(This story was updated on Friday, October 4 with a response from Dr. Modena.)
New questions are being raised about the integrity and reliability of research published by a prominent Italian cardiologist and her colleagues. Last November, as previous reported here, Maria Grazia Modena, a former president of the Italian Society of Cardiology, and 8 other Italian cardiologists were arrested as part of a broad investigation into serious medical misconduct at Modena Hospital. To date the Italian authorities have not issued any indictments, but at least one aspect of the investigation appears to involve unauthorized research and failing to obtain informed consent from patients in clinical trials.
The new questions center on the same issue of research misconduct and the possibility that informed consent was not obtained from patients. The questions– which were brought to my attention by a reader– center on a number of significant inconsistencies and highly improbable statements and statistics in a report of a purported randomized controlled trial published in the journal Heart in 2010. The questions raised about the paper lead to the inevitable suspicion that the trial very likely was not randomized and that patient consent may not have been properly obtained.