Code of
Practice for the Promotion of Animal Medicines
Précis of Committee meetings held in 2008
Case No. 268. Schering-Plough Animal
Health / Pfizer Limited: Promotional material for Spirovac
The issues revolved around whether SPIROVAC was licensed
against both strains of L. hardjo – L. hardjo bovis and L. hardjo
prajitno.
The words to which complaint was made were contained in
advertisements, specifically Cattle Practice, November 2007 (Veterinary
Surgeon Journal), and in editorial coverage in Dairy Vet and British
Dairying and were:-
1. “That Spirovac works against both strains of
leptospirosis (L. hardjo bovis and L. hardjo prajitno).” 2. “Licensed
against both strains of leptospirosis.”
The Complainant argued that these constituted a breach of
Clauses 4.3 and 4.7. These are recited below:-
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.
4.7 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.
The Complainant maintained that as the SPC provides that
protection against the latter had not been demonstrated by challenge, it was
not licensed for use against that strain and that the two items of promotion
were misleading and intimated a consistency with the SPC, which was not in
fact correct.
The Chairman drew attention to the VMD’s correspondence
disclosed by the parties which refers to the protection not having been
demonstrated by challenge and that in fact no model existed. He took the
view that the case, like many others, related to the wording of the
promotion.
A discussion ensued regarding the lack of challenge: the
fact that no challenge had occurred, reference being drawn particularly to a
paper “Immunity to Bovine Leptospirosis” by W A Ellis et al
2000 in which it is stated:-
“This leaves claims of efficacy against hardjo
type Prajitno infection unproven for Leptavoid-H or any other Leptospira
hardjo vaccine. While it is reasonable to assume that a vaccine, which
protects against the heterologous strain, will also protect against the
homologous strain, there is one qualification that should be made. That is,
if the natural route of infection for hardjo Prajitno is the venereal
route then arguments based on a systemic vaccine protecting against systemic
infection may not necessarily hold true.”
These important comments followed a statement that the
challenge route chosen (super conjunctional) whilst appropriate for
hardjo bovis, was clearly inappropriate for hardjo Prajitno
studies.
Also noted were the comments in the study regarding CMI
(cell mediated immunity) studies, and the relatively slight response to
in-vitro antigen stimulation.
The Chairman drew attention to the way the SPC for the
product reflected in the item “indications for use” identified only one
target strain – the bovis strain. It was only in section 5 further on in the
SPC under “Immunological Properties” that reference is made to activity
against the strain in-vitro, with the warning as regards the lack of
challenge – this reference is repeated under “Further information” in the
data sheet, where use against the bovis strain only is given under the
“Uses” heading.
The Respondent’s representatives first referred to the
nomenclature and the changes in terms (in this précis only the single
description “Bovis” and “Prajitno” has been used throughout for simplicity).
They then discussed the science between the two strains
which they said was not fully understood.
Under questions from the Chairman, the Respondent’s
representatives accepted fully the importance of the Ellis paper and that no
model establishing an effective challenge had been able to be created; that
protection cannot be proved; and also accepted the differing results from
in-vitro application disclosed from the CMI studies.
The Respondent’s Representatives emphasised that they had
fully recognised that the product could not be promoted as “protection”
against the Prajitno strain, and that they had, therefore, elected to use
the words “works” which they felt accurately reflected the SPC wording, in
the sense that the product had been shown to be active; in their view the
term equated to having “an effect”.
The Respondent’s Representatives were questioned closely
by both the Chairman and Members, querying whether readers would not equate
“works” with “being effective” and would assume that meant “protection”. The
Respondent’s Representatives did not consider this was the case. They never
intended to imply any protection from the product against this strain.
The Respondent’s Representatives also explained that
their process had been designed to obtain European regulatory approval as
well as UK regulatory approval, and that the current impracticality of
obtaining a proper challenge model ensured that they could not promote the
same effectiveness of Spirovac against both strains. However, they took the
view that in producing the product’s Data Sheet, the choice of placement as
regard the product’s activity against the Prajitno strain, could have been
placed, if they wished, under the Indications for Use paragraph and,
therefore, in their view, anything that was contained in the SPC as regards
the product’s capabilities constituted a licence. In responding to the
enquiry, the Respondent’s Representatives did not consider that the
promotion suggested the product was equally effective against both strains.
They emphasised their wording was intended to recognise the differences,
notwithstanding that they argued that it was licensed against both strains,
because that was what was stated in the SPC.
After discussion, the Members were unanimous in their
view on the word “works” which was felt to be both misleading and contrary
to the SPC.
There was greater discussion on the licensing issue where
some Members sympathised with the view expressed by the Respondent and felt
that the Respondent was entitled to treat the words in the SPC as amounting
to a licence. However, on a vote being taking, the decisions of the
Committee were:-
Item 1
The Committee considered that the wording complained of
was misleading and was inconsistent with the SPC since it amounted to a
claim that Spirovac conferred protection against L. hardjo prajitno
when the SPC acknowledges that such protection has not been demonstrated.
Accordingly the Committee found a breach of clauses 4.3 and 4.7.
Item 2
The Committee considered that the wording complained of
was misleading and (by a majority) was inconsistent with the SPC since it
amounted to a claim that Spirovac was licensed for use against both L.
hardjo bovis and L. hardjo prajitno when it is only licensed for
use against L. hardjo bovis. Accordingly the Committee found a
breach of clauses 4.3 and (by a majority) 4.7. It was noted by some
Members of the Committee when the Chairman read out the wording of the
decision for approval, that it did not specifically refer to the use of the
word “works” and it was agreed that the Undertaking sought from the
Respondent should specifically refer to the word.
Undertaking
All participants found in breach of the Code are required
under Rule 15(i)(a) to give an undertaking that the practice in question (if
not already discontinued) will be discontinued.
Pfizer Ltd signed the following undertaking on 14
February 2008:
1. We acknowledge the decision(s) of the Committee in
Case 268/01/2008 as set out in your letter of 5 February 2008.
2. We accept the decision(s) of the Committee and
undertake that the practice(s) in question (if not already discontinued)
will be discontinued forthwith, and to that end, we have taken the following
steps in relation to any promotion of Spirovac® (until or unless
specifically authorised for such treatment by the product’s SPC without any
acknowledgement or other qualifying statement to the effect that protection
by Spirovac® against L. hardjo prajitno has not been demonstrated):
(a) Forthwith to cease and immediately to suspend any
practice which includes any claim that Spirovac® “works” against L.
hardjo prajitno, or which by other words, connotations or means,
suggests or implies or tends to imply that that product provides
protection against that strain; or
(b) Forthwith to cease and immediately to suspend any
practice which includes any reference to Spirovac® being licensed for
use against L. hardjo prajitno.
3. We hereby give an assurance that we will take all
possible steps to avoid a similar breach, or breaches, of the Code occurring
in the future.
On 10 July 2008 the NOAH Board discussed a Report from
the NOAH Code of Practice Committee regarding a breach of an Undertaking by
Pfizer Animal Health, relating to the promotion of Spirovac®.
Three promotional items issued following the Undertaking
were deemed by the Code of Practice Committee to be in breach of this
Undertaking, and this decision was then reported to the NOAH Board.
Pfizer was formally reprimanded for their conduct. Pfizer
will be writing to all recipients of the offending material to apologise,
and to correct any misunderstanding that may have arisen, namely to explain
that Spirovac® only has a licensed claim for protection against one of the
two strains of bovine leptospirosis, the hardjo bovis strain.
Although Spirovac® has been shown to stimulate an antibody response against
the second strain, hardjo prajitno, protection against this strain
has not been demonstrated by challenge studies and it therefore has no
licensed claim against this strain.
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NOAH Ltd
5 August 2008 (for updated case 268)
Any further cases in 2008 will be added here in due course |
