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
Study at issue	TORCH (Calverley et al 2007)
Core issue	Use of TORCH secondary endpoint/post-hoc data in promotion without adequate, immediate context that the primary endpoint was non-significant
Primary endpoint result (TORCH)	All-cause mortality did not meet statistical significance (p=0.052)
Complaint received	07 August 2014
Case completed	11 December 2014
Applicable Code	2014
Breach clauses	7.2 (x4), 7.4 (x4), 9.1
No breach clauses	2, 23.1
Sanction	Undertaking received
Appeal	No appeal

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

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What happened

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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 meet statistical significance (p=0.052).
The complainant also alleged that Seretide promotional material was accessible to the public via an unsecured area of a GSK website.
The PMCPA Panel reviewed a range of current and historical materials that referenced TORCH secondary endpoint data, including a website page, slide decks, detail aids, and iPad materials.
The Panel’s key concern was whether secondary endpoint claims were presented within the context of the overall study findings—specifically, whether the non-significant primary endpoint was clearly and integrally presented alongside the secondary endpoint claims.

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Outcome

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No breach of Clauses 7.2 and 7.4 for the Seretide.co.uk “Efficacy and Clinical Evidence” page because each reference to TORCH secondary endpoints was preceded by a clear statement that the primary endpoint did not meet statistical significance (p=0.052).
Breach of Clauses 7.2 and 7.4 for certain campaign materials where secondary endpoint data was not sufficiently qualified by (or was presented before) the non-significant primary endpoint, creating a misleading impression incapable of substantiation.
No breach of Clauses 7.2 and 7.4 for some materials (e.g., Secondary Care Campaign Detail Aid; cube items; certain specialist modules) where the primary endpoint qualification was prominent and integral to pages discussing secondary endpoints.
No breach of Clause 23.1 regarding alleged promotion to the public: the Panel considered that unrestricted access was permissible provided public vs HCP sections were clearly separated and the intended audience identified; the site stated “For UK Healthcare Professionals” and directed non-HCPs to a public site.
Breach of Clause 9.1 because there was not a consistent approach to certification/qualification across materials discussing TORCH secondary endpoints; high standards were not maintained.
No breach of Clause 2; the Panel did not consider the circumstances warranted it.
Clause 7.10 was raised initially (re “landmark” descriptor), but the Panel concluded there was no complaint on that narrow point and therefore made no ruling on Clause 7.10.

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Key facts

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