Pradaxa and Xarelto: A Case Study in Evidence Based Medicine

A discussion of the controversies surrounding the RE-LY and ROCKET-AF trials, which led to the initial FDA approvals of dabigatran (Pradaxa) and rivaroxaban (Xarelto) respectively.

Please note that in the years since this video was posted, additional studies have been published which support the use of these drugs. I leave the video up because the issues discussed are still relevant. However, if you are a layperson, please do NOT stop taking your Xarelto or Pradaxa just because you watched this video. Instead, discuss your concerns with your physician. There are more than one alternative anticoagulant out there.

I declare that I have no conflicts of interest, and receive no compensation from the pharmaceutical or device industries.

Original RE-LY Trial: http://www.ncbi.nlm.nih.gov/pubmed/19717844

Original ROCKET-AF Trial: http://www.ncbi.nlm.nih.gov/pubmed/21830957

BMJ Criticisms of Dabigatran RE-LY:
http://www.ncbi.nlm.nih.gov/pubmed/25056265
http://www.ncbi.nlm.nih.gov/pubmed/25055831
http://www.ncbi.nlm.nih.gov/pubmed/25055829

BMJ Criticism of ROCKET-AF and Rivaroxaban:
http://www.ncbi.nlm.nih.gov/pubmed/26843102
Recent media coverage of dabigatran and RE-LY:
https://www.washingtonpost.com/news/federal-eye/wp/2015/10/15/fda-was-lax-and-kowtowed-to-drugmaker-in-review-of-controversial-blood-thinner-watchdog-says/
http://www.nytimes.com/2014/02/08/business/new-emails-in-pradaxa-case-show-concern-over-profit.html
http://www.nytimes.com/2014/02/06/business/study-of-blood-clot-drug-pradaxa-unnerved-its-maker-documents-suggest.html

Recent media coverage of rivaroxaban and ROCKET-AF:
http://www.nytimes.com/2016/02/23/business/fda-asks-if-faulty-blood-monitor-tainted-xarelto-approval.html?_r=0
http://www.cbsnews.com/news/did-heart-drug-makers-withhold-data-from-medical-journal/

Видео Pradaxa and Xarelto: A Case Study in Evidence Based Medicine канала Strong Medicine