Gilead speaker training meeting: unclear purpose and off-label positioning of Zydelig for Richter’s transformation (AUTH/3031/4/18)

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Key facts

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Case number	AUTH/3031/4/18
Complainant	Anonymous, non-contactable health professional
Company	Gilead
Meeting / activity	Gilead Oncology Faculty Meeting (speaker training meeting)
Location	Frankfurt, Germany
Date of meeting	March 2018
Medicine	Zydelig (idelalisib)
Therapy area	Chronic lymphocytic leukaemia (CLL) and follicular lymphoma (FL)
Key compliance issues	Unclear purpose of meeting in advance; positioning idelalisib as preventing Richter’s transformation using off-licence/indirect comparison narrative; insufficient slide-level caveats; downloadable portal content
Applicable Code year	2016
Complaint received	19 April 2018
Case completed	3 June 2019
Appeal	No appeal
Breach clauses	3.2, 7.2, 9.1
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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An anonymous health professional complained about a Gilead Oncology Faculty Meeting in Frankfurt (March 2018), described by Gilead as a speaker training meeting for Zydelig (idelalisib) in CLL/FL.
The complainant alleged the meeting was disguised promotion, unbalanced, and included disparagement of competitors and proactive discussion of off-label data.
The complainant said it only became clear after arrival that the premise was to train speakers who would then speak about Zydelig.
The Panel focused on whether the meeting’s primary purpose (speaker training) was made clear in advance, and whether content crossed into promotion of unlicensed use.
The Panel found invitation emails and related documentation gave the impression of a clinical/therapy meeting with some presentation skills training, rather than a speaker training event with an expectation of future speaker engagements.
The Panel reviewed a presentation on “Prevention of Richter’s transformation” and related sessions and concluded the overall narrative positioned idelalisib as preventative for Richter’s transformation, including via indirect cross-trial comparisons and off-licence data, with insufficient caveats on the slides (which were downloadable from the Faculty portal).

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Breach found: failure to make the intended purpose of the meeting sufficiently clear at the outset (high standards not maintained).
Breach found: Zydelig positioned as a preventative treatment for Richter’s transformation (off-licence promotion) and related claims not presented appropriately.
No breach found: allegation that the meeting was disguised promotion (as such) was not upheld.
No breach found: allegations about disparagement/unbalanced statistics lecture and certain competitor comments were not upheld due to insufficient evidence/burden of proof.
No appeal.

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Breach Clause(s): 3.2
Breach Clause(s): 7.2
Breach Clause(s): 9.1
No breach Clause(s) considered: 2
No breach Clause(s) considered: 3.2 (in relation to a separate allegation about off-label discussion during Q&A/RIALTO)
No breach Clause(s) considered: 7.2
No breach Clause(s) considered: 7.3
No breach Clause(s) considered: 7.4
No breach Clause(s) considered: 8.1
No breach Clause(s) considered: 12.1

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