AUTH/2475/1/12: Pfizer v Johnson & Johnson – Nicorette Invisi Patch leavepiece comparisons with varenicline | PMCPA Case

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Key facts

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Case number	AUTH/2475/1/12
Parties	Pfizer v Johnson & Johnson
Product/material	Nicorette Invisi 25mg Patch leavepiece (six-page gatefold; ref 06491)
Comparator referenced	Varenicline (Champix)
Main issues	Tick/cross table implying varenicline “not recommended” as a safer option to smoking; misleading comparative safety impression; bar chart from Stapleton et al (2008) presented in a way readers would assume applied to Nicorette Invisi Patch; “excellent safety profile” overclaim
Complaint received	31 January 2012
Case completed	21 June 2012
Applicable Code year	2011
Appeal	Appeal by respondent (unsuccessful on the appealed points)
No breach clauses	7.2, 7.9 and 9.1 (for the quoted varenicline SPC statement about psychiatric illness history)
Breach clauses	7.2 (x2), 7.3 (x2), 7.4 (x2), 7.8, 7.9 (x2), 7.10 (x2), 8.1 and 9.1 (x2)
Sanction	Undertaking received

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

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What happened

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Pfizer complained about a six-page gatefold leavepiece for Nicorette Invisi 25mg Patch distributed to prescribers by Johnson & Johnson (ref 06491), used and left with prescribers after a product detail (material no longer in use at the time of the case).
A table compared Nicorette Invisi Patch with varenicline (Champix) across several “patient situations”. One row stated “Indicated as a Safer Option to Smoking” with a green tick for Nicorette (“may be suitable”) and a red cross for varenicline (“not recommended”).
Below the table, the leavepiece quoted the varenicline SPC: “Care should be taken with patients with a history of psychiatric illness…”. Pfizer alleged “cherry picking” because Nicorette’s SPC also contained warnings/precautions (eg cardiovascular disease, diabetes, phaeochromocytoma, uncontrolled hyperthyroidism) not shown on that page.
Another page headed “NRT is well tolerated and has an excellent safety profile” included a bar chart titled “Adverse drug reactions in an independent study comparing NRT (all forms) and varenicline” (Stapleton et al, 2008). Pfizer argued the observational cohort design and timing could mislead readers and could not support robust safety comparisons; it also argued “adverse drug reactions” implied causality.
The back page included the bullet “Well tolerated with an excellent safety profile” referenced to Tønnesen et al (1999), which studied Nicorette 10mg/15mg patches (some patients achieved 25mg nicotine by combining patches), not Nicorette Invisi 25mg Patch.
Johnson & Johnson appealed multiple breach findings; the Appeal Board upheld the key rulings on the table and bar chart issues.

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Outcome

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Breach findings upheld on appeal for the tick/cross table implying varenicline was not a safer alternative to smoking and for the bar chart presentation implying a Nicorette Invisi Patch vs varenicline safety comparison and lacking substantiation for Nicorette Invisi Patch.
No breach for the specific statement quoting the varenicline SPC about psychiatric illness history (Panel ruled it was not misleading; these “no breach” rulings were not appealed).
Breach for describing safety as “excellent” (both on the NRT/bar chart page and on the back page summary claim), as overclaiming/misleading in context.

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AUTH/2475/1/12: Pfizer v Johnson & Johnson – Nicorette Invisi Patch leavepiece comparisons with varenicline

Key facts

What happened

Outcome

Clauses

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