CardioExchange Archive

UPDATE (Posted Monday, November 21): Over the weekend more details emerged about this story. An executive summary of the report from the investigative committee at Erasmus MC, dated November 16, appeared on the Erasmus website. Here is a brief summary, based on help received from Google Translate, Babel Fish, and native Dutch speakers:

As previously reported (below), the committee found “serious deficiencies” in obtaining informed consent in at least one and possibly another of the DECREASE (Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echocardiography) studies led by Poldermans (see the table below). Although some patients may have had procedures they would not have received otherwise, the committee found no evidence that any patients had been hurt by these procedures.

The committee found “several serious errors and protocol violations” in the DECREASE II and DECREASE VI studies and raised the possibility that the blind may have been broken in the DECREASE II, IV, and VI studies. For the DECREASE II and VI studies the committee determined that there was no independent endpoint evaluation. For DECREASE VI the committee found evidence of data fabrication in submitted abstracts for the study (the trial has not been published).

The committee recommended that the the DECREASE VI study be discontinued and its sponsor, Roche Diagnostics, informed about the decision. It recommended that the editors of the journal in which DECREASE II was published (The Journal of the American College of Cardiology) be told about the questions raised about informed consent in the trial, but the committee did not feel the publication needed to be retracted.
The committee found no evidence of scientific misconduct in other researchers, and noted that junior colleagues of Poldermans were in no position to challenge his authority.

The investigative committee is composed of a former dean, an emeritus professor of hematology, and an emeritus professor of hematology, all associated with Erasmus, as well as professors of cardiology and internal medicine from Leiden University Medical Center.

Here is the original story (posted Friday, November 18):

Don Poldermans, a well-known researcher in cardiovascular medicine in the Netherlands, has been fired for scientific misconduct by the Erasmus Medical Center in Rotterdam.

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.”

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 Dutch language press release.

Poldermans had been a professor of medicine and the head of section the 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 preoperative cardiac risk assessment and perioperative cardiac management in noncardiac 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 noncardiac surgery. He was the senior author of a 2006 paper in the 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 preoperative 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.”

The following is taken from a review article by Poldermans in a European Heart Journal supplement:

Summary of key findings of the Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echocardiography (DECREASE) series of studies:

DECREASE I: In high-risk patients undergoing non-cardiac surgery, perioperative beta-blockade with bisoprolol significantly reduces cardiac death and MI in the short- and long-term
DECREASE II: Patients identified as intermediate risk on the basis of a simple clinical assessment do not need pre-operative echocardiographic cardiac stress testing, provided that they receive bisoprolol to maintain resting heart rate at 60–65 b.p.m.
DECREASE III: In high-risk patients undergoing major vascular surgery, fluvastatin XL significantly reduces myocardial ischaemia and the combined endpoint of cardiovascular death and MI
DECREASE IV: In intermediate-risk patients, bisoprolol significantly reduces cardiac death and MI, with a non-significant trend towards a beneficial effect of fluvastatin XL
DECREASE V: In high-risk patients with extensive stress-induced ischaemia, coronary revascularization (added to tight heart rate control with bisoprolol) does not produce any additional reduction in death and MI and delays surgery.

In addition, DECREASE VI was testing NT-proBNP for the evaluation of cardiac risk in patients undergoing vascular surgery.

Thanks to Marilyn Mann, Ray Lau, Greta Carraway, Rick Lange, and Jacqueline Limpens for technical and linguistic support.