AUTH/2590/3/13: Shire voluntary admission over Lancet reprint bar chart (Replagal) – no breach | PMCPA Case

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Key facts

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Case	AUTH/2590/3/13
Company	Shire Pharmaceuticals Limited
Material	Journal reprint (The Lancet Mehta et al 2009) distributed in a reprint carrier with a four-page A4 summary (ref UK/HG/REP/12/0008a)
Product(s)	Replagal (agalsidase alfa); competitor referenced: Fabrazyme (agalsidase beta)
Issue	Incorrect Fabrazyme bar in figure 4 (GFR decline) in the original chart; corrected figure published by The Lancet and included at end of reprint
Applicable Code year	2012
Clauses considered	Clauses 2, 7.2, 9.1
Decision	No breach
Complaint received	21 March 2013
Case completed	16 April 2013
Appeal	No appeal
Notable quantities/dates	220 official reprints received; carrier certified 21 Aug 2012; reps asked to return remaining copies 14 Feb 2013; ~40 returned

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

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Shire Pharmaceuticals voluntarily admitted that a The Lancet reprint (Mehta et al 2009), used to promote Replagal (agalsidase alfa), contained a bar chart that was incorrect and potentially misleading about Fabrazyme (agalsidase beta) (Genzyme).
The bar chart (figure 4) included a Fabrazyme comparator bar “plotted for reference and comparison” showing ~-2.8 ml/min/1.73m² annualised change in GFR; the underlying Germain et al (2007) value was ~-1.1 ml/min/1.73m².
Genzyme identified the error after publication (Dec 2009); the lead author requested correction and The Lancet published a correction (Jan 2010).
Shire obtained and distributed 220 official reprints (certified 21 Aug 2012) in a reprint carrier via sales reps and at conferences; the reprint included the original article plus the correction at the end (standard journal practice).
Shire noted the reprint and carrier did not clearly flag that an error existed; readers might not notice the corrected figure at the end.
After Genzyme found a reprint at a meeting (email 14 Feb 2013), Shire asked reps to return remaining copies; ~40 were returned.
Unable to reach consensus with Genzyme, Shire self-referred to the PMCPA.

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