Second Erasmus Probe Finds Scientific Misconduct by Poldermans

October 19, 2012

ROTTERDAM, the Netherlands — A follow-up investigation by Erasmus Medical Center of research led by Dr Don Poldermans has concluded that "violation of academic integrity occurred due to the lack of source documents, inaccurate data collection, and the use of fictitious data" [1,2].

Poldermans was fired by Erasmus last year on an initial investigation of these allegations. A second, lengthier investigation has now recently concluded and is said to have found similar conclusions to the first one--that research headed up by Poldermans included "serious shortcomings in the procedure used to record informed consent, the submission of publications based on unreliable data, and scientifically inaccurate data collection."

Poldermans issued a response calling the investigation a "witch hunt" with disproportionate and unjustified accusations. He says he may have been guilty of "administrative carelessness" but strongly denies any fraudulent activity.

Erasmus press officer David Drexhage told heartwire that the investigation had found that data used in several of Poldermans's DECREASE studies have not been able to be retrieved from hospital records. For example, in the pilot study DECREASE-6, of 169 patients in the database, only five could be found in the hospital data system. "So 164 patients could not be accounted for, and we do not know for sure if these patients really existed."

Drexhage added: "Data were found to be missing from several of the DECREASE studies, and also no informed consent could be found for some of the earlier studies."

The exact reasons for missing data are not clear. In the case of the DECREASE-6 pilot study, the first author--Dr Herman H Feringa--and the principal investigator--Poldermans--produced contradictory statements regarding the way in which the data were produced, with each saying the other was responsible, the investigation report notes.

Feringa, who now works in the US, declined many invitations to appear before the committee, instead submitting written answers to questions that the committee said produced an "insufficiently clear picture."

Drexhage told heartwire that although exact details have not been able to be clarified, the committee decided that the responsibility for all the shortcomings in the various studies must lie with Poldermans as the principal investigator.

Poldermans's Response

In a response, posted in Dutch [translated here using Google translate], on artsennet.nl, Poldermans says the lack of informed consent for one of the studies was a case of "administrative carelessness" for which he has apologized and accepted "extreme consequences (dismissal)" [3].

But he says that he is innocent of any form of cheating. "Allegations in the press in terms of 'messing around with data' miss each base," and "nothing has been proven," he states.

In response to accusations that one study was not conducted in accordance with the approved protocol, Poldermans said he "made use of research already done that yielded the same information as the protocol described, thus saving patients useless and burdensome research," and his only error was not having informed the ethics committee.

He stresses that the investigation has found no deliberate manipulation of research or that no patient was medically compromised or otherwise harmed.

He says some of the documentation from two studies was lost, in one case due to water damage, in another case due to lack of space. "I cannot be held responsible for the disappearance of archival material from closed spaces within the Erasmus Medical Center." He says for the other three trials there was no legal obligation to retain documents.

On the accusation of use of fictitious data (in the DECREASE-6 pilot study), he says this is based entirely on an "illogical explanation of the whistleblower." He says the first author of the study left the data at Erasmus when he left for the US in 2007, and the computer on which they were held was destroyed.

Poldermans adds that the conclusions of the investigation "are demonstrably false, while other findings are largely based on speculation and unilateral witness statements. The report is thus unnecessarily damaging for myself, for my former coresearchers, and ultimately the Erasmus Medical Center."

News of a follow-up investigation at Erasmus was first reported by Cardiobrief.

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