Code of Practice for the
Promotion of Animal Medicines
Précis of Report to Chief Executives of Cases in 1999 for Circulation
to Veterinary Press
The Code of Practice Committee met in March, June, September, October
and December 1999. Nine 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: 192/1/99
Pfizer Limited complaint against Schering Plough Animal
Health
Promotional Brochure and 'Best Practice Guide' Brochure, Video and Promotion Within
Farmers Weekly Internet Website December 18-24 1998 Re "Autoworm First Grazer"
This complaint involved the argument that the "interrupted"
nature of the 7 dose Autoworm Bolus gave a better chance of immunity than competitor
products. The six items of complaint and the decisions of the Committee were as follows:
1. That the wording of the Brochure, the Best Practice Guide and the
video in suggesting that the Autoworm grazer gave the best opportunity for natural
immunity was far too simplistic and more precise than reality permitted, and as such was
misleading and could not be substantiated. A breach of Code of Practice clause
5.5 was ruled.
2. That the Respondent had only been able to provide data for the
Autoworm 5 dose bolus and it appeared that the simulation model had not been tested with
the Autoworm 7 dose bolus, sustained release morantel bolus or 2 dose doramectin injection
programme. Accordingly, it was said, the model had not been adequately validated. The
Respondent referred to the worm simulation model, by Dr Chris Taylor which had been used
to justify validity. It was not felt that this aspect of the promotion involved any breach
of the Code. No breach.
3. That the quote "The persistent presence of avermectin has
been shown to interfere significantly with the development of immunity" from a
paper (Taylor et al, 1997) was untrue, as it was taken out of context. The Committee
agreed that this was definitely misleading and conflicted with information which appeared
in the Taylor paper. A breach of Code of Practice clause 4.3 was ruled.
4. That the promotion was misleading in that it failed to make it clear
that it was based on the opinion of veterinary surgeons only rather than the collection of
scientific data on immunity. A breach of Code of Practice Code clause 4.3 was
ruled.
5. That the statement "Now roundworms are present on the
pasture for most of the season so immunity can be generated relatively quickly"
(Video) was misleading. Schering-Plough Animal Health were said to have accepted the
complaint and that the phrase "more readily" would be more accurate. The
Committee noted that this would be changed for the future. Nevertheless the Committee
rejected the complaint and found no breach.
6. That the promotion was a directly disparaging comment on the
Complainant’s own product which was unsubstantiated, but which the Respondent
maintained reflected discussions with farmers, and that if required they were willing to
secure figures to support their contention. No breach.
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CODE OF PRACTICE CASE NO: 193/1/99
Merial Animal Health complaint against Schering Plough Animal
Health
Promotional Brochure, The Best Practice Guide and Video Re: "Autoworm First
Grazer"
This case involved a different complaint but the same Respondent and
the same product for essentially the same reasons as were involved in Case 192/1/99 (see
above). The 5 items of complaint and Committee rulings were as follows:
1. That the statement "Autoworm gives cattle the best
opportunity to build up natural protection" had not been supported by the supply
of scientific data. A breach of the Code of Practice Clause 5.2. was ruled.
2. That there was no evidence to support the contention that if
Ivermectin is used properly (i.e. in accordance with the product data sheet) it will "interfere
with the vaccine". It was agreed that promotions should assume use in accordance
with recommendations and thus the comparison was unfair to single out ivermectin and was
misleading by distortion. A breach of Clause 5.5 was ruled.
3. That the statement "No resistance to Autoworm has ever been
reported...." insinuated there were no reports of resistance to oxfendazole
contained within the Autoworm bolus, and that this was not an accurate statement in that
there had been several reports of resistance to Oxfendazole The Respondent maintained that
this statement referred to reports within Europe. No breach.
4. That the claim that the Autoworm 7 bolus gives the best "Immunity
Opportunities" was quite simply false, and that exposure depends on pasture
contamination. The Committee held that the wording of the Brochure, the Best Practice
Guide and the video, in maintaining that Autoworm grazer gave the best opportunity for
natural immunity, was far too simplistic and more precise than reality permitted, and as
such was misleading and could not be substantiated. A breach of Code of
Practice clause 5.5 was ruled.
5. In relation to the table under the heading "Comparative live
weight gains during one grazing season" The Respondent offered to have its worm
simulation model independently assessed; this could be assessed in approximately 1 month
either by G Gettingby or Liverpool University. No breach.
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CODE OF PRACTICE CASE NO: 195/5/99
Boehringer Ingelheim complaint against Schering Plough Animal
Health
Promotional Detail Aid and Mailing Publication Re: "Finadyne Injection"
This case involved a promotional detail aid and a mailing publication,
and comprised of 5 separate items concerning Finadyne, and comparisons with other
preventative treatment products and their inherent risks.
Highly relevant to the Committee’s consideration was that the
competitive product Metacam had been actively promoted against the Respondent’s
product.
The 5 items of complaint and the committee’s rulings went as
follows:
1. That the words "Remember, when you don’t want to take
risks, take Finadyne" and "why take risks?" implied that other
products do carry a risk which thus disparages other products. The Committee considered in
the context of the company’s continuing promotional campaign that there was no
breach.
2. That the comparison of percentages in the wording "Finadyne
reduced lung damage by 73% a level of performance unmatched by carprofen and ketoprofen
and meloxicam" was misleading in apparently referring to a single trial, when in
reality the results of two entirely separate trials were being utilised. Breach
of Code of Practice Clause 5.5
The Committee also commented on the lack of references being supplied
in the case of this promotion.
3. That the words "Finadyne cuts lung damage to the bone" with
a comparison of a reduction of lung lesions of 73% in the case of Finadyne and 50% in the
case of Meloxicam together with the statement "setting an unbeaten standard" again
led readers to assume there had been a direct comparison when in fact that was not the
case. No breach.
4. That the detail made under the title "with fast action that
lasts" misled through implying they relate to a single trial by showing a direct
comparison of the two products on one chart. Breach of Code of Practice Clause
5.5
5. That the graph "clinical effect can be measured 3 days after
a single dose" was misleading in that the graph represented an effect on body
temperature after the administration of Finadyne alone, when in fact the data related to
Finadyne plus Ceftofur. Breach of Code of Practice clause 5.5.
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CODE OF PRACTICE CASE NO: 196/5/99
Hoechst Roussel Vet complaint against Fort Dodge Animal Health
Promotional Literature and Advertisements/Press Releases
Re: "Equest Oral Gel For Horses"
This case involved promotional literature and advertisements/press
releases relating to encysted redworms. The 8 items of complaint and the committee rulings
were as follows:
1. That in the statement, "Unique single dose control of
encysted redworms" was misleading in that there was no reference to inhibited
larvae. Breach of Code of Practice Clause 4.3.
2. That the statement "The only wormer that controls encysted
developing larvae as small redworms in one standard dose" and "that is why
killing encysted redworm larvae while they are still encysted - before they emerge - is an
important method of control" constituted a misleading promotion because only
encysted developing larvae are treated. The data sheet indicates moderate efficacy against
a minority group. In the context of the whole document the Committee held no breach.
3. - "New Equest is the only wormer that kills small strongyles
in the encysted developing stages in a single standard dose, before they can emerge and
before they can cause further intestinal damage". Likewise the Committee
held that there was no breach.
4. - "Longer lasting protection - four treatments a year .....
control in encysted developing larvae of small redworm" - it was argued that the
problem was that only a small percentage of the larvae are attacked. No breach.
5. That the statement "single standard dose against encysted
developing cyathastomes" and "economical single activity against encysted
cyathastomes". - leads the reader to think that there are no larvae other than
encysted developing larvae, whereas these are a minor part of the population in the gut
wall. The Committee determined that, as far as the first quotation was concerned, there
was no breach. However, the second quotation was found to be misleading. It was noted
that the leaflet had been withdrawn in May, nevertheless it constituted a breach
of Clause 4.3 of the Code.
6. - "larval cyathastomosis is the result of large number of
encysted cyathastome larvae developing and being released into the intestinal lumen".
Again the complaint related to the failure to identify the remaining inhibited larvae
in the gut wall. No breach was found.
7. That in the statement - "EQUEST used four times a year will
suppress faecal egg output thereby minimising pasture contamination and the risk of larval
cyathastomosis," use of the word "minimise" in its ordinary parlance
implies a minimal risk of pasture contamination, not a mere reduction, and thus the claim
made was misleading. Breach of Code of Practice Clause 4.3
8. - Press release and Veterinary Practice March 1993 states that
"Equest we are told not only eradicates small redworms with only four single doses
per year but is also the only anthelmintic that controls encysted developing cyathastome
larvae (small strongyles) with a single standard dose". Although the Committee is
unable to act on editorial text the Respondent had quite candidly acknowledged that the
report was a reproduction of a press release supplied by the Respondent company. The
relevant words to which the Committee took objection were ‘eradicates small
redworms’. The Respondent’s representatives freely acknowledged that this was an
error and that it was not now being repeated. Nevertheless the Committee determined
that these words had constituted a breach of Code of Practice Clause
4.5.
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CODE OF PRACTICE CASE NO: 198/8/99
Fort Dodge Animal Health complaint against Hoechst Roussel Vet:
Panacur Equine Guard Promotional Leaflets:
(1) "10 Good Reasons and 10 Common Questions"
(2) "The Efficacy of Panacur Equine Guard Against Inhibited Encysted and Developing
Encysted Small Redworm Larvae in the Gut Wall"
(3) "A Review Of Larval Cyathostomosis and its Prevention"
1. - That the statement "Moxidectin is only licensed to
remove 80% of the later developing encysted larvae (LL3 and L4) from the gut wall". The
reader might not actually realise that Moxidectin is licensed to deal with 80% of all
encysted developing larvae as opposed to later developing encysted larvae. The Committee
decided that anyone who had sufficient knowledge to understand the importance of the word
"later" in the context of this statement, would equally understand the meaning
of "LL3 & L4", and thus would not be misled. Accordingly it was held by the
Committee that there was no breach.
2. That the statement"These account on average for only
19% of the total larval population". was misleading, because it failed to
recognise that the total larval population includes all the encysted stages and the
luminal larvae. The Committee felt that the failure to make clear in this sentence that
the word "total" relates to larvae in the gut wall, was misleading to a lay
reader, and indeed could cause misunderstanding of the intended message of the paragraph
as a whole. Breach of Code of Practice Clause 4.3.
3. That the statement"This means that only 15% of the total
larvae present in the gut wall are removed." was misleading, because to attain
the figure of 15%, the author has taken 80%, which is the average efficacy given for
encysted developing cyathostomes, and multiplied that by 19%, which is the
Respondent’s interpretation of published data on the proportion of developing as
against inhibited encysted cyathostomes. The Complainant alleged two false assumptions:-
(a) That EQUEST® has no efficacy against inhibited stages. Whilst
there may not yet be a data sheet claim for inhibited states there is evidence for
efficacy, some of which was statistically significant: and
(b) That relative proportions of inhibited and developing encysted
cyathostomes is the Respondent’s interpretation of some of the literature, which was
unreasonable and misleading because variability can occur.
The Respondent maintained that there was no data sheet licence for the
arguments raised by the Complainant and that the use of the 19% figure was sound. The
Committee recognised that there were two arguments raised by the Claimant. The Committee
considered that to state an absolute in this form, without qualification or words to
indicate that the promotion relied on the licensed claims of the product, or without other
recognised and acceptable data to support such a statement, was misleading to a lay
reader, contrary to Clause 4.3 of the Code of Practice. However,
the Committee felt that the use of percentages calculated in the manner explained was
acceptable, bearing in mind that the calculation clearly referred to an average.
4. That the statement"Moxidectin removes only 15% of all small
redworm larvae" under a pictorial pie chart disclosing that proportion was
misleading as it did not present the full facts. The Respondent argued that it is an
accurate approach by reference to the licensed claims of the Complainant’s own
product. The Committee considered that as in Item 2 (above) this could mislead a lay
reader, contrary to Clause 4.3 of the Code of Practice. The
Committee noted that the Respondent was prepared to add the words "in the gut wall".
5. That the statement"Panacur Equine Guard is also effective
against 99% of encysted developing larvae within the gut wall" and the reference to
the Freedom of Information Summary, was inappropriate. The Respondent acknowledged
that there was a typographical error in the reference. The Committee considered that this
was not only an acknowledged and honest typographical mistake which was to be corrected,
but also an obvious mistake. Accordingly there was no breach.
6. That the statements"developing encysted larvae which account
for on average only 15% of the total population within the gut wall" and "Moxidectin
has the potential to leave behind 88% of the total population of the small redworm larvae
in the gut wall, as it only removes around 12% of the total larval burden within the gut
wall" misled contrary to Clause 4.5 of the Code of Practice on the grounds that
the 15% calculation relates to complex issues and that it is inappropriate to give such an
absolute figure in the circumstances. The Respondent argued that it is accurate and that
the variation in figures can be accounted for by a more up-to-date and more appropriate
set of trials. The Committee noted that this promotion was for the veterinary recipient
and accepted the Respondent’s explanation as regards the differing percentages used,
reflecting more recent studies based on northern temperate climactic conditions. For the
same reasons as set out under item 3 above, the Committee did not consider that the method
of calculation of the percentages gave rise to any justifiable complaint. Accordingly no
breach was held to have taken place.
7. The claim that Panacur Equine Guard™ works against
encysted cyathostomosis "even when resistant adults are present", was
misleading. The Committee were satisfied that this statement is not supported by
the data sheet for the product, and did not consider that the Respondent’s
justifications or explanations were sufficient. The statement is made without any
reference, and accordingly misleads, contrary to Clause 4.3 of the Code of
Practice.
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CODE OF PRACTICE CASE NO: 200/9/99
Merial Animal Health complaint against Novartis Animal Health
Promotional Leaflet Re: "The Unwelcome Effect Of Spot On Flea Treatment"
The complaint concerned a promotional brochure item which showed, on
the first page, a picture of the rear head of a boy in the foreground and a view over the
boy’s shoulder to a dog,tied up to a tree, a significant distance away. Underneath
was the heading "the unwelcome effect of spot on flea treatment".
On the second page was wording commenced with the sentence "The
insecticides in spot on flea treatments can get in the way of the friendship between
owners and their pets". The wording then continued to identify the effects of
spot-on flea treatment and the advantage of the product being promoted in that there was
no delay incurred in contact between humans and the pet. On the third page was a further
picture with the boy and dog in close contact. Underneath this picture was the wording "The
welcome touch of PROGRAM".
The complaint alleged that the use of the images in question
contravened Clause 5.5, by making over-sentimental use of imagery with the wording in
question, resulting in undue emphasis and distorted the comparison between the two
formulations, and secondly The Respondent maintained by their written comments, that the
campaign was factual and that the visuals addressed the need of the data sheet
requirements, thereby differentiating their product from spot on products.
1. The Committee determined that the picture showing the rear of a
boy's head and a dog tied up, with the words "the unwelcome effect of spot on flea
treatment" constituted a comparison which was not factual, or fair, and was
capable of misleading through distortion and presenting a potential effect far beyond that
which is legitimate. Breach of Code of Practice Clause 5.5
2. The words on the second page "The insecticides in spot-on
flea treatments can get in the way of the friendship between owners and their pets".
The Committee determined that, as in Item 1, these words constituted a comparison
which was in breach of Code of Practice Clause 5.5.
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CODE OF PRACTICE CASE NO: 201/10/99
Pfizer Animal Health complaint against Fort Dodge Animal Health
Promotional Leaflets for Cydectin Injection For Sheep
Re: "One Shot Scab Control" and "It Could Be Ewe"
The case involved the promotional leaflets for cydectin injection for
sheep "One shot scab control" and "It could be ewe"
1. Leaflet "One Shot Scab Control" That this was a
leaflet which had been prepared for distribution in the Republic of Ireland where the
licensing and marketing conditions were different. The Committee unanimously agreed that
notwithstanding the Respondent’s explanation that this was an isolated and unintended
incident, there was a clear and admitted breach of the provisions of the Medicines Act. A
breach of Clauses 4.6 and 5.1.
2. Leaflet "It could be ewe" The complaint here was
that the leaflet had been discovered in apparent breach of the original Undertaking from
Case No. 190/9/1988. The Committee noted that an undertaking had been entered into that
the leaflet would be withdrawn. There was no evidence that the distribution was as a
result of failures on the part of Fort Dodge Animal Health. The Committee did not think it
appropriate to make any further formal decision in the matter.
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CODE OF PRACTICE CASE NO: 202/11/99
Pfizer Limited Complaint against Boehringer Ingelheim
Promotional Leaflet: Metacam® Oral Suspension
Re: "Metacam.....has been shown in canine sales to be a more preferential Cox-2
inhibitor than Carprofen or Ketoprofen"
This single item complaint related to the statement "METACAM
... has been shown in canine sales to be a more preferential COX-2 inhibitor than
Carprofen or Ketoprofen."contained in the Respondent's promotional leaflet:
"METACAM ORAL SUSPENSION"
The Complainant Company maintained that the statement constituted
an unfair and unbalanced comparison between Carprofen and Metacam (Meloxicam) in that
there is only one peer review published reference, namely, Ricketts et al (1999) American
Journal Veterinary Research 591441-1446 which compares COX-2 preferential inhibition of
Carprofen and Meloxicam in dogs. The Respondent emphasised that the Ricketts paper was the
subject of a refereed critique, which thereby questioned the validity of the reference.
The Committee ruled that the statement is misleading, contrary to Clause 5.5
because the promotion fails to make it clear that the statement is based on only one
study, without acknowledging the contrary view of others.
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CODE OF PRACTICE CASE NO: 203/11/99
Novartis Animal Health complaint against Intervet UK Ltd
Promotional Item: Cardiovet "All these ladies rely on the world's leading ACE
inhibitor for a longer, healthier life"
The statement to that "All These Ladies Rely on the
World’s Leading ACE Inhibitor for a Longer, Healthier Life", and in
particular a section of page 4 of the leaflet headed "potentially beneficial for
dogs with CRF" and the wording "furthermore, in cases where renal
function is compromised, there may be no need to change existing Cardiovet therapy or
adjust the dose of Cardiovet - since enalapril has been shown to be effectively excreted
over 24 hours, with no risk of cumulation," were inaccurate when referenced to
quoted sources, which state the reverse. Further, the claim that enalapril has been shown
to be effectively excreted over 24 hours with no risk of cumulation could not be
substantiated.
1. The words "may be no need to adjust the dose of
Cardiovet", were misleading, and did not permit critical unbiased judgements and
decisions to be made, contrary to Clause 4.3.
2. The Committee did not consider that the claim as intended by the
Respondent Company could not be substantiated and accordingly held there was no breach.
3. As regards the statement "with no risk of cumulation" the
Committee unanimously concluded that this claim had not been substantiated contrary
to Clause 5.2 of the Code of Practice.
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NOAH Ltd
4 August 2000 |
