A GP complained that a number of articles about Boehringer Ingelheim’s product Pradaxa (dabigatran) which appeared in the Daily Mail, The Telegraph and the Express on 5 April 2011, referred to the use of the medicine to prevent stroke, an unlicensed indication.
Pradaxa was indicated for the primary prevention of venous thromboembolic events in adults who had undergone elective total hip or knee replacement surgery. Boehringer Ingelheim had made an application to the European Medicines Agency (EMA) to extend the licence to prevention of stroke and systemic embolism in atrial fibrillation.
The complainant was concerned that the articles contained exaggerated claims about Pradaxa which had arisen from misleading press releases issued by Boehringer Ingelheim. The coverage contained quotations from UK experts and patient group representatives and it was likely that Boehringer Ingelheim had facilitated access to these individuals and approved this unlicensed promotion of Pradaxa within the UK.
The claims for stroke prevention were based on a retrospective subanalysis of the Randomized Evaluation of Long-Term Anti-coagulant Therapy (RE-LY) study (Connolly et al 2009), which compared the effect of Pradaxa with warfarin in preventing strokes in people with atrial fibrillation. The complainant noted that this promotion took place after an application was made to the EMA to extend the licence of Pradaxa for the prevention of thromboembolism and stroke in people with atrial fibrillation and the recent approval by the Food and Drug Administration (FDA) for the same.
The complainant also alleged that the press articles disparaged warfarin, a current option, referring to it as a rat poison. The complainant noted that packs of Pradaxa were also pictured.
The complainant alleged that the promotion to the public of an unlicensed indication was irresponsible and would encourage the public to seek the prescription of Pradaxa for this purpose.
The detailed response from Boehringer Ingelheim is given below.
The Panel noted that the Code prohibited the advertising of prescription only medicines to the public. However, the Code permitted information about prescription only medicines to be supplied directly or indirectly to the public but such information had to be factual and presented in a balanced way. It must not raise unfounded hopes of successful treatment or be misleading with respect to the safety of the product. Statements must not be made for the purpose of encouraging members of the public to ask their health professional to prescribe a specific prescription only medicine. Complaints about articles in the press were judged on the information provided by the pharmaceutical company or its agent to the journalist and not on the content of the article itself.
The Panel noted that Boehringer Ingelheim had engaged as spokespeople two health professionals and two patient organisation representatives. At least one of the health professionals was briefed by Boehringer Ingelheim’s media agency, and the company had facilitated the availability of the spokespersons for interviews. The Panel considered that Boehringer Ingelheim was responsible under the Code for comments made by these spokespersons. Companies could not use independent experts as a means of avoiding the restrictions in the Code. The Panel noted that the contract between Boehringer Ingelheim and one health professional spokesperson referred to some of the requirements of the Code, but did not refer either to the prohibition on the promotion of prescription only medicines to the public or the Code requirements on the content of information directed at the public. The Panel considered that this was a significant omission particularly as the press release was aimed at the consumer press.
The Panel noted that the health professional spokesperson briefed by Boehringer Ingelheim’s media agency was quoted in the press release issued by Boehringer Ingelheim to the consumer press and that some of the press articles included further quotes from him and other spokespersons. The Panel was concerned that this health professional spokesperson was quoted in The Telegraph article describing Pradaxa as preventing ‘clots better than warfarin but with less bleeding which is pretty much the holy grail for such drugs’.
The Panel noted that the press release discussed the comparative data in relation to stroke prevention from Flaker et al (2011) a sub-group analysis of the RE-LY study, Connelly et al (2009) the RE-LY study and Connelly et al (2010a) newly identified events in the RE-LY study. The press release included quotations from the same health professional which described Pradaxa as an ‘invaluable option’ for patients. The press release did not include the pack shot.
The press release stated that, compared to well-controlled warfarin, 150mg dabigatran twice daily showed a 39% reduction in the risk of stroke in patients with paroxysmal atrial fibrillation, 36% reduction in the risk of stroke in patients with persistent atrial fibrillation and a 30% reduction in the risk of stroke in patients with permanent atrial fibrillation. There was no mention of major haemorrhage or any other adverse event in the press release. The Panel noted that Pradaxa was not authorized for use in atrial fibrillation. The Panel questioned whether in the absence of information in the consumer press release about side effects the press release was balanced.
The Panel noted that the press release mentioned warfarin solely in relation to its use as a comparator in Flaker et al and the RE-LY studies. It did not refer to warfarin as rat poison and otherwise made no disparaging remarks about the medicine. The Panel had no evidence about how warfarin had been described by Boehringer Ingelheim’s spokespersons or at any press conference. No breach of the Code was ruled in that regard.
The Panel was concerned about the very positive statements in the ‘Notes to Editors’ section of the press release which described Pradaxa as ‘leading the way in new oral anticoagulants/direct thrombin inhibitors …targeting a high unmet medical need’ and queried whether this was a fair reflection of the evidence. The press release did not refer to Pradaxa as a ‘super pill’ or as a ‘revolutionary drug’. These phrases only appeared in the press articles.
Overall the Panel was very concerned about the content of the press release and the briefing material for spokespersons. The Panel considered that these would in effect encourage members of the public to ask their health professional to prescribe a specific prescription only medicine. The Panel was concerned about the lack of information in a consumer press release relating to side effects. A breach of the Code was ruled. The press release advertised a prescription only medicine to the public for an unlicensed indication. The Panel ruled a breach of the Code in that regard. The Panel considered that promotion of Pradaxa for an unlicensed indication was inconsistent with the terms of its marketing authorization. A further breach of the Code was ruled.
The Panel considered that high standards had not been maintained and ruled a breach of the Code. The material promoted a prescription only medicine to the public in an indication that was not yet licensed. The Panel noted that promotion prior to the grant of a marketing authorization was listed as an example of an activity that was likely to be in breach of Clause 2. Overall the Panel considered that the press release and the material for spokespersons brought discredit upon, and reduced confidence in, the industry. A breach of Clause 2 was ruled.
Friday, September 23, 2011
Tales From the PMPCA contd. - The Case of the Disparaged Rat Poison