AUTH/2259/8/09: Pfizer breached undertaking and misled with Champix comparative and NHS-derived charts

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Key facts

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Case number	AUTH/2259/8/09
Parties	Johnson & Johnson/Director v Pfizer
Product	Champix (varenicline)
Indication (as stated)	Smoking cessation
Materials	Leavepiece “How you and 12 weeks of Champix can aid smoking cessation with your patients” (ref CHA693); GP journal advertisement (ref CHA752a)
Key evidence cited	Aubin et al (open-label randomised trial); NHS Stop Smoking Services statistics (England, April 2007–March 2008); NHS Stop Smoking Services: Service and Monitoring Guidance 2009/10 (adapted from Cochrane reviews)
Complaint received	25 August 2009
Case completed	11 November 2009
Applicable Code year	2008
Breach clauses	2, 7.2 (x6), 7.3, 7.4, 7.8 (x2), 9.1 and 25
Sanctions applied	Undertaking received; Advertisement
Appeal	No appeal

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

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What happened

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Johnson & Johnson complained about Pfizer’s promotion of Champix (varenicline) via a leavepiece (ref CHA693) and a GP journal advertisement (ref CHA752a).
The leavepiece compared Champix with an “NRT patch” using Aubin et al (open-label trial) and included claims such as “Champix at 12 weeks enabled significantly more smokers to quit than those who used NRT patch (p<0.001)”.
Key study-design details (including the open-label nature and differences in treatment duration/endpoint timing between Champix and NiQuitin CQ Clear) were placed in footnotes rather than in the main body near the claims.
The leavepiece used “NRT patch” wording throughout, with only limited mention that the comparator was specifically NiQuitin CQ Clear, creating an impression the results applied to NRT patches generally.
The leavepiece also presented three adjacent pie charts from NHS Stop Smoking Services data (self-reported 4-week quits) in a way that invited direct comparisons without statistical analysis and without adequate explanation of the observational/audit nature of the data.
The leavepiece omitted relevant NHS data showing 55% quit success with no pharmacotherapy, which the Panel considered important context.
The GP advertisement reproduced a comparative bar chart from NHS guidance (adapted from Cochrane reviews) that implied Champix superiority without known statistical significance and without patient numbers.
Although the ad stated the 4-week quit rates were extrapolated, Pfizer could not substantiate the calculation/assumptions behind the extrapolation.
Because the leavepiece was considered “caught by” a prior undertaking (Case AUTH/2203/1/09), the Director pursued the undertaking aspect.

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Outcome

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Breach found for the leavepiece: the material was caught by the prior undertaking; footnotes were insufficient for integral study limitations; claims were misleading and did not enable readers to form their own opinion of therapeutic value.
Breach found for misleading generalisation/ambiguity: “NRT patch” wording implied broader applicability than the specific comparator (NiQuitin CQ Clear).
Breach found for misleading impression of treatment duration/endpoint timing: key comparator timing details were relegated to footnotes.
Breach found for pie charts: presentation invited unsupported comparisons; observational/audit nature and limitations were inadequately explained; omission of “no pharmacotherapy” data was misleading.
No breach on implied NHS endorsement for the leavepiece heading “Champix and the NHS Stop Smoking Service”.
No breach on the GP advertisement’s overall impression (it was clearly an advertisement, not NHS guidance).
Breach found for the GP advertisement bar chart: it implied statistically significant superiority when significance was unknown.
No breach on the narrow point that further explanation of how 4-week quit rates were calculated was required (the basis was considered clear), but breach found because Pfizer could not substantiate the extrapolated 4-week data.

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Key facts

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