COMPLAINTS RESOLUTION PANEL DETERMINATION

Complaint 2009-12-018 Bio Magnetic Underlay

Meeting held 15 April 2010

1.      The complaint concerned a television advertisement broadcast on Channel 10 in December 2009.

2.      The advertisement made claims related to the relief of various forms of pain, including sciatica, arthritis, muscle spasms, head pain, back pain, arthritis, and sore muscles. It also made reference to the relief of insomnia.

3.      The advertisement promoted the Bio Magnetic Underlay.

4.      The advertiser was Bio Magnetic Pty Ltd.

5.      The complainant requested anonymity.

6.      The complainant alleged that the advertisement breached sections 4(1)(b), 4(2)(a), 4(2)(c), and 4(4) of the Code, citing the references to pain relief and insomnia made in the advertisement. The complainant also expressed concern about the use of the expression “drug-free” in the advertisement.

7.      Through legal counsel, the advertiser argued that “for every paper purporting to show that magnetic therapy has no value – there is at least an equal number of studies demonstrating benefit.”

8.      The advertiser provided documentary material in support of the claims made in the advertisements.

9.      The advertiser argued that the words “drug-free” were not intended to convey that the advertised product would provide the same benefits as pain medication.

10.  The advertiser argued that the use of the words “Bio Magnetic Underlay” did not constitute scientific information falling within section 4(4) of the Code.

11.  The Panel reviewed the evidence material provided by the advertiser. It consisted primarily of a table summarising a range of research material, together with full copies of selected research material.

12.  The majority of the evidence was wholly irrelevant. Evidence was provided which related to products such as magnetic footwear insoles and magnetic bracelets. No submission was made by the advertiser to indicate how such evidence could be extrapolated to a bedding underlay product. Studies were submitted involving subjects with serious health conditions such as diabetic neuropathy, fibromyalgia, post-operative pain, and postpolio syndrome. No submission was provided as to how such evidence could be extrapolated to support the claims made in the advertisement which related to entirely dissimilar conditions. For example, the representation that sciatica pain could be relieved by a magnetic bedding underlay, was not supported in any direct sense by the evidence provided – none of the evidence related to sciatica, while a study that did relate to bedding (mattresses) involved fibromyalgia and not sciatica. Headache pain was addressed in one study (summarised in the review paper) but this involved headbands, not bedding, and in any case disclosed a result that was not statistically significant. In other words, to the extent that any evidence was provided relating to headache pain, it suggested a null result. Similarly – again by way of example only – there did not appear to be any evidence related to muscle spasms or insomnia in the advertiser’s submission. The most relevant study, in terms of the types of pain measured and the use of bedding products, was an unpublished study that did not appear to have undergone peer review, and for which a complete report outlining methodology and measures was not provided (it was also of unestablished relevance to the advertised products because of the “dosage” issue below).

13.  Also raising questions of relevance was the fact that much of the evidence emphasised the importance of magnet power in relation to therapeutic effects. Indeed, one paper was provided which related specifically to the importance of this question. This paper was apparently provided to support an argument that negative studies relating to magnets in pain relief reached “unwarranted” conclusions because of inadequate magnet “dosage”. Despite the apparent significance of this issue, evidence as to the distribution and power of magnets in the advertised products, or the applicability of study results involving various magnet strengths to the advertised products, was not provided by the advertiser.

14.  Leaving aside the issue of relevance, the evidence provided by the advertiser was modest and generally presented methodological difficulties, particularly as regards blinding. The Panel also noted that, as the advertiser explicitly acknowledged, many studies suggested that magnetic pain relief products provide no benefits whatsoever.

15.  On balance, in the Panel’s view, some of the material provided by the advertiser could, at best, be regarded as providing very modest support for very modest and qualified claims of very modest pain relief effects in relation to the advertised products, if it could be shown to be relevant to the advertised products. As noted, however, no submission was made establishing such relevance and establishing such relevance was clearly necessary.

16.  Section 4(1)(b) of the Code requires that advertisements for therapeutic goods “contain correct and balanced statements only and claims which the sponsor has already verified.” Section 4(2)(a) of the Code prohibits representations that are “likely to arouse unwarranted and unrealistic expectations of product effectiveness”. Section 4(2)(c) of the Code prohibits representations that “mislead directly or by implication or through emphasis, comparisons, contrasts or omissions”.

17.  For the reasons noted above, the Panel was satisfied that the representations in the advertisements regarding the relief of pain, including the relief of pain from sciatica, arthritis, muscle spasms, and head pain, and back pain, or the temporary relief of aches and pains. These aspects of the complaint were therefore justified.

18.  Section 4(4) of the Code requires scientific information to be “presented in a manner that is accurate, balanced and not misleading”, and requires that publication of scientific research results should “identify the researcher and financial sponsor of the research.” The Panel did not consider that the statements in the advertisement amounted to scientific information or scientific research results, since the words used merely made reference to a general body of evidence, and did not cite quantitative or detailed data, nor any specific trial or research, and did not use words that would require scientific training on the part of readers. The Panel therefore considered that this aspect of the complaint was not justified.

19.  The Panel requests Bio Magnetic Pty Ltd, in accordance with subregulation 42ZCAI(1) of the Therapeutic Goods Regulations 1990:

a)      to withdraw the advertisement from further publication;

b)      to withdraw any representations that the advertised products have benefits in relation to the relief of pain, including the relief of pain from sciatica, arthritis, muscle spasms, and head pain, and back pain, or the temporary relief of aches and pains;

c)      not to use the representations in (b) above in any other advertisement unless Bio Magnetic Pty Ltd satisfies the Panel that the use of the representation would not result in a contravention of the Therapeutic Goods Act 1989, the Therapeutic Goods Regulations 1990 or the Therapeutic Goods Advertising Code;

d)     where the representation has been provided to other parties such as retailers or website publishers, and where there is a reasonable likelihood that the representation has been published or is intended to be published by such parties, to advise those parties that the representation(s) should be withdrawn;

e)      to arrange for publication on the website www.biomagnetic.com.au of a retraction in the form of, and in accordance with, the conditions set out in the attachment to this determination; and,

f)       within 14 days of being notified of this request, to provide evidence to the Panel of its compliance, including a response in writing that they will comply with the Panel’s sanctions, and where appropriate, supporting material such as copies of instructions to advertising agents or publishers, or correspondence with retailers and other third party advertisers.

20.  The advertiser’s attention is drawn to the provisions of sub-regulations 42ZCAI(3) and (4) which permit the Panel to make recommendations to the Secretary in the event of non-compliance with this request, including a recommendation that the inclusion of the goods on the Register be cancelled.

Dated 28 May 2010

For the Panel

Jason Korke

Chairman

In this determination, unless otherwise specified:

a)      “the Act” means the Therapeutic Goods Act 1989;

b)      “the Regulations” means the Therapeutic Goods Regulations 1990;

c)      “the Code” means the Therapeutic Goods Advertising Code;

d)     “the Register” means the Australian Register of Therapeutic Goods;

e)      “any other advertisement” appearing in sub-regulation 42ZCA1(1)(d) is not confined to advertisements in specified or broadcast media (in relation to which complaints may be made to the Panel under Regulation 42ZCAB).

An advertisement is to appear on the homepage of the website www.biomagnetic.com.au at the earliest booking opportunity.

A copy of the retraction advertisement, in the context of the home page, is to be provided to the Complaints Resolution Panel for approval before it is posted live on the website.

No other copy should be included in the advertisement.