AUTH/2164/9/08: MSD v Takeda – Actos/Competact ad implied CV event reduction and misused “independent” | PMCPA Case

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Key facts

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Case number	AUTH/2164/9/08
Parties	Merck Sharp & Dohme v Takeda
Products	Actos (pioglitazone); Competact (pioglitazone and metformin)
Material	Two-page journal advertisement in Pulse (ref AB080313)
Main claim at issue	“Pioglitazone sustains glycaemic control, but that’s not all – in an independent meta-analysis, it has also been shown to reduce ischaemic CV events in Type 2 diabetes”
Key issue	Overall impression implied CV event reduction as a product benefit/indication and described a Takeda-funded/data-supplied meta-analysis as “independent”
Applicable Code year	2008
Complaint received	1 September 2008
Case completed	16 February 2009
Breach clauses (final)	Clause 3.2; Clause 7.2 (x2)
Clause 7.4	No breach on appeal
Sanctions	Undertaking received; additional sanctions not applied

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

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Merck Sharp & Dohme complained about a two-page journal advertisement (ref AB080313) for Actos (pioglitazone) and Competact (pioglitazone/metformin) issued by Takeda UK Limited, which appeared in Pulse.
The ad used a dominant “ticktock ticktock ticktock ticktock time to act” headline across an overweight man’s chest, alongside the claim: “Pioglitazone sustains glycaemic control, but that’s not all – in an independent meta-analysis, it has also been shown to reduce ischaemic CV events in Type 2 diabetes”.
MSD alleged the claim promoted pioglitazone outside its marketing authorisation, was unbalanced/misleading/exaggerated, and was not substantiated.
The Panel considered the overall presentation (visual + continuous claim) would lead some readers to interpret pioglitazone as being used for glycaemic control and to reduce CV events, despite CV event reduction not being a licensed indication.
The ad described Lincoff et al (2007) as an “independent meta-analysis” even though Takeda provided funding and the database of eligible trials (as acknowledged in the paper).
Takeda appealed. The Appeal Board upheld some findings and overturned one (substantiation).

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Breach upheld: Clause 3.2 (promotion outwith the terms of the marketing authorisation).
Breach upheld: Clause 7.2 (misleading presentation/undue emphasis) – upheld on appeal, including the misleading use of “independent meta-analysis”.
No breach on appeal: Clause 7.4 (substantiation) – the Appeal Board ruled the particular CV event reduction claim was capable of substantiation by Lincoff et al.
The Appeal Board did not consider the circumstances warranted additional sanctions requested by the complainant.

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