Following an investigation, Karolinska Institutet has found that surgeon and visiting professor Paolo Macchiarini acted in some cases “without due care,” but that his behavior “does not qualify as scientific misconduct.”
Karolinska’s Vice Chancellor has also recommended that Macchiarini submit an unspecified number of corrections “to clarify and rectify the failings that the inquiry has brought to light.”
Macchiarini is most well-known for pioneering the creation of tracheas from cadavers and patients’ own stem cells. However, the glow of his success was diminished somewhat after four Karolinska surgeons filed a complaint, alleging Macchiarini had downplayed the risks of the procedure and not obtained proper consent, among other accusations.
An external review by Bengt Gerdin of Uppsala University concluded in May that Macchiarini had committed misconduct in seven papers. All co-authors on the papers had two weeks to respond, after which the vice-chancellor would reach an official decision.
That decision, announced today during a press conference (and summarized in a press release from Karolinska), was that
…while on some points Visiting Professor Paolo Macchiarini did act without due care, it does not qualify as scientific misconduct.
Vice chancellor Anders Hamsten said in a statement:
Now that we have examined the allegations of scientific misconduct in all seven indicted articles, we have found that they contain certain flaws but nothing that can be considered scientific misconduct.
Hamsten said Gerdin’s
…examination was extremely valuable for the inquiry, but the documents to which he had access lacked significant data on the pre- and postoperative status of two of the patients. The comments sent in by Professor Macchiarini and his co-authors have had a significant influence on how the case has been assessed. Now that we have all the relevant material on hand, we have a much clearer picture of what happened.
As the Karolinska statement notes, Macchiarini’s accusers
pointed out that the results concerning the patients’ clinical progress as expressed in the papers did not match the patients’ medical records as kept at Karolinska University Hospital, and that there was no evidence that a synthetic tracheal transplant can develop into a functional airway. They also questioned the claim that the first patient had suffered a relapse of his tracheal cancer and that surgery was therefore necessary.
The four doctors also
criticised Professor Macchiarini for not having obtained a permit from the regional Ethical Review Board and the Swedish Medical Products Agency before the operation. However, Karolinska Institutet did not examine this issue in its inquiry since the Swedish Research Council’s definition of scientific misconduct does not cover breaches of the Ethical Review Act and the Medicinal Products Act.
At the same time, Karolinska Institutet concluded that a decision to perform the three operations was taken by the hospital.
“Karolinska University Hospital made the decision to operate following a transparent process and in what it saw as the absence of alternative therapeutic solutions,” says Professor Hamsten. “These decisions did not address research aspects.”
Karolinska did identify some issues:
The inquiry shows that the interaction between Karolinska Institutet and Karolinska University Hospital has not functioned satisfactorily, and the Vice-Chancellor’s decision promises improvements to procedures, regulations and support structures for clinical trials and clinical therapy research. The line between clinical application and research when it comes to experimental therapy will need to be better defined, and clearer guidelines for academic research and academic healthcare will be drafted.
Professor Macchiarini has also been instructed to submit errata to the journals that published some of the scientific papers to clarify and rectify the failings that the inquiry has brought to light.
“Some aspects of Paolo Macchiarini’s research do not meet our high quality standards,” says Professor Hamsten. “We will now be remedying the deficiencies our inquiry uncovered with him, the heads of his department and representatives from Karolinska University Hospit
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