Justus Liebig University in Germany has been investigating concerns that Joachim Boldt, number two on the Retraction Watch Leaderboard and now up to 92 retractions, may have “manipulated” more data than previously believed.
Until now, the vast majority of Boldt’s retractions were thought to have involved inadequate ethics approval. However, new retraction notices for Boldt’s research suggest that there’s evidence the researcher also engaged in significant data manipulation.
The first retraction from the university investigation emerged last year. Two of three new notices cite the investigation specifically, and an informant at the university told us that there are more retractions to come.
Here are the retracted papers that are freshly on the record, starting with an August retraction for a 1991 Anesthesiology paper (cited 37 times, according to Thomson Scientific’s Web of Knowledge):
The article by Boldt et al., entitled “Blood Conservation Techniques and Platelet Function in Cardiac Surgery,” from the September 1991 issue of Anesthesiology, has been retracted in its entirety by agreement between the Journal Editor-in-Chief, James C. Eisenach, M.D., and Wolters Kluwer. This article is being retracted following an investigation at Justus Liebig University, Giessen, Germany, which concluded that Dr. Boldt manipulated and falsified the data in this article.
We also found a retraction notice in Acta Anaesthesiologica Scandinavica for “Influence of volume replacement with different HES–solutions on microcirculatory blood flow in cardiac surgery“, cited 30 times:
The above article, published online on 30 December 2008 in Wiley Online Library (wileyonlinelibrary.com), has been retracted by agreement between the journal Editor-in-Chief, Prof. Lars S. Rasmussen, and John Wiley & Sons Ltd. The retraction has been agreed following an investigation carried out by the Justus Liebig University, which has concluded that there is evidence that the original research data on which the article builds has been manipulated.
A confidential statement from the university, sent to several journal editors, explains that the university “establishes and declares severe scientific malpractice by Dr. Boldt.” (We have permission to quote the letter, but not print it in full.)
Here’s what the statement says about an investigation into some MD theses with Boldt as a co-author:
Three publications showed data which were significantly different from the data in the theses, e.g. changed mean values and/or standard deviations although the two studies clearly described the same groups of patients. The type of changes and the circumstances strongly suggested that Dr. Boldt had falsified the original data without informing the graduate students.
More recently, three further problematic pairs of MD theses and publications by Dr. Boldt and his doctoral students were brought to the attention of JLU. In these cases, the laboratory work was done at JLU between the years 1990-1996. In two pairs, again significant differences are seen between the thesis and the publication in the journal and in both cases the changes were such that the data in the publication looked more favorable and consistent and were most likely falsified by Dr. Boldt. In the third case, the data in the thesis and the journal article are congruent, but the cohort of patients was described as being selected in retrospect in the thesis while the journal article stated that this was a prospective study.
Based on these findings, the university statement adopted a strong conclusion:
In view of these inconsistencies and Dr. Boldt’s misconduct in this and many other aspects of scientific integrity, JLU recommends that journal editors retract all papers where Dr. Boldt is the responsible author even if there is no obvious indication of falsification. All articles by Dr. Boldt – if still available – should be read with great caution because they may contain falsified data.
An external revision showed that substantial parts of the papers ‘Colloid osmotic pressure and extravascular lung water following extracorporeal circulation’ by J. Boldt, B. von Bormann, D. Kling, U. Börner, J. Mulch, G. Hempelmann published in Herz 1985; 10(6):366–375 and ‘Volume replacement with a new hydroxyethyl starch preparation (3 percent HES 200/0.5) in heart surgery’ by J. Boldt, B. von Bormann, D. Kling, U. Börner, J. Mulch, G. Hempelmann published in Infusionsther Klin Ernahr 1986;13(3):145–151 are identical. The measured data of the parameters ‘lung water’, ‘hemodynamics’, ‘oxygenation’ etc. of the patient groups I (human albumin) and II (HES) are identical (including standard deviations). This is also true for the demographic data and values of excretion, blood loss, transfusion etc. Moreover, the same time points for measurement are chosen, and no new parameters were investigated. In the later paper, published in Infusionstherapie und Klinische Ernährung (now Transfusion Medicine and Hemotherapy) in 1986, only the control group was increased by n = 2, and a further group (gelatine) was added. Whether or not the 11 patients originate from the control group of the earlier paper, cannot definitely be ascertained, but the groups I and II are absolutely identical. Only individual percent values vary marginally due to the slightly altered sample composition. Thus it is obvious that the later study repeats important contents of the above mentioned paper from 1985 published in Herz. Neither in the text nor in the references does one find any hint regarding the previously published article. After consulting with the Editor-in-Chief of Transfusion Medicine And Hemotherapy, S. Karger Publishers therefore decided to retract the contribution ‘Volume replacement with a new hydroxyethyl starch preparation (3 percent HES 200/0.5) in heart surgery’ by Boldt J, von Bormann B, Kling D, Börner U, Mulch J, Hempelmann G. published in Infusionsther Klin Ernahr 1986;13(3):145–151.
We reached out to Anesthesiology, Acta Anaesthesiologica Scandinavica, and Transfusion Medicine and Hemotherapy.
Not surprisingly, Boldt has lost his position at the university, according to the statement:
In 1996, he left Giessen and became head of department at the Hospital of the City of Ludwigshafen. However, he kept his post as external extraordinary professor at JLU. In February 2011, JLU deprived Dr. Boldt of the title of professor on account of non-fulfillment of teaching obligations.
Speaking of Boldt’s previous retractions due to issues with ethics approvals, a new paper in Accountability in Research has analyzed retractions over a 30-year period stemming from ethics issues (more than three-quarters of which included Boldt as a co-author).
Papers retracted for ethical reasons often continue to be cited, since some authors believe the results remain valid. But in an insightful note, the paper says that issues with ethical approvals can be the “tip of the iceberg,” and editors of papers retracted for these reasons should ensure that no additional problems exist:
Most retracted cases that were cited as the result of noncompliance with ethical processes were linked to the Boldt cases (78.8%). Those papers reported the results of clinical research led by Joachim Boldt, an anesthetist, mainly for testing hydroxyethyl starch in patients. According to the joint statement by the editors of 16 journals affected by the Boldt cases, the papers were “unethical” because “IRB approval for the research was misrepresented in the published article” (No authors listed 2011).
However, subsequent to that decision, investigation revealed that the studies had been based on fabricated data, including the use of fictional patient information (Wilkes et al., 2013). This suggests an increased demand for the editor’s post-retraction responsibility in providing the full picture with respect to associated problems: editors should subsequently require that sponsors or institutes reexamine ethically retracted papers and clarify whether or not such data can be associated with other scientific misconduct. Exposed ethical noncompliance as the reason for retraction may just be the tip of the iceberg. Even if a study is labeled as “unethical research” at an early stage of an investigation, the complete picture of scientific misconduct, which usually takes longer to establish than ethical problems, may not emerge.
Update 11/18/15 7:39 p.m. Eastern: We’ve just realized that the 1986 retraction is our new record for time for publication to retraction, at 29 years (although we know of another retraction request 52 years after the pub date).
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