Précis of Committee meetings held in 2012
- 285 : Boehringer Ingelheim / Novartis Animal Health: Onsior
- 286: Pfizer Animal Health / Novartis Animal Health: Zolvix
Case No. 285/03/12. Complaint by Boehringer Ingelheim Limited against Novartis Animal Health regarding promotion of Onsior®
This one item case brought by Boehringer Ingelheim Ltd involved Novartis Animal Health’s Onsior advertisement, which appeared in the Veterinary Times 7th November 2011, volume 41, number 44, at page 13 and Vet Record, 26th November 2011, volume 169, number 22 at pages 564 – 565.
The Complainant alleged that the statement: “Onsior persists at the source of inflammation, but exits the bloodstream quickly, sparing vulnerable organs from prolonged exposure”, particularly in its juxtapositioning as a bullet point under the heading “the only pain relief with proven tissue selectivity” constituted breaches of Code of Practice clauses 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 5.1 and 5.2. on the grounds that the statement could only be taken to infer a special safety benefit of the product by comparison with other NSAID’s, which was unsubstantiated and not proven, and was inconsistent with the SPC of the product. Originally in inter-company correspondence the Complainant had also objected to the header words which referred to “proven tissue selectivity” in themselves, but in the complaint to NOAH their relevance was limited to the context, as a header, within which the complaint should be judged. These Code of Practice clauses are recited below:
4.1 Upon reasonable request, participants must promptly provide members of the veterinary and pharmaceutical professions, registered merchants and the business user with accurate and relevant information about the animal medicines which they market.
4.2 Information must reflect current knowledge or responsible opinion.
4.3 Information must be accurate, balanced and must not mislead, either directly or by implication, so that critical unbiased judgements and decisions can be made.
4.4 Where promotional material refers to supporting information, such information must be available on request within 5 working days or a clear reference must be given to where it can be found. In the case of company data this must be stated as such. The phrase “Data on file” must not be used as a reference. In the case of information published in a journal, a reference to the journal must be given. In the case of information published on a website, the address must be given.
4.5 All information included in promotional material must be capable of substantiation and substantiation must be provided within 5 working days unless there are genuine extenuating circumstances requiring a short extension. In that event, an explanation must be supplied within 5 days with an estimate of the time in which substantiation will be supplied.
Such substantiation need not be provided, however, in relation to the validity of indications approved in the current marketing authorisation.
4.6 All information must be presented so as to maintain the respect and confidence of veterinary surgeons, pharmacists, Suitably Qualified Persons, the business user and the public, and to promote the correct use of animal medicines.
4.7 Promotion must not be inconsistent with the SPC, except that a veterinary surgeon or other appropriately qualified person employed or engaged by a participating company may in appropriate circumstances give information about off-SPC use in response to a technical enquiry from another veterinary surgeon.
5.1 Claims for the usefulness of an animal medicine must be based on an up-to-date evaluation of all the evidence and must reflect this evidence accurately and clearly.
5.2 Exaggerated claims must not be made and all-embracing claims and superlatives avoided. Claims must not imply that an animal medicine, or an active ingredient, has some special merit, quality or property unless this can be substantiated.
The Respondent responded that it was an undisputed fact that Onsior (Robenacoxib), due to its short half life, was cleared significantly more rapidly from the blood than other NSAIDs, whilst lasting longer and at higher concentrations at the sites of inflammation. This was consistent with its SPC. The Respondent maintained that the phrase “sparing vulnerable organs” is consistent also with the SPC and reflected a direct quotation from Prof Peter Lees BPharm, PhD, Cbiol, FIBiol, FILT, Drhc(GENT), Hon Fellow ECVPT, HonAssocRCVS, argued to be widely acknowledged as one of the most respected veterinary pharmacologist in the field of NSAID research, which principle, it was argued, had gained comprehensive endorsement by respected veterinary anaesthetists and orthopaedic surgeons, whose papers were also quoted in the formal response.
The parties’ representatives presented their respective cases extremely competently.
It seemed that the short half life of product in the plasma was not disputed nor was the longer persistence at the points of inflammation. The question was whether those undisputed fact provided a benefit, in that the potentially toxic effects of NSAIDs, which could adversely affect diseased well-perfused organs of dogs and cats (e.g. liver, heart, kidney and intestinal system), could be lessened thereby. The complaint was that the words, especially use of the term “sparing” in the context of “vulnerable organs” implied a safety benefit, which was not justified and could not be substantiated. In particular, the Complainant was concerned that the promotion might encourage veterinary surgeons to be less cautious in prescribing Onsior, when circumstances reflected by the contra-indications contained in its SPC might exist (use of NSAID’s to treat dogs and cats who may be suffering from chronic renal disease, for example). It was essentially an issue of misleading and non-substantiated promotion, notwithstanding the number of Clauses of the Code in which respect the Complainant suggested their promotion was in breach.
The Respondent’s case was that all the promotion was doing was to reflect scientific evidence, as supported by the authorities supplied by them, comprising the following: –
(1). “Start of new generation of NSAID’s?” Professor Peter Lees (2011 – May) Veterinary Times.
(2). “Long-acting and tissue targeting NSAID’s: a pharmacokinetic and pharmacodynamic view” Prof Peter Lees (2010) WVOC proceedings.
(3).”Clinical use of non-steroidal anti-inflammatory agents (NSAID’s); The current position.” Prof Stuart Carmichael EJCAP volume 21 Issue 2 (2011 October).
(4).”Combining enzyme specificity and tissue selectivity of cyclooxygenase inhibitors: towards better tolerability? “Professors K Brune and D. E. Furst (Rheumatology 2007 one of nine).
(5). “Pharmacodynamics and pharmacokinetics of non-steroidal anti-inflammatory drugs in species of veterinary interest” Prof Peter Lees et al (2004) JVPT 27, 479-490.
As such the Respondent had denied that they were claiming any safety benefit, but were simply ensuring the veterinary profession was properly informed as regards current scientific findings.
The section referable to robenacoxib in the EJCAP paper, was particularly noted, as was the fact this was not a peer reviewed document and had been commissioned and paid for by the advertiser. As such, therefore, it might not constitute competent quality of evidence and, which could be challenged on that basis. Other papers relied upon, (for example, Prof Lees’ paper “Long acting and tissue targeting NSAID is: a pharmacokinetic and pharmacodynamic view”) may have been peer reviewed, which supported the viewpoint expressed.
- It was emphasised that Prof Lees standing in the science in question was very highly respected within the profession. One member in particular stated that Prof Lees’ calibre was such that he would not make published statements which were not correct.
- The evidence “accounted for a safety profile”, but that did not necessarily mean that the product was safer. It was pointed out that toxicity was quite frightening to young and inexperienced veterinary surgeons, who were brought up on the principle of caution in the use of NSAIDs, where one was dealing with cats and dogs which either had or, perhaps because of age, could have renal etc disease. The risk was that such inexperienced but qualified persons might be persuaded by the advertisement that in those circumstances, this product could be used more safely.
- Conversely, this relatively new science needed to be seen in the context of tissue selectivity, where previously the market leader (Metacam®) was applauded for the fact that it had prolonged exposure in the plasma, so as to remain in situ, thereby relieving the animal from pain caused by the inflamed joints. What this new science was suggesting was that the risk of continued exposure to the toxic effects of NSAID’s to vulnerable organs could be reduced by the fast exiting from the blood, but that the longevity of treatment on the inflamed joints would continue, notwithstanding, and would be unaffected by that speedy exit from the blood. In that regard it was suggested all the promotion did was to reflect current scientific evidence.
In order to resolve the clear differences in discussion in what was a complex set of issues, the Chairman steered the discussion firstly as to the factual findings provided by the papers relied upon by the Respondent; secondly, as to the meanings of the expressions used in the promotion; and thirdly, whether those meanings could be substantiated and were not inconsistent with the product’s SPC.
In general there was agreement that the argument as to juxtapositioning with the header relating to tissue selectivity did not assist the Complainant’s case. To the contrary, in fact, a number of members felt that it gave the proper context in which to give the further information, concerning the product exiting the bloodstream quickly. Ultimately it was agreed that the promotion did imply that there may be a safety benefit to vulnerable or well perfused organs by the speedy exiting from the bloodstream of Robenacoxib and that the scientific papers had clearly established such an implication i.e. that the speedy exiting from the bloodstream of it may give rise to a safety benefit to vulnerable or well perfused organs.
Accordingly, the unanimous findings of the Committee relating to the promotional words:-
“Onsior® persists at the source of inflammation but exits the blood stream quickly, sparing vulnerable organs from prolonged exposure”
were as follows:
1. The words comprised a first bullet point of additional or subsidiary information designed for the qualified veterinary reader under the header words in bigger font size:
“Onsior® is different from other NSAIDs
It’s the ONLY pain relief for cats and dogs with proven tissue selectivity”.
2. There was no complaint as regards the ‘header’ words and accordingly, the Committee proceeded on the basis that the product Onsior® (robenacoxib) has such properties.
3. Onsior® (robenacoxib) does exit the bloodstream quickly.
4. As organs such as kidney, heart, liver and gastrointestinal system are highly perfused (with blood) organs and the scientific papers (in particular, the article by Peter Lees in Veterinary Times entitled Start of new generation of NSAIDs?) refer to rapid clearance of robenaxocib from well-perfused organs, the Committee found that the product Onsior® (robenacoxib) would exit quickly from organs such as kidney, heart, liver and gastrointestinal system of cats and dogs.
5. The EPAR for Onsior ® is that robenacoxib shows better GI tolerability than positive controls but that in animals with hepatic disorders, long-term oral treatment of robenacoxib could increase liver enzymes compared to positive controls but that such increases were in the normal range and no clinical evidence was noted for increased risk of liver adverse events. The citation of the EPAR for Onsior® by the Complainant was selective in its quotation.
6. In general, the SPCs of most NSAIDs have contra-indications regarding their use with animals with renal, cardiac or hepatic disorders (e.g. Metacam, Rimadyl, Previcox as well as Onsior)
7. Accordingly the qualified audience to which the promotion was directed would understand the phrase “vulnerable organs” to mean organs which were well-perfused e.g. kidney, heart, liver and gastrointestinal system and not diseased organs and therefore would not be taken to suggest that Onsior® could or should be used on any animal with hepatic, cardiac, renal or GI pathologies which, the Committee accepted would, if such had been suggested, have been contrary to the product’s SPC.
8. However, the use of the phrase “sparing vulnerable organs from prolonged exposure” did imply to the competent qualified veterinary reader that an NSAID such as Onsior ® which exits the blood quickly may have a better safety profile than an NSAID which exits the blood more slowly (all other variables remaining the same) (“the Implication”).
9. The Committee considered the scientific papers cited by the Respondent substantiated the Implication, particularly the articles by Professor Lees, Stuart Carmichael, Professor Brune and Professor Furst and also the Onsior® European Public Assessment Report. None of which evidence was disputed by the Complainant.
Accordingly, there was no breach of the Code of Practice by the promotion in the terms of the complaint.
Code of Practice for the Promotion of Animal Medicines Précis of Committee meeting held on 5 October 2012
Case No. 286/08/12 : Complaint by Pfizer Animal Health against Novartis Animal Health regarding Zolvix® advertisement
This one item case brought by Pfizer Animal Health Limited against Novartis Animal Health involved the advertising of their product Zolvix®, which appeared on the programme for the National Sheep Association’s event. “Scotsheep 2012” on 6 June 2012. It was alleged, and not disputed by the Respondent, that the same advertisement or phrase to which complaint was made, had appeared in other press and web formats throughout recent months.
The complaint related to the strap line or phrase “ZOLVIX® – THE WORLD’S MOST EFFECTIVE WORMER”.
The Complainant maintained that the phrase was grammatically a superlative, but even if considered as a comparison, it would imply that Zolvix® had been compared to all other anthelmintics, and had been objectively assessed as superior. As such, the complaint alleged that the phrase was in breach of Code of Practice clause 5.2, which is recited below:
5.2 Exaggerated claims must not be made and all-embracing claims and superlatives avoided. Claims must not imply that an animal medicine, or an active ingredient, has some special merit, quality or property unless this can be substantiated.
The Respondent, relying on a significant quantity of papers in evidence, maintained that monepantel is a highly effective broad spectrum anthelmintic with efficacy against all major gastrointestinal nematodes, as shown in the SPC for Zolvix® and had been validated by a significant bank of trials. In comparison, due to widespread anthelmintic resistance development, all other broad-spectrum classes had increasingly been shown to have reduced efficacy against many gastrointestinal nematodes. It was, however, acknowledged in the Respondent’s formal response that “on particular farms in particular geographies, other wormers currently may be of equal effectiveness, [but] on aggregate across the world Zolvix® is demonstrated to be consistently and clearly the most effective wormer”.
Arising out of discussion prior to hearing the parties’ presentation, the following points arose from Members’ comments:
- There was no doubt that Zolvix® was currently a very effective anthelmintic, at any rate against some nematodes in some territories and conditions.
- A large proportion of the evidence and trials relied upon by the Respondent were carried out in Australia, where it is acknowledged the problem of resistance to anthelmintics is probably the greatest in the world.
- One factor which may explain why there is greater resistance in Australia is that within Europe, and in particular the United Kingdom, other practices were adopted in conjunction with the use of recently developed anthelmintics to which there was reduced resistance. These included rotation of various types of anthelmintics and adopting protective timings of the movements of animals to new pastures.
- History had shown that there is no “cure-all” solution for sheep worms: in due course worms would frequently gain resistance to what had previously been new very effective anthelmintics.
- The term “nematodes” comprised only one type of worms.
- The various papers relied on by the Respondent showed differing results and in any event were by no means comprehensive as against even all the nematodes referred to, and certainly did not cater for all worms, nor even all gut worms. It was noted that in the Respondent’s formal response that there was reliance on the phrase “economically significant” worms, but even with that qualification, it was not necessarily the case that Zolvix® always performed better than, for example, the Pfizer product derquantel-abamectin. Whilst P R Little et al: Veterinary Parasitology 181 (2011) 180-193(Pfizer conducted research) did not provide a direct comparison with Zolvix®, it established high rates as against various nematodes. Conversely the Novartis GCP Final Study Report 13 February 2009 based on Australian studies purported to establish 99.8 – 100% effectiveness of Zolvix®, but only in the case of Haemonchus Contortus. Likewise the Novartis trials discussed in the Kaminsky et al dated 12 November 2011 as against that nematode, established a like result at between 99.98% and 99.8%, depending on whether the geometric or arithmetic mean was adopted; with similar results also as against Trichostrongylus Colubriformis. The Novartis paper George et al 26 March 2012 established similar results but again only as against Teledorsagia- spp. larvae, all such trials being conducted in Australia. Moreover tape worms, not being nematodes, could be in some circumstances an economically significant parasite, by its ability to exacerbate conditions created by other worms. It was felt relying on a qualification such as “economically significant” should be treated with caution, because what may be perceived currently as economically insignificant may subsequently be shown to have been incorrect.
- Some members expressed reservations as regards the reliability of the evidence in the context of the claim made, given that the majority had been commissioned by the Respondent, or were trials conducted by the Respondent’s personnel, but it was recognized that all but one were peer reviewed.
The farmer members of the Committee were particularly emphatic in their view, firstly that the promotion did constitute a superlative, and secondly, that superlatives should always be avoided in advertising animal medicines, whether or not the promoted claim could be substantiated. In their view, promotion of animal medicines should be limited to information, not hyperbolic claims.
The Complainant’s presentation relied on the argument that the promotional words “the world’s most effective wormer” constituted a superlative, that was all embracing, and which was incapable of substantiation, and whilst the item was grammatically a superlative, and therefore contrary to clause 5.2 anyway, the Complainant queried whether the evidence that had been provided by the Respondent justified such claimed superiority. It was suggested that:
- The product is licensed only for sheep, with no claims for any other species in the product’s SPC.
- The indications for use in the product’s SPC showed that the spectrum of activity as a broad-spectrum anthelmintic for the treatment and control of gastrointestinal nematode infections with associated diseases in sheep, including lambs, hoggets, breeding rams and ewes, were limited to: – Haemonchus contortus;Teladorsagia circumcincta; Teladorsagia trifurcata; Teladorsagia davtiani; Trichostrongylus axei; Trichostrongylus colubriformis; Trichostrongylus vitrinus; Cooperia curticei; Cooperia oncophora; Nematodirus battus; Nematodirus filicollis; Nematodirus spathiger; Chabertia ovina; and Oesophagostomum venulosum.
Thus the Complainant argued:
- that the product was effective only against nematodes i.e. roundworms. But the term “worms” also included other sheep parasites, such as flat worms (fluke, fasciola hepatica) and tapeworms (moniezia expansa).
- even in relation to round worms, a significant omission from the licensed indications for the product was sheep lung worm (Dictyocaulus filaria), which is a roundworm, and is indicated in many other licensed wormers within the United Kingdom.
Looking at the Respondent’s references which sought to justify the superiority claimed, they were internal studies, and were limited to particular strains only, in Australia. The Complainant did not seek to challenge the merit of the studies, but considered that they in fact relate to strains which have little relevance to the United Kingdom. Accordingly, the references failed to substantiate the claim made by the Respondent in its promotion, whilst it was suggested a recent study (Geurden et al, Vet’s. Par. 189 (2012) 308-316) indicated that.
The Complainant also drew attention to other factors, for the superiority claimed by the Respondent to be substantiated, and stated that to achieve this, there had to be proof that the product catered for:
- resistance to other products, guidelines on anthelmintic usage and economic implications of poor worming practice;
- duration of cover and protection;
- proven efficacy against all possible worms (and stages) in all species;
- efficacy in all possible locations and climates; and
- greater efficacy than all other wormers in all such circumstances.
This, the Complainant maintained, had not been shown by the four Australian studies, as previously discussed. Indeed, to be able to make such a forthright claim the Complainant would recommend a meta-analysis of all results to establish statistical superiority.
The Respondent’s presentation reiterated that Zolvix® was the world’s most effective wormer, in that it was a highly effective oral drench, monepantel (4-AD group), being the first new group over 25 years. It has a unique mode of action, with no known resistance by sheep nematodes. The product was stated to come from the first new class of broad-spectrum anthelmintic called AADs. 25 years ago there had been little concern referable to anthelmintic resistance. But now it is perceived as a large threat to the viability of sheep farming. It was claimed Zolvix® has a novel mode of action with no known resistance in sheep nematodes and therefore the concern of the Respondent had been how to market it, taking into account the industrial policy of broad-spectrum wormer groups known as Sustainable Control of Parasites in Sheep (SCOPS). The task was said to be the launching of Zolvix® responsibly, whilst retaining the life of existing groups and preserving the efficacy of monepantel and to help farmers and vets to engage in addressing anthelmintic resistance. To meet this marketing demand, which was considered to be unique, the Respondent had decided that monepantel was too valuable to the sheep industry, for it to be used as just another wormer as it had the potential to help manage resistance and prolong the life of other wormer classes. The concern of the Respondent was that it was considered that in many cases sheep farmers and veterinary surgeons do not discuss worm control. This was an opportunity for the two groups to re-engage and they were very concerned that if Zolvix® was used irresponsibly, resistance to it would arise, this being in the background of four broad-spectrum wormer classes in the UK, which when launched had good efficacy, but which, in the face of resistance, that effectiveness had reduced.
In taking what the Respondent considered to be a responsible approach to the marketing of Zolvix®, it was stated that discussion had taken place with global and national key opinion leader groups, developing recommendations for use and ensuring the use of Zolvix® was managed in a strategic way; the pre-launching of workshops on anthelmintic resistance by reference to the sheep veterinary Society and SQPs and finally providing post-launch ongoing education and marketing of the strategic use of the product.
The three key means behind the strategic use of Zolvix® were: (a) mid-season lamb dose; (b) quarantine treatment; (c) use on farms with multiple anthelmintic resistance to be confirmed by a veterinary surgeon.
Explaining why the current advertisement was so bold, it was stated that since the product’s launch in 2010, there had been good sales, and the Respondent’s approach to its marketing of the product had been praised by interested groups. However, it was the Respondent’s view that there are still many sheep farmers that are not discussing worm control on anthelmintic resistance with their veterinary surgeons. Thus the current promotion was designed to create the “cut through” by which to engage with farmers; the positioning of Zolvix® as a resistance management tool and emphasizing at all times that farmers still needed to gain a prescription for Zolvix® from their veterinary surgeons. A global chart, collated by Dr Kaminsky and Dr Hosking of the Respondent from clinical papers published on anthelmintic resistance across the world was produced. It was suggested that these papers show there is resistance to all the major classes of broad-spectrum wormers, including combinations of wormers.
A graph was produced, which purported to show the United Kingdom surveys on anthelmintic resistance for white drenches which data was considered now to be quite old, but which showed a breakdown between England, Scotland, Wales and the Republic of Ireland and as between highland and lowland farms, showing between 50% to 100% level of resistance. It was suggested that as resistance is defined as a wormer being less than 95% effective, the farmer will see little change in production at this level and therefore that is an explanation why many farmers do not recognise that they have a problem. The need is early treatment and therefore getting farmers now to understand the problem.
A further graph was produced by which it was suggested that UK ML data shows that there is resistance developing to this class and that there was a need for farmers to act now, without delay.
A comparison chart comparing monepantel with levamisole (2-LV), fenbendazole (1-BZ) and Ivermectin (3-ML), was used in support of the Respondent’s claim that Zolvix® is the most effective wormer. The comparison purported to show efficacy (particularly Zolvix efficacy) against various three resistant GI nematodes. In the case of H.Contortus and T. Circumcincta, monopantel had efficacy of between 99.7% and 99.9% compared to a range between 0% and 24% of the other wormers. In the case of T.Colubriformis the range runs from 0% in the case of fenbendazole, 80%. in the case of levamisole, 99.8% in the case of monopantel and 100% in the case of Ivermectin. Another chart purported to compare Zolvix® efficacy with multidrug resistant H. Contortus, at: 99.7% at the 4th larval stage, and 99.9% efficacy at the adults’ stage, compared to a range between 3% and 70% efficacy of other combination products, including moxidectin and abamectin. It was claimed that global field studies showed Zolvix® achieved a worldwide average efficacy of 99.9% including sites with triple resistance. In an internal field study of four groups of eight sheep dealing with artificially infected Australian field strains of Haemonchus (NE), with treatment on day five and collection for total worm counts on day 24, comparing STARTECT® (derquantel+abamectin) and Zolvix®, indicated 100% reduction in the case of Zolvix®, compared to between 10% and 20% efficacy of abamectin alone and STARTECT®, it being suggested that there was no significant difference between STARTECT® and abamectin alone. Reference was made to the George et al paper, which it was claimed that in a head-to-head comparison between Startect® and Zolvix® as against fourth stage larvae Teledorsagia L4’s, the efficacy of monepantel was 98.1% compared to STARTECT® at 82.6% and abamectin at 34.3%.
It was suggested that although the trials were Australian, such trials were applicable globally, and the strains used were the ones displaying the greatest resistance and thereby the worst problems for sheep farmers.
In conclusion, it was stated that the Respondent’s defence to the claim that the promotion is in breach of clause 5.2, by the use of the word “most”, was twofold: firstly, it was considered that Zolvix® is indeed the world’s most effective wormer, but secondly they considered the word “most” was more of a comparative statement than a superlative. The promotion was stating that Zolvix® is more effective than any other wormer. The Respondent’s representatives added that the use of the word “avoided” in the context of the word “superlative” in the clause was more advisory than a prohibition. Secondly, the second element of the clause is to answer the question of whether the advertisement is all-embracing and total in its position. In response to that it was suggested that the advertisements were clearly targeted to sheep farmers in both the trade publications and in the particular farmer leaflet that was produced. At the RWAS/NSA sheep event in Scotland, the board displaying the promotion was, in the Respondent’s opinion, aimed at sheep farmers and that there was no benefit in communicating with cattle or goat farmers.
During the course of the Respondent’s presentation, the following questions were raised by members of the Committee:
- Was the product distributed throughout the United Kingdom to which the representatives confirmed that it was.
- As regards previous promotions since launch of the product, it was acknowledged that this was the second since that of May 2012 and that it differed from the previous promotions.
- In answer to the Chairman’s repeated question as to whether it was maintained that the promotion did not constitute a superlative or claim that was all-embracing, the representatives eventually maintained that the promotion was not either.
- In answer to the Chairman’s request, it was confirmed that the Committee could rely on the papers supplied to determine whether the claim had been substantiated.
- A number of questions were raised as regards worms within UK habitat, which had significant resistance, and which were economically significant. In that context the Chairman drew attention to the Little et al paper referable to the Pfizer combination product STARTECT®, at page 192, indicating efficacy of 98.9% save in two example strains, where the efficacy was 95.9% and 97.0% respectively. Out of a list of some 29 parasitic worms, in varying stages, the Respondent’s representatives accepted all but three were economically significant in the UK, albeit suggesting that two of the others were relatively minor in terms of quantity of outbreaks.
- To the suggestion that farmers would think the advertisements suggested a cure-all solution as opposed to a useful management tool, which could encourage a failure not to use appropriate husbandry techniques, such as a rotation of anthelmintic treatment combined with appropriate pasture control, the Respondent argued strongly that everything that they were seeking to do was to encourage good husbandry, but to cater for the problem that farmers were generally not aware of the extent to which resistance to anthelmintics could be affecting their flocks, which they tended to consider existed elsewhere and not in relation to their farms. Thus it was suggested that the promotion was directed towards “every flock, every year, but not every sheep”, which could be relating to a quarantined flock, or in different seasons, but in all circumstances was specifically being directed to the sheep farmer. The urgent need was for appropriate treatment with early use of the product.
Following the presentations, the Chairman, in guiding the discussion thereafter, suggested that it was important to consider whether the promotion did constitute “an all-embracing claim and a superlative” and if it did, whether the Committee’s initial views as expressed before the presentations remained that the first sentence of clause 5.2 of the Code of Practice: “exaggerated claims must not be made an all embracing claims and superlatives avoided” constituted a prohibition, irrespective of substantiation of the promoted claim. Thereafter, even if technically unnecessary, if the Committee ultimately concluded the promotion was a breach through being an all-embracing superlative, irrespective of substantiation; it would be appropriate, and in fact only fair to the Respondent, to examine whether or not the promoted claim could be substantiated.
It was quite clear that there was unanimity in the view that this promotion did constitute an all-embracing claim and a superlative.
The Chairman then asked the members to consider, taking into account the presentations, whether in fact the promotional words could be substantiated. A comprehensive discussion ensued, carefully considering all the supporting evidence supplied by, and arguments expressed by the Respondent and its representatives, resulting in unanimity that they could not.
Accordingly, the unanimous decision of the Committee is that the phrase or strapline ‘Zolvix® – the World’s most effective wormer’ in a promotion contained in the National Sheep Association’s event ‘Scotsheep 2012’ on 6 June 2012 and elsewhere, did constitute a breach of Clause 5.2 of the Code of Practice.
In coming to their unanimous decision the Committee held that:
A) The phrase clearly constituted an all-embracing claim and a superlative.
B) As such, the Committee considered that that, of itself, constituted a breach, irrespective of whether the claim could, or could not, be substantiated. The Committee’s view was that on a proper construction, the first sentence of Clause 5.2 meant that all-embracing claims and superlatives are prohibited. Their justifications for that conclusion were:-
- The Code of Practice constitutes the industry’s regulations governing advertising, such that the clauses set out what either must, or must not, be included in promotions governed by the Code. Whilst in a different context, “avoided” could mean “should not be used”, in the context of the Code of Practice, the Committee’s view was that as the Code of Conduct was not intended to be a recommendation as to “best practice” and because of the use of the phrase “must not” earlier in the sentence, the proper construction was that superlatives and all embracing claims were prohibited.
- It was significant that the phrase “unless this can be substantiated” was not used to qualify the first sentence but only the second sentence.
C) Although not necessary to consider, because of the above construction, the Committee considered that it was right and proper to consider whether, if they were wrong on the above construction, Novartis had substantiated the claim that Zolvix® was the world’s most effective wormer. Upon a careful consideration of the scientific papers provided, the Committee came to the view that it was not substantiated. In particular, the papers did not show, that on a balance of probabilities, the product is the World’s most effective wormer:-
- In all territories
- In all conditions; and
- Against all gut worms (anthelmintic-resistant or not) – even ‘economically significant’ worms, by which words it was suggested the strapline was qualified later on the same page.
Rather, the Committee considered that the scientific papers demonstrated that monepantel (the active ingredient of Zolvix®) was very effective against specific nematodes from specific regions of the world. Furthermore, the Committee considered that the Little/Hodge/Maeder et al paper (Veterinary Parasitology 181 (2011) 180-193), which was a review of a number of studies and which of them demonstrated that derquantel-abamectin had in excess of 95% efficacy against a large number of nematodes (most of them economically significant) was a powerful counterargument that the strapline of which complaint was made was not a correct statement.