Napp Pharmaceuticals: BuTrans ‘pain in dementia’ campaign ruled misleading and unsubstantiated (AUTH/2723/7/14)

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Key facts

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Case	AUTH/2723/7/14
Parties	Clinician v Napp Pharmaceuticals Limited
Medicine	BuTrans (buprenorphine transdermal patch)
Materials	BMJ advertisement (UK/BUTR-13054b); website page (UK/BUTR-12036); detail aid (UK/BUTR-13057)
Therapy area / theme	Pain management in dementia; agitation/aggression as possible pain indicators
Key issue	Promotion implied robust evidence for BuTrans analgesic efficacy in dementia and implied reduced antipsychotic use; evidence base not sufficiently robust and claims not substantiated
Applicable Code year	2014
Complaint received	23 July 2014
Case completed	7 November 2014
Appeal	Appealed by both respondent and complainant; Panel report to Appeal Board
Breach clauses	Clause 7.2 (x2) and 7.4 (x2)
No breach	Clause 7.2 (BMJ advertisement on narrow allegation re agitation)
Sanctions (per case page)	Undertaking received; Recovery of items; Additional sanctions: none

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

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A consultant psychiatrist complained about Napp’s BuTrans (buprenorphine transdermal patch) promotional campaign focused on pain in patients with dementia.
Materials included: a BMJ advertisement (ref UK/BUTR-13054b), a website page (ref UK/BUTR-12036) and a detail aid (ref UK/BUTR-13057).
The complainant alleged the website/detail aid implied evidence for BuTrans use in dementia and blurred pain management with agitation/aggression, going beyond the evidence.
Key website claims included: “That’s why the once-weekly BuTrans patch is a sensible choice in dementia” and statements that BuTrans was “associated with reduced agitation and aggression” as part of a step-wise approach, plus “Effectively managing pain in dementia can help reduce pain-related behavioural disturbances, limiting unnecessary use of antipsychotics.”
The main clinical study cited for BuTrans in dementia was Husebo et al (2011), a stepwise analgesia protocol where only a minority received BuTrans; primary outcome was agitation, not pain.
The Panel considered the detail aid within scope even though Napp’s response initially focused on the ad and webpage.
Both the complainant and Napp appealed aspects of the Panel’s decision; the Panel also reported the matter to the Appeal Board due to seriousness.

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Website and detail aid: Breaches upheld on appeal for misleading presentation of evidence and lack of substantiation for analgesic efficacy in dementia, and for implying BuTrans could limit unnecessary antipsychotic use without evidence.
BMJ advertisement: No breach of Clause 7.2 (upheld on appeal) on the narrow allegation that it promoted BuTrans for agitation; the Appeal Board considered it sufficiently clear the ad promoted BuTrans for pain relief in dementia patients.
The Panel required the campaign to be suspended pending appeal; following upheld breaches, the material at issue had to be withdrawn.
The Appeal Board took no further action following the Panel’s report (i.e., no additional sanctions beyond withdrawal/undertaking/recovery noted on the case page).

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Clause 7.2 (breach, upheld on appeal) – ruled in relation to website/detail aid claims promoting BuTrans to treat pain in dementia and the implied antipsychotic-limiting claim.
Clause 7.4 (breach, upheld on appeal) – claims for analgesic efficacy in dementia and implied antipsychotic-limiting claim could not be substantiated.
Clause 7.2 (no breach, upheld on appeal) – BMJ advertisement not misleading on the narrow allegation of promoting BuTrans for agitation.

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