Boehringer Ingelheim has fallen foul of the ABPI Code of Practice on five counts in a row over an advertisement for its anti-stroke pill Pradaxa.
The breaches – adjudged by Code watchdog the PMCPA - all come under clause 7, which deals with information, claims and comparisons.
A GP complained that the advertising for Pradaxa (dabigatran) included a claim for therapeutic equivalence with enoxaparin (Sanofi-Aventis’ Lovenox) based on non-inferiority studies regarding the use of both after total hip or total knee replacement respectively.
The PMCPA pointed out that such studies show the difference between two medicines is not considered clinically important.
The thrust of the GP’s argument was that claiming equivalence was misleading, exaggerated the facts, could not be substantiated and endangered patients’ safety by suggesting Pradaxa was as safe as Lovenox.
While the PMCPA panel did not accept that the ad implied Pradaxa’s superiority it did find that the ad, containing an image of perfectly balanced scales, implied Pradaxa “had been shown to be unequivocally equivalent to enoxaparin and that was not so”.
Since that was misleading, it breached clauses 7.2 and 7.3. The claim could also not be substantiated (7.4) and did not reflect the available evidence about the safety of Pradaxa (7.9).
The ad also contravened clause 7.10, which says that a medicine must be presented “objectively and without exaggerating its properties”, and “all-embracing claims must not be made”.
The panel turned down complaints about doses not being stated on the ad although when the complainant appealed against this the PMCPA did reiterate it was “good practice” to include the relevant dosage particulars.
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