October 9th, 2012
Erasmus Medical Center Releases Final Report on Cardiovascular Research Scandal
Larry Husten, PHD
After an extensive investigation, a large medical center in the Netherlands has confirmed earlier charges of research misconduct against a prominent cardiovascular researcher. On Tuesday, Erasmus Medical Center in Rotterdam released a final report on the scientific integrity of trials conducted by Don Poldermans, a well-known and highly prolific Dutch cardiovascular researcher. The final report contains numerous allegations of scientific misconduct related to several clinical trials run by Poldermans at Erasmus MC.
Poldermans admits responsibility for some instances of misconduct but also vigorously denies the most serious charges involving scientific fraud. He provided CardioExchange with detailed written responses to the charges and also presented a spirited defense during an exclusive interview conducted in August during the ESC meeting in Munich.
In a statement to the press, Erasmus MC said that the new report confirms the earlier suspicions raised in the case, which ignited a firestorm of controversy in the Netherlands last winter. The press statement mentions”serious shortcomings” in obtaining informed consent for patients enrolled in studies and the submissions of “unreliable data” based on “scientifically inaccurate data collection.” Poldermans and Erasmus MC are in full agreement, however, that the misconduct “did not lead to health damage to patients.”
In a statement prepared for CardioExchange in response to the report, Poldermans apologizes for his “administrative carelessness” and accepts full responsibility for the missing consent forms. He accepts the “extreme consequence” — his dismissal from Erasmus MC — over this issue, but emphasizes that no harm occurred to any of the patients and, further, that no additional or unnecessary treatments or diagnostic procedures took place. He vigorously denies any larger scientific misconduct or fraud.
The committee report — and Poldermans defense — are often highly technical, and the report is based on incomplete and inconsistent information obtained by the investigating committee at Erasmus MC. One problem is missing data. Investigators scrutinizing Polderman’s work have been unable to find the case files and other documentation for some patients in the trials. Consequently, the report raises concerns about possible data fabrication. Poldermans strongly denies this suggestion and states that he properly stored all the files at Erasmus MC. His defense is that some records were damaged by water and some records disappeared when the hospital itself threw out boxes of documents stored in the archives.
Poldermans had been a professor of medicine and the head of perioperative cardiac care at Erasmus MC. He was widely published and active in the field, serving as a member of the European Society of Cardiology committee for practice guidelines and as the chairperson of the ESC guidelines on preoperative cardiac risk assessment and perioperative cardiac management in noncardiac surgery. He was also the lead author of the influential 1999 New England Journal of Medicine DECREASE study on the use of bisoprolol during vascular surgery. Poldermans now works as a vascular medicine physician at a nonteaching hospital in the Netherlands.
CardioExchange will publish a follow-up story in the near future based on an interview with Poldermans conducted in Munich during the ESC.
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