AUTH/2593/4/13: Genzyme v Shire – Lancet reprint used to promote Replagal with an incorrect comparative bar chart | PMCPA Case

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Key facts

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Case number	AUTH/2593/4/13
Parties	Genzyme Therapeutics Ltd v Shire Pharmaceuticals Limited
Product(s)	Replagal (agalsidase alfa); comparator referenced: Fabrazyme (agalsidase beta)
Material	Reprint folder / carrier “The Replagal Reprint Collection” including Mehta et al (The Lancet 2009) and a “Department of Error” corrected bar chart (The Lancet 2010)
Main issue	Incorrect bar chart created an incorrectly favourable comparison; correction was remote and not clearly signposted in promotional use
Meeting context	Association of Inherited Cardiac Conditions, London, 19 November 2012
Applicable Code year	2012
Complaint received	10 April 2013
Case completed	7 August 2013
Panel decision	No breach (Clauses 7.2, 7.3, 7.4, 2, 1.8)
Appeal outcome	Breach of Clauses 2, 7.2, 7.3 and 7.4; no breach of Clause 1.8
Sanctions	Undertaking received; Advertisement

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

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What happened

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Genzyme complained about Shire’s use of an official The Lancet reprint (Mehta et al 2009) in a promotional reprint folder (“The Replagal Reprint Collection”) to promote Replagal (agalsidase alfa) at a meeting on 19 November 2012 (Association of Inherited Cardiac Conditions, London).
The Mehta et al paper included a bar chart showing decline in renal function (eGFR). The Fabrazyme (agalsidase beta) bar was wrong: it showed ~2.8 ml/min/year/1.73m² decline, when the correct value was ~1.1 ml/min/year/1.73m² (which favoured Fabrazyme).
The Lancet published a correction (“Department of Error”, 2010). The official reprint Shire distributed included the corrected bar chart on a later page, but the incorrect bar chart remained in the main body and did not signpost the correction.
Genzyme argued Shire knew about the error from 2009 inter-company dialogue and had given an undertaking (8 February 2010) not to deliberately refer to or use the bar chart in its uncorrected form (while reserving the right to use the article when accompanied by the correction notice).
Genzyme alleged the promotional use created an inaccurate, misleading comparison with Fabrazyme and that the correction was too remote to prevent readers being misled.
Shire said it distributed the official corrected reprint (Lancet-sanctioned) and that the steps taken (including citations to both the original and correction on the folder/summary) were sufficient; it also withdrew remaining stock when concerns were raised.

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Outcome

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Panel (first instance): ruled no breach of Clauses 7.2, 7.3, 7.4, 2 and 1.8 in this case.
Appeal Board (on Genzyme’s appeal): ruled Shire had knowingly used promotional material including an incorrect and misleading comparison; breaches of Clauses 7.2, 7.3, 7.4 and 2.
Clause 1.8: No breach (as listed on the PMCPA case page).

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AUTH/2593/4/13: Genzyme v Shire – Lancet reprint used to promote Replagal with an incorrect comparative bar chart

Key facts

What happened

Outcome

Clauses

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