Boehringer, Pradaxa & Manipulating The Public
September 21st, 2011 // 4:35 pm @ jmpickett
In its rush to promote its Pradaxa bloodthinner, Boehringer Ingelheim has brought shame on pharma. A doctor complained to an industry overseer that a series of newspaper articles that were published earlier this year referred to an unapproved indication, exaggerated claims and disparaged a rival medicine.
And so, after reviewing press releases and investigating the genesis of the articles, the Prescription Medicines Code of Practice Authority determined that the drugmaker breached no fewer than five clauses in the voluntary industry code of regulations governing good behavior. In doing so, Boehringer Ingelheim brought discredit on – and reduced confidence in – the pharmaceutical industry.
At issue was the concern that members of the public seeking a treatment for stroke prevention would be encouraged to seek prescriptions for a drug that had not been approved for that purpose. And the PMCPA found that Boehringer Ingelheim, seeking to boost Pradaxa, ignored certain basic procedures for composing press releases and training spokespeople who are encouraged to speak to the media.
This is not the first time, by the way, that Boehringer has been criticized for prematurely promoting a medication. Last year, the drugmaker provided grants to The Discovery Channel for a documentary about Hypoactive Sexual Desire Disorder, which is listed in the Diagnostic and Statistical Manual of Mental Disorders, just before seeking FDA approval for a pill to treat female sexual dysfunction. The approval never came and development was subsquently halted (see here and here).
Here’s the background on the latest episode: Pradaxa was approved for primary prevention of venous thromboembolic events in adults who had undergone elective total hip or knee replacement surgery. The drugmaker, meanwhile, had applied to the European Medicines Agency for approval to market the drug for preventing strokes and systemic embolism in atrial fibrillation, or afib.
Last April, a few newspaper articles suddenly appeared just after press releases were issued touting the results of a study comparing the effect of Pradaxa with warfarin in preventing strokes in people with atrial fibrillation (see here and here). Meanwhile, the drugmaker had retained two health professionals and two reps from patient groups to act as spokespeople.
However, one of the health professionals was quoted in the press release saying Pradaxa “could provide an invaluable option for patients suffering from all AF types.†And one newspaper article quoted one health professional saying that Pradaxa prevents “clots better than warfarin but with less bleeding which is pretty much the holy grail for such drugs.â€
Since at least one of the health professionals was briefed by Boehringer Ingelheim’s media agency and the drugmaker had made these folks available to the media, the PMCPA held Boehringer Ingelheim responsible for their comments and reminded the drugmaker that independent experts cannot be used to avoid restrictions on communicating unapproved indications to the public.
Apparently, a contract between the drugmaker and one of these spokespeople did refer to certain restrictions, but not the prohibition on promoting prescription-only meds to the public or 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 PMCPA found.
Since there was no information to suggest the drugmaker provided materials to its spokespeople or prompted them to disparage warfarin, the PMPCA decided there was no breach of the rules. However, the PMCPA did note that the press releases did sport an oversight – there was no mention of any adverse events, such as major hemorrhages, in the press release discussing the study.
The PMCPA panel was also concerned about the “very positive statements†in the ‘Notes to Editors’ section of one press release, which described Pradaxa as ‘leading the way in new oral anticoagulants/direct thrombin inhibitors…targeting a high unmet medical need’ and wondered whether this fairly reflected the known evidence.
And so, overall, the PMCPA expressed concern “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 considered that high standards had not been maintainedâ€
Source: Pharmalot
