Pfizer Champix journal ad: superiority claim vs NRT ruled misleading due to lack of study design context

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Key facts

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Case number	AUTH/2203/1/09
Case reference	AUTH2203109
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)
Key issue	Comparative superiority claim vs NRT held misleading due to lack of relevant study design details/context (open-label setting) in the ad
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 ad included the claim: “CHAMPIX at 12 weeks provides significantly greater quit success vs. NRT (NiQuitin CQ Clear)”.
Johnson & Johnson alleged the claim was misleading and not supported by robust data, citing methodological limitations of the underlying open-label comparison study (Aubin et al 2008), including potential bias and the inclusion of patients with prior unsuccessful NRT patch use.
Pfizer responded that the claim was supported by Aubin et al (an open-label, randomised trial) and provided efficacy figures and statistical results from the study; Pfizer also noted the ad was no longer in use.
The Panel considered that open-label data could be used in promotion, but readers must be given sufficient information about the study to assess the data; the main body of the ad provided no relevant details about the study design.

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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 it was not a fair reflection of the study findings in context (the study authors’ conclusion referred to effectiveness “in an open-label setting”) and the ad did not provide relevant study design details.
A breach of Clause 7.2 was ruled.

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