MSD’s Januvia leavepiece: linagliptin efficacy chart used in isolation led to misleading indirect comparison

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Key facts

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Case	AUTH/2581/2/13
Complainant	Boehringer Ingelheim Limited and Eli Lilly and Company Limited
Respondent	Merck Sharp & Dohme Limited
Product	Januvia (sitagliptin)
Competitor product referenced	Trajenta (linagliptin)
Therapy area	Type 2 diabetes
Material	Leavepiece (ref DIAB-1061227); page at issue included bar chart adapted from Gallwitz et al (2012)
Main issue	Use of Gallwitz et al efficacy chart in isolation and subsequent implied/indirect comparison with Januvia claims
Complaint received	27 February 2013 (HTML); PDF text also states 28 February 2013
Case completed	15 April 2013
Applicable Code year	2012
No breach	Clause 7.8 (re omission of hypoglycaemia/weight endpoints)
Breach	Clauses 7.2, 7.3, 7.8, 9.1
Sanctions	Undertaking received; additional sanctions not stated
Appeal	No appeal

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

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Boehringer Ingelheim and Eli Lilly complained about a Merck Sharp & Dohme (MSD) promotional leavepiece for Januvia (sitagliptin) (ref DIAB-1061227), used as a linagliptin rebuttal/objection-handler.
The leavepiece included a bar chart (adapted from Gallwitz et al (2012)) showing HbA1c reductions for linagliptin vs glimepiride at 52 and 104 weeks (linagliptin: 0.38% at 52 weeks; 0.16% at 104 weeks).
Complainants said the chart was not sufficiently complete/balanced because it omitted key secondary endpoints from Gallwitz et al (hypoglycaemia and weight change), which favoured linagliptin.
The chart page was followed by a page of Januvia selling points, including “Significant HbA1c reductions”, which complainants said would prompt indirect comparisons with linagliptin.
MSD argued the leavepiece was intended to distinguish Januvia from linagliptin in “hot spots” and that Gallwitz et al was the key active-comparator linagliptin study; it said not all study details needed to be included.

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No breach of Clause 7.8 (in relation to omission of hypoglycaemia and weight results from Gallwitz et al, given the stated purpose and that those endpoints related to linagliptin vs sulphonylurea).
Breach of Clause 7.2: using Gallwitz et al efficacy data in isolation did not provide a fair and balanced overview of linagliptin efficacy and would unfairly raise doubts about its clinical value.
Breach of Clause 7.8: the bar chart did not give a clear, fair and balanced view of linagliptin efficacy.
Breach of Clause 7.3: the juxtaposition of the linagliptin chart with the Januvia claim “Significant HbA1c reductions” created a misleading indirect comparison.
Breach of Clause 9.1: high standards were not maintained.
No appeal.

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