Regarding the Effect of Dabigatran Plasma Concentrations

Accepted Manuscript

Letter to the Editor: Regarding "The Effect of Dabigatran Plasma Concentrations..." byReilly PA et al1

Rama B. Rao, M.D., FACMT

PII: S0735-1097(14)02204-9

DOI: 10.1016/j.jacc.2014.02.610

Reference: JAC 20088

To appear in: Journal of the American College of Cardiology

Received Date: 13 February 2014

Accepted Date: 18 February 2014

Please cite this article as: Rao RB, Letter to the Editor: Regarding "The Effect of Dabigatran PlasmaConcentrations..." by Reilly PA et al1, Journal of the American College of Cardiology (2014), doi:10.1016/j.jacc.2014.02.610.

This is a PDF file of an unedited manuscript that has been accepted for publication. As a service toour customers we are providing this early version of the manuscript. The manuscript will undergocopyediting, typesetting, and review of the resulting proof before it is published in its final form. Pleasenote that during the production process errors may be discovered which could affect the content, and alllegal disclaimers that apply to the journal pertain.

http://dx.doi.org/10.1016/j.jacc.2014.02.610

MANUSCRIP

T

ACCEPTED

ACCEPTED MANUSCRIPT

1

Letter to the Editor: Regarding "The Effect of Dabigatran Plasma Concentrations..." by Reilly

PA et al1

Rama B. Rao, M.D., FACMT

Emergency Medicine

Director Medical Toxicology

New York Presbyterian Hospital

Weill Cornell Medical College

525 East 68th Street

Box 573

New York, NY 10065

United States

9173197750

2127464883 (fax)

[email protected]

No conflicts to declare.

MANUSCRIP

T

ACCEPTED

ACCEPTED MANUSCRIPT

2

To The Editor:

Regarding “The Effect of Dabigatran Plasma Concentrations…” by Reilly PA et al1,

Recently unsealed court documents reveal internal pharmaceutical correspondence that

suppressed important data regarding dabigatran therapy for patients with atrial fibrillation.2,3

The original manuscript suggests that up to 20% of patients using the 110mg and 150 mg BID

dosing will fall outside of the optimal concentration range of 35 to 300 ng/mL. Corporate emails

suggests that the range may be narrower.3 These data were removed from the final manuscript to

avoid losing the marketing advantage of being a monitor-free anticoagulant. 4,5

Given that up to 20 % of patients will fall out of range and be at risk for irreversible major

bleeding or inadequate anticoagulation, one wonders how such an omission can be justified.

Pharmaceutical companies that put profit over patients damage their scientific credibility.

Perhaps pulling dabigatran from hospital formularies will send a message that clinicians will not

be complicit in undermining the public trust.

MANUSCRIP

T

ACCEPTED

ACCEPTED MANUSCRIPT

3

References

1. Reilly PA, et al. The effect of dabigatran plasma concentrations and patient characteristics on

the frequency of ischemic stroke and major bleeding in atrial fibrillation patients. J American

Coll Cardiol 2014;63:321-328

2. Unsealed Court Documents in Pradaxa Case. Court Case 3:12-md-02385-DRH-SCW

Document 349-6. Filed 12.26.13. Page ID 7684-7715: Draft of Pradaxa Research Paper.

Accessed in In New York Times, Business Section February 5, 2014

http://www.nytimes.com/interactive/2014/02/05/business/pradaxa-doc-

viewer.html?&action=click&contentCollection=Business%20Day&module=RelatedCoverage&r

egion=Marginalia&pgtype=article. Accessed 13 Feb 2014.


Document350-13 Filed 12.26.13 Page ID 7848. In New York Times, Business Section February

5, 2014 http://www.nytimes.com/interactive/2014/02/05/business/pradaxa-doc-




Document 408-4 Filed 2.6.2014 Page ID 10297. In New York Times, Business Section February

5, 2014 http://www.nytimes.com/interactive/2014/02/05/business/pradaxa-doc-



5. Thomas K. New emails in Pradaxa® case show concern over profit. New York Times

February 7, 2014. http://www.nytimes.com/2014/02/08/business/new-emails-in-pradaxa-case-

show-concern-over-profit.html Accessed on 13 Feb 2014.