3 More Retractions For Emory Cardiology Group Reply

Three more articles from R. Wayne Alexander’s research group at Emory have been retracted in the last two months. Three papers were retracted in 2011, bringing the group’s current total to 6. (News about the recent retractions was first reported on Retraction Watch.)

Click here to read the full post on Forbes.

 

R Wayne Alexander
R Wayne Alexander

 

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The Italian Research Scandal Grows: New Questions And More Confusion Reply

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 abovehave 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.

Click here to read the full post on Forbes.

 

 

 

New Questions Raised About Italian Cardiologists Already Under Cloud Of Suspicion 1

(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.

Click here to read the full story on Forbes.

Nine Italian Cardiologists Arrested In Broad Investigation Of Research Fraud And Misconduct 2

The Arrest of Maria Grazia Modena, from Il Resto Del Carlino

Nine Italian cardiologists have been arrested as part of a broad investigation into serious medical misconduct at Modena Hospital, according to multiple reports in the Italian media. The investigation encompasses at least 67 other individuals and a dozen medical equipment companies, including 6 foreign companies. The charges include conspiracy, fraud, embezzlement, bribery, forgery and performing unauthorized clinical trials. Several news reports mentioned that stents and angioplasty balloons were involved.

According to one Italian website, the investigation started in 2011 in response to allegations by a group, Amici del Cuore (Friends of the Heart), that patients at the Modena Hospital (Policlinico di Modena) received treatments and procedures as part of unauthorized experiments. In some cases the procedures may have resulted in fatal outcomes. The accused physicians “performed experimental tests without making it known to patients for the sole purpose of writing about these trials in specialized magazines collecting money through bogus non-profit organization,” the website reported. [All translations in this story taken from Google Translate.]

“We wanted to ask questions about certain procedures that went far beyond the standard ones, and that seemed unusual to us,” the president of Friends of the Heart, Professor Giovanni Spinella, told Il Salvagente. “We were aware that invasive procedures were performed, often on peripheral organs, and sometimes had little to do [with] the heart. And unfortunately had caused discomfort and damage to several patients.”

Another Italian site quoted a police official who called it “a major operation” and said the accused “committed human clinical trials without authorization and installed medical devices and equipment defective in patients unaware of being subjected to an experimental treatment.” The accused physicians then “created false medical records to cover medical errors.” The Italian media said the investigation included recordings of telephone conversations between the suspects. The Italian police named the operation camici sporchi (“dirty gowns”).

The most prominent person arrested was Maria Grazia Modena, the chief of cardiology at Modena Hospital and a former president of the Italian Society of Cardiology. (Grazia Modena was the subject of a profile in Circulation European Perspectives (PDF) in 2007.) Modena, 60 years old, was trained partly at New York University and the Mayo Clinic. The second main focus of the investigation appears to be the head of the catheterization laboratory at the hospital, Giuseppe Sangiorgi. According to news reports, he is the only arrested physician who is still in jail.

Here are the names of the nine physicians:

  • Maria Grazia Modena, chief of cardiology
  • Giuseppe Sangiorgi, head of the catheterization laboratory
  • Luigi Vincenzo Politi
  • April Alexander
  • Simona Lambertini
  • Giuseppe Biondi Zoccai
  • Fabrizio Clement
  • Alessandro Mauriello
  • Andrea Amato, 36