Janssen Medical Cloud website: out-of-date prescribing information in materials, misleading graph scale, and unqualified use of “safe”

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Key facts

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Case number	AUTH/3168/2/19
Case reference	Complainant v Janssen (Janssen Medical Cloud website)
Complainant	Contactable individual describing themself as a concerned UK health professional
Respondent/company	Janssen
Product(s)	Edurant; Prezista; Symtuza; Trevicta; Xeplion; Invega; Risperdal (oral tablets/solution); Risperdal Consta; Stelara; Tremfya; Zytiga
Material/channel	Company website (Janssen Medical Cloud), including webpages, downloadable presentations/slide decks, and a video; “recommend this content to a colleague” email functionality
Key issue	Currency and presentation of prescribing information (including embedded PI in materials), misleading graph presentation, and unqualified use of the word “safe”
Dates (received/completed if stated)	Complaint received: 27 February 2019; Case completed: 27 June 2019
Appeal	Not stated
Code year	Not stated
Breaches/clauses	Breaches: 4.1, 4.6, 7.2, 7.9, 9.1. No breach: 2, 12.1, 14.1, 16.1 (and no breach of 4.1 for multiple specific PI allegations on webpages).
Sanctions	No explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

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

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What happened

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A contactable individual describing themself as a concerned UK health professional complained about the Janssen Medical Cloud website, described on its homepage as for healthcare professionals and stating it contained promotional content.
The complainant alleged the site was promotional and that some areas “probably should not be”, raising multiple concerns including: out-of-date prescribing information (PI), presentation of graphs, wording in “meet the team” profiles, and availability/prominence of PI for a video.
Specific materials/products referenced in the complaint included Edurant, Prezista, Symtuza, Trevicta, Xeplion, Invega, Risperdal (oral forms), Risperdal Consta, Stelara, Tremfya, and oncology materials including Zytiga.
Janssen stated the website was intended to be promotional (with broader HCP resources) and was certified under Clause 14.1; it also described processes for PI updates and access via a homepage PI repository.
Janssen acknowledged breaches relating to two items: a downloadable schizophrenia presentation (Pharmacy Academy) and a Tremfya video clip, and stated both items were withdrawn in March 2019.

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Outcome

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No breach of Clause 4.1 was ruled for allegations that PI was out-of-date for Edurant, Symtuza, Stelara, Zytiga, and for schizophrenia portfolio product pages (Trevicta, Xeplion, Invega, Risperdal oral tablets/solution, Risperdal Consta) as presented on the website pages.
Breach of Clause 9.1 was ruled for Edurant because a table headed “Special warnings and precautions when prescribing Edurant” did not include all relevant special warnings/precautions from the SPC (including pregnancy-related information), which the Panel considered misleading and not maintaining high standards.
No breach of Clause 7.2 was ruled for one Prezista-related graph (eGFR) where the y-axis started at 60, as the Panel did not consider it exaggerated differences in that instance.
Breach of Clause 7.2 was ruled for a second graph (“Discontinuation rates for treatment-experienced patients”) because the y-axis started at 0.2, which the Panel considered misleading and exaggerating differences.
Breach of Clause 7.9 was ruled for the “meet the medical team” wording “safe and effective use of Janssen medicines”, as it might be seen as a claim that medicines were safe and the word “safe” must not be used without qualification.
Breach of Clause 4.1 was ruled for out-of-date PI within a downloadable schizophrenia presentation (Pharmacy Academy) for Trevicta, Xeplion and Risperdal Consta; and breach of Clause 9.1 was also ruled for failure to maintain high standards.
Breach of Clause 4.1 was ruled for the Tremfya video because PI provided at the end of the video was not up-to-date; and breach of Clause 4.6 was ruled because the webpage (and the beginning of the video) did not contain a clear prominent statement as to where PI could be found.
No breach of Clause 12.1 (disguised promotion) was ruled regarding the website overall and the “recommend this content to a colleague” email functionality; and no breach of Clauses 4.1, 4.2, 4.3, 4.4 and 14.1 was ruled in relation to that email functionality.
No breach of Clause 14.1 was ruled for oncology presentations (including where an internal reviewer comment appeared), as the Panel considered what was published had been certified as required.
No breach of Clause 16.1 was ruled (training), as the complainant did not show on the balance of probabilities that staff training failed to meet Code requirements.
No breach of Clause 2 was ruled; the Panel considered the circumstances did not warrant Clause 2 despite errors and Clause 9.1 breaches.

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Clauses

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Clause 4.1 – Breach (out-of-date PI within a downloadable schizophrenia presentation for Trevicta, Xeplion, Risperdal Consta; and out-of-date PI in Tremfya video). No breach for multiple other PI allegations on website pages (including Edurant, Symtuza, Stelara, Zytiga, and schizophrenia portfolio pages).
Clause 4.6 – Breach (no clear prominent statement on the webpage and at the beginning of the Tremfya video as to where PI could be found).
Clause 7.2 – Breach (misleading graph with suppressed zero starting at 0.2 for discontinuation rates). No breach (eGFR graph starting at 60 did not exaggerate differences in that instance).
Clause 7.9 – Breach (use of “safe” in “safe and effective use of Janssen medicines” without qualification in “meet the team” profiles).
Clause 9.1 – Breach (high standards not maintained due to misleading omission in Edurant warnings table; and due to errors including out-of-date PI items on the website).
Clause 12.1 – No breach (website not disguised promotion; “recommend to a colleague” functionality not disguised promotion).
Clause 14.1 – No breach (certification issues alleged for oncology presentations and email functionality; Panel considered requirements met).
Clause 16.1 – No breach (training allegation not proven on balance of probabilities).
Clause 2 – No breach (Panel did not consider circumstances warranted particular censure).

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Janssen Medical Cloud website: out-of-date prescribing information in materials, misleading graph scale, and unqualified use of “safe”

Key facts

What happened

Outcome

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