MSD/Schering-Plough Ezetrol insert in The Pharmaceutical Journal: cholesterol target claim ruled misleading (Clauses 7.2, 7.4, 7.10)

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Key facts

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Case number	AUTH/2085/1/08 and AUTH/2086/1/08
Parties	Media/PMCPA Director v Merck Sharp & Dohme and Schering-Plough
Product	Ezetrol (ezetimibe)
Material	Four-page promotional insert distributed with The Pharmaceutical Journal, titled “NICE guidance on ezetimibe: A pharmacist’s perspective”
Main issue upheld	Claim that 35% of UK CHD patients were not reaching cholesterol targets “despite effective treatment therapies” was too general and misleading/exaggerated; not substantiated
Clauses breached	7.2, 7.4, 7.10
Clauses not breached (as considered)	No breach for omission of statin compliance discussion; no breach for omission of statement about lack of robust cardiovascular outcome data
Complaint received	25 January 2008
Completed	10 March 2008
Applicable Code year	2006
Appeal	No appeal
Sanctions	Undertaking received; additional sanctions not stated

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

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A pharmacist’s letter in The Pharmaceutical Journal criticised a four-page promotional insert for Ezetrol (ezetimibe), jointly sponsored by Merck Sharp & Dohme and Schering-Plough.
The insert, titled “NICE guidance on ezetimibe: A pharmacist’s perspective”, was written by a pharmacist from an NHS Trust and distributed with the journal; prescribing information appeared on the back page.
The complainant alleged: (1) the insert omitted discussion of patient compliance with statins; (2) it used older data to support a claim that “Thirty five percent of patients with coronary heart disease in the UK are not reaching current government cholesterol targets despite effective treatment therapies”; and (3) it failed to state ezetimibe had no robust cardiovascular outcome data (unlike some statins).
The matter was taken up by the PMCPA Director under the Code; the Authority asked the companies to respond under Clauses 7.2, 7.4 and 7.10.

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Breach found for the claim: “Thirty five percent of patients with coronary heart disease in the UK are not reaching current government cholesterol targets despite effective treatment therapies” (referenced to Brady et al 2005). The Panel ruled it too general, only applicable in limited circumstances, and therefore misleading, exaggerated and not substantiated.
No breach for omission of statin compliance discussion (Panel did not consider it misleading given the insert’s purpose and Ezetrol’s licensed indication).
No breach for omission of a statement that ezetimibe had no robust cardiovascular outcome data (Panel considered readers would understand the role of surrogate markers and that Ezetrol lowered total and LDL cholesterol).
No appeal.

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