GSK Seretide: TORCH secondary endpoints used without primary endpoint context in some slide decks and iPad materials (AUTH/2726/8/14)

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Key facts

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Case number	AUTH/2726/8/14
Complainant	Anonymous, non contactable health professional
Company	GlaxoSmithKline UK
Medicine	Seretide (salmeterol/fluticasone)
Therapy area	COPD
Core issue	Use of TORCH secondary endpoint (and post-hoc) data in promotion without adequate, immediate context that the primary endpoint was non-significant (p=0.052) in some materials
Secondary issue	Alleged public accessibility of HCP promotional content via search/unsecured access
Applicable Code year	2014
Complaint received	07 August 2014
Case completed	11 December 2014
Appeal	No appeal
Breach clauses	Clause(s) 7.2 (x4), 7.4 (x4) and 9.1
No breach clauses	Clause(s) 2, 7.2, 7.4 and 23.1
Sanctions	Undertaking received; additional sanctions: Not stated

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

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An anonymous, non-contactable health professional complained about GlaxoSmithKline UK’s use of the TORCH study (Calverley et al 2007) in promotional materials for Seretide (salmeterol/fluticasone) in COPD.
The complainant cited a critical editorial (Gøtzsche 2014) and argued it was misleading to promote favourable secondary endpoints (and/or post-hoc analyses) when the TORCH primary endpoint (all-cause mortality) did not reach statistical significance (p=0.052).
The complainant also alleged Seretide promotional content was accessible to the public via an unsecured area of a GSK website.
The Panel reviewed multiple items (website pages, slide decks, detail aids, iPad materials) and focused only on items that referred to TORCH secondary endpoint data (including post-hoc analysis), as these were within scope.
The Panel’s key concern was whether secondary endpoint claims were placed in the context of the overall TORCH findings—especially the non-significant primary endpoint—and whether that context was within the visual field of the claim (not “after” the claim or relegated to links/pop-ups).

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No breach was ruled for some materials where each reference to TORCH secondary endpoints was clearly preceded by the primary endpoint caveat (including Seretide.co.uk “Efficacy and Clinical Evidence” page and the Secondary Care Campaign Detail Aid).
Breach rulings were made where secondary endpoint benefits were presented without adequate, immediate qualification about the non-significant primary endpoint (notably certain slide decks and iPad pages).
No breach was ruled for the allegation that the promotional site being discoverable via search meant it was promoting to the public; the Panel considered the site appropriately identified its intended audience and met relevant supplementary information requirements.
A breach of high standards was ruled due to inconsistent approach to certification/qualification across materials.
No breach of Clause 2 was ruled.

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