AUTH/2659/11/13: Member of the public v Pfizer — Clinical trial disclosure (Conbriza and Xiapex) (No breach after appeal)

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Key facts

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Case number	AUTH/2659/11/13
Complainant	Anonymous, contactable member of the public
Respondent	Pfizer
Products	Conbriza (bazedoxifene); Xiapex (collagenase clostridium histolyticum)
Issue	Clinical trial disclosure timing/availability (based on CMRO transparency assessment)
Source referenced	“Clinical Trial Transparency: an assessment of the disclosure results of company-sponsored trials associated with new medicines approved recently in Europe” (CMRO, 11 Nov 2013)
Applicable Code	2012
Clauses considered	2, 9.1, 21.3
Panel decision	Xiapex: breach of 21.3 and 9.1 initially; no breach of 2. Conbriza: no breach.
Appeal outcome	Appeal successful; Xiapex Point X study completed Oct 2012 and was non-evaluable at end Jan 2012, therefore outwith scope; no breach of 9.1 and 21.3.
Final outcome	No breach of the Code
Complaint received	21 November 2013
Case completed	12 June 2014

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

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What happened

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An anonymous, contactable member of the public complained about alleged non-disclosure/late disclosure of clinical trial results, based on a published transparency assessment in Current Medical Research & Opinion (CMRO) (11 Nov 2013).
The CMRO study reviewed publicly available sources (searched 27 Dec 2012–31 Jan 2013) and reported disclosure rates for medicines approved by EMA in 2009–2011; detailed product-level data were available via a linked website.
The complainant alleged breaches by Pfizer in relation to two products: Conbriza (bazedoxifene) and Xiapex (collagenase clostridium histolyticum), citing Clauses 2, 9 and 21.
Pfizer responded that it had disclosed trials for which it was responsible, and explained sponsorship/marketing authorisation changes (Xiapex originator Auxilium; Conbriza previously Wyeth).
For Xiapex, Pfizer said it sponsored Study B1531002 (Point X Study), completed Oct 2012, and issued basic results on 29 Oct 2013 with posting awaited on ClinicalTrials.gov; a manuscript had been accepted by the Journal of Hand Surgery (British).
For Conbriza, Pfizer said Conbriza was approved Apr 2009 and first launched May 2010 (not launched in the UK), and that publications existed for studies flagged as undisclosed in the CMRO analysis but were not identified in time for the CMRO manuscript.
The Panel initially ruled a breach for Xiapex (Clause 21.3 and 9.1) due to lack of evidence that results were publicly available and no evidence of agreed delayed disclosure; Pfizer appealed.
The Appeal Board found the Xiapex Point X study completed Oct 2012 and therefore was non-evaluable under the CMRO cut-off (end Jan 2012) and outwith the scope of the complaint; it ruled no breach.

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Outcome

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Final case outcome: No breach of the Code.
Appeal successful: no breach of Clauses 9.1 and 21.3 (2012 Code) for Xiapex because the study at issue was out of scope (non-evaluable at end Jan 2012).
No breach for Conbriza: Panel accepted that results of relevant evaluable studies were disclosed within the required timeframe (by May 2011, based on first launch May 2010).
No breach of Clause 2 was ruled.

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AUTH/2659/11/13: Member of the public v Pfizer — Clinical trial disclosure (Conbriza and Xiapex) (No breach after appeal)

Key facts

What happened

Outcome

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