Astellas Pharma Europe: Milan ‘advisory board’ ruled promotional and not a genuine advisory board (Xtandi/enzalutamide) (AUTH/2747/1/15)

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Key facts

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Case number	AUTH/2747/1/15
Complainant	Anonymous, non-contactable health professional
Company	Astellas Pharma Europe Ltd
Issue	Arrangements for a meeting (Pan-European Uro-oncology Advisory Board Meeting)
Location / date of meeting	Milan (airport hotel), Italy; 27/28 February 2014
Therapy area / product	Prostate cancer; enzalutamide (Xtandi)
Key allegation	Meeting presented benefits of enzalutamide for an unlicensed (pre-chemotherapy) indication; invitation not truthful; promotion disguised as advisory board
UK attendees	5 UK advisors (within 108 advisors from 23 countries)
Payments	Advisors paid €1,000 (South East Europe €500); speakers €1,500 (as stated by Astellas)
Applicable Code year	2014
Complaint received	14 January 2015
Undertaking received	14 April 2015
Appeal Board consideration	14 May 2015 (reported to Appeal Board; no appeal hearing)
Corrective statement issued	1 July 2015
Case completed	14 May 2015
Clauses breached	2, 9.1, 12.1, 18.1, 20.1
No breach	Clause 3.1
Sanctions (as listed)	Undertaking received; corrective statement; advertisement; public reprimand; suspended from membership of the ABPI (in relation to this case; see AUTH/2780/7/15)

Download the full case report (PDF)

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

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What happened

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An anonymous, non-contactable health professional complained about arrangements for a Pan-European Uro-oncology Advisory Board Meeting held in Milan (airport hotel) on 27/28 February 2014.
The complainant said Astellas invited them and colleagues to provide advice on prostate cancer, but the meeting was large (more than 100 clinicians) and included presentation of benefits of enzalutamide (Xtandi) in a pre-chemotherapy (chemo-naïve) setting that was not yet authorised at the time.
The meeting format included an introductory plenary with two external speaker presentations (“The role of the androgen receptor signalling pathway in mCRPC” and “Enzalutamide in mCRPC”) plus Q&A, followed by parallel national/regional group sessions using workmats/exercises.
UK attendees (5 UK advisors) were paid for attendance (Astellas stated €1,000 per advisor; some regions €500). Dinner was provided (€60/head) and overnight accommodation/travel were arranged.
The Panel questioned whether there were valid and cogent reasons for holding the UK element outside the UK (UK HCPs were not otherwise attending an international meeting in Milan) and whether speaker availability justified the location.
The Panel found the time genuinely devoted to providing advice was less than 50% of meeting time (Q&A after presentations was viewed as enabling participation rather than providing advice), with no pre-reading/preparation required.
Materials for the exercises included universally positive statements about enzalutamide based on PREVAIL data and did not state that the data/indication discussed was unlicensed; the exercises looked like assessment of potential promotional claims and “place in pathway” positioning.
The Panel concluded the arrangements were not those of a genuine advisory board for UK health professionals; UK HCPs were effectively paid to attend a promotional meeting.

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Outcome

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Breach found: the meeting was not a genuine advisory board and did not meet the Code’s requirements for consultants/advisory boards.
Breach found: UK health professionals received payment to attend a meeting the Panel considered promoted the medicine; promotional activity was disguised as an advisory board.
No breach of Clause 3.1: Xtandi was licensed in the UK at the time (post-docetaxel indication), so this was not promotion of an unlicensed medicine. (The Panel noted it could not rule on promotion of an unlicensed indication because the relevant clause was not cited.)
Breach found: high standards not maintained and the arrangements brought discredit upon and reduced confidence in the industry (Clause 2).
The Panel reported Astellas Pharma Europe to the Appeal Board (Paragraph 8.2 of the Constitution and Procedure).
The Appeal Board required Astellas Pharma Europe to issue a corrective statement to all UK attendees, referring to the case report (Paragraph 11.3).

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