Summary
Don Poldermans[1] is a Dutch former cardiovascular medicine researcher who was fired for scientific misconduct and ethics concerns over informed consent. He was employed by Erasmus Medical Center in Rotterdam, Netherlands, where he was the head of the perioperative cardiac care unit. In addition, he was a member of the European Society of Cardiology Committee for Practice Guidelines and he acted as the Chairperson of the Task Force for the European Society of Cardiology.
Scientific misconduct: the 2011/2012 investigation edit
Don Poldermans was conducting research for Erasmus when accusations regarding the integrity of Poldermans’ work were brought forward.[2][3][4] In order to investigate this case, Erasmus appointed a Committee for the Investigation of Scientific Integrity.[5] The Committee found Poldermans to have committed misconduct on several counts. The primary studies that have been brought into question are four of the Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echocardiography (DECREASE) studies, specifically DECREASE VI, IV, III, and II.[6] DECREASE I was too far in the past to be investigated.
First, some of the randomized controlled trials did not obtain written informed consent from the participants before randomly allocating them to different strategies. These actions were a serious breach of medical research conduct.
Second, the committee determined that the data were not collected according to the protocol described beforehand and reported in the publications. For example, events such as myocardial infarction were not diagnosed by a panel of independent researchers, but by a single person who made no documentation for the reason for the categorisations, which were later found to be contradictory to the patients' own medical records.
Third, the committee determined that, in several cases, these trials had fabricated data.
Last, the committee found that untrustworthy data had been knowingly submitted for publication, another breach of proper scientific conduct.
After the 2011/2012 investigation edit
A project running at the time of the investigation, DECREASE VI, was abandoned, because patients had not given consent to take part. The manner in which previous data was collected, reported, and occasionally fabricated indicates academic misconduct, bringing the legitimacy of the current data into question.
The enquiry decided that DECREASE II need not be retracted because it believed that Dobutamine Stress Echo, the subject of the study, was no longer used in hospitals. This belief appears to be incorrect. DECREASE VI led to two publications, which were also not retracted. No other researchers were disciplined in this inquiry. The Committee informed all parties involved in the funding of the project.
Poldermans was dismissed from his position at Erasmus Medical Center. Two professors will supervise the research done by Poldermans’ students and will establish whether or not the projects in question can be completed successfully. If this is not possible, then the professors will find new research projects for the students affected. Don Poldermans acknowledged the committee’s decision but he claimed that his misconduct was unintended.
Without Poldermans' trials, the remaining credible trials suggest that the recommendation for initiation of a perioperative course of beta blocker seems to increase mortality by 27%.[7]
The 2014 investigation report edit
Erasmus university issued a third investigation report[8] in 2014. This covered DECREASE I which had not been covered in the previous investigations. It stated that the individual patients enrolled in DECREASE I could not be identified for cross-checking against the medical records. It therefore could not conclude on the accuracy or otherwise of the DECREASE I publications. An independent analysis[9] by British researchers listed inconsistencies in the published DECREASE I reports that put their accuracy into doubt.
References edit
- ^ Marcus A (November 17, 2011). "Breaking news: Prolific Dutch heart researcher fired over misconduct concerns". Retractionwatch.com. Retrieved January 10, 2012.
- ^ "Erasmus medical centre sacks professor for 'scientific misconduct'". DutchNews.nl. 2011. Archived from the original on 2011-12-22. Retrieved Jan 18, 2012.
- ^ Berkhout K.; Rosenberg E. (17 November 2011). "Nieuw geval van wetenschapsfraude - hoogleraar Erasmus MC ontslagen". nrc.nl. Retrieved January 10, 2012.
- ^ "Erasmus MC Zegt Hoogleraar Ontslag Aan". Rotterdam: Erasmus MC. 2011-11-17. Retrieved Jan 10, 2012.
- ^ van der Maas P.J; Löwenberg B; Peters R.J.G; Rabelink A.J.; Oosting J.M; Juttmann R.E.; Struhkamp R.M. (16 Nov 2011). "Report Summary". Erasmus MC, University Medical Center Rotterdam: Committee for the Investigation of Scientific Integrity. Retrieved Jan 17, 2012.[permanent dead link]
- ^ "Reducing cardiac risk in non-cardiac surgery: evidence from the DECREASE studies". European Society of Cardiology. 2009. Archived from the original on 2014-03-05.
- ^ Bouri, S; Shun-Shin, MJ; Cole, GD; Mayet, J; Francis, DP (Jul 31, 2013). "Meta-analysis of secure randomised controlled trials of β-blockade to prevent perioperative death in non-cardiac surgery". Heart. 100 (6): 456–464. doi:10.1136/heartjnl-2013-304262. PMC 3932762. PMID 23904357.
- ^ Erasmus University. "2014 Report on Academic Conduct". Archived from the original on 11 September 2014. Retrieved 10 September 2014.
- ^ Cole, GD; Francis, DP (Aug 29, 2014). "Perioperative β blockade: guidelines do not reflect the problems with the evidence from the DECREASE trials". BMJ (Clinical Research Ed.). 349: g5210. doi:10.1136/bmj.g5210. PMID 25172044. S2CID 13845087. Retrieved 10 September 2014.