Retractions of publications are a sign that a journal takes seriously its responsibility for the integrity of its publications. Erroneous, unethical or fraudulent studies must be indicated to be such by using the possible formats “Expression of Concern”, “Erratum”, “Corrigendum” and “Notice of Retraction” or “Retraction Note” in order to ensure the scientific community that the publications in question have been assessed correctly and can be quickly identified as such in the literature databases.
Until a few years ago, relatively few retracted publications in the field of intensive care medicine were made public (Table 1). Recently, there has been an exponential growth in publication retractions both in biomedical literature and in the field of intensive care (Figure 1). This has as much to do with the capabilities of modern information technology and their impact on academic medicine and medical research as with changes in career opportunities for researchers and the changing financial environment for research. And the number of publications retracted can be expected to rise in the future.
Two cases of research fraud in critical care medicine and anaesthesia
In the field of intensive care medicine, the majority of article withdrawals were made by leading international scientific journals of the United States and Europe (Am J Resp Crit Care Med, Chest, Crit Care Med, Intensive Care Med). These are rather high-impact and not low-impact journals. It is interesting to note that out of 28 involved journals, two national journals, namely “Anaesthesia and Intensive Care” and “Anaesthesiology Intensive Care Emergency Medicine Pain Therapy” from Australia and Germany, respectively are responsible for a quarter of all withdrawals in the field of intensive care (Table 1): All six articles retracted by “Anesthesia and Intensive Care” were articles of the Japanese author Fujii and all six withdrawals by the journal “Anaesthesiology Intensive Care Emergency Medicine Pain Therapy” were publications of Boldt in Germany. These two cases of scientific misconduct represent almost half (22/48) of all publication retractions in this area of medical research and therefore need further scrutiny. In seven of the 48 retracted articles in the area of intensive care, “Intensive Care Medicine” was involved and six of them were publications of Boldt. The exact scope of his fraud has neither been clearly determined, nor fully investigated. What is clear is that Joachim Boldt as an author of more than 215 publications on clinical trials had no authorization from the relevant ethics committees at both places where he worked (University Hospital of Giessen and Klinikum Ludwigshafen) for carrying out research on patients. Therefore, a total of 88 of his publications were retracted in March 2011 for the time being.
The Fujii fraud: In 2000, a letter to the editor was published in “Anesthesia and Analgesia” that questioned the credibility of information on adverse drug reactions, because they were almost always identical in the 47 articles of the Japanese author Dr. Yoshitaka Fujii. Against this background of suspicion of falsifying data, many years later, when the author submitted a manuscript to another journal, the matter was thoroughly investigated in cooperation with the publisher and the author’s research institution with the result that it was found that no ethics committee approval had been obtained for the study, and furthermore, data manipulation was detected. At the same time, the British anesthesiologist Dr. John Carlisle checked the integrity of the data of a total of 168 randomized controlled trials that Dr. Fujii had published over the years. He gave overwhelming statistical evidence that it was highly unlikely that the statistical distributions of continuous and categorical variables described in the publications are what could be expected to occur by chance. After further examination of several Japanese universities where Dr. Fujii had worked continuously only for a few years each, the suspicion of falsification could not be discounted. Finally, a hitherto unprecedented number of 189 publications in anesthesia and intensive care medicine journals were recommended for retraction by the Japanese Society for Anesthesia.
In the case of the Japanese anesthesiologist Dr. Yoshitaka Fujii, who had worked in six Japanese universities and falsified a large number of publications, the involved academic institutions, in collaboration with the Japanese Society of Anesthesiology, quickly analyzed 300 articles after a group of editors and researchers suspected fundamental problems in many of his publications[2-4].
Although the fraudulent publications were discovered to be such only years later, recommendations to have these retracted were made to the responsible editors in a relatively short time, because the involved Japanese institutions and journals worked together constructively. Although research scandals are rated negatively by the public, in the end, particularly research institutions can benefit from this kind lively professionalism.
The Boldt fraud: In announcing the retraction of an article by Dr. Joachim Boldt, a group of editors declared that lack of ethics committee approval of a study does “not (...) mean that the research results per se are fraudulent”. Data fraud was found in 10 of the publications. The Klinikum Ludwigshafen could not find study documents on 92% of patients recruited for studies. Suspicious homogeneity in the mortality data was seen in five publications. Six publications on cardiac and major abdominal surgery showed suspiciously low interleukin-6 measurement variability[16-21]. For two of the six articles[17,19] data for comparative analysis were available in a thesis. The dissertation showed that the articles misrepresented a single study as two separate studies, and that data had been manipulated to conceal the double publication.
Dissertations as a data source for fraudulent publications were found in two other retractions, one of which had already been withdrawn due to lack of ethics committee approval[23-25]. As of today, 89 publications have been retracted because they had failed to obtain ethics committee approval; there are additional articles that have been retracted because of data falsification and double publications: two because of proven fabrication of data[26,27], and two because of proven data manipulation[28,29].
In 2012, the Klinikum Ludwigshafen pointed out that only those publications of Dr. Boldt had been examined that had appeared after 1999. Because nearly 40% of clinical trials were carried out at the University Hospital Giessen, and articles based on these trials were published prior to 1999 and because thesis data were falsified in publications[17,19,22-25], it can be assumed that falsification occurred prior to 1999.
In the meantime, comparative analysis of theses and publications are being carried out at the University of Giessen. Initial results have led to a series of further retractions, all of which are explained by systematic data falsification and partly with simultaneous dual publication[30-33] and trial design change. From a confidential communication from the University of Giessen to the editors of the journals involved, from which “Retraction Watch” was permitted to quote, it can be assumed that there are still large numbers of other publications of clinical studies of Boldt that will be retracted because of scientific misconduct going beyond lack of approval from ethics committee. Among the most important issues that arise from the fraudulent series of Boldt is: How was it possible for Boldt to publish over a period of 25 years, working at two research facilities only, at least 217 articles on clinical trials involving thousands of patients with more than 180 co-authors (Christian J Wiedermann, unpublished survey) without arousing any suspicion of misconduct in institutions where he worked and the co-authors?