Lilly: oncology handbook contained Vitamin B12 dosing error (AUTH/2849/6/16)

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Key facts

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Case	AUTH/2849/6/16
Company	Eli Lilly and Company Limited
Complainant	Consultant oncologist and a pharmacist
Material	8th edition, Handbook of Systemic Treatments for Cancer (UKONC00326, February 2014)
Medicine referenced	Alimta (pemetrexed)
Main issue	Vitamin B₁₂ IM dose stated as 1g instead of 1mg (1000mcg) in association with Alimta therapy
Complaint received	03 June 2016
Case completed	07 November 2016
Panel breaches	Clauses 7.2, 7.4, 9.1
Appeal outcome	Clause 2 breach ruled by Appeal Board; no breach of Clauses 9.10 and 12.1 upheld
Sanctions	Undertaking received; Advertisement

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

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A consultant oncologist and a pharmacist complained about a medically significant error in the 8th edition of the Handbook of Systemic Treatments for Cancer (UKONC00326, Feb 2014) relating to Alimta (pemetrexed).
The error stated the intramuscular dose of Vitamin B₁₂ (hydroxocobalamin) as 1g instead of 1mg (1000mcg) when used before and during Alimta treatment.
The complainants also challenged the handbook’s disclaimer, which suggested Lilly’s role was limited, and alleged the arrangement was not arm’s length and could amount to disguised promotion.
Lilly said the handbook was a non-promotional medical educational item, accepted full responsibility for the 8th edition (and prior editions), and explained it had outsourced production to a third party while remaining closely involved.
Lilly said it was notified of the Vitamin B₁₂ error on 18 March 2016, removed the handbook from its oncology website the same day, and briefed customer-facing teams to destroy copies (email 21 March 2016).
After receiving the complaint (3 June 2016), Lilly commissioned a comprehensive third-party review; following an interim report showing additional errors/omissions, Lilly sent a withdrawal/destruction letter dated 16 June 2016 to oncology health professionals in its database (over 3000 recipients) and followed up by email (18 June where permission existed).
Lilly stated it would not publish further editions of the handbook.

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Breach found: Clauses 7.2, 7.4, 9.1 (Panel).
Clause 2: Panel ruled no breach, but on appeal the Appeal Board ruled a breach of Clause 2 because any dosing error is serious and reduced confidence in the industry’s ability to produce complex material to required quality standards.
No breach: Clause 9.10 (sponsorship sufficiently clear) and Clause 12.1 (not disguised promotion) were upheld on appeal.

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