Tillotts Pharma: ‘Educational update’ journal supplement ruled disguised promotion and misleading cost/guideline messaging (Octasa) (AUTH/2610/6/13)

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Key facts

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Case number	AUTH/2610/6/13
Complainant	Warner Chilcott UK Ltd
Respondent	Tillotts Pharma UK Ltd
Medicine	Octasa (mesalazine modified-release tablets)
Comparator mentioned	Asacol (mesalazine modified release)
Material	Journal supplement (ref UK/OC/0001/0113) in the British Journal of Clinical Pharmacy
Main issues	Disguised promotion; insufficiently prominent sponsorship declaration; misleading/unsubstantiated cost claims; misleading guideline messaging on brand prescribing/interchangeability; in vitro data implying clinical similarity; unclear/incorrect data presentation (graph/table); failure to maintain high standards
Complaint received	17 June 2013
Case completed	10 September 2013
Appeal	No appeal
Applicable Code year	2012
Breaches	Clause(s) 7.2 (x7), 7.3 (x3), 7.4 (x4), 7.10, 9.1 (x2), 9.10 and 12
No breach	Clause(s) 2 and 7.2 (in specified elements)
Sanctions	Undertaking received; Additional sanctions: Not stated

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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Warner Chilcott UK complained about Tillotts Pharma UK’s promotion of Octasa (mesalazine modified-release tablets) via a journal supplement (ref UK/OC/0001/0113) published in the British Journal of Clinical Pharmacy.
The supplement was prominently presented as an “Educational update”, used journal-style formatting, and listed two independent authors, but included Octasa prescribing information and was used by Tillotts to support Octasa vs Asacol.
Tillotts provided data and reviewed and approved the article; the Panel considered the company inextricably linked to its production and therefore responsible under the Code.
The declaration of sponsorship appeared on the cover but was in very small white text on a dark grey band at the bottom; the Panel considered it insufficiently prominent at the outset.
Key claims focused on cost (eg “lowest cost” and large savings for 300 patients) and implied interchangeability across modified-release mesalazine brands, relying heavily on in vitro dissolution data.
Specific issues included: unclear basis for “lowest cost” claims (acute vs maintenance; dose ranges), misleading take-home message about prescribing by brand, extrapolation from in vitro data to clinical equivalence, an unlabelled graph axis, and inaccurate/unclear cost table assumptions.

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Breach ruled for disguised promotion: the promotional nature was considered disguised by the prominent “Educational update” presentation.
Breach ruled for inadequate prominence of the sponsorship declaration.
Multiple breaches ruled for misleading and/or unsubstantiated claims and comparisons (including cost claims, guideline interpretation, in vitro-to-clinical inference, and data presentation).
No breach of Clause 2 (discredit): despite poor standard, the Panel did not consider it such as to bring discredit upon or reduce confidence in the industry.
No breach for the statement about keeping costs down “without compromising patient care” in the specific context of Mesren discontinuation and Octasa being essentially a rebrand of Mesren.

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Applicable Code year: 2012
No breach: Clause(s) 2 and 7.2 (in relation to the “without compromising patient care” statement; and on a narrow basis regarding relapse risk evidence in the cost table discussion)
Breach: Clause(s) 7.2 (x7), 7.3 (x3), 7.4 (x4), 7.10, 9.1 (x2), 9.10 and 12

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