Cardiologists Arrested: Human Experimentation

http://www.forbes.com/sites/larryhusten/2012/11/11/nine-italian-cardiologists-arrested-in-broad-investigation-of-research-fraud-and-misconduct/

Larry Husten, Contributor

A medical journalist covering cardiology news.

PHARMA & HEALTHCARE | 11/11/2012 @ 7:59PM  (FiDA highlight)

NineItalian CardiologistsArrested In BroadInvestigation Of Research Fraud And Misconduct

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 clinicaltrials. 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