AUTH/2607/5/13: Pfizer v GlaxoSmithKline – Votrient COMPARZ/PISCES leavepiece (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/2607/5/13
Parties	Pfizer v GlaxoSmithKline
Product	Votrient (pazopanib)
Material	Leavepiece titled “New data – COMPARZ study” (ref (UK/PAZ/0332/12))
Therapy area	Advanced/metastatic renal cell carcinoma
Comparator referenced	Sunitinib (Sutent)
Main issues alleged	Transparency of ITT vs PP analyses in a non-inferiority trial; substantiation of non-inferiority claim; patient preference claim linked to an “assume equal efficacy” question; alleged lack of high standards (Clause 2)
Clauses cited	2, 7.2, 7.3, 7.4 and 7.8
Applicable Code year	2012
Complaint received	28 May 2013
Case completed	11 September 2013
Outcome	No breach
Appeal	Appeal by complainant (Pfizer); unsuccessful; Panel rulings upheld

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

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Pfizer complained about a GlaxoSmithKline (GSK) promotional leavepiece for Votrient (pazopanib) titled “New data – COMPARZ study” (ref (UK/PAZ/0332/12)).
The leavepiece summarised COMPARZ (head-to-head, non-inferiority trial vs sunitinib) and referenced PISCES (patient preference crossover study vs sunitinib).
Pfizer alleged the leavepiece was misleading because it did not clearly state the progression-free survival (PFS) analysis population (intention-to-treat (ITT)) and did not present the per-protocol (PP) sensitivity analysis.
Pfizer also challenged the claim: “COMPARZ complements the PISCES study which demonstrated patient preference for Votrient”, arguing PISCES relied on an assumption of equal efficacy which a non-inferiority trial could not prove.
Pfizer further alleged a deliberate attempt to mislead (Clause 2), citing that GSK presented only the analysis where non-inferiority was met and published PP analysis only on its website.
The Panel ruled no breach; Pfizer appealed; the Appeal Board upheld the Panel’s rulings (appeal unsuccessful).

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No breach of the ABPI Code (Applicable Code year: 2012).
The Panel and Appeal Board considered that, although it might have been helpful to label the ITT analysis explicitly, the leavepiece was not misleading in context.
It was acceptable in the circumstances to present the primary ITT analysis without also presenting the PP sensitivity analysis, given the similarity/consistency of results.
The PISCES patient-preference claim was not misleading and could be substantiated; the “work equally well” assumption was acceptable for a preference question and did not imply proven equivalent efficacy.
No breach of Clause 2 was found because no other breaches were found and the material was considered an accurate, fair and balanced summary.

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