Servier advisory board (Lonsurf): allegations of attendee selection bias, disguised promotion and PV failures – no breach (AUTH/3158/2/19) | PMCPA Case

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Key facts

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Case number	AUTH/3158/2/19
Parties	Employee v Servier
Issue	Arrangements for an advisory board
Medicine	Lonsurf (trifluridine/tipiracil)
Therapy area	Metastatic colorectal cancer (mCRC)
Advisory board date	23 June 2017
Complaint received	05 February 2019
Case completed	30 May 2019
Applicable Code year	2016
Allegations	Advisor selection influenced by reps/commercial; pressure on medical colleague; neutropenia framed as predictor/indicator of efficacy; failure to report AEs; disguised promotion
Attendance (as stated)	10 health professionals and 3 Servier employees
Outcome	No breach of Clauses 2, 7.2, 7.4, 7.9, 9.1, 12.1, 15.9, 23.1, 25.1
Appeal	No appeal
Published	May 2020 Code of Practice Review

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

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A Servier employee complained about a metastatic colorectal cancer (mCRC) advisory board held on 23 June 2017 concerning Lonsurf (trifluridine/tipiracil).
Allegations included that representatives and a senior commercial manager influenced which health professionals (HCPs) were invited (including inviting “favourite” HCPs and those who “contributed heavily to sales”).
It was alleged a medical colleague was put under “extreme pressure” by a senior commercial manager to accept attendee recommendations.
It was alleged the meeting discussed neutropenia as an “indicator/predictor of efficacy” and that this reflected a careless attitude to patient safety.
It was alleged that when clinicians shared real-life examples of neutropenia/other adverse events during case discussions, Servier made no effort to document/report them via pharmacovigilance.
It was alleged the advisory board was a disguised promotional meeting for “loyal users” of Lonsurf, citing commercial involvement and an internal email after the meeting.

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The Panel ruled no breach in relation to advisor selection and inducement concerns.
The Panel expressed serious concerns about the acceptability of using a neutropenia “predictor of response” concept, and noted concerning wording in speaker/chair briefing documents, but found no evidence the claim was used to promote Lonsurf.
The Panel ruled no breach regarding adverse event reporting from the advisory board discussions, noting the cases were stated to be hypothetical and that briefing materials addressed PV follow-up if specific events arose.
The Panel ruled no breach that the meeting was disguised promotion.
The Panel ruled no breach of Clause 2 (reserved for particular censure).

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