The decision by KI’s vice chancellor will be followed by a request to retract the paper, published by the journal Respiration.
In the paper, the researchers described the case of a man with an acute lung disorder, in which he received an experimental treatment involving the use of his own blood-derived cells and the drug erythropoietin, which stimulates the production of red blood cells. The patient “demonstrated an immediate, albeit temporary, clinical improvement,” according to the authors. However, he ultimately died of multisystem organ failure.
Among the 26 co-authors on the paper, KI declared that last author Macchiarini, first author Philipp Jungebluth, and two middle authors had committed misconduct over the course of this project. The KI release, issued yesterday, did not specify the nature of the misdeeds.
“Autologous Peripheral Blood Mononuclear Cells as Treatment in Refractory Acute Respiratory Distress Syndrome” has been cited twice since it was published in 2015, according to Clarivate Analytics’ Web of Science.
KI has investigated Macchiarini before. Although in 2015 the university initially decided he had not committed misconduct, the following year, it reopened its investigation. He was dismissed from KI in March 2016. Months later, KI declared Macchiarini and three co-authors committed misconduct in a 2014 paper published by Nature Communications, which was eventually retracted. (For more on this ever-updating story, see our timeline.)
Jungebluth was among the three co-authors flagged in the probe into the 2014 Nature Communications paper. The other two authors, Sebastian Sjöqvist and Mei Ling Lim, were listed as co-authors on the 2015 Respiration paper, as well, but yesterday’s announcement identified the other two responsible authors as Bernhard Holzgraefe and Håkan Kalzén.
Professor Anders Ekbom, acting pro-vice chancellor at KI, told Retraction Watch this is the first time the institute has investigated this paper, and each of the 26 co-authors was investigated individually. According to yesterday’s release:
None of the researchers who have been found guilty of scientific misconduct are employed by Karolinska Institutet and therefore they will not be subject to any disciplinary measures under employment legislation.
Although Kalzén has a page associated with KI, Ekbom explained he is affiliated with KI as a graduate student, but “he has never been employed, he is employed by the Karolinska University Hospital.”
Yesterday’s announcement concludes:
A decision is expected from the Vice-Chancellor in the spring regarding scientific misconduct relating to six articles of which Paolo Macchiarini was the main author. These include an article published in The Lancet describing the transplantation of a synthetic prosthesis into human trachea.
In October, the Expert Group on Scientific Misconduct at Sweden’s Central Ethical Review Board recommended retracting six papers co-authored by Macchiarini, including The Lancet paper; the Respiration paper was not on that list.
Update Feb 1 2018 13:25 UTC: We asked KI about the nature of the misconduct in the paper; a spokesperson told us:
The research lacked any biological hypothesis based on either in vitro or in vivo (animal) data. This contravenes articles 14, 16, 17 and 21 of the 2013 Declaration of Helsinki (articles 31, 21, 18 and 12 of the 2008 version). There was also no approval in place from the Regional Ethical Review Board for the clinical treatment.
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