Don Poldermans

Last updated

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.

Contents

Scientific misconduct: the 2011/2012 investigation

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.

Vox estimated that Polderman's actions led to approximately eight hundred thousand deaths. [7]

After the 2011/2012 investigation

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%. [8]

The 2014 investigation report

Erasmus university issued a third investigation report [9] 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 [10] by British researchers listed inconsistencies in the published DECREASE I reports that put their accuracy into doubt.

Related Research Articles

<span class="mw-page-title-main">Scientific misconduct</span> Violation of codes of scholarly conduct and ethical behavior in scientific research

Scientific misconduct is the violation of the standard codes of scholarly conduct and ethical behavior in the publication of professional scientific research. It is violation of scientific integrity: violation of the scientific method and of research ethics in science, including in the design, conduct, and reporting of research.

<span class="mw-page-title-main">Informed consent</span> Ethical precondition for obtaining voluntary assumption of risk

Informed consent is a principle in medical ethics, medical law, media studies, and other fields, that a person must have sufficient information and understanding before making decisions about accepting risk, such as their medical care. Pertinent information may include risks and benefits of treatments, alternative treatments, the patient's role in treatment, and their right to refuse treatment. In most systems, healthcare providers have a legal and ethical responsibility to ensure that a patient's consent is informed. This principle applies more broadly than healthcare intervention, for example to conduct research, to disclose a person's medical information, or to participate in high risk sporting and recreational activities.

<span class="mw-page-title-main">Clinical trial</span> Phase of clinical research in medicine

Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted.

<span class="mw-page-title-main">Human subject research</span> Systematic, scientific investigation that involves human beings as research subjects

Human subject research is systematic, scientific investigation that can be either interventional or observational and involves human beings as research subjects, commonly known as test subjects. Human subject research can be either medical (clinical) research or non-medical research. Systematic investigation incorporates both the collection and analysis of data in order to answer a specific question. Medical human subject research often involves analysis of biological specimens, epidemiological and behavioral studies and medical chart review studies. On the other hand, human subject research in the social sciences often involves surveys which consist of questions to a particular group of people. Survey methodology includes questionnaires, interviews, and focus groups.

The regulation of science refers to use of law, or other ruling, by academic or governmental bodies to allow or restrict science from performing certain practices, or researching certain scientific areas.

Research ethics is a discipline within the study of applied ethics. Its scope ranges from general scientific integrity and misconduct to the treatment of human and animal subjects. The societal responsibilities that science and research have are not traditionally included and are less well defined.

<span class="mw-page-title-main">Erasmus MC</span> Hospital in Rotterdam, Netherlands

Erasmus University Medical Center based in Rotterdam, Netherlands, affiliated with Erasmus University and home to its faculty of medicine, is the largest and one of the most authoritative scientific University Medical Centers in Europe. The hospital is the largest of the eight university medical centers in the Netherlands, both in terms of turnover and number of beds. The Erasmus MC ranks #1 of the top European institution in clinical medicine and #20 in the world according to the Times Higher Education rankings.

A Clinical Research Coordinator (CRC) is a person responsible for conducting clinical trials using good clinical practice (GCP) under the auspices of a Principal Investigator (PI).

A glossary of terms used in clinical research.

Steven E. Nissen is an American cardiologist, researcher and patient advocate. He was chairman of cardiovascular medicine at the Cleveland Clinic, in Cleveland, Ohio.

Various organizations have created guidelines for human subject research for various kinds of research involving human subjects and for various situations.

Yoshitaka Fujii is a Japanese researcher in anesthesiology, who in 2012 was found to have fabricated data in at least 219 scientific papers, of which 183 have been retracted.


The Revised Cardiac Risk Index (RCRI) is a tool used to estimate a patient's risk of perioperative cardiac complications. The RCRI and similar clinical prediction tools are derived by looking for an association between preoperative variables (e.g., patient's age, type of surgery, comorbid diagnoses, or laboratory data) and the risk for cardiac complications in a cohort of surgical patients (the "derivation cohort"). Variables that have independent predictive value in a logistic regression analysis are incorporated into the risk index. Ideally, the accuracy and validity of the risk index is then tested in a separate cohort (the "validation cohort"). In 1977 Goldman, et al., developed the first cardiac risk index, which included nine variables associated with an increased risk of perioperative cardiac complications. This became known as the Original Cardiac Risk Index (or alternatively the Goldman Index). In 1999, Lee et al. published a cardiac risk index derived from 2893 patients and validated in 1422 patients aged ≥ 50 undergoing major noncardiac surgery, which became known as the Revised Cardiac Risk Index (RCRI). Lee identified six independent variables that predicted an increased risk for cardiac complications. A patient's risk for perioperative cardiac complications increased with number of variables that were present.

Professor Bodo-Eckehard Strauer is a German cardiologist who has made award-winning contributions to cardiovascular science including pivotal reports that transfusions of patients' own bone marrow cells into the coronary arteries can increase the pumping efficacy of a weak heart. These landmark publications have been the basis for the new field of autologous bone marrow stem cell therapy for heart disease. In a press statement on 24 February 2014, his institution reported that it had found "evidence of scientific misconduct", and that it had sent a report "to the city’s public prosecutors".

Professor Peter Sleight M.D.(Cantab.), D.M. (Oxon.) FRCP FACC was a distinguished and internationally renowned research cardiologist and an Honorary Consultant Physician at the John Radcliffe Hospital in Oxford and the Oxford University Hospitals NHS Foundation Trust. Sleight was Emeritus Field Marshal Alexander Professor of Cardiovascular Medicine at the University of Oxford and an Emeritus Fellow of Exeter College, Oxford.

Unethical human experimentation is human experimentation that violates the principles of medical ethics. Such practices have included denying patients the right to informed consent, using pseudoscientific frameworks such as race science, and torturing people under the guise of research. Around World War II, Imperial Japan and Nazi Germany carried out brutal experiments on prisoners and civilians through groups like Unit 731 or individuals like Josef Mengele; the Nuremberg Code was developed after the war in response to the Nazi experiments. Countries have carried out brutal experiments on marginalized populations. Examples include American abuses during Project MKUltra and the Tuskegee syphilis experiments, and the mistreatment of indigenous populations in Canada and Australia. The Declaration of Helsinki, developed by the World Medical Association (WMA), is widely regarded as the cornerstone document on human research ethics.

Annarosa Leri is a medical doctor and former associate professor at Harvard University. Along with former professor Piero Anversa, Leri was engaged in biomedical research at Brigham and Women’s Hospital in Boston, an affiliate of Harvard Medical School. Since at least 2003 Anversa and Leri had investigated the ability of the heart to regenerate damaged cells using cardiac stem cells.

<span class="mw-page-title-main">Piotr Ponikowski</span>

Piotr Ponikowski is a Polish cardiologist, Professor of Medical Sciences, Rector of the Wrocław Medical University and Head of the Polish Cardiological Society (2017-2019). His scientific interests include research on heart failure, coronary heart disease and heart arrhythmia.

Philip James Devereaux is a Canadian cardiologist, clinical epidemiologist, and perioperative care physician. Devereaux conducts clinical research within cardiac and perioperative fields, with a focus on vascular surgical complications.

References

  1. ↑ Marcus A (November 17, 2011). "Breaking news: Prolific Dutch heart researcher fired over misconduct concerns". Retractionwatch.com . Retrieved January 10, 2012.
  2. ↑ "Erasmus medical centre sacks professor for 'scientific misconduct'". DutchNews.nl. 2011. Archived from the original on 2011-12-22. Retrieved Jan 18, 2012.
  3. ↑ Berkhout K.; Rosenberg E. (17 November 2011). "Nieuw geval van wetenschapsfraude - hoogleraar Erasmus MC ontslagen". nrc.nl. Retrieved January 10, 2012.
  4. ↑ "Erasmus MC Zegt Hoogleraar Ontslag Aan". Rotterdam: Erasmus MC. 2011-11-17. Retrieved Jan 10, 2012.
  5. ↑ 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 ]
  6. ↑ "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.
  7. ↑ Piper, Kelsey (2024-08-23). "The staggering death toll of scientific lies". Vox. Retrieved 2024-08-23.
  8. ↑ 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.
  9. ↑ Erasmus University. "2014 Report on Academic Conduct". Archived from the original on 11 September 2014. Retrieved 10 September 2014.
  10. ↑ 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.
This page is based on this Wikipedia article
Text is available under the CC BY-SA 4.0 license; additional terms may apply.
Images, videos and audio are available under their respective licenses.