MSD breach of undertaking after withdrawn Cozaar banner reappeared in MIMS update (AUTH/2261/9/09)

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Key facts

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Case number	AUTH/2261/9/09
Company	Merck Sharp & Dohme
Product	Cozaar (losartan)
Material type	Electronic banner advertisement in MIMS Monthly Update
Issue	Previously withdrawn/similar claim reappeared after an undertaking; publisher used an employee’s locally saved copy in error
Claim at issue	“Evidence from a new independent review by the Cochrane collaboration suggests that there are no clinically meaningful BP lowering differences between available AIIAs”
Complaint received	04 September 2009
Case completed	07 October 2009
Applicable Code year	2008
Breach clauses	Clause 25
No breach clauses considered	Clauses 2 and 9.1
Sanctions applied	Undertaking received
Appeal	No appeal

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

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Merck Sharp & Dohme (MSD) had previously given an undertaking in Case AUTH/2212/3/09 after a Cozaar (losartan) claim was ruled misleading.
MSD instructed the publisher of MIMS Monthly Update to withdraw and delete the Cozaar digital banner and received confirmation (11 June 2009) that copies were deleted from servers.
Despite this, an electronic banner advertisement for Cozaar appeared in MIMS Monthly Update issued/emailed on 1 September 2009 and was understood to have been circulated to several thousand health professionals.
The banner included the claim: “Evidence from a new independent review by the Cochrane collaboration suggests that there are no clinically meaningful BP lowering differences between available AIIAs”.
MSD identified the issue on 3 September 2009, investigated, and found the publisher had mistakenly used a locally saved copy retained by an employee.
MSD informed the PMCPA Director and made a written voluntary admission; MSD also informed Takeda (the complainant in the earlier case).

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Breach ruled: Clause 25 (breach of undertaking).
No breach ruled: Clauses 2 and 9.1 (Panel did not consider MSD failed to maintain high standards or brought discredit/reduced confidence in the industry in the circumstances).
The Panel accepted MSD had taken all possible steps to comply and had been “very badly let down” by the publisher, but still had “no option” other than to rule a breach because the undertaking was not complied with.

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