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Letters Response

Novo Nordisk replies to BMJ investigation on incretins and pancreatic damage

BMJ 2013; 347 doi: https://doi.org/10.1136/bmj.f4386 (Published 10 July 2013) Cite this as: BMJ 2013;347:f4386

"Novo Nordisk replies to BMJ investigation on incretins and pancreatic damage" - Re: let's start this discussion again

Dear Editor,

1. I endorse the comments posted by Peter C Gøtzsche
http://www.bmj.com/content/347/bmj.f4386/rr/657934

Evidence does not support Novo Nordisk statements.

I would like to share with the BMJ Open Data Campaign this data about liraglutide and other incretins.(2, 3) I do not own this data because it was collected from public databases. In addition, this data complies with the terms and conditions of ClinicalTrials.gov and WHO ICTRP.

2. Novo Nordisk say, "Finally, regarding the allegation that drug companies withhold important data: Novo Nordisk strongly objects to the accusation that it withheld data and takes this matter extremely seriously. All available data held by Novo Nordisk on pancreatic effects of liraglutide have been shared with the regulatory agencies and are publicly available."

I also take it very seriously when evidence does not support statements about an active pharmacological principle, especially when there are serious concerns about the safety and effectiveness of a molecule. The source of the misleading information (e.g., pharmaceutical company, peer-review medical journal, governamental, academic institution, etc) doesn't matter.

3. I also endorse the analysis published by the BMJ Editor.(1)

I would like to quote the last paragraph in this response letter to Novo Nordisk:

"Science thrives on open challenge and objective debate. Patients will not receive safe and effective care in an environment characterised by commercial secrecy, bullying of academics and journal editors, or reliance on overstretched regulators."

4. figshare is for me a synonym of open data and transparency.(5) Question threads in both incretin articles are now open - references 2 and 3 cited in this letter -.

Yours sincerely,

Jorge R.

References

1. Godlee Fiona. Secrecy does not serve us well BMJ 2013; 346:f3819

2.Ramirez, Jorge H (2014): Unpublished and published liraglutide studies in humans. figshare.
http://dx.doi.org/10.6084/m9.figshare.1134664
Retrieved 08:09, Aug 22, 2014 (GMT)

3. Ramirez, Jorge H (2014): Incretin mimetics: analysis of unpublished studies. figshare.
http://dx.doi.org/10.6084/m9.figshare.1104132
Retrieved 08:27, Aug 22, 2014 (GMT)

4. Ramirez, Jorge H (2014): Request of retraction: "Conelly S, et al. Dabigatran versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med 2009; 361:1139-1151". figshare.
http://dx.doi.org/10.6084/m9.figshare.1144305
Retrieved 08:29, Aug 22, 2014 (GMT)

5. http://chaoticpharmacology.wordpress.com/2014/08/20/figshare-a-synonym-o...

Competing interests: I support open data and transparency in research: especially when there are serious concerns (e.g., pancreas cancer and pancreatitis) about the safety of active pharmacological principles in humans.

22 August 2014
Jorge H Ramirez
Professor of Pharmacology
Universidad del Valle
Cll 4B 36-00 Univalle sede San. Fdo. Edificio 116.