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Suspicions around surgeon deepen

Published fredag 5 februari kl 19.35
"This is the institution that awards the Nobel Prize in Medicine"
(5:42 min)
Photo: MONTAGE: SVERIGES RADIO.
Photo montage: Swedish Radio

The affair dubbed "the largest research scandal in Swedish history", involving surgeon Paolo Macchiarini's implantation of artificial windpipes, has put Stockholm's Karolinska Institute in the spotlight.

Ulrika Björkstén, head of Swedish Radio’s science department, which has reported extensively on the story, says the affair raises questions about medical ethics and experimental surgery.

Björkstén said the scientific community is reacting strongly because of Karolinska's reputation as a top-tier university hospital and as the sole arbiter of the Nobel Prize in Medicine.

"Swedish scientists are now very worried about this tarnishing the reputation of Swedish science worldwide," said Björkstén.

Macchiarini performed the first artificial windpipe implantation in 2011, a feat that gained the doctor international acclaim. He performed three transplants with artificial windpipes at Karolinska between 2011 and 2014 and five others such surgeries in other countries - four in Krasnodar, Russia and one in Illinois. But patients suffered serious complications. Six of the eight patients later died and one has been in intensive care since 2012.

The Karolinska Institute University Board announced this week that it would not extend surgeon Macchiarini's contract when it expires in November. The hospital board also plans to launch an independent review of his time at the hospital, beginning with his hire as a visiting professor in 2010.

"The University Board deems such an inquiry to be an important part of restoring the confidence of the public, the scientific community, staff and students in the university," says a press release on Karolinska's website.

According to the statement, the inquiry will not consider whether Karolinska "shall conduct research on synthetic trachea or sit in judgement on suspected scientific misconduct". However, it will consider whether any laws were broken in the recruitment of Macchiarini, whether the hospital ensured Macchiarini's activities followed rules for research ethics, and whether allegations of scientific misconduct in 2014 were handled correctly.

The inquiry team will be led by a lawyer and external researchers and will be assembled next week. The press release says the inquiry should be concluded this summer.

The whole affair has put experimental surgery, ethics, and review procedures at the world-renowned Karolinska Institute in the public spotlight.

In the artificial windpipe implantation that Macchiarini performed in 2011, the windpipe used a medical-grade plastic scaffold, which was "seeded" with the patient's own stem cells. Macchiarini had previously performed implantations using the stem cell "seeding" technique using tracheas from donors.

Meanwhile, Macchiarini published papers that made his transplantations seem more successful than they were. In 2014, colleagues at Karolinska filed a complaint at the hospital, citing the discrepancies. The hospital ordered an investigation of the complaint, and Bengt Gerdin, a professor emeritus from Uppsala University, found that the discrepancies between Macchiarini's papers and journal logs were enough to constitute scientific misconduct.

Macchiarini fought the allegations and the Karolinska Institute vice-chancellor Anders Hamsten dismissed the charge in August. But last month, a three-part Swedish Television documentary raised suspicions about Macchiarini’s work again. Among other things, the documentary told the story of a patient in Krasnodar, a 33-year-old woman whose condition was not life-threatening. Her first implant failed. She received a second one in 2013 but then died in 2014. The documentary prompted Karolinska to reopen an inquiry into scientific misconduct, which it announced last week.

Swedish Radio science department head Björkstén said that Macchiarini has responded to emails saying that he is currently traveling, but he also says that he will not answer questions.

In January, Macchiarini published an article in the medical journal The Lancet defending his surgeries at Karolinska, saying he had followed ethical protocol.

Björkstén said that The Lancet, a leading scientific publication that has published Macchiarini's papers, has not seemed to acknowledge the latest suspicions about the doctor.

"The original articles are still found online. There has been no retraction. There is no errata published. In The Lancet, Macchiarini is still presented as somebody who has been unjustly suspected of scientific misconduct, and his articles are still out there for anyone to find who wants to get inspired by them," she said.

For the science department, she said, Macchiarini's story was one of a kind.

"There are stories about leading, internationally-renowned scientists who have been proven to have conducted scientific misconduct, and who have cheated and lied," Björkstén said. "But I have definitely not seen anything to this extent, and I think what also makes it so much worse is that it's in medicine. It's medical research. There are human beings, patients who have suffered, and it looks like, in some instances, been lied to about the probability of success in these kinds of operations."

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