Over the weekend Erasmus University published their executive summary (in Dutch) of the investigation which resulted in the dismissal of Professor Don Poldermans. The investigation commission included members from Erasmus, Leiden and Amsterdam Medical Centres.
Prof. Dr. P.J. van der Maas, former dean of Erasmus MC (Chair)
Prof. Dr. B. Löwenberg, Emeritus Professor of Hematology, Erasmus MC
Prof. Dr. R.J.G. Peters, Professor of Cardiology, Amsterdam MC
Prof. Dr. A.J. Rabelink, Professor of Internal Medicine, Leiden UMC
Mr. J.M. Oosting, head of Legal Affairs, Erasmus MC
Administrative support is provided by Dr. RE Juttmann and Dr. R.M. Struhkamp.
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.
DECREASE VI: is a trial for testing NT-proBNP for the evaluation of cardiac risk in patients undergoing vascular surgery.
The investigation concluded that there were serious deficiencies in getting patients’ consent for inclusion in the studies, that data collection was sloppy and that data was fabricated. However no patients were harmed. Data manipulation was not found. The responsibility for the misconduct was that of the Professor Poldermans and not of any of the other researchers. The Commission found several serious errors and protocol violations in the D2 and D6 studies and possibly in D4. Evidence of data fabrication was found in submitted abstracts for the D6 study (not published).
The D6 study sponsored by Roche Diagnostics is to be discontinued.
The Commission believes that the Journal which published the D2 study should be informed (The Journal of the American College of Cardiology) but that retraction of the publications was not needed.