pointed out that its Glucosamine (C6H13NO5) is completely different to Glucosamine Hydrochloride (HCl), the latter having never been shown to be effective. A great deal of caution is necessary when reviewing glucosamine products to make a distinction between these salts, and confusion in this regard could well lead to incorrect and uninformed conclusions about the efficacy or lack thereof of these products.

In support of its efficacy claims, it submitted a bundle of documentary evidence, and elaborated on why this evidence conforms to proven scientific method and application, whereas those relied on by the complainant (specifically the research by Wandel et al.) do not. It submitted and referred to various articles questioning those relied on by the complainant, and noting certain irregularities and inaccuracies in the conclusions, noting that even the article cited by the complainant (Evidence Based Medicine 2011(16);2:52-53) points to such inadequacies.

It also referred to a Cochrane Collaboration published in a review in 2009 which found (after considering 25 studies) that “… Randomized Control Trials (RCT) in which the Rotta preparation of glucosamine [Dona ®] was compared to a placebo found glucosamine superior for pain and function”.

Insofar as product registration is concerned, it noted that its product is recognised by the Medicines Control Council (the MCC) as a Complementary Medicine, and it is not for the ASA to direct the MCC to do otherwise. In any event, the complainant is incorrect, as glucosamine is only a schedule 3 substance “when intended for the treatment of primary and secondary osteoarthritis, osteochondrosis and spondylosis”. The advertising makes no direct claim of treatment. As such, the complainant’s argument that the advertising is illegal falls away.

With reference to Appendix F, it noted that the Medicines and Related Substances Act does not distinguish between “full” product registration as called for in Appendix F and any other type of registration. Moreover, not all products are immediately registerable, and section 14(2) makes it clear that products only become registerable by means of a resolution by the MCC. Be that as it may, Dona ® is registered with the MCC as a Complementary and Alternative Medicine. A document to prove this was also attached.

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

Legality
The complainant took issue with the fact that the product contains a schedule 3 substance, and was therefore not allowed to be marketed to ordinary consumers in terms of the applicable legislation. Clause 3.3 of Section II reads as follows:

“Advertisements should not contain anything which might lead or lend support to criminal or illegal activities, nor should they appear to condone such activities”.

In British American Tobacco/ K Williams and Others / 17013 (16 May 2011), the Directorate was faced with a similar allegation insofar as tobacco legislation was concerned. The Directorate ruled as follows:

“In considering this clause, the Directorate has to pay attention to the wording. It is noted that the clause effectively seeks to prevent advertising from having content that depicts, condones, or encourages illegal acts. In other words, the aim here is to prevent, for example, advertising showing a situation where a vendor sells cigarettes to children (thus depicting an illegal situation). The clause does not, however, contain any wording that says or implies that tobacco products may not be advertised as such.

While the Directorate is mindful of the fact that there are laws in place that contain such restrictions, these laws and regulations are not administered by the ASA. Clause 13 of the Preface to the Code also specifically point out that the Code seeks to complement rather than replace legislation, and it would be nonsensical for the ASA to attempt to enforce or administer legislation that already falls within the jurisdiction of the appropriate regulatory authorities.

The Code does contain a provision requiring advertising to be ‘LEGAL, decent, honest and truthful’ (our emphasis). However, as noted in the Final Appeal Committee ruling under the reference Dunhill / P Ucko / 8978 (5 March 2008), this provision appears in the Preamble to the Code, and can only be said to have been contravened IF one of the substantive clauses contained in the Code (refer Sections II through V) and/or the appendices to the Code have been contravened. This again suggests that the ASA is not able to pronounce on the legality of the respondent’s advertising, as there is no provision contained in these sections of the Code that prohibits the advertising of tobacco”.

This ruling also drew attention to the ruling in Aquila Private Game Reserve / Fairy Glen Private Game Reserve / 10323 (25 April 2008), where the Directorate had to deal with an allegation that the advertiser (Aquila) was promoting and advertising animals on its reserve without having the requisite permits for keeping such animals. The Directorate ruled as follows:

“The question of whether or not the respondent has the necessary permits to keep certain animals ‘in captivity’ is not an advertising issue. The complainant did not submit that the respondent’s advertising communicates, for example, that one can/must keep wild or endangered animals ‘in captivity’ without authorisation.

Accordingly, the complainant’s objection regarding the Western Cape Nature Conservation Laws Amendment Act falls outside the ASA’s jurisdiction and will therefore not be considered”.

Clearly the ASA does not have the jurisdiction to determine whether or not the respondent’s product should, or should not be regarded as a schedule 3 medicine. This is something for the appropriate authorities to determine. In any event, even if this were the case, it would potentially mean that the advertising was in contravention of the Medicines and Related Substances Act, which the ASA does not administer or enforce.

In addition, the advertising does not encourage people or advocate the practice of advertising scheduled substances to ordinary consumers, and can therefore not be said to “lead or lend support to” or “condone” the practice of doing so.

Accordingly, the Directorate cannot find that the advertising at issue is in contravention of Clause 3.3 of Section II. By the same reasoning, the Directorate cannot, at this time, find that the advertising contravenes the preamble’s Clause 1.1 of Section I of the Code.

This aspect of the complaint is therefore dismissed.

Appendix F
At a resolution passed by the ASA board on 4 February 2012, it was decided that Appendix F should no longer form part of the ASA Code. In terms of the ASA’s Articles of Association, the Directorate has to immediately give effect to any decision taken by the Board. The implication of this is that, while Appendix F was still in force at the time of receiving the complaint and the response, the Directorate is now precluded from considering this matter in terms of the now defunct appendix.

As a result, the Directorate is not in a position to consider whether or not the respondent’s advertising is in contravention of Appendix F.

Substantiation
Clause 4.1 of Section II requires advertisers to hold in their possession documentary evidence for any direct or implied claims that are capable of objective verification. It also stipulates that such documentary evidence should emanate from, or at least be evaluated by and independent and credible expert in the field to which the claims relate. It further stipulates that such documentary evidence should confirm the accuracy of the claims.

The respondent submitted a substantial bundle of literature in support of its advertising claims, and explained why it believes that the complainant has misinterpreted the research, or placed too much reliance on evidence that has since been debunked by newer studies.

The problem that the Directorate is faced with, however, is that it is not a technical and/or scientific expert. As such, the Directorate has no way of knowing, as a matter of fact, whether or not the findings of these articles can be extrapolated and applied to the respondent’s product. In addition, the Directorate has no way of knowing whether the findings of these articles adequately confirm the accuracy of the claims made in the advertisement.

The vast majority of these articles appear to emanate from industry journals (i.e. dealing with osteoarthritis and cartilage), and nearly all specifically examine the benefits of glucosamine and / or glucosamine sulphate, many being specifically targeted at, for example, the knee, whereas the advertising indicates an efficacy for all affected joints.

In Aquafresh / Colgate-Palmolive / 17956 (30 November 2011), the Advertising Industry Tribunal upheld the Directorate’s approach in rejecting substantiation of a technical nature in the absence of express verification from an independent and credible expert in the field. The AIT specifically noted as follows:

“After considering the written appeal documents and listening to the arguments presented, the AIT found that it was in no better position than the Directorate was. The independence of the studies from which abstracts or summaries had been taken was not questioned but there was no acceptable independent expert evidence submitted linking these to the product or the product claims”.

Likewise, what is missing from the respondent’s submissions is express verification from an independent and credible expert in the field of osteoarthritis confirming the accuracy of the claim made in the advertisements. In the absence of this, the Directorate cannot assume that the claim contested is adequately supported by the evidence presented.

The claim “… DONA ® has been clinically proven to not only aid in the reduction of pain, inflammation and swelling of affected joints in OA, but also to improve mobility and prevent further progression of OA” is therefore currently unsubstantiated and in breach of Clause 4.1 of Section II of the Code.

Accordingly, the respondent is instructed to:

Withdraw this claim from its advertising,

Action the withdrawal of this claim with immediate effect upon receipt of this ruling,

Ensure that the claim is withdrawn within the deadlines stipulated in Clause 15.3 of the Procedural Guide,

Refrain from making this claim again until new substantiation has been submitted in accordance with Clause 4.1.7 of Section II, and a new ruling issued accepting this claim.
The complaint is upheld.

 

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One Response to Nycomed-Dona – does it work?

  1. Kevin Charleston 17 August, 2012 at 7:08 am #

    Summarily dropping Appendix F is quite an infuriating action by the ASA. I can understand they are under legal pressure by the Solal lawsuit – and it might have been a defensive move. However, the inconsistency this displays is astounding.

    The ASA’s website still refers to Appendix F; and there have been at least 5 rulings subsequent to 4 February 2012 in which the Directorate is clearly ruling on Appendix F.

    One of the unfortunate side-effects of this is that the ASA Code of Advertising Practice it is now supports quack advertising. Imagine an advertisement with a headline HIV/AIDS? a picture of the product and some general ‘healing’ type words making no specific medical claim. By dropping Appendix F, this is now perfectly ok according to the CAP.

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