MSD v Roche & GSK: Bonviva preference campaign misled by implying equivalence with Fosamax Once Weekly

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Key facts

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Case number	AUTH/1790/1/06 & AUTH/1791/1/06
Complainant	Merck Sharp & Dohme Limited
Respondents	Roche Products Limited; GlaxoSmithKline UK Limited
Medicine	Bonviva (ibandronic acid)
Comparator referenced	Alendronate / Fosamax Once Weekly
Materials	Pharmacy leavepiece (BNV/DAP/05/20703/1); mailer (BNV/MLP/05/20705/1); journal advertisement (BNV/ADO/05/21553/1)
Main claims at issue	“Faced with 52 or 12 tablets a year…”; “Patients prefer a monthly to a weekly bisphosphonate”; “71% chose Bonviva once-monthly over alendronate once-weekly”
Key SPC difference highlighted	Bonviva: efficacy on femoral neck (hip) fractures not established; Fosamax: reduces risk of vertebral and hip fractures
Breach clauses	7.2 and 7.3
Clause 7.10 (2006 Code)	No breach ruled (transition period)
Sanctions	Undertaking received
Complaint received	25 January 2006 (also stated as 26 January 2006 in the report)
Case completed	10 May 2006 (also stated as 11 May 2006 in the report)
Appeal	Yes; unsuccessful
Applicable Code year	2003

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

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Merck Sharp & Dohme (MSD) complained about Roche Products Ltd and GlaxoSmithKline UK Ltd promotional materials for Bonviva (ibandronic acid): a pharmacy leavepiece (BNV/DAP/05/20703/1), a mailer (BNV/MLP/05/20705/1) and a journal advertisement (BNV/ADO/05/21553/1).
The materials compared Bonviva (once-monthly) with alendronate/Fosamax Once Weekly (once-weekly) using the question: “Faced with 52 or 12 tablets a year, what would [your] patients prefer?” and claims including “Patients prefer a monthly to a weekly bisphosphonate” and “71% chose Bonviva once-monthly over alendronate once-weekly”.
MSD alleged the comparison was unfair, inaccurate and misleading because it implied comparable clinical benefits, despite differences in the SPCs: Bonviva’s SPC stated efficacy on femoral neck (hip) fractures had not been established, while Fosamax’s SPC stated it reduced the risk of vertebral and hip fractures.
MSD also questioned whether the BALTO patient preference study (Emkey et al 2005), used to support the 71% claim, provided a fair basis for promotion given patients may not have been fully informed about comparative evidence.

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Breach ruled: Clauses 7.2 and 7.3 (misleading claims and substantiation) in relation to the direct comparison and implied equivalence.
No breach ruled: Clause 7.10 of the 2006 Code (rational use) was not applied due to the 2006 Code transition period.
Appeal by Roche and GSK was unsuccessful; the Appeal Board upheld the breaches of Clauses 7.2 and 7.3.

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