Lilly v Novo Nordisk: Levemir advertorial breached Code over ‘weight advantages’ claim (AUTH/2045/9/07)

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Key facts

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Case	AUTH/2045/9/07
Parties	Lilly v Novo Nordisk
Medicine / topic	Levemir (insulin detemir) – promotion/advertorial in Pulse
Material	Double page advertisement (ref UK/LM/0607/0040), Pulse August 2007, headed ‘Advertisement Feature’
Main issue(s)	Weight ‘advantages’ claim and ambiguous weight-loss presentation; SPC consistency; substantiation
Study cited	PREDICTIVE observational study; subgroup insulin-naïve type 2, 12 weeks, n=1,798 (plus other trials referenced)
Complaint received	12 September 2007
Case completed	5 February 2008
Applicable Code year	2006
Breach clauses	Clause 3.2; Clause 7.2 (two breaches); Clause 7.4 (one breach)
No breach / not upheld	Clause 2 (no breach); Clause 9.10 (no breach); Clause 10.1 (no breach); Clause 7.4 (no breach for hypoglycaemia claim)
Appeal	Appeal by respondent; Appeal Board upheld breaches regarding weight
Sanction(s)	Undertaking received; additional sanctions not stated

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

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Eli Lilly complained about a double-page Pulse (Aug 2007) ‘Advertisement Feature’ for Levemir (insulin detemir), styled as an advertorial: ‘Levemir in type 2 diabetes an overview for primary care’.
The piece cited four Novo Nordisk-sponsored trials, including PREDICTIVE (multinational, non-interventional, uncontrolled observational study; overall ~30,000; subgroup used in ad: European insulin-naïve type 2 patients followed 12 weeks, n=1,798).
Lilly challenged hypoglycaemia-related statements and argued the ad failed to highlight hypoglycaemia risk/was inconsistent with the SPC.
Lilly also challenged the stand-alone heading claim ‘Weight advantages with Levemir’ and the way weight-loss figures were presented (52% lost weight; 43%, 26.3%, 15.6% lost 1/2/3kg; plus ‘over half lost an average of more than 2.5kg’), alleging ambiguity and undue emphasis.
Lilly alleged the advertorial was disguised promotion and that sponsorship was not declared (Clauses 10.1 and 9.10), and that the overall impact brought discredit (Clause 2).

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Not disguised promotion: No breach of Clause 10.1; the Panel considered it clearly headed ‘Advertisement Feature’ and included prescribing information.
No sponsorship declaration required: No breach of Clause 9.10 because it was clearly an advertisement and readers would know it was produced by Novo Nordisk.
Hypoglycaemia claim context accepted: No breach of Clause 7.4 for the claim about not increasing hypoglycaemia risk, as the comparison was understood to be versus baseline oral therapy.
No ruling on one hypoglycaemia statement: The Panel made no ruling on ‘major hypoglycaemic events were significantly reduced…’ because Lilly did not cite a clause.
Weight messaging breached the Code: The ‘Weight advantages with Levemir’ section was ruled inconsistent with the SPC and misleading/ambiguous; breaches upheld on appeal.
No Clause 2 breach: The Panel did not consider the issues warranted Clause 2 censure.

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Clause 3.2 (breach) – promotion must be in accordance with the marketing authorisation / not inconsistent with SPC particulars (breach related to weight expectations vs SPC).
Clause 7.2 (breach; two breaches noted on PMCPA page) – information must be accurate, balanced, fair, objective and unambiguous; must not mislead (breaches related to weight claim and ambiguous/cumulative weight-loss figures).
Clause 7.4 (breach; one breach noted on PMCPA page) – claims must be capable of substantiation (breach related to ‘Weight advantages with Levemir’).
Clause 9.10 (no breach) – sponsorship declaration (not required here as it was clearly an advertisement).
Clause 10.1 (no breach) – disguised promotion (Panel found it was clearly promotional).
Clause 2 (no breach) – discredit to the industry (not upheld).

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