AUTH/3028/3/18: Ex-Employee v AbbVie — Synagis poster attribution and uncertified case studies | PMCPA Case

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Key facts

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Case number	AUTH/3028/3/18
Complainant	Ex-employee (contactable)
Company	AbbVie
Product	Synagis (palivizumab)
Main issues	Disclosure of company involvement in poster; uncertified case-study (Pathways) document used at promotional meeting(s)
Applicable Code year	2016
Complaint received	23 March 2018
Case completed	17 October 2018
Breach clauses	9.1, 9.10, 14.1
No breach clauses	2, 15.2
Sanctions	Undertaking received

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

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A contactable ex-employee complained about (1) the production and promotion of an Embrace Stars poster and (2) the use of case studies at regional Embrace meetings.
The poster related to Synagis (palivizumab) for prevention of serious lower respiratory tract disease requiring hospitalisation caused by RSV in high-risk children.
The poster carried the declaration: “This poster has been reviewed for compliance purposes by AbbVie with no influence on the content/opinions being presented”.
The complainant alleged AbbVie’s involvement went beyond compliance review (including edits via a communications agency and involvement of an AbbVie representative), and that the poster was presented as health-professional authored.
The complainant also alleged that case studies were used/presented at meetings without going through the company’s approval/certification process (referred to as the Zinc process).
During the process, additional evidence included a draft poster with track changes/comments and later an email from a nurse referenced as an author.

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Breach: Clause 9.10 — AbbVie’s declaration on the poster did not accurately reflect its involvement and was misleading to readers.
Breach: Clause 9.1 — high standards were not maintained (linked to the misleading declaration/attribution of involvement).
Breach: Clause 14.1 — failure to certify the Pathways document (case studies) used in the context of a promotional meeting.
No breach: Clause 15.2 — the complainant did not establish, on the balance of probabilities, that it was inappropriate for promotional staff to present case studies as alleged, nor that the representative failed to maintain high standards on the narrow allegation about creating the poster.
No breach: Clause 2 — the circumstances did not warrant this particular censure; upheld on appeal.
Appeal by the complainant was unsuccessful on Clauses 15.2 and 2; the Appeal Board upheld the Panel’s rulings.

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