Case Summary
A complainant, who described him/herself as a concerned UK health professional, complained about an Octasa 1600mg (modified release mesalazine) journal advertisement) placed by Tillotts Pharma UK Limited. The advertisement was headed ‘Big picture thinking’ and featured the photograph of an elderly man who appeared to be holding three photographs of himself spanning the years to when he was a young man/boy. The main claim was ‘Always once-daily designed to aid adherence’.
Octasa 1600mg was indicated for the treatment of mild to moderate ulcerative colitis and for the maintenance of remission.
The complainant alleged that although the advertisement claimed ‘Always once a day’, the summary of product characteristics (SPC) stated that in acute disease the dose could be given 2-3 times a day.
In the complainant’s view, the boy in the inner picture appeared to be under the age of 18. Although the product was not excluded from this age group, safety and efficacy had not been excluded (sic) and in the picture it appeared it was equally suitable for all age groups, and there was also no text in the advertisement to convey this safety message.
The detailed response from Tillotts is given below.
The Panel noted that Octasa 1600mg modified release was indicated for adults andthe dose should be adjusted according to the severity of the disease and tolerance. For acute disease, in the event of exacerbation, the dose could be increased to 4800mg daily, once daily or in 2-3 divided doses and once clinical remission was achieved, the dose should gradually be decreased to maintenance dose. The maintenance dose was 1600mg once daily.
The Panel noted that the dose of 4800mg of Octasa did not have to be given as a split dose; patients could take three tablets together in a once daily dose. There was thus the possibility that Octasa 1600mg could always be given once daily.
The Panel noted that the advertisement might give some readers the impression that the medicine must only be given once daily whereas the SPC gave a choice in acute disease between once daily or divided doses. the Panel noted that the focus of the advertisement was on the maintenance of remission and as the indicated dose for maintenance of remission was one 1600mg tablet daily, and tablets must be swallowed whole, maintenance treatment was, by necessity, always once daily.
On balance the Panel considered that the claim at issue, ‘Always once daily’, was not inaccurate as such. The advertisement did not refer to the possibility in acute disease of taking the medicine in 2-3 doses but this did not render the claim misleading. The claim was capable of substantiation. The Panel therefore ruled no breaches of the Code.
With regard to the photograph of the youngest man/boy, in the advertisement, the Panel noted Tillotts’ submission that the peak incidence of ulcerative colitis occurred in the age range 15 to 25 years of age and that the model used for the inner image in the advertisement was 16 years old when the photograph was taken.
According to their SPCs Octasa 400mg and 800mg modified release tablets were indicated for children above the age of 6 with a maximum maintenance daily dose of 2g. The normal adult dose was recommended for those with a body weight of above 40kg. It appeared that the use and safety of mesalazine for treating ulcerative colitis in paediatric patients was well established, with a mg/kg of body weight ratio. However, Octasa 1600mg was only indicated for adults including the elderly and the SPC stated that the safety and efficacy of Octasa in children and adolescents aged younger than 18 years of age had not been established.
In the Panel’s view, the age of the man/boy in the smallest photograph at issue was difficult to determine but most would think he was a late teenager/young adult. The other two photographs were clearly of adult males. The theme of the advertisement was that the condition was lifelong. Health professionals would have to decide whether patients were suitable for the product and one of the factors to be considered would be their age.
On balance the Panel did not consider that the advertisement promoted the use of Octasa 1600mg in children or that it was suitable for all age groups as alleged. The Panel therefore ruled no breach of the Code.
Given its rulings of no breaches of the Code, above the Panel did not consider that high standards had not been maintained and ruled accordingly, including that there was no breach of Clause 2 of the Code.
NO BREACH OF THE CODE
CASE AUTH/3313/2/20
COMPLAINANT v TILLOTTS
Promotion of Octasa
A complainant, who described him/herself as a concerned UK health professional, complained about an Octasa 1600mg (modified release mesalazine) journal advertisement) placed by Tillotts Pharma UK Limited. The advertisement was headed ‘Big picture thinking’ and featured the photograph of an elderly man who appeared to be holding three photographs of himself spanning the years to when he was a young man/boy. The main claim was ‘Always once-daily designed to aid adherence’.
Octasa 1600mg was indicated for the treatment of mild to moderate ulcerative colitis and for the maintenance of remission.
The complainant alleged that although the advertisement claimed ‘Always once a day’, the summary of product characteristics (SPC) stated that in acute disease the dose could be given 2-3 times a day.
In the complainant’s view, the boy in the inner picture appeared to be under the age of 18. Although the product was not excluded from this age group, safety and efficacy had not been excluded (sic) and in the picture it appeared it was equally suitable for all age groups, and there was also no text in the advertisement to convey this safety message.
The detailed response from Tillotts is given below.
The Panel noted that Octasa 1600mg modified release was indicated for adults andthe dose should be adjusted according to the severity of the disease and tolerance. For acute disease, in the event of exacerbation, the dose could be increased to 4800mg daily, once daily or in 2-3 divided doses and once clinical remission was achieved, the dose should gradually be decreased to maintenance dose. The maintenance dose was 1600mg once daily.
The Panel noted that the dose of 4800mg of Octasa did not have to be given as a split dose; patients could take three tablets together in a once daily dose. There was thus the possibility that Octasa 1600mg could always be given once daily.
The Panel noted that the advertisement might give some readers the impression that the medicine must only be given once daily whereas the SPC gave a choice in acute disease between once daily or divided doses. the Panel noted that the focus of the advertisement was on the maintenance of remission and as the indicated dose for maintenance of remission was one 1600mg tablet daily, and tablets must be swallowed whole, maintenance treatment was, by necessity, always once daily.
On balance the Panel considered that the claim at issue, ‘Always once daily’, was not inaccurate as such. The advertisement did not refer to the possibility in acute disease of taking the medicine in 2-3 doses but this did not render the claim misleading. The claim was capable of substantiation. The Panel therefore ruled no breaches of the Code.
With regard to the photograph of the youngest man/boy, in the advertisement, the Panel noted Tillotts’ submission that the peak incidence of ulcerative colitis occurred in the age range 15 to 25 years of age and that the model used for the inner image in the advertisement was 16 years old when the photograph was taken.
According to their SPCs Octasa 400mg and 800mg modified release tablets were indicated for children above the age of 6 with a maximum maintenance daily dose of 2g. The normal adult dose was recommended for those with a body weight of above 40kg. It appeared that the use and safety of mesalazine for treating ulcerative colitis in paediatric patients was well established, with a mg/kg of body weight ratio. However, Octasa 1600mg was only indicated for adults including the elderly and the SPC stated that the safety and efficacy of Octasa in children and adolescents aged younger than 18 years of age had not been established.
In the Panel’s view, the age of the man/boy in the smallest photograph at issue was difficult to determine but most would think he was a late teenager/young adult. The other two photographs were clearly of adult males. The theme of the advertisement was that the condition was lifelong. Health professionals would have to decide whether patients were suitable for the product and one of the factors to be considered would be their age.
On balance the Panel did not consider that the advertisement promoted the use of Octasa 1600mg in children or that it was suitable for all age groups as alleged. The Panel therefore ruled no breach of the Code.
Given its rulings of no breaches of the Code, above the Panel did not consider that high standards had not been maintained and ruled accordingly, including that there was no breach of Clause 2 of the Code.
A complainant, who described him/herself as a concerned UK health professional, complained about an Octasa 1600mg (modified release mesalazine) journal advertisement (ref PU-00264) placed by Tillotts Pharma UK Limited in the January 2020 edition of Guidelines in Practice. The advertisement was headed ‘Big picture thinking’ and featured the photograph of an elderly man who appeared to be holding three photographs of himself spanning the years to when he was a young man/boy. The main claim was ‘Always once-daily designed to aid adherence’.
Octasa 1600mg was indicated for the treatment of mild to moderate ulcerative colitis and for the maintenance of remission.
COMPLAINT
The complainant alleged that although the advertisement claimed ‘Always once a day’, the summary of product characteristics (SPC) stated that in acute disease the dose could be given 2-3 times a day, so it was not always once a day as claimed.
In the complainant’s view, the boy in the inner picture appeared to be under the age of 18. Although the product was not excluded from this age group, safety and efficacy had not been excluded (sic) and in the picture it appeared it was equally suitable for all age groups, and there was also no text in the advertisement to convey this safety message.
When writing to Tillotts, the Authority asked it to consider the requirements of Clauses 2, 7.2, 7.4, 7.8, and 9.1 of the Code.
RESPONSE
Tillotts confirmed that the advertisement was withdrawn from use on 20 August 2020.
With regard to the dosage schedule, Tillotts stated that in all clinical circumstances Octasa 1600mg could be prescribed with a once daily dosage regimen, and it was not possible to prescribe the maintenance dose of Octasa 1600mg in any other regimen than once daily. ‘Always once-daily’ in the context of the advertisement informed prescribers that there was no dose within the particulars of the Octasa 1600mg SPC at which divided dose prescribing was required. In all circumstances, in mild and mild to moderate ulcerative colitis patients, it was usual, even preferential, for Octasa 1600mg to be prescribed as a once daily regimen. A once daily regimen was supported by clinical guidelines, such as those issued by the National Institute for Health and Care Excellence (NICE) for the management of ulcerative colitis (NG130, May 2019).
Lower strengths tablets of Octasa (400mg and 800mg, and other brands of mesalazine at the same dose) required prescribers to split the dose when prescribing doses above 2.4g daily. Non-adherence and pill burden was a significant problem in the management of patients with mild and mild to moderate ulcerative colitis. To aid adherence the Octasa 1600mg tablet had been specifically developed for once daily dosing, therefore it was important that this treatment attribute was brought to the attention of prescribers. It was a statement of fact that Octasa 1600mg could always be prescribed as a once daily dose. In this context ‘always’ did not mean ‘restricted to’ or ‘only’ as implied by the complainant. In this context ‘always’ meant that there were no circumstances when a once daily dose could not be prescribed.
Octasa 1600mg was indicated for the induction of remission and maintenance of remission of ulcerative colitis, in this advertisement the focus was on the maintenance of remission; in that regard, Tillotts noted the claims ‘Supporting patients to stay adherent was vital in reducing their risk of relapse’, and ‘One tablet once-daily for the maintenance of remission’. As the indicated dose for maintenance of remission was one 1600mg tablet daily, and tablets must be swallowed whole, maintenance treatment was, by necessity, always once daily.
Choosing not to prescribe Octasa 1600mg once daily would be unusual and offered no proven benefits over a once daily dose. By splitting the dose of Octasa 1600mg the prescriber could be detrimentally increasing the risk of patients being non-adherent to their regimen.
Tillotts submitted that the claim ‘Always once daily’ was not in breach of Clauses 2, 7.2, 7.4, 7.8 or 9.1.
With regard to the photograph of the patient as a young man/boy, Tillotts submitted that feedback from specialist nurses and gastroenterologists was that young adult males in remission were the patients most likely to be non-adherent, and the patient group in which a one tablet once daily maintenance regimen was most likely to aid adherence, helping to reduce the risk of relapse. The imagery and the statement ‘Always once daily’ were intended to draw this to the attention of the prescriber.
Tillotts explained that the model used for the inner image in the advertisement was 16 years old when the photograph was taken. A selection of images of young adults were scrutinised by a team including regulatory affairs, code compliance, medical affairs, and marketing to select an image that was consistent with the Octasa 1600mg SPC and the age range of patients typically referred to gastroenterology with suspected ulcerative colitis.
Tillotts stated that it chose a young adult because peak incidence of ulcerative colitis occurred in the age range 15 to 25, therefore the image was typical of the age of patients being referred to gastroenterologists with suspected ulcerative colitis.
The imagery displayed in the Octasa campaign was intended to convey that commencing in young adulthood maintenance treatment was likely to be required throughout the patient’s life.
Tillotts submitted that its review team considered that the inner image of a young adult male was consistent with the particulars of the Octasa 1600mg SPC and did not give the appearance that ‘it was equally suitable for all age groups’ as stated by the complainant, as all age groups would include children of any age. Tillotts submitted that this therefore demonstrated that it had taken careful steps to ensure that it did not breach the Code. Tillotts did not believe that the advertisement breached Clauses 2, 7.2, 7.4, 7.8 or 9.1.
Tillotts stated that the safety of mesalazine for treating ulcerative colitis in paediatric patients was very well established, with a mg/kg of body weight ratio. Octasa 400mg and 800mg tablets were licensed for use in paediatric patients over the age of six years. Previous Octasa campaign imagery, prior to the launch of Octasa 1600mg tablets, showed an image to represent a minor. The image in the Octasa 1600mg advertisement campaign was changed specifically to avoid any risk that Octasa 1600mg tablets were perceived as being suitable for all age groups.
When developing the campaign for Octasa 1600mg Tillotts was cognisant of the Panel’s ruling in Case AUTH/2059/10/07, where the age of the figure could not be determined, and that associated images such as a doll lying on the floor of a school playground and adjacent text stating ‘Prescribe early’ implied the product could be prescribed for a young teenager. There was no such associated imagery or text in the Octasa advertisement that could mislead the reader to believe that Octasa 1600mg could be prescribed for all age groups. Tillotts stated that it had had no comments about this advertisement from any other health professional. Tillotts therefore did not believe that the use of the image breached the Code. Tillotts stated that it had taken thorough steps to ensure that the imagery was both representative of a typical ulcerative colitis patient and consistent with the Octasa 1600mg tablet SPC and with that in mind it denied breaches of Clauses 9.1 and 2.
PANEL RULING
The Panel noted that Octasa 1600mg modified release was indicated for adults including the elderly (>65 years). The SPC stated that the dose should be adjusted according to the severity of the disease and tolerance. For acute disease, in the event of exacerbation, the dose could be increased to 4800mg daily, once daily or in 2-3 divided doses and once clinical remission was achieved, the dose should gradually be decreased to maintenance dose. The maintenance dose was 1600mg once daily.
The Panel noted the complainant’s submission that in acute disease, Octasa 1600mg could be given two or three times a day. In that regard the Panel noted that the dose of 4800mg did not have to be given as a split dose; patients could take three tablets together in a once daily dose. There was thus the possibility that Octasa 1600mg could always be given once daily. The SPC did not state that in acute disease the dose should be given two or three times a day.
The Panel noted that the advertisement might give some readers the impression that the medicine must only be given once daily whereas the SPC gave a choice in acute disease between once daily or divided doses. In general the Panel considered that patients would probably prefer to take their medicine once a day rather than in divided doses. The Panel further noted that whilst Octasa 1600mg was indicated for the induction of remission and maintenance of remission of ulcerative colitis, the focus of the advertisement at issue was on the maintenance of remission and as the indicated dose for maintenance of remission was one 1600mg tablet daily, and tablets must be swallowed whole, maintenance treatment was, by necessity, always once daily.
On balance the Panel considered that the claim ‘Always once daily’ was not inaccurate as such. The advertisement did not refer to the possibility in acute disease of taking the medicine in 2-3 doses but this did not render the claim at issue ‘Always once daily’ misleading. The claim was capable of substantiation. The Panel therefore ruled no breach of Clauses 7.2 and 7.4 of the Code.
With regard to the photograph of the youngest man/boy, in the advertisement, the Panel noted Tillotts’ submission that the peak incidence of ulcerative colitis occurred in the age range 15 to 25 years of age and that the model used for the inner image in the advertisement was 16 years old when the photograph was taken.
According to their SPCs Octasa 400mg and 800mg modified release tablets were indicated for children above the age of 6 with a maximum maintenance daily dose of 2g. The normal adult dose was recommended for those with a body weight of above 40kg. It appeared that the use and safety of mesalazine for treating ulcerative colitis in paediatric patients was well established, with a mg/kg of body weight ratio. However, Octasa 1600mg was only indicated for adults including the elderly (>65 years). The Octasa 1600mg SPC stated that the safety and efficacy of Octasa in children and adolescents aged younger than 18 years of age had not been established.
In the Panel’s view, the age of the man/boy in the smallest photograph at issue was difficult to determine but most would think he was a late teenager/young adult. The other two photographs were clearly of adult males. The theme of the advertisement was that the condition was lifelong. Health professionals would have to decide whether patients were suitable for the product and one of the factors to be considered would be their age.
The Panel noted that the supplementary information to Clause 7.8 stated that care must be taken to ensure that artwork did not mislead as to the nature of a medicine or any claim or comparison and that it did not detract from any warnings or contraindications. For example, depictions of children should not be used in relation to products not authorized for use in children in any way which might encourage such use.
On balance the Panel did not consider that the advertisement promoted the use of Octasa 1600mg in children or that it was suitable for all age groups as alleged. The Panel therefore ruled no breach of Clause 7.8 of the Code.
Given its rulings of no breaches of the Code, above the Panel also ruled no breach of Clauses 9.1 and 2.
Complaint received 20 February 2020
Case completed 7 January 2021
