Lilly & Daiichi-Sankyo: Efient launch consumer press release misleading on clopidogrel “up to 25%” non-response (AUTH/2222/4/09, AUTH/2227/4/09)

📊

Key facts

⌄

Case numbers	AUTH/2222/4/09 and AUTH/2227/4/09
Parties	Anonymous Lilly employee v Eli Lilly and Company Limited and Daiichi-Sankyo UK Ltd
Material	Consumer press release for Efient (prasugrel) (ref UKEFF00062/March 2009)
Product	Efient (prasugrel)
Complaint received	10 April 2009
Completed	10 June 2009 (AUTH/2227/4/09); 11 June 2009 (AUTH/2222/4/09)
Applicable Code year	2008
Key issue	Claim that “up to 25%” of patients do not respond adequately to clopidogrel was not sufficiently balanced and was misleading
Breach clauses	9.1 and 22.2
No breach clauses considered	22.1 and 2
Sanctions	Undertaking received; additional sanctions: Not stated
Appeal	No appeal

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

📋

⌄

An anonymous Lilly employee complained about a consumer press release (ref UKEFF00062/March 2009) issued jointly by Eli Lilly and Company Limited and Daiichi-Sankyo UK Ltd to mark the UK launch of Efient (prasugrel).
The complainant alleged the release over-emphasised efficacy versus clopidogrel and downplayed bleeding risk, and that it made a “cheap point” about “25% resistance” to clopidogrel based on limited evidence.
The Authority asked the companies to respond in relation to Clauses 2, 9.1, 22.1 and 22.2 (Code 2008).
The press release included the statement: “research has also shown that up to 25% of patients do not respond adequately to clopidogrel”.
Lilly and Daiichi-Sankyo argued variability in clopidogrel response was well documented, cited publications, and stated the press release had been pre-vetted and approved by the MHRA.

⚖️

⌄

No breach of Clause 22.1: the Panel considered the press release was not an advertisement per se for Efient.
Breach of Clause 22.2: the “up to 25%” statement did not adequately reflect the unresolved scientific position and was misleading.
Breach of Clause 9.1: high standards had not been maintained.
No breach of Clause 2: although concerned, the Panel did not consider the circumstances warranted the particular censure of Clause 2.
No appeal.

🔒

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