AUTH/2045/9/07: Lilly v Novo Nordisk – Levemir advertorial in Pulse and “weight advantages” claim | PMCPA Case

📊

Key facts

⌄

Case	AUTH/2045/9/07
Complainant	Eli Lilly and Company Limited
Respondent	Novo Nordisk Limited
Medicine	Levemir (insulin detemir)
Material	Double page advertisement (ref UK/LM/0607/0040) in Pulse, August 2007; headed “Advertisement Feature”
Main issue upheld	Weight messaging (“Weight advantages with Levemir”) misleading/ambiguous and inconsistent with SPC
Study cited	PREDICTIVE observational study; subgroup insulin-naïve European type 2 patients, 12 weeks (n=1,798)
Applicable Code year	2006
Complaint received	12 September 2007
Case completed	5 February 2008
Appeal	Appeal by respondent; Appeal Board upheld breaches on weight
Breach clauses (as listed on PMCPA page)	Two breaches 7.2 and one of 7.4
Other breaches in report	Clause 3.2 (breach) also ruled and upheld on appeal
Sanction	Undertaking received

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

🤖

Got a question about this case?

Ask one of our 13 specialist ABPI advisors — instant answers, 24/7.

Ask AskAnzal AI

🎬 Expert Video Walkthrough

🎬

Video walkthrough — coming for members

Subscribe now and get expert video analysis for every case as we publish them.

Subscribe — from £299/yr

📋

⌄

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 summarised four Novo Nordisk-sponsored trials, including a subgroup analysis from PREDICTIVE (multinational, non-interventional, uncontrolled observational study; subgroup: insulin-naïve European type 2 patients initiated on Levemir, 12 weeks, n=1,798).
Lilly alleged claims about hypoglycaemia and weight were misleading and/or unsubstantiated, and that the advertorial was disguised promotion without declared sponsorship.
Key disputed weight messaging included the heading “Weight advantages with Levemir”, a prominent bar chart emphasising weight loss, and figures presented as: 52% lost weight; 43%, 26.3% and 15.6% lost 1, 2 or 3kg; plus “over half lost an average of more than 2.5kg in only 12 weeks”.

⚖️

⌄

No breach for alleged disguised promotion: the Panel considered it was clearly headed “Advertisement Feature” and readers would not be misled as to promotional nature (no breach of Clause 10.1).
No breach for lack of sponsorship declaration: as it was clearly an advertisement, no declaration of sponsorship was required (no breach of Clause 9.10).
No breach for the hypoglycaemia “without increasing risk” claim: in context it was a baseline comparison (oral therapy alone vs after adding Levemir) and was considered substantiated (no breach of Clause 7.4).
The Panel made no ruling on the “major hypoglycaemic events significantly reduced…” claim because Lilly did not cite a clause as required by Paragraph 5.2 of the Constitution and Procedure.
Breach findings related to weight messaging were upheld on appeal.

📖

⌄

Clause 3.2 (breach) – weight section inconsistent with the Levemir SPC/marketing authorisation particulars.
Clause 7.2 (breach) – misleading/ambiguous presentation of weight data (including cumulative percentages not explained) and overall misleading impression.
Clause 7.4 (breach) – “Weight advantages with Levemir” not capable of substantiation in the way presented.
Clause 9.10 (no breach) – sponsorship declaration not required because it was clearly an advertisement.
Clause 10.1 (no breach) – not disguised promotion.
Clause 2 (no breach) – Panel did not consider the matter warranted Clause 2 censure.

🔒

Members get the complete breakdown — Clauses, Sanction, Signatory Lens, Audit checklist, and 3 Key Questions.

Best value

£249/year

Annual — save £99

£29/mo

Monthly

Join Now — Instant Access