Allegations raised by a Swedish television documentary may prompt the Karolinska Institute to reopen a misconduct investigation involving surgeon and tissue engineering pioneer Paolo Macchiarini.

Allegations raised by a Swedish television documentary may prompt the Karolinska Institute to reopen a misconduct investigation involving surgeon and tissue engineering pioneer Paolo Macchiarini.

Conan Fitzpatrick/SVT

Karolinska Institute may reopen ethics inquiry into work of pioneering surgeon

A documentary on Swedish Television (SVT) has prompted the Karolinska Institute (KI) in Stockholm to consider reopening its investigation into possible misconduct by surgeon Paolo Macchiarini. After an investigation last year into Macchiarini’s work at KI, where he performed experimental trachea surgery on three patients, Vice-Chancellor Anders Hamsten concluded that the surgeon had not committed misconduct, although some of his work did “not meet the university’s high quality standards in every respect.” But the documentary has raised new concerns by suggesting that Macchiarini misled patients.

Macchiarini’s work focused on developing tissue-engineered tracheas to replace those damaged by injury or illness. He and his colleagues developed polymer scaffolds seeded with the patients’ own stem cells that were supposed to grow into living tissue to replace a damaged or missing trachea. He conducted three transplants at KI and its associated hospitals.

In 2014, colleagues at KI raised questions about whether Macchiarini’s papers describing successful outcomes were accurate, as several patients fared poorly and two of the three treated at KI died. The university asked an independent investigator to assess the charges. The investigator, Bengt Gerdin, a professor emeritus of surgery at Uppsala University in Sweden, concluded that differences between published papers and lab records were serious enough to constitute scientific misconduct. But a few months later, KI Vice-Chancellor Anders Hamsten concluded that Macchiraini had not committed misconduct. Additional material Macchiarini submitted after Gerdin’s report was published had convincingly countered Gerdin’s conclusions, Hamsten said at the time.

The documentary, a three-part series aired this month on Swedish television, presents evidence that before the surgeries, Macchiarini reassured patients by telling them that animal experiments had been successful when none had taken place. It also follows the story of a woman who received an engineered trachea as part of a clinical trial Macchiarini was conducting in Krasnodar, Russia. Her trachea had been damaged in an accident, but the injury was not life-threatening and she was relatively healthy before receiving the transplant. She did not survive.

“We’ve seen footage in SVT’s documentary that is truly alarming, and I empathise deeply with the patients and their relatives,” Hamsten says in a statement KI issued yesterday. “Although the university management knew that he had operated and researched [in Krasnodar], the information that has emerged in the documentaries on the ethical nature of these operations is new to Professor Hamsten,” the statement says. “[G]iven the way Macchiarini’s activities in Russia have been described in the documentary, they would never have been approved.” (Macchiarini told Science in April 2015 that the clinical trial in Russia had been put on hold.)

KI said in its statement that it will also look into allegations raised in an article in Vanity Fair published earlier this month. That story claimed that Macchiarini included false information on his CV when KI recruited him in 2010.