AUTH/2138/7/08: In-vitro BMJ advertisements for Gaviscon Advance found misleading due to implied in-vivo/clinical claims

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Key facts

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Case number	AUTH/2138/7/08
Case reference	G-NHS-UK-51-07 (advertisements reference); Case AUTH/2138/7/08
Complainant	Public health physician
Respondent/company	Reckitt Benckiser Healthcare (UK) Limited
Product(s)	Gaviscon Advance (sodium alginate and potassium bicarbonate)
Material/channel	Two journal advertisements (“Advertisement Feature”) in the BMJ (double-page spreads with prescribing information)
Key issue	In-vitro data presented with conclusions implying in-vivo/clinical oesophageal protection and clinical benefit, considered misleading
Dates (received/completed if stated)	Complaint received 7 July 2008; Case completed 26 August 2008
Appeal	Not stated
Code year	2008 Constitution and Procedure; Clause 7.2 noted as same in 2008 Code as in 2006 Code
Breaches/clauses	Clause 7.2
Sanctions	Not stated

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

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A public health physician complained about two advertisements for Gaviscon Advance (sodium alginate and potassium bicarbonate) issued by Reckitt Benckiser Healthcare (UK) Limited and published in the BMJ.
The advertisements were titled: (1) “The Role for Liquid Alginate Suspension (Gaviscon Advance) in the Protection of the Oesophagus Against Damage by Bile in the Refluxate” (BMJ 22 March) and (2) “...Against Damage by Pepsin in the Refluxate” (BMJ 12 April).
The complainant alleged the ads presented in-vitro data but made claims about expected in-vivo effects, misleading readers by extrapolating to clinical situations without substantiation.
Reckitt Benckiser argued the abstracts were clearly in-vitro, did not claim in-vivo studies had been conducted, and were reproduced as peer-reviewed meeting abstracts without additional claims; the audience (BMJ) was health professionals.
The Panel noted the abstracts, originally written for a scientific purpose, were being used unchanged for a promotional purpose, with prescribing information at the bottom of the right-hand page of each double-page spread.

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The Panel ruled both advertisements were misleading.
A breach of Clause 7.2 was ruled for each advertisement.
For the bile-acid advertisement, the Panel found the claim “In-vivo, the mode of action of Gaviscon Advance is expected to give oesophageal protection...” and reference to “a wider clinical benefit” implied clinical relevance without supporting data.
For the pepsin advertisement, the Panel found the conclusions did not refer to the study being in-vitro and appeared to relate directly to the clinical situation, despite being supported only by in-vitro data.

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