NEJM Boehringer RE-LY (#Pradaxa dabigatran) – 3rd request of retraction #AllTrials

https://twitter.com/JorgeHernnRamre/status/501686099886870529

Addendum: comments in the figshare fileset

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.

August 19, 2014. 7:20AM (Bogotá time zone)
Second URL attached below: 1st request of retraction

Third URL attached below: 2nd request of retraction

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 centers pic.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/J6rLCUnEwxpic.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Dabigatran (Pradaxa) unpublished studies: 81.4% (6th URL)
Ramirez, Jorge H (2014): Dabigatran (Pradexa) – List of published and unpublished ClinicalTrials.gov records (Search Date: July 24, 2014) completed before January 2012.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 @Boehringer Thank you @pash22 for sharing this document. I’ll read it throughly.
— Jorge H. (@JorgeHernnRamre)
20 Août 2014


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