AUTH/2071/11/07: GP v Takeda – Competact/Actos leavepiece and mixed use of relative vs absolute risk

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Key facts

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Case number	AUTH/2071/11/07
Case reference	AC070946 (leavepiece reference)
Complainant	General practitioner
Respondent/company	Takeda UK Limited
Product(s)	Competact (pioglitazone and metformin); Actos (pioglitazone)
Material/channel	Promotional leavepiece (one sheet of A4)
Key issue	Misleading presentation by mixing relative risk reduction for benefits with absolute risk figures for harms, without clear context/clarity
Dates (received/completed if stated)	Complaint received 29 November 2007; Case completed 3 April 2008
Appeal	Yes – appealed by Takeda; unsuccessful (Appeal Board upheld breach)
Code year	Not stated
Breaches/clauses	Clause 7.2
Sanctions	No explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

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

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A general practitioner complained about a Takeda UK Limited promotional leavepiece (ref AC070946) for Competact (pioglitazone and metformin) and Actos (pioglitazone).
The complaint alleged that data from Lincoff et al (2007) (a meta-analysis on pioglitazone and ischaemic cardiovascular events) was presented in a misleading way.
The leavepiece included the claim: “18% relative risk reduction seen with pioglitazone treatment in the composite primary outcome of mortality, MI or stroke compared to the control group”.
The leavepiece also stated: “The meta-analysis showed an increase in serious heart failure with pioglitazone (2.3% vs 1.8%), but there was no corresponding increase in mortality”.
The complainant’s concern was that advantages were expressed as relative risk reduction while disadvantages were expressed as absolute risk figures, making the overall impression misleading.
Takeda said the leavepiece was produced in response to enquiries following media coverage on glitazones and cardiovascular risk, and aimed to share information from Lincoff et al (2007).

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The Panel ruled that presenting one outcome as relative risk reduction and another (serious heart failure) only as absolute risk was misleading, and it was not made clear that the serious heart failure data were absolute risk figures.
A breach of Clause 7.2 was ruled.
Takeda appealed.
The Appeal Board upheld the Panel’s ruling, finding it misleading to refer only to relative risk reduction without also providing the absolute risks needed to judge clinical impact (including that the absolute reduction for the composite endpoint was 1.3%).
The appeal was unsuccessful.

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