Sanofi: representative implied there was no clinical reason to prescribe Levemir after ‘failed’ non-inferiority trial discussion

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Key facts

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Case number	AUTH/2477/2/12
Parties	Consultant Physician v Sanofi
Issue	Conduct of a representative; implied competitor disparagement; use of unpublished comparative data; internal briefing/training and certification controls
Product(s)	Lantus (insulin glargine); comparator referenced: Levemir (insulin detemir, Novo Nordisk)
Setting	Hospital diabetes centre meeting
Meeting date	25 January 2012
Complaint received	3 February 2012 (PDF) / 06 February 2012 (website listing)
Completed	17 April 2012
Applicable Code year	2011
Breach clauses	7.2, 7.4, 8.1, 9.1, 15.2, 15.9
Appeal	No appeal
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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A consultant physician complained about a Sanofi representative’s conduct at a hospital diabetes centre meeting (25 January 2012).
The representative discussed comparative data from the (then unpublished) EFFICACY trial (once-daily Lantus vs once-daily Levemir in type 2 diabetes) without using presentation materials.
The complainant alleged the representative disparaged Levemir and stated (not exact words) that because Levemir had failed a non-inferiority trial vs Lantus, there was “no reason clinically” to prescribe Levemir.
Sanofi denied the representative said that, but internal briefing materials included strong language (eg “failed study”, “New Ammunition”) and a message that Lantus “should be the only choice when a once-daily basal insulin is needed”.
Training materials encouraged representatives to practise verbalising the “messages” in their own words; the Panel was extremely concerned there was no detailed written guidance on how to describe the EFFICACY data.
Sanofi identified that one internal presentation to the sales team had not been formally certified (though reviewed/approved by two final signatories); Sanofi accepted this item breached certification requirements.

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Breach found: the representative misleadingly implied there was no clinical reason to prescribe Levemir (Clause 7.2).
Breach found: the implication could not be substantiated (Clause 7.4).
Breach found: the implication disparaged Levemir (Clause 8.1).
Breach found: the representative did not maintain high standards (Clause 15.2).
Breach found: internal briefing materials advocated a course of action likely to be in breach of the Code (Clause 15.9).
Breach found: Sanofi failed to maintain high standards in how it briefed representatives and in not providing adequate written guidance (Clause 9.1).
No appeal.

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