According to a statement from Erasmus Medical center, an investigation found that Poldermans was
careless in collecting the data for his research. In one study it was found that he used patient data without written permission, used fictitious data and that two reports were submitted to conferences which included knowingly unreliable data.
Poldermans, according to Erasmus, has accepted the conclusions of the committee and “expressed his regret for his actions,” but said his actions were “unintentional.”
CardioBrief has learned that some researchers closely familiar with Poldermans work had been suspicious for years about his perioperative studies. (See update below)
The news has been reported on the Dutch website NRC and then subsequently in English on DutchNews.NL and Retraction Watch. Erasmus Medical Center has also issued a statement and a Dutch language press release.
Poldermans had been a professor of medicine and the head of the section of perioperative cardiac care at the Erasmus Medical Center. He was widely published and active in the field, serving as a member of the ESC committee for practice guidelines and as the chairperson of the ESC guidelines on pre-operative cardiac risk assessment and perioperative cardiac management in non-cardiac surgery.
Poldermans was a highly prolific author and researcher. He was the first author of an influential New England Journal of Medicine paper in 1999 on the use of bisoprolol during vascular surgery and the senior author of a 2009 NEJM paper on the use of fluvastatin during vascular surgery. He was also the co-author of a 2005 NEJM editorial on beta-blockers in non cardiac surgery. He was the senior author of a 2006 paper in Archives of Internal Medicine on the value of the ankle-brachial index, the senior author of a JACC paper in 2010 on the timing of pre-operative beta-blocker therapy in vascular surgery patients, and the first author of a 2003 Circulation paper on statins in vascular surgery.
In the 2009 NEJM paper Poldermans reported he had received “consulting fees from Medtronic, Novartis, and Merck and grant support from Novartis.”
Update: Polderman’s work on perioperative beta blockers has been the subject of considerable criticism and scrutiny. In a highly influential study published in JAMA demonstrating the dangers of stopping trials early for benefit, Montori and colleagues used Poldermans’ NEJM study on perioperative bisoprolol as a prime example of the problems associated with ending a trial early:
Take, for example, the RCT evaluating the efficacy of bisoprolol in patients with a positive dobutamine echocardiography result and undergoing elective vascular surgery. At the time the trial was stopped, investigators had enrolled 112 patients (the authors had planned to recruit 266 patients, expecting an RR of 0.50), and the results had exceeded the O’Brien-Fleming boundary for benefit. The RR for the primary end point (cardiac death or nonfatal myocardial infarction) was 0.09 (95% CI, 0.02-0.37). This very large treatment effect is likely too good to be true. It is inconsistent with the researchers’ expectations; with the magnitude of effect (ie, RRs of 0.65 to 0.85) of β-blockers in tens of thousands of patients with acute myocardial infarction or chronic management of congestive heart failure; with results in day to-day clinical practice; and with results of other trials, including a recently conducted RCT in 496 patients undergoing vascular surgery that showed no significant effect of -blockers on cardiac death or nonfatal myocardial infarction.
It’s a warning sign when prominent researchers write in a journal like JAMA that the results of a trial are “too good to be true.” Now the real scrutiny of Poldermans’ work is likely to begin.
Here is the Erasmus Medical Center statement:
Erasmus MC dismisses professor
Erasmus MC dismissed Prof. D. Poldermans on 16 November because of violation of academic integrity. Research carried out under his leadership was not always performed in accordance with current scientific standards.
An inquiry committee on Academic Integrity concluded that the professor was careless in collecting the data for his research. In one study it was found that he used patient data without written permission, used fictitious data and that two reports were submitted to conferences which included knowingly unreliable data.
The professor agrees with the committee’s conclusions and expressed his regret for his actions. Poldermans feels that as experienced researcher he should have been more accurate but states that his actions were unintentional.
The study that gave rise to the inquiry committee having to take action was the health of patients who had to undergo surgery. The aim of the study was to identify which factors can contribute to being able to better estimate the risks of complications. There were no medical implications for the patients who took part in the studies.
Erasmus MC will, however, endeavor to inform the patients concerned personally and apologize to them.
For more information, see the press release.
Hat tip: Adam Marcus at Retraction Watch.