AUTH/2456/11/11: GP complaint about Pradaxa e-promotion on doctors.net.uk (No breach)

📅 2011 | 🖉 Dr Anzal Qurbain
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Key facts

Case numberAUTH/2456/11/11
ComplainantGeneral practitioner
CompanyBoehringer Ingelheim Limited
ProductPradaxa (dabigatran)
ChannelThird-party website (www.doctors.net.uk); e-promotion
Key allegationsRelative risk presented without absolute risk; prescribing information omitted in connection with linked reprints; misleading omission regarding 75mg strength for AF indication
Materials referencedClinical paper summary β€œDabigatran versus warfarin in patients with atrial fibrillation” (DBG2430); webpage β€œPradaxa – stroke prevention in atrial fibrillation” (DBG2686); hyperlinks to Connolly et al (2009, 2010)
Authority focusClauses 4.1 and 7.2; supplementary information to Clause 10.1
Applicable Code year2011
Panel decisionNo breach of the Code
Complaint received15 November 2011
Case completed2 February 2012
AppealNo appeal

Download the full case report (PDF)


Reviewed by Dr Anzal Qurbain (FFPM) β€” ABPI Final Signatory

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What happened

  • A general practitioner complained about Boehringer Ingelheim’s promotion of Pradaxa (dabigatran) on a third-party website (www.doctors.net.uk).
  • The complaint focused on a clinical paper summary (β€œDabigatran versus warfarin in patients with atrial fibrillation”, ref DBG2430) which the complainant said presented only relative risk for key outcomes (dabigatran 150mg/110mg vs warfarin), allegedly omitting absolute risk.
  • The complainant also alleged that hyperlinks to Connolly et al reprints (2009, 2010) created a promotional facility to download/print reprints, which required prescribing information (PI) to accompany them, and that PI was omitted.
  • A second webpage (ref DBG2686) headlined Pradaxa for stroke prevention in atrial fibrillation; the complainant alleged it was misleading by omission because it did not state the AF indication was restricted to 150mg and 110mg (not 75mg, which existed for a different indication).
  • The complainant repeated the PI-with-reprints concern for the second page.
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Outcome

  • No breach of the Code was ruled.
  • No breach of Clause 7.2 (relative risk/absolute risk) for the clinical paper summary table because absolute rates were also stated.
  • No breach of Clause 4.1 (prescribing information availability) because the webpages provided a prominent, direct link to PI via a red banner; linked pages were treated as part of the same material.
  • No breach in relation to reprints because the Panel considered access via hyperlinks to be solicited (so the unsolicited reprint provisions were not engaged as alleged).
  • No breach for alleged misleading omission about the 75mg dose on the AF page; the Panel considered reference to 75mg was not required because the page did not mention dose and was about AF stroke prevention.
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