Janssen: PAH symposium video ruled misleading (relative risk without absolute risk; mislabelled ARR; TRITON context missing)

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Key facts

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Case	AUTH/3727/1/23
Parties	Complainant v Janssen Limited
Material	Symposium video on Janssen Medical Cloud website (Janssen website for UK healthcare professionals)
Therapy area	Pulmonary arterial hypertension (PAH)
Medicines mentioned	Opsumit (macitentan); Uptravi (selexipag)
Event context	Janssen-sponsored symposium at European Respiratory Society Congress 2021; later hosted as a video
Main issues upheld	Relative risk reduction without absolute risk; incorrect ARR labelling; TRITON data presented without context including failure to meet primary endpoint
Breach clauses	Clause 5.1; Clause 6.1 (x3)
No breach clauses	Clause 11.2 (x3); Clause 12.1; Clause 12.6
Applicable Code	2021
Complaint received	12 January 2023
Case completed	28 February 2024
Appeal	No appeal
Sanctions	Undertaking received

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

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A UK cardiologist complained about a Janssen-hosted video of a Janssen-sponsored PAH symposium (“Connect, confirm, combine in pulmonary arterial hypertension”) on a Janssen website for UK healthcare professionals.
The complaint focused on the third presentation (“Combining therapies: Having a PAH plan”) and alleged the content was misleading by:
- presenting relative risk reduction without absolute risk reduction (ARR) (AMBITION study slide),
- showing Kaplan–Meier curves with incorrect ARR labelling (GRIPHON slide), and
- presenting TRITON secondary/within-arm outcomes without context, including that the study failed to meet its primary endpoint.
The complainant also alleged off-label promotion of macitentan (Opsumit) for initial combination therapy and alleged prescribing information was only referenced at the end of the long video.
Janssen accepted there was a human error in graph labelling (ARR mislabelled) but argued the Kaplan–Meier curves and numbers at risk allowed viewers to assess absolute effects; it also argued macitentan’s licence allowed use “as monotherapy or in combination” and that prescribing information was signposted on the webpage header/footer and in the video.

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Breach of Clause 5.1 (Failing to maintain high standards).
Breach of Clause 6.1 (x3) (Making a misleading claim), relating to:
- relative risk reduction presented without accompanying absolute risk (AMBITION slide),
- TRITON within-arm/secondary information presented without context including failure to meet the primary endpoint, and
- incorrect ARR information (relative risk reductions mislabelled as ARR) on GRIPHON Kaplan–Meier curves.
No breach of Clause 11.2 (x3) (off-label allegations about macitentan) – Panel found macitentan was licensed “as monotherapy or in combination” and the complainant was mistaken about the indication.
No breach of Clause 12.1 (prescribing information) – no evidence the video was downloadable such that PI had to be integral; no allegation about PI legibility/clarity.
No breach of Clause 12.6 (prominent statement of where PI can be found online) – PI location was signposted on the webpage and in the video; Panel suggested improving contrast/visibility and noted it would be helpful to mention PI location at the start of a long presentation.
No appeal.

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Breach of Clause 5.1 Failing to maintain high standards
Breach of Clause 6.1 (x3) Making a misleading claim
No Breach of Clause 11.2 (x3) Requirement that a medicine must be promoted in accordance with the terms of its marketing authorisation and must not be inconsistent with the particulars listed in its summary of product characteristics
No Breach of Clause 12.1 Requirement to include prescribing information
No Breach of Clause 12.6 Requirement to include a prominent statement as to where the prescribing information can be found on promotional material on the internet

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