An investigation has concluded that surgeon Paolo Macchiarini, famous for transplanting tissue-engineered tracheae into more than a dozen people, committed scientific misconduct. The Karolinska Institute in Sweden, where Macchiarini is a visiting professor, commissioned the external investigation in response to allegations brought by four researchers at the institute and the affiliated Karolinska University Hospital in Stockholm, where several of the transplants were performed.
The external investigator, Bengt Gerdin, professor emeritus of surgery at Uppsala University, submitted his report (in Swedish) on 13 May. (The newspaper Svenska Dagbladet first reported the findings yesterday.)
The allegations leveled by the Karolinska researchers involved three surgeries performed at Karolinska for people who had a damaged trachea. One patient, described in a paper in The Lancet, survived for 2 years after receiving the artificial trachea, which incorporated human stem cells. Another patient survived for just 2 months. A third is still alive, but has been in intensive care at Karolinska since the surgery in August 2012.
Gerdin told ScienceInsider that, according to Swedish law’s relatively narrow definition of research misconduct, his primary task was to compare the data presented in six papers describing the technique with lab and patient records at the institute and its hospital. “There were data in the papers that could not be found in the medical records,” he says. The number of mismatches, Gerdin says, led him to conclude that there was “a systemic misrepresentation of the truth that lead the reader to have a completely false impression of the success of the technique.” Such a misrepresentation constitutes serious misconduct, he says.
ScienceInsider was not able to reach Macchiarini. He told Retraction Watch that he could not comment until he had seen an English translation of the report.
The physicians who reported Macchiarini also alleged that he did not get proper authorization for the surgeries and failed to get informed consent from the patients. Such issues fall under Swedish health care law rather than scientific misconduct regulations, Gerdin says, so his report did not pass judgment on those allegations. “I have listed the issues that I have found in a way that other authorities can pick up that thread,” he says. The Swedish Medical Products Agency has referred the case to a prosecutor, he says. (The Svenska Dagbladet newspaper reported on 7 May that the agency had begun an investigation.)
A separate investigation by Karolinska’s ethics council into allegations of misconduct brought by Pierre Delaere, a surgeon at UZ Leuven in Belgium, had cleared Macchiarini of wrongdoing.
Karolinska Institute spokesperson Claes Keisu says that the institute is working on an English translation of Gerdin’s report, which should be available next week. Macchiarini and other parties will then have 2 weeks to comment on the findings. Karolinska’s vice-chancellor will then decide what action to take, Keisu says. He says a decision is expected in mid- or late June.