Roche v Procter & Gamble and Sanofi-Aventis (Alliance for Better Bone Health): misleading fracture messaging and disparagement of Bonviva

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Key facts

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Case number	AUTH/1885/8/06 and AUTH/1886/8/06
Complainant	Roche Products Limited
Respondents	Procter & Gamble Pharmaceuticals UK Ltd and Sanofi-Aventis (Alliance for Better Bone Health)
Products	Bonviva (ibandronate) and Actonel (risedronic acid)
Main issues	Misleading claim about vertebral fractures; disparagement via symposium slide; patient market research alleged disguised promotion
Key materials	Actonel leavepiece (A2925) and exhibition panels; sponsored symposium slide (“Beware of subgroup analyses!”); patient telephone survey questionnaire
Breach clauses	Clause 7.2; Clause 8.1
No breach findings	No breach of Clause 10.2 (and therefore no breach of Clauses 7.2, 8.1 and 2) in relation to the patient survey
Complaint received	22 August 2006
Case completed	8 December 2006
Applicable Code year	2006
Appeal	No appeal
Sanctions	Undertaking received; additional sanctions not stated

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

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Roche alleged a concerted campaign by Procter & Gamble and Sanofi-Aventis (Alliance for Better Bone Health; Actonel/risedronate) to mislead clinicians about Bonviva (ibandronate) and disparage it.
An Actonel leavepiece (A2925) and exhibition panels used the headline claim: “Only 14% of symptomatic osteoporotic fractures are vertebral”, referenced to NICE.
At a company-sponsored symposium, an independent speaker used a slide (“Beware of subgroup analyses!”) showing bar charts implying ibandronate increased fracture risk by 44% in a subgroup (femoral neck BMD > –3.0) and decreased risk by 64% in another subgroup.
Roche also complained about a patient market research telephone survey comparing a weekly bisphosphonate with hip+spine fracture data vs a monthly bisphosphonate with spine-only data; Roche alleged this was misleading/disparaging and disguised promotion.

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Breach: Claim “Only 14% of symptomatic osteoporotic fractures are vertebral” ruled misleading (minimised vertebral fractures; implied they were uncommon; omitted wrist fractures context) – Clause 7.2.
Breach: Symposium slide ruled to have disparaged Bonviva despite limited use/context – Clause 8.1.
No breach: Patient telephone survey was not considered disguised promotion – no breach of Clause 10.2; therefore no breach of Clauses 7.2, 8.1 and 2 in relation to the survey.
No appeal.

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