Novartis breach: Seebri Breezhaler evidence review misleading on COPD mortality and exacerbations (AUTH/2588/3/13)

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Key facts

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Case number	AUTH/2588/3/13
Complainant	The Drug and Therapeutics Bulletin
Company	Novartis Pharmaceuticals UK Ltd
Material	Booklet: “Evidence Review of Seebri Breezhaler (glycopyrronium bromide)” (ref SBH12-CO17), for formulary packs
Product / therapy area	Seebri Breezhaler (glycopyrronium bromide) for COPD maintenance bronchodilator treatment
Main issues	Unqualified mortality claim; unreferenced/unsupported inference that reducing exacerbations reduces mortality; unclear/misleading presentation of secondary endpoints and statistical significance
Applicable Code year	2012
Complaint received	18 March 2013
Case completed	01 May 2013
Appeal	No appeal
Breach clauses	Clause 7.2 (x3), Clause 7.4 (x2), Clause 9.1
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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The Drug and Therapeutics Bulletin complained about a 16-page booklet, Evidence Review of Seebri Breezhaler (glycopyrronium bromide) (ref SBH12-CO17), issued by Novartis for use in formulary packs.
On page 6, under “The importance of reducing exacerbations”, the booklet stated: “The 180 day mortality rate following a COPD exacerbation is 33% [Anzueto 2010] and therefore reductions in exacerbations can reduce mortality rates”.
The complainant alleged the 33% figure was presented without clarifying it related to a particularly ill subgroup (patients admitted with acute hypercapnic respiratory failure) and was therefore misleading.
The complainant also alleged the conclusion that reducing exacerbations reduces mortality was unproven and unsubstantiated.
On the facing page (page 7), a table summarised secondary outcomes from GLOW-1 and GLOW-2; the complaint raised that secondary endpoint data was given undue weight and the presentation could mislead.

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The Panel ruled the unqualified claim “The 180 day mortality rate following a COPD exacerbation is 33%” was misleading and could not be substantiated.
The Panel ruled the claim “reductions in exacerbations can reduce mortality rates” was misleading, unsubstantiated, and (given adjacent Seebri exacerbation data) implied a mortality benefit for Seebri.
The Panel ruled the table of secondary outcomes was misleading because the secondary nature of endpoints was not immediately obvious and the presentation was not sufficiently complete to allow readers to appreciate statistical significance.
The Panel ruled that high standards had not been maintained.
No appeal.

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