Novartis breached ABPI Code over Jakavi webpage claim implying statistically significant survival benefit vs BAT

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Key facts

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Case	AUTH/3675/7/22
Company	Novartis
Product	Jakavi (ruxolitinib phosphate)
Channel	Novartis UK health professional website (Jakavi webpage)
Main issue upheld	Claim “Improved survival benefit compared with BAT” implied statistically significant survival benefit vs BAT; footnote did not negate misleading impression
Key data point referenced by Panel	COMFORT-II 5-year survival footnote: P=0.06 (not significant, for descriptive purposes only)
Applicable Code	2021
Complaint received	4 July 2022
Case completed	29 September 2023
Appeal	No appeal
Sanctions	Undertaking received; additional sanctions not stated
Breach clauses	Clause 6.1; Clause 6.2; Clause 5.1
No breach clauses (not exhaustive)	Clause 2 (overall); Clauses 6.1 and 6.2 (banner claim); Clauses 6.1, 6.2, 5.1, 2 (other narrow allegations as ruled)

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

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What happened

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An anonymous (initially contactable) health professional complained about promotional claims on the Jakavi (ruxolitinib phosphate) webpage on the Novartis UK health professional website.
The webpage (published February 2022) included a banner line (“The day you choose Jakavi… is the day you could change their life”), a “Response / Control / Survival” graphic, and four promotional boxes including “Improved survival benefit compared with BAT” and “Well-characterised safety profile”.
The complainant alleged the survival messaging was not statistically significant and that “survival” was a hanging comparison; they also alleged “well-characterised” implied safety.
Novartis said the page was HCP-gated, certified by a registered UK pharmacist, and that a footnote disclosed the COMFORT-II p-value (P=0.06, not significant) and crossover correction details.
The Panel focused on the overall impression of the claim “Improved survival benefit compared with BAT” and whether a busy HCP would take it as statistically significant.

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Outcome

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Breach found for the claim “Improved survival benefit compared with BAT” because it implied a statistically significant survival benefit vs BAT when that was not the case; the footnote did not correct the misleading impression.
No breach for the banner claim “The day you choose Jakavi… is the day you could change their life” (based on the narrow allegation that it implied benefit within a day).
No breach for the “Response / Control / Survival” graphic being a hanging comparison (based on the narrow allegation).
No breach for “Well-characterised safety profile” implying the product was “safe” (complainant provided no evidence for that narrow allegation).
No breach of Clause 2 (Panel considered Clause 5.1 ruling adequately covered the matter).

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Clauses

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Breach of Clause 6.1 Making a misleading claim
Breach of Clause 6.2 Making an unsubstantiated claim
Breach of Clause 5.1 Failing to maintain high standards
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 6.1 Requirement that information must be accurate, up-to-date and not misleading (in relation to “The day you choose Jakavi…”)
No Breach of Clause 6.2 Requirement that claims/information/comparisons must be capable of substantiation (in relation to “The day you choose Jakavi…”)
No Breach of Clause 6.1 Requirement that information must be accurate, up-to-date and not misleading (in relation to the “Response / Control / Survival” graphic allegation)
No Breach of Clause 6.2 Requirement that claims/information/comparisons must be capable of substantiation (in relation to the “Response / Control / Survival” graphic allegation)
No Breach of Clause 5.1 Requirement to maintain high standards at all times (in relation to the “Response / Control / Survival” graphic allegation)
No Breach of Clause 2 Requirement that activities or materials must not bring discredit upon, or reduce confidence in, the pharmaceutical industry (in relation to the “Response / Control / Survival” graphic allegation)
No Breach of Clause 6.1 Requirement that information must be accurate, up-to-date and not misleading (in relation to “well characterised” implying “safe”)
No Breach of Clause 6.2 Requirement that claims/information/comparisons must be capable of substantiation (in relation to “well characterised” implying “safe”)
No Breach of Clause 5.1 Requirement to maintain high standards at all times (in relation to “well characterised” implying “safe”)
No Breach of Clause 2 Requirement that activities or materials must not bring discredit upon, or reduce confidence in, the pharmaceutical industry (in relation to “well characterised” implying “safe”)

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Key facts

What happened

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Clauses

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