Précis of Report to Chief Executives of Cases in 2000 for Circulation
to Veterinary Press
The Code of Practice Committee met in January, March, July, September,
October and December. Eight new cases were heard and a summary of the cases and rulings is
given below. Undertakings have been received in all circumstances where so required.
CODE OF PRACTICE CASE NO. 204/12/99
Boehringer Ingelheim Ltd complaint against Pfizer Animal Health
Promotional Leaflet: Rimadyl Promotional Mailer
The issue revolved around a pre-existing dispute between the parties
concerning the extent to which the peer reviewed paper "Ricketts et al" had been
challenged by Kay-Mugford and others. The Complainant in the present case alleged that the
promotion constituted a breach under Clause 5.1 and 5.5 of the Code, whilst the Respondent
defended its position by reference to the Ricketts et al paper as being the only valid
peer reviewed scientific paper.
1) "Graph that shows that Carprofen has a many times better COX-2
selectivity than does Meloxicam" (mailer).
On the graph, and the question of whether it was misleading in that it did not reflect an
up-to-date evaluation of all the evidence. The Committee found no breach
as the Kay-Mugford claims had not been demonstrated.
2a)"High COX-2 selectivity explains RIMADYL'S remarkable safety
profile" (mailer)
It was alleged that this was an incorrect quotation as the paper actually said "helps
explain". When considered in full the Committee found mailer statement was not untrue
and that the Complainant had not substantiated the complaint. There was therefore no
breach.
2b) "High COX-2 selectivity helps explain RIMADYL'S remarkable
safety profile" (mailer). (The juxta- positioning with graph - brochure).
The Committee found that the statement's juxta-position to the graph could (however
inadvertently) lead readers to assume it was making a comparison which could not be
substantiated and was therefore misleading, contrary to Code of Practice 5.5.
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CODE OF PRACTICE CASE NO. 205/12/99
Merial Animal Health complaint against Schering-Plough Animal
Health
Advertisement: "Autoworm For Unbeatable Performance"
This was a two item case; the underlying issues being, whether the word
'unbeatable' either in its own right or in the context of the advertisement as a whole was
a superlative, contrary to provisions of the Code of Practice Clause 5.2.
Secondly, in relation to the first item, whether the use of such word
was inaccurate. It had been argued by the Complainant that the alleged inaccuracy was that
the words referred only to comparisons between AUTOWORM and non-bolus anthelmintics.
Finally there was the issue raised by the second item - whether the
words constituted an unfair comparison contrary to Code of Practice Clause 5.5, given that
there were several publications which demonstrated AUTOWORM could interfere with the
development of immunity.
1) "Unbeatable" and "new data gathered from 110 farms
and fed into worming evaluation model clearly shows that AUTOWORM First Grazer can deliver
better live weight gains than the newer injectable and pour-on wormers, as well as
traditional drenching" (advertisement).
1a) First part of the first item, relating to the general use of the
word "unbeatable", the Committee considered this item regarding the general and
repeated use of the word "unbeatable" in the context of the advertisement in
question and held that this was an all embracing claim and for like reasons to those given
in relating to the second item below, was contrary to clause 5.2 of the Code of
Practice. However, the Committee wished to make it clear that in reaching its
decision was in no way maintaining that terms of "top parity" were necessarily
contrary to the Code.
1b) Use of the word "unbeatable" in the context of the words
"new data gathered.........as well as traditional drenching".
The context of the justification given for the use of the term "unbeatable" in
the first paragraph of the wording in the advertisement, dealing with liveweight gains,
the Committee held that there was no breach.
2) "And with the dramatic rise in lungworm in adult cattle, it's
important that this extra liveweight gain is not at the expense of the animal's natural
immunity. AUTOWORM releases a dose of wormer every three weeks to promote an unbeatable
number of opportunities for immunities to develop during the grazing season (unlike an
ivermectin sustained release bolus which may interfere with the development of immunity -
due to the persistent presence of wormer in the gut)" (advertisement).
The Committee concluded the reader might be led to believe that
AUTOWORM First Grazer cannot interfere with the development of natural immunity, when in
fact AUTOWORM First Grazer can have this effect, and therefore this constituted a breach
of Clause 5.5 of the Code of Practice.
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CODE OF PRACTICE CASE NO. 206/6/00
Pfizer Limited complaint against Merial Animal Health
Frontline promotional Materials "No Fleas, No Ticks, No Compromise" And "No
Fleas, No Ticks, Just Confidence"
The issues surrounding this three item case were as follows:-
(1) In relation to the first item, whilst FRONTLINE SPRAY was
identified for the treatment of dogs and cats suffering from flea allergy dermatitis,
FRONTLINE SPOT ON was not. This distinction was not made clear in the promotional
materials. The Respondent's response was that the promotion anticipated a revised SPC.
(2) The second item related to the promotion of FRONTLINE for broad
spectrum insecticidal activity against certain named parasites, and that FRONTLINE SPOT ON
is not licensed for this use. The Respondent argued that there was evidence as regards
efficacy against all save for Neotrombicula.
(3) The third item suggested that the promotional words "complete
environmental control" misleads through not providing accurate and balanced
information. The Respondent maintained that over a period of time the effect of FRONTLINE
on animals would ultimately provide environmental control as well, through breaking the
life cycle of fleas.
(1) PROMOTION "NO FLEAS, NO TICKS, NO COMPROMISE":
"demonstrated efficacy against FAD" PROMOTION "NO FLEAS, NO TICKS, JUST
CONFIDENCE": "Flea allergy dermatitis highly effective in pets suffering from an
allergy to flea bites"
The Committee held that there was no breach in
respect of this item.
(2) LEAFLET "NO FLEAS, NO TICKS, NO COMPROMISE": "Broad
acaracidal/insecticidal activity against Sarcoptes scabiei, Trichodectes canis,
Cheyletiella spp, Linognathus setosus and Neotrombicula autumnalis - Fipronil has been
shown to have a broad spectrum acaracidal/insecticidal activity resulting in many
independent publications".
The Committee held that the promotion here was misleading, contrary
to Code of Practice Clause 4.3, as the reader may be led to understand that
FRONTLINE TM SPOT ON has the same capability of action against each of the parasites:
Sarcoptes, Trichodectes, Cheyletiella, Linognathus and Neotrombicula as FRONTLINE SPRAY,
when that is not in fact supported by any refereed evidence nor indicated in the Data
Sheets for either FRONTLINE SPRAY or FRONTLINE SPOT ON.
(3) LEAFLET "NO FLEAS, NO TICKS, NO COMPROMISE":
"Complete Environmental Control"
The Committee held that this is misleading, contrary to
Clause 4.3 of the Code because the wording of the promotion clearly indicates
that FRONTLINE will act quickly to provide a complete environmental control, when in fact
it is clear from the Data Sheet that optimum and quicker controls in the environment
require additional treatment.
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CODE OF PRACTICE CASE NO. 208/7/00
Pfizer Limited complaint against Merial Animal Health
Frontline: Technical Bulletin "Comparative Efficacy Of Fipronil Spot On And
Selamectin Spot On Against Fleas (Ctenocephalides Felis) On Dogs
In this two item case, the complaint related to the heading
"Comparative efficacy of fipronil Spot On and selamectin Spot On against fleas
(Ctenocephalides felis) on dogs", combined with the graph below it. It was alleged
that the heading and graph was unfair in its comparison with selamectin, in that it
concentrated on a 24 hour period without acknowledging that in 36 hours the efficacy of
the two products were identical at 99%. Secondly the graph incorrectly implied that
selamectin is only 50 - 100% effective against flea infestation and that it did not
persist for 30 days.
The Respondent was represented and argued the brochure was more to do
with speed of kill, and speed of kill could be described as efficacy and drew attention to
the comparative study. Veterinary surgeons would be more than able to identify the message
within the context that it was being made. It was accepted that the efficacy guidelines
from EMEA took 48 hours as the definition for efficacy. Further the Respondent considered
that the promotion was reasonable in that selamectin most recently registered only 50%
effective at day 30.
The unanimous decision of the Committee was:-
That looking at the title of the promotion and considering its role in
the leaflet as a whole and in relation to the graph, the promotion was misleading as it
failed to make clear that the data was directed to speed of kill rather than to overall
efficacy of the products, and moreover, provides a misleading impression that the efficacy
of Selamectin falls off at day 30. Accordingly there was a breach of Code of
Practice Clause 5.5, in that the promotion was a misleading, unfair and
unbalanced comparison between the two products.
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CODE OF PRACTICE CASE NO. 209/7/00
Vetoquinol (UK) Limited complaint against Merial Animal Health
'Pastuerellosis At Grass' Leaflet
This four item case involved a complaint by Vetoquinol UK Limited
against a promotion leaflet distributed by Merial Animal Health Limited entitled
'Pasteurellosis at Grass' and related to data in the form of a graph which appears inside
the back page of the leaflet under a heading "Immunisation with P. Haemolytica
A1", and a sentence below "Has been shown to provide protection against other P.
Haemolytica A Sereotypes".
Section headed "Immunisation with P. Haemolytia A1 has
been shown to provide protection against other P. Haemolytia A Serotypes", and the
graphs within that section.
Item 1:- that the promotion misleads the reader into thinking that
PASTOBOV was used in the Study.
The Committee concluded that the promotion misled the reader to
understand that PASTOBOV was used in the study, when in fact it was not, and was therefore
in breach of clause 4.3 of the Code of Practice.
Item 2:- that the data presented refers to goats and interspecies
differences are such that this cannot support in any way, cross protection in calves or
cattle, contrary to clause 4.3 (misleading) of the Code of Practice
The Committee concluded that there was no breach,
because reference has been made sufficiently clearly to the fact that the study involved
goats not calves. Nor did the Committee consider that the promotion would cause there to
be any loss of confidence by the profession, contrary to clause 4.6 of the Code of
Practice.
Section headed "Immunisation with P. Haemolytia A1 has
been shown to provide protection against other P. Haemolytia A Serotypes", and use of
the Study "Cross- protection Studies in three Serotypes of Pasteurella haemolytia in
the goat model", Charles W Purdy et al.
Item 3:- It is not accurate to compare or extrapolate from this
study, in that the study involves transthoracic injection into the lungs of goats, when
PASTOBOV is administered subcutaneously.
The Committee concluded that there was no material inaccuracy or
failure to evaluate evidence and that there was therefore no breach.
Item 4:- That the paper presented at BCVA in October 1999 (relied
upon by the Respondent to support use of the Purdy et al Study) shows that in all clinical
parameters except lung consolidations A1 vaccination produced no protection against A6
challenge. The promotion presents lung consolidations as the sole indication of
protection.
The Committee considered that as lung consolidation was the subject
matter of the promotion there was no breach.
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CODE OF PRACTICE CASE NO. 210/7/00
Boehringer Ingelheim Ltd complaint against Intervet UK Ltd
"Vasotop" 3 Promotional Materials
This case involved a complaint by Boehringer Ingelheim Limited against
2 advertisements and 1 technical bulletin, distributed by Intervet UK Limited for their
product VASOTOP®, the wording in the promotions were identical.
The complaint was that both the technical data sheet and the
advertisements maintained three benefits attributable to VASOTOP, one of these being
nephroprotection. The studies relate to healthy dogs, not dogs susceptible to disease. The
complaint emphasises the failure to draw attention to the warning in the data sheet
regarding adverse renal affects of ACE inhibitors in dogs with heart failure and that the
data sheet recommended regular monitoring of renal function.
The Respondent argued that their product has nephroprotective
properties. The literature shows that renal blood flow is promoted as is renal function,
and that this prevents degenerative morphological changes. It is also suggested that the
technical bulletin at any rate is more by way of educational guidance than promotion.
The Committee unanimously held:-
(i) That the advertisements and technical bulletin are in
breach of clause 4.3 of the Code of Practice in that they are not balanced
and are misleading in that critical unbiased judgements and decisions cannot be made. This
is because they are promoting Vasotop for the specific licensed cardiac indication and
claim nephroprotection as one of three aspects of protection afforded, when the data sheet
makes it clear that the use of this compound in the treatment of animals with congestive
heart failure may result in the lowering of systematic blood pressure and pre-renal
uraemia (azotaemia) and that renal function should be monitored both before and seven days
after treatment. No mention is made of this warning in the advertisements. Further the
data relied upon in support of the nephroprotection is not based on studies relating to
diseased dogs.
(ii) That in the case of the advertisements, the wording implies a
special property in Vasotop, namely nephroprotection in diseased animals, which cannot be
substantiated, contrary to clause 5.2 of the Code of Practice.
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CODE OF PRACTICE CASE NO. 212/9/00
Pfizer Ltd complaint against Norbrook Laboratories (GB) Ltd
Noromectin Pour-On 'Crying Farmer' Advertisement And Advertisement 'Your Profits Are
Greater With ??'
In this case complaint was made regarding the promotional words
contained in an advertisement showing a crying farmer '…..protection to 100% of the
significant internal parasites for 5 weeks as well as season long protection for external
parasites when housed'. The complaint was made on the grounds that the licensed indication
for the product is only 4 weeks against lung worm and 3 and 2 weeks respectfully against
other key intestinal parasites. Further, it was complained that the reference to season
long protection was only justified when animals are not exposed to other sources of
infestation. As regards the advertisement 'Your profits are greater with …..' the
Complainant argued that greater profits could only come from lower costs or higher
productivity. Also complaint was made as regards the statement 'For quality and duration
of activity upgrade today' on the grounds that the product has no greater benefit than any
other avermectin.
The Respondent was represented, arguing that as regards the 'Crying
Farmer' advertisement the promotion was designed for housing cattle so that the
persistence of the product against nematodes becomes irrelevant. As regards the other
advertisement, the Respondent argued that as their product was cheaper than its
competitor, the claim is made out and that upgrade referred to other Anthelmintics.
The Committee's unanimous decisions were:-
1. 'Crying Farmer' advertisement
1.1 '…..protection to 100% of the significant internal
parasites for 5 weeks as well as season long protection for external parasites when
housed'.
Having regard to the advertisement as a whole and particularly the references to 'all
parasites affecting my animals at pasture', the claim was misleading contrary
to Clause 4.5 of the Code.
1.2 '……season long protection…..'.
The issue primarily related to the word 'protection'. As the claim for season long
protection given by the product when cattle are housed cannot be justified, the promotion
was misleading, contrary to Clause 4.3 of the Code.
2. 'Your profits are greater with' advertisement
2.1 'Profits come from lower costs'.
The Committee held the promotion was a 'puff' and would not mislead and there was
therefore no breach.
2.2 'For quality and duration of activity upgrade today'
Taking in the context as a whole, the reader could be misled into thinking the product had
benefits over all Avermectins when this had not been demonstrated and was therefore
misleading, contrary to Clause 4.5 of the Code.
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CODE OF PRACTICE CASE NO. 214/11/00
Pfizer Limited complaint against Boehringer Ingelheim Limited
Promotion Of Metacam Solution For Injection Pre-Op Claim
In this complex case involving no less than 16 items, the issues
involved two promotions: a detailer and an advertisement. Lengthy discussions took place,
the Respondent being represented.
The unanimous decisions of the Committee were:-
Item 1
In so far as the promotion "In all respects, as effective as Ketoprofen in the
management of post surgical pain" is limited to itself, no breach,
but see item 2(b) below.
Item 2a
"Ketoprofen is proven to be clinically superior to Carprofen". This
statement was held to be, in itself, misleading, contrary to Clause 4.3 of the
Code of Practice in that the words reflect an abstract of a presentation at
the 6th International Congress of Veterinary Anaesthesiology, Thessaloniki Greece in 1997.
At the time of publication there existed a paper by the same authors published in JAVMA,
which did not include this statement This inadvertent breach was acknowledged by the
Respondent by its representative and in its response, and the Committee noted that as a
result the promotion in that form had been withdrawn. However, the Committee decided that
even if the subsequent publication had not existed, they would still have held the
promotion misleading, because the actual wording of the presentation was "Ketoprofen
seems to provide better analgesia than Carprofen, but is associated with longer bleeding
times". The wording "seems to" would not justify the use of the bold and
very firm promotional words "is proven".
Item 2b
"Ketoprofen is proven to be clinically superior to Carprofen" in conjunction
with the promotional words immediately above it - "In all respects, as effective as
Ketoprofen in the management of post surgical pain" under a heading "Metacam -
Genuine clinical efficacy". This statement was held to be misleading contrary
to Clause 4.3 of the Code of Practice, because the reader would wrongly
understand that since it is claimed that in all respects Metacam is as effective as
Ketoprofen in the management of post surgical pain, and it is further represented that
Ketoprofen is proven to be clinically superior to Carprofen, it is being represented that
Metacam is proven to be clinically superior to Carprofen. This is not justified by the
evidence relied upon by the Respondent.
Item 3
The heading "Metacam - Genuine 24 hour relief", the emphasis given by the
pie chart and the bold colouring of "Metacam - 24 hours" with the different
colouring and sizing of "Carprofen ; 8 hours": The Committee held that this
combination of representational techniques constituted an unfair comparison between the
products, contrary to Clause 5.5 of the Code of Practice in that
it did not involve a comparison which was like for like and relied on the use of two
different observers. It was noted that the promotion had been withdrawn by the Respondent
because of the reference to 8 hours duration for Carprofen, which the Respondent accepted
should in fact be 9 hours. The Committee's decision was, however, that even with the
correction, the promotion would still be in breach of the Code.
Item 4
The authority relied upon to support the comparison between Metacam and Carprofen in
the context of post operative pain relief, namely the Lascelles Study, constituted
reliance on a wrong document, and this fact, coupled with the promotional words that
"Metacam has a 16 hour advantage over Carprofen in terms of pain relief" had
been acknowledged by the Respondent as being contrary to Code of Practice
Clauses 4.3 (in that it misled) and Clause 5.2 (in
that it could not be substantiated). It was noted that the Respondent had withdrawn the
promotion.
Item 5
The wording in the mailer "Genuinely longer acting than Carprofen" utilising
the pie chart and the larger print "Metacam - 24 hours" and "Carprofen 8
hours". The Committee held that this combination of representational techniques
constituted an unfair comparison between the products contrary to Clause 5.5 of
the Code of Practice in that it did not involve a comparison which was like
for like and relied on the use of two different observers. It was noted that the promotion
had been withdrawn by the Respondent because of the references to 8 hours duration for
Carprofen which the Respondent accepted should in fact be 9 hours. The Committee's
decision was, however, that even with the correction the promotion would still be in
breach of the Code.
Item 6
"Metacam achieves peak plasma levels faster than Carprofen" under a heading
"Metacam - Genuine speed of action". The Committee held that this was a
misleading statement contrary to Clause 4.3 of the Code of Practice,
because it wrongly linked peak plasma levels with speed of action.
Item 7
Graph where data is presented comparing a minimum, mean and maximum COX-1/COX-2 rating
for Metacam, Carprofen and Ketoprofen under a heading "Metacam - Preferential COX-2
inhibitor in dogs". The Committee held that this comparison was unfair contrary
to Code of Practice Clause 5.5 in that the data used for the graph originates
from 7 different studies all using different techniques. The Committee agreed with the
Complainant that that is not appropriate nor scientifically correct, on the facts of this
case, to calculate a mean from the data, including, as it does, 2 studies which involve
human studies. Further the article referred to in support (Kay Mugford), neither justifies
that form of presentation of data, nor its conclusion.
Item 8
"The most recent study of NSAID's in dogs shows that unlike Metacam, Carprofen
and Ketoprofen are relatively non specific COX inhibitors". The Committee held there
was no breach as it was supported by an adequate reference.
Item 9
"…… consistent COX-2 inhibitors in a range of different studies"
being a statement directly above the graph which claims to its right:- "Better COX
profile e.g. Metacam". The Committee held that the juxtaposition of this statement,
the title ("Metacam - Preferential COX-2 inhibitor in dogs") and the graph
provide a misleading representation of the only two studies which directly compare the
merits of Metacam and Carprofen, contrary to Clause 4.3 of the Code of Practice.
Item 10
Under the heading "Metacam - Post-Operative Ongoing assurance - Gastro-intestinal
safety" the statement "No incidence of occult blood". The Committee held
that in the context of this heading - particularly the categorical nature of the reference
to "On going assurance" the statement "no incidence of occult blood"
was contrary to the data sheet indication for the product, in breach of Clause
5.3 of the Code of Practice.
Item 11
"Room temperature storage - no need to warm before use" under the heading
"Metacam - Genuine convenience Pre-Op". As this is a correct statement of fact,
the Committee held there was no breach.
Item 12
"Metacam Pre Op - The Evidence" Synopsis 2 : comparison of the
post-operative analgesic and sedative effects of Carprofen and papaveretum in the dog:
Although the Committee expressed the gravest concerns at the practice of summarising
references or authorities without the approval of the author, in this particular item the
Committee held there was no breach of the Code of Practice.
Item 13
"Metacam Pre-Op - The Evidence": Synopsis 3. Post-operative analgesic and
sedative effects of Carprofen and Pethidine in dogs, and the statement in the promotion
"Carprofen provided slightly better pain relief than did Pethidine up to 8-10
hours" as a "conclusion": In fact the relevant wording in the paper reads
"Carprofen provided good analgesia during the 18 hours the dogs were in
hospital". The Committee held that this was misleading, contrary to Clause
4.3 of the Code of Practice as that which was stated in the promotion was not
the conclusion of the authors in the paper referred to.
Item 14
"Metacam Pre-Op - The Evidence", Synopsis 6. "A comparison of the
administration of Ketoprofen and Carprofen pre-operatively in the treatment of
post-operative pain in dogs": This was acknowledged by the Respondent as being
superseded by a later paper (see item 2(a) above). However, even the original reference is
not correctly quoted, in that the paper stated "Ketoprofen seems to provide better
analgesia than Carprofen" whereas the promotion states "Ketoprofen provided a
better analgesic…..". As such this constituted a misleading summary, contrary
to Clause 4.2 of the Code of Practice.
Item 15
"Metacam - Genuine 24 hour pain relief" (mailer). The Committee held that
this heading in the context used did not constitute a breach of
the Code of Practice.
Item 16
"Genuine 24 hour pain relief - a new way to ease recovery" (mailer). The
Committee again held no breach.
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NOAH Ltd
1 November 2001 |
