More details have emerged about the research scandal in the Netherlands, in which prominent Erasmus Medical Center cardiovascular researcher Don Poldermans was fired for scientific misconduct. Anonymously leaked portions of a report from the Erasmus Medical Center investigation first appeared on Scribd over the weekend [Editor’s note: the Scribd link is no longer working]. Later an executive summary of the report, dated November 16, appeared on the Erasmus website. All the documents are in Dutch. Here is a brief summary, based on help received from Google Translate, Babel Fish, and native Dutch speakers.
As previously reported, 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.
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.
Hat Tips: Marilyn Mann, Ray Lau, Greta Carraway, Rick Lange, and Jacqueline Limpens.