AUTH/1933/12/06 & AUTH/1934/12/06: Bonviva leavepiece and “62% vertebral fracture reduction” claim (Roche/GSK) – appeal upheld, no breach | PMCPA Case

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Key facts

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Case number	AUTH/1933/12/06 and AUTH/1934/12/06
Parties	Primary care trust prescribing advisor v Roche Products Limited and GlaxoSmithKline UK Ltd
Medicine	Bonviva (ibandronic acid)
Material	Leavepiece (ref P117551)
Main issue	Whether a “62% reduction in risk of vertebral fracture over 3 years” (from a 2.5mg daily study) was presented clearly enough in a leavepiece promoting 150mg once-monthly dosing
Clause(s) considered	Clause 7.2
Panel decision	Breach of Clause 7.2 (initially)
Appeal outcome	Appeal successful; no breach of Clause 7.2
Complaint received	18 December 2006
Case completed	22 February 2007
Applicable Code year	2006

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

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A primary care trust (PCT) prescribing advisor complained about a Bonviva (ibandronic acid) leavepiece (ref P117551) co-promoted by Roche Products Limited and GlaxoSmithKline UK Ltd.
Bonviva 150mg (one tablet) once a month was promoted for osteoporosis in postmenopausal women at increased risk of fracture.
On an ‘Efficacy’ page, a box stated ‘Bonviva: reduction in risk of vertebral fracture over 3 years’ with a large downward arrow showing “62%”.
Next to the arrow, the leavepiece stated the data were adapted from a 3-year randomised, double-blind, placebo-controlled study in which 977 received Bonviva 2.5mg daily and 975 received placebo (Chesnut et al 2004).
The complainant alleged it was unacceptable/unethical to use daily-dose study data to promote the monthly formulation and that monthly vertebral fracture efficacy had not been demonstrated in clinical trials, making the material misleading.
The Authority asked the companies to respond in relation to Clause 7.2.
The companies argued the monthly indication was supported via accepted regulatory “bridging” (including BMD bridging) and that the leavepiece clearly stated the source dose (2.5mg daily).

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Panel (initial): Breach of Clause 7.2 ruled because, in context, it was not sufficiently clear that the 62% fracture reduction related to once-daily Bonviva rather than once-monthly.
Appeal Board (final): Appeal successful; no breach of Clause 7.2. The Appeal Board considered it acceptable to use bridged data in promotion provided it is clear the source data are from the 2.5mg daily dose, and found the page did make this sufficiently clear.

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