BMJ 2016;352:i837 doi: 10.1136/bmj.i837 (Published 12 February 2016)

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NEWS Nobel official resigns in wake of storm over Italian surgeon Nigel Hawkes London

The secretary general of the Nobel Assembly, Urban Lendahl, has resigned from his position because he could be involved in a new investigation1 into Paolo Macchiarini, a prominent surgeon whose recruitment by the Karolinska Institute in Stockholm, Sweden, he had supported.

The Nobel Assembly had nothing to do with Macchiarini’s appointment, but Lendahl stood down “out of respect for the integrity of the Nobel Prize work,” said a statement to the press.2 Macchiarini, born in Switzerland to Italian parents, has operated in many European countries during a high profile career and became a visiting professor at Karolinska in 2010. There he carried out several tracheal transplants using a synthetic windpipe made of a polymer material, the first such operations ever conducted. His claims of success were contested, and a previous investigation found evidence of scientific misconduct in seven papers.

Bengt Gerdin, of Uppsala University, who carried out the investigation, found that Macchiarini had claimed positive outcomes that did not match the medical records of three patients who had undergone the procedure. He said that Macchiarini had “dressed up the results”—in one case describing minor postoperative problems while omitting to mention serious problems that had led to a patient’s death—and that this amounted to misconduct. Macchiarini responded to the findings by saying that Gerdin did not have access to all relevant patient records and claiming that he had been subjected to “a potentially disastrous miscarriage of justice.”3 The Karolinska vice chancellor, Anders Hamsten, ruled that Macchiarini had acted “without due care” but that his behaviour did not amount to scientific misconduct. He was instructed to provide errata to the journals that had published the articles, but, if the institute hoped that this would lay the issue to rest, it was mistaken.

In January a long feature article in the magazine Vanity Fair4 made a series of claims about Macchiarini’s history, finding evidence that his curriculum vitae might have been exaggerated, as well as claims about his private life. A television documentary, The Experiments, broadcast in Sweden in January, also raised more significant professional issues, prompting the institute first to undertake that Macchiarini’s contract will not be renewed when it ends in November and then to announce the new investigation, led by a lawyer. The investigation will aim to discover whether due diligence was employed over Macchiarini’s recruitment; whether his For personal use only: See rights and reprints http://www.bmj.com/permissions

research was conducted in a proper manner and correctly documented; whether anything, or enough, was done to ensure that his extramural activities complied with the institute’s scientific and ethical requirements; whether the allegations of misconduct were properly handled; and why his contract of employment was extended in 2015 despite “the obvious doubts” about his activities. The fallout from this new investigation could be extensive, and not only in Sweden. Macchiarini has operated in France, Germany, Italy, Russia, Spain, and the United Kingdom and has been widely taken at his own estimation as a surgical superstar. The Lancet published a laudatory profile in 2012, in which Macchiarini quoted TS Eliot: “Only those who risk going too far can possibly find out how far one can go.”5 The Swedish documentary gave public voice to complaints made by four Karolinska doctors who had first raised doubts about Macchiarini. They claimed that they had had great difficulties in getting their concerns, which related to patient care and the way Macchiarini had reported clinical outcomes of patients he had operated on at Karolinska, taken seriously by the institute’s board and by Hamsten. They said, “After [a] first meeting at least nine attempts on our part were initiated to bring attention to these circumstances and implement a moratorium and an investigation to prevent further patients from being put in what seemed to be life threatening danger.”Error! Hyperlink reference not valid. The Karolinska argues that the documentary raised fresh issues of which it was previously unaware, including a series of operations Macchiarini conducted in Russia, which Hamsten described as “truly alarming” and “wholly irreconcilable with the Karolinska’s values and what we expect of our employees.”

The documentary showed cases in Russia whose severity did not seem to warrant the use of an experimental technique, and it suggested that patients were not fully informed of the risks. A spokesman for the institute told the journal Science that Macchiarini had overexploited the Karolinska brand in his work in Russia and that his work there had undermined the institute’s reputation and damaged the public’s trust in it. Macchiarini told Science that the documentary was “a gross misrepresentation of fact.”

Macchiarini has responded to the criticisms by denying that he would ever fabricate results and accusing his critics of breaching the confidentiality of his patients by publishing information about them. “I have never, and would never plagiarise, fabricate Subscribe: http://www.bmj.com/subscribe

BMJ 2016;352:i837 doi: 10.1136/bmj.i837 (Published 12 February 2016)

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NEWS

or withhold data, or misrepresent results—nor would I stand by and see others do so,” he wrote in a guest post on the website Retraction Watch. He did not respond to repeated requests for comment from Vanity Fair, the magazine reported. In its announcement of the new investigation, the Karolinska board said that it had full confidence in Hamsten and urged him to remain in office until it is complete. “Whether the outcome of the investigation will lead the board to change its stance in this respect is not a matter for speculation at present,” it said.

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Karolinska Institutet. Press release: the board initiates external investigation. 5 Feb 2016. http://ki.se/en/news/the-board-initiates-external-investigation. Karolinska Institutet. Press release: message from the chairman of the Nobel Assembly. Feb 2016. www.nobelprizemedicine.org/4696-2/. (In Swedish and English.) Error! Hyperlink reference not valid.Vogel G. Artificial trachea researcher responds to misconduct report. Science 2015 Jun 26. www.sciencemag.org/news/2015/06/artificialtrachea-researcher-responds-misconduct-report. Ciralsky A. The celebrity surgeon who used love, money and the pope to scam an NBC news producer. Vanity Fair 2016 Feb. www.vanityfair.com/news/2016/01/celebrity-surgeonnbc-news-producer-scam. Holmes D. Paolo Macchiarini: crossing frontiers. Lancet 2012;379:886. www.thelancet. com/journals/lancet/article/PIIS0140-6736%2812%2960382-1/fulltext.

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Nobel official resigns in wake of storm over Italian surgeon.

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