AUTH/2454/11/11: Pharmacist v Celgene — advisory board honoraria alleged as disguised promotion (No breach)

📅 2011 | 🖉 Dr Anzal Qurbain
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Key facts

Case numberAUTH/2454/11/11
ComplainantRegional cancer hospital pharmacist
CompanyCelgene Limited
MedicineVidaza (azacitidine)
Therapy area / indication (as stated)Treatment of certain adult patients with myelodysplastic syndromes (MDS), chronic myelomonocytic leukaemia (CMML) or acute myeloid leukaemia (AML)
AllegationInappropriate promotional activity / disguised promotion and inducement via advisory panels and honoraria
Honoraria mentioned£600 (Vidaza advisory board); £500 (separate October network pharmacists advisory board, unrelated to Vidaza)
Vidaza advisory board attendance (as stated)Four clinicians (incl. chair), one pharmacist, three Celgene employees
Key timingComplaint received 7 November 2011; meeting held 14 November 2011; case completed 20 December 2011
Applicable Code year2011
Clauses consideredClauses 2, 9.1, 12.1, 18.1 and 20.1
OutcomeNo breach of the Code
AppealNo appeal

Download the full case report (PDF)


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

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What happened

  • A regional cancer hospital pharmacist complained about alleged inappropriate promotional activity by Celgene Limited relating to Vidaza (azacitidine) in myelodysplasia.
  • The complainant said they were invited (around Aug 2011, around the time of Scottish Medicines Consortium (SMC) submission) to an advisory panel meeting with travel reimbursement plus a £600 honorarium.
  • The complainant said they were invited to another meeting for senior regional pharmacists post-SMC (again with a £600 honorarium) and believed other pharmacists and haematologists were approached.
  • The complainant had not attended the meetings but was concerned that an agenda they had seen did not appear to support a genuine advisory/review panel.
  • Celgene stated there was only one Vidaza-related advisory board in Scotland; the date changed, resulting in two invitations being sent.
  • The Vidaza advisory board was held on 14 November 2011 and attended by four clinicians (including the chair), one pharmacist, and three Celgene employees; Celgene said no presentations were delivered by Celgene attendees and the chair ran the meeting.
  • Celgene said the £600 honorarium reflected time to prepare for and attend a three-hour meeting; genuine travel costs were reimbursed.
  • Celgene also described a separate October 2011 network pharmacists advisory board (unrelated to azacitidine) held before BOPA, with a £500 honorarium, focused on romidepsin and lenalidomide indication extensions.
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Outcome

  • No breach of the Code was ruled.
  • The Panel did not consider the Vidaza advisory board, its arrangements, or documentation to be disguised promotion.
  • The Panel considered the attendees were engaged as genuine consultants with a legitimate need, reasonable numbers, and reasonable compensation.
  • The Panel considered the payment reflected services provided and was not a pecuniary advantage offered as an inducement to prescribe.
  • The Panel noted the invitation should have referred to the preparation work required by attendees (commentary), but this did not result in a breach.
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