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Dutch Investigation Finds Serious Flaws In Influential New England Journal Of Medicine Study

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Erasmus Medical Center says it has wrapped up its investigation of Don Poldermans, the disgraced cardiology researcher who was fired for research misconduct. The full extent of the misconduct has never been known, and from an examination of the Erasmus report it appears likely that it never will be known.

One major finding-- though downplayed in the medical center's press release-- is that the most prestigious and influential publication from the Poldermans' group, the 1999 publication of the DECREASE 1 study in the New England Journal of Medicine-- appears to be riddled with serious problems.

The integrity of the DECREASE 1 study is particularly important because it provided much of the basis for European guidelines regarding the use of beta blockers during noncardiac surgery. One research group estimated that this guideline could possibly have been responsible for as many as 800,000 deaths in Europe over 5 years. (Updated European and US guidelines will be released shortly.

The Dutch investigators found a number of important discrepancies between the trial conduct and the written protocol found in the archive of the Medical Ethics Committee. Poldermans told the investigators that there was an updated version of the protocol but this document has not been found.

In one important discrepancy, the NEJM article states that adverse events were evaluated by an adverse events committee consisting of 2 cardiologists, but both cardiologists told the investigators that they had no awareness that their names were listed in the publication. One said he remembered that Poldermans had asked him to judge some ECGs and the other had no recollection of being involved in the study in any way. Poldermans told the committee that the cardiologists had seen the data for all patients in the study.

Even more troubling are the discrepancies involving the trial's safety committee. The role of this committee is especially important because the trial was stopped early after the first interim analysis. The NEJM paper states that the decision to stop the trial was made by the safety committee. But the 2 members of this committee told the investigation that they had no recollection of being on the safety committee or of analyzing the study data. One member said that he had given some advice to Poldermans by telephone about "stopping rules." Poldermans told the investigators that, contrary to the published report, the decision to stop the trial had been made by "the steering committee."

Perhaps surprisingly, the report does not conclude that the trial is invalid. Instead, it concludes that doubts about the scientific integrity can neither be confirmed nor denied.

The report contains a cursory review of Poldermans' 495 publications, in some cases reviewing only the abstracts and not the full texts of the papers. The investigators attempted to determine whether the reported studies really occurred, whether the investigators received proper approval to perform the studies, and 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 article was written with Google Translate and the kind assistance of a native Dutch speaker. But it seems clear that the report provides little reassurance that large-scale scientific misconduct did not take place during Poldermans' reign as a leading cardiovascular researcher. But the cautious investigators take a more benign view, going only so far as to say that it is impossible to conclude that large-scale scientific misconduct and fraud did not occur.

Medicine faculty of the Erasmus MC, taken in the afternoon (Photo credit: Wikipedia)