MSD Janumet e-detail: “helps more patients get to goal” ruled a hanging comparison and subgroup data was over-emphasised (AUTH/2377/12/10)

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Key facts

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Case	AUTH/2377/12/10
Parties	Novo Nordisk v Merck Sharp & Dohme
Product	Janumet (sitagliptin and metformin)
Material	Screen 7 of an e-detail (ref 02-11 JMT.10.GB.37010.AV)
Main issue	Hanging comparison in headline; undefined “goal”; over-emphasis of small subgroup HbA1c reduction
Study cited	Raz et al (2008)
Subgroup highlighted	Baseline HbA1c ≥10% (n=19 in e-detail; paper referenced n=20 with note that 19 contributed to full-analysis-set)
Complaint received	23 December 2010
Case completed	5 April 2011
Applicable Code year	2008
Breach clauses	7.2 (x3), 7.3 and 7.4 (x4)
Appeal	Appeal by respondent (unsuccessful on the appealed points)
Sanction	Undertaking received

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

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Novo Nordisk complained about screen 7 of an e-detail for Janumet (sitagliptin + metformin) produced by Merck Sharp & Dohme (ref 02-11 JMT.10.GB.37010.AV).
The screen headline stated: “Powerful HbA1c reductions helps more patients get to goal” and presented HbA1c reduction data from Raz et al (2008).
Novo Nordisk alleged the headline was a hanging comparison (“more patients” compared to what) and was misleading and unsubstantiated.
Novo Nordisk also alleged the screen failed to state what “goal” meant (Raz et al used HbA1c <7%; NICE guidance referenced a general target of ≤6.5% in relevant settings).
Novo Nordisk further alleged undue emphasis was placed on a 1.8% HbA1c drop shown for a small high-baseline subgroup (n=19) using a visually prominent white arrow in a bright pink circle.
MSD argued the headline reflected a general relationship between HbA1c reduction and goal attainment and that the subgroup analysis was pre-specified and clinically relevant.
The Panel ruled breaches; MSD appealed the subgroup-related rulings, but the Appeal Board upheld them.

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The headline was ruled a hanging comparison and therefore not capable of substantiation.
The material was ruled misleading because it did not define the HbA1c “goal” and was not sufficiently complete for readers to assess therapeutic value.
The subgroup presentation (1.8% reduction in n=19) was ruled over-emphasised and misleading, particularly given its visual prominence and lack of statistical robustness.
On appeal, the Appeal Board upheld that the subgroup result was over-emphasised and misleading; it also upheld that Clause 7.3 applied because the data came from a parallel-group comparison (sitagliptin + metformin vs metformin alone).
Breach clauses recorded: 7.2 (x3), 7.3 and 7.4 (x4).

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