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PMCPA Case

AUTH/1859/6/06: Anonymous employees v Merck Sharp & Dohme (DEXA service, grants and migraine reviews) – no breach on appeal

📅 2006 | 🖉 Dr Anzal Qurbain
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Key facts

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Case numberAUTH/1859/6/06
PartiesAnonymous Employees v Merck Sharp & Dohme
TopicMedical and educational goods and services (DEXA osteoporosis service), grants, migraine therapy review services
Applicable Code year2003
Complaint received30 June 2006
Case completed22 November 2006
Panel decisionDEXA service: breaches of Clauses 2, 9.1 and 18.1; reported to Appeal Board under Paragraph 8.2. Grants and migraine services: no breach.
Appeal outcomeNo breach of Clause 18.1 and hence no breach of Clauses 9.1 and 2; no further action.
Medicines mentionedFosamax (alendronate); Maxalt; Imigran
Key materials referenced“DEXA Placements DIY Guide” (unauthorised); DXA checklist (unauthorised); “Guide to Proposal Development” (statement: “Environment positive for Fosamax…”); template patient letters without sponsorship disclosure

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 complainant (on behalf of a number of employees) raised concerns about three UK services/programmes run by Merck Sharp & Dohme (MSD).
  • DEXA (osteoporosis) service: A sales division implemented a one-day forearm bone scanner (DEXA) placement service in GP practices (described as operating between 2000–2004; complainant alleged 2002–2004) to improve diagnosis of osteoporosis.
  • The complainant alleged sales metrics influenced which practices received scanners and that representatives were required to enter into the electronic territory management system (ETMS) the number of patients who went on to Fosamax (alendronate) as a result of scans.
  • The Panel reviewed internal materials including a funding proposal referencing the “prescribing environment” and alendronate market share, and unauthorised materials: a slide set “DEXA Placements DIY Guide” and a DXA checklist.
  • The unauthorised slides included criteria such as “sales data, Fosamax target, speaker meeting, influential contact” and other sales-oriented prompts (eg “GP RX intent”).
  • The unauthorised checklist included “triggers” such as “Fosamax is bisphosphonate of choice” and monitoring of what treatment was initiated.
  • Template patient letters used by practices did not state the service was sponsored by MSD.
  • Special Products Business Unit: The complainant alleged ROI calculations were being done for grants to hospital units, potentially conflicting with “unconditional” grants.
  • Migraine team: The complainant alleged “switch/upgrade” programmes intended to support switching from Imigran to Maxalt; MSD provided materials for migraine therapy review services (2001, 2003, 2004 onwards).
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Outcome

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  • Final outcome (Appeal Board): NO BREACH OF THE CODE in relation to the matters appealed; the Appeal Board ruled no breach of Clauses 18.1, 9.1 and 2.
  • Panel (initial) – DEXA service: ruled breaches of Clauses 18.1, 9.1 and 2 and reported MSD to the Appeal Board under Paragraph 8.2 of the Constitution and Procedure.
  • Appeal Board – DEXA service: while concerned/alarmed by the unauthorised materials and lack of clarity on provenance, found the complainant had not established on the balance of probabilities that the arrangements amounted to a breach.
  • Special Products Business Unit: Panel found no evidence ROI calculations were made for grants; no breach.
  • Migraine therapy review services: Panel found no evidence the service was intended to support switching from Imigran to Maxalt; no breach.
  • The Appeal Board decided to take no further action regarding the Panel’s Paragraph 8.2 report, given its rulings of no breach.
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