AUTH/2168/9/08: Roche v Novartis – Zometa exhibition panel and adapted Forest plot | PMCPA Case

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Key facts

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Case number	AUTH/2168/9/08
Parties	Roche Products Limited v Novartis Pharmaceuticals UK Ltd
Product	Zometa (zoledronic acid)
Setting	Exhibition panel at VII International Meeting on Cancer Induced Bone Disease (Edinburgh, 29 June–2 July 2008)
Key material	Exhibition panel with comparative headline and adapted Forest plot from Pavlakis et al (2005) Cochrane Review
Main issue upheld	Adapted Forest plot did not reflect sample sizes/weights and created a misleading immediate impression
Breach clause(s)	Clause 7.8
Other clauses considered	Clauses 7.2, 7.3, 7.4, 7.10, 8.1, 9.1 (no breach)
Complaint received	19 September 2008
Case completed	12 January 2009
Applicable Code year	2008
Appeal	No appeal
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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Roche complained about Novartis’ promotion of Zometa (zoledronic acid) on an exhibition panel at the VII International Meeting on Cancer Induced Bone Disease (Edinburgh, 29 June–2 July 2008).
The panel headline stated: “Zometa reduces the risk of SREs more than any other bisphosphonate in advanced breast cancer”.
A claim above a Forest plot stated: “Intravenous zolendronate 4mg … reduces rate of skeletal events, delays the time to a skeletal event, and significantly reduces the risk of developing a skeletal event”.
The Forest plot was adapted from Pavlakis et al (2005), a Cochrane Review on bisphosphonates for breast cancer.
Roche alleged the headline and comparative presentation were inaccurate/unbalanced, misleading, incapable of substantiation and disparaging; and that the adapted Forest plot visually implied equal study weight by making box sizes appear similar despite different sample sizes.
Roche also alleged the plot compared different endpoints (events vs time-based measures) and that the strapline “Maintaining strength. Relieving pain” was ambiguous and should have been referenced per an alleged inter-company agreement.

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Breach found: Clause 7.8 (misleading presentation of data) because the adapted Forest plot did not reflect sample sizes and created a misleading immediate impression.
No breach of Clauses 7.2, 7.3, 7.4 and 8.1 in relation to the headline claim on the narrow grounds alleged (meta-analysis vs lack of head-to-head RCTs; and not depicting all presentations).
No breach of Clauses 7.2, 7.3, 7.8, 7.10 and 8.1 regarding the allegation about different endpoints (the Cochrane review addressed heterogeneity and reporting).
No breach of Clauses 7.2 and 7.10 for the strapline “Maintaining strength. Relieving pain” (considered sufficiently within the licensed indication and not ambiguous/all-embracing).
No breach of Clause 9.1 regarding failure to add references per inter-company dialogue (Panel noted agreements should be clear and complied with, but failure to do so was not a Code breach; and there was no Code requirement to reference that claim).
The Panel stated it was very concerned about the exhibition panel and noted additional issues (eg, strength of the comparative headline; lack of clarity that comparisons were vs placebo/no bisphosphonate; uncertainty about pamidronate risk reduction figure), but it could not rule on points not formally alleged.

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