MSD takes Januvia rap
pharmafile | July 9, 2013 | News story | Medical Communications, Sales and Marketing | Januvia, MSD, Merck, PMCPA
Merck Sharp & Dohme has been censured by the PMCPA for failing to uphold standards in the way it promoted its type 2 diabetes drug Januvia (sitagliptin).
The manufacturer made multiple infringements of the ABPI Code of Practice by comparing it to Boehringer Ingelheim and Eli Lilly’s own diabetes brand Trajenta (linagliptin).
Comparisons are allowed – but the PMCPA panel upheld Boehringer and Lilly’s complaint that the way MSD did it in a leave piece would give people the impression that Januvia was more effective than it is.
The leave piece used a bar chart depicting glycaemic data from Gallwitz et al (2012), a non-inferiority study assessing the efficacy and safety of Trajenta versus glimepiride (a sulphonylurea) but the panel queried whether this study, in isolation, “gave an accurate and balanced overview of the efficacy of linagliptin”.
Other studies suggest Trajenta reduces HbA1c compared to placebo in a range from -0.72% after 52 weeks to -0.57% at 18 weeks – so the panel suggested that the figure might be more in the region of -0.5-0.6% – rather than the -0.38% and -0.16% in Gallwitz et al.
The PMCPA felt the bar chart would unfairly raise doubts about the clinical value and efficacy of Trajenta and was therefore misleading.
This page of the leavepiece was followed by another page which outlined the key selling points of Januvia, among them: ‘Significant HbA1c reductions’.
The PMCPA said the reader would draw an indirect comparison between this claim and the very small reductions in HbA1c depicted for Trajenta in the bar chart on the previous page – thus making a misleading comparison.
This meant MSD breached clause 7.2, which says comparisons “must be accurate, balanced, fair, objective and unambiguous” and “must not mislead either directly or by implication, by distortion, exaggeration or undue emphasis”.
It also fell foul of clauses 7.3 (“A comparison is only permitted in promotional material if it is not misleading”) and 7.8 (“Graphs and tables must be presented in such a way as to give a clear, fair, balanced view”).
As a result of all this, MSD was deemed to have breached clause 9.1, a catch-all which states “high standards must be maintained at all times”.
MSD did not appeal and the verdict will be published in the PMCPA’s August Review.
Adam Hill
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