Code of
Practice for the Promotion of Animal Medicines
Précis of Committee meetings held in 2006 for Circulation
to the Veterinary Press
Case No. 248 - Pfizer Animal Health /
Schering-Plough Animal Health regarding advertisements and brochures for
Nuflor Injectable Solution
This three item case, involved Schering-Plough’s product
NUFLOR Injectable Solution, in which respect it was alleged by the
Complainant, that the promotions were in breach of Code of Practice Clause
4.8 [promotion must not be inconsistent with the SPC, except that a
veterinary surgeon or other suitable 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 three items of promotion which complaint were made:-
-
“Efficacy of Nuflor in the treatment of BRD where
M.bovis is isolated”;
-
“Nuflor is effective against M.bovis” (Nuflor
technical bulletin No. 2.); and
-
“Acts fast on a broad spectrum of pathogens
including ….M.bovis”.
The argument of the Complainant was that the NUFLOR SPC
states under indication for use “Diseases caused by florfenicol
susceptible bacteria. Therapeutic treatment of respiratory tract infections
in cattle due to M. haemolytica, P. multocida and H. somnus.” (on the
basis that M.haemolytica is Mannheimia – a bacteria). It was accepted
that NUFLOR is indicated for the treatment of bovine respiratory disease due
to these three bacteria. However, it was suggested that the SPC does not
list M. bovis under indications for use, or ‘Pharmacodynamic
Properties’. It was argued that Mycoplasmas were not a sub-set of bacteria
and therefore not covered by the generic statement relating to bacteria on
an SPC.
The Respondent’s presented independent modern scientific
data to the committee that illustrated (or proved) that Mycoplasma bovis
was considered a form of mollicutes (the class name of degenerate bacteria
lacking a cell wall) and was therefore a bacterium and consequently the
promotional claims made were not inconsistent with the SPC In the
Respondent’s view, the SPC did not isolate M. bovis as lacking an
indication, but was inclusive and in that regard, the specific reference to
BRD which simply gives a list commencing with the word “including”,
indicates that there must be a wider family of bacteria not specifically
referred to within the SPC, but not excluded within the indication either.
In the event, the unanimous decision of the Committee
was:-
The Committee considered, based on both the evidence
presented by the respondent and the understanding of individual members,
that Mycoplasma bovis was a bacterium, or at least had not been
proved not to be a bacterium, and therefore the promotion complained of was
not inconsistent with the statement in the SPC that Nuflor was indicated for
use in respect of "diseases caused by florfenicol susceptible bacteria".
Accordingly the Committee found no breach of clause 4.8.
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249. Arnolds Veterinary Products / Janssen Animal
Health regarding Danilon Equidos advertisement
This two item case involved an advertisement for Janssen
Animal Health’s DANILON® EQUIDOS product which appeared in the 18 August and
8 September 2005 editions of Horse and Hound, and also issue of 274 of ‘Your
Horse’. The allegation was that this advertisement was in breach of Clause
4.3 of the Code. [Information about animal medicines must be accurate,
balanced and must not mislead, either directly or by implication, so that
critical unbiased judgements and decisions can be made].
Under a heading “DANILON® is a next generation prodrug
‘bute’ that’s kinder to the stomach and very palatable”, there were the
three following paragraphs:-
-
“Its unique formulation depends upon the liver to
convert it into ‘bute’. This has two distinct advantages.
-
Firstly, it carries a greatly reduced risk of stomach
ulcers, a well-known consequence of all non-steroidal anti-inflammatories.
These ulcers, of course, affect horses’ health and performance.
-
Secondly, it’s incredibly palatable. I proved that by
trialling it on my old hunter, Hannah, who was notorious for rejecting
traditional ‘butes’.”
The advertisement goes on to indicate that the source of
the promotional words is one “George Young MRCVS, Bearl Farm Veterinary
Clinic, Bywell, Stocksfield”. The two points of complaint identified,
referable to the above promotion, is stated by the Complainant to be as
follows:-
1) It was argued that the content of paragraph 2 of the
promotion, was highly misleading, because the reader of the advertisement
would immediately associate the two claimed benefits of “greatly reduced
risk of stomach ulcers” and “incredible palatability” to be a comparison
against the two other licensed POM of Equipalazone Powders and Prodynam, the
traditional products.
2) Secondly, it was argued that the palatability comment
in paragraph 3, did not constitute a statistically relevant trial as it
involved only one horse. It was emphasised that anecdotal evidence is
insufficient and a properly clinically proven fact is necessary,
particularly if the promotion is, as was the case here, targeted at a
consumer where the audience is less informed and more likely to be misled.
The unanimous decision of the Committee was as follows:-
First item:
1. The Committee considered that the statement "it
carries a greatly reduced risk of stomach ulcers, a well known consequence
of all non-steroidal anti-inflammatories" was not accurate or balanced since
the SPC for Danilon Equidos merely states "low ulcerogenic potential" and
the Respondent had no data to show a greatly reduced rate of ulcers compared
to Equipalazone and Prodynam. Accordingly the Committee found a breach
of clause 4.3.
Second item:
2. The Committee considered that the statement "it's
incredibly palatable. I proved that by trying it on my old hunter, Hannah,
who was notorious for rejecting traditional 'butes'" was not accurate or
balanced since the SPC contains no statement regarding palatability and the
Respondent had no evidence to support a claim to improved palatability
compared to other products other than the anecdote quoted. Accordingly the
Committee found a breach of clause 4.3.
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250. Pfizer Animal Health / Schering-Plough Animal
Health Nuflor Injectable Solution MIC study vs Tulathromycin (Draxxin:
Pfizer)
This one item case involved a complaint concerning the
Respondent’s promotion of a Minimum Inhibitory Concentration sensitivity
trial which compared NUFLOR and tulathromycin (Draxxin) against Histophilus
somni. It was alleged that in the context of the claim within the study,
which apparently demonstrated that 26% of H. somni isolates were resistant
to tulathromycin, constituted a breach of Clauses 4.2, 4.3 and 5.5 of the
NOAH Code of Practice, in that the claim did not reflect current scientific
opinion, was not accurate and did mislead and that it constituted a
comparison of products which were not factual or fair.
The essential point of issue, was that it was argued that
trials of this nature involved a key component that standard quality control
(QC) strains should be used under strictly applied conditions, and that if
the results of the standard QC strain are outside that expected, the results
from the field strains (under investigation), have to be considered invalid.
In the context of testing field strains of H. somni, it is important
that they are grown using special culture medium and test conditions, in
particular a CO2 enriched environment. The Complainant alleged
that the methodology of laboratory testing used was not in strict accordance
with the QC guidelines. This, it was argued by the Complainant, rendered the
trial unsatisfactory and, thereby, the promotion in breach of the Code of
Practice as alleged.
The Respondent’s Representatives produced the results of
a further trial, which was carried out by, and certified by, the same
laboratory as the original one – The Regional Veterinary Diagnostic
Laboratory of Ille et Vilaine in Rennes, to validate the original test, and
to support their argument that the original trial was not rendered
unsatisfactory by the failure to include H. somni ATCC700025. The
Respondent also provided reports of the various quality control procedures
utilised in both the original and new tests. It was noted, however, that the
Complainant would not have had sight of these repeated tests.
The Committee were asked to consider whether the absence
of the H. somni ATCC700025 control invalidated the results and
conclusions of the original laboratory study. After discussion it was clear
that the unanimous decision of the Committee was that:-
The Committee considered that it had not been proved that
the study in question had not employed adequate quality control procedures.
Accordingly the Committee found no breach of clause 4.2, 4.3
or 5.5.
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251. Merial Animal Health Limited / Novartis Animal
Health Limited - Stronghold Promotions
This case involved the extension to the
definition of promotion in Code of Practice Clause 1.1 and responses to
alleged technical enquiries. The Complainant, Merial Animal Health Limited
alleged the promotion of the concurrent use of Novartis Animal Health’s
Milbemax product with Pfizer Animal Health’s Stronghold product, constituted
a breach of Code of Practice Clauses 4.2, 4.3, 4.6, 4.7 and 5.1.
It was considered that the primary
issue revolved around Clause 4.7 in that “Promotion must not be
inconsistent with the SPC, except that a veterinary surgeon or other
suitably 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 2005 Data Sheet contained the
wording referable to the “Precautions for use” of the product,
being the basis upon which the complaint was raised, namely “During
the treatment with Milbemax, no other macrocyclic lactone should be
administered”. The 2006 Data Sheet has the same words under
the heading ‘Further information’. This warning was similarly
contained in the SPC.
The sample letter in question appeared
to be possibly a standard form of letter, although it was stated, by the
Respondent, to be used in response to questions. The question was stated to
‘often be asked’. The heavily worded disclaimer at the bottom of the
page, indicated that this was “not a legally binding statement”.
There were two paragraphs which appeared to be directed to different
situations. The first: “The half life for Milbemax is 1- 4 days, so
our opinion is that blood levels should be negligible by one week after
dosing” was not necessarily directed to concurrent use, but could
easily involve a question of when Milbemax can be administered when another
macrocyclic lactone is known to have been administered previously. The
second “Novartis has conducted studies with adult dogs and kittens,
giving Milbemax and selamectin together at peak levels of each product. No
adverse effects occurred in these studies which Novartis could attribute to
either synergistic or potentiating effect of the two products”
seemed definitely to be directed to concurrent use.
It was alleged, by the Respondent, that
the critical issue in determining safe periods within to administer their
product, when other products may have been used in treatment, was the blood
level. Other treatments may well still be present in the animals fur, from
topically applied treatments, but what mattered in terms of danger to the
animal, was whether there were still traces of the previous treatment in the
bloodstream of the animal, and graphs were shown which indicated, so far as
the Respondent was concerned, that within 3 - 4 days all traces would have
disappeared. Accordingly, to be absolutely safe, the Respondent advised a
gap of one week between treatments.
It was alleged that the letter, that
was the subject matter of the complaint, the letter that was supplied in the
response, together with a third sample that was provided in the
presentation, were all attempts to respond to technical enquiries, in that
whilst the form of the letter was largely the same, there had been re-use by
copying and pasting previous responses, and every response was a specific
response, individually tailored to the enquiry that was being made. It was
said that the number of enquiries was 4 or 5 , which could have been written
or verbal, and it was always veterinary surgeons who raised the queries. The
Respondent was unable to say in relation to the 4 or 5 enquiries whether
these involved concurrent use or use following previous treatment of another
product. The Respondent was aware of the specific problems concerning
treatment of Collies, but in the Respondent’s view, this was not a problem
when using their own product.
As regard the distinction between the
two paragraphs, one appearing to be dealing with the timescale within which
the product could be administered to an animal which had been treated with
another product previously, whereas the second involving concurrent use, the
Respondent maintained that the significant factor was the time within which
previous treatment would remain in the blood, and that the Respondent always
advised a seven day period was appropriate, but it was agreed that this
second paragraph indicated concurrent use, and accepted it was possibly an
error to describe or refer to concurrent use, contrary to the SPC’s warning.
It was intended to be a safety valve or a declaration of comfort to the
users, and not deliberately to promote concurrent use. It was not accepted
by the Respondent that the advice given was contrary to the Cascade
principles and therefore encouraging veterinary surgeons to commit an
illegal act.
The unanimous decision of the Code of
Practice Committee was:-
(1) the example letter dated 24 November 2005 complained
of constituted promotion of Milbemax inconsistent with the SPC since it
would or might encourage prescribing or use of Milbemax concurrently with
selamectin; and
(2) it was not appropriate to provide information about
concurrent administration of Milbemax and selamectin when (a) the provision
of such information was not necessarily required to answer the technical
enquiry in question, (b) the letter failed to state that administration of
the two products concurrently would be contrary to the Cascade and (c) the
letter failed to state that Novartis did not encourage concurrent
administration of the two products.
Accordingly the Committee found a
breach of clause 4.7. In view of this finding the Committee did
not consider it necessary to rule upon the allegations that the letter was
also in breach of clauses 4.2, 4.3, 4.6 or 5.1.
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253. Merial Animal Health / Bayer Animal Health -
Prague 2006 Offer
This case, which arose shortly after
the alteration to Code of Practice Rule 18 governing gifts and hospitality,
was brought by Merial Animal Health Limited against the Respondent, Bayer
plc, referable to the forthcoming WSAVA Congress in Prague in October 2006,
in which the Respondent was offering to take recipients to Prague “to
coincide” with the 31st WSAVA Congress. Such offer included the costs
being paid, by the Respondent, of return flights from Stansted, Edinburgh,
Manchester or Birmingham with Czech Airlines, departing Tuesday 10 October
2006 and returning Sunday 15 October 2006 (with the ability for the return
date to be extended), five nights bed and breakfast accommodation in the 5
star hotel, Corinthian Towers, four hospitality evenings and an all-day
sight-seeing Prague tour. Attached to the offer leaflet was an order form
for some 40 different products of the Respondent and in the wording of the
pamphlet, ‘offer’ was paragraphed under the heading ‘secure your place
now’; in order to secure your place, orders must be delivered by 30 June
2006 latest. Orders may be taken as two deliveries within a three month
period before the 30 June 2006 …… Bayer reserves the right to invoice the
practice for up to £1500 should any part of the order not be taken by 30
June 2006.” Additionally there was a note “this trip,
or elements of it, may be considered by the tax authorities as a benefit in
kind and therefore liable to taxation and insurance. Bayer will provide
recipient details, if required to do so, by the tax authorities. If you
require any advice on this issue, you should contact your tax advisor”.
Finally, in a white on red background box, it was specifically stated on the
order form for product “registration for WSAVA Congress is not
included in the offer, due to the varied individual interests and
requirements by the participants …..”
Code of Practice Clause 18 comprises
two parts as follows:-
18.1 Sponsorship, gifts and hospitality shall not be such as to
bring discredit upon, or reduce confidence in, the industry.
18.2 No gift shall be offered or issued with the sale or purchase
of an animal medicine, other than price or product itself, unless it is
directly related to the correct use, administration or disposal of that
medicine, by the person to whom it is offered, or the intended end user of
the medicine.
The Respondent confirmed that the
decision to provide the hospitality had been taken prior to the change in
Rules, repeating an arrangement provided in previous years and the
Respondent had been asked, by those that attended before, if this would be
continued. It was explained that it was not possible, in practical terms, to
arrange for registration, which was the reason for not including that, but
that this offer was only made to large purchasers of goods who were already
customers on the Respondent’s priority scheme. It was not supplied
generally, or to non-customers. The purchasers who almost certainly would
continue to purchase the Respondent’s products. The company felt it
appropriate to charge £1500 if, however, such customers having taken
advantage of the offer, then took their custom elsewhere. Moreover, during
the course of the hospitality evenings, there were training sessions
provided.
In answer to the query “how could the
hospitality gift be directly related to the correct use, administration or
disposal of ‘that medicine’”? (given that the form had some 40
different products), it was said that the company was represented at the
WSAVA and also all the benefits of the trip were included on the WSAVA
website. These extra benefits were nothing to do, specifically, with the
company’s offer. They were part of the Congress itself.
The unanimous decision of the Committee
was that the offer was a gift offered with the purchase
of animal medicines which did not consist of price or product itself and
which was not directly related to the correct use, administration or
disposal of those medicines. Accordingly the Committee found a breach
of clause 18.2.
It was not felt necessary to consider
whether or not there had been a breach of 18.1, given the decision that
there had been a clear breach of 18.2.
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254. Boehringer-Ingelheim / Pfizer Animal Health -
Rimadyl Palatable Tablets
This one item case brought by the Complainant, Boehringer
Ingelheim Limited, regarded the promotional use of the words “…..
stimulates cartilage regeneration” in relation to Pfizer’s product
Rimadyl, on the grounds that this was unsubstantiated by reference to the
SPC and therefore misleading contrary to Clause 4.3 of the Code. The
advertisement appeared in the 3rd July 2006 issue of the Veterinary Times.
Clause 4.3 of the Code provides that “Information
about animal medicines must be accurate, balanced and must not mislead,
either directly or by implication, so that critical unbiased judgements and
decisions can be made”.
It was decided that the Complainant’s complaint that the
Respondent had by its use of this advertisement, broken an earlier voluntary
undertaking, was not substantiated by the facts. These were that that
voluntary undertaking had been quite explicitly limited to the earlier use
of wording “The new licence variations now states that Rimadyl
stimulates cartilage regeneration” which form of wording was not used in
the July 3rd advertisement.
The precise words of the SPC in question were identified
as being contained under section 4, Pharmacological Properties, Subsection
4.1 ‘Mechanism for Actions’:
“In addition, therapeutic concentrations of
Carprofen have been demonstrated (in vitro) to increase proteoglycan
synthesis in chondrocytes from canine arthritic cartilage. Stimulation
of proteoglycan synthesis will narrow the difference between the rate of
degeneration and regeneration of cartilage matrix resulting in a slowing
of the progression of cartilage loss”.
It was explained to the Respondent’s Representatives that
the Committee had two questions:-
-
Firstly, the SPC seems to make a very specific
statement and in particular appeared to limit the licensing indication
to in vitro circumstances. How was it felt that the Respondent was
entitled to rely on the SPC to demonstrate “in vivo”
circumstances? The response to this was that, the words contained in the
second part of the relevant section in the SPC, could only relate to in
vivo circumstances. Further, under closer questioning, the
Representatives indicated that each of the sections were supported by
different studies.
-
Secondly it was suggested that the exact language of
the SPC does not actually reflect the words “stimulates cartilage
regeneration”. If that is what the SPC is meant to mean, why does it
not say it as such? The Representatives answer was that whilst that may
not be the exact words, it is the only meaning that can be given to
those words. It was stated that the process of securing authorisation
and the wording in an SPC, involves a very specific and clear cut
technical process. The issues were managed by technicians and not
marketers. Nevertheless, what was now stated in the promotion, in the
Representatives view, was entirely consistent with what, in effect, the
SPC was stating and that accordingly they went through the process step
by step to justify their view that it was consistent.
The Representatives put forward a published paper; “Carprofen
Simultaneously Reduces Progression of Morphological Changes in Cartilage and
Subchondral Bone in Experimental Dog Osteoarthritis” (Pelletier et al
10 April 2000, revised 4 July 2000). The Representatives highlighted firstly
part of the heading; “Carprofen Simultaneously Reduces Progression of
Morphological Changes in Cartilage” and in the final paragraph, the
words “carprofen reduces the progression of early cartilage
loss/degradation”.
The Chairman acknowledged the usefulness of the
publication, but commented that it would have been helpful if this had been
supplied earlier, both to the Complainant in inter-company discussions, and
certainly in terms of the Representatives’ formal reply. The Respondents
stated, at this point, that the Complainant had not communicated with them
regarding the second revised advert, only the first one that they then
changed. They apologised for not including it in their formal response to
the second complaint, but the first they heard of the second complaint was
when they were notified by the Secretary of the formal complaint.
The Respondent’s representatives argued that in the case
of arthritic cartilage the rate of regeneration is less than the rate of
degeneration and leads to progressive loss of cartilage. It was maintained
that Rimadyl increases the rate of regeneration by comparison to the rate of
degeneration, thereby slowing the progression of cartilage loss. It was
argued that this was the meaning of the words in the SPC forming the second
part of the section headed “Mechanism of Action” which stated “Stimulation
of proteoglycan synthesis will narrow the difference between progression of
cartilage loss”. It was acknowledged that Rimadyl had no impact on the
rate of degeneration of canine arthritic cartilage and reference was made to
Benton et al (1977 - at page 209) “stimulation of new GAG
synthesis was not mirrored by any significant changes in the rate of GAG
release from explants into the culture medium, an assay that serves as a
measure of the rate of cartilage proteoglycan matrix degradation”. It
was argued that it was reasonable in these circumstances to suggest that
Rimadyl “stimulates cartilage regeneration”. However, it was suggested that
for the purpose of clarification to the normal reader, the statement “stimulates
cartilage regeneration” which is contained and supported by the SPC,
should be qualified to indicate the effect of this mode of action, so that “Rimadyl
stimulates cartilage regeneration, thereby slowing the progression of
cartilage loss”. Effectively, the form of words as used in the
advertisement in dispute.
The Chairman acknowledged that the technical language of
an SPC does not make good advertising copy, and that inevitably, more
accessible language would be needed. But nevertheless, it is the job of the
Code of Practice Committee to see that that process does not give a
misleading view. The Respondent’s Representatives agreed, pointing out their
willingness to remove wording from earlier advertisements which arguably
could be criticised.
The consensus of the Committee was that what had been
unclear in most of the Members’ minds previously, had been considerably
helped by the ‘Pelletier’ article and by the presentation by the
Representatives. It was accepted that the language contained in the SPC is
sometimes inappropriate for promotional use, and that in these circumstances
the net effect was backed up by the technology in question, and was thereby
not misleading. It was felt that the presentation had made it clear that the
promotional words were a genuine and sincere attempt to get a message across
correctly.
The Committee considered that the statement "The new
licence variation now demonstrates that Rimadyl also stimulates cartilage
regeneration, thereby slowing the progression of cartilage loss" was a
fair summary of the SPC. Accordingly the Committee found that there was
no breach of clause 4.3.
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255. Intervet / Schering-Plough Animal Health -
Cepravin Dry Cow
This one item case involved a complaint from Intervet UK
Limited, relating to Schering-Plough Animal Health’s promotional activities
for Cepravin Dry Cow, whereby it was alleged that the statement “……it’s
the only dry cow tube licensed to reduce cell counts” is in breach
of 4.3 in that "information about animal medicines must be accurate,
balanced and must not mislead, either directly or by implication, so that
critical unbiased judgements and decisions can be made.” The above
statement appeared in both a leaflet and detailer (SPOO1271 (0406)) and the
full sentence on the leaflet is: “With up to 10 weeks broad spectrum
cover against the major mastitis causing bacteria, it’s the only dry cow
tube licensed to reduce cell counts”.
Concern was expressed by members of the Committee that
the advertisement (as opposed to the detailer) would be read by ‘farmer’
readers. Mastitis involves a whole range of bacteria, not just
Streptococcus uberis. But the SPC only provides an indication in
relation to Streptococcus uberis.
The precise words of the SPC in question contained under
section 4 Pharmacologic Properties, subsection Pharmacodynamics are:-
“……. Effective levels of cefalonium are maintained
in most quarters for up 10 weeks after infusion of CEPRAVIN Dry Cow.
Cattle treated with CEPRAVIN Dry Cow have a lower incidence of
Streptococcus uberis infection during the dry period and the
immediate post-calving period, with accompanying lower somatic cell
counts”.
The Respondent’s Representatives drew on the full context
of the words, the subject of the complaint, and it was suggested to them
that that context could create greater misunderstanding, given that
Streptococcus uberis is not the only cause of mastitis. The
Representatives maintained that that was a major cause of mastitis. Further,
they maintained that was an absolutely true statement to state that the
product is the only dry cow tube licensed to reduce cell counts. Under
queries being raised, the Representatives agreed that all dry cow tube
products reduced cell counts, but their product was the only one that was
specifically licensed. Queries referable to the detailer were raised, in
that it provided specific detail as to the reduction in cell counts. The
Representatives emphasised that they were relying entirely on the reference
on the SPC, and that there was no intention to mislead. It was acknowledged
that a farmer would not necessarily see the detailer. However, the
Representatives pointed out that they always emphasised the need for
appropriate reference to be made to expert veterinary opinion.
The Representatives also drew attention to one of the
points that had been raised in the formal response, namely, that the wording
had been used since 2002. The Chairman sought clarification as to when the
advertisement (as opposed to the detailer) had been first produced. The
Representatives were unable to clarify if the advertisement (as opposed to
the detailer) had been used, prior to 2006.
The Chairman felt that in view of the question of the
wording having been in existence since 2002, the Committee should consider
the implication of Rule 7 which gave a right to the Committee to dismiss an
application if it was at least two years after the event first giving rise
to the complaint. The Chairman emphasised that even in those circumstances,
the Committee must consider that it is fair to dismiss such an application.
In this case the Representatives had been unable to confirm what form the
promotion had been utilised in previous years and in particular whether the
data contained in the detailer would have accompanied that promotion. It was
for the Respondent to justify its argument and in the light of that the
Committee decided that it would be inappropriate to apply Rule 7.
The Committee considered that the statement "it's the
only dry cow tube licensed to reduce cell counts", without making it
clear that the SPC refers only to lower cell counts accompanying
Streptococcus uberis infection, was misleading. Accordingly, the
Committee found that there was a breach of clause 4.3.
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257. Intervet / Merial Animal Health -
ProteqFlu
The complaint from Intervet UK Limited relates to Merial
Animal Health’s promotional activities for ProteqFlu and constituted four
issues.
It was alleged that in printed material, press releases
and seminars the Respondent was promoting information which was inconsistent
with the SPC, contrary to Code of Practice Clause 4.7, by way of inclusion
of a trial claiming efficacy after one vaccination, when the SPC states that
protection is provided two weeks after the second vaccination. The complaint
centred on the following four items (2 in bullet point 3):-
-
Page 11 of the brochure titled “Equine Flu vaccines.
Are you seeing the whole picture?” included the words “Equine influenza
vaccines typically confer protection 2 weeks after the second dose.
However, this study demonstrates that ProteqFlu induced rapid protection
following a single dose which may be of significant value in the face of
an outbreak”. The Complainant maintained that this statement makes the
claim that the trial demonstrates an onset of protection (not afforded
by other vaccines) which is inconsistent with the ProteqFlu SPC, and
then further promotes this by stating that this protection may be of
value to the user.
-
Page 14 of the brochure titled “Proceedings of the
Merial Symposium on Equine Infectious Diseases. Marrakech 24th January
2006” states “The recombinant influenza vaccine induced a rapid onset of
immunity with a single administration, which may be of significant value
in the face of an influenza outbreak”. The Complainant maintained that
this vaccine (known to be ProteqFlu, as described on page 12) promotes
single dose use contrary to the SPC. This brochure is a Merial
production and clearly promotional, as evidenced by the ProteqFlu
branding throughout (pages 2, 17, 30 and 31).
-
Press Release UK Vet Vol 11 No 8 November 2006 states
“ProteqFlu is the only EIV vaccine proven to provide rapid protection
after a single dose”, “...our study remarkably demonstrates protection
following a single dose” and “Since traditional equine flu vaccines
typically confer protection two weeks after the second dose....evidence
of onset of immunity after a single dose is of significant value in the
face of an outbreak”, which the Complainant maintained repeated the same
claim, contrary to the SPC.
Clause 4.7 requires that “promotion must not be
inconsistent with the SPC, except that …….” (the exception not being
material to the case).
The Complainant alleged that they had challenged the
Respondent repeatedly over the use of this trial and on previous occasions
the Respondent had agreed to withdraw the material, but has since proceeded
to use this trial again with a change of promotional material. The original
wording was understood to be “In a recent challenge study, protection
against Newmarket 5/03 was confirmed after a single dose”.
The precise words of the SPC are contained under section
4, Clinical Particulars, subsection 4.2 ‘Indications for use, specifying the
target species:-
“Active immunisation of horses of 4 months of age or
older against equine influenza to reduce clinical signs and virus excretion
after infection. Onset of immunity: 14 days after primary vaccination
course. Duration of immunity induced by the vaccination scheme: 5 months
after primary vaccination course and 1 year after the third vaccination.”
It was noted that the complaint not only referred to the
promotions being in breach of 4.7 of the Code of Practice, but also alleged
they were contrary to Regulation 10(1) of the Veterinary Medicines
Regulation (Order 2006), which came into force on 1st October 2006 and which
provided that it was an offence to advertise medicinal claims not in the SPC.
Committee discussions included equine vaccines and horse
racing (including all other events operating under Jockey Club rules) where
owners, trainers and veterinary surgeons have to comply with Jockey Club
Rules, which themselves specified two doses.
The Respondent’s Representatives emphasised that what the
promotions were endeavouring to do was to supply important information to
Veterinary Surgeons, to whom the promotions were directed, that in the
circumstances of an equine outbreak of flu, speed of protection was
essential and that whilst, to provide guaranteed immunity the full course of
two vaccinations as specified in the SPC would be required, nevertheless,
the trial referred to in the promotions indicated that ProteqFlu, contrary
to inactive vaccines, had been shown to provide rapid protection following a
single dose. They emphasised that this was something which was critically
important and had been shown to be of particular relevance following a
recent outbreak of flu in the Newmarket area which had caused very serious
difficulties. The importance of rapid protection could not be underestimated
in those circumstances.
The Representatives drew attention to the Jockey Club
Rules which required two doses anyway. They drew attention to the fact that
the promotion only appears within technical brochures and that it was
promotion directed to veterinary surgeons and not the general public, using
the term ‘may’ throughout, thus indicating its intention was informative
only. The Respondent’s sales representatives had been very strictly
instructed as to the information that could be given which was to recite the
terms of the SPC, and in the event of queries outside the licensed
indications of the SPC, reference had to be made to the technical department
for advice. The Representatives emphasised that in their view the Respondent
had followed the voluntary undertaking that had been previously given “to
the letter”.
The Representatives were questioned as to whether the
promotion did not imply their product had an advantage over other inactive
vaccines by suggesting rapid protection after a single dose, which was
treatment which was inconsistent with the SPC indication; the apparent
highlighting of this perceived advantage and the inter-changeability within
the brochures and advertisements of the terms “protection”, “immunity” and
“onset of immunity”. The Representatives argued that the promotions were
providing valuable information to Veterinary Surgeons, within the context of
an outbreak, not routine or standard use.
The Committee considered (unanimously with regard to
items 1, 3 and 4 and with one dissenting vote with regard to item 2) that
all four items complained of were inconsistent with the SPC because they
amounted to a claim that ProteqFlu and ProteqFlu-Te gave immunity after a
single dose whereas the SPC states that onset of immunity is 14 days after
the primary vaccination course of two doses. Accordingly the Committee found
that all four items were in breach of clause 4.7.
Back to list of cases...
NOAH Ltd
20 March 2006 (for cases 248, 249 and 250)
16 June 2006 (for cases 251 and 253)
20 October 2006 (for cases 254 and 255)
11 June 2007 (for case 257) |
