Astellas breached Clause 7.2 after Qutenza ‘consensus statement’ insert implied independent/NICE-backed positioning

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Key facts

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Case	AUTH/2465/12/11
Complainant	PCT prescribing support pharmacist
Company	Astellas Pharma Ltd
Material	Qutenza (capsaicin patch) loose insert/journal insert (ref QUT11153UK) in Guidelines in Practice (Nov 2011); electronic version available to subscribers
Main issue	Misleading impression of independent “consensus” and misleading implication of NICE review/status via “adapted from NICE” algorithm and NICE-like presentation
Applicable Code year	2011
Clauses breached	Clause 7.2 (x2)
Complaint received	13 September 2011
Case completed	27 January 2012
Appeal	No appeal
Sanctions	Undertaking received; additional sanctions: Not stated

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

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A prescribing support pharmacist at a PCT complained about a loose insert for Qutenza (capsaicin patch) placed in Guidelines in Practice (Nov 2011); an electronic version was also available to subscribers.
The insert was headed “Consensus statement on the use of Qutenza … in peripheral neuropathic pain” and included “Recommendations of the Consensus Panel”.
An algorithm (stated to be “adapted from NICE Guidelines”) showed first-, second- and third-line treatments for neuropathic pain (excluding diabetic patients) and indicated Qutenza “may be considered… at any stage in the algorithm… alone or in combination”.
The complainant objected that Qutenza had never been assessed by NICE and alleged the piece was misleading, mimicked NICE style/presentation, and could imply NICE endorsement/positioning (including potentially first line).
The Panel noted the piece was clearly promotional (labelled “Promotional Article”, with logos and prescribing information), but focused on whether it was misleading about independence and NICE status.

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Breach found: Clause 7.2 (x2).
The title “Consensus statement…” was ruled misleading because it did not make clear at the outset that the meeting and statement were organised and entirely funded by Astellas (the disclosure appeared mid-page in small font).
The algorithm and “adapted from NICE Guidelines” presentation was ruled misleading because it was not sufficiently clear that Qutenza had not been reviewed by NICE; some readers could gain that impression, compounded by layout and similarity to NICE flowcharts and the suggestion there was detail about Qutenza in the full NICE guideline.
No appeal.

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