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PMCPA Case

AUTH/2152/8/08: Novo Nordisk v Sanofi-Aventis – Promotion of Lantus (mailer and leavepieces)

📅 2008 | 🖉 Dr Anzal Qurbain
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Key facts

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Case numberAUTH/2152/8/08
Case referencePromotion of Lantus
ComplainantNovo Nordisk Limited
Respondent/companySanofi-Aventis
Product(s)Lantus (insulin glargine); Levemir (insulin detemir)
Material/channelMailer (LAN08/1041) and leavepieces (LAN08/1038, LAN08/1039)
Key issueMisleading presentation/context of comparative dosing and weight-gain data (including reliance on footnotes and omission of relevant subgroup results)
Dates (received/completed if stated)Complaint received 5 August 2008; Case completed 5 November 2008
AppealNot stated
Code year2008 Code (clauses cited same as 2006; Panel used 2008 Code)
Breaches/clausesClause 7.2 breached; Clauses 8.1, 7.4, 9.1, and 2 not breached
SanctionsNo explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

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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  • Novo Nordisk complained about a mailer and two leavepieces produced by Sanofi-Aventis promoting Lantus (insulin glargine); Novo Nordisk marketed Levemir (insulin detemir).
  • Mailer (LAN08/1041) used once in early 2008: under headings including “Once daily”, it included a table (“12 month comparison of Lantus vs insulin detemir (n=582)”, Rosenstock et al 2008) comparing HbA1c reduction, once-daily injection rates, and total daily insulin dose.
  • Novo Nordisk alleged the table presentation was misleading because the Levemir total daily dose shown (0.78U/kg*) related to the combined once- and twice-daily Levemir cohort, while the row above referred to once-daily injections; readers had to rely on a footnote to understand the dosing split.
  • Leavepiece (LAN08/1038) “Why choose Lantus to complement OADs?” (withdrawn voluntarily after inter-company dialogue in relation to Case AUTH/2141/7/08): two centrefold pages paired a claim of “up to a 2% reduction in HbA1c in 24 weeks” (INITIATE study, Yki-Järvinen et al 2007) with a titration recommendation to titrate up to 0.5U/kg (Monnier and Colette 2006). Novo Nordisk alleged the juxtaposition misled readers into linking the 2% HbA1c reduction to the 0.5U/kg titration advice.
  • Leavepiece (LAN08/1039) “Lantus – getting the balance right for your diabetes patients” (also withdrawn voluntarily after inter-company dialogue in relation to Case AUTH/2141/7/08): a page “... but what about weight gain?” included a prominent bar chart for type 2 diabetes comparing weight change after 1 year with once-daily Lantus (+3.9kg) vs twice-daily Levemir (+3.7kg) (p=NS), referenced inter alia to Rosenstock et al; Novo Nordisk alleged the presentation was misleading because it omitted the once-daily Levemir comparison.
  • The Director referred the LAN08/1038 matter to the Panel because the leavepiece had been withdrawn for different allegations and it was not clear the claims at issue would not be used again.
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Outcome

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  • Mailer (LAN08/1041): Breach of Clause 7.2 ruled because the table presentation was misleading; no breach of Clause 8.1 (disparagement) and no breach of Clause 9.1 (high standards) were ruled.
  • Leavepiece (LAN08/1038): Breach of Clause 7.2 ruled because, in context, readers would likely link the 2% HbA1c reduction claim to the titration statements without a clarifying statement, creating a misleading impression.
  • Leavepiece (LAN08/1039): Breach of Clause 7.2 ruled because reporting only some Rosenstock et al weight-gain data (prominent once-daily Lantus vs twice-daily Levemir) omitted the once-daily Levemir comparison applicable to 45% of patients, making the presentation incomplete and misleading; no breach of Clause 7.4 (substantiation) and no breach of Clause 9.1 were ruled; no breach of Clause 2 was ruled.
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