Pfizer v Johnson & Johnson: Nicorette slide implied an underpowered study could prove “no difference” vs varenicline

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Key facts

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Case number	AUTH/2324/6/10
Parties	Pfizer v Johnson & Johnson
Product	Nicorette (nicotine transdermal patch)
Comparator mentioned	Champix (varenicline)
Material	Presentation slide: “Stapleton: Combination Success Rates at 4 weeks” within “Hitting ‘Hard to Reach Targets’ with High Dose & Combination NRT” (ref 05607)
Main issue	Slide implied the study was powered to compare varenicline vs combination NRT; footnote about lack of power was insufficient to prevent a misleading impression
Key claim(s) on slide	“No statistically significant difference between combination NRT and varenicline” with “ns” on chart; footnote: “Evaluation not designed to detect a difference between combination NRT and varenicline”
Complaint received	07 June 2010
Case completed	22 July 2010
Applicable Code year	2008
Breach clauses	7.2, 7.8 and 9.1
Sanction	Undertaking received
Appeal	No appeal

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

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Pfizer complained about a Johnson & Johnson Nicorette (nicotine transdermal patch) presentation titled Hitting "Hard to Reach Targets" with High Dose & Combination NRT (ref 05607).
The complaint focused on a slide titled Stapleton: Combination Success Rates at 4 weeks, referenced to Stapleton et al (2008) (published paper dated 2007).
The slide showed a bar chart of 4-week abstinence rates comparing combination NRT (66.3%) vs varenicline (72.1%), with “ns*” between the bars.
Bullets under the chart included: “2 out of 3 smokers on combination NRT were abstinent at 4 weeks” and “No statistically significant difference between combination NRT and varenicline*”.
A small footnote stated: “Evaluation not designed to detect a difference between combination NRT and varenicline”.
Pfizer argued the slide implied there was no difference between treatments, despite the authors stating the evaluation lacked adequate statistical power to test that comparison, and that the slide’s design/wording created a misleading impression that the study was powered for the comparison.
Pfizer also alleged the slide omitted other relevant conclusions from the paper (including that varenicline was more effective than NRT overall in that setting), meaning it did not fully and accurately reflect the authors’ views.

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The Panel ruled the slide was misleading because its design and content implied the study was powered to detect a difference between varenicline and combination NRT when it was not.
The Panel ruled the footnote was insufficient to negate the misleading impression.
Breaches were ruled for Clauses 7.2, 7.8 and 9.1.
The Panel did not consider the slide misleading due to omission of other outcomes from Stapleton et al; no breach was ruled on that specific allegation under Clause 7.2.
No appeal.

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