We’ve been desperate for a more elegant solution to anticoagulation than rat poison for seemingly an eternity. Now, we have them: direct thrombin and factor Xa inhibitors. The studies supporting their use seem favorable.
But, as the old story goes – and as previously reported on this blog many times – Boehringer Ingelheim has been selectively reporting only the most favorable aspects of their flagship drug, dabigatran. Increased cardiovascular events have been downplayed through study design not powered to detect a difference. Issues with fixed dose therapy – and lack of a range of options for patients with renal impairment – rear their ugly head in multiple case reports.
Then, the most damning – the recent legal action reveals Boehringer Ingelheim, after selling dabigatran as not requiring monitoring nor having a reliable assay to monitor its effects, was hiding information on both counts. There is, in fact, substantial individual-patient variability in dabigatran efficacy and bleeding risk, and the HEMOCLOT test is, in fact, a reliable method of measuring activity. Review of internal documents shows employees were aware many patients might benefit from routine monitoring of levels – but this would eliminate one of its selling points (and cost savings) over warfarin. These e-mails also specifically address the potential damaging effect on sales if said information were released in the scientific literature.
Clearly, yet another case where first-mover status into a lucrative market trumped patient-safety concerns. If you wonder where the rampant skepticism regarding conflict-of-interest comes from on this blog – this is a beautifully flagrant example.
“Dabigatran: how the drug company withheld important analyses”
http://www.bmj.com/content/349/bmj.g4670 (free fulltext)
Previous EM Lit of Note Posts:
“Rivaroxaban Can Be Reversed, But Not Dabigatran” – Sept 2011
“Scattering Tacks In The Road” – Jan 2012
“Dabigatran — Uncharted Waters and Potential Harms” (Annals of Internal Medicine) – May 2012
“Dabigatran – It’s Everywhere!” – Sept 2012
“Not-So Routine Surgery on Dabigatran” – Sept 2012
“Dabigatran: Hidden Danger in the Home” – Nov 2012
“Dabigatran & CES1 SNP rs2244613” – Mar 2013