Boehringer censured over Pradaxa marketing
pharmafile | September 23, 2011 | News story | Medical Communications | ABPI Code of Practice, Boehringer
Boehringer Ingelheim has been heavily censured by the body which enforces the ABPI’s Code of Practice for the content of a press release and material for spokespeople on its oral anticoagulant Pradaxa.
Chief among a host of breaches, the PMCPA panel ruled Boehringer guilty of breaking clause 2 of the Code – the most serious offence, used only for a firm which has brought “discredit upon, and reduced confidence in, the industry”.
A GP complained after seeing articles in the Daily Mail, Telegraph and Express on 5 April 2011, referring to the use of Pradaxa (dabigatran) to prevent stroke: the drug is not licensed for this, although an application had been made to the European Medicines Agency to extend the licence.
Pradaxa is in fact indicated for the primary prevention of venous thromboembolic events in adults who have had hip or knee replacements.
Therefore two breaches of the Code were ruled: for promoting a prescription only medicine to the public for an unlicensed indication, which was inconsistent with the terms of its marketing authorisation.
While clearing the company of describing Pradaxa as a ‘super pill’ or ‘revolutionary drug’ – which press reports did – or disparaging current option warfarin as a ‘rat poison’, the PMCPA was very concerned about many other elements of the release which had formed the basis for the press reports.
In particular, the panel questioned whether describing Pradaxa as “leading the way in new oral anticoagulants/direct thrombin inhibitors … targeting a high unmet medical need” was a fair reflection of the evidence.
A breach of the Code was also ruled for a lack of information in a consumer press release relating to potnetial side effects, such as major haemorrhage, or any other adverse event.
The PMCPA also found that a contract between Boehringer and one health professional spokesperson whose comments were used by the media did not refer either to the ban on promoting prescription only medicines to the public or the Code requirements on information directed at the public.
This was a “significant omission” since the release was aimed at the consumer press. The spokesperson briefed by Boehringer’s media agency was quoted in the Telegraph describing Pradaxa as preventing “clots better than warfarin but with less bleeding which is pretty much the holy grail for such drugs”.
The panel believed that Boehringer was guilty in effect of encouraging people to ask their doctor to prescribe a specific prescription only medicine.
Adam Hill
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