Retraction Watch has obtained copies of a misconduct complaint filed against surgeon Paolo Macchiarini, who is currently under investigation by the Karolinksa Institute in Stockholm for allegedly downplaying dangers of an experimental surgery, along with other misconduct accusations. We’re posting them here to allow researchers and clinicians to review and perhaps comment on them.
In the six articles listed below, the implantation of synthetic tracheal grafts is depicted as a viable treatment option for patients with non-resectable tracheal pathologies and is associated with negligible complications. The three patients who have undergone synthetic tracheal implantation at Karolinska University Hospital have all suffered from serious complications which have not been reported in these six publications. It is our opinion that these six articles neglect to address the morbidity associated with these procedures and omit the majority of complications which these patients have endured. Furthermore, the claim in these six articles that a synthetic trachea transplant can develop into a functional airway is unsubstantiated by the findings in the patients’ medical records. During the analysis of the six articles listed below, we have found that all six articles contain falsified data or that crucial data has been omitted or neglected.
These questions should have been addressed at the time of application for ethical permission to perform medical research on human subjects. However, inquires we have made to the Regional Ethical Review Board have revealed that no such application has been applied for or approved. Had such an application been filed, then it is questionable if ethical permission would have been granted because of the lack of evidence in a large animal model. Furthermore, the tracheal transplant procedures cannot be considered to be examples of immediate or compassionate use since all three patients were operated electively and the procedures were planned months in advance.
As supporting evidence, the four doctors also produced an analysis of six of Macchiarini’s papers. Each one lists inconsistencies and inaccuracies, including:
- Inquires have been unable to identify any application for synthetic tracheal transplantation filed at the Regional Ethical Review Board.
Unapproved informed consent form signed 17 days after the transplantation.
Serial fabrication and omission of biopsy findings.
Serial fabrication and omission of bronchoscopic findings.
Fabrication and omission of clinical status.
The documents also include de-identified medical histories of patients who underwent the procedure, along with papers drawn from those cases, and other such cases and papers, all of which refer to the original complaint.
When Nature spoke to Macchiarini last month about these allegations, he declined to comment on most issues but did speak up regarding the accusation that only one patient of three signed an informed consent form, and that was dated 17 days after the procedure. From Nature:
“Of course there was consent. We would never have proceeded with the transplants if there wasn’t.” He adds: “I do not know why the form is dated 17 days after the procedure and can only assume it is some kind of clerical issue.” The patient “signed it in my presence, prior to the operation”. He adds that “there was absolutely no ethical breach”.
The rest of the documents obtained by Retraction Watch include: