FDA Research Misconduct — Part II. Further Comments About Dabigatran (Pradaxa)

JAMA Internal Medicine

Seife C. Research Misconduct Identified by the US Food and Drug Administration: Out of Sight, Out of Mind, Out of the Peer-Reviewed Literature. JAMA Intern Med. Published online February 09, 2015. doi:10.1001/jamainternmed.2014.7774.

Retraction Watch

“FDA has repeatedly hidden evidence of scientific fraud,” says author of new study
Author: Cat Ferguson. February 9th, 2015


Note:

This publication reminds me the RE-LY trial “Randomized Evaluation of Long Term Anticoagulant Therapy With Dabigatran Etexilate.”

Response to:
Cohen Deborah. Concerns over data in key dabigatran trial. URL: http://www.bmj.com/content/349/bmj.g4747/rr/778288
October 17, 2014.

No further comments.


Part II. Further comments.

Probability of Stroke Within 1 year: FDA review (2010) vs. J Am Coll Cardiol (2014)

ac.els-cdn.com S0735109713053850 1-s2.0-S0735109713053850-main.pdf _tid=61a9531e-b13c-11e4-bbe5-00000aacb360 acdnat=1423583542_306ce9f04fb92fc2beb3bae600f23ea8 FDA - Dabigatran -  Meeting of the Cardiovascular and Renal Drugs Advisory Committee

  4 comments for “FDA Research Misconduct — Part II. Further Comments About Dabigatran (Pradaxa)

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