New questions are being raised about yet another published study from an embattled Italian research group. It also appears that despite attempts by some of the participants to respond to some of the previous questions and accusationst there is little likelihood that the growing scandal will be resolved anytime soon.
The new allegations are the latest episode in an ongoing saga that began last year with the arrest of 9 Italian cardiologists as part of a broad investigation into serious medical misconduct at Modena Hospital (Policlinico di Modena). The most prominent figure arrested was Maria Grazia Modena, the former head of cardiology. Since the arrests last year I have reported about numerous errors and other problems related to 2 studies by many of the same cardiologists published in the journals Heart and the American Journal of Cardiology.
The new questions concern a paper published in Circulation Cardiovascular Inteventions. Specifically, the paper claims that the study enrolled all consecutive STEMI patients from 2002 to 2008, obtained informed consent from all patients, and achieved 100% followup at 1 year. In addition, I found 2 mathematical errors in Table 2, including the apparent paradox of a subgroup of low risk men (n = 548) being larger than the entire group of men (n = 522). (Click to enlarge the image of the Table.)
The question about the enrollment of all STEMI patients is further complicated by the fact that (at least) 2 previous papers (the Heart and AJC papers mentioned above) have claimed to enroll, obtain consent, and achieve complete followup of the same STEMI population from the same hospital at the same time. Do the authors claim that informed consent was obtained for each of these studies and from each of the patients?
A Weak Defense
In response to my story about the American Journal of Cardiology paper the first author of that study, Daniel Monopoli, sent a lengthy response. (I have reprinted the entire response at the bottom of this post.) Readers should of course judge for themselves, but I do not believe Monopoli has satisfactorily resolved any of the questions raised about the paper. In some instances I think he has, inadvertently, worsened his position.