P&G/Sanofi slide kit on Bonviva: disparagement and unclear origin of FDA-derived analyses (AUTH/1911/11/06, AUTH/1912/11/06)

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Key facts

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Case number	AUTH/1911/11/06 and AUTH/1912/11/06
Parties	Roche and GlaxoSmithKline v Procter & Gamble and Sanofi-Aventis
Product(s)	Bonviva (ibandronate) (Roche); Actonel (risedronate) (P&G/Sanofi)
Material	Slide kit (ACT 3206) “Do all bisphosphonates have the same fracture efficacy? Non-vertebral Fracture Risk in Ibandronate Clinical Trials”
Main issue	Disparagement of competitor product and misleading impression about origin/consistency of analyses with FDA material
Complaint received	07 November 2006
Case completed	05 March 2007
Applicable Code year	2006
Breach clauses	7.2 and 8.1
Clause 2	Not upheld
Appeal	No appeal
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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Roche (on behalf of itself and GlaxoSmithKline) complained about a promotional slide kit (ACT 3206) produced by Procter & Gamble and Sanofi-Aventis (Alliance for Better Bone Health) about Roche’s Bonviva (ibandronate); P&G/Sanofi jointly promoted Actonel (risedronate).
The slide kit, titled “Do all bisphosphonates have the same fracture efficacy? Non-vertebral Fracture Risk in Ibandronate Clinical Trials”, was proactively distributed to clinicians for use at speaker meetings.
Content drew on FDA website material (FDA reviewers’ clinical data summary) and included tables/graphs described as “deduced” from FDA report tables.
Slide 14 presented non-vertebral fracture numbers for the ITT population by femoral neck T-score subgroup (above/below -3.0 SD), including 47 fractures (placebo) vs 68 (Bonviva 2.5mg) for T-score above -3 SD; subsequent slides graphed these data and stated the ≥ -3 SD subgroup represented 87% of the ITT population.
The Panel considered that FDA material was juxtaposed with company-created slides and some slides did not clearly indicate origin, potentially implying consistency with or endorsement by the FDA.
Clause 2 was alleged (reduced confidence), but the Panel did not uphold it.

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Breach of Clause 8.1 (disparagement) for presenting data in a way that disparaged Bonviva.
Breach of Clause 7.2 (misleading) because the origin of analyses was not sufficiently clear and readers might think the increased fracture risk message was consistent with the FDA report when it was not.
No breach of Clause 2 (Panel said Clause 2 is reserved for particular censure and this did not meet that threshold).
Slide kit had been withdrawn (noted as withdrawn pursuant to earlier cases).

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