royal swedish academy sciences
The Royal Swedish Academy of Sciences says the credibility of medical research needs to be repaired.
In the wake of an ever-widening scandal surrounding surgeon Paolo Macchiarini, the vice-chancellor of the Karolinska Institute (KI) in Stockholm has resigned. Anders Hamsten was in charge of an investigation last year into Macchiarini's work at KI. Although an independent investigator commissioned by the university found evidence of misconduct, Hamsten decided in August that Macchiarini had made mistakes but was not guilty of misconduct. KI announced yesterday that it will reopen the investigation.

Macchiarini, a visiting professor at KI from 2010 until October 2015, led surgeries to implant artificial tracheae into several patients between 2011 and 2014. At the time, the operations were hailed as breakthroughs in regenerative medicine, but six of the eight recipients have since died. In 2014, several of Macchiarini's colleagues at KI raised questions about the published descriptions of the technique's success. That eventually led to the misconduct investigation, which concluded in August with Hamsten clearing Macchiarini of the charges. In November, the university gave Macchiarini a new 1-year contract as a senior researcher.

A television documentary, The Experiments, aired on the Swedish public television channel SVT, has brought renewed attention to the case, however. In an opinion piece published early this morning in Swedish newspaper Dagens Nyheter, Hamsten admits that he and others at KI made serious mistakes in their dealings with Macchiarini and that he "completely misjudged" the surgeon. "[I]t seems very likely that my decision in this case was wrong," he writes. "I realise it will be difficult for me to continue working as Vice Chancellor of Sweden's most successful university with credibility and effectiveness."

"The fact that Karolinska Institute's reputation has been tarnished by the 'Macchiarini affair' is extremely serious and is something for which I am obviously responsible," he adds.

Hamsten says that the documentary and subsequent media attention has uncovered new information about the first patient to receive an artificial trachea and subsequent animal studies of the technique. The university is "now endeavouring to investigate this information thoroughly and arrange an independent examination," he writes. "But there is much to indicate that the judgement reached by KI last summer should be amended to scientific misconduct, which in plain language means research fraud."

The whistleblowers who originally raised questions about Macchiarini's work have written, however, that they gave Hamsten all the relevant information in their initial reports in 2014, which detailed why they thought papers published by Macchiarini were incorrect.

A KI statement announcing Hamsten's resignation very late Friday night also said that the misconduct case against Macchiarini will be reopened, without saying who would lead it. On Thursday, the Royal Swedish Academy of Sciences said the inquiry should be transferred from KI to Sweden's Central Ethical Review Board to safeguard its impartiality.

The new misconduct investigation is separate from an independent inquiry, announced on 4 February, into the way the institute has handled its relationship with Macchiarini since 2010. On Tuesday, KI announced that this investigation will be led by Sten Heckscher, a former president and justice of the Supreme Administrative Court of Sweden. He will be assisted by Ingrid Carlberg, a former medical journalist at Dagens Nyheter¸ and Carl Gahmberg, a professor of biochemistry at Helsinki University.

Hamsten's resignation follows that of Urban Lendahl, who stepped down last week from his position as secretary general of the Nobel Assembly, which chooses the winners of the Nobel Prize in Physiology or Medicine. Lendahl was involved in Macchiarini's hiring at KI, and he said he expects to be involved in the investigation into Karolinska's relationship with the surgeon.

KI says that the university's government will appoint a new vice-chancellor based on a proposal from the University Board. Until then, the current pro-vice-chancellor, molecular endocrinologist Karin Dahlman-Wright, will replace Hamsten.