Code of
Practice for the Promotion of Animal Medicines
Précis of Committee meetings held in 2007
Case No. 259/02/07 Fort Dodge Animal
Health / Alstoe: Vetergesic® Brochure
Alstoe were found in breach of one of three complaints
brought by Fort Dodge Animal Health relating to their brochure “Vetergesic®
- The Key to Pain Management”. The three items were:-
1. On the title page:- “The Best Opiate For Routine Use
in Cats”.
2. On the final page:- “Superior effects to Morphine,
Butorphanol or Pethidine”.
3. Finally, the reference to a P. M. Taylor paper,
reference (6) in the brochure states:-
‘Butorphanol - In a recent large UK field study in cats
presenting for normal routine surgery the Vetergesic treated group had
significantly better levels of analgesia than the butorphanol group, both in
the immediate postoperative phase and after 24 hours. Over 80% of cats
receiving Vetergesic were pain free 24 hours after surgery.(6)’
It was alleged that these statements constitute an
endeavour to present Vetergesic as a better alternative to the Complainant’s
product Torbugesic; the Respondent had used superlatives and disparaging
statements and had misquoted papers, all constituting breaches of the Code,
by reference to Clauses 5.2 (Exaggerated claims & avoidance of
superlatives), 6.1 (not disparaging of another product) and 10.1(Quotations
must accurately reflect the meaning of the author and the significance of
the study).
Alstoe’s response was that:-
(i) The promotion “the best opiate” needs to be read in
the context of “routine use”, and within that context it is justified;
(ii) The promotion “superior effects to Morphine,
Butorphanol or Pethidine” needs to be read in the context of post-operative
analgesia, and within that context was likewise justified;
and
(iii) the Taylor 2006 paper is accurately reflected by
the promotional piece ‘Butorphanol - In a recent large UK field study” etc..
A preliminary issue involving an attempt by the
Complainant to include further data received shortly before the meeting, to
which the Respondent objected, on the grounds of having too little time in
which to provide an effective response, was considered. The Committee
decided not to consider the extra material.
The unanimous decisions of the Committee were:-
Item 1
The Committee considered that the word "best" was a
superlative which should have been avoided. Accordingly the Committee found
a breach of clause 5.2.
Item 2
The Committee considered that the statement complained of
was justified and was not disparaging of the products of other companies.
Accordingly the Committee found no breach of clauses 5.2 or
6.1.
Item 3
The Committee considered that the statement complained of
was not a quotation and was not disparaging of the products of other
companies. Accordingly the Committee found no breach of
clauses 6.1 or 10.1.
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Case No. 260/02/07: Boehringer
Ingelheim / Novartis Animal Health: Promotion of Fortekor®
Novartis Animal Health were found in breach of both items
of complaint brought by Boehringer Ingelheim Limited, relating to several
items of Novartis Animal Health’s promotion of Fortekor®, including a
promotional CD mailer entitled “Enter the Fortekor competition and win a
Littman master cardiology stethoscope” and a poster advertising talks by
John Sauvage to Veterinary Practitioner. Part of the CD track 8, to which
complaint was made, contained the words “evidence of the benefits of early
treatment was presented by Clarke Atkins at BSAVA on ACVIM in 2006. He
showed that the use of an ACEi in dogs with mitral regurgitation, prior to
the onset of congestive heart failure, significantly increased survival by 9
months or 36%, compared to dogs who were treated with an ACEi after the
onset of congestive heart failure”. The Complainant maintained that this
statement was in breach of Code of Practice Clauses 4.2 (information about
animal medicines must reflect current knowledge or responsible opinion), 4.3
(must be accurate, balanced and not mislead), 4.7 (must not be inconsistent
with the SPC) and 5.2 (must not be exaggerated or all embracing or make use
of superlatives).
The second issue involved a statement in the poster: “If
Fortekor can give 261 extra days if used pre CHF, then it is our duty to
make sure that everyone’s aware of the fact”. This, the Complainant
maintained, was in breach of Code of Practice Clauses 4.3 and 5.2.
The Respondent’s response was that heart disease and
specifically mitral regurgitative disease, is a chronic progressive
condition with a continuum in severity from the presence of some cardiac
abnormality (heart disease) through heart failure, to eventually severe
congestive heart failure and death. Accordingly congestion (oedema) is only
one of the clinical signs which may occur in heart failure. Fortekor is
licensed for the treatment of heart failure and its licence is not
restricted to use with patients whose clinical signs include pulmonary
congestion. Fortekor specifically blocks the adverse effects initiated by
angiotensin II (part of the Renin-Angiotensin-Aldosterone System, RAAS). The
Respondent argued that the product’s competences as described in the CD were
not without the SPC, exaggerated or unbalanced, and that the studies by Dr
Atkins do reflect current opinion and are consistent with the outcome of the
SVEP (Scandinavian veterinary enalapril prevention) trial quoted. Insofar as
the poster advertisement was concerned, the Respondent acknowledged that the
benefits of Fortekor use could be misinterpreted if the quotation was taken
out of context and further pointed out that the poster had not been in use
since September 2006, and had been replaced by one that does not feature
that comment. Nevertheless, the Respondent maintained the principle of using
the VETPROOF/VETMED studies by Dr Atkins, to provide evidence for benefits
of ACE inhibitors in canine heart failure is fully justified.
The Committee made the following decisions:-
Item 1
The Committee considered (with one dissenting vote) that
the statement complained of was not inconsistent with the SPC. Accordingly
the Committee found no breach of clause 4.7.
The Committee considered that the statement complained of
was not an accurate or balanced reflection of the research abstract referred
to since it omitted reference to the fact that the survival benefit was lost
when the end-point considered was CHF-caused death. Accordingly the
Committee found a breach of clause 4.3.
Item 2
The Committee considered (with one dissenting vote) that
the statement complained of was not inconsistent with the SPC. Accordingly
the Committee found no breach of clause 4.7.
The Committee considered that the statement complained of
was misleading since the study in question did not involve Fortekor (benazepril)
but enalapril. Accordingly the Committee found a breach of clause 4.3.
The Committee considered that the statement complained of
was an exaggerated claim since it gave the impression that every dog in the
study benefited by at least 261 days' extra survival whereas this was a
median figure and this survival benefit was lost when the end-point
considered was CHF-caused death. Accordingly the Committee found a
breach of clause 5.2.
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Case No. 261/03/07: Boehringer
Ingelheim / Ceva Animal Health: Meloxidyl® Promotional Materials
The Committee considered that two items of complaint
brought by Boehringer Ingelheim Limited were not in breach. Boehringer
Ingelheim maintained that the brochure of the Respondent’s, CEVA Animal
Health, entitled “Keep on Top of the Treatment of Arthritis” (P1 MEL-03-07)
contained a phrase “Meloxidyl has been shown to have excellent palatability,
equal to the leading meloxicam product”, which was in breach of Clause 4.4
(promotional material which refers to supporting information must be
available on request without delay etc) and 4.5 (capable of substantiation).
Additionally, the Complainant objected to the reference given supporting
this promotion as “data on file”. The Respondent was relying on a
palatability study which upon the request of the Complainant, had been sent
with a substantial amount of the report obliterated or masked. The
Respondent maintained what was shown in the abridged report was sufficient
to support the promotion. The Members of the Committee had to hand the full
report.
The Committee’s decision, after a vote was taken was as
follows:-
Item 1
The Committee considered (by a majority of 5-4) that the
Respondent had substantiated the statement complained of without delay.
Accordingly the Committee found no breach of clause 4.5.
Item 2
The Committee unanimously considered that the use of the
expression "data on file" was not in itself a breach of clause 4.4.
Accordingly the Committee found no breach of clause 4.4.
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Case No. 263/03/07: Boehringer
Ingelheim / VetXX: Advertisement For Flexicam®
The Committee considered three items of complaint brought
by Boehringer Ingelheim Limited, involving an advertisement by VetXX Limited
for their product Flexicam® and found them not in breach. The items were as
follows:-
1) “Proven flexibility for your patients”. 2) “Flexicam
is Meloxicam” 3) “[Flexicam is Meloxicam] at a price that gives both you and
your arthritis patients a whole new level of flexibility / Flexicam will
give you the flexibility to price treatment the way you choose”.
The Complainant maintained that the promotion referred to
was in breach of Code of Practice Clauses 4.3, 4.5, 4.7, 5.2 and 5.5, that
is to say information being accurate and balanced and not misleading;
capable of substantiation and substantiation being provided without delay,
not being inconsistent with the SPC; not being exaggerated or all embracing
or using superlatives and comparisons being factual, fair and being capable
of substantiation.
The Respondent’s response was that the first item
revolved around the word “proven” and it maintained that Meloxicam has been
shown as a well demonstrated fact to be effective in relieving signs of
arthritis which helps restoration of joint mobility and flexibility, and
that the term flexibility is therefore appropriate in the licensed
indication under the SPC. Insofar as the second item was concerned the
intention was to show the reader that there was now an alternative way of
purchasing Meloxicam, in that Flexicam is bio-equivalent to Meloxicam, as
contained in the Complainant’s own product Metacam. The Complainant now has
no propriety rights to Meloxicam since the expiry of its patent. Insofar as
the third item was concerned, the Respondent maintained that the customer
now had a flexibility of choice regarding the price of the alternative
treatments.
The Committee decided unanimously as follows:-
Item 1
The Committee considered that the statement complained of
was not inconsistent with the SPC and was sufficiently substantiated.
Accordingly the Committee found no breach of clauses 4.5, 4.7
or 5.5.
Item 2
The Committee considered that the statement complained of
was accurate and not misleading. Accordingly the Committee found no
breach of clauses 4.3 or 5.5.
Item 3
The Committee considered that the statement complained of
was justified and not misleading. Accordingly the Committee found no
breach of clauses 4.3 or 5.5.
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Case No. 264/03/07: Merial Animal
Health / Novartis Animal Health: Prac-Tic Advertisement
Novartis Animal Health Limited were found in breach of
one of the two items of complaint brought by Merial Animal Health Limited,
relating to an advertisement / brochure “Prac-tic with pyriprole” in which
two statements were made. The first was “New freedom from fleas and ticks”
and the second was “Kills 100% of fleas in 24 hours, 99% of ticks in 48
hours and offers a full month’s protection”. The Complainant maintained that
both statements were in breach of Code of Practice Clause 4.2 (information
about animal medicines must reflect current knowledge or responsible
opinion), 4.3 (information about animal medicines must be accurate, balanced
and must not mislead), 5.1 (must be capable of substantiation and
substantiation provided without delay), 5.1 (claims for usefulness must be
based on up-to-date evaluation reflected accurately and clearly) and 5.2
(claims must not be exaggerated or all-embracing, superlatives should be
avoided etc).
The Respondent responded that the first item did not
imply superiority over any product in the market and that the phrase “New
freedom” had to be read as one not split adjective, reflecting simply the
introduction of a new molecule, without any comparative implication. In
relation to item two, the Respondent maintained the promotion was within the
product’s SPC which states: “Pyriprole kills fleas within 24 hours post
exposure. One application prevents flea infestation for four weeks”.
Additional evidence was also provided by the Respondent to support that
claim.
The Committee’s decisions were as follows:-
Item 1
The Committee considered that the statement complained of
implied that the product was superior to existing products when that had not
been demonstrated. Accordingly the Committee found a breach of clauses
4.3 and 5.2.
Item 2
The Committee considered (with one dissenting vote) that
the statement complained of was not exaggerated, inaccurate, misleading,
unsubstantiated or not reflective of current knowledge. Accordingly the
Committee found no breach of clauses 4.2, 4.3, 4.5, 5.1 or
5.2.
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Case No. 265/07/07. Merial Animal
Health Limited / Intervet UK Limited: Equilis Prequenza advertisement
This was a one item case, involving the statement in an
advertising campaign for the Respondent, Intervet’s Equilis® Prequenza
product, containing the words “leaves no depot at the site of
injection”, which statement appeared in the advertisement of the
Respondent contained in the Veterinary Times on the 29th January 2007.
The Complainant suggested that this statement was in
breach of Code of Practice Clauses 4.1, 4.2, 4.3, 4.5, 4.7, 5.1 and 5.2
which clauses are recited below:-
4.1 Upon reasonable request, participants must
promptly provide members of the veterinary and pharmaceutical professions,
registered merchants and the business user with accurate and relevant
information about the animal medicines which they market.
4.2 Information about animal medicines must
reflect current knowledge or responsible opinion.
4.3 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.
4.5 All information included in promotional
material must be capable of substantiation and substantiation must be
provided without delay in response to enquiries.
Such substantiation need not be provided, however, in
relation to the validity of indications approved in the current marketing
authorisation.
4.7 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.
5.1 Claims for the usefulness of an animal
medicine must be based on an up-to-date evaluation of all the evidence and
must reflect this evidence accurately and clearly.
5.2 Exaggerated claims must not be made and
all-embracing claims and superlatives avoided. Claims must not imply that an
animal medicine, or an active ingredient, has some special merit, quality or
property unless this can be substantiated.
The Chairman summarised the issues as follows:-
-
The question of inconsistency with the SPC;
-
The question of providing substantiation for the
claim and the speed of substantiation;
-
The question of whether a special merit or quality
was claimed which was not justified
The Respondent was represented at the meeting.
On the second issue relating to the substantiation, the
Chairman suggested that there was a sub-issue referable to the initial
Complainant’s letter of 1st February 2007 to the Respondent which did ask
for substantiation, but then somewhat muddled the issue by referring to the
SPC and not specifically referring to Code of Practice Clause 4.5. There was
then the communication from the Complainant dated 19th February 2007 which
specifically referred to substantiation and Clause 4.5 to which a response
was given the following day, providing the paper referred to. A discussion
ensued on the 3rd of April 2007 between the parties. No correspondence then
ensued until the Complainant made their complaint and notified the
Respondent of their intention to do so. It was only as part of the process
of providing a response, that further data involving the EPAR was also
provided.
Additionally, the Complainant maintained that the
complaint wrongly inferred new product technology, when what was being
promoted was old technology. The Committee considered the fact that there
were two other bullet points in the promotion which contained the words
“The only vaccine to offer proven efficacy against both Newmarket/03 and
South Africa/03 under severe challenge” and “The choice of
ready to use syringes and vials with peel-off labels”, and the
extent to which these provided a context in which the actual words, the
subject of the complaint, implied a new technology.
The Respondent’s Representatives expressed surprise that
the use of the term ‘depot’, should be contentious, as both companies were
involved in manufacturing vaccines and the term was very well known to
persons involved in this industry, and its use was not inconsistent with the
SPC.
As regards substantiation of the words, they explained
that Equilis® Prequenza uses a second generation of ISCOM (immune
stimulating complex) technology, namely ISCOM Matrix, developed for use in
animal vaccines. All ISCOM technology involves a change away from
traditional chemical adjuvants which formed depots. Traditionally the depot
was part of the way in which vaccines worked and where stimulation of the
immune system took place. The new technology removes the depot effect by
removing the emulsion and oils from the solution. As a result, the new
technology is more effective as it disperses to all parts of the body and in
particular, provides encouragement of immunology directly through the spleen
and bone marrow. The full technology was not entirely understood and it was
still necessary to tease out exactly how it worked in relation to different
species. In that regard, horses had been found to react well to the new
technology, but there was more doubt in terms of humans and cats. By way of
explanation, it was pointed out that a traditional adjuvant was usually a
cloudy liquid which, if left motionless, resulted in the material forming a
deposit at the bottom of the container, with clear solution at the top. The
new technology has no visible indication of the adjuvant whatsoever, the
solution being entirely clear, which means it is distributed more quickly
and dispersed away from the area of the injection.
The Representatives acknowledged that their formal reply
had provided additional argument to support substantiation, namely the EPAR
paper, but maintained their original substantiation to the Complainant was
sufficient. The Representatives also explained that the newer technology of
ISCOM Matrix enabled a single adjuvant to be used as part of the product;
formerly there would have had to be a separate ISCOM for each antigen, for
example, one for flu and one for tetanus. ISCOM and ISCOM Matrix technology
involves speedier distribution through the whole body, but not in any way
changing the principle of establishing immunology through injection of a
vaccine. The difference relied upon no longer using chemical adjuvants. A
Member sought clarification as to whether the new technology actually
provided an advantage to the immunology response, to which the
Representatives acknowledged it was a very difficult question to answer. The
key was to look at safety in the context of any given situation and also the
relevant species involved and emphasised that cats and humans remained
problem species for use of the new technology. Additionally, because of cost
benefits in manufacturing, much more antigen was included within the
product, leading to effective immunity before the conclusion of the
three-injection protocol, which was not the case for other products. Trials
were still on-going, but so far the results were encouraging.
Finally as regards the timing of substantiation, the
Representatives produced a paper which they argued showed that
substantiation had been supplied without delay.
In summary the conclusions of the committee were as
follows:
The Committee considered that the wording complained of
was not inconsistent with the SPC. Accordingly the Committee found no
breach of clause 4.7.
The Committee considered that the claim in question had
been substantiated and without delay. Accordingly the Committee found
no breach of clauses 4.1, 4.2, 4.3, 4.5 or 5.1.
The Committee considered that the wording complained of
was neither an exaggerated claim nor implied a special merit or quality
which had not been substantiated. Accordingly the Committee found no
breach of clause 5.2.
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Case No. 266/10/07: Boehringer
Ingelheim / Novartis Animal Health: Promotion of Fortekor®
Novartis were found in breach of two complaints brought
by Boehringer Ingelheim Limited related to Novartis Animal Health’s
promotion of Fortekor® by a mailer which contained the following words of
which complaint was made:-
Item 1
“Fortekor treatment initiated early and continued long-term
does not lead to adverse cardiac effects and is not associated with
worsening of MVD”
Item 2
“Pimobendan treatment initiated early and continued long-term,
is associated with progressive worsening of MVD and with the development
of specific mitral valve lesions”
The Complainant maintained that the promotion was in
breach of the following Code of Practice clauses:-
4.3 Information about animal medicines must be
accurate, balanced, and must not mislead, either directly or by implication,
so that critical unbiased judgments and decisions can be made
4.6. All information must be presented so as to
maintain the respect and confidence of the veterinary and pharmaceutical
professions, registered merchants, the business user and the public, and to
promote the correct use of animal medicines
4.7 Promotion must not be inconsistent with the
SPC, except that a veterinary surgeon or other 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.
6.1 The products or services of other companies
must not be disparaged directly or by implication.
Firstly, the Complainant argued that the Respondent’s use
and reliance on the Chetboul et al paper ‘Comparative Adverse Cardiac
Effects of Pimobendan and Benazepril Monotherapy in dogs with Mild
Degenerative Mitral Valve Disease: A Prospective Controlled Blinded and
Randomised Study’ had been inappropriate and misplaced as supporting the
promotional words to which complaint was made for the following reasons:-
-
The study related to dogs with asymptomatic mild
Mitral Valve Disease and thus, in the view of the Complainant showed no
symptoms of heart failure at any time.
-
Both the Complainant’s product Vetmedin® (pimobendan)
and the Respondent’s product Fortekor® (benazepril) are licensed for
treatment of dogs suffering (in the case of Vetmedin®) from congestive
heart failure and (in the case Fortekor®) heart failure.
-
The Complainant relied on a letter from the VMD,
written not in relation to this case, which advised “Where a
product is indicated for CHF or HF we would not expect the company to
promote the use of the products in animals which have heart disease but
are not yet showing clinical signs of disease”
Accordingly the Complainant maintained that the promotion
was in breach of clause 4.7 in that both products were “outwith their SPC”.
Secondly, the Complainant maintained that the promotion
would lead a reader to conclude that the statements made gave a negative
implication relating to the use of Vetmedin® overall, including use in its
licensed indication (treatment of congestive heart failure in dogs). This
implication was given in five specific ways:
-
The use of the word ‘early’ in both promotional
items, but where the definition of that word in the two items was
different, which the reader would not necessarily appreciate. In the
first item, the claim is associated in early use of Fortekor® within a
licensed indication, whereas its use in the second item could only be in
the context of use of the competitor’s product Vetmedin® outwith that
product’s SPC, i.e. an unlicensed use. Thus would, it was alleged,
mislead the reader.
-
A false association was created by the blending of
on- and off-licence use by the repetition of the claims on the back
cover.
-
Use of the present tense expands the relevance of the
promotional claims to a more all-embracing use, when it was argued by
the Complainant that when reporting a single study the past tense should
be used.
-
The use in the promotion of “NYHA class 1” as a
descriptor of the dogs in the study as opposed to the term “asymptomatic
MVD” meant that a more confusing and less descriptive terminology was
used in the promotion compared to the study – which more frequently
referred to asymptomatic MVD.
-
The Complainant drew attention to the differing words
of the promotion compared to the actual words of the study.
As such the Complainant argued the promotion was
also in breach of the Code of Practice clauses 6.1 & 4.3 by disparaging the
Complainant’s product and by misleading the reader and as such would not
maintain the confidence and respect of veterinary and pharmaceutical
professions.
The Respondent’s formal response emphasised the following
points:-
-
As regards the allegation that the promotions were
inconsistent with the SPC, it was suggested that the mailer did not seek
to promote efficacy of the product, but rather was to highlight
differences in safety/tolerability between the two products.
-
That the use discussed for Fortekor® / pimobendan is
on-label, because the dogs in the study were in NYHA stage 1 heart
failure (writer’s underlining), not congestive heart failure. It was
argued that there are no definitive criteria and guidelines as to when
heart failure starts, there being a continuum from heart disease to
heart failure. Thus it was denied the use was in breach of clause 4.7.
-
On the second issue identified by the Respondent as
disparaging Vetmedin® the Respondent repeated its argument that the
promotion related to a comparison of the safety/tolerability of the two
products rather than for their therapeutic efficacy.
-
On the five points specifically raised by the
Complainant in their support of the complaint, the Respondent
maintained:-
(a) ‘Early – not considered misleading, and
additionally clarified on the back page of the mailer as relating to
NYHA stage 1.
(b) ‘False association between promotional
statements’ – The Respondent maintained the layout makes the sourcing of
the information clear whilst the summary quoted was clearly referenced.
(c) ‘Use of present tense’ – Not considered
materially to change the message of the piece, and argued to be
widespread in other companies’ material, including material of the
Complainant.
(d) ‘NYHA classification’ – Argued to be widely used
within cardiology studies (including the paper referenced) and within
cardiac therapy SPCs.
(e) ‘Marketing interpretation of the referenced
paper’ was argued not to be misleading.
The Chairman suggested that there were two primary
principles and potential breaches of the code involved, namely clause 4.7,
being without the SPC and clause 6.1- disparagement of the Complainant’s
product.
The Chairman sought to clarify heart disease/failure and
the NYHA classification. His understanding was that classes or stages 2, 3 &
4 NYHA constituted progressively worsening stages of heart failure. By
contrast, NYHA stage 1 was generally regarded as heart disease, not heart
failure. He was concerned that he may have been over simplifying the issue –
and asked the veterinary members of the committee to comment.
A veterinary member commented that from the ordinary
veterinary surgeon’s perspective the Chairman’s summary was correct. Class 1
NYHA involved an asymptomatic stage and therefore clinically normal.
The Chairman moved the discussion on to consider the
meaning of disparagement. His personal view was to be very reluctant to say
that fair comparison based on scientifically accurate analysis would of
itself constitute disparagement. The question was at what point does such
comparative promotion become not justified under the terms of the Code of
Practice. A majority of members felt that referring to off-label use of a
competitor’s product would not automatically be disparagement.
On hearing the representatives of the Respondent, it was
suggested by them that the promotion was intended to draw attention to two
different cardiac situations – early and late stages. It was stated that it
was technically impossible to trial dogs in the late stage of disease. Thus
the trial was not to test efficacy of the products; rather it was to examine
safety and tolerability of use in the early stages.
The Chairman pointed out, by reciting the selection
criteria for the dogs as set out in the paper “(1) left apical systolic
heart murmur of low grade (I or II/VI); (2) echocardiographic and Doppler
signs of MVD….” and (3) left atrial and ventricular diameters within normal
ranges with no decrease in systolic function….” i.e. normal range, normal
activity, that dogs in effect whilst clearly having abnormalities did not
have any symptoms.
In response, it was argued that that stage or class of
abnormality would lead to later stages and the point at which the animal
could be said to be suffering heart failure was not capable of being
established with any certainty or accuracy.
The Chairman suggested that progression might not take
place at all. It was argued in response that the almost inevitable
likelihood was such that dogs in this condition would progress to later
stages. MVD does not admit normal life expectancy and this would usually not
exceed 1 to 3 years.
The Respondent’s representatives continued by emphasising
again that the promotion was not a comparison of efficacy, but was a
comparison of safety and tolerability.
The Chairman commented that looking at the mailer itself
a number of statements refer to “early treatment with Fortekor®” and asked
if the representatives would agree that the natural conclusion any reader
would come to is that ‘early’ treatment of MVD with Fortekor is a good idea.
The Respondent’s representatives replied that the
question had to be answered both “yes” and “no”. “Yes” in the sense that the
promotion was reflecting the study which was dealing with dogs at stage 1
NYHA, whereas “No” in that they were not suggesting treatment in the context
of congestive heart failure.
The representatives maintained that there was no
encouragement to use Fortekor® – the intention was simply to assist
veterinary surgeons decide when to commence use of Fortekor®. Early use did
not pose any risk. They continued by maintaining that NYHA stage 1 took all
factors into account, and this could be termed heart failure. This was
therefore within the licensed indication. The promotion clearly
distinguished NYHA stage 1, and relied on the trial which showed no untoward
effects when other trials and studies had involved treatment at a later
stage.
The Respondent’s representatives insisted that they were
willing to make adjustments to the wording if required, but that heart
failure is a continuum and MVD lesions constitute heart failure by one
definition or another. This would be on-label use of Fortekor®, whereas in
the case of pimobendan, early treatment must be off-label because its
indication is for congestive heart failure, which is a later stage than NYHA
stage 1.
The Chairman queried why the mailer suggested to the
reader asking the reader’s Novartis territory manager ‘more about the new
study’? The representative said this was simply to enable copies of the
study to be supplied if requested.
The Respondent’s representatives acknowledged that the
purpose of the mailer was to promote Fortekor®, but in the context of
advising veterinary surgeons that early treatment was safe – no adverse
effects will arise through early treatment of heart failure with pimobendan.
They confirmed that they were encouraging use of Fortekor® for dogs with
mild MVD, on the basis that as such the dogs were suffering from heart
failure.
The Respondent’s representative totally rejected the
suggestion of disparagement, maintaining that in their view the mailer quite
clearly showed by its layout with one set of data referable to use of
Fortekor® in what they maintained was on-label use, with the other set
detailing what in their view clearly discussed off-label use of pimobendan.
The Chairman suggested that as regards any breach of
clause 4.7 there were two questions:-
(1) Does the Mailer encourage the prescribing of
Fortekor® for dogs with stage 1 NYHA? And
(2) If the answer to (1) is yes, is that inconsistent
with the SPC?
The Committee agreed that mild MVD was a condition in
which the valve was failing, but in which this failure was fully compensated
and in which cardiac output was maintained, so that the heart as an organ
was not failing.
As regards the second item the Committee approved the
Chairman’s analysis that this turned on how clear it would be to the reader
that the use of pimobendan, the competitor product, was off-label. Further,
was the message being given overly negative?
The decisions of the Committee were as follows:-
Item 1
The Committee considered that the item complained of encouraged the
prescription of Fortekor for dogs with NYHA Stage 1 MVD and therefore was
inconsistent with the SPC because such dogs do not have heart failure as
opposed to mitral valve disease. Accordingly the Committee found a breach
of clause 4.7.
Item 2
By a majority the Committee considered that the item complained of was
disparaging of a competitor's product since it failed to make it clear that
the Chetboul study cited concerned off-label use of pimobendan and since it
presented the conclusions of the study with regard to pimobendan in an
unduly negative manner. For the same reasons the majority of the Committee
considered that the item complained of was not a balanced presentation of
the study. Accordingly the Committee found a breach of clauses 6.1 and
4.3.
On the issue of whether the Respondent should be required
to cease the promotion immediately in accordance with Rule 15 (ii) in
addition to providing the undertaking, the Committee considered the breaches
were sufficiently serious to warrant this, it being noted that in any event
the Respondent had indicated the promotion was no longer being used anyway.
Formal Code of Practice Reprimand
for Novartis Animal Health
On 13 February 2008 the Board of NOAH discussed a Report
from the Code of Practice Committee regarding Novartis’s conduct in a recent
case, number 266. Novartis were formally reprimanded for their conduct which
was:
- a refusal to sign an undertaking relating to the breach of the code
in Case 266, heard on 24 October 2007; and
- for its general attitude and failure to abide by the spirit of the
Code as required by Rule 17; and
- that it continued to challenge the decision of the Committee in
relation to the breaches of the Code.
Back to list of cases...
NOAH Ltd
6 July 2007 (for cases 259, 260, 261, 263 and 264)
18 September 2007 (for case 265)
23 November 2007 (for case 266) |
