AUTH/2011/6/07: Anonymous PCT Chief Pharmacist v Takeda (Actos/Competact ‘Dear Healthcare Professional’ letter) – No breach | PMCPA Case

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Key facts

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Case number	AUTH/2011/6/07
Complainant	Anonymous PCT Chief Pharmacist
Company	Takeda UK Limited
Product(s)	Actos (pioglitazone); Competact (pioglitazone/metformin)
Material	Promotional ‘Dear Healthcare Professional’ letter (ref AC070548)
Main issue	Alleged misleading presentation of PROactive study cardiovascular outcomes (primary vs secondary endpoints), safety (heart failure data), and background therapy optimisation/statin subgroup interpretation
Applicable Code year	2006
Clauses considered	7.2, 7.4, 9.1 and 9.2
Decision	No breach
Complaint received	15 June 2007
Case completed	8 August 2007
Appeal	No appeal
Publication	November 2007 Code of Practice Review

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

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A chief pharmacist to a primary care trust complained about a promotional ‘Dear Healthcare Professional’ letter sent by Takeda UK Limited (ref AC070548).
The letter was headed with Competact (pioglitazone/metformin) and Actos (pioglitazone) logos and titled: ‘Pioglitazone – An oral anti-hyperglycaemic agent: Summary of beneficial effects on cardiovascular risk and cardiovascular outcomes in Type 2 diabetes’.
The letter summarised results from the PROactive study (Dormandy et al 2005).
Allegations included: (1) inappropriate linking of PROactive results to cardiovascular benefits because the primary endpoint did not reach statistical significance; (2) misleading safety presentation by allegedly using a re-analysis rather than originally published adverse event results (heart failure, hospitalisation, death); (3) patients’ cardiovascular medicines were not optimised (only ~40% on statins) and Actos allegedly showed no advantage in statin users.
The Authority asked Takeda to respond to Clauses 7.2, 7.4, 9.1 and 9.2 of the Code.

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No breach of the Code was ruled.
No breach of Clause 7.2 (misleading claims) in relation to use of secondary endpoints when the primary endpoint showed a trend and was clearly caveated.
No breach of Clauses 7.2 and 7.4 regarding the heart failure statement; the Panel considered it could be substantiated and was not misleading.
No breach of Clause 7.2 regarding optimisation of background therapy/statin use and subgroup assertions.
No breach of Clauses 2 or 9.1 (as considered by the Panel).

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