Boehringer’s Pradaxa advertising breaches Code
pharmafile | January 21, 2011 | News story | Medical Communications | ABPI, Bayer Schering Pharma, Boehringer Ingelheim, Code of Practice, PMCPA, Sanofi-Aventis
Boehringer Ingelheim has fallen foul of the ABPI Code of Practice on five counts in a row over an advertisement for its anti-blood clotting drug 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). This was based on non-inferiority studies regarding the use of both in the prevention of venous thromboembolism (VTE) 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.
Bayer Schering Pharma and Sanofi-Aventis escape censure
Meanwhile both Bayer Schering Pharma and Sanofi-Aventis escaped censure after separate allegations were laid against them.
An anonymous complaint said that, at a meeting on sexual health, two named Bayer Schering reps were poorly informed about contraception and generally unprofessional.
But the complainant, “a very disappointed nurse”, submitted no material to support this position and there was a question over the date and location of the meeting.
On the balance of probabilities, no breach was ruled by the PMCPA.
The Sanofi case related to a document called ‘Oncology Product Pipeline Update’ and a complaint that it had been used by company reps to discuss and promote unlicensed products.
However, it was marked for internal information only, so had been distributed in error, and the panel ruled the reps had not been instructed to promote medicines in it.
Thus Sanofi avoided a breach of clause 2 of the Code, which deals with bringing discredit to, and reducing confidence in, the pharma industry.
But in conclusion, the panel said it was “extremely concerned” about the content of the document.
Adam Hill
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