Précis of Committee meetings held in 2011
- 281 : Intervet/Schering Plough Animal Health / Dechra Veterinary Products Ltd: Felimazole
- 282 : Novartis Animal Health/Animalcare: Benazacare
- 283 : Boehringer Ingelheim / MSD Animal Health: Cobactan
Case No. 281/05/11. Intervet/Schering Plough Animal Health/Dechra Veterinary Products Ltd: Felimazole
This case originally involved four items of complaint brought to the Committee’s attention by Intervet /Schering-Plough Animal Health involving promotion of Felimazole® by Dechra Veterinary Products Ltd in the 11 April 2011 edition of the Vet Times and also in their Felimazole detail aid/brochure. However one of the items was withdrawn by agreement of the parties prior to the meeting.
The original four items to which complaint was made are as follows:
Item 1: As being that referred to in both paragraphs numbered (1), in connection with both the advertisement and the detailer, as being essentially the same, that is to say the words: “Are you taking a heavy-handed approach to hyperthyroidism?” combined with both the image of the hammer etc. and the supporting text “Felimazole offers you the smallest starting dose and dose adjustments of any licensed treatment for feline hyperthyroidism” together with the alleged vagueness of the brochure as a whole.
Item 2: As being the words from the advertisement: “Felimazole offers you the smallest starting dose and dose adjustments of any licensed treatment for feline hyperthyroidism’ comprising paragraph 2 of the complaint, but this has been withdrawn.
Item 3: Identified as being the words : “FELIMAZOLE, YOU DON’T HAVE TO!” combined with the words “ARE YOU TAKING A HEAVY-HANDED APPROACH TO HYPERTHYROIDISM?”, as contained in page 6 of the brochure and comprising paragraph two of the detailer.
Item 4: Identified as being the Felimazole dosing table on page 4 of the detailer comprising paragraph numbered 5 of the complaint.
The Chairman introduced to the meeting the various considerations behind the complaint sent by the Complainant and the response as supplied by the Respondent.
He drew attention to the two clauses of the Code whereby the Complainant maintained items one and three were in breach, that is to say clause 4.3, misleading, and clause 6.1, disparaging the Complainant’s product: Vidalta ™.
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.
6.1 The products or services of other companies must not be disparaged either directly or by implication.
In relation to item 2, which had been withdrawn, the Chairman drew attention to the fact that the terms of agreement would make the promotion not make sense or would at least be ungrammatical, in that in the advertisement changing the word “smallest” in the phrase “Felimazole offers you the smallest starting dose and dose adjustments of any licensed treatment for feline hyperthyroidism” to “small” would not work.
In relation to item 3 the Chairman asked the Secretary to clarify the reasoning behind his determination as to the difference between this item and item one.
The Secretary explained that the basis whereby items were determined depended on the actual words used.
Thus in the case of item 1 the words to which complaint was being made were “are you taking a heavy-handed approach to hyperthyroidism?” as supported by other text and images. In the case of item three, the words to which complaint was being made were: “With Felimazole, you don’t have to!”, again, as supported by text; in particular the words: “are you taking a heavy-handed approach to hyperthyroidism?”.
As regards item four the Chairman referred to the table to which complaint was being made to which it was said that it was misleading (clause 4.3) and was inconsistent with the SPC of the product (clause 4.7).
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.
The Chairman asked the members, in particular the independent veterinary surgeon, to explain the meaning and the reasoning behind the complaint and its response, being referable to the difference between a daily dose of one 5 mg tablet compared with a twice daily dose of 2.5 mg.
The independent veterinary surgeon explained firstly that it was clearly stated in the product’s SPC, that the efficacy of 2×2.5 mg tablets daily was greater than 1×5 mg tablet daily.
He went on to explain that there were potentially compliance problems with asking pet owners to administer tablets orally to cats, which could be difficult. There was, therefore, a marketing advantage to have a single dose per day regime or try to imply that a daily dosage of a single 5 mg tablet application was as acceptable as twice daily 2.5 mg tablet application, when in fact this was not the case according to the SPC.
Other members drew attention to the asterisk which was on the previous page before the table, against the statement “2.5 mg twice a day” and its reference to the note on the last page of the detailer, which stated “for optimal efficacy, the starting dose for Felimazole should be 2.5 mg twice daily”, and suggested that the asterisk should have been against the 5 mg once a day entry, and moreover it should have been also put against the 5 mg reference on the table and that it would have been quite easy to have done so. Members pointed out, of course, that it was in the interest of the marketing thrust to avoid indicating any greater benefit which came from administering two tablets as opposed to one.
Reverting to discussing items one and three, which it was felt involved the same issues, it was explained by more than one member that it was correct that there was only one competitor licensed orally administered drug to treat hyperthyroidism in cats, and that was Vidalta, the Complainant’s product; that the latest science relied upon by the Respondent that starting with lower dosage was now perceived as being preferable was correct, but that the two drugs worked differently, in not having the same active ingredient. Vidalta’s active ingredient, carbimazole, works in vivo by being converted, in the body, to methimazole. The active ingredient in the Respondent’s product: thiamazole is effectively the same ingredient as methimazole. Accordingly Felimazole works directly once administered; Vidalta works indirectly, being converted first. Also it is produced in a manner whereby it is released over a period of time. The net effect of these features is that the dosage efficacy between the two are different: the Chairman drew attention to the article supplied by the Respondent with its formal response: “Canine and Feline Endocrinology and Reproduction (Feldman and Nelson) at page 201 where it states “a 5 mg dose of carbimazole is approximately equal to 3 mg of methimazole”. Likewise in the paper “Pharmacologic Management of Feline Hyperthyroidism” (Trepanier) it was stated at page 784 “a 5 mg dose of carbimazole yields approximately 50% lower methimazole in the plasma concentrations than does a 5 mg dose of methimazole. A number of members opined the view that, broadly speaking, a 5 mg dose of Felimazole (thiamazole) equates to 10 mg of Vidalta (carbimazole). They also stated that the 10 mg dose of Vidalta would be likely to be absorbed over a longer period of time than its equivalent 5 mg dose of Felimazole, which it could be assumed was the explanation for the contra indication in that product’s SPC, referred to above, which indicated that the greatest efficacy would come from a daily dose of two 2.5 mg tablets, rather than one 5 mg tablet.
There was also discussion on the side-effects that could arise from the treatment by these drugs. The independent veterinarian said that in his experience vomiting was the most usual side effect, but unmasking of renal disease was an important consideration, well known by most small animal practitioners.
In response to the Chairman’s enquiry, it was confirmed by members that in general the oral administration of the two licensed products in question would be the preferred initial treatment to either surgery or radioactive iodine.
A member emphasised the importance of meeting “peaks” and “troughs” in treatment; arguably the controlled release of Vidalta was helpful in that regard, and it also emphasised one of the reasons for ideal efficacy arising through a daily dose 2 x 2.5 tablets, rather than a single 5 mg tablet of Felimazole.
The Chairman suggested that item 3 in its particular wording, specifically indicating that using Felimazole avoided a heavy handed approach, made it very clear that the promotion was directed against Vidalta, in a way which was arguably misleading. However, he counselled caution in suggesting that the promotion actually disparaged the competitor product.
A member suggested the key to understanding the purpose behind the promotion lay in considering starting doses. There was a sub-text innuendo.
Another member asked why the parties agreed on a change to “small” in the withdrawn item 2 where relating to the advertisement, when the obviously preferable alternative word was “lower”, as used in the detailer.
Another member suggested that the introduction to the market of the 2.5 mg Felimazole tablet is quite recent.
At this point the Chairman decided to ask the parties’ representatives to join the meeting
The Chairman then invited the Complainant’s representatives to make their presentation.
In summary the Complainant argued that the promotion involved a negative title and negative imagery, focusing on alleged negative safety aspects of the only other oral licensed treatment: Vidalta. Data was shown suggesting that the Complainant’s product Vidalta had increased market share over the years 2007 to date, at the expense of Felimazole, so that it was now the market leader, and it was suggested that this lay behind the marketing thrust of the promotion.
The use of the phrase “heavy-handed approach, combined with the picture of a hammer crushing a nut, could only be interpreted as suggesting using Vidalta was a heavy-handed approach.
The reference in the detailer to the words of Professor Gunn-Moore, raised issues of safety, suggesting serious harm may be caused by that heavy-handed approach. Again the Complainant’s view was that this could only be taken to relate to using Vidalta. In relation to item three, stating that with Felimazole, you don’t have to use a heavy-handed approach, the promotion inevitably implied that if the reader used Vidalta, it would be heavy-handed.
In commenting on the formal response of the Respondent, it was suggested that it did not seek to dispute that the promotion was directed against use of Vidalta, which as a result was disparaging that product; even if there was technical or medical support for the propositions relied upon, its form of presentation was inaccurate and as a result disparaging. The representatives drew attention to the Guidance Note no 2, relating to “safety”, which stated that attacking the safety of another licensed product, which given the existence of the licence must be deemed safe, would inevitably be a disparagement of that product, and that therefore items one and three were both misleading contrary to clause 4.3, but also disparaging, contrary to clause 6.1 (even if the Respondent did not intend to disparage the Complainant’s product).
Moving on to item four, the Complainant’s representatives suggested that the chart or table selectively omitted important SPC prescribing information on the difference between selecting 2.5 mg twice daily as opposed to 5 mg once daily, which should only be used where compliance is a problem, otherwise reduced efficacy will result.
Commenting on the Respondent’s response, it was suggested that this implied that the qualification of the “starting dose” section on the preceding page related to this table. However the table is in the “long-term medical management” section, and includes a dose which is not licensed for starting treatment. Accordingly the qualification referring to optimal efficacy for the starting dose for Felimazole being 2.5 mg twice daily does not in fact refer to long-term use. The Felimazole SPC indicates reduced efficacy will result from once daily use of 5 mg, regardless whether this is a starting or maintenance dose.
In summary in relation to item four, the Respondent’s case was that the table omitted clinically important and commercially disadvantageous SPC information; its omission could be detrimental to the clinical treatment of hypothyroid cats and was therefore misleading (clause 4.3) and inconsistent with the SPC (clause 4.7).
During the course of the presentation the Chairman raised queries regarding to the withdrawn item 2, pointing out that the agreed alterations would not make grammatical sense to the current promotion in changing “small” for “smallest”. The response was that whilst the principle had now been agreed, obviously the actual wording of the promotion would have to be altered to make sense, within the terms of the agreed principle.
Again in response to queries the Respondent’s representatives confirmed their view that adopting treatment by surgery would be likely to be the last resort, and treatment by oral medication would generally be preferred. Inevitably that therefore meant that the adverse concerns expressed in the promotion in the view of the Representatives could only be said to apply to Vidalta.
The Chairman also drew attention to their presentation slide, which referred to questions coming back from vets, and queries as to the safety of using Vidalta. The Representatives were unable to provide supporting evidence for these statements but confirmed nevertheless that they had been received.
The Chairman raised concerns in the supporting material of the Respondent’s response governing the ratio between the two treatments and the extent to which it could be said that 10 mg of Vidalta would equate to 5 mg of Felimazole, which the Representatives confirmed was broadly an acceptable comparison. They would constitute very similar doses of pharmacologically active compound.
Another member raised the issue of the absorption of Felimazole and the sustained release feature of Vidalta. The Representatives agreed that the breaking down and conversion of Vidalta would operate over a longer time than would be the case with Felimazole. They also emphasised the distinction between a starting dose and incremental doses. There was very little difference in relation to incremental doses. The representatives confirmed in response to the Chairman’s comment that the fact that there are lower dosages available with Felimazole does not mean usage of 10 mg Vidalta tablets is unsafe. It was this aspect of the promotion which the Complainant felt was particularly disparaging. A discussion ensued about the relative benefits of the two products and in particular the manner in which there could be a residual retention of benefit in one product as against the other.
The Complainant’s representatives confirmed that the price of each product was similar.
The Respondent’s representatives were then invited to give their presentation.
They emphasised the importance of the evolution of treatment of feline hyperthyroidism and the importance of a low starting dose; the importance of small dose adjustments; and the need to manage the risks associated with renal disease and with hypothyroidism following treatment. It was suggested that historically there had been a heavy-handed approach with lower disease awareness and knowledge and unsophisticated treatment and monitoring, whereas recent developments in medical knowledge emphasised that with better knowledge of the disease a more measured approach with regular monitoring and optimum patient care was what was necessary. A table showing the development since 1988 of the medical approach to this disease was supplied. Reference was made to the various articles which had been supplied with the formal response and which the Committee had already discussed, (see above).
Having regard to that background the representatives of the Respondent then looked at the promotion firstly in the context of items one and three and thereafter item 4. In so far as items one and three were concerned it was stated that the objectives of the phrase “are you taking a heavy-handed approach to hyperthyroidism?” was to obtain and reflect current and developing key opinion leaders’ thinking in relation to treating feline hyperthyroidism. It was to promote the findings of the latest studies relating to feline hyperthyroidism. It was to translate the new information into best practice recommendations and point out the risks associated with non-adherence. It was designed to have the fullest impact and challenge vets’ current approach to all the treatments they currently employ and persuade them to adopt the emerging best practice recommendations and to promote Felimazole’s product features, namely a low starting dose, small dose adjustments and flexibility of dosing, in addressing the best practice recommendations.
It was stated that the promotional words to which complaint had been made had been comprehensively researched; accurately represented the attitudes of key opinion leaders; was based on sound documented scientific evidence; had a high level of resonance with vets, and was not misleading, exaggerated or disparaging to Vidalta and therefore was not in breach of clauses 4.3 in 6.1 of the Code of Practice.
In relation to the withdrawn item two, the representatives of the Respondent emphasised that in their view the original position was factually correct but they were prepared to concede the change to “lower starting dose” to “low starting dose as it related to their detail aid and to change “smallest dose adjustments” to “small dose adjustments” as it related to the detail aid and concede the change to “small starting dose and dose adjustment” as it related to the advertisement.
Again queries were raised as to how this would actually work grammatically and the representatives confirmed that it was a question of adopting a principle rather than specifically the exact wording.
The representatives of the Respondents then went on to discuss item 4 and presented slides of the table and the preceding page and rear page of the detailer, relying on the footnote to which on the previous page there had been made a reference as against the 5 mg position. It was suggested that the illustrated dose combinations are consistent with the current Felimazole’s SPC; the issue was already addressed by an asterisk on the previous page; and that whilst they were prepared to move the asterisk from “2.5 mg twice a day” to “5 mg once daily” and move the qualifying statement to the bottom of the same page, they did not see that the present detailer in relation to the table was in reality a breach of the Code of Practice clauses 4.3 and 4.7.
In answer to the Chief Executive and other members the Respondent’s representatives confirmed that they did not wish to rely on any question of there being a material difference in the treatments provided by the two medications; emphasising that the message they were trying to give in the promotions was to persuade vets not to overdose. They rejected that there was an implicit message that Vidalta was unsafe. They emphasised that there was no explicit or even implied reference to Vidalta. The intention was to emphasise the benefits of low dosage, not specifically to criticise or compare with Vidalta. In responding to a suggestion from a member that they were attempting to challenge the status quo and that Vidalta is a large part of that status quo, the representatives stated that they were challenging all earlier approaches to treatment, including the use of Vidalta but not specifically Vidalta. It was the purpose of the promotion to educate. In responding to another member’s query that the active ingredients of the two products in context of dosage was not in their final effect that different, the reference to 2:1 ratio and 10 mg to 6 mg comparison was accepted by the representatives. They accepted that in reality the appropriate comparable dose for the Vidalta was very similar to that of Felimazole. They conceded that the difference in ranges were not reflected by dosage. They were not in a position to deal with the issues of concentration in the blood and sustained release that one product might have as against the other and that in any event they were not seeking to challenge the sustained release or the clinical profile of Vidalta. In terms of sale comparisons they stated that they considered that Felimazole was now ahead of Vidalta. They suggested that the promotions had stimulated a lot of debate and they had had a number of congratulatory communications from readers. It was confirmed that a single 2.5 mg dose of Felimazole would be off label.
The Chairman congratulated both sets of representatives on their presentations and asked them to leave the room.
A lengthy discussion ensued. It became quickly clear that there was unanimity of agreement, largely on the basis of the discussion that had taken place prior to the presentations, that the promotion very definitely would be seen by readers to relate to Vidalta and did not seek simply to educate readers. In reality the starting dosage of each medicine, and incremental dosage for each medicine, were broadly similar, in their effect. To the extent, therefore, that there was a suggestion that Felimazole was preferable to Vidalta in that context was misleading. There was, however, much more difficulty in concluding that necessarily the promotions were disparaging of Vidalta. A number of members drew attention to Guidance Note 2 and the fact that suggesting a competitor product was unsafe was in the terms of that guidance note automatically likely to be taken to disparage that product. However, assisted by the Chairman’s comments that drew a distinction between stating a product was unsafe, as opposed to being less safe, there was eventual unanimity that whilst items one and three were misleading, they did not disparage Vidalta, because there was no suggestion, even implicitly, from the promotions that Vidalta was unsafe. They could, however, reasonably be taken by a reader to infer that using Vidalta was less safe than using Felimazole, which was misleading.
In relation to item four, there was general agreement that the failure to place the asterisk against the 5 mg entry in the table was misleading. A number of members emphasised their concern that the present failure to draw attention to the different efficacy between a daily dosage of two tablets of 2.5 mg of Felimazole, as opposed to a single 5 mg tablet, would lead to veterinary surgeons to prescribe the latter single tablet, because of the difficulties of compliance in getting cats to accept orally the tablets. Apart from the obvious difficulties that can arise with the owner being bitten, cats could quite often hold the tablet in their mouths and subsequently reject it.
Members also noted two issues not included in the actual complaint of the Complainant. Firstly the failure to draw attention to the contra indication in the SPC of Felimazole, which required a minimum dosage of 2×2.5 mg per day, meant that the promotion could be read as suggesting an off label use. Secondly there was an omission of the information required by clause 7.2 of the Code of Practice, specifically 7.2 (iv).
In terms of what had actually been stated in the complaint, however, it was in due course agreed by the members that item 4 of the promotion was not inconsistent with the SPC of Felimazole.
Accordingly the unanimous decisions of the Committee were: –
1. In relation to items one and three referable to the words in the advertisement and detailer “Are you taking a heavy-handed approach to hyperthyroidism”? (as supported by text and image); and to the words in the detailer “with Felimazole, you don’t have to!” relating to the strapline “Are you taking a heavy-handed approach to hyperthyroidism?”, the Committee took the view that this advertisement and detailer by implication referred to Vidalta, in particular because Vidalta is the only other licensed oral treatment on the market for hyperthyroidism. Both the advertisement and the detailer implied that Vidalta is less safe in treating hyperthyroidism than Felimazole because Vidalta’s smallest dose is 10 mg/day. The Committee, whilst acknowledging that the scientific reports emphasized the importance of using low doses to avoid causing hypothyroidism in cats, was of the view that it was significant that the active ingredient in Vidalta (carbimazole) was different to that for Felimazole (methimazole) and studies presented to the Committee suggested that carbimazole needed to be taken in larger quantities to achieve the same pharmacokinetic effect as methimazole, Accordingly, the Committee was of the view that such an implication that Vidalta is less safe is in fact not correct, and therefore constitutes misleading promotions. The Committee, however, did not consider that the implication of these promotional items was that Vidalta is unsafe, which would have been a more serious finding, especially as there is no evidence to show that it is unsafe, nor, it should be recorded, did the Respondent, whether in its formal response or its submissions, suggest that such an implication was being made by the Respondent’s promotional words or image.
Accordingly the Committee found that both the advertisement and the detailer by reason of these two items misleads contrary to Clause 4.3 of the Code of Practice, by reasons of their implication that Vidalta is less safe than Felimazole. The Committee, however, did not agree that the promotional items disparaged the Complainant by being the manufacturer of Vidalta, which might have been the case if the implication had been that Vidalta was unsafe. Accordingly, it did not find any breach of Clause 6.1 of the Code of Practice.
2. In relation to item four, the Committee found that the table in question, on page four of the detailer, suggests that one dosage of 5 mg per day of Felimazole has the same efficacy as two doses of 2.5 mg, without any reference to the actual contrary indication (that 2 x 2.5 mg per day has greater efficacy than 1 x 5 mg per day) is thus misleading, contrary to Clause 4.3 of the Code of Practice.
The Committee would add that it considered that a contributory background fact to its finding of breach was because prescribers and users generally prefer to administer 1 rather than 2 doses because of difficulties in administering tablets to cats, which raises compliance concerns.
Nevertheless, the Committee did not consider that the table constituted a breach of Clause 4.7 of the Code of Practice, in that it was considered not inconsistent with the product’s SPC.
Although not part of the complaint, and therefore not discussed with the parties’ Representatives, the Committee also recommend that future promotional material for Felimazole should not:-
a. Imply a single 2.5 mg dose per day is a permitted starting dose, because that is contrary to the product’s SPC; (in this regard, the Committee considered that an asterisk appropriately placed referencing a footnote to this effect would be an effective way of avoiding such an implication) and
b. Omit the inclusion of the information required by Code of Practice Clause 7.2, in particular 7.2(iv) that “at a minimum, side effects, precautions, contra-indications and withdrawal periods of the product in the recommended dosage, and any other warnings relevant to the advertised indication(s) and the species of animal to which reference is made, consistent with the SPC”.
Background to the Complaint
This Case was originally brought to the Committee on 19 August 2011 to determine the preliminary issue raised by the Respondent relating to Rule 7 (a) on the grounds that the conduct, to which complaint was being made, had been in existence and had been carried on for more than two years (in fact four years). At that meeting the Committee determined that in accordance with Rule 7 (b) it would be unfair not to hear the complaint. The unanimous decision of the Committee was that the complaint involved promotion by Animalcare’s representatives which was, therefore, within the jurisdiction of the Committee and the Code of Practice.
The Case was then heard on the 16th of September 2011. The Respondent declined the opportunity to be represented and failed to pay the appropriate fee. The Respondent cited the reason as anti-trust and anti-competition. The unanimous decision of the Committee, in the absence of the Respondent Company supplying any contrary factual evidence, found that the Respondent had offered infusion pumps in exchange for veterinary practices entering into written contracts with the Respondent for the supply of one or more medical products including Benazecare® and that it was more likely than not that infusion pumps were provided upon signature of the contract. Furthermore, the Committee had no doubt that that the acts in question did amount to promotion as defined by Clause 1.1. Therefore, this did constitute a breach of Clause 18.2 as it constituted a discount referable to price within the exception provided by the Clause.
Animalcare were also reported to the Board of NOAH, under Rule 17 and 18, as they had not co-operated with the Rules and Procedures of the Code, in that they refused to submit substantiation in their defence and failed to pay the appropriate fee. They had also not signed the Undertaking issued by the Code of Practice Committee following the hearing of the Case, on September 16th, which was brought by Novartis Animal Health, and at which they were found in breach of Rule 18.2.
The Respondents, represented by their Chief Executive Mr Stephen Wildridge, were called to a meeting of the NOAH Board on October 18th. As this was the first complaint brought before the Code of Practice Committee against Animalcare, the Board took this into consideration. The Board instructed Animalcare to re-engage with the Rules and spirit of the Code and to pay the fee, provide the Committee with documentation and justification to support their position relating to the Case. Additionally, if this engagement was not forthcoming, within 7 days of the formal notification, then the Board would reconvene to decide what, if any, further sanctions should be taken against Animalcare pursuant to Rule 21 of the Code.
The Respondent re-engaged and co-operated by making a formal response and paid the fee. At the request of the Board, this extraordinary circumstance was considered by the Code of Practice Committee on the 8th of November 2011.
This one item complaint originally arose by the letter of Ms Gaynor Hillier on behalf of the Complainant: Novartis Animal Health, dated 5th July 2011, which alleged that Animalcare’s sale agents or representatives had been engaged in offering veterinary equipment to veterinary practices (viz infusion pumps) in consideration for the conversion of accounts with Novartis’s Fortekor to Animalcare’s Benazecare, which Novartis maintained was in breach of Clauses 18.2 and 18.1of the Code of Practice.
Committee Meeting 8 November 2011
The Chairman informed the Committee that the Respondent, following the reports made to the Board, had been reprimanded by the Board for its failure to co-operate.
The Chairman advised the precise status of the meeting and what its consideration should be. The meeting on 16 September 2011 had given a full opportunity to both parties to present their cases and for the Committee to make a full decision in the light of the information supplied to it. It was entirely a matter for the Respondent, whether or not to participate. Accordingly, there was no question of permitting any suggestion that the decision taken on 16 September 2011 was wrong. All that was now happening was that this was an opportunity for the Respondent to put its case, if it so wished, that there was no breach of Code of Practice Clauses 18.1 or 18.2, so that the Committee can consider whether it should continue to require the Respondent to provide the Undertaking in the form originally sought, or at all, which, to date, had not been given.
The Chairman then commenced a discussion as regards the facts now to be considered in the context of the complaint
The representatives of both parties were invited into the meeting.
The Chairman introduced himself. He explained that the meeting had been convened to consider whether the prior decision in Case 282, in the light of information being given by the Respondent, which had not been supplied to the Committee at their earlier meeting, should be reconsidered. The Chairman emphasised that he felt it was only proper for the benefit of the Respondent’s representative, to hear the presentation by the Complainant, and at any event, there were some members of the Committee, who had not been present at the earlier meeting. It was accepted that the intention of this meeting was to see if the Committee, in light of the information which had not been made available to the Committee at the earlier meeting, should adopt a different decision on Clause 18.2 to that which had been adopted on 16th September. The Chairman accepted that if that were the case, the terms of the current Undertaking, required of the Respondent might be altered or not now required.
The Complainant’s representatives were invited to give their presentation. However, they queried why it was the case that the Committee would not be considering whether there was a breach of Clause 18.1. The Chairman explained that as the Committee, at the previous meeting, had decided that the subject of the complaint did not constitute a breach of Clause 18.1, there was no point in reconsidering it now, because the information to be heard from the Respondent was designed to see if the Committee’s view, as regards a breach of Clause 18.2, might now be altered.
The Complainant’s representatives proceeded to provide details of the type of infusion pump that was being offered, namely a Vetpro 2000. They were being retailed at £960.51.
By way of background, it was explained that both parties’ products had the same active ingredient: Benazepril which is an ACE inhibitor.
Whilst the Complainant had previously operated equipment deals in relation to Fortekor, following review by an internal committee in 2008, this practice was deemed non-compliant with the NOAH Code of Practice and, in particular, reference was made to Case Number 271 which was felt by the Complainant to have shown their decision taken to cease operating equipment deals was correct. It was in this knowledge that it had recently become known to the Complainant through comments made to their sales representatives by veterinary practices that Animalcare had provided practices with veterinary equipment (infusion pumps) in exchange for the sale of a licensed veterinary product, namely Benazecare® on a fixed term contract. Following this, letters were exchanged with the Respondent in March 2011. Although the practice was acknowledged as having taken place by Animalcare in inter-company correspondence, which was referred to, the Respondent had not provided the Complainant with any documents connected with the scheme and, as no agreement could be reached between the parties, the reference had been made to the Committee.
Having set out the terms of Clause 18.2, it was maintained that an infusion pump is not related to the correct use of the medication’s administration or its disposal and that products SPC makes no reference to fluid therapy. Infusion pumps are neither diagnostic nor an educational system at a retail price indicated it was considered in any event, the price would be excessive. They drew attention specifically to the Chairman’s note in Case 271, which was that the purpose of Clause 18.2 was to ensure that any prescription by prescriber of a pharmaceutical for animals was not in any way influenced or induced (or perceived as influenced or induced) by the offer of gifts, but was solely based upon the quality of the product or the price of the product.
The Complainant’s representatives were thanked for their presentation, and the Respondent’s representative was invited to give his presentation.
He maintained that some of the comments made in the Complainant’s presentation were incorrect but he did not intend to address those points, as they were not relevant to the issues.
He said that Animalcare supplied licensed and non-licensed products over a fixed term to secure a discount that would support the provision of equipment. He said equipment deals were common practice in the industry and the process was conducted strictly in accordance with both the spirit and the wording of the Code of Practice.
The Chairman asked for more precise details of how it was suggested that the discount plan justified provision of the equipment. The Respondent’s representative said that he did not intend to provide details which could be used by competitors. He considered adequate information had been given to support the nature of the discount plan, which was provided to veterinary practices on a case-by-case basis. This discount could then be taken by provision of equipment.
The Chairman asked how the practice related to “Price”, as required by the Code of Practice Clause 18.2. The Respondent’s representative stated that what was carried out was entirely normal and common practice within the industry, whereby discounts were given for supply. He confirmed that they did not influence the contracts made for the supply of medicinal product with the wholesaler intermediary. As with other manufacturers, the discount was offered to the veterinary practice if they purchased through the wholesaler intermediary a particular quantity of products, the amount being decided on a case-by-case basis.
The Chairman asked if he could give an exact example, for example, if a veterinary practice purchased 100 products, how much rebate, if any, would be supplied. The Respondent’s representative said the process was one way: assuming the pre-agreement determined a particular amount justifying a discount then on purchase achieving that target, the cash discount was supplied. In answer to the Chairman’s query whether this was a direct payment, it was confirmed that it was, as was the case with other manufacturers. Everything was on a case-by-case basis, and there were no particular requirements governing value, product or time, which elements would be negotiated between the Animalcare sales representative and the veterinary practice at the time the contract was agreed.
The Respondent’s representative stated that the sample copy provided to the Committee was an edited version of what would be negotiated on a case-by-case basis. In answering queries from the Chairman, he stated it was a précis of what had been offered with the exact wording, albeit removing specific value time & product details. He confirmed that some of the products were licensed and some were not. He confirmed that the equipment was supplied when the contract started. If the required quantity of product was in the event not purchased, then the practice would owe the balance due. This balance would relate precisely to the value of the infusion pump, which in turn would cross relate to the cash discount negotiated at the outset, albeit that the cash discount was earned as the quantity of product was achieved, over the term of the contract.
A member asked if it was not the case that the only advantage that this gave to the practice was that of not having to borrow money and pay interest for the purchase of the equipment? In effect, if the equipment was being purchased at the normal price, and this equated to the discount that was being offered, then the practice might as well take the cash discount, save for the benefit of not having to borrow money at the time of entry into the contract to pay for the equipment. The Respondent’s representative said that he was not prepared to go into specific details. He, however, did confirm that if given a hypothetical example, suggested by the Chairman, of, say, equipment value totalling £950, and ultimately securing a discount of say, £912, once the product had been purchased, then the practice would be liable to pay the difference. That was the risk the practice took. He confirmed that equipment was delivered directly by Animalcare and that they supply equipment as part of their product range, in addition to the medicinal products. The value of the equipment was based on their normal list price. He insisted that no one got equipment free. He suggested it was not a gift. If practices did not purchase the required quantity of product, then they would be charged the balance of the invoice price, representing the difference between whatever discount to which they were entitled and agreed upfront, and the actual value of the equipment that was supplied, based on their own list price.
The Respondent insisted that other members of the industry were carrying out a similar set of policies. In his view, the whole arrangement came down to a discount and therefore price, within the meaning of the rule.
The Respondent’s representative was thanked for his responses, and the Complainant’s representatives were asked if they had any brief comment and simply stated that they felt the Committee had to make a decision as to when the issue of purchase of product, and price cross related to the supply of the equipment, which in their view was not at the point of product purchase and therefore not relative to price.
The representatives were asked to leave the room.
A lengthy discussion ensued and the Committee’s unanimous decision was based on its finding that equipment is offered and supplied by Animalcare Limited upon the signing of the agreement. The Committee expressed unease about the fact that Animalcare had not supplied redacted copies of contracts actually supplied to veterinary practices. The Committee, however, on the basis of the equipment deal sample in blank agreement supplied to it, noted that if the products to which veterinary practices were said to have agreed to purchase were actually purchased over the period of the contract, then the infusion pumps (being the equipment in this case) would be retained by the veterinary practice.
The Committee noted Animalcare’s submission in the e-mail of 3rd November 2011 that its practice fell into example 7 as set out in the minutes of the 16 September 2011 meeting. The Committee rejected that submission as Animalcare actually offered the equipment rather than simply provide an equivalent value in cash, from which the veterinary practice could purchase the equipment.
The Committee’s view was that, as such, a piece of equipment is neither the price nor the product within the meaning of Clause 18.2; that such amounts to a gift being offered in relation to the sale; or purchase; or prescription of animal medicine. Furthermore the Committee took into account that Guidance Note 4, paragraph 7, states that the word “gift” includes any pecuniary advantage being offered, with the exception of price or product itself.
Accordingly, having heard the representations of the Respondent, the Committee saw no reason to come to a different decision to which it did on 16 September 2011; in particular because the fact decided on 16 September 2011 by the Committee that more likely than not the equipment being supplied was delivered on or about the time when the contract was entered into, had now been confirmed by the Respondent.
Accordingly, the unanimous decision of the Committee was that the practice, to which complaint was made, was in breach of Code of Practice Clause 18.2.
Animalcare would be asked to provide the Undertaking originally sought after the meeting of 16 September 2011. A cheque had now been received for the required fee in respect of that meeting.
The Committee’s decision was reported back to the Board and Animalcare were asked to provide the signed Undertaking before the close of business on Wednesday 23rd November 2011.
The signed Undertaking was duly received and in so far as the Code of Practice Committee is concerned, the Case can now be considered as closed.
This two item case involved a complaint by the Complainant: Boehringer Ingelheim Limited concerning an advertorial and an advertisement of the Respondent: MDS Animal Health in the August 2011 edition of Dairy Farmer of their products Cobactan® 2.5 and Cobactan® MC as combination therapy for “Early Lactation Therapy” (“ELT”). Discussions and alterations had taken place since the June and July promotions in Dairy Farmer, but these alterations did not satisfy the Complainant. The primary concern involved what was felt by the Complainant to be promotion of the use of combination therapy with a fourth generation cephalosporin antibiotic to farmers as a generalist early first-line approach to mastitis, through the ELT branding. This, the Complainant alleged, was both off-label and irresponsible promotion of medicines, with the potential for serious public health consequences. The Respondent’s general response to these concerns was that the Cobactan combination therapy as a first-line treatment related to cases of E.coli mastitis and therefore was not a generalist approach. The promotion specifically referred to the successful treatment of a number of E.coli mastitis cases on an individual farm in Lancashire. The Respondent maintained that the advertisement described the case study where, with the close involvement of the veterinary surgeon, the use of Cobactan combination therapy as a first-line treatment was the best treatment of choice for E.coli mastitis, as part of appropriate herd mastitis management protocol.
The two specific items of complaint related to:
Item 1: ELT Combine and cure for the high hopes herd advert. Dairy Farmer August 2011. Page 5.
“ELT: Early Lactation therapy” Juxtapositioned with “Cobactan Achieve More” Juxtapositioned with “Combination therapy success for the High Hopes herd: Mastitis rates halved on Lancs farm”
Item 2: Early Lactation therapy: ELT sponsored series brought to you by MSD Animal Health, manufacturers of Cobactan advertorial. Dairy Farmer August 2011, Page 7.
“Early Lactation Therapy ELT sponsored series brought to you by MSD Animal health, manufacturers of Cobactan” Juxtapostioned with “Look out for a regular ELT column in Dairy Farmer, where we will examine why a standard tube plus an injectable antibiotic works, and we’ll be speaking to some of the farmers who were involved in the trials”.
The Complainant alleged that the promotions were in breach of Code of Practice Clauses 3; 4.2; 4.3; 4.6; 4.7; 5.1; 5.2; 6.1; 6.2 & 7.6.
The Complainant’s representative was invited to present the Complainant’s case:
The two specific items were referred to with the above background raised by the June and July editions of the Dairy Farmer and the advertisements and advertorials contained in those editions.
The concerns of the Complainant related to the combination of ELT with Cobactan Combination Therapy; that this is farmer targeted material and that the BVA Guidelines are aimed at the veterinary profession. Bacteriology and sensitivity fall under the remit of the veterinary surgeon. Cobactan is only licensed for use in E.coli mastitis, not for the general treatment of mastitis cases, whilst farmers’ general knowledge of the causative pathogens involved in early cases of mastitis is generally going to be limited. ELT branding indicates an early, first-line generalist approach to the treatment of all causes of mastitis. It was maintained that the articles provided a take-home message to the farmer that only Cobactan Combination Therapy can be used within that generalised ELT approach. Accordingly, it was alleged that, the general thrust of the promotions was misleading and encouraged off-licence use. The Committee for Veterinary Medicines Products (CVMP – an EU group involved in the regulation of veterinary medicines) have produced guidelines which make it clear that off label use should be strongly discouraged, that this is not in line with industry guidelines and breaches a number of Clauses of the NOAH Code of Practice, as set out above.
The representative then proceeded to deal with the specific complaints and two items in question.
In relation to item 1 the concern was that the words “ELT: early lactation therapy” being juxtapositioned with “Cobactan achieve more” juxtapositioned with “combination therapy success for the High Hopes herd: mastitis rates halved in Lancs farm” provided a misleading message to farmers, bearing in mind that Cobactan Combination Therapy is only licensed in E.coli mastitis. It suggests ELT as an early treatment with only Cobactan Combination Therapy, thereby encouraging off-label inappropriate use of the fourth-generation cephalosporin.
In answer to a query from the Chairman, it was explained that the combination use of Cobactan 2.5% was only licensed for the combination therapy in E-coli, although it could be used singly for other purposes, as clarified also by members on the Committee.
In answer to queries from members that in the August edition of both the advertisement and the advertorial, there is specific reference to E.coli mastitis, the representative maintained that there was an insufficiency of emphasis in the promotion, sufficient to make clear to the farmer reader the distinction of that form of mastitis from other forms of mastitis, when considering the appropriate ELT.
In relation to item 2, the concern related to the words “Early Lactation Therapy ELT sponsored series brought to you by MSD Animal health, manufacturers of Cobactan” juxtapositioned with “look out for a regular ELT column in Dairy Farmer, where we will examine why a standard tube plus an injectable antibiotic works, and we’ll be speaking to some of the farmers who were involved in the trials.”
Here the Complainant maintained that this constituted a generalist use of fourth-generation cephalosporin in circumstances where the pathogen was unknown. It thereby gave a misleading message to farmers, suggesting only Cobactan Combination Therapy for ELT; and thereby encouraging off-licence use of the fourth-generation cephalosporin.
The Complainant maintained that E.coli mastitis represented only 19.8% of mastitis cases found in UK farms and to emphasise the use of a product that was a fourth-generation cephalosporin as a first-line treatment for ELT in these circumstances was misleading, inappropriate and not compliant, as explained above.
The Respondent’s representatives were then invited to give their presentation.
They maintained that the whole issue hinges around the use of an educational approach to mastitis control whereby the Respondent, rather than promoting antimicrobials in isolation, would prefer to promote a management protocol for the prevention and control of this condition. In that regard, it was maintained that ELT is entirely consistent with the NOAH Code of Practice and is a responsible approach to disease, encouraging, in the view of the Respondent, the vet-farmer relationship. Accordingly, the Respondent’s approach was maintained to be an educational and informative one, with education of and communication with all members of the industry, including “Studio Bovine” video links that bring information from international conferences to the Respondent’s customers. In the specific issue of udder health, they wish to promote of veterinary surgeons and farmers working together; the use of case studies to emphasise what can be achieved through vet & farmer working together; the provision of sponsored bacteriology and sensitivity facilities at an independent laboratory, combined with an aim to be educational and informative.
They stated that Cobactan Combination Therapy is a licensed treatment contained within the Cobactan MC SPC. It is licensed to be used to treat cases of E.coli mastitis, which is highlighted in both the advertorial and the advertisement; and that the case study use was on a farm where E.coli was the dominant pathogen found.
It was argued that E.coli is an important pathogen in UK dairy farms and reference was made to the Andrew Bradley paper whereby 19.8% of mastitis cases are attributable to E.coli and that after Strep uberis it is the most prevalent environmental mastitis causing pathogen.
ELT was stated to encompass three key points: (1) careful monitoring of at risk animals (i.e. early lactation animals); (2) early identification of clinical mastitis and (3) early treatment of clinical cases of mastitis with an appropriate antibiotic.
It was maintained that the promotion constituted an educational approach that was not specific to any particular antibiotic and that it recognised the importance of good management practice to be used as part of a mastitis control strategy. Reference was made to the Dairy Co’s 6 point plan and the original ‘5 point plan’ of the 1960s. It was stated that the Respondent’s material works within clinical and scientific opinion and does not disparage such opinion with the vet:farmer relationship being emphasised in the advertisement and the advertorial. The Respondent strongly agrees with the BVA eight-point plan and the responsible use of antibiotics, involving an antimicrobial choice with any treatment protocols being based on farm history and discussions between the vet and the farmer. The Respondent maintained agreement with the findings made in the Andrew Bradley peer review paper referred to above. They stated that 19.8% of mastitis cases constitutes a significant proportion. On the farm, in the case study, E.coli had been identified and in consultation with the veterinary surgeon Cobactan Combination Therapy had been prescribed as the treatment of choice for E.coli cases.
In relation to the Code of Practice Clauses in respect of which the Complainant alleged the promotions to be in breach, the Respondent argued that there had been no disparagement of products or services provided by other companies; or that the promotion had been used in a way that would discredit or reduce confidence in the industry; that the information provided reflected current knowledge; that the information provided was accurate and informative; that all the information provided maintained respect and confidence; that all the information provided was consistent with the relevant SPC; that treatment of E.coli mastitis is a specific licensed claim for Cobactan Combination Therapy and that the promotions were not all embracing in their claims. Finally the Respondent maintained its promotional material was not designed to disguise its true nature.
In answer to queries from the Chairman and members of the Committee, the representatives stated that heifers were at greater risk of mastitis; that the use of the ELT logo was based on an educational principle, which was not limited to Cobactan Combination Therapy; that this therapy would only be used with the involvement of vet and discussion between the vet and the farmer; that their promotion was designed to be educational and informative, making known to farmers the latest R&D benefits; that E.coli mastitis was highlighted, because it was the dominant example found in the illustrated case study. As such, it highlighted the very significant 19.8% proportion of mastitis cases. This was recognised as being typical in early lactation cases. The point was made that E.coli mastitis was highly toxic and in the cases of E.coli mastitis there often was an urgent need for early treatment and that in the case study the treatment of choice was found to be Cobactan Combination Therapy. In answer to the query as to whether it was irresponsible to use such therapy as the treatment without first treating with another antimicrobials, the representatives emphasised that there had to be close consultation with the veterinary surgeon and knowledge of the likely pathogens that were involved on that particular farm and in that herd when treatment decisions were being made.
The Complainant’s representative was offered the opportunity for a short response and emphasised the purpose of the promotion was, in his opinion, to provide a take-home message, which effectively maintained a first-line treatment for mastitis cases consisting of Cobactan Combination Therapy in general ELT circumstances, which was inappropriate. It was pointed out that, however much discouraged, there were inevitably stocks of animal medicines on farms retained by farmers from previous prescribed treatment, as to which comment, there was general agreement expressed by members.
The representatives of the parties were thanked for their respective presentations, and left the room.
A lengthy and careful examination of the various issues then ensued. The Committee formed a view quickly that the advertorial was educational, albeit a promotion, which was balanced, fair and to which little objection could be made, whether on the basis as put by the Complainant or at all.
However, in the context of the advertisement, a few members, and in particular the independent farmer member, raised concerns as to the use of the ELT logo and in their view, the relatively minimal reference to E.coli mastitis. There was general agreement that the issue highlighted by the Complainant was highly pertinent, and that as a generality, a fourth-generation cephalosporin such as Cobactan Combination Therapy should not be used as a first-line treatment in all cases of mastitis. However, most members, particularly emphasised by the veterinary surgeon members, recognised there could be circumstances when there is evidence of the E.coli pathogen (e.g. other recent cases in the same herd), and in those circumstances it was crucial that this treatment should be available for immediate use, if thought appropriate by the veterinary surgeon. This was because E.coli mastitis is highly toxic and could result very quickly in the death of the animal and the spread of the disease within the herd. In that regard, the Committee noted that the advertisement did clearly relate to a specific case study, in which just those circumstances existed.
Both the Chief Executive of NOAH and the Technical Executive emphasised the sensitivity of this subject, and in particular the Regulator’s general abhorrence of such first-line treatment and urged care in the manner in which the decisions and the minutes expressed the recognition that there could be circumstances when the use of a fourth-generation cephalosporin should be used before other antimicrobial treatment.
Accordingly the decisions of the Committee were:-
The unanimous view of the Committee was that neither the advertisement nor the advertorial in the August edition of the Dairy Farmer (that is the versions amended from earlier editions) were such as to give rise to a general message that Cobactan® combination therapy can be used as a generalised antibiotic for the purpose of treating any form of mastitis, whether such was caused by E.coli or other pathogens. It considered the advertorial was fair and balanced whilst accepting its purpose was promotion and not merely an educational article. With regards to the advertisement, it considered that there was no “take home” message that Cobactan ® combination therapy was appropriate as a generalised antibiotic treatment for any form of mastitis.
In particular, the advertisement described the use of Cobactan® combination therapy on a specific farm, and there was no suggestion that the facts stated were incorrect. Furthermore, the use of the “Early Lactation Therapy” logo was not misleading or incorrect as it was intended to describe a particular form of therapy for cows and heifers for treating mastitis as set out in the advertorial and was not promoted as being a therapy whereby Cobactan® combination therapy should always be used for treating mastitis – in particular, because the advertorial referred to treating mastitis with an “appropriate antibiotic”.
The Committee also took the view that in certain circumstances, it is appropriate to use Cobactan® combination therapy where there is either clinical or laboratory evidence of an E.coli mastitis problem in the herd without first treating with a narrow spectrum antimicrobial. In this regard, the Committee took account of the following
- The SPC for Cobactan 2.5% states that it is indicated for the treatment of ‘Acute E.coli mastitis with signs of systemic involvement’,
- The SPC merely indicated that narrow spectrum antibacterial therapy should be used for first line treatment where susceptibility testing suggests the likely efficacy of this approach. The Committee’s view was that in certain circumstances, if the severity of the case so warranted it, it was appropriate to use a fourth-generation cephalosporin as an initial treatment and that such was not off-SPC use.
- Where E.coli mastitis is present, the potential (sometimes fatal) consequences for the animal and the herd, and the speed with which these consequences could occur, would justify treatment with Cobactan® combination therapy before another narrow spectrum antimicrobial has been used .
- The marked efficacy of using a fourth-generation cephalosporin (cefquinome) for treating E.coli mastitis in comparison to ampicillin and cloxacillin (see Shpigel  Dairy Science Journal 80:318-323)
In the light of these findings the Committee considered there was no breach.
The Committee welcomed the alterations agreed by the parties whereby referral to E.coli was included as were reflected in the August editions of the advertisement and advertorial, without which, such might have given the impression that Cobactan® combined therapy was appropriate as a generalist antibiotic for curing mastitis.
Furthermore, the Committee accepted the principle, and wished to emphasise, that when promoting a fourth-generation cephalosporin for treatment of mastitis, care is needed to ensure that the reader, especially when this is likely to be an end-user, is not misled into wrongly believing that such is appropriate for a generalist treatment of mastitis and indeed emphasised the need for responsible use of broad spectrum antibiotics. However, in this case, the Committee was of the view that such care had indeed been taken by the Respondent.