News

Italian police arrest nine cardiologists

BMJ 2012; 345 doi: http://dx.doi.org/10.1136/bmj.e7698 (Published 13 November 2012) Cite this as: BMJ 2012;345:e7698
  1. Michael Day
  1. 1Milan

Nine cardiologists have been arrested in Italy over allegations of scores of unauthorised clinical experiments in which at least two people are believed to have died.

The nine, who work or have worked at the Policlinico di Modena hospital, are also suspected of fraud, embezzlement, and falsifying public documents, said a statement from the Modena public prosecutor’s office.

The arrests were made on Friday morning. There were also 33 raids on offices and other premises, in an operation involving 150 police.

In a television interview Antonio Diomede, the vice captain of the health investigation department of Parma’s carabinieri (police), said, “This was a very important operation. Medical experiments were conducted on people without authorisation, and defective equipment was used on the patients, who were unaware they were part of a clinical experiment.”

He added that medical records had subsequently been falsified to conceal the illicit activity.

In a later press conference it emerged that the nine doctors are thought to have been involved in tests of unapproved medical devices, some of which were subsequently found to be defective. The tests were seemingly conducted without the approval of the relevant ethics board.

According to La Repubblica newspaper, 66 such studies were carried out, and it reported that at least two deaths have been linked to the tests. Calls by the BMJ to the Modena prosecutor’s office to confirm these figures had not been returned as the BMJ went to press.

The arrested cardiologists include Giuseppe Sangiorgi, who was until 2011 the director of the hospital’s haemodynamics laboratory. He was detained, while the other eight, including the former head of cardiology at the hospital, Maria Grazia Modena, were placed under house arrest. Some are currently employed in hospitals in Rome, Bergamo, and Mantua.

By Sunday morning transcripts from incriminating wire taps in which doctors were allegedly heard talking about making lots of “under the table money” from clinical trials and “secretly” taking patients’ urine samples began to emerge in the press.

Prosecutors have also applied for 12 cardiology equipment manufacturers to be banned from supplying the Italian health service.

The investigation was prompted by a complaint from a patients’ group, Amici del Cuore (Friends of the Heart). Four months before magistrates began their probe in 2011 the group’s president, Gianni Spinella, needed emergency open heart surgery after undergoing a routine coronary investigation by Giuseppe Sangiorgi in Modena’s haemodynamics department.

“There’s no condemnation on our part, because the judiciary has yet to decide what happened. But these are very serious accusations. It’s dreadful,” Spinella told the local newspaper Gazzetta di Modena.

Notes

Cite this as: BMJ 2012;345:e7698