Complaints Register

COMPLAINTS RESOLUTION PANEL DETERMINATION

Complaint 2009-12-004 Herron Saw Palmetto

Meeting held 18 March 2010

1.      The complaint concerned an internet advertisement published at the website www.herron.com.au.

2.      The advertisement included claims related to benign prostatic hyperplasia (BPH). It included statements such as “published clinical trials have confirmed the beneficial effects of the herb Saw Palmetto for the relief from the symptoms of medically diagnosed BPH” and “formulated to be highly effective in providing relief from the symptoms of medically diagnosed BPH”.

3.      An excerpt of the advertisement can be viewed in the relevant Appendix to this determination.

4.      The advertisement promoted Herron Saw Palmetto 1600 tablets.

5.      The advertiser was Herron Pharmaceuticals Pty Ltd.

6.      The complainant requested anonymity.

7.      The complainant referred to a Cochrane review published in April 2009, relating to the saw palmetto ingredient of the product. The complainant argued that the advertisement breached sections 4(1)(b), 4(2)(a), 4(2)(c), 4(2)(g), and 4(4) of the Code because it made claims that did not take into account the findings of this review.

8.      The complainant provided a copy of the abstract of the Cochrane review.

9.      The advertiser stated that “the leading global monographs, which form the basis for registered products making similar/identical claims, have not altered their recommendations on the basis of the findings of this single updated review.”

10.  The advertiser also stated that they had in fact undertaken a review of the 2009 Cochrane review and had concluded that its findings differed from an earlier, more favourable Cochrane review primarily because of the inclusion of one additional study (“the Bent study”)conducted in 2006.

11.  The advertiser stated that, in their view, the additional study “examined men with moderate-to-severe BPH” while positive studies relating to saw palmetto involved subjects with “mild-to-moderate BPH.”

12.  The advertiser argued that the words “published clinical trials have confirmed the beneficial effects of the herb Saw Palmetto for the relief from the symptoms of medically diagnosed BPH” did not breach section 4(1)(b) of the Code, but nonetheless expressed a willingness to replace the word “confirmed” with “support”.

13.  The advertiser argued that the words “formulated to be highly effective” were true, and that the product’s effectiveness was supported by high quality evidence.

14.  The advertiser provided documentary material in support of the claims made in the advertisement, which consisted primarily of a table summarising various clinical trials relating to the saw palmetto ingredient, and an article from a website arguing that the Cochrane review was “flawed by an inappropriate patient population.”

15.  As a preliminary matter, it should be noted that the present complaint was one of two, both relating to saw palmetto, originating with the same complainant, and raising the same concern on the basis of the 2009 Cochrane review. The other complaint was complaint 2009/12/005 Herb Valley Saw Palmetto.

16.  For the sake of consistency, the Panel considered it necessary to review the evidence provided by both advertisers in relation to the saw palmetto ingredient in reaching a decision for each complaint. The advertiser in the present case should be aware that the Panel does not generally regard summary tables relating to evidence as authoritative, and that full copies of studies relied upon should be provided.

17.  Having regard to the entirety of the evidence before it, the Panel was satisfied as follows:

a)      That good, but not overwhelming, evidence was available to support claims that the saw palmetto ingredient may provide symptomatic relief for sufferers of mild-to-moderate benign prostatic hyperplasia;

b)      That the balance of evidence suggested that such claims were not adequately supported in relation to moderate-to-severe cases of BPH; and,

c)      That taken as a whole the evidence did not support excessively strong claims, or claims implying that the scientific case was final, even in relation to mild-to-moderate BPH.

18.  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”.

19.  The Panel was of the view that the words “published clinical trials have confirmed” constituted an unequivocal and absolute representation as to the strength and quality of the evidence for the saw palmetto ingredient. While noting that the positive evidence in relation to mild-to-moderate BPH was of good quality, the Panel did not consider that it could support a claim that the ingredient’s benefits were “confirmed”. The Panel also found that the use of the words “formulated to be highly effective” was, from the perspective of a consumer viewing the advertisement, indistinguishable from an unqualified claim that the advertised product was “highly effective”. The Panel did not accept that, on the balance of the evidence available, the saw palmetto ingredient could be regarded as highly effective without qualification.

20.  The Panel also found that all of the claims relating to the symptoms of BPH were unverified, misleading, and likely to arouse unwarranted expectations in relation to the advertised product since they were not explicitly stated to be related to mild-to-moderate (and not moderate-to-severe) cases of BPH.

21.  These aspects of the complaint were therefore justified.

22.  Section 4(2)(g) of the Code prohibits representations that therapeutic goods are “infallible, unfailing, magical, miraculous”, or that they are “a certain, guaranteed or sure cure”. The Panel did not did not find words in the advertisement that conveyed such representations, and the complainant did not direct the Panel to any such words. The Panel therefore found that this aspect of the complaint was not justified.

23.  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 advertisement did not represent the totality of the evidence in a manner that was balanced, because it overstated the degree to which the benefits of the saw palmetto ingredient were “confirmed”, and because it was not explicitly confined to mild-to-moderate (as opposed to moderate-to-severe) cases of BPH.  This aspect of the complaint was found justified.

24.  The Panel requests Herron Pharmaceuticals 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 product has the advertised benefits in relation to moderate-to-severe cases of BPH, and any unqualified representations that its benefits in relation to BPH have been confirmed or proven by research or that it is highly effective;

c)      not to use the representations in (b) above in any other advertisement unless Herron Pharmaceuticals 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; and,

e)      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.

25.  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 29 April 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).