Boehringer Ingelheim breached Clauses 7.2 and 7.8 over unclear simulated dosing graph on congress stand (Pradaxa)

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Key facts

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Case	AUTH/2757/5/15
Parties	Anonymous v Boehringer Ingelheim
Setting	Congress stand presentation (European Stroke Organisation Congress, Glasgow, 17–19 April 2015)
Material	Presentation ref UK DBG-151019b; slide 16 “Consequences of a missed dose”
Product	Pradaxa (dabigatran)
Main issue	Graph not clearly presented as simulated/theoretical and not clearly identified as adapted from Vrijens and Heidbuchel
Clauses considered	7.2 and 7.8
Breaches	Clause 7.2; Clause 7.8
No breach	Clause 7.2 (regarding allegation that HIV data was used / relevance of HIV data)
Complaint received	08 May 2015
Case completed	01 July 2015
Appeal	No appeal
Sanction	Undertaking received
Applicable Code year	2015

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

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An anonymous, non-contactable complainant challenged a Boehringer Ingelheim (BI) presentation shown on BI’s promotional stand at the European Stroke Organisation Congress (Glasgow, 17–19 April 2015).
The presentation (ref UK DBG-151019b) discussed management of acute ischaemic stroke in patients with non-valvular atrial fibrillation (NVAF) receiving anticoagulation, including NOACs and dabigatran (Pradaxa).
Slide 16, titled “Consequences of a missed dose”, showed a graph comparing once-daily vs twice-daily dosing for a medicine with half-life ~12 hours and Tmax 3 hours, including missed doses on day 7.
The slide cited Vrijens and Heidbuchel (2015) and Nagarakanti et al (2008). The complainant alleged the graph was effectively derived from Comté et al (2007) (HIV antiretroviral modelling) and that extrapolating to cardiovascular patients was questionable and not in patients’ best interests.
BI argued the graph came from Figure 2C of Vrijens and Heidbuchel and represented the authors’ simulation for a hypothetical drug (dose X once daily vs X/2 twice daily), not HIV patient data, and did not refer to dabigatran specifically.

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Breach found: Clause 7.2 (misleading) — slide 16 was misleading because it was not clear the graph was simulated/theoretical rather than clinical data in NOAC patients.
Breach found: Clause 7.8 — the graph presentation was unclear and did not make it clear it was adapted from Vrijens and Heidbuchel.
No breach: Clause 7.2 (on the specific allegation that HIV data was being used / relevance of HIV data) — the Panel accepted the slide was not HIV patient data and therefore it was not misleading to omit the half-lives for lopinavir and ritonavir.
No appeal.

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