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...
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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.
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