Janssen-Cilag Lyrinel XL ad: illustration found to misrepresent study discontinuations and recommendation rates

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Key facts

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Case number	AUTH/2134/6/08
Case reference	Advertisement ref LYR/08-0036
Complainant	A pharmacist
Respondent/company	Janssen-Cilag Ltd
Product(s)	Lyrinel XL (oxybutynin hydrochloride)
Material/channel	Journal advertisement (GP, 6 June; stated by company as published in Pulse, 4 June 2008)
Key issue	Illustration/headline (“Gets our vote”) misleadingly implied very high recommendation/satisfaction by not reflecting discontinuations and by implying too few patients would not recommend
Dates (received/completed if stated)	Complaint received 16 June 2008; Case completed 2 July 2008
Appeal	Not stated
Code year	Not stated
Breaches/clauses	Clauses 7.2 and 7.8
Sanctions	No explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

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

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A pharmacist complained about a Janssen-Cilag Ltd advertisement for Lyrinel XL (oxybutynin hydrochloride) (ref LYR/08-0036) placed in GP, 6 June (Janssen-Cilag stated it was published in Pulse, 4 June 2008).
The ad headline was “Gets our vote” and cited Diokno et al 2002: 1,067 patients enrolled; 795 remained at 3 months; of those, 88% would recommend extended-release oxybutynin to others.
The ad included an illustration of an audience holding up cards; 24 cards were clearly distinguishable and one woman was clearly not holding up her card.
The complainant alleged the picture misrepresented the data: 1 out of 24 not “voting” implied ~4% would not recommend, rather than 12% of those remaining at 3 months, and did not account for dropouts.
Janssen-Cilag argued the image was fair and balanced, that a precise percentage could not be derived from the picture, and that the 88% figure was prominently displayed.
The Panel considered the underlying study context, including that 272 patients discontinued by 3 months (166 due to adverse events, 52 due to lack of efficacy, 49 other reasons).

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The Panel ruled that the illustration was not a fair reflection of the total data and was misleading and exaggerated.
The Panel found the ad implied almost everyone who took Lyrinel XL would be happy to stay on it, which was not supported given the 25% discontinuation at 3 months and that 12% of those remaining would not recommend.
The Panel stated that including some study data as a heading was not sufficient to negate the effect of the illustration.
Breaches were ruled of Clauses 7.2 and 7.8 of the Code.

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