Hospital consultant v Warner Chilcott: Asacol leavepiece claim “up to 72% treatment success” (AUTH/2397/4/11)

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Key facts

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Case number	AUTH/2397/4/11
Parties	Hospital consultant v Warner Chilcott
Product	Asacol (modified release (MR) mesalazine); Asacol 800mg MR tablets referenced
Material	Six-page gate-fold leavepiece (ref AS8538)
Claim at issue	“At 6 weeks, up to 72% of patients achieved treatment success (complete remission or clinical response to therapy) regardless of disease location”
Evidence cited	ASCEND I, II, III (Hanauer et al 2005; Hanauer et al 2007; Sandborn et al 2009)
Audience	Gastroenterologists and related health professionals (eg, irritable bowel disease nurses)
Applicable Code year	2008
Clauses considered	7.2, 7.4, 7.10
Panel decision	Breaches of Clauses 7.2, 7.4 and 7.10
Appeal outcome (final)	No breach of Clauses 7.2, 7.4 and 7.10; appeal successful on all points
Complaint received	6 April 2011
Case completed	22 June 2011

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

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A hospital consultant physician/gastroenterologist complained about a six-page gate-fold leavepiece for Asacol (modified release mesalazine) used with gastroenterologists and related health professionals.
The leavepiece headline was: “For moderately active ulcerative colitis (UC): Back to normal everyday life, sooner – Asacol 4.8g/day vs mesalazine 2.4g/day”.
The challenged claim stated: “At 6 weeks, up to 72% of patients achieved treatment success (complete remission or clinical response to therapy) regardless of disease location”.
The claim cited ASCEND I, II and III trials (Hanauer et al 2005; Hanauer et al 2007; Sandborn et al 2009).
The complainant alleged the claim was misleading because remission rates in the ASCEND studies were reported as <20%.
Warner Chilcott argued “treatment success” was the primary endpoint and a composite of complete remission or clinical response/partial response, and that the definition was included in the claim.

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Panel (initial ruling): Breaches ruled for Clauses 7.2, 7.4 and 7.10 (misleading/exaggerated and not substantiated).
Appeal Board (final outcome): No breach of the Code. The appeal on all points was successful; no breaches of Clauses 7.2, 7.4 or 7.10.

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