AUTH/2203/1/09: Johnson & Johnson v Pfizer – Champix journal advertisement claim vs NRT ruled misleading | PMCPA Case

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Key facts

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Case number	AUTH/2203/1/09
Case reference	Champix journal advertisement
Complainant	Johnson & Johnson Limited
Respondent/company	Pfizer Limited
Product(s)	Champix (varenicline); comparator referenced: NRT patch (NiQuitin CQ Clear)
Material/channel	Journal advertisement published in GP (11 April 2008)
Key issue	Comparative superiority claim vs NRT ruled misleading due to insufficient study-design context (open-label trial) in the advertisement; incorrect referencing to Gonzales et al (2006) instead of Aubin et al for two bullet points.
Dates (received/completed if stated)	Complaint received 27 January 2009; Case completed 5 March 2009
Appeal	Not stated
Code year	Not stated
Breaches/clauses	Clause 7.2
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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Johnson & Johnson Limited complained about a Champix (varenicline) journal advertisement (ref CHA432a) issued by Pfizer Limited and published in GP on 11 April 2008.
The advertisement included the claim: “Champix at 12 weeks provides significantly greater quit success vs. NRT (NiQuitin CQ Clear)”.
The first two bullet points in the ad were referenced in error to Gonzales et al (2006) instead of Aubin et al.
The claim was derived from Aubin et al, described as an open-label, randomised trial comparing a 12-week standard regimen of Champix with a 10-week standard regimen of NRT patch for smoking cessation.
A footnote in the ad stated the recommended treatment course was 12 weeks for Champix and 10 weeks for the NRT patch, and described continuous abstinence rate time windows (weeks 9–12 for Champix; weeks 8–11 for NRT), but no further relevant details about Aubin et al were provided in the main body.
Pfizer stated the advertisement was no longer in use, but defended the robustness of Aubin et al and the use of its results in promotion.
The Panel noted the study authors discussed limitations including the open-label design, and that the authors’ conclusions referred to effectiveness “in an open-label setting”.

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The Panel ruled the claim “Champix at 12 weeks provides significantly greater quit success vs NRT (NiQuitin CQ Clear)” was misleading because the advertisement did not provide sufficient information about the study design for readers to assess the data.
A breach of Clause 7.2 was ruled.

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