AUTH/1814/3/06: Former employee complaint upheld against Merck Sharp & Dohme over Cozaar-linked nurse audit programme

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Key facts

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Case number	AUTH/1814/3/06
Parties	Anonymous former employee (former sales representative) v Merck Sharp & Dohme
Programme	Hypertension Review Programme Supportive of the GMS Contract (HRP-GMS) nurse audit programme (hypertension and Type 2 diabetes audits)
Medicine referenced	Cozaar (losartan)
Complaint received	14 March 2006 (PMCPA page); PDF also states 15 March 2006
Applicable Code	2003 edition
Breach clauses	Clause 2; Clause 9.1; Clause 18.1
No breach	Clause 15.4 (call frequency allegation not proven)
Key issues	Service linked to promotion via Cozaar-branded training slides and targeting criteria; unapproved materials used; incorrect BHS guideline representation; lack of sponsorship disclosure in patient letter
Panel action	Reported company to the Code of Practice Appeal Board (Paragraph 8.2)
Appeal Board view	Extremely serious; serious deficiencies in procedures including copy approval; potential to compromise patient safety by inappropriate prescribing
Sanctions	Undertaking; public reprimand; corrective statement; audit and re-audit of procedures; advertisement; reported to ABPI Board; ABPI membership suspension (minimum 3 months from 2 Oct 2006)
Corrective statement	Mailed July 2006 to all surgeries that participated in or were approached; apologised and confirmed service suspended March 2006 and stopped
ABPI Board consideration	5 September 2006
Completion/publication	Completed 04 September 2006; published in November 2006 Review

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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A former MSD sales representative (anonymous/pseudonym) complained about a nurse audit/disease management programme (HRP-GMS) delivered by a service provider and offered to GP practices (hypertension and Type 2 diabetes audits).
MSD representatives promoting Cozaar (losartan) were responsible for identifying practices to be offered the nurse audit service.
Training slides used with representatives were branded with the Cozaar logo and titled “COZAAR Nurse Audit Programme”, with no instruction to separate services from promotion.
Slides/proformas included targeting criteria that linked access to the audit service to sales/prescribing behaviours (eg “Strong buy into LIFE and COZAAR messages”, agreement to Cozaar as medicine of choice for “A” in BHS ABCD, “call rate of 6 prior to audit plus speaker meeting attendance”, Cozaar market share thresholds).
Some internal materials used had not been through MSD’s approval system; MSD acknowledged the proformas at issue were not reviewed internally.
The HRP-GMS protocol and forms reproduced an incorrect version of BHS guidance (previously ruled on in AUTH/1762/10/05); the Panel considered MSD should have changed the protocol following that earlier ruling.
A patient template letter about the audit did not state that the audit was sponsored by MSD.
A separate allegation claimed representatives were set call objectives requiring up to six calls in six months; the Panel found no evidence to support this allegation and ruled no breach on that point.

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Outcome

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Breach found: the nurse audit programme arrangements did not meet the requirements of Clause 18.1 because the service was clearly linked to promotion of Cozaar.
Breach found: high standards not maintained (Clause 9.1).
Breach found: circumstances brought discredit upon the pharmaceutical industry (Clause 2).
No breach found: Clause 15.4 (call frequency allegation not proven).
The Panel reported MSD to the Code of Practice Appeal Board (Paragraph 8.2 of the Constitution and Procedure).
The Appeal Board described the case as extremely serious, citing serious deficiencies in procedures (including copy approval) and potential to compromise patient safety by inappropriate prescribing.
The audit service was suspended in March 2006 and later stopped (per corrective statement).

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