AstraZeneca breached ABPI Code over Trixeo mortality webpage: 46% risk reduction claim and graph presentation

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Key facts

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Case number	AUTH/3795/7/23
Complainant	Anonymous, contactable complainant (later non-contactable) who described themselves as an employee of AstraZeneca
Company	AstraZeneca
Medicine/material	Trixeo product website (efficacy page) and Trixeo interactive detail aid (IDA/sales aid)
Main issue	Presentation of ETHOS all-cause mortality secondary endpoint: mortality graph and “46% risk reduction” messaging alleged to be misleading
Applicable Code year	2021
Complaint received	07 July 2023
Case completed	06 January 2025
Appeal	No appeal
Breach clauses	Clause 6.1 (x2), Clause 6.2, Clause 6.3, Clause 14.1, Clause 14.4
No breach clauses	Clause 2, Clause 5.1, Clause 6.1 (x2), Clause 6.2, Clause 6.3, Clause 14.1, Clause 14.4
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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An AstraZeneca employee complained about a mortality graph and a “46% risk reduction” claim for Trixeo on the UK HCP product website and in a Trixeo interactive detail aid (IDA/sales aid).
The claim related to all-cause mortality (a pre-specified secondary endpoint) from the ETHOS study.
The complainant alleged the presentation was misleading and overstated Trixeo’s merits, including use of relative risk reduction without absolute risk context.
The Panel assessed the ETHOS publications (Rabe et al. and Martinez et al.) and the way the mortality data were presented, including prominence, layout, and explanatory/statistical context.
The Panel distinguished between (1) the website efficacy page and (2) the IDA slide used by trained representatives in live interactions.

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Website: Breaches found for misleading overall impression and insufficient context around nominal/unadjusted p-values and absolute vs relative risk presentation.
Interactive detail aid (IDA): No breach—because the slide included clearer contextual/statistical information (including ICS/LABA arm stats and “not significant”), and was delivered by trained sales representatives with briefing requirements.
Approval process allegation: No breach—complainant did not evidence claims that concerns had been raised and ignored or that signatories were pressured to follow previous sign-off.

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Breach of Clause 6.1 (x2) Making a misleading claim
Breach of Clause 6.2 Making an unsubstantiated claim
Breach of Clause 6.3 Failing to ensure artwork conforms to the letter and spirit of the Code
Breach of Clause 14.1 Making misleading comparisons
Breach of Clause 14.4 Not encouraging the rational use of the medicine
No Breach of Clause 2 Requirement that activities or materials must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
No Breach of Clause 5.1 Requirement to maintain high standards at all times
No Breach of Clause 6.1 (x2) Requirement that claims/information/comparisons must not be misleading
No Breach of Clause 6.2 Requirement that claims/information/comparisons must be capable of substantiation
No Breach of Clause 6.3 Requirement that all artwork must conform to the letter and spirt of the Code
No Breach of Clause 14.1 Requirement that misleading comparisons must not be made
No Breach of Clause 14.4 Requirement that claims should not imply that a medicine or an active ingredient has some special merit, quality or property unless this can be substantiated

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