AUTH/2388/2/11: NiQuitin patch leavepiece—pharmacokinetic comparisons held to mislead on clinical efficacy

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Key facts

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Case number	AUTH/2388/2/11
Parties	Johnson & Johnson/Director v GlaxoSmithKline Consumer Healthcare
Product	NiQuitin 21mg Clear Patch (nicotine replacement therapy)
Material	Four-page leavepiece (ref NCQ/SYN/KG/0610/02)
Main issue	Comparative pharmacokinetic claims/graphs implying superior clinical efficacy without evidence
Complaint received	16 February 2011
Case completed	19 April 2011
Applicable Code year	2008
Breach clauses	Clause 7.2
No breach clauses	Clause 25; Clause 2 (in relation to alleged breach of undertaking)
Sanctions	Undertaking received; Additional sanctions: Not stated
Appeal	No appeal

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

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Johnson & Johnson complained about a four-page leavepiece for NiQuitin 21mg Clear Patch (NRT) issued by GlaxoSmithKline Consumer Healthcare (ref NCQ/SYN/KG/0610/02).
The leavepiece was distributed to prescribing and non-prescribing health professionals.
It presented head-to-head pharmacokinetic (plasma nicotine) comparisons versus other patches, including Nicorette Invisi 25mg Patch and Nicorette 15mg Patch, plus Nicotinell 21mg.
Key headline/claims included: “NiQuitin 21mg Clear Patch delivers more nicotine than 25mg/16-hour patch” and “delivered 57% more nicotine than the 25mg/16-hour patch… (p<0.0001)”.
Johnson & Johnson alleged the presentation of pharmacokinetic data in isolation implied clinical superiority (eg better quit rates) without evidence, and also raised an alleged breach of prior undertakings (taken up by the Director).
GSK said the purpose was to correct a misconception (supported by market research) that a “25mg” patch must deliver more nicotine than a “21mg” patch, and stated it had removed all clinical outcome references to comply with earlier rulings/undertakings.

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Breach ruled: Clause 7.2.
No breach ruled: Clause 25 (undertaking) and Clause 2 (in relation to the alleged breach of undertaking).
The Panel accepted it was not unreasonable to address prescriber confusion about labelled strength vs nicotine delivery, but found the leavepiece could still mislead on clinical efficacy.

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