New Perspective on the Dutch Cardiovascular Research Scandal

New information and details have  emerged about the cardiovascular research scandal in the Netherlands. One prominent cardiologist with close ties to the central character in the scandal has been cleared of wrongdoing by his institution and a feature magazine article sheds new light on that central character, Don Poldermans.

As previously reported here last November, Poldermans was fired for scientific misconduct by the Erasmus Medical Center in Rotterdam. Poldermans had been a professor of medicine and the head of perioperative cardiac care at the Erasmus Medical Center. He was widely published and active in the field, serving as a member of the European Society of Cardiology committee for practice guidelines and as the chairperson of the ESC guidelines on pre-operative cardiac risk assessment and perioperative cardiac management in non-cardiac surgery. He was also the lead author of the influential (but controversial) 1999 New England Journal of Medicine DECREASE study on the use of bisoprolol during vascular surgery. An investigation at Erasmus found that Poldermans used patient data without written permission, used fictitious data, and submitted two reports to conferences which included knowingly unreliable data.

A few weeks after the Poldermans affair became public, another medical center in the Netherlands, Leiden University Medical Center, announced that it was conducting its own investigation specifically looking at “a professor who had published frequently” with Poldermans. Although no names were publicly disclosed, it subsequently became clear that the primary focus of the investigation was Jeroen Bax, a cardiologist at LUMC who had co-authored more than 350 papers with Poldermans. Bax is an ESC board member and the chairman of the ESC guidelines committee.

LUMC has now completed its investigation and concluded that no “scientists at the Leiden University Medical Centre [were] involved in the violation of academic integrity by” Poldermans. However, the investigation also expressed concern about the large number of papers co-authored with Poldermans by LUMC scientists.

A feature article in the Dutch language publication Medisch Contact provides a much more detailed portrait of Poldermans and fills in much of the background of the entire affair.

Following the initial media storm last fall, the subsequent silence has been received with gratitude by Poldermans. Although he refused to give Medisch Contact an interview, in a phone conversation with the publication he said that he is “happy with the radio silence and that “it is the only way to survive.” He said he’s looking for a new job and expects to find one shortly.

Poldermans believes that the ongoing investigations will largely clear him of any additional or greater wrongdoing, but that he does not expect that his reputation will ever recover. “No one can come unscathed from such a nightmare,” he said.

The article outlines the rise and fall of Poldermans career, focusing especially on Poldermans’ close working relationship with Jeroen Bax and another Erasmus MC scientist, the biomedical statistician Eric Boersma. The three worked together on the original DECREASE study and on subsequent DECREASE studies. It was the conduct of these studies that formed the basis for the subsequent scandal.

In 2004 Poldermans was appointed a professor of perioperative cardiovascular care at Erasmus, the first such multi-disciplinary position in the Netherlands. Medisch Contact notes that it was the same dean who created the chair who subsequently led the scientific misconduct investigation.

When Bax also received a chair, he expressed gratitude to Poldermans in his inaugural lecture. He even stated at the time that “although I was frequently asked to reduce cooperation [with Poldermans], I have never done so.” Later, Bax refused to explain this comment to Medisch Contact. In the lecture he expressed nothing but pride in his relationship with Poldermans: “Nowhere in Netherlands cardiology can one find such a great partnership as we have built.”

The article also provides details about Poldermans prowess in gaining funds for research support from pharmaceutical and device companies, including Glaxo, Novo Nordisk, Pfizer, Novartis, Merck and Medtronic. According to documents in one court case cited by Medisch Contact, Poldermans played a key role in gaining regulatory approval for Exforge (amlodipine and valsartan).

Although colleagues and students of Poldermans had long experienced discomfort with Poldermans’ methods and standards, his downfall began when the group planned to submit data for the DECREASE VI study to a conference. A junior researcher felt the data was not in order and contacted a friend who informed the board of directors. Poldermans was first suspended, but not fired, in July, while the investigation was underway. With the completion of the investigation in November Poldermans was then fired.

The investigation concluded that Poldermans had performed research on patients who had not given written consent and had taken blood samples without permission. “More seriously,” according to Medisch Contact, the investigation found that Poldermans invented research data, stating that he created fictitious survey forms that “can not be traced back to the data in the relevant patient records.”

A broader investigation, which will include earlier work by Poldermans, is still underway and is scheduled for completion in July, according to Rikard Juttmann, integrity coordinator of the Erasmus MC. Poldermans admits that “not in all cases we asked for written consent,” but “that’s all.” He rejects the accusation that he fabricated data.

Dutch reporter Mathijs Smit sought to interview Poldermans colleagues but could find “hardly any people who wanted to speak up for him, including Bax, Boersma, and others. Bax refused to speak with Smit but his wife characterized the investigations at LUMC and Erasmus MC as “witch hunts.”