The publication last week of the final report from the Erasmus Medical Center on the Don Poldermans research scandal in the Netherlands ends the first and most explosive chapter of an ugly episode of scientific misconduct. But there are still many important questions regarding scientific integrity and the culture of medical research raised by the case. And one key detail about the case remains– and is likely to remain– unanswered. Did Don Poldermans commit scientific fraud by fabricating data or was he only guilty of the serious but lesser sin of poor or negligent supervision of a research factory?
The final report on the Poldermans affair from his former institution and employer, Erasmus MC, accuses him of serious scientific misconduct, including:
- “failure to preserve essential source documentation,” so that “further verification and analysis ” is now impossible;
- “failure to record actual medication use, in a study focusing on an intervention using medicines”; and
- failure to obtain informed consent, or to do so improperly.
The most serious accusation is that “fictitious data” was used in one study, “a serious breach of academic integrity.” However, this accusation does not appear to be rock solid, since it is based on disparities between the study data and a database examined by the committee. However, Poldermans claims that the database examined by the committee was provided to them by the whistleblower (a fellow in his laboratory) who did not have access to the original database (which Poldermans claims was destroyed) and was not the database used in the study. It’s unlikely that the full truth about this will ever be known. Poldermans says that the committee’s conclusions were “suggestive, speculative and often even demonstrably false.”
In an hour-long interview with me during the recent ESC meeting in Munich, Poldermans talked a great deal about the case, accepted responsibility for the less serious charges but adamantly denied the more serious charges. Poldermans, who is now working as a vascular medicine physician at a non-teaching hospital, said he has no expectation of ever regaining his former position or resuming research: “that’s something I can accept, but I can’t accept that people would think I faked patients or that patients were hurt,” he told me.
Poldermans described a very difficult situation with the whistleblower, a fellow who was responsible for the now-defunct DECREASE VI trial. His tasks included enrolling eligible patients and obtaining consent. Even if the fellow was himself guilty of the misconduct, Poldermans accepts that he, Poldermans, must accept the blame and responsibility. Poldermans told me that he had no direct involvement in the misconduct of the fellow, but he admits that he should have been suspicious, because there were numerous warning signs. It was clear, said Poldermans, that the fellow was overburdened with his clinical work on top of his research work with Poldermans. The fellow began doing his research work for Poldermans on weekends and nights, when no one else was in the office, which Poldermans now sees as a potential warning sign. Poldermans also allowed him to seek help from other fellows in the office.
Poldermans talked about an episode in which the fellow submitted an abstract for DECREASE VI on the last day of the deadline. The abstract had 1,800 patients, exactly the prespecified number of patients. “I should have been suspicious,” said Poldermans. A few days later the fellow admitted there were additional problems with the abstract and Poldermans withdrew it, but he now agrees that the entire study should have been scuttled at that point as there were too many questions about the reliability of the data.
In his interview with me Poldermans refrained from directly accusing the whistleblower of fraud or any scientific misconduct greater than “mere” sloppiness or overwork. “I don’t gain anything by accusing him,” he said, and, he emphasized, the fellow is protected by strong whistleblower protection laws in the Netherlands. Ultimately, though he acknowledges that he is the responsible party. “Blaming a fellow is not fair,” he told me. “I was the principal investigator.”`
I asked Poldermans about the pressure to perform research and publish papers in his lab. Poldermans is himself a co-author of more than 500 published papers. He mentioned a wall in his office which used a color-coding system to track the progress of research projects. The color green indicated that all the necessary data had been collected. “It was a joke among the fellows that the professor only wanted to see green walls,” Poldermans admits.
“It was a joke among the fellows that the professor only wanted to see green walls”
Poldermans now says that “if I could do it differently I would cut down the number of fellows, and work very closely with just one or two fellows.” (Before the scandal erupted Poldermans had 5 fellows.)
Comment: I’d just like to comment on one or two points in this case. In his response to the storm of events that erupted last year over his case, Poldermans wrote, “the witch hunt that emerged after my resignation from the Erasmus MC led to unnecessary damage to public trust in medical science.” Witch hunts are never acceptable, and by calling it a witch hunt Poldermans defeats a straw man. I wonder what he believes would have constituted a fair response to the case? Some might argue that the committee’s investigation wasn’t thorough enough, since it did not examine the vast majority of Poldermans’ publications. And surely it is Poldermans own mistakes that have caused “unnecessary damage to public trust in medical science.”
Poldermans takes tremendous umbrage over the accusations of fraud leveled at him by the committee and in the press, and it is entirely possible that Poldermans never participated in, nor condoned, fraudulent conduct, beyond negligence and poor administration. But the court of science is not a court of law, and, once serious shortcomings have been found, there can be no presumption of innocence. Clearly if his work had been less sloppy, if there had been more oversight and a greater insistence on quality rather than quantity, the issue would never have emerged. Once any significant degree of scientific misconduct has been found, it is impossible to derail the train of thought that leads to speculations about even worse behavior. For this Poldermans has only himself to blame.
- Final Report from Erasmus MC (Dutch PDF)
- Final Report from Erasmus MC (English PDF)
- Press Release from Erasmus MC (Dutch)
- Don Poldermans response to the Erasmus MC report (Dutch)
- Previous coverage on Cardiobrief
Editorial Note: Don Poldermans agreed to be interviewed on the condition that he would be given the opportunity to review the story prior to publication, but only for the purpose of factual accuracy.