Amgen: sponsored osteoporosis therapy review service challenged over third-party email linking “client product/therapy priorities” (No breach)

📅 2019 | 🖉 Dr Anzal Qurbain
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Key facts

CaseAUTH/3191/4/19
PartiesAnonymous v Amgen Limited
IssueSponsored osteoporosis/bone health therapy review service; allegation that third-party internal email linked reviews to “client product/therapy priorities” (commercial bias/disguised promotion)
Product mentionedProlia (denosumab)
Key evidence citedInternal third-party email dated 14 August 2018 (extracts referencing “Amgen reviews” and “integrate client product/therapy priorities”)
Applicable Code year2016
Clauses consideredClause 2; Clause 9.1; Clause 12.1; Clause 19.2
Panel decisionNo breach of Clauses 19.2, 12.1, 9.1; consequently no breach of Clause 2
AppealAppeal by complainants; unsuccessful (no breach upheld)
Complaint received30 April 2019
Case completed14 October 2020
SanctionsNone

Download the full case report (PDF)


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

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What happened

  • An anonymous contactable group (describing itself as GPs, NHS leaders, pharmacists, NHS patients and current staff of a named third-party provider) complained about therapy review services delivered by that third party for multiple pharma companies, including Amgen.
  • The Amgen-sponsored service related to bone health/osteoporosis; Amgen marketed Prolia (denosumab).
  • The complaint centred on an internal email (14 August 2018) from a senior employee at the third-party provider to its clinical team, which the complainants said linked therapy reviews to “client product/therapy priorities” and implied a return-on-investment mindset (“commercial bias”).
  • The email included: “4 of our 5 regions are currently recruiting Amgen reviews…” and a general statement: “transition and integrate client product/therapy priorities into our internal resource and schedules”.
  • Complainants alleged the email breached the Code (including Clause 2) and argued pharma companies are responsible for third parties acting on their behalf.
  • Amgen responded that the osteoporosis therapy review was a non-promotional service to support NICE guidance (CG146; QS149), with GP-led decision-making, written protocols, sponsorship disclosure, and no product-switch objective or product-specific recommendations by pharmacists.
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Outcome

  • No breach of the Code was ruled by the Panel.
  • No breach findings were upheld on appeal (appeal by complainants unsuccessful).
  • The Panel and Appeal Board both expressed concern about the overall impression/tone of the third party’s email and stated Amgen had been “let down” by its third party, but found insufficient evidence that Amgen’s arrangements breached the Code.
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