A television documentary raised new questions about Paolo Macchiarini and the synthetic tracheas he implanted into eight patients.

A television documentary raised new questions about Paolo Macchiarini and the synthetic tracheas he implanted into eight patients.

Conan Fitzpatrick/SVT

Karolinska Institute has ‘lost confidence’ in Paolo Macchiarini, says it won't renew his contract

The Karolinska Institute (KI) in Stockholm “has lost its confidence” in surgeon Paolo Macchiarini, a senior researcher at the institute, and will end its ties with him. In a statement issued today, KI said that it won't renew Macchiarini's contract after it expires on 30 November 2016.

The move comes in the wake of a chilling three-part TV documentary about Macchiarini, a former media darling who was cleared of scientific misconduct charges by KI vice-chancellor Anders Hamsten last summer. Among other things, The Experiments, broadcast in January by Swedish public television channel SVT, suggests that Macchiarini didn't fully inform his patients about the risks of his pioneering trachea implants. Most of the patients died, including at least one—a woman treated in Krasnodar, Russia—who was not seriously ill before the surgery.

In an email to Science, KI spokesman Claes Keisu writes that Macchiarini has "overexploited Karolinska [Institute’s] brand in his work in Krasnodar. His activities there have undermined KI’s reputation and damaged the public’s trust in KI." Discrepancies in Macchiarini's CV contributed to the decision as well, Keisu writes.

Macchiarini did not immediately respond to a request for comment on KI's decision. In an email to Science on Tuesday, he wrote that the TV series “was a gross misrepresentation of fact,” and that he couldn’t comment further at the moment. The university's statement says that between now and November, the head of Macchiarini's department will ensure that "Macchiarini uses his working hours to phase out the research he has conducted at KI" and that "the work of his research group is dismantled."

The film has also raised questions about the way Hamsten and other administrators at KI, Sweden's most prestigious university and home of the selection committee for the Nobel Prize in Physiology or Medicine, have handled the scandal. Today, the Institute’s Board decided to launch an independent review, to be led by an experienced lawyer, into KI’s 5-year relationship with Macchiarini. Among the things the inquiry should address is whether any errors were made or laws were broken when Macchiarini was hired; whether misconduct charges against him were handled properly; and why, given the controversy, he was given a new 1-year contract  as a senior researcher after his appointment as a visiting professor at KI ended in October 2015.  

“What has happened is having an impact on the reputation of the Institute,” the board's chairman, Lars Leijonborg, told Science earlier this week. Politicians are worrying about fallout from the affair as well. “I am concerned that it will affect the trust that we have from the public, for Sweden as a prominent research nation, and for the Karolinska Institute,” Sweden's minister for higher education and research, Helene Hellmark Knutsson, tells Science.  

Macchiarini replaced missing or damaged windpipes with an artificial trachea made of a polymer scaffold “seeded” with the patients' own stem cells, which were supposed to grow into living tissue. Between 2011 and 2014, he conducted three such transplants at Karolinska University Hospital, four in cooperation with the Kuban State Medical University in Krasnodar, as part of a formal clinical trial, and one—on a toddler born without a trachea—in Illinois.

In 2014, colleagues at KI alleged that Macchiarini's papers made his transplants seem more successful than they were, omitting serious complications. Two patients treated at Karolinska died, and a third has been in intensive care since receiving a trachea in 2012. The Illinois patient also died, as did three patients in Russia. Bengt Gerdin, a professor emeritus of surgery at Uppsala University in Sweden who investigated the charges at KI's request, concluded in May 2015 that differences between published papers and lab records constituted scientific misconduct. But Hamsten rejected that conclusion in August, based on additional material Macchiarini submitted later.

The documentary shows footage of a patient who says Macchiarini reassured him before the surgery that experiments had been done on pigs, when in fact none had taken place. It also follows the wrenching story of the first patient in Krasnodar. A 33-year-old woman, she was living with a tracheostomy that she said caused her pain, but her condition was not life-threatening. The film suggests that she wasn't fully aware of the risks of the operation, and that Macchiarini and his colleagues knew about problems with the implant before the surgery. The patient's first implant failed, and she received a second one in 2013. She died in 2014.

The fact that a relatively healthy patient underwent Macchiarini's experimental procedure caused consternation in Sweden. “We've seen footage in SVT's documentary that is truly alarming, and I empathise deeply with the patients and their relatives,” Hamsten said in a KI statement issued last week.  “The information that has emerged in the documentaries on the ethical nature of these operations is new to Professor Hamsten,” the university said. The operations, if they occurred as shown in the documentary, would never have been approved at KI, the university says.

However, Macchiarini was open about his plan to include patients who didn't have life-threatening conditions in the Krasnodar trial. At KI, “[w]e were allowed to do this type of transplantation only in extreme cases,” he told Science in 2013. “The clinical study for the first time gives us a chance to include patients who are not in such critical shape.”

The KI's investigation into Macchiarini's CV was triggered by a story in Vanity Fair last month.  That article focused on Macchiarini's past relationship with Benita Alexander, an NBC News producer; among other things, Alexander says Macchiarini convinced her that he had operated on several heads of state and that he would marry her in a ceremony officiated by Pope Francis, in the presence of Barack Obama and Vladimir Putin. The story also claimed Macchiarini had embellished his CV.

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