Novartis Entresto podcast: unsubstantiated ‘energy’ claim, ‘best’ implied superiority, and renal safety downplayed (AUTH/3635/4/22)

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Key facts

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Case number	AUTH/3635/4/22
Company	Novartis Pharmaceuticals UK Ltd
Product	Entresto (sacubitril/valsartan)
Material	Episode 2 of ‘Heart to Heart’ podcast series (audio-visual format) on Novartis health professional website
Audience	Developed for heart failure specialist nurses; hosted on a site certified for physicians, pharmacists and nurses
Main issues upheld	Unsubstantiated/misleading “energy” claim linked to dressing; “best” implying Entresto was best; unqualified “slight but acceptable drop in renal function” downplaying safety; insufficiently clear/detailed speaker briefing
Applicable Code	2021
Breach clauses	Clause 6.1; Clause 6.2; Clause 14.4; Clause 5.1; Clause 2
No breach clauses (notable)	Clause 6.5 (use of “new”); and no breach findings on certain narrow allegations under Clauses 6.1, 6.2, 14.4, 5.1 and 2
Sanctions	Undertaking received; Additional sanctions; Advertisement
Complaint received	18 April 2022
Case completed	31 May 2023
Appeal	No appeal

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

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An anonymous cardiac specialist health professional complained about Episode 2 of Novartis’ ‘Heart to Heart’ podcast series promoting Entresto (sacubitril/valsartan).
The podcast was developed for heart failure specialist nurses but was hosted on a Novartis product promotional website for UK health professionals and relevant decision makers.
The episode included an interview conducted by a Novartis employee with a named heart failure specialist nurse discussing guideline changes and sharing “real world experience” of Entresto.
The Panel considered the podcast an Entresto promotional item and noted Novartis had complete editorial control and was responsible for the content.
Key issues included: (1) an “increase in energy” claim linked to being able to get dressed, (2) repeated use of “best” in a way implying Entresto was best, (3) an unqualified statement about a “slight but acceptable drop in renal function”, and (4) whether the speaker briefing was sufficiently clear and detailed.

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Breach found for: Clause 6.1, Clause 6.2, Clause 14.4, Clause 5.1, Clause 2.
No breach found for: Clause 6.5 and (on specific allegations) no breach findings were also made in parts of the case under Clauses 6.1, 6.2, 14.4, 5.1 and 2.
Sanctions applied: Undertaking received; Additional sanctions; Advertisement.
No appeal.

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Breach of Clause 6.1 Requirement that claims/information must be accurate, up-to-date and not misleading
Breach of Clause 6.2 Requirement that claims must be capable of substantiation
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
Breach of Clause 5.1 Requirement to maintain high standards
Breach of Clause 2 Requirement that material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
No Breach of Clause 6.5 Requirement that the word ‘new’ should not be used to describe any product which has been generally available for more than 12 months in the UK

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