Posted on 10/09/2013 6:45:31 PM PDT by neverdem
(Updated with a response from Dr. Maria Grazia 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.
Briefly, the paper describes a trial performed at Modena Hospital in which 214 consecutive patients with a heart attack (ST-elevation myocardial infarction, or STEMI) and multivessel coronary artery disease were randomly assigned to one of three different angioplasty strategies: in the first group only the culprit vessel (the cause of the STEMI) was stented; in the second group, the culprit vessel received an immediate stent, and the other vessels were treated later; in the third group, all the blocked vessels were treated during the initial intervention. After 2.5 years of followup the investigators reported that there was a significant increase in major adverse cardiac events in the...
(Excerpt) Read more at forbes.com ...
I wouldn’t rush to judgment on this one. I’m inclined to agree with the single comment so far, that an arrest by the Italian authorities doesn’t necessarily mean even a probability of guilt, let alone certainty.
And to give them credit, their study seems to find that the method recommended by most cardiologists was NOT the most successful.
Not receiving informed consent is a big deal, unless the Italian definition is absurd. If they lied or designed their experiment via fraud, that is a very big deal.
Science is the pursuit of truth. If it tolerates lies then it isn’t science.
Maybe it’s a cloud of spaghetti?
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.