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The Royal Swedish Academy of Sciences says the credibility of medical research needs to be repaired.

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Swedish academy seeks to stem 'crisis of confidence' in wake of Macchiarini scandal

Anxiety is mounting that the credibility of Swedish science is at stake in the wake of a scandal at the Karolinska Institute (KI) involving surgeon Paolo Macchiarini. The Royal Swedish Academy of Science weighed in on the affair today with a strongly worded demand for a new, fully independent investigation. The academy also wants a Lancet paper by Macchiarini corrected, and it announced a new panel to examine the difficult issues arising from medical studies on very sick patients.

"The decision reflects the fact that the entire Swedish scientific community does not want to sit at rinkside waiting to see what happens," says Bengt Gerdin, a professor emeritus of surgery at Uppsala University who investigated Macchiarini's case last year and concluded that he was guilty of scientific misconduct. Gerdin's conclusions were later dismissed by KI.

The Macchiarini affair was rekindled last month by The Experiments, a troubling three-part documentary on Swedish television that suggested that the Italian surgeon, widely regarded as brilliant, did not fully inform his patients—some of whom had non–life-threatening conditions—of the grave risks of his pioneering trachea implants, and that he misrepresented their condition in his scientific publications. "A number of shortcomings and ethically indefensible working methods have been uncovered, leading to a crisis of confidence in Swedish medical research," the academy says today.

Although it doesn't discuss KI's role directly, the statement appears to be an indictment of how the renowned institute, which picks winners of the medicine Nobel, has handled the affair. A week ago, KI's board announced that it would appoint a new investigation panel; the academy, however, says the inquiry should be transferred to Sweden's Central Ethical Review Board, a national panel for studies on human subjects. "It is of the greatest importance that the case is decided in an impartial manner that gains general acceptance and repairs the credibility of medical research," the statement says.

The decision reflects the fact that the entire Swedish scientific community does not want to sit at rinkside waiting to see what happens.

Bengt Gerdin

Gerdin applauds the decision. The task of the panel set up by KI, he says, is "quite vague with respect to the depth with which it is expected to go into the fraud issue. This reflects, at least in my mind, that KI does not want a thorough penetration of this issue again."

The academy also finds it "deeply unfortunate" that Macchiarini's paper about the first artificial trachea implant, published in The Lancet in 2011, still sits on that journal’s website, unchanged. In his report, Gerdin concluded that the paper, along with several others published by Macchiarini, misrepresented the clinical condition of patients who had received his artificial tracheas, and concluded that this constituted scientific misconduct. KI Vice-Chancellor Anders Hamsten cleared Macchiarini of misconduct charges a few months later, based on additional information Macchiarini had provided. The patient in the first paper, an Eritrean man living in Iceland, had severe complications and died in 2014. The Academy now "demands that a supplement is added to the journal, accounting for the further events, the complications and the patient’s death."

One of Macchiarini's leading critics, Pierre Delaere of the University of Leuven in Belgium, says he's "satisfied" by the academy's initiative. "With the right approach, we will be able to draw lessons that can benefit the entire scientific community," he says. Delaere had long been convinced that Macchiarini's implants could not work; in the documentary, he said he would rather be executed by a firing squad then receive a trachea implant. But KI's ethics council dismissed a complaint by Delaere last year, arguing that his issues were of a “philosophy-of-science kind rather than of a research-ethical kind.”

Last fall, the academy appointed a review panel, chaired by molecular cell biologist Dan Larhammar of Uppsala University in Sweden, to provide guidance on how to handle misconduct cases. Now, the academy says it is establishing a separate committee, led by stem cell scientist Olle Lindvall of Lund University in Sweden, to propose recommendations for clinicians and scientists working at the intersection between clinical research and medical care. The Macchiarini case shows that this boundary "needs be clearer, and that the regulations governing the use of new treatment methods on seriously ill patients are sometimes not respected," the academy says.

Many others in Sweden have expressed worries about the credibility of the country's research and its apparent inability to police itself. “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, told Science last week. Urban Lendahl, secretary general of the Nobel Assembly, resigned from that role on 7 February to prevent his involvement in the Macchiarini investigation from tarnishing the world's most prestigious scientific award.

*Update, 11 February, 4.00 p.m.: This story has been updated to include comments by Bengt Gerdin.