Roche/GSK Bonviva “Building bones” claim ruled misleading and unsubstantiated (AUTH/1971/3/07 & AUTH/1972/3/07)

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Key facts

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Case number	AUTH/1971/3/07 and AUTH/1972/3/07
Complainant	Servier Laboratories Ltd
Respondents	Roche Products Limited and GlaxoSmithKline UK Ltd
Product	Bonviva (ibandronic acid)
Materials	Leavepiece (BON/LVP/06/25189/1) and journal advertisement (BON/DPS/06/25931/2)
Main issue	Claim “Building bones” implied a direct bone-forming/anabolic effect
Applicable Code year	2006
Breach clauses	7.2 and 7.4
No breach	Clause 3.2 (no breach ruled)
Sanctions	Undertaking received; additional sanctions: Not stated
Complaint received	12 March 2007
Case completed	14 June 2007
Appeal	Respondent appeal unsuccessful; breaches upheld

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

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Servier complained about Roche Products Ltd and GlaxoSmithKline UK Ltd promotional materials for Bonviva (ibandronic acid): a leavepiece (BON/LVP/06/25189/1) and a journal advertisement (BON/DPS/06/25931/2).
Both items featured the claim “Building bones” (e.g., “Building bones with one tablet, once a month” and “Building bones, month, after month, after month”).
Servier argued that, in osteoporosis promotion, “Building bones” implies a positive/direct bone formation (anabolic) effect, whereas Bonviva (a bisphosphonate) primarily inhibits bone resorption and does not directly stimulate bone formation.
Roche argued the claim described the net effect (progressive net gains in bone mass/BMD) and was consistent with the SPC and supported by evidence; it also referenced patient leaflet wording about “helps to rebuild bone”.
The Panel and then the Appeal Board assessed whether “Building bones” would be understood as a direct bone-forming action and whether it was substantiated.

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Breach found: Clauses 7.2 and 7.4.
No breach of Clause 3.2 (Panel did not consider the claim inconsistent with the SPC statement that therapy led to progressive net gains in bone mass).
Appeal by Roche/GSK against the Clause 7.2 and 7.4 rulings was unsuccessful; breaches were upheld by the Appeal Board.
Sanction recorded: Undertaking received.

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