The journal Anesthesia & Analgesia, which calls itself “The Gold Standard in Anesthesiology,” has retracted a paper on cardiopulmonary bypass priming and has raised questions about 200 additional published papers by the author, Joachim Boldt, the head of the Department of Anesthesiology and Intensive Care Medicine, Klinikum Ludwigshafen, Bremserstr, Germany. A detailed report about the retraction was first reported by Adam Marcus and Ivan Oransky on Retraction Watch, a blog that covers scientific misconduct by tracking retractions of scientific papers.
The Editor-in-Chief of Anesthesia & Analgesia, Steven Shafer, a professor of anesthesiology at Columbia University, outlined the episode in a letter to readers published on the journal website. The paper in question, “Cardiopulmonary Bypass Priming Using a High Dose of a Balanced Hydroxyethyl Starch Versus an Albumin-Based Priming Strategy” by Joachim Boldt, Stephan Suttner, Christian Brosch, Andreas Lehmann, Kerstin Röhm, and Andinet Mengistu, was published in December 2009. In his letter Shafer recounts what happened next:
Shortly following publication the Journal received several letters from concerned readers that the variability in the cytokine assay was too low to be believed. Upon reviewing the results, we concurred with that assessment. We also believed that the variability in blood gas results reported in the paper was too low to be believable.
The editors then contacted the Landesärztekammer Rheinland-Pfalz (“LÄK”), the Rheinland State Medical Board, which was responsible for oversight of research performed at Boldt’s institution .
LÄK determined that there was no IRB approval, no informed consent, no randomization process, and no follow-up questionnaire as described in the study. These are very serious misrepresentations in Professor Boldt’s manuscript. As a result, the entire manuscript is compromised, and is hereby retracted.
Fabrication is easy to disprove by providing original research data (e.g., patient medical records, laboratory records, disk files from research equipment) to demonstrate the validity of the report. Despite having several months to collect such data, Professor Boldt has not provided LÄK with any original research data to refute the allegation of data fabrication. LÄK has not reached a conclusion that the data were fabricated. This is still an open question, and LÄK is continuing its investigation.
Shafer concludes:
Based on the findings of LÄK, the report published in Anesthesia & Analgesia is fraudulent. Numerous representations in the manuscript are untrue. It is possible that the study was never performed at all. If the study were performed as reported, then that would represent a profound violation of research ethics, as there was no IRB approval or patient informed consent.
Noting that Boldt has published more than 200 papers, Shafer observes:
A shadow has been cast over that body of work based on a determination that the report published in Anesthesia & Analgesia is fraudulent.
In the paper, Boldt and colleages report– or purport to report– a comparison between two different priming solutions for cardiopulmonary bypass: high-volume priming with a modern balanced hydroxyethyl starch (HES) preparation versus an albumin-based priming regimen. Retraction Watch explains that the paper is part of an ongoing controversy in anesthesiology known as the “Great Fluid Debate,” and notes that Boldt has disclosed receiving support from several companies:
Boldt has disclosed receiving funding for his research from makers of hetastarch products including B. Braun, Baxter and Fresenius Kabi. He also has received funding from Plasmaselect and Bernburg, as well as Edwards Lifesciences, which makes devices that allow clinicians to monitor fluids in surgery patients.
Shafer told Retraction Watch that there may be important clinical implications if Boldt’s research is discredited:
Older colloidal solutions are known to interfere with coagulation and renal function and may contribute towards inflammation. Newer colloidal solutions appear to have addressed these limitations. However, some of that research was performed by Prof. Boldt. The safety and efficacy of modern solutions is potentially compromised by the finding of misrepresentations in his research.”
Retraction Watch also reported that Shafer said the Boldt paper “was reviewed by several cardiovascular anesthesiologists, none of whom caught the bogus data. Nor did Shafer himself suspect anything when he reviewed the report — including the parts about blood gases, an area of particular expertise for him.”
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