Boehringer Ingelheim: Micardis/Micardis Plus journal ad implied unproven 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 and hydrochlorothiazide)
Material/channel	Journal advertisement in Prescriber (19 February)
Key issue	Headline implied beneficial effects on long-term cardiovascular consequences (morbidity/mortality) inconsistent with SPC; claim found misleading, exaggerated and unsubstantiated
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 and 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 …” followed by “… but with hypertension, you do have the POWER to be prepared for it …”, alongside the Micardis and Micardis Plus logos.
The complainant alleged the claim was misleading and exaggerated and demonstrated an irresponsible approach to promotion of prescription-only medicines.
Micardis and Micardis Plus were indicated solely for the treatment of essential hypertension in adults.
The Authority asked Boehringer Ingelheim to respond in relation to Clauses 3.2, 7.2, 7.4 and 7.10 of the Code.
Boehringer Ingelheim argued the claim was clearly about hypertension control and did not claim reduction/avoidance of future events; it cited evidence of antihypertensive efficacy and referenced clinical guidelines about the goals of hypertension treatment.

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The Panel noted the SPCs stated that the effects of Micardis and Micardis Plus on mortality and cardiovascular morbidity were currently unknown.
The Panel considered the claim implied beneficial effects on long-term consequences of hypertension (cardiovascular morbidity and mortality) and that “You can’t know what will happen tomorrow …” implied an event other than continuing hypertension.
The Panel ruled the implication was misleading and inconsistent with the SPCs.
The Panel also ruled the claim was exaggerated and could not be substantiated; the submitted studies demonstrated antihypertensive efficacy but did not investigate any cardioprotective effect.

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