GE Healthcare v Bracco: Niopam promotion and the IMPACT study—misleading by omission (Clause 7.2)

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Key facts

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Case	AUTH/2169/9/08
Parties	GE Healthcare v Bracco
Product	Niopam (iopamidol)
Main issue	Promotion using IMPACT study alleged to omit pertinent methodological information; misleading impression created by materials and charts
Study referenced	IMPACT study (Barrett et al 2006), published in Investigative Radiology
Key methodological concern	Secondary endpoint data from two studies (VIRPACT and INVICTA) combined such that CIN became the primary endpoint in IMPACT; omission of this complexity and sample size/power context
Panel concerns on visuals	Bar chart gave immediate visual impression of a statistically significant difference although the study failed to demonstrate a difference
Breach clauses	Clause 7.2 (x2)
Clause 2	Not breached
Complaint received	30 September 2008
Case completed	19 December 2008
Applicable Code year	2008
Appeal	No appeal
Sanction	Undertaking received (additional sanctions: Not stated)

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

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GE Healthcare complained that Bracco’s promotion of Niopam (iopamidol) using the IMPACT study (Barrett et al 2006) omitted pertinent information about the study’s conduct, design and analysis.
Bracco materials (including a sponsored webcast and leavepieces) described/implied IMPACT as a “prospective, multi-centre, double-blind, randomised parallel group” study.
GE Healthcare alleged IMPACT was actually a combination of two separate Bracco studies (VIRPACT and INVICTA) and that, contrary to the impression given, CIN was not the primary endpoint in those original studies (it was secondary).
Promotional materials included bar charts showing CIN-related outcomes; the Panel was concerned one chart created an immediate visual impression of a statistically significant difference when the study failed to demonstrate a difference.
Bracco argued IMPACT was valid and prospectively defined, with blinded review and that CIN rates were not known until unblinding; however, the Panel focused on what the promotional materials omitted and the impression created.

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Breach found: Clause 7.2 (x2) for misleading promotion by omission of material information (study methodology/sample size and the complexity of pooled secondary endpoints becoming a primary endpoint).
No breach: Clause 2 was not upheld (Panel said Clause 2 is reserved for particular censure).
Other alleged clauses (7.4, 7.10, 9.1) were not considered because they were not the subject of intercompany dialogue.
No appeal.

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