AUTH/2246/7/09: Roche/Director v Novartis – Zometa leavepiece (strapline ambiguity, misleading forest plot, oral compliance claims)

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Key facts

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Case number	AUTH/2246/7/09
Parties	Roche/Director v Novartis
Product	Zometa (intravenous (iv) zoledronic acid)
Material	Promotional leavepiece (metastatic breast cancer)
Key issues	Ambiguous strapline implying prevention of bone metastases; misleading adapted forest plot inviting comparisons/superiority; misleading/unsubstantiated oral bisphosphonate compliance claims; failure to provide substantiation (one poster); breach of undertaking
Complaint received	06 July 2009
Case completed	29 October 2009
Applicable Code year	2008
Breach clauses (as listed)	3.2, 7.2 (x3), 7.3, 7.4 (x3), 7.5, 7.8 (x5), 7.10 (x2), 8.1, 9.1 (x2) and 25
Sanctions applied	Undertaking received; Additional sanctions: Not stated

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

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Roche complained about a Novartis promotional leavepiece for Zometa (iv zoledronic acid) aimed at metastatic breast cancer.
The leavepiece used the strapline “Protects them to the bone”, which Roche said implied Zometa prevented bone metastases (beyond its licensed indication of preventing skeletal related events (SREs) in patients with advanced malignancies involving bone).
Page 2 included a forest plot adapted from Pavlakis et al (2005) (Cochrane review) under the heading “Zometa reduces the risk of SREs”. Roche alleged the adaptation and presentation invited unfair comparisons and implied superiority.
Page 3 claimed “There are compliance issues with oral bisphosphonates” and showed discontinuation rates (44% at 3 months; 65% at 6 months) adapted from Hoer et al (poster), which Roche said was not applicable to the UK metastatic breast cancer setting and was misleading/disparaging.
Roche also alleged Novartis failed to provide requested substantiation (posters) within 10 working days.
Because Roche alleged a breach of undertaking from a previous case (AUTH/2168/9/08), the Director took up that aspect to ensure compliance with undertakings.

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Strapline “Protects them to the bone”: Breach of Clause 3.2 and Clauses 7.2, 7.4, 7.10 upheld on appeal; no breach of Clause 3.1; no breach of Clause 9.2; Clause 9.1 breach ruled by Panel but overturned on appeal; no breach of Clause 2.
Heading “Zometa reduces the risk of SREs” + forest plot context: On the narrow allegations, no breach of Clauses 7.2 and 7.4 was ruled for the page as a whole (the more serious issues were addressed under the forest plot adaptation findings below).
Forest plot adaptation (Pavlakis et al): Breaches ruled for misleading/unclear presentation and unfair comparison; included a breach of undertaking (Clause 25) upheld on appeal; Clause 2 breach ruled by Panel but overturned on appeal.
Substantiation requests: No breach for Hoer et al request; breach for failure to provide Heatley poster substantiation within 10 working days.
Oral bisphosphonate compliance graph/claims (Hoer et al): Breaches ruled for misleading, not substantiated, unbalanced, and (in context) disparaging/all-embracing.
Quotations beneath the compliance graph: No breach ruled (quotations considered clear, not misleading, not disparaging, and not taken out of context).

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