AUTH/2792/9/15: Anonymous v GlaxoSmithKline (SUMMIT study press release) — No breach | PMCPA Case

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Key facts

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Case number	AUTH/2792/9/15
Complainant	Anonymous (described themself as a respiratory physician)
Company	GlaxoSmithKline
Material	Corporate press release / LSE announcement: “GSK and Theravance announce results from the SUMMIT COPD CV Survival Study”
Medicine	Relvar Ellipta (fluticasone furoate/vilanterol 100/25mcg)
Study	SUMMIT (Study to Understand Mortality and Morbidity in COPD)
Study size / scope	16,485 COPD patients; 43 countries
Primary endpoint (as described)	Risk of dying on Relvar vs placebo; stated as 12.2% lower but not statistically significant (p=0.137)
Secondary endpoints (as described)	Lung function decline (8ml/year reduction vs placebo, p=0.019; significance not inferable because primary endpoint not met); on-treatment cardiovascular event risk 7.4% lower vs placebo (p=0.475; not statistically significant)
Key allegations	Misleading use of “survival”; misleading presentation of results; omission of black triangle; raising unfounded hopes; bringing industry into disrepute
Clauses considered	2, 4.11, 7.2, 7.4, 9.1, 26.2, 26.3
Panel decision	No breach of the Code
Complaint received	25 September 2015
Case completed	7 October 2015
Appeal	No appeal
Applicable Code year	2015

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

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An anonymous complainant (described themself as a respiratory physician) alleged a GlaxoSmithKline (GSK) corporate press release about the SUMMIT COPD study was deliberately misleading.
The press release headline included the phrase “SUMMIT COPD CV Survival Study”.
The complainant argued the study failed to demonstrate a survival benefit for Relvar Ellipta (fluticasone furoate/vilanterol 100/25mcg), so referencing “survival” and stating “the risk of dying… was 12.2% lower than on placebo” could mislead clinicians, patients and the public.
The complainant also alleged the press release should have displayed the inverted black triangle (Relvar subject to additional monitoring) and suggested the release could raise unfounded hopes and bring the industry into disrepute.
The Authority asked GSK to respond under Clauses 2, 4.11, 7.2, 7.4, 9.1, 26.2 and 26.3.
GSK stated the press release (8 September 2015) was a London Stock Exchange announcement aimed at shareholders/financial markets, issued because results were share price sensitive; it was not promotional.
The press release stated the primary endpoint was not met: “risk of dying… 12.2% lower… not statistically significant (p=0.137)”, and contextualised secondary endpoints (including noting that statistical significance could not be inferred because the primary endpoint was not met).

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No breach of the Code was ruled.
The Panel found the press release was clearly aimed at financial markets (LSE/NYSE/NASDAQ referenced at the outset), not clinicians, patients or the public.
Use of “survival” in the heading was considered a descriptor of study design and not misleading given the repeated, clear statements that the primary endpoint was not met.
No requirement to include a black triangle because the press release was not promotional material.
No breach of public information requirements: the release was balanced, unlikely to raise unfounded hopes, and not intended for patients taking the medicine.
The Panel considered high standards had been maintained; no breach of Clause 2.

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