The Boldt scandal still in need of action: the example of colloids 10 years after initial suspicion of fraud
Year: 2018
Type: article
Abstract: 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 [ 1 ]. 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 [ 2 ]. The data of this publication had been fabricated, and the notice of retraction was published in 2010 [ 3 ]. 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 Ludwigshafen after he had left the University Hospital of Giessen in 1996 [ 2 ]. In March 2011, editors of 18 journals announced their intention to publish formal retraction notes to the 88 papers in each journal [ 4 ]. Additionally, two of the retracted publications were probably falsified as well since human albumin used in cardiac surgery patients reported here in fact was not available in the hospital for this indication [ 5 , 6 ]. With regard to studies published from 1984 to 1998, ethical issues and possible fraud by Dr Boldt remain unclear because IRB documentation was checked only for studies published from 1999 onwards.
Source: Intensive Care Medicine
Language: English
Subfield: Safety Research
Field: Social Sciences
Domain: Social Sciences
Open Access status: hybrid
Estimated APC paid: $5,190
OpenAlex ID: W2810913844