Boehringer in hot water over Pradaxa risks
pharmafile | February 19, 2014 | News story | Sales and Marketing | Boehringer, Pradaxa, Xarelto, dabigatran, lawsuit
Boehringer Ingelheim attempted to delay and revise the publication of important drug information surrounding its new anticoagulant Pradaxa.
This is according to internal company documents released this week by a US court.
The study they wanted to delay showed that its big-selling anticoagulant Pradaxa (dabigatran etexilate) may require closer monitoring by medical staff as more patients were having bleeds than would be expected.
A key aspect of the drug’s appeal is supposed to be that it does not require such monitoring and therefore is easier for patients to take – any data suggesting otherwise could dampen the drug’s revenue stream.
This is important information for doctors to know as patients could be at risk of haemorrhaging, but Boehringer did not release it right away.
In an email published by the court one anonymous employee complained that the paper would harm the company’s marketing efforts and make discussions with regulatory agencies more difficult, and asked if its publication could be avoided.
Andreas Clemens, a medical team leader for the drug, wrote that he believed the findings were important and should be published – but with revision. “The world is crying for this information, but the tricky part is that we have to tailor the messages smart.”
In another email Clemens expressed concern that the paper ‘could be a liability issue’ for the company.
Lawsuits
The drug is seen as the next generation treatment to follow warfarin, as it does not require the same level of dosing adjustments as the 50-year-old pill, the medicine it is looking to replace.
But there have now been hundreds of adverse events involving haemorrhages reported since its launch in 2012, with more than 2,000 US lawsuits currently in place against Pradaxa.
It was in connection to one of these class action lawsuits that chief judge David Herndon of the US District Court in East St Louis, Illinois, ordered the release of the Boehringer’s documents.
Another research manuscript concluded: “While a fixed dose of dabigatran has significant advantages in both safety and efficacy compared to warfarin, adjusting the dose at steady-state to attain an optimal plasma concentration range may further improve the benefit-risk ratio.”
This suggestion that monitoring the drug’s plasma concentration might be of benefit undercut an essential element of Boehringer’s marketing point that monitoring was unnecessary, wrote Jutta Heinrich-Nols, an international project manager for the company.
She added in an email that it would ‘undermine our efforts to compete’ with other new oral anticoagulants fighting for market share, which include Pfizer’s Eliquis and Janssen/Bayer’s Xarelto.
Heinrich-Nols wrote she ‘cannot believe’ that the company would release the paper after spending a decade developing a drug with the “clearly defined target of no monitoring needs,” before added that: “This will make any defense [sic] of no monitoring to HA [health authorities] extremely difficult . . . and undermine our efforts to compete with other NOACs [novel oral anticoagulants].”
She concluded: “As I am not empowered to release or stop any publications I would like to ask you to check once again whether this is really wanted.”
The revised paper was published online late last year in the Journal of the American College of Cardiology. It reports that safety and efficacy outcomes were correlated with plasma concentrations, with the patient’s age being the most important covariate.
Ben Adams
Related Content
GSK settles first Zantac lawsuit due for trial in US
UK-based pharmaceutical and biotechnology company GSK has reached a settlement with a US man who …
Lilly and Boehringer’s Jardiance reduces hospitalisation and CV death risk from heart failure at Phase 3
Boehringer Ingelheim and Eli Lilly have announced strong Phase 3 news on their sodium-glucose co-transporter-2 …
Boehringer withdraws its £700m investment in Hikma Pharmaceuticals
Boehringer has revealed that it intends to withdraw its investment from Hikma Pharmaceuticals, with the …
