Erasmus Health care Center says it has wrapped up its investigation of Don Poldermans, the disgraced cardiology researcher who was fired for study misconduct. The full extent of the misconduct has by no means been acknowledged, and from an examination of the Erasmus report it appears very likely that it never ever will be known.
One key finding– however downplayed in the health-related center’s press release– is that the most prestigious and influential publication from the Poldermans’ group, the 1999 publication of the Reduce 1 research in the New England Journal of Medication– appears to be riddled with significant troubles.
The integrity of the Decrease 1 review is particularly important simply because it supplied much of the basis for European tips with regards to the use of beta blockers in the course of noncardiac surgery. One research group estimated that this guideline could potentially have been accountable for as a lot of as 800,000 deaths in Europe over 5 many years. (Up to date European and US guidelines will be launched shortly.
The Dutch investigators located a variety of crucial discrepancies among the trial perform and the written protocol found in the archive of the Medical Ethics Committee. Poldermans informed the investigators that there was an updated version of the protocol but this document has not been located.
In 1 crucial discrepancy, the NEJM report states that adverse occasions had been evaluated by an adverse occasions committee consisting of 2 cardiologists, but the two cardiologists informed the investigators that they had no awareness that their names have been listed in the publication. One particular stated he remembered that Poldermans had asked him to judge some ECGs and the other had no recollection of being involved in the review in any way. Poldermans advised the committee that the cardiologists had seen the information for all individuals in the study.
Even a lot more troubling are the discrepancies involving the trial’s security committee. The part of this committee is especially essential simply because the trial was stopped early right after the initial interim examination. The NEJM paper states that the determination to stop the trial was created by the safety committee. But the two members of this committee informed the investigation that they had no recollection of being on the safety committee or of analyzing the study data. One particular member explained that he had offered some suggestions to Poldermans by telephone about “stopping guidelines.” Poldermans advised the investigators that, contrary to the published report, the choice to quit the trial had been created by “the steering committee.”
Perhaps remarkably, the report does not conclude that the trial is invalid. As an alternative, it concludes that doubts about the scientific integrity can neither be confirmed nor denied.
The report consists of a cursory assessment of Poldermans’ 495 publications, in some instances reviewing only the abstracts and not the full texts of the papers. The investigators attempted to determine whether or not the reported studies really occurred, whether the investigators received appropriate approval to complete the research, and regardless of whether informed consent was obtained. The investigation was hampered by a lack of documentation and missing records.
An English translation of the Dutch report has been promised. This write-up was written with Google Translate and the kind assistance of a native Dutch speaker. But it looks clear that the report provides little reassurance that huge-scale scientific misconduct did not consider location throughout Poldermans’ reign as a major cardiovascular researcher. But the cautious investigators get a much more benign see, going only so far as to say that it is impossible to conclude that big-scale scientific misconduct and fraud did not take place.
Medicine faculty of the Erasmus MC, taken in the afternoon (Photograph credit score: Wikipedia)
Dutch Investigation Finds Significant Flaws In Influential New England Journal Of Medication Examine
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