Requested (Jul 29, 2014) & Retracted by the author (Aug 23, 2014): “Conelly S, et al. Dabigatran versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med 2009; 361:1139-1151”] – Question Thread Open

http://figshare.com/articles/_NEJM_Boehringer_RE_LY_Pradaxa_dabigatran_3rd_request_of_retraction_AllTrials/1144305

Requested  Jul 29, 2014   amp; Retracted by the author  Aug 23, 2014    Conelly S, et al. Dabigatran versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med 2009; 361 1139-1151   - Question Thread Open (3)Requested  Jul 29, 2014   amp; Retracted by the author  Aug 23, 2014    Conelly S, et al. Dabigatran versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med 2009; 361 1139-1151   - Question Thread Open (2)Twitter___Recherche____boehringer__jorgehernnramre__4_ RE_LY.018 Twitter___Recherche____boehringeruk__jorgehernnramre__4_ Twitter___Recherche____boehringer__nejm  Any_reason_not_to_retract_this_paper__NEJM___RE_LY___Pradaxa___Dabigatran___Boehringer__1_ 1b.014 2b.012Randomized_Evaluation_of_Long_Term_Anticoagulant_Therapy__RE_LY__With_Dabigatran_Etexilate...

Description

August 19, 2014. 6:00AM (Bogotá time zone) 

Third request of retraction:
NEJM, Boehringer, Pradaxa, dabigatran, RE-LY study.
(1st URL attached below).

This Fileset will be continuosly updated

1- Old versions will be available in the history of this archive.

2- Changes will also be included below this comment.

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August 19, 2014. 7:20AM (Bogotá time zone)

Second URL attached below: 1st request of retraction

Third URL attached below: 2nd request of retraction

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August 19, 2014. 9:40AM (Bogotá time zone)

Key publications before Twitter discussion.

Cohen Deborah. Concerns over data in key dabigatran trial BMJ 2014; 349:g4747 [4th URL]

Cohen Deborah. Dabigatran: how the drug company withheld important analyses BMJ 2014; 349:g4670 [5th URL]

——————————————————————-

August 19, 2014. 10:30AM (Bogotá time zone)

Twitter messages —> Click to expand information

Dabigatran: how the drug company withheld important analyseshttp://t.co/Bzo2kH4LDQ

— The BMJ (@bmj_latest)28 Juillet 2014

 

@JorgeHernnRamre Hi, as per our Transparency policy and industry standards , you can request our data here http://t.co/SjjUm4cRgY

— Boehringer (@BoehringerUK)28 Juillet 2014

 

@BoehringerUK @JaneSymons1 @Dominic_Tyer @andrewspong@pharmagossip Angers (+/- 300.000 habitants) = 11 centerspic.twitter.com/2wkvI9crWL

— Jorge H. (@JorgeHernnRamre)28 Juillet 2014

 

@BoehringerUK @JaneSymons1 @Dominic_Tyer @andrewspong@pharmagossip Please forget my question… All the best wishes.http://t.co/2IjNNRmiqY

— Jorge H. (@JorgeHernnRamre)29 Juillet 2014


@deb_cohen
@pharmagossip @JaneSymons1 @Dominic_Tyer @BoehringerUK@andrewspong Déjà vu… http://t.co/J6rLCUnEwx pic.twitter.com/cDWFXy2Mhf

— Jorge H. (@JorgeHernnRamre)26 Juillet 2014

 

@JaneSymons1 @Dominic_Tyer @BoehringerUK @JorgeHernnRamre@andrewspong @DMAILhealth Conflicted? http://t.co/dRFfjdElUO

— pharmagossip (@pharmagossip)24 Juillet 2014

 

@BoehringerUK @bmj_latest “RE-LY was and remains one of the largest studies ever done” http://t.co/6aEaeP25Xu pic.twitter.com/cdbNt41rAN

— Jorge H. (@JorgeHernnRamre)30 Juillet 2014

Dabigatran (Pradaxa) unpublished studies: 81.4% (6th URL)

Ramirez, Jorge H (2014): Dabigatran (Pradexa) – List of published and unpublished ClinicalTrials.gov records (Search Date: July 24, 2014) completed before January 2012. figshare.
Retrieved 15:50, Aug 19, 2014 (GMT)

First request of retraction

@Boehringer @NEJM The RE-LY #pradaxa clinical trial (NCT00262600) is unreliable This is a request for retraction pic.twitter.com/soTHmqvFh2

— Jorge H. (@JorgeHernnRamre)29 Juillet 2014

Second request of retraction (3rd URL below)

Boehringer rapid response (7th URL below)

Closed: 11:10AM Bogotá time zone

____________________________________________

August 20, 2014. 4:00AM (Bogotá time zone)

Harry Magnani – Via ResearchGate (8th URL)

“No reason not to retract. I am surprised that in this day and age when all trials should be registered that results could be cherry-picked for the FDA! What the manufacturer did was fraudulent and unethical and it actually deserves being put on the FDA’s black-list because lives were put at risk by concealing vital information.

I was responsible within Organon BV for the clinical development of several antithrombotic drugs (Orgaran and Arixtra) and I can honestly state that all data pertinent to both efficacy and safety, including the effect of special situations e.g. renal dysfunction, were investigated and rationalised in the dosing recommendations. Furthermore, because the clinical indications for the drug occur mainly in elderly patients (both male and female) special care was taken to include as many of these as possible in the clinical development of the drug.

However I have also been on the receiving end of a company’s displeasure (Sanofi) when I refused to retract my opinion on Arixtra after the main DVT prophylaxis trials were completed: that it could cause thrombocytopenia and therefore potentially could cause HIT – which has been vindicated albeit in a very, very small percentage of cases (less than 1%). Companies should be reminded that drugs are developed first and foremost for patients and profit should be a secondary aim.

Please note that I perform independent consultacy work for Aspen Pharmacare in my retirement, I am not and never have been an employee of that company.” —-Harry Magnani

____________________________________________

August 20, 2014. 4:20AM (Bogotá time zone)


[“You could have had a much safer drug,” said Dr. Deborah Cohen, the investigations editor at The BMJ, who wrote two articles last month critical of Pradaxa’s record. By carefully monitoring drug levels in patients, “you could reduce major bleeds by 30 to 40 percent, compared to well-controlled warfarin,” she said.]

Weighing Pradaxa’s Risks
By RONI CARYN RABIN
—- 9th URL —-

Note:

I agree with D. Cohen. Two more points:

1) The majority of phase 1 trials in which bleeding clinical outcomes were measured remain unpublished.

2) Not all data from these trials is available in the web page Boehringer. Furthermore, most reports are summaries: no detailed information about dabigatran clinical trials (phase 1 to 3). These aspects have been already discussed & attached in the Twitter messages of this fileset.

____________________________________________

August 20, 2014. 4:35AM (Bogotá time zone)

Last question for Boehringer attached as a ResearchGate screencapture in this Fileset

Twitter message:

 

@deb_cohen @ChristosArgyrop @stephensenn @DavidJuurlink @BoehringerThank you @pash22 for sharing this document. I’ll read it throughly.

— Jorge H. (@JorgeHernnRamre)20 Août 2014

 

 

_____________________________________________

Links

Dear NEJM Editor,

About the last ResearchGate question by Stephen Senn:

(1) How I can ask for a retraction of this paper in the NEJM website? letters are only received during the first 3 weeks of publication.

(2) This discussion is about a drug associated serious safety concerns and evidence that data is being withheld by Boehringer to regulators and prescribers. Evidence definitively does not support Boehringer statements.

(3) This paper should have never been published by the NEJM.

(4) Why the NEJM wants to keep this paper unretracted?

(5) This is medicine, science, and open debate.

(6) I also have other concerns about dabigatran on the NEJM. For example,

http://www.nejm.org/doi/pdf/10.1056/NEJMp1302834 Any raw data available for this paper?

“In summary, although there are qualifications, we can rely on RE-LY.”
http://www.nejm.org/doi/full/10.1056/NEJMe0906886 

(7) Concerns about this trial are everywhere (not only the BMJ)
Dabigatran for atrial fibrillation: Why we can not rely on RE-LY

(8) This request of retraction disclosed raw data almost 1 month ago.

(9) RE-LY = Unreliable

(10) First request = July 29, 2014

(11) If the NEJM wants to keep this paper published: it is not my decision

(12) I’ll keep this fileset

Request of retraction —-> Retracted by myself — without the advice of anyone

Question thread remains open

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