Micardis/Micardis Plus journal advertisement: implied long-term cardiovascular benefit

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Key facts

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Case number	AUTH/2211/3/09
Case reference	Micardis and Micardis Plus journal advertisement (ref MIC2508d)
Complainant	A general practitioner
Respondent/company	Boehringer Ingelheim Limited
Product(s)	Micardis (telmisartan); Micardis Plus (telmisartan/hydrochlorothiazide)
Material/channel	Journal advertisement in Prescriber (19 February)
Key issue	Headline implied unproven long-term cardiovascular morbidity/mortality benefit; misleading, exaggerated and unsubstantiated versus SPCs
Dates (received/completed if stated)	Complaint received 2 March 2009; Case completed 30 March 2009
Appeal	Not stated
Code year	Not stated
Breaches/clauses	Clauses 3.2, 7.2, 7.4, 7.10
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 journal advertisement for Micardis (telmisartan) and Micardis Plus (telmisartan/hydrochlorothiazide) issued by Boehringer Ingelheim Limited, appearing in Prescriber (19 February) (ref MIC2508d).
The ad showed a man rowing a canoe-like boat on a rough sea and used the headline: “You can’t know what will happen tomorrow … … but with hypertension, you do have the POWER to be prepared for it …” alongside the product logos.
The complainant alleged the claim was misleading and exaggerated and demonstrated an irresponsible approach to promoting prescription-only medicines.
Micardis and Micardis Plus were indicated solely for the treatment of essential hypertension in adults.
The Authority asked the company to respond in relation to Clauses 3.2, 7.2, 7.4 and 7.10.
Boehringer Ingelheim argued the claim related to treating hypertension effectively now and in the future (24-hour blood pressure control), did not mention future events, and was substantiated by evidence of antihypertensive efficacy and by guideline context about reducing cardiovascular morbidity and mortality as a goal of hypertension management.

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The Panel ruled the claim implied Micardis and Micardis Plus had beneficial effects on long-term consequences of hypertension (cardiovascular morbidity and mortality).
The Panel noted the SPCs stated the effects of the medicines on mortality and cardiovascular morbidity were currently unknown.
The Panel found the implication misleading and inconsistent with the SPCs.
The Panel found the claim exaggerated and not substantiated by the data provided (which demonstrated antihypertensive efficacy but did not investigate cardioprotective effects).
Breaches were ruled under Clauses 3.2, 7.2, 7.4 and 7.10.

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