Code of
Practice for the Promotion of Animal Medicines
Précis of Committee meetings held in 2011
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 However one of the items was withdrawn by agreement of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the complaint, but this has been withdrawn.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In relation to item 2, which had been withdrawn, the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 2x2.5 mg
tablets daily was greater than 1x5 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 2x2.5 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”.
Case No. 282/07/11.
Novartis Animal Health/Animalcare regarding promotion of Benazacare
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.
The Complaint
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.
Case No. 283/8/11 : Boehringer Ingelheim / MSD Animal
Health: Promotion of Cobactan
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 [1997] 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.
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