The Boldt scandal still in need of action: the example of colloids 10 years after initial suspicion of fraud
Dr Boldt had a prolific publication record of randomized clinical trials when readers questioned the authenticity of a study comparing albumin and hydroxyethyl starch (HES) for cardiopulmonary bypass priming published in Anesthesia & Analgesia in December 2009 . For the investigator-initiated study it turned out that there was no institutional review board (IRB) approval, no written informed consent of patients, and patient or laboratory data were missing; effects of albumin in bypass priming were described, although the hospital had not been providing albumin solutions for cardiac surgery since 1999 . The data of this publication had been fabricated, and the notice of retraction was published in 2010 . In the subsequent investigation, the medical authority responsible for the City Hospital of Ludwigshafen, Germany was unable to verify IRB approvals for a total of 88 publications on single-center clinical studies performed at Dr Boldt’s new workplace in...
Compliance with ethical standards
Conflicts of interest
CJW has received lecture fees and/or travel cost reimbursements from the Plasma Protein Therapeutics Association, Kedrion, CSL Behring, Grifols and Baxter, and remuneration for consulting from CSL Behring, Grifols, and Daiichi Sankyo. MJ has received fees for lectures and/or consulting from Baxter, CSL Behring, Fresenius and Astute Medical, and research grand support from Fresenius.
- 2.Klinikum Ludwigshafen (2010) Untersuchungsbericht der Kommission für die Pressekonferenz am 29. November 2010. https://www.klilu.de/content/veranstaltungen___presse/pressearchiv/2010/untersuchungsbericht_der_kommission_fuer_die_pressekonferenz_am_29_november_2010/index_ger.html. Accessed 9 Jun 2018
- 4.Rasmussen LS, Yentis SM, Van Aken H et al (2011) Editors-in-chief statement regarding published clinical trials conducted without IRB approval by Joachim Boldt. Minerva Anesthesiol 77:562–563Google Scholar
- 6.Boldt J, Brosch Ch, Röhm K et al (2008) Is albumin administration in hypoalbuminemic elderly cardiac surgery patients of benefit with regard to inflammation, endothelial activation, and long-term kidney function? Anesth Analg 107:1496–1503. https://doi.org/10.1213/ane.0b013e31818370b2 CrossRefPubMedGoogle Scholar
- 7.Carlisle J, Pace N, Cracknell J et al (2013) What should the Cochrane Collaboration do about research that is, or might be, fraudulent? http://cochranelibrary-wiley.com/doi/10.1002/14651858.ED000060/full. Accessed 9 Jun 2018
- 11.Palus S (2015) Three more retractions for former record-holder Boldt, maybe more to come. http://retractionwatch.com/2015/08/13/three-more-retractions-for-former-record-holder-boldt-maybe-more-to-come/. Accessed 9 Jun 2018
- 12.Zarychanski R, Abou-Setta AM, Turgeon AF et al (2013) Association of hydroxyethyl starch administration with mortality and acute kidney injury in critically ill patients requiring volume resuscitation: a systematic review and meta-analysis. JAMA 309:678–688. https://doi.org/10.1001/jama.2013.430 CrossRefGoogle Scholar
- 13.Hackenbroch V (2011) Arzneimittel: Wissenschaftliches Vakuum. http://www.spiegel.de/spiegel/print/d-76121103.html. Accessed 9 Jun 2018