AUTH/2799/10/15: Anonymous oncologist v Pierre Fabre – Vinorelbine (Navelbine) congress booth claims | PMCPA Case

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Key facts

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Case number	AUTH/2799/10/15
Parties	Anonymous oncologist v Pierre Fabre
Medicine	Navelbine (vinorelbine)
Issue	Promotional claims on congress booth panels and an efficacy brochure (including “Rare Cumulative Toxicity”, “79%… escalate to 80mg/m²”, and “Easily Manageable Adverse Events”)
Setting	ESMO Congress, Vienna (25–29 September 2015)
Complaint received	07 October 2015
Case completed	26 January 2016
Applicable Code year	2015
Breach clauses	7.2, 7.4, 9.1
No breach clauses considered	2, 7.2, 7.4, 7.9 and 9.1 (in relation to other allegations/claims)
Sanctions	Undertaking received; additional sanctions not stated
Appeal	No appeal

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

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An anonymous, non-contactable complainant (oncologist) challenged promotional materials for Navelbine (vinorelbine) displayed/distributed on the Pierre Fabre exhibition stand at the ESMO Congress in Vienna (25–29 September 2015).
The complainant objected to the phrase “Rare Cumulative Toxicity” on stand panels and in an efficacy brochure, stating that in their experience many patients experienced adverse reactions (notably gastrointestinal).
The complainant also challenged brochure claims that “79% of patients were able to escalate to the standard dose of 80mg/m²” and “Easily Manageable Adverse Events”.
The complainant alleged a Pierre Fabre representative gave a misleading explanation about “rare cumulative toxicity” (linked to 3-weeks-on/1-week-off dosing), and raised concern that patient safety might be at risk.
Pierre Fabre argued the stand was organised/funded by the French global team and that materials at an Austrian meeting should fall under Austrian/French requirements; the UK affiliate said it had not seen the materials in advance and briefed UK staff not to use or refer to them.
The Panel determined the activity was within scope of the UK Code because UK staff substantially manned the stand and the UK affiliate invited 20 UK oncologists and directed them to the stand.

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Breach: Clauses 7.2 and 7.4 for the claim “79% of patients were able to escalate to the standard dose of 80mg/m²” (misleading and not sufficiently substantiated for the broad implication made).
No breach: Clauses 7.2, 7.4, 7.9 for “Rare Cumulative Toxicity” (Panel accepted distinction between cumulative vs acute toxicity and found supporting data provided).
No breach: Clauses 7.2, 7.4, 7.9 for “Easily Manageable Adverse Events” (given therapy area and specialist audience; claim taken from cited study; not unreasonable).
Breach: Clause 9.1 (high standards not maintained) as a consequence of the misleading/unsubstantiated dose-escalation claim.
No breach: Clause 2 (no evidence patient safety adversely affected; on balance no breach).
No breach regarding the alleged misleading verbal exchange at the stand (insufficient evidence; complainant non-contactable; company could not identify individuals; burden of proof not met).
No appeal.

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