Code of Practice for the Promotion of Animal MedicinesPrécis of Report to Chief Executives of Cases in 2002 for Circulation to Veterinary PressThe Code of Practice Committee met formally in May, July and October 2002. Four new cases were heard and a summary of the cases and rulings are given below. An Undertaking has been received in respect of each Case.
CODE OF PRACTICE CASE NO. 224/3/02 Boehringer Ingelheim Ltd complaint against Intervet UK Ltd - "Vasotop" This case involved three separate promotion claims, albeit with a revised advertisement during the course of the complaint also becoming involved. 1. Re “Vasotop. The same action on the surface. Greater ACEi activity at a deeper level”: The Bender Paper. The Complainant queried the justification of using a paper relating to one species as supporting a product claim in a difference species. After consideration of the facts in the instant case, the Committee decided that there was no breach. It was not felt that use of a trial on species in support of a product designed for treating a different species would necessarily be a breach; everything would depend on the facts of each case. 2. Re “ Vasotop. The same action on the surface. Greater ACEi activity at a deeper level”: The Francis quote. The concern here was that the writer of the paper, Dr Francis, was a human cardiologist with no known experience in dogs. There was nothing in the promotion which was not within the SPC or data sheet. The Members felt that on the facts of this Case, Dr Francis not having any known expertise in dogs, did not render his findings irrelevant and therefore there was no breach. 3. Data Sheet ‘Further Information’. The objection was the use of the data sheet in its reference to ‘patients’. Members considered that in the context of the use of the word within the data sheet, it was obvious that this related to various species, and not just humans. Therefore the Committee held there was no breach. 4. “Vasotop. The next generation ACEi” The issue revolve around whether the reader would construe the term ‘next generation’ as meaning something which had a special merit, quality or property (as it required by Clause 5.2 of the Code of Practice), or would it be read as the next stage in product marketing or sales. The Committee were of the view that on the facts of this case, the use of the expression did constitute a claim to a special merit, quality or property which had not been substantiated. While the Committee accepted that the product might have improved properties, these did not justify a claim that it was a ‘next generation’ product. Accordingly, this promotion was in breach of Code of Practice Clause 5.2. 5. Flier: “Triple action Vasotop ….. Good news travels fast” (Bender paper) This was brought in as an argument to support the Respondent’s case, but which promotion was considered by the Complainant to be, in itself, a breach of Code of Practice Clause 4.3. The Respondent’s representatives had confirmed that this was a ‘one-off’, not to be repeated. In any event, the issues being the same in its reference to the Bender paper, the Committee held for the reasons set out in respect of issue number (1) above, that there was no breach. 6. “Vasotop. The same action on the surface. Greater ACEi activity at a deeper level”. (Zhang) The issue here was the reference within the text which seemed to be inappropriate as Zhang et al Circulation 95, 176-182 was not concerned with the inhibition of angiotensin II. The Committee considered that the second reference to Zhang (as opposed to its use earlier in the same advertisement in a context in respect of which no complaint was made), did not substantiate the claim made that the product inhibited the formation of angiotensin II. While the Committee accepted that that claim appeared in the SPC, the Zhang paper did not support the claim but was concerned with inhibition of kinin degradation. Accordingly the Committee held that there was a breach of Code of Practice Clause 4.5. 7. Revised Text Advertisement: In studies in dogs and humans ramipril has been shown to give pronounced inhibition in key organ tissues at the local level, where the direct degenerative effects of angiotensis II can occur”. Bender Again, the Committee held there was no breach as regards the repeated reference to Bender for the reasons set out in issue number one above. Back to list of cases...
CODE OF PRACTICE CASE NO. 226/5/02 Intervet UK Ltd complaint against Virbac Limited
Advertisement for Equimax In this two item case, the Complainant objected to the Respondent’s advertisement promoting Equimax as follows:- “The first and only all-in-one horse wormer”; and “Kills all major worms”.
The complaint was that the product is not effective against encysted small redworms, and that, notwithstanding the reference to a note in small print “if required add a treatment for encysted small redworms”, the promotion was misleading and, being so all embracing, was improper. After hearing the Representatives comments and after lengthy consideration, the Committee’s decision was:- In relation to “the first and only all-in-one horse wormer” the product description constituted a breach of Code of Practice Clauses 4.3 and 5.2, because it was considered by the Committee that to claim that Equimax was an all-in-one horse wormer, in the context of a single dose, was both misleading and exaggerated, given that the Respondent accepted that the product was not effective for treatment for encysted small redworms.
As regards the promotion “kills all major worms” the Committee likewise held there was a breach of Code of Practice Clause 4.3 and 5.2, because in the context of use in a single dose as advertised, such words were both misleading and exaggerated, given that the Respondent accepted that the product was not effective for the treatment of encysted small redworms.
This case was subsequently referred to the Committee by the Complainant because of promotions which had continued after the Committee’s decision having been notified to the Respondent. The Respondent’s explanation was that to withdraw the publication would have incurred expense and that the Marketing Manager was away from the Office and therefore not implemented in a timely fashion. Whilst Committee members had a measure of sympathy for the Respondent, it was felt that the explanation did not satisfy the necessity for the Committee to be seen to act robustly to uphold the discipline of membership, and observance of the Code and the Rules and Constitution of the Code of Practice Committee. Accordingly the Committee agreed that a report should be made and submitted to the Board pursuant to Rule 17 with the parties being notified accordingly. However, in the interim period, between the claimed breach of the undertaking and the next Board meeting, the Complainant had raised the issue of a second advertisement which the Respondent held had been carefully prepared to avoid any breach of the Rules, but which the Complainant maintained was as much in breach as was the earlier advertisement. Consequently the Board agreed not to consider the Rule 17 referral to the Board in reference to breach of the first undertaking, until the Code of Practice had reconvened to discuss the second new complaint and to await the recommendation of the Code of Practice Committee, which then met to consider the matter. A voluntary undertaking had been given by the Respondent not to perpetuate the publication pending the Committee meeting. The Chairman summarised the particular concerns, referable to the Undertaking which it was alleged had been broken by the further advertisement, in that the wording of the Undertaking is:- “Not to use the expression “all-in-one horse wormer” without sufficient qualification and in any event not in the use of a single dose ……..”
The first issue raised by the Complainant was that, if one looked at the advertisement as a whole, there is reference to “all-in-one horse wormer” and also a quotation referring to a “single dose wormer” on the same page. Effectively, therefore, the reader would consider that there was an ‘all-in-one horse wormer’ which could be serviced by a single dose. This had been precisely the concern of the Committee in its first decision. The second issue, as summarised by the Chairman, was the reference to the ‘all-in-one horse wormer’, in that it was alleged that it “kills roundworms, tapeworms and bots”. The unanimous decision of the Committee was that both elements of the second advertisement broke the terms of the Undertaking. Accordingly the Committee resolved to report Virbac Limited to the Board under paragraph 17 of the Rules of Procedure, for breaching the undertaking on two occasions. Mr Retief Kotze was invited to represent Virbac at the Board of Management meeting on 13 March 2003. Subsequently, it was unanimously agreed to issue Virbac Limited with the following reprimand and that the wording of such a reprimand would be drafted by the Chief Executive for Board approval at their next meeting in May:- “The Board unanimously agreed that the first breach was in Virbac’s failure to action the withdrawal of the offending advertisement, which subsequently reappeared in publications. The Board accepted Virbac’s explanation and apology that this was an administrative oversight, in that the instruction to withdraw the offending advertisement was a result of it occurring during a holiday of their Marketing Manager. Notwithstanding this, the Board and Code of Practice Committee considers that, bearing in mind that all correspondence of Code of Practice cases is required under the terms of the Code to be with the Chief Executive / Managing Director of the company, the responsibility for implementation of the undertaking lies with the signatory of the Undertaking. Accordingly, therefore, the Board expressed its disappointment that the withdrawal did not take place immediately after the undertaking was issued. "However, the Board also unanimously decided, after full consideration, that the second breach, i.e. the placing of a modified advertisement, which was still in breach of the conditions of the undertaking, had been made knowingly, albeit that Virbac did so because it considered that it would otherwise be at a competitive disadvantage. But this reason was not felt to justify or even to provide mitigation for such action. Consequently it was in relation to this second breach that the Board felt that this reprimand should be issued, as Virbac’s actions were felt by the Board not only to be a breach, as was decided by the Committee, but also to be wholly contrary to the spirit of the Code. "Amendments to the Code of Practice rules were approved at the NOAH AGM on Thursday 24 April 2003, whereby the option of requiring the respondent to publish, at his own cost, an apology of similar magnitude and in the same media as any promotion found in breach. As this case preceded this new ruling the Board felt it was not appropriate to exercise this option on this occasion, but wished it to be noted that it was an example of where it would be likely that such a requirement would be sought by the Board in future cases.”
Virbac have acknowledged the reprimand and the case is now closed. Back to list of cases...
CODE OF PRACTICE CASE NO. 228/7/02 Boehringer Ingelheim Ltd complaint against Pfizer Ltd
Rimadyl Detailer This four item case related to a detailer produced by the Respondent in which only one item was found to be in breach:- In relation to a heading “Safety for long term use” combined with a bar chart using an asterisk to denote a lack of statistical significance, the Complainant had 4 complaints:- The dosage given in this study, 8.8 mg/kg was not the licensed dose and therefore safety could not automatically be inferred.
Additional to the group on 8.8 mg/kg dose, another group was being treated with Rimadyl at 4.4 mg. It was noted that within this group the size of lesions actually increased at the femoral condyles. Given this group was treated at closer to the licensed dose, it was argued that it was misleading that the Respondent did not disclose this finding.
The convention is to use an asterisk to indicate clinical significance. The Complainant was concerned that in this promotion the Respondent appeared to be reversing the convention and was using the asterisk to indicate no significance, which could mislead readers. Further it was argued that it was inappropriate to use non-statistically significant results to support a promotional claim.
Complainant argued that an 8 week period was insufficient for study on long-term use in this condition. Animals may have osteoarthritis present for many years.
By a majority decision, the Committee decided that the use of an asterisk to denote lack of statistical significance on top of bars in a bar-chart, apparently showing an improvement between Rimadyl and a placebo, was misleading, given that such an asterisk is conventionally used to denote statistical significance, despite the Respondent’s attempt to indicate what the asterisk represented, and therefore the Committee held this was a breach of Clause 4.3 of the Code of Practice, in that it could mislead the reader. Back to list of cases...
CODE OF PRACTICE CASE NO. 229/8/02 Pfizer Ltd complaint against Schering-Plough Animal Health
Zubrin - Tepoxalin Technical Monograph This case, related to one item of complaint, related to the Complainant’s concern at what they saw was the Respondent creating a new statistical classification by use of the claim “statistically, or preliminary significant statistical superiority…” in their Tepoxalin Technical Monograph, and also the words “preliminary significantly superior” in a table in the same paper. The Complainant alleged that what was p>0.05 would usually be treated as statistically insignificant, and not as the Complainant had described such results, contrary to Code of Practice Clauses 4.3 (unbalanced and misleading) and 5.5 (unfair comparison and misleading through undue emphasis). The Respondent maintained that the category of preliminary statistical significance reflected by p=0.05 to p<0.1 was being used frequently by Regulatory Authorities, and that in any event the p values were clearly stated within the same publication. During discussion it became clear that the use of the word “preliminary” had emanated from the USA and meant “approaching” or “close to”, and therefore quite different from its usual meaning within the UK. The unanimous decision of the Committee was that the use of the expression “preliminary significant statistical superiority” without explaining that ‘preliminary’ meant ‘approaching’ or ‘close to’ was misleading and therefore in breach of Code of Practice Clause 4.3. Back to list of cases... NOAH Ltd
10 October 2003 | 