August 19, 2014. 6:00AM (Bogotá time zone)
Third request of retraction:
NEJM, Boehringer, Pradaxa, dabigatran, RE-LY study.
(1st URL attached below).
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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
— Boehringer (@BoehringerUK)28 Juillet 2014
— Jorge H. (@JorgeHernnRamre)28 Juillet 2014
— Jorge H. (@JorgeHernnRamre)29 Juillet 2014
— Jorge H. (@JorgeHernnRamre)26 Juillet 2014
— pharmagossip (@pharmagossip)24 Juillet 2014
— 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Dabigatran (Pradaxa) unpublished studies: 81.4% (6th URL)
Ramirez, Jorge H (2014): Dabigatran (Pradexa) – List of published and unpublished ClinicalTrials.gov records (Search Date: July 24, 2014) completed before January 2012.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
— 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 —-
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
— Jorge H. (@JorgeHernnRamre)20 Août 2014
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.”
(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